IFS PACsecure

Standard for auditing quality and safety of packaging materials

Version 1 October 2012

IFS publishes information, opinions and bulletins to its best knowledge, but cannot take any responsibility for any mistakes, omissions or possibly misleading information in its publications, especially in this document. The Standard owner of the present document is: IFS Management GmbH Am Weidendamm 1A 10117 Berlin Germany Managing Director: Stephan Tromp AG Charlottenburg HRB 136333 B VAT-N: DE278799213 Bank: Bank code number: Account number: IBAN number: BIC-/Swift-Code: Berliner Sparkasse 100 500 00 190 029 765 DE96 1005 0000 0190 02 97 65 BE LA DE BE

All rights reserved. All publications are protected under international copyright laws. Without the expressed written consent of the IFS Standard owner any kind of unauthorised use is prohibited and subject to legal action.This also applies to the reproduction with a photocopier, the inclusion into an electronic database/software, or the reproduction on CD-Rom. No translation may be made without official permission by the IFS Standard owner. The IFS PACsecure is available online via: www.ifs-certification.com Or by Mail, Fax and E-mail: IFS Management GmbH Am Weidendamm 1A 10117 Berlin Germany Phone: +49-(0) 30-72 62 50-74 Fax: +49-(0) 30-72 62 50-79 E-mail: [email protected]

IFS PACsecure
Standard for auditing quality and safety of packaging materials

Version 1 October 2012

International Featured Standards IFS PACsecure Version 1

ACKNOWLEDGEMENTS IFS is pleased to acknowledge the essential support provided by the following experts:
James D Downham Larry Dworkin Larry Shortt Thomas Maiwald Dr. Andrea NiemannHaberhausen President & CEO of PAC,The Packaging Association of Canada PAC, The Packaging Association of Canada L & G Shortt Solutions Limited, Canada real,- SB-Warenhaus GmbH, Germany Det Norske Veritas, Germany

IFS likes to thank all all companies who contributed in the development of the PACsecure Standard, which is the basis for the IFS PACsecure Standard:
Acorn Packaging Agriculture and Agrifood Canada Agropur Division Natrel Alcan Packaging Alte-Rego Atlantic Packaging Ball Packaging Products Bericap Bothwell Cheese Brewers Association of Canada Bright Cheese House,The Cadbury Adams Canada Canadian Corrugated Case Association Canadian Council of Grocery Distributors Canadian Food Inspection Agency Canadian General Standards Board Canadian Plastics Industry Association CanAmera Foods Canbra Foods Limited Central Graphics Chantler Packaging Ciom/Novacote Coca-Cola Cousins Currie Crown Packaging Dainty Foods Dare Foods Ellis Packaging FoodCon GayLea Foods General Mills Canada Graham Packaging Graphic Packaging Guelph FoodTechnology Centre Health Canada High Liner Foods Ian Britt and Associates JM Smucker Jones Packaging Kraft Canada Kraft Foods Global Labelad Langen Packaging Loblaw Brands Maple Leaf Consumer Foods Maple Lodge Farms McCain Foods MultiPak Minute Maid Company Canada,The Nestle Canada Norampac Owens-Illinois Glass Containers Old Dutch Foods Ontario Ministry of Agriculture and Food Packaging Association of Canada Packall Parmalat Canada Peel Plastics Products Plasticap Polytainers Primex Packaging Services R.A. Miller & Co. Reinhart Foods Richards Packaging Robinhood Multifoods Ropak Sandler Consulting Saputo Bakery Division Saxco Canada Scott Paper Limited Silgan Plastics Smucker Foods of Canada Smurfit MBI Sobeys Sonoco Specialty Paper Tetra Pak Canada The Packaging Group TWDTechnologies W.G. Pro Manufacturing WC Parchment WG Corporate WinPakTechnologies

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IFS is grateful to the members of the IFS International Technical Committee and the associated national working groups in France, Germany, Italy and United States. The IFS PACsecure Standard is the result of the international partnership between IFS and the Packaging Association of Canada.

Members of the IFS International Technical Committee

Andrea Artoni Sabrina Bianchini Yvan Chamielec Fayal Bellatif Roberta Denatale/ Eleonora Pistochini Gerald Erbach Jean-Franois Feillet Ccile Gillard-Kaplan Almudena Hernandez Luc Horemans Dr. Horst Lang Joachim Mehnert Patricia Menendez/ Maria Lpez de Montenegro Dr. Angela Moritz Alberto Peir Bizhan Pourkomailian Horst Roeser Nuria Sanz Levia Sergio Stagni Stephen Thome Dr. Bert Urlings Karin Vo Roman Winer Stefano Zardetto CONAD, on behalf of ANCD (Associazone Nazionale Cooperative tra Dettaglianti), Italy Det Norske Veritas, Italy EMC Distribution Groupe Casino, France Eurofins certification, France Auchan, on behalf of Federdistribuzione, Italy METRO AG, Germany Meralliance, France Groupe Carrefour, France AENOR, Spain Scamark Groupement Leclerc, France Globus SB-Warenhaus Holding GmbH & Co. KG, Germany DQS, Germany Dia Group, Spain REWE Group; REWE-Zentral-AG, Germany Mercadona, Spain Mc Donalds Europe, United Kingdom COOP , Switzerland El Corte Ingles, Spain COOP , on behalf of ANCC (Associazone Nazionale Cooperative Consumatori), Italy Dawn Food Products, USA Vion Food, The Netherlands EDEKA Zentrale AG & Co. KG, Germany HARIBO GmbH & Co. KG, Germany Voltan, Italy

IFS Team
George Gansner Dr. Helga Hippe Seon Kim Christin Kluge Nina Lehmann Stphanie Lemaitre Lucie Leroy Clemens Mahnecke Marek Marzec Caroline Nowak Ksenia Otto Sabine Podewski Maria Thalmann Serena Venturi Stephan Tromp Marketing/Business Development Director Quality Assurance Management Director Shop Manager Quality Assurance Project Manager Project Manager Academy/Marketing/Communications Technical Director Project Manager Technical Project Manager Business Consultant Central/Eastern Europe Representative, South America Office Manager Project Manager Auditor Approval/Examination Project Manager Project Manager Managing Director

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Table of contents
Part 1: Audit Protocol
1 2 2.1 2.2 2.3 3 3.1 3.2 3.3 3.4 4 5 5.1 5.2 5.3 5.4 5.5 5.5.1 5.5.2 5.5.2.1 5.5.2.2 5.5.3 5.6 5.7 5.7.1 5.7.2 5.7.2.1 The history of International Featured Standards and IFS PACsecure Standard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Purpose and contents of the audit protocol . . . . . . . . . . . . . . . Extraordinary information to the certification body by the certified company . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . General requirements for the quality and product safety management system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Types of audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Initial audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Follow-up audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Renewal audit (for recertification) . . . . . . . . . . . . . . . . . . . . . . . . Extension audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Scope of the audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The certification process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preparation of an audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Certification body selection contractual arrangements . . Duration of an audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Drawing up an audit time schedule . . . . . . . . . . . . . . . . . . . . . . Evaluation of requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Scoring a requirement as a deviation . . . . . . . . . . . . . . . . . . . . Scoring a requirement as a non-conformity . . . . . . . . . . . . . . Major . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . KO (Knock out) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Scoring a requirement with N/A (not applicable) . . . . . . . . . Determination of the audit frequency . . . . . . . . . . . . . . . . . . . . 11 12 12 13 13 14 14 14 14 15 16 18 18 18 19 20 21 21 22 22 23 24 24 24 24 25 25 26 27 27

Audit report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Structure of the audit report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The different steps for the audit report . . . . . . . . . . . . . . . . . . . Drawing up the pre-report of the audit and the outline of the action plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.7.2.2 Companys completion of the corrective action plan . . . . . . 5.7.2.3 Auditor validation of the action plan . . . . . . . . . . . . . . . . . . . . . 5.7.3 Further rules about the audit report . . . . . . . . . . . . . . . . . . . . . .

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5.7.3.1 Link between two consecutive audit reports (initial and renewal audits) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.8 5.8.1 5.8.2 5.8.3 5.8.4 6 6.1 6.2 6.3 7 8 9 10 11 12 12.1 12.2 12.3 Scoring and conditions for issuing audit report and certificate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Specific management of the audit process in case one or several KOs has/have been scored with D during the audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Specific management of the audit process in case one or several Major non-conformity(ies) has/have been issued . Specific management of the audit process in case the final score is < 75 % . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Specific management of the audit process in case of multi-site companies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Awarding the certificate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Deadlines for awarding certificate . . . . . . . . . . . . . . . . . . . . . . . . Certification cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Information about conditions of withdrawal of certificate . Distribution and storage of the audit report . . . . . . . . . . . . . . Supplementary action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appeal and complaints procedure . . . . . . . . . . . . . . . . . . . . . . . Ownership and usage of the IFS PACsecure logo . . . . . . . . . Review of the Standard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IFS Integrity Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preventive quality assurance actions . . . . . . . . . . . . . . . . . . . . . Quality assurance actions after complaint notification . . . . Sanctions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

27 28 29 29 31 31 31 32 32 33 34 34 34 35 37 37 37 38 38

ANNEX 1 Clarification for the scope application of the different IFS Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ANNEX 2 Certification process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ANNEX 3 Product scopes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ANNEX 4 Flow chart for management of KO scored with D and Major non-conformities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

40 42 43

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Part 2: List of audit requirements

1 1.1 1.2 1.3 1.4 2 2.1 2.1.1 2.1.2 2.2 2.2.1 2.2.2 2.2.3 3 3.1 3.2 3.2.1 3.2.2 3.2.3 3.3 3.4 4 4.1 4.2 4.2.1 4.2.2 4.3 4.4 4.4.1 4.4.2 4.5 4.6 4.7 4.8 4.9 4.9.1 4.9.2 Senior Management Responsibility . . . . . . . . . . . . . . . . . . . . . . Corporate policy/Corporate principles . . . . . . . . . . . . . . . . . . . Corporate structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Customer focus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Management review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Quality management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Documentation requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . Record keeping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Packaging Material Safety Management . . . . . . . . . . . . . . . . . Hazard analysis and risk assessment system . . . . . . . . . . . . . Hazard analysis and/or risk assessment team . . . . . . . . . . . . Hazard analysis and risk assessment . . . . . . . . . . . . . . . . . . . . Resource Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Human resources management . . . . . . . . . . . . . . . . . . . . . . . . . . Human resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Personnel hygiene . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Working conditions and protective clothing for personnel, contractors and visitors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Procedures applicable to infectious diseases . . . . . . . . . . . . . Training and instruction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Sanitary facilities, equipment for personnel hygiene and staff facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Planning and Production Process . . . . . . . . . . . . . . . . . . . . . . . . Contract agreement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Specifications and formulas/configurations . . . . . . . . . . . . . . Specifications and other legally required documentation . Formula/configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Product development/Product modification/Modification of production processes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Purchasing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . General purchasing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Trade of packaging materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . Product wrapping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Factory location . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Factory Exterior . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Plant layout and process flows . . . . . . . . . . . . . . . . . . . . . . . . . . . Constructional requirements for production and storage areas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Constructional requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Walls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 46 47 49 50 52 52 53 55 55 56 57 60 60 61 61 62 64 64 65 67 67 68 68 69 69 71 71 73 74 75 75 76 77 77 77

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4.9.3 4.9.4 4.9.5 4.9.6 4.9.7 4.9.8 4.9.9 4.9.10 4.10 4.11 4.12 4.13 4.14 4.15 4.16 4.17 4.18 4.19 5 5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8 5.9 5.10 5.11 6 6.1 6.2 6.3 6.4

Floors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ceilings/Overheads . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Windows and other openings . . . . . . . . . . . . . . . . . . . . . . . . . . . . Doors and gates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Lighting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Air conditioning/Ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Water supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Compressed air . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Cleaning and disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Waste disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Risk of foreign material, metal, broken glass and wood . . . Pest monitoring/Pest control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Receipt of goods and storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Maintenance and repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Traceability (including GMOs and allergens) . . . . . . . . . . . . . . Allergens and specific conditions of production . . . . . . . . . . Measurements, Analysis, Improvements . . . . . . . . . . . . . . . . . Internal audits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Site factory inspections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Process validation and control . . . . . . . . . . . . . . . . . . . . . . . . . . . Calibration, adjustment and checking of measuring and monitoring devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

77 78 78 79 79 80 80 81 81 84 85 87 89 91 92 93 94 96 96 96 98 98 99

Control of quantity/filling quantity . . . . . . . . . . . . . . . . . . . . . . . 100 Product analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101 Product quarantine (blocking/hold) and product release . . 103 Management of complaints from authorities and customers 103 Management of incidents, product withdrawal, product recall . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104 Management of non-conformities and non conforming products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105 Corrective actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106 Packaging material defense/Food defense and external inspections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107 Defense assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107 Site Security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109 Personnel & Visitor Security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109 External Inspections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111

ANNEX 1 GLOSSARY/DEFINITIONS LIST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112

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Part 3: Requirements for Accreditation Bodies, Certification Bodies and Auditors

IFS accreditation and certification process 0 1 1.1 1.2 1.3 1.4 1.5 1.6 1.7 2 2.1 2.2 2.3 2.4 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119 Requirements for the Accreditation Bodies . . . . . . . . . . . . . . 119 General requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119 The training of the accreditation committee (or competent person) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119 Competences of the assessor of the accreditation body . . 120 Frequency of the assessments of certification bodies . . . . . 120 Accreditation of an internationally-active certification body 121 Conditions for recovering accreditation after withdrawal or suspension . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121 Transfer of certification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122 Requirements for the Certification Bodies . . . . . . . . . . . . . . . . 122 ISO/IEC 17065 IFS accreditation process . . . . . . . . . . . . . . . . . . 122 Signing of contract with the proprietor of IFS . . . . . . . . . . . . . 122 Certification decision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123 Certification bodies responsibilities for IFS PACsecure trainers and the IFS PACsecure auditors (including freelancers) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123 Specific requirements for IFS PACsecure trainers . . . . . . . . . 125 Requirements for IFS PACsecure auditors . . . . . . . . . . . . . . . . 126 Conversion of auditors to get the IFS PACsecure version 1 auditor approval . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126 Requirements for new IFS PACsecure auditors . . . . . . . . . . . 126 Requirements before applying for the IFS PACsecure examinations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126 General requirements for auditors when applying for IFS PACsecure examinations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127 IFS examination process (for new auditors, as specified in chapter 3.2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128 Maintenance of auditors qualification (for both types of auditors, as specified in chapters 3.1 and 3.2) . . . . . . . . . . . . 129 Scope extension for IFS-approved auditors . . . . . . . . . . . . . . . 130 Audit team . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130 General rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130 Specific rules for audit team and auditing 3 consecutive times . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131

2.5 3 3.1 3.2 3.2.1 3.2.2 3.3 3.4 3.5 3.6 3.6.1 3.6.2

ANNEX 1 Product scopes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132

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Part 4: Reporting and IFS Audit Portal

0 1 1.1 1.2 1.3 1.4 2 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133 Reporting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133 Audit overview (Annex 1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133 Audit report (Annex 2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135 Action plan (Annex 3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135 Minimum requirements for IFS PACsecure certificate (Annex 4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135 The IFS Audit Portal and the IFS Database (www.ifs-certification.com) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136

ANNEX 1 Final Audit Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139 ANNEX 2 Detailed Audit Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143 ANNEX 3 Action plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145 ANNEX 4 Certificate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146

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Part 1: Audit Protocol

The history of International Featured Standards and IFS PACsecure Standard

Supplier audits have been a permanent feature of retailers systems and procedures for many years. Until 2003 they were performed by the quality assurance departments of the individual retailers, wholesalers and food services. The ever-rising demands of consumers, the increasing liabilities of retailers, wholesalers and food services, the increasing of legal requirements and the globalisation of product supply, all made it essential to develop a uniform quality assurance and food safety Standard. Also, a solution had to be found to reduce the time associated with a multitude of audits for involved stakeholders. The associated members of the German retail federation Handelsverband Deutschland (HDE) and of its French counterpart Fdration des Entreprises du Commerce et de la Distribution (FCD) drew up a quality and food safety standard for retailer branded food products named the IFS Food, the first Standard of the IFS family, which is intended to allow the assessment of suppliers food safety and quality systems in accordance with a uniform approach. This Standard is now managed by IFS Management GmbH, a company owned by FCD and HDE, and applies to all the post-farm gate stages of food processing. IFS Food Standard has been benchmarked with GFSI Guidance Document and is recognised by GFSI (Global Food Safety Initiative). The first version implemented (version 3) of the IFS Standard was developed by the HDE and launched in 2003. In January 2004, an updated version, version 4, was designed and introduced in collaboration with the FCD. Within 2005/2006, the Italian retail associations also joined the International Food Standard and the development of version 5 was a collaboration of retail federations from France, Germany and Italy as well as retailers from Switzerland and Austria. For IFS Food version 6, the International Technical Committee and the French, German and Italian working groups have been actively involved, in addition to retailers, stakeholders and representatives of industry, food services and certification bodies. During the development of IFS Food version 6, IFS gained input from a recently formed IFS North American working group and retailers from Spain, Asia and South America. Based on this experience, the IFS PACsecure Standard is a new one in the IFS (International Featured Standards) family covering another part of the supply chain.

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The fundamental objectives of IFS PACsecure, as well as for other IFS Standards, are: to establish a common standard with a uniform evaluation system, to work with accredited certification bodies and qualified IFS approved auditors, to ensure comparability and transparency throughout the entire supply chain, to reduce costs and time for both suppliers and retailers, to meet GFSI requirements. As announced on February 15th 2012, IFS Management GmbH, owner of the GFSI benchmarked IFS Food Standard, IFS Logistics and other supply chain Standards, together with The Packaging Association of Canada (PAC), have joined to bring the worlds foremost packaging standard for primary and secondary packaging to the industry. PACsecure was created by PAC to provide packaging manufacturers and converters the ability to certify primary and secondary packaging materials for the food industry. However, the IFS PACsecure Standard is applicable to all kinds of packaging materials. Developed by a technical working group made up of some of North Americas largest global packaging and food manufacturers, the Standard is now managed by a joint effort of the PAC through their technical expertise and know-how in the packaging industry and IFS and its global network of food safety and quality standards infrastructure.

2
2.1

Introduction
Purpose and contents of the audit protocol

This audit protocol describes the specific requirements made on the organisations involved in IFS PACsecure audits. The purpose of the protocol is to define the criteria to be followed by a certification body performing audits against the IFS requirements, and in accordance with the accreditation norm ISO/IEC 17065. It also details the procedures to be observed by the companies being audited, and clarifies the rationale of auditing them. Only accredited certification bodies to ISO/IEC 17065 for the scope of IFS PACsecure, and which have signed an agreement with the scheme owner can perform audits against the IFS PACsecure Standard and can issue IFS PACsecure certificates. The IFS requirements for certification bodies are clearly described in Part 3 of this document.

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2.2

Extraordinary information to the certification body by the certified company

In accordance with ISO/IEC Guide 65, the company shall inform its certification body about any change or information indicating that the products may no longer comply with the requirements of the certification system (e.g. recall, alert on products, etc.). For IFS, this information shall be made within 3 working days.

2.3

General requirements for the quality and product safety management system

In general, when auditing in accordance with IFS, the auditor assesses if the various elements of a companys quality and product safety management system are documented, implemented, maintained, and continuously improved. The auditor shall examine the following elements: organisational structure in relation to responsibility, authority, qualification and job description, documented procedures and the instructions concerning their implementation, inspection and testing: specified requirements and defined acceptance/tolerance criteria, actions to be taken in case of non-conformities, investigation of the causes of non-conformities and the implementation of corrective actions, conformity analysis of safety and quality data and review of implementation in practice, handling, storage and retrieval of quality and packaging material safety records, such as traceability data, document control. All processes and procedures shall be clear, concise and unambiguous and the personnel responsible shall understand the principles of the quality and product safety management system. The quality and product safety management system is based on the following methodology: to identify the processes needed for the quality and product safety management system, to determine the sequence and interaction of these processes, to determine the criteria and methods required to ensure the effective operation and control of these processes, to ensure the availability of information necessary to support the operation and monitoring of these processes,

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to measure, monitor and analyse these processes, and implement the necessary action to achieve planned results and continuous improvement.

3
3.1

Types of audit
Initial audit

An initial audit is a companys first audit to IFS PACsecure. It is performed at a time and date agreed between the company and the selected certification body. During this audit the entire company is assessed, both in relation to its documentation and the processes themselves. During the audit, all criteria of the IFS requirements shall be assessed by the auditor. In the case of a pre-audit, the auditor who performs this audit shall be different from the auditor who performs the initial audit.

3.2

Follow-up audit

A follow-up audit is required in a specific situation when the results of the audit (an initial audit or a renewal audit) have been insufficient to allow the award of the certificate (see chart N 6). During the follow-up audit, the auditor focuses on the implementation of the actions taken to correct the Major non-conformity determined during the previous audit. The follow-up audit shall be performed within a six months period from the date of the previous audit. In general, the auditor who performed the audit where a Major non-conformity has been identified shall perform the follow up audit. If the Major non-conformity is related to production failure(s), the follow up audit shall be performed at least 6 weeks after the previous audit and no later than 6 months after the previous audit. For other kinds of failures (e.g. documentation), the certification body is responsible for the determination of the date of the follow-up audit. If there is no follow-up audit performed after 6 months from the date of the previous audit, then a complete new audit is necessary. In the event that the follow-up audit establishes that requirements remain inadequate, a complete new audit is necessary. The elimination of Major non-conformities shall always be established by an on-site visit by the auditor.

3.3

Renewal audit (for recertification)

Renewal audits are those which are performed after the initial audit. The period in which a renewal audit shall be performed is shown on the certificate. A renewal audit involves a full and thorough audit of a com IFS, October 2012

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pany resulting in the issue of a new certificate. During the audit, all criteria of the IFS requirements shall be assessed by the auditor. Particular attention is paid to the deviations and non-conformities identified during the previous audit, as well as to the effectiveness and implementation of corrective actions and preventive measures laid down in the companys corrective action plan. Note: corrective action plans from the previous audit shall always be assessed by the auditor, even if the previous audit has been performed more than one year ago. Therefore, audited companies shall always inform their certification body if they have already been IFS certified in the past. The date of the renewal audit shall be calculated from the date of the initial audit and not from the date of issue of the certificate. Furthermore, the renewal audit can be scheduled at earliest 8 weeks before and at latest 2 weeks after the renewal audit due date (see also section 6.2). Companies are responsible for maintaining their certification. The certification bodies shall contact companies in advance in order to set a date for a new audit. In general, the expected date of each audit shall be uploaded in the IFS Audit Portal, in the diary function and at latest 2 weeks (14 calendar days) before the audit due date (it is possible to change the date short term).

3.4

Extension audit

In specific situations, such as new products and/or processes to be included in the audit scope or each time the audit scope would need to be updated on the certificate, then, for an IFS PACsecure certified company, it is not necessary to perform a complete new audit, but to organise an on-site extension audit during the validity period of the existing certificate. The certification body is responsible for determining relevant requirements to be audited and relevant audit duration. The extension audit shall be performed by the auditor who performed the normal audit. The report of this extension audit shall be represented as an annex adjoined with the current audit report. Conditions for passing the extension audit (relative score 75 %) are the same as normal one, but only focused on specific requirements which have been audited; the original audit score does not change. If the extension audit demonstrates compliance, the certificate shall be updated with the new scope and uploaded in the Audit Portal. The updated certificate shall keep the same due date of end of validity as the current certificate. If, during the extension audit, a Major non-conformity or a KO (Knock Out non-conformity) has been identified, the full audit is failed and the current certificate shall be suspended as described in 5.8.1 and 5.8.2.
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Scope of the audit

IFS PACsecure is a Standard for auditing primary and secondary packaging material manufacturers and converters. Although initially developed for food contact packaging material manufacturers (e.g. plastic foils for vegetables, cans for beverages, paper wrapping for flour, etc.) IFS PACsecure is also applicable to non-food contact packaging materials, such as: packaging materials for products intended to be used on the skin (e.g. cosmetic products), packaging materials for products not intended to be used on the skin (e.g. household products, consumer goods, hardware, etc.). The Standard can only be used when packaging material is processed, converted or printed and applies both to B to B and B to C businesses. As a result, IFS PACsecure shall not apply to the following activities: importation (offices, e.g. typical broker companies) transport, storage and distribution. For clarification of the scope determination between IFS PACsecure and other IFS Standards (Food, Broker, Logistics, Cash & Carry/Wholesale and HPC) please see Annex 1. If the company trades packaging materials as finished products and if it wants to include them in the audit scope, the suppliers of these products shall themselves be IFS PACsecure certified (if the trade products are under the same product scope) or certified under a comparable scheme (if the trade products are under a different product scope) and the specific requirements in the audit check-list (Part 2) related to trade of packaging materials (4.4.2.1 to 4.4.2.3) shall be fulfiled. If this is not the case, those products shall be excluded from the certificate and the certificate shall mention: trade activity is not included. If the above mentioned requirements are fulfiled, those traded packaging materials shall clearly be specified on the certificate, detailing the product scope(s), and specified in the report, both in the audit scope and in the company profile. The scope of the audit shall be defined and agreed between the company and the certification body before the audit takes place. The scope shall be clearly and unambiguously stated in the contract between the company and the certification body, in the audit report and on the certificate. The audit shall be performed at a time to ensure the full scope of products and processes, as mentioned in the report and on the certificate, can be effectively assessed. If, between two certification audits, new processes or products different
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from those included in the scope of the current IFS PACsecure audit are implemented, the certified company shall immediately inform its certification body, who shall perform a risk assessment to decide whether an extension audit should be performed or not (see also 3.4). The results of this risk assessment, based on hygiene and safety risks, shall be documented. The audit shall be specific to the site where all the processing of the products is undertaken. Where decentralised structures exist and the audit of a certain location is insufficient for gaining a complete view of the companys processes, then all other relevant facilities shall also be included in the audit. Full details shall be documented within the company profile in the audit report. The audit scope shall include the complete activity of the company (i.e. the same kind of production on several lines for products under industry brands and retailer/wholesaler brands). The scope shall be reviewed and agreed at the beginning of the audit after an initial risk assessment. Furthermore, the scope can be modified after the risk assessment (for instance, if a further activity interferes with the one concerned by the audit scope). The audit scope shall make reference to the audited product scope(s) corresponding to the type of packaging materials being processed/converted during the audit (see Annex 3). If, under exceptional circumstances, the company decides to exclude specific product ranges (product lines) from the scope of the audit, then this shall be clearly noted and included in the audit report and on the IFS PACsecure certificate. Auditing of multi-location companies with central management If defined processes are centrally organised in a company with several production sites (e.g. purchasing, personnel management, complaint management), the central managing site headquarter shall also be audited and relevant audited requirements outcome shall be considered in the audit reports of each production site. Note: Each production site shall be audited separately in a period of maximum 12 months after the central managing site and shall have its own audit report and certificate. Each site shall be mentioned in the relevant contract. If the central managing site does not have any production activity, this site cannot be IFS certified as an independent company. The time for auditing the central managing site shall be described in the company profile of the report. The audit of the managing site shall always take place before the audit of each production site in order to have a preliminary overview. Note: If it is not possible to perform an audit at the managing site, then it shall be ensured that, during the audit of the production site, all necessary information from the managing site is available (e.g. a representative of the managing site should attend at the audit(s) of the production site(s)).
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5
5.1

The certification process

Preparation of an audit

Before being audited, the company shall review all requirements of the IFS PACsecure Standard in detail. On the day of the audit, the current version of the Standard shall be available at the site being audited. The company is responsible for acquiring the current version of the Standard. In order to prepare for an initial audit, a company may carry out a pre-audit, which is only intended to be used in-house. The pre-audit cannot include any recommendations. If the audit is not an initial audit, the company shall also inform the certification body so that the auditor can check the corrective action plan from the previous audit. The expected date for the initial or renewal audit shall be communicated to the IFS offices via the IFS Audit Portal. This shall be the responsibility of the certification body.

5.2

Certification body selection contractual arrangements

In order to undertake the IFS PACsecure audit, the company shall appoint a certification body which is approved to perform such audits. It is the responsibility of the company to verify that the certification body is accredited for IFS PACsecure certification. Only those IFS approved certification bodies which shall be accredited to ISO/IEC 17065 for IFS PACsecure and shall have signed a contract with IFS (see Part 3) can carry out IFS PACsecure audits and issue certificates. The list of all IFS international approved certification bodies, by country, is available on the website www.ifs-certification.com. Certification bodies can have auditors qualified for one or several product scopes. Confirmation of the product scopes for which the certification body can perform audits shall be obtained from the individual certification body. IFS PACsecure audits can be carried out by an audit team only if all members of the audit team are IFS approved auditors. Additional requirements for audit teams are described in detail in Part 3 of the Standard, chapter 3.6. An auditor is not allowed to perform more than 3 consecutives audits of the same companys site (whatever the time between audits); rules in case of audit team are also detailed in Part 3, chapter 3.6. A contract shall exist between the company and the certification body detailing the scope of the audit, the duration and reporting require IFS, October 2012

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ments. The contract shall have a reference to Integrity Program (see chapter 12), in relation to the possibility of on-site audits organized by Quality Assurance Management of the IFS offices. The audit shall take place when products of the audit scope are being processed/converted. The audit shall preferably be carried out in the language of the company being audited and the certification body shall make every attempt to appoint an auditor whose native language or main working language is the language of the company. If this is not possible, the audit should be carried out in English language. Furthermore, languages used by the auditor for leading an audit others than native language shall be approved by IFS offices prior to undertaking audits (see also Part 3). Nevertheless, and in all cases, the audit report, certificate and action plan shall be written in English language.

5.3

Duration of an audit

The certification bodies have an appropriate system for estimating the minimum time needed for an audit. A number of factors, which are detailed in the contract between the certification body and the company, play a role in determining the time required for a comprehensive audit. They include: the size of the site the type of production/conversion process the scope of the audit the number of production lines involved the number of personnel employed at the site the number of non-conformities found in the previous audit. Experience shows that the minimum audit duration on site shall be 2 working days. Exceptions to this requirement, including decreasing linked to multi-site companies, shall be precisely explained by the certification body/the auditor on the first page of the report, in the company profile field. The audit duration might be extended, depending on the above factors. If the auditor estimates that additional time is necessary, the audit duration shall be extended. The above-mentioned requirements shall apply equally to renewal audits, which shall be considered as completely new audits. A normal audit day duration is 8 hours.

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Independently from audit duration, besides on-site audit, preparation of the audit shall be at least 2 hours. 1/3 of the audit duration shall be spent, as a minimum, in the production/converting area of the site. Additionally, time for generation of the audit report is typically 0,5 days. Note 1: For multi-location companies, audit duration could be decreased by a maximum of 0,5 days, if requirements have already been audited at the central managing site. Note 2: For an audit team, the minimum audit duration shall be 1 day. In addition to the calculated audit time, minimum 2 hours shall be added. This additional time shall be allocated to the team and not to an individual auditor for common tasks (e.g. opening and closing meeting, discussion about audit findings, etc.). See also Part 3, chapter 3.6 about audit team.

5.4

Drawing up an audit time schedule

The certification body shall provide the audit time schedule. The audit time schedule includes appropriate details concerning the scope covered and the complexity of the audit. The audit time schedule shall be sufficiently flexible to respond to any unexpected events which may arise during the site inspection activity within the certification audit. The audit time schedule takes into consideration a review of the audit report and action plan relating to the previous audit, whatever the date when the previous audit has been performed. It also specifies which of the companys products or product ranges are to be audited. The company can only be audited at a time when it is actually producing/converting the products specified in the scope of the audit. The audit time schedule shall be sent to the auditee before the audit, to ensure availability of responsible persons at the day of the audit. In case of an audit team, the audit time schedule shall clearly indicate which auditor performs which part of the audit. If the IFS PACsecure audit is performed in combination with another standard/norm, the audit time schedule shall clearly indicate when each standard or part of it has been audited. The audit shall be scheduled based on the following steps: the opening meeting the evaluation of existing quality and product safety systems; achieved by checking documentation (HACCP/risk assessment, quality management documentation)

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the on-site inspection and interviewing of the personnel the final conclusions drawn from the audit the closing meeting. The company will assist and co-operate with the auditor during the audit. As part of the audit, personnel from different levels of management are interviewed. It is advisable that the companys senior managers are present at the opening and closing meetings so that any deviations and non-conformities can be discussed. The auditor(s) who conduct(s) the audit will assess all the requirements of IFS PACsecure which are relevant to the companys structure and function. During the closing meeting, the auditor (or lead auditor in the case of an audit team) shall present all findings and discuss all deviations and non-conformities which have been identified. As specified by ISO/IEC 17065, the auditor may only issue a provisional assessment of companys status during the closing meeting. The certification body shall issue a provisional audit report and outline an action plan to the company, which shall be used as a basis for drawing up corrective actions for the determined deviations and non-conformities. The certification body is responsible for making the certification decision and the preparation of the formal audit report after the receipt of the completed action plan. The issue of the certificate is dependent on the audit results and on agreement on an appropriate action plan.

5.5

Evaluation of requirements

The auditor assesses the nature and significance of any deviation or non-conformity. In order to determine whether compliance with a requirement of IFS PACsecure has been met, the auditor has to evaluate every requirement in the Standard. There are different levels to rank the findings.

5.5.1

Scoring a requirement as a deviation

In IFS PACsecure there are 4 scoring possibilities. Scoring with: A: Full compliance with the requirement specified in the Standard B: Almost full compliance with the requirement specified in the Standard, but a small deviation was found C: Only a small part of the requirement has been implemented D: The requirement in the Standard has not been implemented

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Points are awarded for each requirement according to the following chart: Chart N 1: Scoring
Result A B (deviation) C (deviation) D (deviation) Explanation Full compliance Almost full compliance Small part of the requirement has been implemented Requirement has not been implemented Points 20 points 15 points 5 points 20 points

The auditor shall explain all scorings with B, C and D in the audit report. In addition to this scoring, the auditor can decide to give the company a KO or a Major non-conformity that will subtract points from the total amount. These possibilities are explained within the next chapters.

5.5.2

Scoring a requirement as a non-conformity

In IFS, there are two (2) kinds of non-conformities which are Major and KO. Both will lead to a subtraction of points from the total amount. If the company gets at least one of these non-conformities, the certificate cannot be awarded. 5.5.2.1 Major A Major is defined as follows: A Major non-conformity can be given to any requirement which is not defined as KO requirement. When there is a substantial failure to meet the requirements of the Standard, which includes product safety and/or the legal requirements of the production and destination countries. A Major can also be given when the identified non-conformity can lead to a serious health hazard. A Major will subtract 15 % of the possible total amount of points. Chart N 2: Evaluation of a Major
Evaluation Major Scoring 15 % of possible total amount is subtracted Result No certificate awarding is possible

See also section 5.8 for the general management of audit process in case of Major non-conformity(ies).

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5.5.2.2 KO (Knock out) In IFS, there are specific requirements which are designated as KO requirements (KO Knock Out). If during the audit the auditor establishes that these requirements are not fulfiled by the company, this results in non-certification. In IFS PACsecure the following 9 requirements are defined as KO requirements: 1.2.4 Responsibility of the senior management

3.2.1.2 Personnel hygiene 4.2.1.2 Raw material specifications 4.2.2.1 Product formula compliance 4.12.1 4.18.1 5.1.1 5.9.2 5.11.2 Foreign material management Traceability system Internal audits Procedure for withdrawal and recall Corrective actions

KO requirements shall be evaluated according to the following scoring rules: Chart N 3: Scoring for a KO requirement
Result A B (deviation) C (deviation) KO (= D) Explanation Full compliance Almost full compliance Small part of the requirement is implemented The requirement is not implemented Awarded scores 20 points 15 points No C scoring is possible 50 % of the possible total amount of points is subtracted => No certificate awarding is possible

Important note A C scoring is not possible for KO requirements. In this respect, the auditor can only use A, B or D (= KO). When a KO requirement has been scored as D, 50 % of the possible total amount of points will be subtracted automatically meaning that the company is not approved for IFS PACsecure certification. A KO cannot be scored with N/A, except KO 4.2.2.1. See also section 5.8 for the general management of audit report in case of one or several KO requirements.

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5.5.3

Scoring a requirement with N/A (not applicable)

When the auditor decides that a requirement is not applicable for a company, the auditor has to use as scoring: N/A: Not applicable and provide a short explanation in the audit report. N/A scoring is possible for any requirements of the IFS PACsecure audit checklist, except for KO requirements (exception for KO 4.2.2.1). N/A requirements shall not be included in the outline action plan, but they shall be listed in a separate table in the audit report. If there are a significant number of requirements which are deemed as not applicable, using a total points score for the audit may be misleading; however, the scoring system for IFS PACsecure is based on a percentage of the total available score and it is this which is used to decide the status of the site i.e. foundation or higher level.

5.6

Determination of the audit frequency

For all products and for all certification levels, the audit frequency for IFS PACsecure audits is 12 months, starting from the date of the audit and not the date of issue the certificate. Further regulations are described in 6.2 (certification cycle).

5.7

Audit report

Following each audit, a full written report shall be prepared in the agreed format (see Part 4).

5.7.1

Structure of the audit report

The audit report shall provide transparency and confidence to the reader and will be completed by the auditor. The audit report is subdivided into different sections. General information about the company with compulsory fields (see Part 4) General audit result with detailed description of the scope General summary in a tabular format for all chapters. The result of the audit will specify the level and percentage General summary of all chapters and comments about follow up of corrective actions implemented from the previous audit Observations on KO requirements and Major non-conformities

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Summary of all established deviations and non-conformities for each chapter (1 to 6) Separate list (including explanations) of all requirements evaluated with N/A (not applicable) All deviations (B, C, D) and KO requirements scored with a B, non-conformities (Major, KO requirement scored with a D) identified during the audit, are presented in a separate action plan. Following the allocation of a grade, non-conformities and deviations, the company has to produce a corrective action plan. In this way, the reader of the report can see the non-conformities and deviations, and also the corrective actions that the company is initiating.

5.7.2

The different steps for the audit report

5.7.2.1 Drawing up the pre-report of the audit and the outline of the action plan The auditor shall explain all non-conformities (KO requirements scored with a D and Majors), all deviations (B, C, D) and KO requirements scored with a B, and all requirements that are found N/A. The action plan shall include all the requirements which are not evaluated with A or N/A. The outline action plan shall conform to the outline action plan as specified in Part 4, Annex 3. It shall include the elements of the chart N 4. The auditor shall complete all of field A in chart N 4 explaining and justifying the deviations and non-conformities finding before sending the company the outline action plan and the pre-report of the audit. The certification body or the auditor shall send the company both the pre-report of the audit and the outline action plan within two weeks of the audit date. Note: If the auditor identified deviations during the audit and the audited company has already planned corrective actions, the deviations shall be noted in the audit report and a comment shall be added indicating the company has already planned corrective actions.

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Chart N 4: Outline action plan

Number of the requirement IFS requirement Evaluation Explanation (by the auditor) Corrective action (by the company) Responsibility Date and status of implementation (by the company) Field C Release by the auditor

Field A 1.2.1 1.2.2 1.2.3 1.2.4 KO 1.2.5 An organisation chart Competences and responsibilities Job descriptions with clearly The senior management shall ensure Employees with influence B C D KO/D Major

Field B

Field D

5.7.2.2 Companys completion of the corrective action plan The company shall enter proposed corrective actions (field B of chart N 4) for all deviations (B, C, D) and KO requirements scored with a B and non-conformities (Major, KO requirements scored with a D) listed by the auditor. For all evaluated deviations with score C and D, as well as non-conformities, Major or KO requirements scored with a B and/or a D, the company shall clearly state the responsibilities and implementation deadlines for corrective action (chart N 4, field C). The company shall forward the corrective action plan to the certification body within 2 weeks of having received the pre-report of the audit and the action plan layout. If this deadline is not respected, the company has to undergo a complete initial or renewal audit. An IFS PACsecure certificate shall not be awarded unless the corrective actions for requirements scored with a C or D, and KO requirements scored with B, specify responsibilities and implementation dates in the action plan. The final decision of awarding the IFS PACsecure certificate is dependent both on final scoring and on relevance of corrective action plan communicated by the company to the certification body. The company shall always submit a written corrective action plan before receiving the final report and the certificate. The intention of the corrective action plan is for the company to strive for continuous improvements.

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5.7.2.3 Auditor validation of the action plan The auditor or a representative of the certification body shall validate the relevance of the corrective actions in the last column of the action plan before preparing the final audit report (Field D of the chart N 4). If the corrective actions are not valid or are inadequate, the certification body shall return the action plan to the company for completion in due time.

5.7.3

Further rules about the audit report

5.7.3.1 Link between two consecutive audit reports (initial and renewal audits) When the auditor scores a requirement with C or D, corrective actions shall be implemented before the renewal audit. This means the certification body shall read the audit report and the action plan of the previous audit, even if the report was issued by another certification body. If C and/or D scorings remain the same from one audit to the next, or if scorings are getting worse, the auditor shall assess in accordance with the IFS chapter related to Corrective actions (chapter 5.11 of the audit check-list, Part 2). This link between two consecutive audits ensures a continuous improvement process.

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5.8

Scoring and conditions for issuing audit report and certificate

Chart N 5: Scoring and awarding of certificates

Audit result At least 1 KO scored with D > 1 Major and/or < 75 % of the requirements are fulfilled Max 1 Major and 75 % of the requirements are fulfilled Status Not approved Action company Actions and new initial audit to be agreed upon Actions and new initial audit to be agreed upon Report form Report gives status Report gives status Certificate No

Not approved

No

Not approved unless further actions taken and validated after followup audit

Send completed action plan within 2 weeks of receiving the preliminarily report. Follow-up audit max. 6 months after the audit date Send completed action plan within 2 weeks of receiving the preliminarily report. Send completed action plan within 2 weeks of receiving the preliminarily report.

Report including action plan gives status

Certificate at foundation level, if the Major nonconformity is finally solved as controlled during the follow-up audit Yes, certificate at foundation level, 12 months validity Yes, certificate at higher level, 12 months validity

Total score is 75 % and < 95 %

Approved at foundation IFS PACsecure level after receipt of the action plan Approved at higher IFS PACsecure level after receipt of the action plan

Report including action plan gives status

Total score is 95 %

Report including action plan gives status

Note: the total score is calculated as follows: Total number of points = (total number of IFS requirements requirements scored with N/A) 20 Final score (in %) = number of points awarded/total number of points. The certificate shall always be issued in English language. If requested by the customer, it can additionally be issued in a different language.

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5.8.1

Specific management of the audit process (report, certificate, uploading) in case one or several KOs has/have been scored with D during the audit (see also Annex 4)

In case one or several KO is/are scored with D during the audit, the current IFS PACsecure certificate shall be suspended in the IFS Audit Portal by the certification body as soon as possible and a maximum 2 working days after the audit date. In the database, explanation about reasons for suspending the current certificate shall be given in English language. Clear explanations about the identified non-conformity(ies) shall be provided by giving the number of involved KO requirement(s). These explanations shall be detailed and be the same as those described in the action plan. Note: All users having access to the IFS Audit Portal and having mentioned the respective company in their favourites list will get an e-mail notice from the IFS Audit Portal that the current certificate has been suspended. In each case, the audit shall be completed and all requirements shall be evaluated in order to give the company a complete overview about its situation. Furthermore, it is recommended to complete the action plan for improvement purposes. The audit report where one or several KO requirement(s) have been scored with D shall always be uploaded into the IFS Audit Portal (only for administrative purpose, but will not be visible). In these situations, a complete new audit shall be performed. The new audit shall be scheduled no earlier than 6 weeks after the audit where a KO requirement was scored with D.

5.8.2

Specific management of the audit process (report, certificate, uploading) in case one or several Major nonconformity(ies) has/have been issued (see also Annex 4)

In case one or several Major non-conformity(ies) is/are issued during the audit, the current IFS PACsecure certificate shall be suspended in the IFS Audit Portal by the certification body as soon as possible and a maximum 2 working days after the audit date. In the database, explanation about reasons for suspending the current certificate shall be given in English language. Clear explanations about the identified non-conformity(ies) shall be provided by giving the number of involved requirement(s). These explanations shall be detailed and be the same as those described in the action plan.

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In cases where more than one Major non-conformity have been identified, a complete new audit shall be performed. The new audit shall be scheduled no earlier than 6 weeks after the audit where Major nonconformities were issued. If the Major non-conformity is related to production failure(s), the follow up audit shall be performed at least 6 weeks after the previous audit and no later than 6 months after the previous audit. For other kinds of failures (e.g. documentation), the certification body is responsible for the determination of the date of the follow-up audit. The audit report where one or several Major non-conformity(ies) has/have been identified shall always be uploaded into the IFS Audit Portal after receiving the action plan (only for administrative purpose, but will not be visible). Specific situation in case of follow-up audit: If a Major non-conformity has been identified with a total score of 75 % or above and then resolved, and if the audit result is deemed positive: The certification body shall mention on the updated audit report: in the date section: specify the date of the follow up audit in addition to the date of audit when the Major non-conformity was identified, in the final result of audit section: specify that a follow up audit has taken place and that the Major non-conformity has been solved, in the observations regarding KO non-conformities and Majors section explain on which requirement the Major nonconformity has been solved. The company cannot be certified with higher level even if the final total score is equal or more than 95 %. The same valid date of the certificate remains in the certification cycle as described in 6.2. It shall be defined on the certificate the date of initial audit and date of follow up audit. If it was during an initial audit, the longest certificate valid due date is calculated using initial audit date, plus one year and 8 weeks. 01. October, 2012 26. November, 2012 25. November, 2013 25. September, 2013 03. December, 2013 25. November, 2014.

Example: Initial audit date 1: Date of issue of certificate: Certificate valid until: Renewal date (audit where Major has been issued) 2: Follow up audit: Latest date of validity of the certificate:

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The report (first of the audit with the estimated Major, then updated with results of follow up audit) shall be uploaded into the IFS Audit Portal after performing the follow up audit with the proviso that the Major non-conformity is finally solved.

5.8.3

Specific management of the audit process in case the final score is < 75 %

In these situations, the certification is failed and a complete new audit shall be performed. The new audit shall be scheduled no earlier than 6 weeks after the audit where the final score was <75 %.

5.8.4

Specific management of the audit process in case of multi-site companies

All KO requirements shall be audited at all sites even if some of them are partly managed at the central managing site. In the audit report of each site, only the audit date of the respective site shall be mentioned; the audit date of managing site is not additionally necessary. In case that a Major non-conformity or a KO scored with D has been issued during the audit of the central managing site, all audited production sites are also affected and the certificates of these sites shall be suspended (according the procedure described above). After a successful audit of the central managing site (or after positive follow-up after a Major was issued in the central managing site), the certificates of the production sites can be reinstated. Depending upon which non-conformity has been issued in the central managing site, a new audit of the production sites may also be necessary.

Awarding the certificate

A certificate shall be issued to one specific site. Detailed minimum mandatory information to be published on the IFS PACsecure certificate is determined in Part 4. Note: the final audit score, in percentage, can also be published on the certificate, if required by customer and/or audited company.

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6.1

Deadlines for awarding certificate

The certification body is responsible for the decision to award or not award the IFS PACsecure certificate. The decision is made by person(s) other than those who have carried out the audit. The certification shall be valid effectively from the date of issue stated on the certificate itself and shall end after 12 months. The date for the renewal audit shall be calculated from the date of the initial audit, not from the date of issue the certificate. If the audit is not performed in due time, the retailers or other users will be informed via the Audit Portal. The time between the date of the audit and the awarding of certificate is determined as follows: 2 weeks to draw up the pre-report of the audit 2 weeks for the company to respond to the deviations and nonconformities (i.e. draw up the action plan) 2 weeks for the auditor to check the proposed corrective actions, for the certification procedure and upload of the audit report, the action plan and the certificate to the Audit Portal. In total: 6 weeks between the date of audit and uploading the audit report to the Audit Portal and awarding the certificate: Target time: 6 weeks, Maximum time: 8 weeks.

6.2

Certification cycle

Even if the renewal audit due date changes every year and does not completely correspond to the anniversary date, the certificate validity date shall remain the same each year. Due date of the certificate is determined as follows: initial audit date + 8 weeks. This allows to avoid gaps between two (2) consecutive certificates and to avoid that a company scheduling the audit earlier loses some months of certificate validity. Example: Initial audit date: 01. October, 2012 Date of issue of certificate: 26. November, 2012 Certificate valid until: 25. November, 2013 Renewal audit date: Certificate valid until: 25. September, 2013 25. November, 2014 (independently from the renewal audit date).

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Chart N 6: Certification cycle

Oct. 2012 Nov. D J F M A M J J A Sept. O Nov. D J F M A M J J A S Oct. 2013 2014 < 12 months IA: 01. 10. 2012 RA: 25. 09. 2013 = 12 months C: 25. 11. 2013
IA: Initial audit RA: Renewal audit C: Issue a certificate valid until

Nov. D J F M A M J J A S

> 12 months RA: 05. 10. 2014 C: 25. 11. 2015

= 12 months C: 25. 11. 2014

Note: the certificate shall always be edited on the basis of a certification decision and after the several steps of certification decision according to ISO/IEC 17065. Ideally, the renewal audit shall be performed within eight (8) weeks of the date of expiry of certificate to have enough time for the several steps of the certification process. The renewal audit shall be scheduled at earliest eight (8) weeks before and at latest two (2) weeks after the audit due date (due date is anniversary date of the initial audit). If this is not the case, or if the several steps of the certification process were not completed in time, the certificate cannot be renewed with the due date but with the actual new date; this will lead to a break in the certification. In the example above, this means that the audit shall never be scheduled before 06. August and after 15. October. The previous audit report remains a further eight (8) weeks (after audit due date) on the Audit Portal, but if the renewal audit takes place later than described above, the report will be automatically inactivated from the IFS Audit Portal.

6.3

Information about conditions of withdrawal of certificate

Withdrawal of certificate by the certification body is only permitted in case of any information indicating that the product may no longer comply with the requirements of the certification system (ISO/IEC 17065). The only exception of this rule may be related to the non-payment of the current audit by the certified company. The contract between certification body and audited company shall be harmonized with the certification cycle (see above chart N 6).

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Distribution and storage of the audit report

Audit reports shall remain the property of the company and shall not be released, in whole or part, to a third party without the companys prior consent (except where required by law). This consent for distribution of the audit report must be in writing and can be granted by the company vis--vis the certification body and/or vis--vis the relevant user. The certification body shall keep a copy of the audit report. The audit report shall be stored safely and securely for a period of five years. Access conditions to information about audit reports are fully detailed in Part 4.

Supplementary action

The decision on the level of supplementary actions required on the basis of the certificate shall be made at the discretion of the individual buying organisation.

Appeal and complaints procedure

The certification body shall have documented procedures for the consideration and resolution of appeals against the results of an audit. These procedures shall be independent of the individual auditor and will be considered by senior management of the certification body. Appeals will be finalised within 20 working days of receiving information from the auditee. The certification body shall have documented general procedures for handling complaints received from the companies and/or other relevant parties. An initial response will be given within ten (10) working days of receiving the complaint. A letter confirming receipt of the complaint will be issued within a maximum of five (5) working days. A full written response will be given after the completion of a full and thorough investigation into a complaint. For the handling of complaints received by the IFS offices, the basis for the complaint management is described in the IFS framework agreement with certification bodies: If the complaint relates to the quality of the content of IFS PACsecure audits or IFS PACsecure audit reports, IFS offices require the certification body to provide a statement on the cause and the measures introduced to rectify the problem within 2 weeks.

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If the complaint relates to administrative errors, e.g. in IFS PACsecure audit reports, IFS PACsecure certificates or in the IFS database, IFS offices ask the certification body to provide a statement and rectify the problem within one (1) week. The statement shall be issued in writing by e-mail or post.

10

Ownership and usage of the IFS PACsecure logo

The copyright of IFS PACsecure and the registered trademark is fully owned by the IFS Management GmbH. The IFS PACsecure logo can be downloaded via the secured section of the IFS Audit Portal. Furthermore, the below terms and conditions shall be checked by the auditor during the audit and results of this check shall be described in the company profile of the audit report as a compulsory field (see Part 4, section 1.1). If the auditor identifies during an audit that the company does not fulfil the conditions of logo usage, the auditor shall note it in the company profile of the audit report and shall inform the IFS offices accordingly. Terms and conditions for using the IFS PACsecure logo and communication about the IFS PACsecure certification Application These terms and conditions apply for both IFS PACsecure and all IFS logos in general. Form, design and colour of the IFS PACsecure logo When used, the IFS PACsecure logo must comply with the form and colour of the scale drawing. If it is used in documents, black and white print is also permitted. The IFS PACsecure logo can be used in print, physical and electronic form, and in films, providing the forms and formats are respected. The same conditions apply to the use of the logo as a stamp. Restriction of comment and interpretations When an IFS PACsecure certified company, an IFS PACsecure supporting company or an IFS PACsecure certification body publishes documents bearing the IFS logo, comment and interpretations referring to the IFS shall be clearly identifiable as such. Use of the IFS PACsecure logo in promotional material An IFS PACsecure certified company, an IFS PACsecure supporting company (broker, food manufacturer, retailer, logistics provider or wholesaler) which accepts IFS PACsecure certificates from their suppliers or service providers, or an IFS certification body may use the IFS

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logo for promotional reasons and publish information about IFS certification provided that it is not visible on final product packaging which are available to the end-consumer (B to C business). Companies which provide products and/or services to IFS certified or supporting companies, but which are not themselves IFS certified (e.g. manufacturers of devices, clothing, cleaning materials or service providers which would like to promote that their products and/or services help to fulfil the IFS requirements) must ask for express written permission to IFS Management GmbH to use the IFS PACsecure logo and/or any other IFS logo(s). The IFS PACsecure logo and information about the certification may be used in correspondence with relevant IFS users. Presentations mentioning IFS on the internet are only permitted if they are in a direct link with product safety (e.g. within information about the safety/quality management system). The IFS PACsecure logo may be displayed on any kind of general communication (e.g. exhibitions for business contacts, brochures, generic articles about packaging, product safety and quality management in general, vehicles). The IFS PACsecure Standard was developed in order to assure the product safety and quality. It must be ensured that all information concerning certifications refers clearly to IFS. The IFS logo may not be used in presentations having no clear connection to IFS. Further restriction on the use of the IFS PACsecure logo The IFS PACsecure logo shall not be used in a way that could show intent that the IFS owner is responsible for the certification decision. Furthermore, the same applies for opinions and interpretations which could be deriven from it. In the event of suspension or withdrawal of the IFS PACsecure certification, the certified company has to immediately stop the inclusion of the IFS logo on its documents or other associated material and cease all communications regarding IFS. The audited company must demonstrate that they have complied with these requirements. Communication of the IFS PACsecure certification All the above mentioned rules apply to any communication regarding IFS PACsecure. This also means that using the wordmarks IFS, International Featured Standards, or IFS PACsecure or similar is not allowed when communicating on finished products, which are available to the end-consumer.

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11

Review of the Standard

The Review Committee needs to demonstrate control of the quality and content of the Standard and will review annually the Standard and the Protocol to ensure that they are still in compliance with their requirements. The Review Committee shall be formed with all participants involved in the audit process: the representatives of retailers, representatives of the industry, of (non) food services and of certification bodies. The objective of the Review Committee is to share experiences, discuss and decide about the changes to the Standard, the requirements of the audit report and training.

12

IFS Integrity Program

The IFS Integrity Program launched in early 2010 includes different measures to assure the quality of the IFS certification scheme, with a focus on the review of audits conducted by the IFS certification bodies and their auditors. There are two cornerstones of this program:

12.1

Preventive quality assurance actions

Quality assurance activities monitor the entire IFS system. Surveillance audits at the certification body offices and on-site supplier audits are carried out on a regular basis in order to assess the IFS system. These audits are undertaken regardless of whether or not a complaint has been made. The sampling for these surveillance audits is based on a random selection process and by use of objective criteria. These criteria are both economic criteria (e.g. number of issued certificates) and quality criteria (e.g. the review and analyses of IFS certification processes and corresponding reports). A surveillance office audit of a certification body (CB) takes place at the accredited certification bodys premises to verify the correct application of the IFS regulations at the certification body offices and to promote continuous improvement. Additionally, surveillance on-site supplier audits at certified companies may be undertaken. In general, surveillance on-site supplier audits are announced 48 hours before the audit date. In these audits the documentation reviewed in the office audit of the certification body, or in the IFS database, is compared with the real situation found at the company. Witness audits can also be performed. In this case, Integrity auditors assess an IFS PACsecure auditor during a real IFS PACsecure audit.

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12.2

Quality assurance actions after complaint notification

A detailed complaint management process analyzes all necessary information. Retailers or any other interested parties have the right to forward any possible non-conformity to IFS for investigation as part of the Integrity Program. The IFS Offices collect complaints concerning IFS PACsecure audits, reports, certificates or other circumstances in which the integrity of the IFS brand is in question. Retailers, certification bodies, employees of IFS-certified companies or any person can use the complaint form on the IFS website www.ifs-certification.com or can send an e-mail to [email protected] to inform IFS about a certain issue. In addition to any complaints received, IFS also analyses the IFS database using analytical tools in order to identify any deficiencies. If IFS Quality Assurance Management is informed of significant discrepancies between the results of an IFS PACsecure audit and a subsequent retailer audit, this will be investigated within the complaint management process as described below. The IFS Offices will gather all necessary information in order to investigate the cause of the complaint and to establish if there are deficiencies by certified companies, accredited certification bodies or IFS-approved auditors in meeting IFS requirements. Appropriate steps are taken to fully investigate a complaint, which may include a request to a certification body to carry out internal investigations and provide a statement on the outcome of their investigations to IFS. In the event that a complaint cannot be successfully resolved by the investigation undertaken by the certification body, an on-site investigation audit will be undertaken at the certified company(s). In general, investigation audits are announced 48 hours before the audit date, however in special cases unannounced audits are undertaken. Witness audits can also be performed. In this case, Integrity auditors assess an IFS PACsecure auditor during a real IFS PACsecure audit. Audits carried out as part of the Integrity Program are conducted by auditors employed by IFS and completely independent of the auditees.

12.3

Sanctions

If, following a complaint or preventive quality assurance actions, the cause of a deficiency has been found to be the fault of a certification body and/or an auditor, IFS will forward all necessary information anonymously to an independent Sanction Committee. The Sanction Committee, which is made up of a lawyer and participants from industry, retailers and certification bodies, shall make a decision on whether a breach exists and on its severity.

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Sanctions will be issued to the certification body and/or its auditors if the Sanction Committee concludes that a breach has been committed. The type of sanction depends on the number of breaches previously committed by the auditor and/or the certification body as well as the level of severity of such breaches. IFS Management informs the appropriate accreditation body if a breach for a certification body and/or for an auditor has been established. All these procedures are laid down in the contract between IFS and each certification body and all stakeholders of the IFS system are informed of the process. The IFS Integrity Program strengthens the reliability of the IFS scheme by checking the implementation of the IFS Standard in practice. Chart N 7: Summary of IFS Integrity Program activities
Integrity Program

Complaint management Investigation audits

Preventive QA measures Surveillance audits

Witness audit

On-site supplier audit

CB office audit

Witness audit

On-site supplier audit

CB office audit

IFS quality management sufficient evidence at hand/breach likely Sanction committee

Chairman lawyer

Participant from retailers

Participant from the industry

Participant from CBs without right to vote

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ANNEX 1: Clarification for the scope application of the different IFS Standards
IFS PACsecure is a Standard for auditing food and non-food packaging material manufacturers and converters and only concerns packaging processing and/or converting companies. IFS Food is a Standard for auditing food product suppliers/manufacturers and only concerns food processing companies or companies that pack loose food products. IFS Food shall be used when a product is processed or when there is a hazard for product contamination during the primary packing. IFS Logistics is a Standard for auditing companies whose activities are logistics oriented for food and non-food products, as well as packaging materials, such as transport, storage, distribution, loading/unloading, etc. It applies to all types of activities: delivery by road, rail or ship; frozen/refrigerated products or ambient stable products. Clarifications/examples of scope application between IFS PACsecure and IFS Logistics: IFS Logistics only concerns logistics activities where companies have a physical contact with already processed/converted packaging materials (transport, storage and/or distribution, transport and storage of pallets). When the processing company has its own logistics and/or transport department/activities (storage and distribution), it is included in the IFS PACsecure under the specific sub-chapter about transport or storage. Note: If the logistics operation owned by the processing company is situated in the same location as the company, and if the company or the customer wishes to get this operation IFS Logistics certified, an IFS Logistics audit can be performed. In this case, the following requirements shall be fulfiled: the logistics operation is only used for already packed packaging materials, in case of two (2) certificates (IFS PACsecure and Logistics), the respective scopes of each audit and certificate shall be clearly defined, the requirements of IFS PACsecure concerning transport and storage shall be anyway evaluated during the IFS PACsecure audit, an IFS PACsecure audit of the processing company shall be performed; IFS Logistics is an additional audit, all relevant documents shall be located at the platform.

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ate chapter of IFS PACsecure about storage and transport shall be clearly defined in the respective contract, or IFS Logistics applies. IFS Broker is a Standard for auditing companies such as trade agencies, brokers or any other companies that do not take physical possession of the products or material (e.g. which do not have warehouses, packing stations or truck fleet, but are legal entities with mailboxes, offices etc.). The Standard applies to food, packaging and household and personal care products. Matrix for the determination of the right IFS Standard
N Main activity of the company International Featured Standards IFS Food 1 Food processing (when products are processed or as soon as there is a hazard for product contamination) HPC processing (when products are processed or as soon as there is a hazard for product contamination) Food, Non-Food, HPC, packaging materials logistics activities Logistics activities only as service, no trading activities (when companies have a physical contact with already primary packed products or only for specific unpacked goods, such as meat carcasses or bulk/tanker transport (glucose syrup, milk, grain, etc.) Food, HPC, packaging trading without product contact (when no physical possession of products, only purchase sale from an office, no logistics activities) Cash & Carry/Wholesale (when distribution of products, small amount of processing activities can be included, under specific requirements) Packaging materials processing/converting (when packaging products are processed/ converted) IFS HPC IFS Log. 2 IFS Broker IFS C & C/ W. IFS PAC secure

Combined certification 7 Food/HPC/packaging material trading and Food/HPC/packaging material logistics Combined audit for trading AND logistics activities, with a specific combined check-list X X

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ANNEX 2: Certification process

1. Decision by the company to get certified against the IFS Standard 2. Reading of the respective copy of IFS Standard 3. Evaluation of the current status by the company 4. Selection by the company of the IFS certification body (accredited and approved). Quotation, decision and signature of contract Voluntary: Pre-Audit 5. Audit planning and preparation Realisation of the audit on-site at the determined date, by an auditor competent in the relevant scopes Together with certification body: Determination of the audit date Determination of audit times Definition of the audit scope

Opening meeting Evaluation of the documentation Site assessment and interviews of employees Creation of the audit conclusions Determination of 1 Major and particular circumstances Not approved before further actions Suspension of the current certificate Action plan and preliminary audit report sent to audited company Corrective actions of the non-conformities which have led to the Major within 6 months Validation of the corrective actions by the certification body 6. Closing meeting Information about the determined non-conformities 7. Preparation of a preliminary audit report and preparation of action plan by the auditor (2 weeks) 8. Completion of the action plan and determination of corrective actions by the audited company (2 weeks) 9. Return of the fulfilled action plan to the certification body/auditor (2 weeks) 10. Proofreading of the completed action plan by the certification body/auditor Checking the complete audit report and action plan (with mandatory review) by the certification body 11. Certification decision, determination of the certificate validity by the certification body 12. Awarding of certificate and sending of the final report to the audited company 13. Uploading of the audit datas into the IFS Audit portal (audit details, report, action plan and certificate) by the certification body 14. Three months before the audit expires, a reminder will be sent to the company by the IFS Audit portal for scheduling a new audit with the certification body. The audit shall be scheduled no later than the renewal audit date scheduled in the certificate. Determination of Majors, KO Audit not approved Suspension of the current certificate Action plan and preliminary audit report sent to audited company Voluntary completion of the action plan and return to the certification body Finalisation of the action plan and report upload into the IFS Audit portal No certificate

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ANNEX 3: Product scopes

In IFS PACsecure version 1, all activities of the company are related to product scopes as follows: Table 1: Product scopes
1. Flexible packaging 2. Rigid plastic 3. Paper 4. Metal 5. Glass 6. Other natural materials

Multi component packaging materials (e.g. Tetra Pak) have to be assigned based on the material which is the main component of the material. The main component of multi component packaging materials shall be mentioned in the scope of the audit on the report. Materials to be considered as other natural materials are, for example wood, clay, cork, jute, textiles, banana leaves, etc.

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ANNEX 4: Flow chart for management of KO scored with D and Major nonconformities
IFS PACsecure audit Audit result 1 Major and 75 % of the requirements are fulfilled =>15 % of the total possible amount is subtracted Not approved unless further actions are taken and validated after followup audit Suspension of the current certificate, max. two (2) working days after audit date Inserting the explanations in English about non conformity in IFS portal Send preliminary report and action plan template to the audited company Mandatory: completion of the action plan by the audited company and return to the certification body within two (2) weeks Uploading report in IFS portal (not visible) Time period to the next audit Initial audit, if > 6 months between audit where Major was issued and next audit Follow-up audit, if < 6 months between audit where Major was issued and next audit (earliest after six (6) weeks in case of failure concerning production activities) > 1 Major and/or < 75 % or More than one Major or One or several KOs scored with D Not approved Suspension of the current certificate, max. two (2) working days after audit date Inserting the explanations in English about non-conformity(ies) in IFS portal Send preliminary report and action plan template to the audited company Recommended: completion of the action plan by the audited company and return to the certification body within two (2) weeks Uploading report in IFS portal (not visible) Time period to the next audit Full new audit, scheduled not earlier than six (6) weeks after the audit where non-conformity(ies) was/were identified Positive audit result Uploading final IFS report in portal (visible)

Positive audit result Uploading final IFS report in portal (visible): In case of follow up audit: Define in the date section date of initial audit and date of follow up audit Define in the final result of audit section that a follow audit has taken place and that the Major has been solved In the observations regarding KO and Majors, explain on which requirement Major has been solved The company can not be certified with higher level, even if the final score is 95 % Date of end of validity of certificate based on date of initial audit

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Part 2: List of audit requirements

The following list contains the IFS PACsecure auditing requirements. The below chart demonstrates the connection between IFS PACsecure and PACsecure Prerequisite Program requirements. Additionally, there are examples given on questions auditors should ask (5th column) and examples for KO or Major scoring (6th column). The PACsecure Packaging Material Manufacturer & Converter Generic Food Safety Prerequisite Program (PP) contains foundation requirements on documentation, management and food safety program maintenance, and considers current packaging industry practices. The IFS PACsecure was developed taking into account this Program. PACsecure documents, workbooks and plans (Packaging Material Manufacturer & Converter Generic Food Safety Prerequisite Program, HACCP Workbooks and HACCP Plans) can be obtained from the Packaging Association of Canada. These documents can assist, for example, in implementing HACCP for a specific packaging material manufacturer, like e.g. manufacturers of flexible packaging and may be used as industry guidelines as mentioned in requirement 2.2.1.1

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Connection with PACsecure PP requirement number 5.0

Text/Number of connected PACsecure PP (Prerequisite Program) requirement

What to check? What should be asked?

Example for KO/Major

Part 2

Senior Management Responsibility

1.1 5.0 Management commitment to the food safety system is required. This may be demonstrated by the development and approval of a food safety policy or other statements of commitment to the food safety system. How and where is corporate policy documented? What are the contents of the corporate policy? How was corporate policy communicated to all employees? <corporate policy>, <posters> <documented evidence of corporate policy communication> Environmental responsibility and sustainability are included in the IFS PACsecure Standard, even if it is a packaging material safety and quality standard, in order to initiate/develop in companies processes of awareness for both topics. What short, medium and long term quality objectives are addressed? How are the objectives attained? What is the time frame to attain the objectives? Who is responsible for objectives attainment? What actions are taken by specific departments, e.g. purchase, to attain the objectives? <written review meeting minutes>, <list of attendees at review meeting>, <quality objectives>

Corporate policy/Corporate principles

1.1.1

The senior management shall draw up and implement a corporate policy. This shall consider as a minimum: customer focus environmental responsibility sustainability ethics and personnel responsibility product requirements (includes: product safety, quality, legality, process and specification). The corporate policy shall be communicated to all employees.

International Featured Standards IFS PACsecure Version 1

1.1.2

The corporate policy shall have objectives specifying responsibilities and timelines appropriate for the size and complexity of the organization.

IFS, October 2012

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1.1.3

From the corporate policy, the quality and packaging material safety objectives shall be communicated to the employees in the respective departments and shall be effectively implemented.

What quality objectives are defined? Are these objectives known by concerned employees? What tools are used to measure that the objectives have been attained? <list of attendees at review meeting>, <mailing list of review meeting minutes>, <posters showing the different department objectives> When is objective achievement reviewed? How often is this review performed? <review>, <review minutes>, <internal audit report> How is relevant information transmitted to concerned persons? <posters>, <distribution of meeting minutes> There is basically no review/other rating of objectives available.

1.1.4

The senior management shall ensure that the achievement of all objectives is regularly reviewed, as a minimum at least once a year.

1.1.5

All relevant information related to packaging material safety and quality shall be communicated effectively and in a timely manner to the relevant personnel.

A packaging material safety and/or legality issue occurs due to missing communication within the company.

1.2

Corporate structure Is an organisation chart available? How is the organisation structured? <organisation chart> For which positions do written job descriptions exist? What is regulated in the job descriptions? Who, for example substitutes QA manager during his absence? <responsibility description for important key staff dedicated to a specific person, e.g. QA Manager, Production Manager, Shift Leader > 5.0 What is the content of the job descriptions? For which positions do job descriptions exist? For each prerequisite program and HACCP Plan the responsibility for complying with the requirements of this standard is assigned to a competent employee. When a packaging material Safety and Legality issue occurs due to failure to define responsibilities for existing company regulations.

1.2.1

An organisation chart shall be available showing the structure of the company.

International Featured Standards IFS PACsecure Version 1

1.2.2

Competences and responsibilities, including deputation of responsibility shall be clearly laid down.

1.2.3

Part 2

Job descriptions with clearly defined responsibilities shall exist and shall be applicable for employees whose work has an effect on product requirements.

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Connection with PACsecure PP requirement number 5.0 The authority to develop, implement and maintain the prerequisite programs will be established by management. How is it ensured that employees know their responsibilities? How does senior management ensure that employees know their responsibilities? Who is responsible for packaging material safety? When senior management does nothing to ensure that employees know their responsibilities. When during the audit the Auditor has evidence that key employees are not aware of their responsibilities and this leads to a packaging material safety and/or legality issue. Key employees are not aware of their responsibilities.

Text/Number of connected PACsecure PP (Prerequisite Program) requirement

What to check? What should be asked?

Example for KO/Major

Part 2

1.2.4 KO

KO N 1: The senior management shall ensure that employees are aware of their responsibilities related to packaging material safety and quality and that mechanisms are in place to monitor the effectiveness of their operation. Such mechanisms shall be clearly identified and documented.

1.2.5

Employees with influence on product requirements shall be aware of their responsibilities, and shall be able to demonstrate their understanding of their responsibilities.

5.0

Key personnel and responsibilities will be identified in the written program.

<interview of at least: QSMD, person responsible for labeling/printing, person responsible for product development, person responsible for production, person responsible for monitoring CPs > Who is the IFS PACsecure representative? What are the responsibilities of the IFS PACsecure representative? Is the function of the IFS PACsecure representative clearly laid down? <job description>, <organization chart> How were the necessary resources defined? <budget plan>

1.2.6

The company shall have an IFS PACsecure representative nominated by senior management.

No IFS PACsecure representative exists.

International Featured Standards IFS PACsecure Version 1

1.2.7

The senior management shall provide sufficient and relevant resources to meet the product requirements.

When senior management doesnt provide enough resources and this leads to a packaging material safety and/or legality issue.

IFS, October 2012

 IFS, October 2012

1.2.8

The department responsible for quality and packaging material safety management shall have a direct reporting relationship to the senior management. What criteria are used to ensure process control? What is done to ensure that processes are known to relevant personnel (incl. permanent staff and temporary/seasonal workers)? Processes can be understood as ISO processes (see also chapter 2.3, Part 1 of the standard) How does management ensure that all relevant packaging safety laws are in place and known? How does management ensure that purchased products comply with all relevant legislation? How does management ensure that manufactured products comply with all relevant legislation? <packaging material laws subscription>, <training> For example, if regulatory bodies come to the company and identify that something is wrong (related to legality/quality/safety) on a private label product, the company shall inform the relevant customer accordingly. If this product is also manufactured for other customers and if the identified deviation/ non-conformity also has an impact on the other private labels, the company shall also inform these other relevant customers. When key personnel have no process knowledge and this leads to a packaging material safety and/or legality issue.

Who is the QS manager? To whom does the QS manager report? <job description>, <organization chart>

1.2.9

The company shall ensure that all processes (documented and undocumented) are known by the relevant personnel and are applied consistently.

1.2.10

The company shall have a system in place to ensure that it is kept informed of all relevant legislation on packaging material safety and quality issues, scientific and technical developments and industry codes of practice.

When absence of legal knowledge and information on relevant laws lead to a packaging material safety and/or legality issue.

International Featured Standards IFS PACsecure Version 1

1.2.11

The company shall inform its customers, as soon as possible, of any issue related to product specifications or other legally required documentation in particular of all non-conformity(ies) identified by competent authorities related to products which could have, has or has had a defined impact on safety and/or legality of respective products. This could include, but are not limited to cautionary issues.

1.3

Customer focus Part 2

1.3.1

A documented procedure shall be in place to identify fundamental needs and expectations of customers.

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How are customer needs and expectations identified? How often are these identified? <questionnaire/survey regarding customer needs and expectations>

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Connection with PACsecure PP requirement number What were the results of the last customer survey? <analysis of customer surveys> How these results were evaluated regarding quality objectives? <quality objectives> Have identified needs influence on the production process? <survey analyses> 6.1 6.6 When the quality management system is not reviewed regularly and there is no assurance that it works properly.

Text/Number of connected PACsecure PP (Prerequisite Program) requirement

What to check? What should be asked?

Example for KO/Major

Part 2

1.3.2

The results of this procedure shall be evaluated and considered to determine quality and packaging material safety objectives.

1.4

Management review

International Featured Standards IFS PACsecure Version 1

1.4.1

Senior management shall ensure that the quality and packaging material safety management systems are reviewed at least annually or more frequently if changes occur. Such reviews shall contain, at least, results of audits, customer feedbacks, process compliance and product conformity, status of preventive and corrective actions, follow up actions from previous management reviews, changes that could affect the packaging material safety and quality management systems and recommendations for improvement.

IFS, October 2012

Management will When is the quality and safety managedetermine the internal ment system reviewed and evaluated? activities required to How often was the system reviewed last ensure the requirements year? of this standard are met. What was the result of the review? <review report> The food safety pro Does the management review take into gram shall be reviewed consideration, as a minimum, the assessat least once per year to ment of the following: assess if it is: documents from the previous manage Current. That is, it ment review, reflects factors results from internal and external audits, including, but not as well as inspections, limited to: performance indicators for customers, Applicable standcomplaints and withdrawals/recalls, ards. incidents, corrective actions, results out Operational/Process/ of specifications and non-conforming materials, Material changes. process performance and product Organization compliance, changes. review of hazard analysis/risk assessment Scientific developments. system and changes which may affect qua Implemented. lity and packaging material safety system, Maintained. evolutions of scientific information related to products, Results of the re-assess improvement of quality system efficiency ment are used to and production process, update, maintain or improvement of product, related to improve the food safety customer requirements, system. needs in resources (including investments)?

 IFS, October 2012

1.4.2

This review shall include the evaluation of measures for the control of the quality and packaging material safety management system and for the continuous improvement process.

6.1

The frequencies of completing activities will be established and will ensure the effective implementation and maintenance of the packaging material safety system. When is infrastructure (building, machinery, transport) evaluated? What was the result of infrastructure evaluation? <audit report> Who evaluated infrastructure? What were the results of the infrastructure assessment? <corrective actions> <investment plan> Were the results used for further infrastructure planning? <investment plan> What risks were identified according to the results of infrastructure assessment? <hazard analysis> What are infrastructure related investments for the near future? <investment plan> When infrastructure is not evaluated and therefore a risk for legality, safety and quality of products occurs.

Based on the review result, have any actions for improvement been taken? <improvement actions>

1.4.3

The company shall identify and review regularly (e.g. by internal audits or on-site inspection) the infrastructure needed to achieve conformity to product requirements. This shall include, as a minimum, the following: buildings supply systems machines and equipment transport. The results of the review shall be considered, with due consideration to risk, for investment planning.

International Featured Standards IFS PACsecure Version 1

1.4.4

The company shall identify and review regularly (e.g. by internal audits or on-site inspection) the work environment needed to achieve conformity to product requirements. This shall include, as a minimum the following: staff facilities environmental conditions hygienic conditions workplace design external influences (e.g. noise, vibration). The results of the review shall be considered, with due consideration to risk for investment planning.

When work environment is not evaluated and therefore a risk for legality, safety and quality of products occurs.

Part 2

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When is the work environment (staff facilities, environmental conditions, safety and security at work, hygienic conditions, workplace design etc.) evaluated? What was the result of work environment evaluation? <audit report> Who evaluated work environment? What were the results of the work environment assessment? <corrective actions> <investment plan> Were the results used for further work environment planning? <investment plan> What risks were identified according to the results of the work environment assessment? <hazard analysis> What are work environment related investments for the near future? <investment plan>

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Connection with PACsecure PP requirement number

Text/Number of connected PACsecure PP (Prerequisite Program) requirement

What to check? What should be asked?

Example for KO/Major

Part 2

Quality and Packaging Material Safety Management System 4.1

2.1

Quality management

2.1.1

Documentation requirements

International Featured Standards IFS PACsecure Version 1

IFS, October 2012

Control of Documents Documents are created and maintained to ensure the effective development, implementation, maintenance and improvement of the food safety system. A document control procedure is established that will define how documents are: Approved. Reviewed, revised and updated. Remain legible and easily identifiable. Identified, including current status (e.g. revision level). Maintained so current versions are available for use and unintended use is prevented. Each prerequisite program requires proper documentation of the program elements and supporting information including, but not limited to: Standard operating procedures. Forms. Checklists. Corrective Action Reports. Food Safety Program Reassessment.

 IFS, October 2012

2.1.1.1

The system of packaging material safety and quality management shall be documented and implemented, and shall be retained in one location (packaging material safety and quality manual or electronic documented system). 4.1 What rules exist regarding document control? Do the documents have an identification code? How is the identification code structured? How can a revision be identified? Who is responsible for changes <procedure for documents> Are all documents legible? Are the documents unambiguous? Are the documents available at the right places? Also after office hours? How do relevant employees have access to documents? How are document changes communicated to relevant employees? Are there any distribution lists for documents? <examples>, <procedure>, <distribution lists> How is document validity identified? How is it ensured that only valid documents are in circulation? When documents do not state clearly which exist, are in use and valid.

4.1

Where is documentation concerning the quality system for quality assurance and packaging material safety retained? <procedure for document control>

When there is no quality system for quality assurance and packaging material safety in place.

2.1.1.2

A documented procedure shall exist for the control of documents and their amendments.

2.1.1.3

All documents shall be clearly legible, unambiguous and comprehensive. They shall be available to relevant personnel at all times.

4.1

When documents are unavailable and this endangers legality, safety or quality of the product.

International Featured Standards IFS PACsecure Version 1

2.1.1.4

All documents which are necessary for compliance with the product requirements shall be available in their latest version.

4.1

When void/obsolete or out-of date documents are not identified as such and thus endanger legality, safety or quality. Are the reasons for any amendments to documents, critical for the product requirements recorded? <examples>

2.1.1.5

The reason for any amendments to documents critical for the product requirements shall be recorded.

4.1

Part 2

2.1.2 4.2

Record keeping Records are established to provide objective evidence of conformity to the requirements of the food safety program. What records exist? Are the records complete? Are the records available? When insufficient or no records are made and thus endanger legality, safety or quality.

2.1.2.1

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All relevant records necessary for the product requirements shall be complete, detailed and maintained and shall be available on request.

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Connection with PACsecure PP requirement number 4.2 A procedure is established that will define how food safety related records are maintained so that they are: Legible. Readily identifiable and retrievable. Auditable. Protected and stored to prevent damage or deterioration. Stored for an appropriate retention period. Properly disposed. Records include, but are not limited to, completed: Forms. Checklists. Service Agreements and Contracts. Corrective Action Reports. Food Safety Program Reassessment. Are records plausible? Are records legible? What kind of assurance is given that records cannot be subsequently manipulated? Are the records reviewed by a supervisor? When records are illegible and therefore no evidence exists for legally required checks/inspections.

Text/Number of connected PACsecure PP (Prerequisite Program) requirement

What to check? What should be asked?

Example for KO/Major

Part 2

2.1.2.2

Records shall be legible and genuine. They shall be maintained in a way that subsequent manipulation of records is prohibited.

International Featured Standards IFS PACsecure Version 1

2.1.2.3

All records shall be kept in accordance with legal requirements and for a minimum of one year after the recommended converting time. For products which have no recommended converting time, the duration of record keeping shall be justified and this justification shall be documented.

4.2

When records are not stored in accordance to legal requirements. Where are records stored? Who stores records? How long are records kept? On what basis were record storage times defined? For products with a short recommended converting time, was record storage time definition based on hazard analysis? If a recommended converting time is defined, corresponding records shall be available at least until that date. <procedure documents>, <hazard analysis>

IFS, October 2012

 IFS, October 2012

2.1.2.4

Any amendments to records shall only be carried out by authorized persons.

4.1

How are amendments to records carried out? Who is authorized to make amendments? How are amendments authorized?

When a general problem exists regarding record changes/amendments in the company.

2.1.2.5

Records shall be securely stored and easily accessible.

What is the process in place to make documents and data available and readable? <backup system>, <storage condition>

2.2 See generic HACCP models PACsecure The companys hazard analysis/risk assessment plan is based on what principles? Has every site/plant a separate hazard analysis/risk assessment plan? Which specific regulations are taken care of in hazard analysis/risk assessment plan? < hazard analysis plan> are the legal requirements of the destination country are known, especially the labeling regulation?

Packaging Material Safety Management

2.2.1

Hazard analysis and risk assessment system

International Featured Standards IFS PACsecure Version 1

2.2.1.1

The basis of the companys packaging material safety control system shall be a fully implemented, systematic and comprehensive hazard analysis and/or risk assessment system, based upon the Codex Alimentarius principles or on industry guidelines. It shall take into account any legal requirements of the production and destination countries which may go beyond such principles. The hazard analysis and/or risk assessment system shall be implemented at each production site.

If there is no hazard analysis/risk assessment plan. If legal requirements are not included in hazard analysis/risk assessment plan If there is no hazard analysis/risk assessment plan for each individual site/plant.

2.2.1.2

Part 2

The hazard analysis and/or risk assessment system shall cover all raw materials, products or product groups as well as every process from goods into dispatch, including product development and product packaging.

Does hazard analysis/risk assessment plan cover all product groups and processes incl. product development and product wrapping material? Which processes are performed? <product group overview>, <flow chart>

When the hazard analysis/risk assessment plan does not cover all product groups and processes.

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Connection with PACsecure PP requirement number Is the hazard analysis/risk assessment plan based upon scientific literature or technically verified specifications or other legally required documentations relating to the manufactured products and procedures? How are new technical developments taken care of? <references of used literature, etc.> Does the hazard analysis/risk assessment system meet all applicable regulatory requirements of the country in which it is established, including the required and applicable risk assessments and supporting documentation? (Where applicable, such regulatory requirements will supercede requirements of the standard. Related to Canadian and US law, certain forms and formats are required.) How are product development/product modification and hazard analysis interconnected? When hazard analysis/risk assessment plan is not based on scientific literature or technically verified data about products and processes and therefore causes a packaging material safety or legality risk.

Text/Number of connected PACsecure PP (Prerequisite Program) requirement

What to check? What should be asked?

Example for KO/Major

Part 2

2.2.1.3

The company shall ensure that the hazard analysis and/or risk assessment system is based upon scientific literature, or technical verified specifications or other legally required documentations relating to the manufactured products and procedures. This shall be maintained in line with new technical process development.

2.2.1.4

The hazard analysis and/or risk assessment system shall be reviewed and necessary changes shall be made when any modification is made in the product, process or any step.

2.2.2

Hazard analysis and/or risk assessment team Although there is a lack of product knowledge no external expert has been consulted and this results in packaging material safety and legality risk. Who is member of the hazard analysis/ risk assessment team? Which departments/functions are included in the hazard analysis/risk assessment team? How was qualification for hazard analysis/risk assessment team membership verified? <evidences for education, advanced training> What hazards are connected to the product? Does a contract exist with an external expert? <service contract>

International Featured Standards IFS PACsecure Version 1

2.2.2.1

IFS, October 2012

Assemble hazard analysis and/or risk assessment team The hazard analysis and/or risk assessment team shall be multidisciplinary and include operational staff. Personnel appointed as hazard analysis and/or risk assessment team members shall have specific knowledge of hazard analysis and/or risk assessment, product and process knowledge and the associated hazards. Where competent knowledge is not available, external expert advice shall be obtained.

 IFS, October 2012

2.2.2.2

Those responsible for the development and maintenance of the hazard analysis and/or risk assessment system shall have an internal team leader and shall have received adequate training in the application of the hazard analysis and/or risk assessment principles. Who is member of the hazard analysis/risk assessment team? Is the team well known across the company? How was it announced? <job descriptions>, <team matrix>, <blackboard notice>, <presence of management in any hazard analysis brief>, <result of hazard analysis rewiew include in Management review>, <attribution of resources> See generic HACCP models PACsecure Form 1 Does a complete product description exist for each product? What is included in the product description? <product description> <product specification> When there are no product descriptions for each product. When product descriptions do not provide essential product data. When essential information does not match legislation (e.g. migration test values). When no hazard analysis/risk assessment team exists or no person has been appointed hazard analysis team leader.

What is the content of a hazard analysis/risk assessment training course? <hazard analysis training proofs> When was the last hazard analysis/risk assessment training course held? <training evidences> Who participated in the hazard analysis/risk assessment training course? <training evidences>

2.2.2.3

The hazard analysis and/or risk assessment team shall have strong senior management support and shall be well known and established across the whole facility.

2.2.3

Hazard analysis and risk assessment

International Featured Standards IFS PACsecure Version 1

2.2.3.1

Describe product The assessment shall make reference to the full description of the product including all applicable relevant information on product safety such as: composition (raw materials, rework, reprocessing, recycled waste etc.), physical, chemical and microbiological parameters, methods of treatment, wrapping, labeling, durability (shelf life), conditions for storage and method of transport.

Part 2

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Connection with PACsecure PP requirement number Form 1 What is the intended use of the product by customer? What is the intended use of the product by final consumer? Are there any restrictions for usage? <product description> Are flow charts available for all products? Are the flow charts dated? <flow charts for all products> When there is a packaging material safety risk for consumers due to lack of definition for usage. Flow charts are unavailable for any of the products, charts or are not conform to the specifications or other legally required documentation. When flow charts are not validated.

Text/Number of connected PACsecure PP (Prerequisite Program) requirement

What to check? What should be asked?

Example for KO/Major

Part 2

2.2.3.2

Identify intended use The intended use of the product shall be described in relation to the expected use of the product by the consumer, taking into account vulnerable groups of consumers. Form 3

2.2.3.3

Construct flow diagram A process flow diagram shall be evaluated against each product, or product group, and for all variations of the processes and sub-processes.

2.2.3.4

On-site confirmation of the flow diagram The risk assessment team shall review the processes at all operation stages against the flow diagram. Where appropriate, amendments of the diagram will be made. Form 3, 5, 6, 7

Form 3

Was the flow chart confirmed during a hazard analysis/risk assessment meeting? <meeting minutes>

2.2.3.5

Conduct a hazard analysis and risk assessment for each step An assessment shall be available of all physical, chemical and biological hazards that may reasonably be expected.

Does a hazard analysis/risk assessment exist for each step? <hazard analysis> Does it include every hazard? Which biological, physical and chemical hazards can be expected? <hazard analysis>

When a hazard analysis/risk assessment was not performed for each step. When hazards were not properly assessed or not all significant hazards were taken into account and a safety issue exists. Does a hazard analysis for all product groups including harm and likelihood exist? <hazard analysis> When, due to lack of a hazard analysis, a safety risk exists.

International Featured Standards IFS PACsecure Version 1

IFS, October 2012

2.2.3.5.1

The hazard analysis shall demonstrate the motivation if a hazard is a risk, taking into account the likelihood of harm to the consumer and the potential severity of damage (effect, potential consequences).

 IFS, October 2012

2.2.3.5.2

All risks that need specific monitoring and/or preventive actions shall be identified as Control Points (CP). Clear limits and registration of the risk identification shall be available.

4.1 6.5 Form 3, 5, 6, 7, 8 Which CPs were defined? How many CPs exist Is a clear limit defined for each CP? What clear limits are defined? How were the critical limits determined? <hazard analysis> <flow chart> <decision tree>

Each prerequisite program requires proper documentation of the program elements and supporting information including, but not limited to: Standard operating procedures. Forms. Checklists. Corrective Action Reports. Food Safety Program Reassessment. Changes to the prerequisite programs will be reviewed and approved by authorized personnel. How are CPs monitored? Are the CPs under control? How is the monitoring of each CP documented? Who documents? Are date, time, responsible employee and result/reading documented? How long will records be stored? Where are records stored? Which prerequisite measures are documented? How are the measures documented? <hazard analysis> <flow chart>, <decision tree>, <prerequisite measures> When CPs were not identified as such and/or they are not under permanent control so that a safety risk exists.

When there are no clear limits for each CP or they are insufficient and this causes a safety risk.

International Featured Standards IFS PACsecure Version 1

2.2.3.5.3

For all risks that are identified as Control Points (CP) to manage the identified risk, the company shall implement, maintain and document specific preventive measures and monitoring procedures. Records of monitoring shall be maintained for a relevant period.

Form 3, 5, 6, 7, 8

2.2.3.6

Form 10

Part 2

What corrective actions exist for each CP? When was a corrective action carried out? Where are corrective actions documented? Who documents the taken corrective actions? <CP records> <corrective actions>

When there are no corrective actions defined or no corrective actions are taken. When corrective actions are not documented.

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Establish corrective actions For each CP corrective actions shall be established. In case the monitoring indicates that a particular CP is not under control, adequate corrective actions shall be taken and documented. Such corrective actions shall also take into account any non-conforming products.

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Connection with PACsecure PP requirement number 6.2 Form 10 Verification activities are completed for each prerequisite program to confirm that the programs are: Properly implemented. Adequately maintained. Suitable to the operations of that establishment in controlling identified food safety hazards. Verification activities may include, but are not limited to: Internal Inspections. Document review. Internal Audits. External Audits, Assessments, Inspections. End product testing. Documents are created and maintained to ensure the effective development, implementation, maintenance and improvement of the food safety system. What hazard analysis/risk assessment plan related documents exist? Do these documents include processes, procedures and results? <inspection plans>, <records>, <product descriptions>, <hazard analysis>, <risk assessment> How often is the hazard analysis/risk assessment plan verified? What was the date of the last verification? What was the result of the last verification? Does the hazard analysis/risk assessment plan reflect the results of the verification? What was the last date when the hazard analysis/risk assessment plan was changed? <audit reports or other reports for validation> When no verification was carried out and this leads to a safety risk.

Text/Number of connected PACsecure PP (Prerequisite Program) requirement

What to check? What should be asked?

Example for KO/Major

Part 2

2.2.3.7

Establish verification procedures Procedures of verification shall be established to confirm that the risk management system is effective. Verification of the risk management system shall be performed at least once a year. Examples of verification activities include: internal audits, analysis, sampling, evaluations, complaints by authorities and customers. The results of this verification shall be incorporated into the risk management system.

2.2.3.8

Establish documentation Documentation shall be available, covering all processes, procedures, measures and records. Documentation and record keeping shall be appropriate to the nature and size of the company.

4.1

When hazard analysis/risk assessment plan is not sufficiently documented and this leads to a legality issue.

International Featured Standards IFS PACsecure Version 1

Resource Management

IFS, October 2012

3.1

Human resources management

 IFS, October 2012

3.1.1

All personnel performing work that affects product safety, legality and quality shall have the required competence by education, work experience and/or training, commensurate with their role, based on hazard analysis and assessment of associated risks.

D 1.1.1

How is it assured that new employees have the right capabilities for the job?

When, due to lack of education, experience or training the legality or safety of the product is jeopardized.

3.2

Human resources

3.2.1 D 1.1.1 2, 3, 4

Personnel hygiene

3.2.1.1

International Featured Standards IFS PACsecure Version 1

There shall be documented requirements relating to personnel hygiene. These include, as a minimum, the following fields: protective clothing hand washing and disinfection eating and drinking smoking actions to be taken in case of cuts or skin abrasions fingernails, jewelry and personal belongings hair and beards. The requirements shall be based on hazard analysis and assessment of associated risks in relation to product and process. D 2.1.1/2 How is the hygiene policy communicated? <hygiene rules for employees> Are personnel hygiene rules also followed by external service providers/workmen and visitors? <hygiene rules for visitors> How is it assured that external persons know the relevant hygiene rules? <hygiene rules for visitors>

What is the policy regarding personal hygiene? <hygiene rules for employees> The rules regarding personnel hygiene include hand cleaning, food, beverages and other material, smoking, handling of injuries, finger nails and jewelry, hair and beards? Are the rules based on a hazard analysis? <hazard analysis> Where is it allowed to smoke? How should lesions be treated/covered? What kinds of hair restraints are needed in which areas? Example of result from the hazard analysis and assessment of associated risks: if gloves are used, then hand disinfection is not required for low risk production.

When insufficient rules for personal hygiene cause a safety risk. When no corresponding hazard analysis exists.

3.2.1.2 KO

KO N 2: The requirements for personnel hygiene shall be in place and applied by all relevant personnel, contractors and visitors.

When, during the audit major violations of the rules are identified that lead to a safety risk.

Part 2

3.2.1.3

Compliance with personnel hygiene requirements shall be checked regularly.

61

How are employees monitored during work? <hand swab tests, etc.> Is employee compliance to hygiene rules checked on a regular basis? <minutes site inspection>, <list of identified failures>, etc.

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Connection with PACsecure PP requirement number D 1.1.1 D 2.1.1 D 1.2.1 2,3 1 3 Is it allowed to use jewelry and watches in production areas? <personnel hygiene rules> Is allowance based on risk hazard analysis? <hazard analysis> When wearing jewelry or a watch causes a packaging material or employee safety risk.

Text/Number of connected PACsecure PP (Prerequisite Program) requirement

What to check? What should be asked?

Example for KO/Major

Part 2

3.2.1.4

Visible jewelry (incl. piercing) and watches shall not be worn. Any exceptions shall have been comprehensively evaluated by hazard analysis and assessment of associated risks in relation to product and process. This shall be effectively managed. D 2.2.13 1,2,3 What color is plaster and where is it used? Does the plaster contain a metal strip? What is an employee required to observe in case of hand injury? <personnel hygiene rules>

3.2.1.5

Cuts and skin abrasions shall be covered by a colored plaster/bandage (different from the product color)containing a metal strip, where appropriateand in case of hand injuries, in addition to a plaster/bandage, a single use glove shall be worn.

When hand injuries ensue a product safety risk (e.g. an uncovered purulent wound that comes into contact with the product).

3.2.2

Working conditions and protective clothing for personnel, contractors and visitors D 2.1.12 1,2 What are the rules regarding protective clothing? <personnel hygiene rules> Are the protective clothing rules based on hazard analysis? <hazard analysis> When must protective clothing be changed? <personnel hygiene rules> examples of areas: catering, changing rooms, smoking area, toilets, etc. In which production areas is wearing of protective headgear and/or beard snood mandatory? What kind of headgear is used? How shall headgear be used? <personnel hygiene rules> When the lack of protective clothing ensues a product safety risk.

3.2.2.1

Company procedures shall exist to ensure that all personnel, contractors and visitors are aware of the rules regarding the management of wearing and changing of protective clothing in specified areas in accordance with product requirements.

International Featured Standards IFS PACsecure Version 1

IFS, October 2012

3.2.2.2

In work areas where wearing headgear and/or beard snood (coverings) is required, the hair shall be covered completely, so that product contamination is prevented.

D 2.1.2

When incorrect wearing or absence of headgear and/or bear snood ensues a product safety risk.

 IFS, October 2012

3.2.2.3

Clearly defined usage rules shall exist for work areas/activities where it is required to wear gloves (colored differently from the product color). Compliance with these rules shall be checked on a regular basis.

D 2.1.2

In which production areas is wearing of gloves mandatory? <personnel hygiene rules> What kinds of gloves are used? When must gloves be changed? How is the compliance with these rules checked? <on site inspections> How many protective suits/uniforms are at the disposal of each employee? How often is an employee supposed to change his/her protective suit/uniform? How is protective clothing laundered? <personnel hygiene rules> Are there any employees who launder their protective clothing at home? Is protective clothes laundering based on a hazard analysis? <hazard analysis> When employees do not have protective clothing and therefore a product contamination risk exists. When insufficient laundering ensues a product contamination risk.

When missing or unclean gloves ensue a product safety risk.

3.2.2.4

Suitable protective clothing shall be available in sufficient quantity for each employee, when required.

3.2.2.5

When required, all protective clothing shall be thoroughly and regularly laundered. Hazard analysis and assessment of associated risks, together with consideration given to the processes and products of the company shall determine if clothing shall be washed by a contract laundry, on site laundry or by the employee.

International Featured Standards IFS PACsecure Version 1

3.2.2.6

Guidelines shall exist for laundering of protective clothing and a procedure shall be in place for checking its cleanliness, when required.

How is the laundering procedure checked for effectiveness? <protective clothes swab test results> What guidelines exist regarding protective clothes laundering? <personnel hygiene rules> How the good working condition of personnel is followed? How are personnel informed?

3.2.2.7

Senior management shall ensure hazardous working conditions that could cause injuries to personnel are identified and preventive measures are managed.

3.2.2.8

Does an inspection plan exist? <report of inspection>

Part 2

63

The company shall review that preventive measures to ensure personnel safety related to hazardous working conditions are effective, in line with applicable legislation or recognized conventions.

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Connection with PACsecure PP requirement number

Text/Number of connected PACsecure PP (Prerequisite Program) requirement

What to check? What should be asked?

Example for KO/Major

Part 2

3.2.3 D 2.1.12 D 2.2.13 1, 2 1, 2, 3, 4, 5 How shall personnel and visitors behave in case or suspicion of an infectious disease? How is it ensured that personnel and visitors know the guidelines? <personnel hygiene rules> <visitors hygiene rules>

Procedures applicable to infectious diseases When due to an employees infectious disease a product safety risk is given and no preventive steps are taken by the company.

3.2.3.1

There shall be written and communicated measures for personnel, contractors and visitors to declare any infectious disease which may have an impact on packaging material safety. In case of declaration of infectious disease, actions shall be taken in order to minimize risk of contamination of products.

3.3 1, 2, 3 1, 2, 3, 4, 5 D 1.2.14 7.0 D 1/D 2 D 1.1.1

Training and instruction Who is responsible for training? <training evidences> What are the evidences for the trainers qualification? What was the content of the last training session? <training program> How are foreign employees trained/ instructed? Who participates in the training sessions? How are the instruction necessities for each employee determined? How often are training sessions held? <training schedule> Are prospective employees (incl. seasonal and temporary workers) trained/instructed upon employment? Which employees are trained/instructed upon employment? What is the content of these instructions? <training evidences> When due to lack or insufficient training a product safety or legality risk exists. When legally required packaging material safety instructions are not undertaken.

3.3.1

The company shall implement documented training and/or instruction programs with respect to the product requirements and the training needs of the employees based on their job and shall include: training contents training frequency employees task languages qualified trainer/tutor evaluation methodology.

International Featured Standards IFS PACsecure Version 1

3.3.2

D 1.2.14

1, 2, 3, 7

IFS, October 2012

The documented training and/or instruction shall apply to all personnel, including seasonal and temporary workers and employees from external companies, employed in the respective work area. Upon employment, and before commencing work, they shall be trained in accordance with the documented training/instruction programs.

 IFS, October 2012

3.3.3

Records shall be available of all training/instruction events, stating: list of participants (this shall include their signature) date duration contents of training name of trainer/tutor. There shall be a procedure or program in place to prove the effectiveness of the training and/or instruction programs. D 1.2.14 4, 5 How are training contents reviewed? <review test> When are training contents reviewed? When was the latest training content update done? What was the content of the latest update? <audit results> specific issues: non-conformitites, failure, complaints, etc During the on-site audit evidence was given that employees did not act according to knowledge transmitted in the training sessions and this lead to a product safety risk.

D 1.2.14

5, 7

Which training courses are undertaken? Are there any special training courses? Are training courses documented? What has been documented? Have participants signed the training proofs? How often are hygiene training sessions held? What was the content of the last hygiene training session? <training evidences>

No training proofs exist to confirm that employees were trained/instructed.

3.3.4

The contents of training and/or instruction shall be reviewed and updated regularly and take into account companys specific issues, packaging material safety, packaging material related legal requirements and product/process modifications.

3.4 4 1, 2, 3 1, 2, 3, 4, 5, 6, 7, 8, 9 A 3.1.2 7.0 A3 A 3.1.1 A 3.1.2

Sanitary facilities, equipment for personnel hygiene and staff facilities How many employees are there? Do they have access to a cafeteria? Are there locker-rooms? Where are the restrooms? Are there bathing facilities? <plant lay-out> Staff facilities = e.g. changing room, smoking area, dining room, etc. When social facilities are underequipped or are out of proportion to the number of employees so that a safety issue arises.

International Featured Standards IFS PACsecure Version 1

3.4.1

The company shall provide staff facilities, which shall be proportional in size, equipped for the number of personnel and designed and operated so as to minimize packaging material safety risks. Such facilities shall be kept in clean and good condition.

3.4.2

Part 2

The risk of product contamination by foreign material from staff facilities shall be evaluated and minimized. Consideration shall also be given to food and other material brought to work by personnel and personal belongings.

65

May employees bring food and other material from home? <personnel hygiene rules> May employees take medicine along to their work place? <personnel hygiene rules> Does a hazard analysis exist regarding foreign material from social facilities? <hazard analysis>

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Connection with PACsecure PP requirement number

Text/Number of connected PACsecure PP (Prerequisite Program) requirement

What to check? What should be asked?

Example for KO/Major

Part 2

3.4.3

There shall be in place rules and facilities to ensure the correct management for personnel belongings and for food and other material brought to work by personnel, food coming from dining room and from vending machines. The food and other material shall only be stored and/or used in designated areas. A 3.1.2 7,8 Are there locker-rooms for employees and visitors with separation for outdoor and protective clothing?

3.4.4

The company shall provide suitable changing rooms for personnel, contractors and visitors. Where necessary, outdoor clothing and protective clothing shall be stored separately. A 3.1.2 A 3.1.1 6 3

3.4.5

Toilets shall not have direct access to an area where packaging material products are handled. The toilets shall be equipped with adequate hand washing facilities. Sanitary facilities shall have adequate natural or mechanical ventilation. Mechanical airflow from a contaminated area to a clean area shall be avoided. A 3.1.1 1,2

Do toilets open directly into production areas?

When toilet exhaustion poses a contamination risk.

3.4.6

Adequate hand hygiene facilities shall be provided at access points to and within production areas, as well as at staff facilities. Based on hazard analysis and assessment of associated risks, further areas (e.g. wrapping area) shall be similarly equipped. A 3.1.1 1

Are there enough hand washing facilities available at the entrance to processing areas and in social areas?

When a contamination problem occurs due to lack of hand washing facilities.

International Featured Standards IFS PACsecure Version 1

IFS, October 2012

3.4.7

Hand washing facilities shall provide as a minimum: running potable water at an appropriate temperature liquid soap appropriate equipment for hand drying.

Are all hand washing facilities provided with appropriate equipment for hand drying and liquid soap? Are all hand washing facilities provided with running potable water at an appropriate temperature?

 IFS, October 2012

3.4.8

If necessary, following additional requirements regarding hand hygiene shall also be provided: hand contact-free fittings hand disinfection adequate hygiene equipments signage highlighting hand hygiene requirements waste container with hand contactfree opening. A 3.1.1 2

A 2.1.1

1, 2, 3, 4, 5

Are all areas where due to risk assessment extended hygiene requirements are necessary equipped with hand washing facilities with hand contact-free fittings, hand disinfection devices and signs or pictograms? <signs/pictograms>

When a contamination problem occurs due to lack of appropriate hand washing facilities.

3.4.9

Based on hazard analysis and assessment of associated risks, there shall be a program to control effectiveness of hand hygiene. A 3.1.2 6 Do locker-rooms give direct access to processing areas? How is protective clothing handled during breaks/intervals? <personnel hygiene rules> Does a hazard analysis exist for lockerrooms with no direct access to processing areas? <hazard analysis> Are there cleaning facilities for boots and protective aprons?

3.4.10

Changing rooms shall be separated from production area and shall be situated so that they allow direct access to the areas where packaging material products are handled. Based on hazard analysis and assessment of associated risks, exceptions shall be justified and managed.

When a contamination occurs due to locker-room location which leads to packaging material product safety problem.

International Featured Standards IFS PACsecure Version 1

3.4.11

Where the hazard analysis and assessment of associated risks show the necessity, cleaning facilities shall be available and used for boots, shoes and further protective clothing.

Planning and Production Process

4.1

Contract agreement

4.1.1

Part 2

The requirements which are defined between the contract partners shall be established, agreed upon and reviewed concerning their acceptability before a supply agreement is concluded. All clauses related to quality and packaging material safety shall be known and communicated to each relevant department.

When there are no approved specifications or other legally required documentations and no clarity exists if required product can be delivered. What assurances are given that customer requirements and own specifications or other legally required documentations are in accordance with each other? Do written supply agreements with customers exist? Do specific customer requirements for purchased products exist? Who checks and approves specifications or other legally required documentations? Who ensures that the proper raw materials are available whenever needed?

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Connection with PACsecure PP requirement number How is it ensured that customers are informed about product changes? Who checks and approves specifications or other legally required documentations?

Text/Number of connected PACsecure PP (Prerequisite Program) requirement

What to check? What should be asked?

Example for KO/Major

Part 2

4.1.2

Changes of existing contractual agreements shall be documented and communicated between the contract partners.

4.2

Specifications and formulas/configurations

4.2.1

Specifications and other legally required documentation How are specifications or other legally required documentations compiled, checked and approved? Are there specifications or other legal required documentations for all final products? How are up to date specifications or other legally required documentations recognizable? <specifications or other legal required documentation> Form 2 Are specifications or other legal required documentation available for all raw materials, additives, inks, adhesives, solvents, wrapping material and rework? What assurance is given that specifications and other legally required documentation are followed? <evidence of specification compliance, e.g. lab results> What assurance is given that specifications are in conformance with legal requirements? Who writes, checks and approves specifications? When not all specifications for final products are up to date and in conformance with legal requirements.

4.2.1.1

Specifications or other legally required documentation shall be available and in place for all finished products. They shall be up to date, unambiguous and be in compliance with legal and customer requirements.

International Featured Standards IFS PACsecure Version 1

4.2.1.2 KO

KO N 3: Specifications or other legal required documentation shall be available and in place for all raw materials (raw materials, additives, inks, adhesives, solvents, wrapping materials, rework). Specifications shall be up to date, unambiguous and be in compliance with legal requirements and, if existing, with customer requirements.

When not all raw materials, additives, inks, adhesives, solvents, wrapping materials and rework have specifications or other legal required documentation. When specifications do not comply with legal requirements.

IFS, October 2012

4.2.1.3

Where required by customers, product specifications shall be formally agreed.

 IFS, October 2012

4.2.1.4

Specifications or other legally required documentation and/or their contents shall be provided in the relevant location and accessible to all relevant personnel.

Who has access to specifications or other legally required documentation?

When key employees do not have access to specifications or other legally required documentation and a product safety and/or legal requirement issue ensues. When specifications or other legally required documentation are used but have not been properly approved and it is not clear if they can be complied with.

4.2.1.5

There shall be a procedure for the creation, the modification and approval of specifications or other legally required documentation for all parts of the process, which shall include the preliminary acceptance of the customer, if specifications or other legally required documentation have been agreed with customers.

Who writes, amends, checks and approves specifications or other legally required documentation?

International Featured Standards IFS PACsecure Version 1

4.2.1.6

The specification/other legally required documentation control procedure shall include the update of finished product specification in case of any modification: of raw material of formula/configuration of process with influence on the final products of wrapping material with influence on the final products. What assurance is given that specified configuration is followed? How is configuration compliance checked? If no specific technological requirements and/or formulas are agreed between the contract partners, the formula of the supplier is the basis. In this case the requirement shall be rated with N/A. The requirements for product development have to be checked even if there are only product modifications (new ingredient used, changes in packaging) or modifications of production processes.

4.2.2

Formula/configuration

4.2.2.1

KO N 4: Where there are customer agreements in relation to the product formula/configuration and technological requirements, these shall be complied with.

Part 2

When there is evidence that configuration and finished product specifications do not fit together. When during a traceability test there is evidence that agreed upon configuration is not complied with.

4.3

69

Product development/Product modification/Modification of production processes

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Connection with PACsecure PP requirement number How are the processing procedures for product development built up? Do processing procedures for product development also contain a hazard analysis? <hazard analysis> What do product development procedures look like? <product development procedures> What tests are made while a product is developed? <test results> Is developed product submitted to trial runs? <trial run documentation> When no processing procedures were established for product development and a packaging material safety and/or legal issue ensues. When new processing procedures, configurations and product requirements are not ensured by tests and trial runs and enter directly into production and this entails a packaging material safety and/or legality issue which cannot be corrected. When no proof for defined converting time exists and a safety issue can occur. How is recommended converting time determined? <converting tests> Are products submitted to converting time tests? <converting time test results> How often are organoleptic tests made? Who participates in organoleptic tests? Are organoleptic tests documented? How are the results from organoleptic tests taken into consideration during product development? <organoleptic test results evaluation> What kind of process is implemented for legislation approval? Process of information gathering approval process e.g. with customer. Export goes to which countries? Which countries have special requirements?

Text/Number of connected PACsecure PP (Prerequisite Program) requirement

What to check? What should be asked?

Example for KO/Major

Part 2

4.3.1

A procedure for product development shall be in place which incorporates the hazard analysis principles, in accordance with the HACCP and/or risk assessment system.

4.3.2

Product formulation/configuration, manufacturing processes, process parameters and the fulfilment of product requirements shall be established and shall have been assured by factory trials and product testing.

4.3.3

Recommendation for use-tests or adequate processes shall be carried out and consideration given to product formulation/configuration, wrapping material, manufacturing and declared conditions.

4.3.4

Product development shall consider the results of organoleptic assessments.

International Featured Standards IFS PACsecure Version 1

IFS, October 2012

4.3.5

A process shall be in place to ensure that the finished product complies with current legislation of destination country and customer requirements.

 IFS, October 2012

4.3.6

Recommendations for handling and/or use of the packaging materials shall be established. Where appropriate, customer requirements shall be included. How are converting recommendations and/or product use information established? How are converting requirements taken into consideration during product development? <example> When a safety issue occurs due to not taking customer requirements into account.

Who issues the cliches/printing block approval? Who issues the labels? Who approves labels? How is conformity of the product and label reviewed?

Product and labeling are not in conformity with each other, thus creating a legality problem.

4.3.7

The progress and results of product development shall be properly recorded.

4.3.8

The company shall ensure that in the event of changes to product formulation/configuration, including rework and wrapping material, process characteristics are reviewed in order to assure that product requirements are complied with.

4.4

Purchasing How is it ensured that purchased products and services conform to specifications or other legally required documentation or other legal required documentation? When purchased products do not conform to specifications or other legally required documentation and thus entail a safety or legality problem.

4.4.1

General purchasing

International Featured Standards IFS PACsecure Version 1

4.4.1.1

The company shall control purchasing processes to ensure that all externally sourced materials and services, which have an impact on packaging material safety and quality, conform to requirements. Where a company chooses to outsource any process that may have an impact on packaging material safety and quality, the company shall ensure control over such processes. Control of such outsourced processes shall be identified and documented within the packaging material safety and quality management system.

Part 2

71

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Connection with PACsecure PP requirement number Does an approval procedure exist for new suppliers and co-producer? <supplier procedures> How are supplies monitored? Are suppliers graded? <supplier grading systems> Have suppliers been barred? How is a barred supplier identified? How is the qualification of suppliers ensured? <product entry monitoring> <supplier audits> <lab tests> Are there any co-producers? <co-packers list> How are co-producers monitored? Are co-producers IFS PACsecure certified? <certificate> How often are external audits made? <external audit plan> Which criteria are consulted for supplier assessment? Which supplier has analysis certificates? <analysis certificates> How was the hazard analysis for supplier approval performed? <hazard analysis> Who reviews the results of supplier assessments? How often are the results of supplier assessments reviewed? What actions are taken after review of the results for supplier assessments? <audit results> When there are no approval procedures for suppliers and this causes a safety risk.

Text/Number of connected PACsecure PP (Prerequisite Program) requirement

What to check? What should be asked?

Example for KO/Major

Part 2

4.4.1.2

There shall be a procedure for approval and monitoring of suppliers (internal and external), outsourced production or part of it.

4.4.1.3

The approval and monitoring procedure shall contain clear assessment criteria such as: audits, certificates of analysis, supplier reliability and complaints, as well as required performance standards.

No hazard analysis was made.

International Featured Standards IFS PACsecure Version 1

4.4.1.4

The results of suppliers assessments shall be reviewed regularly and this review shall be based on hazard analysis and assessment of associated risks. There shall be records of the reviews and of the actions taken as a consequence of assessment.

When the results for supplier assessment are not taken into account and this causes a safety or legality issue.

IFS, October 2012

 IFS, October 2012

4.4.1.5

The purchased products shall be checked in accordance with the existing specifications or other legally required documentation. The schedule of these checks shall, as a minimum, take into account the following criteria; product requirements, supplier status (according to its assessment) and impact of the purchased products on the finished product. If mentioned in the specifications or other legally required documentation additional required topics shall be checked.

How are purchased products and their specifications reviewed? <incoming product check-list> <lab tests> Does a test schedule exist? <test schedule>

When purchased products are never checked on compliance with specifications or other legally required documentations.

4.4.1.6

The purchased services shall be checked in accordance with the existing specifications or other legally required documentation. The schedule of these checks shall at least take into account the following items: service requirements, supplier status (according to its assessment) and impact of the service on the finished product. Mean purchased products, which have been already processed and which are bought and stored on-site of the audited company. If the company trades packaging materials as finished products and if it wants to include them in the audit scope, the suppliers of these products shall themselves be IFS PACsecure certified (if the trade products are under the same product scope) or certified under a comparable scheme (if the trade products are under a different product scope). Compulsory field in the company profile: specify if the company has trade products.

International Featured Standards IFS PACsecure Version 1

4.4.2

Trade of packaging materials

4.4.2.1

In case a company trades packaging materials, it shall be ensured that a process for approving and monitoring suppliers exists and is implemented.

Part 2

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Connection with PACsecure PP requirement number

Text/Number of connected PACsecure PP (Prerequisite Program) requirement

What to check? What should be asked?

Example for KO/Major

Part 2

4.4.2.2

In case of traded packaging materials, the process for approving and monitoring suppliers shall contain clear assessment criteria such as: audits, certificates of analysis, supplier reliability, complaints as well as required performance standards.

4.4.2.3

In case of packaging materials for private labels, a supplier approval system in accordance with customer requirements shall exist for pre-suppliers of finished or semi-finished products. Does a risk assessment also exist for wrapping material not in direct packaging material contact, to prove the evidence of direct negative influence on the product? How is it ensured that wrapping material complies with current relevant legislation? Who develops, reviews new wrapping material? Are specifications or other legally required documentation available for all wrapping materials used? <wrapping material specifications> Wrapping material that does not comply with legislation. Not all wrapping materials have specifications.

4.5

Product wrapping

4.5.1

Based on hazard analysis, assessment of associated risks and intended use, the company shall determine the key parameters for the wrapping material.

4.5.2

Detailed specifications shall exist for all wrapping materials which comply with the current relevant legislation.

International Featured Standards IFS PACsecure Version 1

4.5.3

IFS, October 2012

For all wrapping material which could have an influence on products, certificates of conformity shall exist which comply with current legal requirements. In the event that no specific legal requirements are applicable, evidence shall be available to demonstrate that wrapping material is suitable for use. This applies for wrapping material which could have an influence on raw materials, semiprocessed and finished products.

 IFS, October 2012

4.5.4

Based on hazard analysis and assessment of associated risks, the company shall verify the suitability of the wrapping material for each relevant product (e.g. organoleptic tests, storage tests, chemical analysis, migration tests). Which system has the company implemented to ensure that wrapping material is suitable and traceable?

How is it ensured that wrapping materials have no negative effects on the product? Has a hazard analysis been performed in relation to suitability of wrapping material? <hazard analysis>

No hazard analysis was made.

4.5.5

The company shall ensure that the wrapping used corresponds to the product being wrapped. The use of correct wrapping shall be regularly checked.

4.5.6

Printing and labeling information shall be legible, indelible and shall comply with agreed customer product specifications or other legally required documentations. This shall be regularly checked and checks shall be documented.

4.6 A 1.1.1 1, 4

Factory location Does a location investigation exist? Can location have a negative influence on product quality? <location analysis> What protective measures have been established if potentially damaging materials/substances are nearby? <protective measures> <corrective actions> Is efficiency of protective measures regularly reviewed? Who reviews the efficiency of the established protective measures? How is efficiency of established protective measures reviewed? When company surroundings have a negative influence on product (e.g. water treatment) and no protective measures have been established and therefore a safety problem exists. When established protective measures are unclear or with questionable efficiency and therefore a safety problem exists.

International Featured Standards IFS PACsecure Version 1

4.6.1.

The company shall investigate to what extent the factory environment (e.g. ground, air) may have an adverse impact on product safety and product quality. If product safety and quality could be compromised, appropriate measures shall be established. The effectiveness of the established measures shall be periodically reviewed (examples: extremely dusty air, strong smells).

4.7 A 1.1.1 2

Factory Exterior

7.0 A 1

Part 2

4.7.1

The factory exterior shall be maintained to be clean and tidy.

75

Are factory exteriors tidy? Are factory exteriors reviewed through internal audits? <audit results>

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Connection with PACsecure PP requirement number A 1.1.1-2 3,6,7,8 Are grounds within the factory premises in good condition? Is natural drainage sufficient? If natural drainage is insufficient, has a suitable drainage system been installed? Are goods stored outdoors? What is stored outdoors? What rules exist for outdoor storage? Is outdoor storage based on hazard analysis? <hazard analysis> No hazard analysis exists for outdoor storage. Goods under outdoor storage are influenced in a way that a safety risk is given (e.g. unprotected primary packaging material is kept outdoors, becomes moldy and is not barred from use). When there are no flow plans and internal flows do not respect the segregation of product processes (e.g. separation of dirty from clean processing areas but personnel cross boundaries without according protective clothing). How is it ensured that cross-contamination is avoided? <waste elimination plan> <personnel flow plan> <materials flow plan> <process flow plan> <hydraulic plan> How is cross-contamination avoided within factory premises? <process flow diagram> 4, 6 The process flow allows for a crosscontamination between raw materials, packaging material, half-finished products and finished products.

Text/Number of connected PACsecure PP (Prerequisite Program) requirement

What to check? What should be asked?

Example for KO/Major

Part 2

4.7.2

All external areas of the factory shall be maintained in good condition. Where natural drainage is inadequate, a suitable drainage system shall be installed. A 1.1.1 5

4.7.3

Outdoor storage shall be kept to a minimum. Where goods are stored outside, hazard analysis and assessment of associated risks shall be undertaken in order to ensure that there is no risk of contamination or adverse effect on quality and packaging material safety.

4.8 A 2.1.8 Form 4 1, 2, 3

Plant layout and process flows

4.8.1

Plans clearly describing internal flows of finished products, packaging materials, raw materials, waste, personnel, water, etc. shall be in place. A site map covering all buildings of the facility shall be available.

International Featured Standards IFS PACsecure Version 1

IFS, October 2012

4.8.2

The process flow, from receipt of goods to dispatch, shall be in place so that contamination of raw materials, packaging, semi-processed and finished products is avoided. The risk of cross-contamination shall be minimized through effective measures.

7.0 A2 A 2.1.8

 IFS, October 2012

4.8.3

In case of sensitive production areas, these shall be operated and monitored to ensure product safety is not compromised. Is there a laboratory on site? Has the lab a direct contact with production premises? Can lab waste (e.g. lab waste water) dirty the production premises? <plant lay-out> <waste water drainage system> When product safety is endangered through the laboratory (e.g. waste water, air circulation, waste disposal).

Are there sensitive areas? Are sensitive areas ventilated? What additional measures are taken?

When ventilation is missing in sensitive areas and a safety problem is given.

4.8.4

Laboratory facilities and in-process controls shall not affect the product safety.

4.9

Constructional requirements for production and storage areas

4.9.1 A 2.1.57 A 1.1.12 1, 2 10

Constructional requirements Are there dirty and clean areas? Are there appropriate storage rooms? No separation of dirty and clean areas even though legally prescribed. When there is no compliance with legal requirements.

4.9.1.1

Rooms where packaging material products are prepared, treated, processed and stored shall be designed and constructed so that packaging material safety is ensured.

4.9.2 A 2.1.57 A 2.1.2 3 1

Walls Are walls mouldy? Extreme mold build-up which ensues a contamination risk.

International Featured Standards IFS PACsecure Version 1

4.9.2.1

Walls shall be designed and constructed to prevent the accumulation of dirt, to reduce condensation and mould growth, and to facilitate cleaning. A 2.1.57

4.9.2.2

The surfaces of walls shall be in a good condition and easy to clean; they shall be impervious and wear-resistant. A 2.1.57 A 2.1.2 2

How often are walls cleaned? <cleaning schedule> <cleaning evidence> Are wall-floor junctions and corners rounded? Part 2

4.9.2.3

The junctions between walls, floors and ceilings shall be designed to facilitate cleaning.

4.9.3 A 2.1.57

Floors Are floors cleanable? How often are floors cleaned? <cleaning schedule> <cleaning evidence>

4.9.3.1

77

Floor covering shall be designed to meet production requirements and shall be in good condition and easy to clean. Surfaces shall be impervious and wear-resistant.

IFS PAC secure number

IFS PACsecure requirement

78

Connection with PACsecure PP requirement number A 2.1.57 How is waste water disposal ensured? How often are gullies cleaned? <cleaning evidence> <drainage schedule>

Text/Number of connected PACsecure PP (Prerequisite Program) requirement

What to check? What should be asked?

Example for KO/Major

Part 2

4.9.3.2

The hygienic disposal of waste water shall be ensured. Drainage systems shall be easy to clean and designed to minimize the risk of product contamination (e.g. ingress of pests, etc.). A 2.1.57 A 2.1.4 1 Are there water or other liquid puddles on the floors of production areas?

4.9.3.3

Water or other liquids shall reach drainage without difficulties, using appropriate measures. Puddles shall be avoided. A 2.1.57 Where is machinery which produces a large amount of waste water located? <machinery lay-out>

4.9.3.4

In packaging material handling areas, machinery and piping shall be arranged so that waste water, if possible, goes directly into a drain.

4.9.4 A 2.1.57 A 1.1.1 3 11

Ceilings/Overheads How often are ceilings cleaned? <cleaning evidence> <cleaning evidence> Ceilings are very dirty and dirt can fall on product.

4.9.4.1

Ceilings (or, where no ceilings exist, the inside of roofs) and overhead fixtures (incl. piping, cableway, lamps etc.) shall be constructed to minimize the accumulation of dirt and shall not pose any risk of physical and/or microbiological contamination. A 2.1.57

4.9.4.2

Where false ceilings are used, an access to the void shall be provided in order to facilitate cleaning, maintenance and inspections for pest control.

How often are false ceilings cleaned? <cleaning evidence> <cleaning evidence>

4.9.5 A 2.1.57 4

Windows and other openings Can dirt accumulate on window sills?

International Featured Standards IFS PACsecure Version 1

IFS, October 2012

4.9.5.1

Windows and other openings shall be designed and constructed to avoid the accumulation of dirt and shall be maintained in good condition.

 IFS, October 2012

4.9.5.2

Where there is risk of contamination, windows and roof glazing shall remain closed and fixed during production.

A 2.1.57 Windows are open and no insect gratings are in place so that pests can enter production areas and a contamination risk exists. Pests are visible. Windows are open and no insect gratings are in place so that pests can enter production areas and a contamination risk exists. Windows with no breakage protection are in production areas where uncovered and broken and unpackaged products are handled which ensues a contamination risk. Doors are open or damaged so that pests can enter production areas and a contamination risk exists. Pests are visible. Do external doors prevent pest entrance into production areas?

Are windows kept open?

4.9.5.3

Where windows and roof glazing are designed to be opened for ventilation purposes, they shall be fitted with easily removable, good condition pest screens or other measures in order to avoid any contamination. A 2.1.57 7, 8 How are windows protected against breakage?

A 2.1.57 A 1.1.1

5 12

Are windows sealed with insect gratings? <pest control schedule> Is integrity of gratings regularly reviewed? <monitoring schedule>

4.9.5.4

In areas where unpackaged product is handled, windows shall be protected against breakage.

4.9.6 A 2.1.5.7 3

Doors and gates Are doors damaged?

International Featured Standards IFS PACsecure Version 1

4.9.6.1

Doors and gates shall be in good condition (e.g. no splintering parts, flaking paints or corrosion) and easy to clean.

4.9.6.2

Based on hazard analysis and assessment of associated risks external doors and gates shall be constructed to prevent the ingress of pests; if possible, they shall be self-closing. A 2.2.1 A 2.2.2 1 1, 2

A 2.1.5.7

4.9.7

Lighting What is the assurance that all working areas are adequately illuminated? Where are fly killing units mandatory? <fly trap plan> Are all fly killing units and lamps protected by splinter shields? <lighting protectors> When fly traps and lighting devices constitute a contamination risk.

Part 2

4.9.7.1

All working areas shall have adequate lighting.

79

4.9.7.2

All lighting equipment shall be protected by shatter proof covers and installed to minimise the risk of breakage.

IFS PAC secure number

IFS PACsecure requirement

80

Connection with PACsecure PP requirement number

Text/Number of connected PACsecure PP (Prerequisite Program) requirement

What to check? What should be asked?

Example for KO/Major

Part 2

4.9.8 A 2.3.1 A 2.3.3 A 2.3.1 A 1.1.1 A 2.3.3 2, 3 14 7 1 Is the use of air during production based on hazard analysis? <hazard analysis> Are there production areas with under- or over-pressurization? Are there areas where large amounts of dust are formed? Do dust extraction devices exist in these areas? How are air filters maintained and cleaned? <maintenance schedule> <maintenance documentation> <cleaning protocols> A 2.3.1 1, 2, 3, 4 1, 2, 3, 4, 5, 6, 7, 8 How is ventilation reviewed?

Air conditioning/Ventilation

4.9.8.1

Adequate natural and/or artificial ventilation shall exist in all areas.

4.9.8.2

If ventilation equipments are installed, filters and other components which require cleaning or replacement shall be easily accessible.

Filters which are not cleaned as programmed constitute a product contamination risk. When air supply causes a contamination which ensue a packaging material safety risk.

4.9.8.3

Air conditioning equipment and artificially generated airflow shall not lead to any product safety or quality risks. A 2.3.3 1

4.9.8.4

Dust extraction equipment shall be installed in areas where considerable amounts of dust are generated.

4.9.9 7.0 A 4 A 4.1.1 A 4.1.1 A 4.1.2 1, 2 5 1, 2, 3, 4, 5, 6, 7

Water supply Where does water supply come from? (City supply, well water, tanker)? Is water demand always covered?

4.9.9.1

Water which is used as ingredient in the production process, or for cleaning, shall comply with legal requirements and shall be supplied in sufficient quantity; this also applies to steam and ice used within the production area. A supply of such water shall be available at all times. A 4.1.36 1, 2, 3, 4, 5

International Featured Standards IFS PACsecure Version 1

4.9.9.2

Recycled water which is used in the process shall not pose a contamination risk. The water shall comply with applicable legal requirements for potable water; records of compliance testing shall be available.

IFS, October 2012

For what purpose is water used in the company (social facilities, cleaning procedures, product ingredient, for washing fruits and vegetables)? Is water treated on site (water hardness correction, chlorination, sterilization, filtration )? Are local legal requirements on hand? Is water analysed according to legal requirements (own water supply, outside supply). Do results comply with standards? <several analysis results>

There is evidence that water does not comply with legal standards and is used for cleaning procedures of surfaces in direct contact with packaging material or as ingredient, or company cannot show that water complies with required standards.

 IFS, October 2012

The checking interval for relevant water safety issues has been clearly overdrawn. The company has no water analysis plan even though it is mandatory and water is used for cleaning procedures or as an ingredient. 7.0 A 4 A 3.1.2 A 4.1.1 4, 5, 6 3, 4 Is water, steam or ice used is a station monitoring in place? <maintenance> <analysis results> What kind of piping system exists? Ring-pipes, water-tanks) What is piping made from? Is analysis and sampling plan based on hazard analysis? Is drinking water system completely separated from non-potable water piping? <hydraulic system lay-out> What other systems are there? (e.g. used water, cooling water, water used for firefighting). Are water systems properly marked and where they are? Are reflux avoidance equipments installed wherever necessary? When contaminated water reaches the product due to bad conditions of piping or improper piping material.

4.9.9.3

The quality of water, whatever the condition of aggregation, shall be monitored following a risk based sampling plan.

International Featured Standards IFS PACsecure Version 1

4.9.9.4

Non-potable water shall be transported in separate, properly marked piping. Such piping shall not be connected to the drinking water system, or allow the possibility of reflux to contaminate potable water sources or the factory environment.

A 4.1.36 A 2.4.1

3, 4 1, 2

All existing water systems are interconnected, no reflux avoidance equipments exist, therefor a contamination hazard is given.

4.9.10 A 2.3.3 4

Compressed air

4.9.10.1

The quality of compressed air that comes in direct contact with packaging material or wrapping material shall be monitored based on hazard analysis and assessment of associated risks. A 2.3.3 4

Part 2

4.9.10.2

Compressed air shall not pose a risk of contamination.

81

4.10

Cleaning and disinfection

IFS PAC secure number

IFS PACsecure requirement

82

Connection with PACsecure PP requirement number 7.0 E 1 E 1.1.13 1, 2, 3, 4, 5, 11 Who is in charge of cleaning and disinfection? <cleaning schedule> What kind cleaning products and disinfectants are used? <up to date cleaning products and disinfectant list> What must be observed when using different cleaning products and disinfectants? <product instructions> What areas are cleaned and disinfected? <cleaning schedule> How often are areas cleaned and disinfected? Where are cleaning and disinfection procedures documented? <cleaning procedures documentation> Do hazard symbols exist? Does a contract exist for external service provider? <external services contract> Cleaning schedules can include SSOPs. When a contamination of packaging material products or tools exists due to the use of inefficient or wrong kind of chemicals or inefficient cleaning procedures.

Text/Number of connected PACsecure PP (Prerequisite Program) requirement

What to check? What should be asked?

Example for KO/Major

Part 2

4.10.1

Based on hazard analysis and assessment of associated risks, cleaning and disinfection schedules shall be available and implemented. These shall specify: objectives responsibilities the products used and their instructions for use the areas to be cleaned and/or disinfected cleaning frequency documentation requirements hazard symbols (if necessary).

4.10.2 4, 5, 12, 16 6 E 1.1.13

Cleaning and disinfection schedules 7.0 E 1 shall be implemented and documented. E 1.1.13

4.10.3

Only qualified personnel shall be allowed to undertake cleaning and disinfection. The personnel shall be trained and retrained to carry out the cleaning schedules.

Are cleaning personnel qualified? <training proof> How often are they trained? Who trains them? Are these trainings documented?

When a product or tools contamination occurs due to untrained cleaning personnel or wrong use of cleaning products or when cleaning process is inefficient. How are cleaning and disinfection controls performed? <cleaning controls> Who performs these controls? <cleaning controls> How often are cleaning and disinfection controls performed? <cleaning controls> Where are cleaning and disinfection controls documented? When cleaning is unsuccessful and this error is not corrected.

International Featured Standards IFS PACsecure Version 1

IFS, October 2012

4.10.4 7, 13

The effectiveness and safety of the cleaning and disinfection measures, based on hazard analysis and assessment of associated risks, shall be verified and documented according to a sampling schedule by using appropriate procedures. Resulting corrective actions shall be documented.

7.0 E 1 E 1.1.13

 IFS, October 2012

When are corrective actions executed? <corrective actions> Who executes corrective actions? Who reviews effectiveness of corrective actions? Where are corrective actions documented? E 1.1.13 8, 14 When are cleaning and disinfection procedures validated? Who adapts cleaning and disinfection procedures? How often are cleaning and disinfection schedules changed? When circumstances have been changed but no adaptations were made for cleaning and disinfection procedures and a contamination risk ensues.

4.10.5

Cleaning and disinfection schedules shall be reviewed and modified, if necessary, in the event of a change to product, process or cleaning equipment.

4.10.6

The intended use of cleaning utensils shall be clearly identified. Cleaning utensils shall be used in a way to avoid contamination. B 2.2.14 13 Are material safety data sheets available for all cleaning chemicals? Are these no older than two years? Are cleaning chemicals instructions up to date? How are instructions transmitted to personnel in charge of cleaning procedures? Where and when can the instructions be inspected? How are cleaning utensils and chemicals recognizable? <chemicals list> Where are cleaning utensils and chemicals stored? <chemicals storage list> When a safety risk occurs due to deficient material safety data sheets.

International Featured Standards IFS PACsecure Version 1

4.10.7

Current material safety data sheets (MSDS) and instructions for use shall be available for chemicals and cleaning agents. Personnel responsible for cleaning shall be able to demonstrate their knowledge of such instructions, which shall be always available on site.

4.10.8

Cleaning chemicals shall be clearly labeled, used and stored appropriately, to avoid contamination.

A 3.2.2 B 2.2.14 E 1.1.13

1, 2, 3 8, 9, 10, 12, 14 1, 9

Part 2

When cleaning utensils can be mixed up with other utensils and packaging material contamination ensues. When improper storage can lead to packaging material and other utensils contamination.

83

IFS PAC secure number

IFS PACsecure requirement

84

Connection with PACsecure PP requirement number A 3.2.1 E 1.1.13 1, 2, 3, 4, 5, 6 9, 15 Where are containers cleaned? When and where are tools cleaned? <cleaning evidence> The tool cleaning process is a product contamination problem; e.g. wet cleaning of containers and pallets during production and near unprotected packaging material.

Text/Number of connected PACsecure PP (Prerequisite Program) requirement

What to check? What should be asked?

Example for KO/Major

Part 2

4.10.9

Cleaning activities shall be carried out in periods of non-production. If this is not possible, these operations shall be controlled as to not affect the product.

4.10.10

Where a company hires a third-party service provider for cleaning and disinfection activities, all requirements specified within section 4.10 shall be clearly defined in the respective contract.

4.11 A 2.4.1 A 2.4.2 1, 2, 3, 4, 5, 6 1, 2, 3, 4, 5, 6, 7, 8

Waste disposal

4.11.1

A waste management procedure shall exist and shall be implemented to avoid cross contamination.

4.11.2

All current legal requirements for waste disposal shall be met.

How is it ensured that current legal waste disposal requirements are met? How is waste material disposed of? How often are packaging material waste and other wastes removed from packaging material handling areas? Who is responsible for waste removal?

When legal requirements regarding waste disposal are not met. When wastes accumulate in packaging material handling areas which ensues a packaging material contamination risk. What kind of waste exists? What wastes are collected in separate containers? How are waste containers marked? Can waste containers easily be cleaned? How often are waste containers cleaned? <cleaning protocol> When waste containers can be mixed up with packaging material containers which ensues a packaging material contamination risk.

4.11.3

Packaging material waste and other waste shall be removed as quickly as possible from areas where packaging material is handled. The accumulation of waste shall be avoided. A 2.4.2 1, 4, 5, 6

International Featured Standards IFS PACsecure Version 1

IFS, October 2012

4.11.4

Waste collection containers shall be clearly marked, suitably designed, in good state of repair, easy to clean, and where necessary disinfected.

 IFS, October 2012

4.11.5

Waste collection rooms and containers (incl. compactors) shall be designed to be kept clean to minimize pest attraction. A 2.4.2 5 What kinds of waste disposal records exist? Who is responsible for waste disposal? <waste disposal register> When wastes are removed by unauthorized persons.

A 2.4.2 A 1.1.1

7 9

Are waste collection rooms kept clean? Are waste collection rooms protected from pests? <integrated pest control>

When waste collection rooms are not protected from pest invasions and there is a contamination risk.

4.11.6

Waste shall be collected in separate containers in accordance with the intended means of disposal. Such waste shall be disposed by authorised third parties only. Records of waste disposal shall be kept by the company.

4.12

Risk of foreign material, metal, broken glass and wood What kinds of foreign material may be found? Where foreign material sources identified through hazard analysis? <hazard analysis> Are staples used? How are contaminated products handled? <segregation records> What is done in case of glass breakage? <glass breakage prevention procedures> What shall be considered when glass fixtures are replaced? <glass handling procedures> Under what circumstances is the use of wood allowed? <hazard analysis> Is the wooden tool in use in good and clean conditions? Who inspects and how often is the wooden tool condition inspected? <plant inspections> When a foreign material contamination occurs due to lack of hazard analysis or when foreign material sources are insufficiently considered.

International Featured Standards IFS PACsecure Version 1

4.12.1 KO

KO N 5: Based on hazard analysis and assessment of associated risks, procedures shall be in place to avoid contamination with foreign material. Contaminated products shall be treated as non-conforming products.

4.12.2

In all areas, e.g. handling of raw materials, converting, wrapping and storage, where hazard analysis and assessment of associated risks have identified the potential for product contamination, the use of wood shall be excluded. Where the use of wood cannot be avoided, the risk shall be controlled and the wood shall be in good order and clean.

When wood gets in contact with open product. When wood poses a contamination risk for packaging material product. When wooden tool condition is not inspected and a contamination risk ensues.

Part 2

4.12.3

85

Where metal- and/or other foreign material detectors are required, they shall be installed to ensure maximum efficiency of detection, in order to avoid subsequent contamination. Detectors shall be subjected to regular maintenance to avoid malfunction.

Where are the foreign material detectors installed? <equipment lay-out>

When foreign material detectors are installed but later on a foreign material risk still persists which has not been taken into account.

IFS PAC secure number

IFS PACsecure requirement

86

Connection with PACsecure PP requirement number Are contaminated products automatically isolated? Who may handle/has access to isolated products? How are isolated products handled? <non-conforming products list> <isolation protocol> When segregation does not work. When isolated products re-enter production line without previous inspection.

Text/Number of connected PACsecure PP (Prerequisite Program) requirement

What to check? What should be asked?

Example for KO/Major

Part 2

4.12.4

Potentially contaminated products shall be isolated. Access and actions for further handling or checking for these isolated products shall be carried out only by authorized personnel according to defined procedures. After this check, contaminated products shall be treated as non-conforming products. How often are detector accuracies checked? Who checks detector accuracy? <metal detector check-list> What corrective actions exist when a detector is defective? Are corrective actions verified? Are operational defects documented? <defect/failure protocols> Are filters and sieves or other technical or mechanical systems like strainers, magnets, vacuum cleaner etc. being used? How often are working conditions of filters or other technical or mechanical systems and sieves inspected? Who inspects/maintains filters and sieves or other technical or mechanical systems? What is the concern of inspection? <maintenance schedule> <monitoring system> Does a hazard analysis exist concerning contamination through glass? <hazard analysis> Where is glass used in the plant? How is glass protected from breakage? <glass register>

4.12.5

The appropriate accuracy of detectors shall be specified. Checks of proper function of detectors shall be carried out regularly. In case of malfunction or failure of a metal and/or foreign material detector, corrective actions shall be defined, implemented and documented.

When proper operation or measuring accuracy is not checked and a foreign material risk occurs.

4.12.6

In cases where special equipment or methods are used to detect foreign material, these shall be properly validated and maintained.

When damage to sieves or filters passes without noticed and this leads to a foreign material contamination risk.

International Featured Standards IFS PACsecure Version 1

4.12.7

IFS, October 2012

In all areas, e.g. handling of raw materials, converting, wrapping and storage, where hazard analysis and assessment of associated risks have identified a potential product contamination, the presence of glass and brittle material shall be excluded. Where the presence of glass or brittle plastic cannot be avoided, appropriate measures shall be in place to protect against breakage.

When no hazard analysis has been conducted. When there exists a contamination risk due to glass usage. When glass is unprotected and there is a contamination risk.

 IFS, October 2012

4.12.8

All stationary objects made of or incorporating glass or brittle material present in areas of handling of raw materials, converting, wrapping and storage shall be listed in a specific register, including details of their exact location. An assessment of the condition of objects on the register shall be performed on a regular basis and recorded. Frequency of this check shall be justified by documents. Is every glass breakage documented? <glass breakage registry> Where is glass breakage documented? <glass register> Are there exceptions to documentation? Are exceptions based on hazard analysis? <hazard analysis> What is done in case of glass breakage? What should be taken into account? Who cleans the production environment? Who permits production continual? <glass breakage prevention procedures> <glass breakage documentation> When no hazard analysis has been made.

Is there a glass fixtures register including location? <glass register> How often and who inspects glass fixture conditions? How often is glass fixtures register up dated? <inspection results> <glass register>

When glass breakage happens unnoticed and a contamination risk ensues.

4.12.9

Breakages of glass and brittle material shall be recorded. Exceptions shall be justified and documented.

International Featured Standards IFS PACsecure Version 1

4.12.10

Procedures shall be in place describing the measures to be taken in case of breakage of glass and/or brittle material. Such measures shall include identifying the scope of goods to be isolated, specifying authorized personnel, cleaning the production environment and release of production line for continued production.

When a contamination risk exists due to glass breakage and because involved product has not been inspected.

4.12.11

Based on hazard analysis and assessment of associated risks, preventive measures shall be in place for handling of all kinds of containers in the production process (turn over, blow, rinse, etc.).

Has a hazard analysis been performed? <hazard analysis> What preventive measures are in place? <preventive measures>

When no hazard analysis has been made. When there exists a contamination risk due to missing preventive measures. Part 2

4.12.12

87

Where visual inspection is used to detect foreign material, the employees shall be trained and operative change shall be performed at an appropriate frequency to maximize effectiveness of process.

4.13

Pest monitoring/Pest control

IFS PAC secure number

IFS PACsecure requirement

88

Connection with PACsecure PP requirement number 7.0 E 2 E 2.1.1 1, 2, 3, 4, 6 How is pest control organized? <pest control procedures> Which pests are controlled? Which kinds of baits are used? <pest control chemicals list> Is product contamination through baits being prevented? <bait map> Who is responsible for pest control? What is inspection schedule? When no pest control is made. When a product contamination can occur due to unmapped baits. When a product safety occurs due to incorrect use of pest control chemicals or wrongly laid out baits.

Text/Number of connected PACsecure PP (Prerequisite Program) requirement

What to check? What should be asked?

Example for KO/Major

Part 2

4.13.1

The company shall have a pest control system in place which is in compliance with local legal requirements, taking into account, as a minimum: the factory environment (potential pests) site plan with area for application (bait map) identification of the baits on site responsibilities, in-house/external used products/agents and their instructions for use and safety the frequency of inspections. The pest control system shall be based on hazard analysis and assessment of associated risks. E 2.1.1 A 1.1.1-2 4, 5 15 Is pest control executed by own staff members? Who is responsible for pest control? What kind of training has the responsible person? <training evidence> Is pest control executed by external services provider? Does a written contract exist between services provider and company? <written contract> What is the content of the contract? What kind of training has the external services provider? <training evidence> Where are inspections and resulting corrective actions documented? <inspection results> Are documents signed and dated by both parties? Which corrective actions were executed lately?

4.13.2

The company shall have qualified and trained in-house staff and/or employ the services of a qualified external provider. Where an external provider is used, the activities required on site shall be specified in a written contract.

When a product contamination occurs due to incorrect handling of bait material.

International Featured Standards IFS PACsecure Version 1

4.13.3

Pest control inspections and resulting actions shall be documented. Implementation of actions shall be monitored and recorded.

E2.1.1

7,11,12

When inspections are not documented.

IFS, October 2012

 IFS, October 2012

4.13.4

Baits, traps and insect exterminators shall be functioning, shall be in sufficient numbers and shall be placed in an appropriate position. They shall be constructed and positioned as not to cause any contamination risk. Are incoming goods inspected for pest contamination? Where is this documented? <incoming goods inspection> Is pest presence documented? <incoming goods inspection> What control measures are taken when pests are found? <corrective actions> Where are these control measures documented? <corrective actions> E 2.1.1 12 When incoming goods are not inspected for pest presence and an uncontrolled invasion ensues.

E 2.1.1

8, 9, 10

Where are electrical fly killers installed? <fly killer map> Are all fly killers correctly working and connected?

When fly killers are positioned in such a way that flies can fall directly on packaging material products.

4.13.5

Incoming deliveries shall be checked on arrival for the presence of pests. Any infestation shall be documented and control measures taken.

4.13.6

The effectiveness of the pest control shall be monitored with the help of regular trend analyses. 7.0 B 2 7.0 B 2 B 2.1.12 1, 2

4.14

Receipt of goods and storage

International Featured Standards IFS PACsecure Version 1

4.14.1

All incoming goods, including wrapping materials, shall be checked for conformity against specifications/other legally required documentation and to a determined inspection plan. The inspection plan shall be risk based. Test results shall be documented.

What goods (incl. semi-processed products) are inspected when received? <receipt checks> What is checked when received? Is receipt documented? Who checks?

Part 2

When no receipt checks are made. When checks do not guarantee legally requirements. When receipt checks do not take into account specifications or other legally required documentation requirements which prevent that products fulfil their given specifications or other legally required documentation.

89

IFS PAC secure number

IFS PACsecure requirement

90

Connection with PACsecure PP requirement number 7.0 B 2 B 2.1.12 B 1.1.13 B 1.2.2 B 2.3.12 3, 19 119 1 112 Where are raw materials, half finished products and packaging materials stored? <storage plan> How is cross-contamination avoided? <product flow plan> When goods are improperly stored and a contamination risk ensues.

Text/Number of connected PACsecure PP (Prerequisite Program) requirement

What to check? What should be asked?

Example for KO/Major

Part 2

4.14.2

The storage conditions of raw materials, semi-processed and finished products as well as wrapping shall in each case correspond to product requirements (e.g. protective covers) and shall not be detrimental to other products. B 2.1.12 Where and how are packaging materials and equipments stored? <materials flow-diagram> How is cross-contamination through packaging materials avoided? <materials flow-diagram> How is return of packaging materials to the storeroom regulated? What kind of storage regulations exist? Are pests taken into account during storage? Are pallets located approximately 1 m from walls? <plant inspection protocol> Are there baits laid out in storage rooms? <pest control schedule> Are there sensitive products stored? What kinds of preventive measures are in place for these goods? <preventive measures> 115 How are chemicals stored? Who uses chemicals and takes them out of storage? <responsibility list> Are the chemicals users trained? Is training documented? <training documentation>

4.14.3

Raw materials, packaging, semiprocessed and finished products shall be stored so as to minimize the risk of cross contamination.

A product contamination risk is given due to storage of packaging materials and equipments (e.g. unprotected external storage of packaging material) When storage facilities are not inspected for pest presence.

International Featured Standards IFS PACsecure Version 1

4.14.4

Appropriate storage facilities shall be available for the management and storage of working materials, process aids, and additives. The personnel responsible for the management of storage facilities shall be trained.

B 2.2.14

IFS, October 2012

When a packaging material or utensils contamination occurs due to inappropriate storage conditions. When a packaging material or utensils contamination occurs due to insufficient knowledge.

 IFS, October 2012

4.14.5 18 7

All products shall be clearly identified. Use of products shall be undertaken in accordance with the principles of First In/First Out and/or First Expired/First Out. B 2.1.12 1 Is storage leased to storage service provider? Does a contract exist? <service provider contract> What is specified in the contract? Has storage service provider an IFS Logistics certification? <certificate copy>

7.0 B 2 B 2.1.12 B 2.3.12

How is FIFO or FEFO ensured?

When goods are taken out of storage without control and a product safety risk ensues.

4.14.6

Where a company hires a third-party storage service provider, the service provider shall be subject to IFS Logistics requirements. If the third party service provider is not certified to IFS Logistics, all relevant requirements equivalent to the companys own warehousing practices shall be fulfiled and this shall be clearly defined in the respective contract.

4.15 B 1.1.13 B 1.2.2 1, 2, 3 1

Transport What is checked before loading? <expedition inspection> Where is inspection documented? What corrective actions are taken?

4.15.1

Before loading transport vehicles, their condition (e.g. absence of strange smells, high dust load, adverse humidity, pests, mould) shall be checked and action taken, if necessary. 7.0 B 1 B 1.1.13

International Featured Standards IFS PACsecure Version 1

4.15.2

Procedures to prevent contamination during transport shall be implemented (packaging material/nonpackaging material/different categories of goods).

May goods be transported alongside with non packaging material products? How is cross-contamination prevented?

When a contamination can occur during transport.

4.15.3

Where goods must be transported at certain conditions, before loading, the condition inside the vehicle shall be checked and documented.

When there are certain conditions specifications for outgoing product but they are not checked before loading and a health issue occurs. Part 2 Are products which require a certain conditions (e.g. humidity during paper transportation) being loaded? Are vehicle conditions checked and documented before loading? <expedition inspection> What are the procedures when vehicle condition is not according to specifications or other legally required documentation? <expedition inspection> How the company ensure the compliance of conditions during transport?

91

IFS PAC secure number

IFS PACsecure requirement

92

Connection with PACsecure PP requirement number Are vehicles equipped with registering devices? <registering devices> How is it ensured that products reach destination under good conditions? When there are condition specifications or other legally required documentations for the product and condition control is not ensured during transport so that a health issue may occur. When absence of cleaning procedures ensue a product contamination problem.

Text/Number of connected PACsecure PP (Prerequisite Program) requirement

What to check? What should be asked?

Example for KO/Major

Part 2

4.15.4

Where goods must be transported at certain conditions maintaining these conditions during transport shall be ensured and documented.

4.15.5

Adequate hygienic requirements for all transport vehicles and equipment used for loading/unloading (e.g. hoses of silo installations) shall exist. There shall be records of the measures taken. B 1.1.13 17

B 1.1.13

1, 2, 3

Are transport vehicles cleaned? Where are cleaning procedures documented? <cleaning protocol>

4.15.6

Loading and unloading areas shall have equipment in place to protect transported products from external influences.

How is goods reception organized? How is loading organized? External influences: e.g. pollen, climate, etc. Are there internal or external transportation regulations? Does a contract exist with a transportation services provider? <service provider contract> Has storage service provider an IFS Logistics certification? <certificate copy>

4.15.7

Where a company hires a third-party transport service provider, all the requirements specified within section 4.15 shall be clearly defined in the respective contract or the service provider shall be subject to IFS Logistics requirements. B 1.1.13 19

4.15.8

Security of transport vehicles shall be appropriately maintained. C 1.1.13 113

Are loading areas shuttered? Are the transports sealed? How is maintenance organized? <maintenance plan> Where are maintenance procedures documented? Which equipments are subject to external maintenance? No maintenance system exists.

4.16

Maintenance and repair

International Featured Standards IFS PACsecure Version 1

IFS, October 2012

4.16.1

An adequate system of maintenance shall be in place, maintained and documented, covering all critical equipment (incl. transport) for compliance with product requirements. This applies both for internal and external maintenance activities.

4.16.2 113

IFS, October 2012

Product requirements and prevention of contamination shall be ensured during and after maintenance and repair work. Records of maintenance and repair work and of corrective actions taken shall be kept.

7.0 C C 1.1.13 C 1.2.12

How is it ensured that maintenance and repair works do not affect product safety? How are lighting fixtures repaired? Where are repair works documented? Are corrective actions necessary after repair works? What rules are in place for re-activating equipment when maintenance is completed? <examples for repair works and maintenance> How is it ensured that materials used in maintenance or repair work are fit for intended use? What kinds of greases are used? <grease list> Are processing interruptions documented? <processing interruptions> Are processing interruptions considered in maintenance planning? Are temporary repairs allowed? Where are these documented? How fast must temporary repairs be definitely mended? Who verifies this? When materials used in maintenance or repair works are not food grade and a safety risk for the consumer ensues.

When a contamination risk for the product occurs due to maintenance and product is not segregated.

4.16.3

All materials used for maintenance and repair shall be fit for the intended use.

B 2.2.14 C 1.2.1

4, 6 1, 2, 4, 5

4.16.4

Failures of plant and equipment (incl. transport) covered by the maintenance system shall be documented and reviewed with a view to adapting the maintenance system. C 1.2.12 1, 2, 4, 5

C 1.2.12

1, 2, 4, 5

International Featured Standards IFS PACsecure Version 1

4.16.5

Temporary repairs shall be carried out so that product requirements are not affected. Such work shall be documented and a short-term deadline set for eliminating the fault. C 1.2.12 1, 2, 4, 5

4.16.6

Where a company hires a third-party maintenance and repair service provider, all the company specified requirements regarding material and equipment shall be clearly defined, documented and maintained.

4.17 7.0 C C 1.1.13 A 2.1.3 1.2.3 1

Equipment Are equipments suitably designed and were they checked before start up? <start up protocol> Part 2 When equipment construction can lead to a packaging material contamination.

4.17.1

Equipment shall be suitably designed and specified for the intended use. Before commissioning, it shall be verified that the product requirements are complied with.

93

IFS PAC secure number

IFS PACsecure requirement

94

Connection with PACsecure PP requirement number C 1.1.13 5 Are conformity certificates or other certificates available for all wrapping materials which come into direct contact with packaging material products? <conformity certificates> Are conformity certificates available for wrapping materials which come into direct contact with raw materials, halffinished or finished products? <conformity certificates> Are conformity certificates available for containers and conveyor belts? <conformity certificates> Are equipments suitably designed and were they checked before start up? <start up protocol> What rules exist for start up of new equipments? Were new equipments immediately considered in maintenance plan? Does an equipment installation plan exist? <machinery installation plan> Wrappings and wrapping materials which come into direct contact with packaging material are not suitable for intended use and therefore a safety risk exists.

Text/Number of connected PACsecure PP (Prerequisite Program) requirement

What to check? What should be asked?

Example for KO/Major

Part 2

4.17.2

For all equipment and tools with direct packaging material contact, certificates of conformity shall exist which confirm compliance with current legal requirements. In case no specific legal requirements are applicable, evidence shall be available to demonstrate that all equipment and tools are suitable for use. This applies for all equipment and tools in direct contact with raw materials, semi-processed and finished products. C 1.1.13 A 2.1.8 3 5

4.17.3

Equipment shall be designed and located so that cleaning and maintenance operations can be effectively performed.

When equipment is installed in a way that cleaning procedures are hindered and thus constitute a contamination source.

4.17.4

The company shall ensure that all product equipment is in good condition without any negative influence on packaging material safety. C 1.1.13 4

7.0 C

International Featured Standards IFS PACsecure Version 1

4.17.5

The company shall ensure that in the event of changes to processing methods and equipment, process characteristics are reviewed in order to assure that product requirements are complied with. 7.0 F 1

What happens in case of equipment failures? <equipment stops>

When equipment stops lead to a product safety issue and these are not segregated.

IFS, October 2012

4.18

Traceability (including GMOs and allergens)

 IFS, October 2012

4.18.1 KO 1, 2, 3, 4, 5, 6, 7, 8

KO N 6: A traceability system shall be in place which enables the identification of product lots and their relation to batches of raw materials and wrapping materials intended or expected to be in direct contact with produced products. The traceability system shall incorporate all relevant receiving, converting and distribution records. Traceability shall be ensured and documented until delivery to the customer. F 1.2.12 2, 3

7.0 F1 F 1.2.12

How is traceability ensured? <traceability procedures> What products come from which supplier? Is there a list available with all current suppliers? <supplier list>

When no traceability system exists and the system does not include raw and wrapping materials. When traceability is not complete up to the supplier.

4.18.2

Downstream traceability records (from production sites to the customers) shall be available. The timeframe for producing these records for review shall be compliant with customers requirements. F 1.2.12 2, 3

4.18.3

Traceability shall be in place to identify the relationship between batches of final products and their labels. F 1.1.12 10

International Featured Standards IFS PACsecure Version 1

4.18.4

The traceability system shall be tested on a periodic basis - at least annually and each time traceability system changes. The test shall verify upstream and downstream traceability (from delivered products to raw materials, and vice versa), including quantity checking. Test results shall be recorded. F 1.2.12 4,5

When was the last traceability test in both directions done? <traceability test results> What percentage of total amount was traced? How big is a lot?

When traceability system is not tested in both directions so that no assurance is given as to its effectiveness. When test results are negative and no corrective actions are taken. Can rework be completely traced? <results from rework traceability test> How is rework documented/ When rework traceability is not ensured.

4.18.5

Traceability shall be ensured at all stages, including work in progress, post treatment and rework. 4,5

4.18.6

Part 2

When lot labeling is done at a step where mix ups occur which unable correct traceability. When is lot labeling done? What is the lot labeling code? <lot labeling example> When are labels applied to product units? How is recommended converting time calculated? <converting time example>

95

Labeling of semi-finished or finished F 1.2.12 product lots shall be made at the time when the goods are directly packed/ wrapped to ensure a clear traceability of goods. Where goods are labeled at a later time, the temporarily stored goods shall have been provided with a specific lot labeling. The recommended converting time of the labeled goods shall be calculated from the original production batch.

IFS PAC secure number

IFS PACsecure requirement

96

Connection with PACsecure PP requirement number F 1.2.12 7 Is a sample bank implemented?

Text/Number of connected PACsecure PP (Prerequisite Program) requirement

What to check? What should be asked?

Example for KO/Major

Part 2

4.18.7

If required by customer, identified samples representative for the manufacturing lot shall be stored appropriately and kept until expiration of the recommended converting time of the finished product and if necessary for a determined period beyond this date.

4.19 B 2.2.14 15

Allergens and specific conditions of production Are allergens identified in specifications? Does a list exist that covers allergens in use? <allergen list> Allergens are not identified and a customer safety issue ensues.

4.19.1

When specified by the customer, the company shall maintain a continuously up to date listing of all raw materials containing allergens used at its premises (e.g. starch as a glue), which also identifies all blends and formulas/configurations to which such raw materials containing allergens are added.

4.19.2

The manufacturing of products which contain allergens requiring declaration shall be carried out as to ensure cross contamination is minimized as far as possible.

Is a procedure in place to avoid contamination of allergen free products? How often is effectiveness of these procedures reviewed? Where are these proofs documented? <examples> Has allergen status been documented in specifications? <finished product specifications> Allergens are not declared and a safety risk for the consumer occurs.

4.19.3

Where customers specifically require that products are free from certain substances or ingredients (e.g. starch), or that certain methods of treatment or production are excluded, verifiable procedures shall be in place.

International Featured Standards IFS PACsecure Version 1

IFS, October 2012

Measurements, Analysis, Improvements

5.1

Internal audits

 IFS, October 2012

5.1.1 KO

KO N 7: Effective internal audits shall be conducted according to a defined agreed audit program and shall cover at least all requirements of the IFS PACsecure Standard. Scope and frequency of internal audits shall be determined by hazard analysis and assessment of associated risks. This is also applicable for off site storage locations owned or rented by the company. How often are internal audits performed? <audit plan> The following issues can be taken into consideration for internal audits: all production steps (packaging area, labeling, GMPs, GHPs, CPs) traceability, control plan (analysis, calibration) documentation management (updates) management of non-conformities (complaints, internal non-conformities, withdrawal, recall) Who are the auditors? <auditors list> How are auditors qualified for this job? <continued education evidence> Have auditors any connection with audit area? No documented audit results.

Does an up to date internal audit plan exist? <audit plan> Is audit plan based on hazard analysis? <hazard analysis>

No internal audits are performed.

5.1.2

Internal audits of activities which are critical to packaging material safety and product specifications or other legally required documentations shall be carried out at least once a year.

International Featured Standards IFS PACsecure Version 1

5.1.3

The auditors shall be competent and independent from the audited department.

5.1.4

Audit results shall be communicated to the senior management and to responsible persons of concerned department. Necessary corrective actions and a schedule for implementation shall be determined and documented and communicated to every relevant person.

Part 2

97

How are audit results communicated to the persons in charge? <audit report distribution> Is the communication immediate and in time to take measures? Are corrective actions documented? <audit report> Is a time schedule in place for corrective actions? <audit report> From which audits were corrective actions derived? <audit report containing corrective actions> How are audit results forwarded to senior management? <audit report distribution> How are audit results evaluated?

IFS PAC secure number

IFS PACsecure requirement

98

Connection with PACsecure PP requirement number How corrective action verification regulated? <verification evidence> Who verifies and when? No corrective actions taken although necessary.

Text/Number of connected PACsecure PP (Prerequisite Program) requirement

What to check? What should be asked?

Example for KO/Major

Part 2

5.1.5

It shall be documented how and when the corrective actions resulting from the internal audits shall be verified.

5.2 7.0 A 1 A 3.1.2 9 How often and who performs site inspections? <site inspections protocol> What is reviewed during site inspections? For which areas do site inspections exist?

Site factory inspections No site inspections are performed.

5.2.1

Factory inspections shall be planned and carried out (e.g. product control, hygiene, foreign material hazards, personnel hygiene and housekeeping). The frequency of inspections in every area (including outdoor areas) and every single activity shall be based on hazard analysis and assessment of associated risks and on the history of previous experience.

5.3 6.5 A mechanism of change control will be established to ensure changes to the packaging material safety system are communicated and implemented.

Process validation and control

5.3.1

The criteria for process validation and control shall be clearly defined.

International Featured Standards IFS PACsecure Version 1

5.3.2

In circumstances where the control of process and working environment parameters (temperature, time, pressure, chemical properties etc.) is essential to ensure the product requirements, such parameters shall be monitored and recorded continuously and/or at appropriate intervals.

How are temperatures monitored? Where are temperatures recorded? <printed measurement data>

In case a legality issue occurs due to missing records. 4.12.4.

IFS, October 2012

 IFS, October 2012

5.3.3

All rework operations shall be validated, monitored and documented. These operations shall not affect the product requirements.

How is it assured that reworks comply to specifications or other legally required documentations? Where is rework documented? <model documentation for rework> Who reviews rework results? Who decides rework liberation? How is it ensured that rework fulfils legally requirements? What happens when a failure occurs? What happens when cold chain is interrupted? <machinery stand still protocol> 6.4 Prerequisite program validation will be planned and implemented. In case failures are not noticed and result in a safety or legal problem.

5.3.4

There shall be appropriate procedures for prompt notification, recording and monitoring of equipment malfunction and process deviations.

5.3.5

Process validation shall be performed using the collected data that is relevant for product safety and the processes. If substantial modifications occur, a revalidation shall be carried out.

5.4

Calibration, adjustment and checking of measuring and monitoring devices C 1.2.12 113 What kinds of monitoring devices exist? <monitoring devices list> What is demanded of monitoring devices? What monitoring device is adequate for which kind of measurement? How are monitoring devices identified? <identification stickers on monitoring devices> Do calibrated devices exist? <monitoring devices list> The company has no measuring and monitoring devices.

International Featured Standards IFS PACsecure Version 1

5.4.1

The company shall identify the measuring and monitoring devices required to ensure compliance with product requirements. These devices shall be recorded on a document and clearly identified.

5.4.2

C 1.2.12

113

No calibration is performed. Part 2

99

All measuring devices shall be checked, adjusted and calibrated, under a monitoring system, at specified intervals and in accordance with defined recognized standard/methods. The results of the checks, adjustments and calibrations shall be documented. Where necessary, corrective actions on devices and, if necessary, on process and products shall be carried out.

How is measuring devices check organized? <calibration procedures> Are measuring devices regularly calibrated? <calibration protocol> Who is responsible for calibration? How is calibration done? Where is it documented? <calibration records> What corrective actions are taken when a tolerance deviation is found? <corrective actions> <calibration protocol> Is calibration up to date? <calibration certificate>

IFS PAC secure number

IFS PACsecure requirement

100

Connection with PACsecure PP requirement number C 1.2.12 113 What actions are taken when measurement results are uncertain? How are embargoed measuring devices identified? <identification stickers> When defective measuring devices are not exchanged and a safety issue ensues. (e.g. defective migration measurement device e.g. gas chromatograph for migration tests).

Text/Number of connected PACsecure PP (Prerequisite Program) requirement

What to check? What should be asked?

Example for KO/Major

Part 2

5.4.3

All measuring devices shall be used exclusively for their defined purpose. Where the results of measurements indicate a malfunction, the device in question shall be immediately repaired or replaced.

5.4.4

The calibration status of the measuring devices shall be clearly identified (labeled at the machine or on a list of test devices).

C 1.2.12

113

How is calibration status of measuring device identified? <measuring devices list>

5.5

Control of quantity/filling quantity How is it ensured that legal requirements for amount control are met? Legal requirements are not met due to lack of or insufficient amount measurements being made.

5.5.1

The frequency and methodology of control of quantity shall be determined so that the legally requirements and customer specifications or other legally required documentation, or if appropriate, guidelines for nominal quantity are met.

5.5.2

A procedure shall exist to define criteria for compliance checking. This procedure shall also, among others, take into consideration the tare, the density and other critical attributes.

5.5.3

Checks shall be implemented and recorded, according to a sampling plan which ensures a proper representation of the manufacturing lot.

International Featured Standards IFS PACsecure Version 1

IFS, October 2012

5.5.4

Results of these checks shall be compliant with defined criteria for all products ready to be delivered.

 IFS, October 2012

5.5.5

For purchased, already pre-packed products from third parties, there shall be evidence about the compliance with the legal requirements.

How is it ensured that purchased, pre-packed products from third parties contain the correct product amount (applicable for retail branded products and other labels)? <inspection plan> <dealer evidence> Are measuring devices in use regularly calibrated? Where is calibration recorded? <calibration protocol> Are there calibrated measuring devices ? <calibration certificate>

No evidence exists that purchased products comply with legal requirements.

5.5.6

If applicable, all equipment used for final checking shall be approved.

5.6 Which chemical, physical or microbiological analyses are made or subcontracted? <analysis results>

Product analysis No results of analyses are available.

5.6.1

There shall be procedures ensuring that all specified product requirements are met, including legal requirements and specifications. Chemical, physical and microbiological analysis required for that purpose shall be performed internally and/or subcontracted.

International Featured Standards IFS PACsecure Version 1

5.6.2

Analyses, which are relevant for packaging material safety, shall preferably be performed by laboratories having appropriate accredited programs/methods (ISO 17025). If the analyses are performed by a factory internal or a laboratory not having appropriate accredited programs/methods, the results shall be verified on a regular basis by laboratories accredited on these programs/methods (ISO 17025).

Is there an analytical laboratory on site? Is it accredited under ISO 17025? <accreditation evidence> Are internal lab results verified by an accredited lab? Which external laboratories are used? Are these accredited under ISO 17025? <accreditation evidence>

5.6.3

Procedures shall exist which ensure the reliability of the internal analysis results on the basis of official recognized analysis methods. This shall be demonstrated by ring tests or other proficiency tests.

How is it ensured that internal analytical methods are appropriate? Are ring tests performed? <ring test performance evidence>

Part 2

101

IFS PAC secure number

IFS PACsecure requirement

102

Connection with PACsecure PP requirement number Does an inspection plan exist? <inspection plan> Who organizes inspection plan? Which products are encompassed by inspection plan? (raw materials, halffinished and finished products, wrapping materials, environmental tests?) <inspection plan> Is inspection plan based on hazard analysis? <hazard analysis> Where are test results documented? <test results> Who reviews analytical results? How are analytical results verified? Are trends investigated? Are corrective actions introduced when results are unsatisfactory? <corrective actions> No inspection plan exists.

Text/Number of connected PACsecure PP (Prerequisite Program) requirement

What to check? What should be asked?

Example for KO/Major

Part 2

5.6.4

A test plan shall be drawn up for internal and external analysis, based on hazard analysis and assessment of associated risks, which covers raw materials, semi-processed and finished products as well as processing equipments and packaging materials, and where necessary environmental tests. The test results shall be documented.

5.6.5

Results of analysis shall be evaluated promptly. Appropriate corrective measures shall be introduced for any unsatisfactory results. The analytical results shall be reviewed regularly in order to identify trends. Trends indicating potential unsatisfactory results shall be taken into consideration.

When test results exist that do not comply with legal requirements and no corrective actions were taken.

5.6.6

Where internal analysis is undertaken, qualified and trained personnel shall be in place, as well as appropriate equipment and premises.

Which tests are performed internally? What qualifications do lab technicians have? <qualification evidence> Is an internal lab available? How is product contamination by internal lab prevented? When and how are organoleptic tests performed? <inspection plan> <documentation of organoleptic test results>

International Featured Standards IFS PACsecure Version 1

5.6.7

IFS, October 2012

For verification of finished product quality, internal organoleptic tests shall be carried out regularly when specified by the customer. These tests shall be in accordance with specifications or other legally required documentation and related to the impact on respective parameters of product characteristic. The results of these tests shall be documented.

 IFS, October 2012

5.6.8

Based on any internal or external information on product risks which may have an impact on packaging material safety, the company shall update its control plan and/or take any appropriate measure to control impact on finished products.

For example, if an alert system informs that a raw material sourced from a specific country regularly has specific rate of dangerous substance, and if the company is used to buying this specific raw material, the company shall increase the frequency of analysis of this raw material, to improve monitoring. On the other hand, if results of analysis always show good results, and if the raw material is considered as a low risk one, the company can decide to decrease the frequency of analysis.

5.7 7.0 B 2 6.3 In response to deviations from the prerequisite programs corrective actions will be determined. Corrective actions may include, but are not limited to: Product hold, assessment and disposition. Ensuring the corrective action is completed. Root cause identification. Preventive actions.

Product quarantine (blocking/hold) and product release Who quarantines or releases products? <job description> How are quarantined products identified? When no procedures exist for product quarantine or release. When quarantined products go unchecked into further use and a safety issue occurs.

International Featured Standards IFS PACsecure Version 1

5.7.1

A procedure shall be in place, based on hazard analysis and assessment of associated risks, for the quarantine (blocking/hold) and release of all raw materials, semi-processed and finished products and wrapping materials. The procedure shall ensure that only products and materials conforming to product requirements are converted and dispatched.

5.8

Management of complaints from authorities and customers How are complaints handled? <complaint handling procedure> If there is no procedure for complaint handling.

5.8.1

A system shall be in place for the management of product complaints.

Part 2

5.8.2

103

All complaints shall be assessed by competent staff. Where it is justified appropriate actions shall be taken immediately, if necessary.

Who ponders about complaint significance? Who defines the actions to be taken? Within what time frame must actions be taken?

IFS PAC secure number

IFS PACsecure requirement

104

Connection with PACsecure PP requirement number Who manages complaint statistics? <complaint statistics> How often are complaint statistics compiled? What actions are taken to avoid recurrence? To whom are complaint statistics data presented? <retailer complaint statistics data> No corrective actions were taken although a failure comes up more frequently or is considered as serious.

Text/Number of connected PACsecure PP (Prerequisite Program) requirement

What to check? What should be asked?

Example for KO/Major

Part 2

5.8.3

Complaints shall be analyzed with a view to implementing preventive actions which avoid the recurrence of the non-conformity.

5.8.4

The results of complaint data analysis shall be made available to the relevant responsible persons and to the senior management.

5.9 7.0 F 1 F 1.1.12 110

Management of incidents, product withdrawal, product recall Who belongs to incident management staff? <phone list> Who is informed when an incident occurs? How are incidents managed? <crisis management procedures> What is an incident? <incident management procedures> communication plan: definition of the internal and external communication (in the case of incidents, product withdrawal, product recall), Who is allowed to report what to whom? How much is distribution involved with incident management? When and who informs customer? <alarm plan> <phone list> A withdrawal/recall management procedure is not enough to define an incident management procedure. 110 If there is no incident management system implemented.

5.9.1

A documented procedure shall be defined for management of incidents and of potential emergency situations that impact packaging material safety, legality and quality. This procedure shall be implemented and maintained. This includes as a minimum: the nomination and training of a crisis team, an alert contact list, sources of legal advice (if necessary), contacts availability, customer information, and a communication plan, including information to consumers. 7.0 F 1 F 1.1.12

International Featured Standards IFS PACsecure Version 1

5.9.2

KO N 8: There shall be an effective procedure for the withdrawal/recall of all products, which ensures that involved customers are informed, as soon as possible. This procedure shall include a clear assignment of responsibilities.

If there is no procedure for recall/withdrawal in place.

IFS, October 2012

 IFS, October 2012

5.9.3

Updated emergency contact details (such as names and phone numbers of suppliers, customers and competent authorities) shall be available. A person of the company, who has the authority to initiate the incident management process, shall be permanently available.

F 1.1.12

What kind of incident management is No incident manageimplemented? ment is available in Who is responsible for communication with the company. customers, press/media and authorities? Is a list of important telephone numbers available? <phone list>, <emergency plan> Who is informed when a crisis occurs? <alarm plan> <phone list> When are media involved? <incident management procedures> How is effectiveness of withdrawal tested? How often is effectiveness of withdrawal tested? <withdrawal test results> When withdrawal procedures are not tested or when test results have shown that the procedures are ineffective but no corrective actions were implemented.

5.9.4

The feasibility, effectiveness and timeliness of implementation of the withdrawal procedure shall be subject to regular internal testing, based on hazard analysis and assessment of associated risks but carried out at least once a year. This shall be carried out in a manner to ensure the effective implementation and operation of the procedure.

F 1.1.12

10

5.10 8

Management of non-conformities and non conforming products What procedures exist for non-conforming products management? How are non-conforming products identified? What rules exist for product quarantine procedures? <quarantine tickets> When no procedures exist for non-conforming products management.

International Featured Standards IFS PACsecure Version 1

5.10.1

A procedure shall exist for the B 2.3.12 management of all non-conforming raw materials, semi-finished and finished products, converting equipment and wrapping materials. This shall include, as a minimum: isolation/quarantine procedures hazard analysis and assessment of associated risks identification (e.g. labeling) decision about the further use (e.g. release, rework/post treatment, blocking, quarantine, rejection/disposal).

5.10.2

Part 2

105

The responsibilities for the management of non-conforming products shall be clearly identified. The procedure for the management of non-conforming products shall be understood by all relevant employees.

Who is responsible for putting non-conforming products into quarantine? <quarantine tickets> Who may release quarantined products? <quarantine tickets> How is it ensured that only authorized persons release quarantined products? <quarantine tickets>

When employees do not know who is authorized to release quarantined products or when the products are in conditions to be released or when products are quarantined and a safety issue occurs.

IFS PAC secure number

IFS PACsecure requirement

106

Connection with PACsecure PP requirement number B 2.3.12 8, 9, 10 What procedures are implemented with non-conforming products? <quarantine tickets> Who decides about non-conforming products? <quarantine tickets> For example, evidences can be provided to show that products have not been placed on the market (e.g. contracts with external waste destroying service providers). Exceptions can be checked with examples (situations which already occurred), by checking the content of the contract. In case of a renewal audit: were the corrective actions of the previous IFS audit applied? What are corrective actions procedures? <corrective actions procedures> No corrective actions procedures exist.

Text/Number of connected PACsecure PP (Prerequisite Program) requirement

What to check? What should be asked?

Example for KO/Major

Part 2

5.10.3

Where non-conformities are present, immediate corrections shall be taken to ensure that product requirements are complied with.

5.10.4

Out of specification finished goods or finished goods that do not meet other legal requirements are not allowed to be put on the market. The material has to be destroyed appropriately. Exceptions shall be agreed in writing with the contract partners.

B 2.3.12

11, 12

5.11

Corrective actions

5.11.1

A procedure shall be in place for the recording and analysis of the non-conformities with the objective to avoid recurrences by preventive actions and/or corrective actions. 6, 3

International Featured Standards IFS PACsecure Version 1

5.11.2 KO

KO N 9: Corrective actions shall be clearly formulated, documented and undertaken, as soon as possible to avoid further occurrence of nonconformity. The responsibilities and the timescales for corrective action shall be clearly defined. The documentation shall be securely stored, and easily accessible.

In response to deviations from the prerequisite programs corrective actions will be determined. Corrective actions may include, but are not limited to: Product hold, assessment and disposition. Ensuring the corrective action is completed. Root cause identification. Preventive actions.

Which corrective actions were implemented? <model corrective action procedures> Where are corrective actions documented? <model corrective action procedures > Who is responsible for corrective actions? <model corrective action procedures > How long may it take to implement corrective actions? <model corrective action procedures >

No corrective actions are taken. Corrective actions are not implemented within a short time span. Corrective actions are not documented No responsibilities are assigned to implement corrective actions.

IFS, October 2012

 IFS, October 2012

5.11.3

The performance of the implemented corrective actions shall be documented and the effectiveness shall be checked.

Where are corrective actions documented? Corrective actions are not documented <model corrective action procedures> and/r verified. How are corrective actions verified? <model with verified corrective action procedures>

Packaging material defense/Food defense and external inspections

6.1 Who has the accountability for the packaging material defense program? What are the competence and qualifications demonstrated for the person(s) responsible for the packaging material defense program? What is the position of the person(s) responsible for the packaging material defense program with respect to the management team? How do management teams support the person(s) responsible for the packaging material defense program? Where are the responsibilities clearly defined? Was this communicated to the members of the company? How?

Defense assessment

International Featured Standards IFS PACsecure Version 1

6.1.1

Responsibilities for packaging material defense shall be clearly defined. Those responsible shall be key staff or shall have access to the top management team. Sufficient knowledge in this area shall be demonstrated.

Part 2

107

IFS PAC secure number

IFS PACsecure requirement

108

Connection with PACsecure PP requirement number What are the legal/customer packaging material defense requirements applicable to the company? How can the company demonstrate compliance with such requirements? What is the process/procedure used to perform the hazard analyisis and assessment of associated risks? Is the hazard analysis in line with legal and/or customer needs and/or expectations? How do the systems assist the company to identify critical or high risk areas? How often is a review of the packaging material defense program performed? What criteria does the company consider in order to determine the frequency to perform the hazard analysis, if is not done annually? How is the company alerted of any packaging material defense breach? How does the company evaluate the effectiveness of the packaging material defense program?

Text/Number of connected PACsecure PP (Prerequisite Program) requirement

What to check? What should be asked?

Example for KO/Major

Part 2

6.1.2

A packaging material defense hazard analysis and assessment of associated risks shall have been performed and documented. Based on this assessment, and based on the legal requirements, areas critical to security shall be identified. Packaging material defense hazard analysis and assessment of associated risks shall be conducted annually or upon changes that affect packaging material integrity. An appropriate alert system shall be defined and periodically tested for effectiveness.

International Featured Standards IFS PACsecure Version 1

6.1.3

If legislation makes registration or on-site inspections necessary, evidence shall be provided.

IFS, October 2012

What are the legal/customer packaging material defense requirements applicable to the company? Based on legal requirements in the country where the plant is located or by the country where the product is consumed, is it required to apply for formal registration? If registration is required, who has this information? Could the company demonstrate compliance? Is there any requirement for periodic inspection? If yes, then: Who performs it? Against what standard?

 IFS, October 2012

When was the last inspection? What was the result of the inspection? Is it required to provide evidence that deviations have been solved? (corrective actions) What are the implications if a major breach is identified?

6.2 Based on the hazard analysis and assessment of associated risks, what areas have been identified as critical? What control measures are in place in order to control the entrance to those areas? How does the company maintain control over who enters to the premises and critical areas? What are the access controls applicable to the following people? Temporary employees Contractors Visitors Employees Carrier drivers Does the company define procedures to identify tampering of raw materials, Works in Process (WIP) and final goods? Are there means to verify if products have been tampered? Are employees trained in the identification of tampered products? Does the design of packaging material include the identification of tamper evident measures? Is it required by law in the country of origin or destination? Are there tests to verify that measures against tampering are properly applied and working properly?

Site Security Unauthorized persons freely enter production or storage areas so that a safety risk occurs.

6.2.1

Based on a hazard analysis and assessment of associated risks, identified areas critical to security shall be adequately protected to prevent unauthorized access. Access points shall be controlled.

International Featured Standards IFS PACsecure Version 1

6.2.2

Procedures shall be in place to prevent tampering and/or allow identification of signs of tampering.

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Personnel & Visitor Security

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Connection with PACsecure PP requirement number Do visitor/contractor access policies include controls to avoid that no members of the company are able to move freely without escorts inside the premises? Are visitors and contractors informed of the packaging material defense rules and their scope while inside company premises? Does the company have defined means to ensure that contractors who will spend a long time inside the plants are properly identified, supervised and escorted inside critical areas? Are there controls to ensure that the access for truck drivers who load or unload products/materials is restricted to defined areas inside and outside the building and company premises? Are there means to watch the movements of non-employees once they enter company premises? (E.g. cameras or guards at defined areas? Other procedures?) If contractors and visitors are provided with access keys, are those keys programmed to limit the access to specified and selected areas? If escorts are required to guide visitors and contractors at all times, are there arrangements to have defined guides at all shifts? Are security/guards aware of how to deal in cases where there are no escorts available at any particular moment? Does the annual training program include packaging material defense? How is packaging material defense and associated controls explained to new employees? Are there records that demonstrate that employees received packaging material defense training?

Text/Number of connected PACsecure PP (Prerequisite Program) requirement

What to check? What should be asked?

Example for KO/Major

Part 2

6.3.1

Visitor policy shall contain aspects of packaging material defense plan. Delivery and loading staff in contact with the product shall be identified and shall respect the access rules of the company. Visitors and external service providers shall be identified in areas with product storage and shall be registered at the time of access. They should be informed about the site policies and their access controlled accordingly.

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6.3.2

All employees shall be trained in packaging material defense on an annual basis or when significant program changes occur. The training sessions shall be documented. Employee hiring and employment termination practices shall consider security aspects as permitted by law.

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Is training updated according to changes in the packaging material defense program? How are employees informed of major changes in the packaging material defense program? Does the system evaluate training effectiveness? Does training include controls of knowledge acquired from the last version of the packaging material defense training? What controls are implemented at the time of hire/termination of an employee or creation/termination of a service by a contractor? Are access controls updated at the time of termination of an employee or when the work is finished on the part of a contractor?

6.4

External Inspections Is there a documented procedure that defines the criteria to follow in case an external organization requires access to the companys premises? Are there clearly defined levels of authority to provide access to external organizations at all times? Does the procedure define the means to proceed if or when a regulatory body requests access to the premises? Are relevant functions aware of their responsibilities under such conditions? Are levels of authority defined with respect to the kind of information that is allowed to be provided? Are there means to ensure a complete record of activities done and details of the visit?

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6.4.1

A documented procedure shall exist for managing external inspections and regulatory visits (if applicable). Relevant personnel shall be trained to execute the procedure.

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ANNEX 1: GLOSSARY/DEFINITIONS LIST

Definitions which are not mentioned within the glossary can be found in relevant regulations and directives. In relation to the terms used within this document and PACsecure documents, the following definitions apply and shall be respected.
Term Additive Explanation Materials such as plasticizers, preservatives, slip agents, antistatic agents, processing aids, and others, added to a base material in order to achieve a specific result. An adhesive substance (as glue or cement, or starch in paper industry). Food causing an adverse reaction that is mediated by an immunological response. Defined allergens are: Cereals containing gluten (i.e. wheat, rye, barley, oats, spelt, kamut or their hybridised strains) and products thereof Crustaceans and products thereof Eggs and products thereof Fish and products thereof Peanuts and products thereof Soybeans and products thereof Milk and products thereof (including lactose) Nuts i.e. Almond (Amygdalus communis L.), Hazelnut (Corylus avellana), Walnut (Juglans regia), Cashew (Anacardium occidentale), Pecan nut (Carya illinoiesis (Wangenh.) K. Koch), Brazil nut (Bertholletia excelsa), Pistachio nut (Pistacia vera), Macadamia nut and Queensland nut (Macadamia ternifolia) and products thereof Celery and products thereof Lupin and products thereof Molluscs and products thereof Mustard and products thereof Sesame seeds and products thereof Sulphur dioxide and sulphites at concentrations of more than 10 mg/kg or 10 mg/litre expressed as SO2. (Commission Directive 2007/68 EC of 27 November 2007 amending Annex III a to Directive 2000/13/EC of the European Parliament and of the Council as regards certain food ingredients.) There are 8 major allergens recognized in the United States according to the 2009 U.S. Food and Drug Administration (FDA) Model Food Code, Definitions section, page 12. (1) Major food allergen means: (a) Milk, egg, fish (such as bass, flounder, cod, and including crustacean shellfish such as crab, lobster, or shrimp), tree nuts (such as almonds, pecans, or walnuts), wheat, peanuts, and soybeans (b) A Food ingredient that contains protein derived from a food, as specified in Subparagraph (1)(a) of this definition. (2) Major food allergen does not include: a) Any highly refined oil derived from a food specified in Subparagraph (1)(a) of this definition and any ingredient derived from such highly refined oil; or b) Any ingredient that is exempt under the petition or notification process specified in the Food Allergen Labelling and Consumer Protection Act of 2004 (Public Law 108-282). Precautionary measures taken to prevent contamination. Person assigned by an accreditation body to perform, alone or as part of an assessment team, an assessment of a Conformity Assessment Body. Systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfiled.

Adhesive Allergen (EU)

Allergen (US)

Aseptic technique Assessor (for accreditation bodies) Audit

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Auditor

An individual who is qualified to provide audits, such as certified auditor. Note: An employee who is qualified and independent of the audited function typically conducts first-party/internal audit within the organization. A totally independent certified auditor who is not involved in the customer-supplier relationship conducts third-party audits. Parasites, bacteria, moulds, or viruses that have the ability to cause illness or death. A company who buys packaging materials from packaging material manufacturer and converter and fill the package with the product. Set of operations that establish, under specified conditions, the relationship between values of quantities indicated by a measuring instrument or measuring system, or values represented by a material measure or a reference material and the corresponding values realised by standards. An operator of a conveyance such as a truck, railcar, vessel, or aircraft used to transport goods. A step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level. Chemical products (e.g. agricultural chemicals, cleaning agents, food and packaging additives, waxes and coatings, heavy metals, inks, solvents, etc.) that have the potential to cause illness or death especially when used in excess of regulatory limits. The removal of soil, residue, dirt, grease or other objectionable matter. General organisation (whereas the site is a unit of the company). An employee who is familiar with and capable of assessing the operation of a piece of equipment or process. Surfaces that contact packaging product. This also includes any surface that might drip or drain onto a surface that contacts packaging product during the normal course of operations. Contact surfaces include equipment such as containers, tables and conveyor belts used in packaging operations. It does not include forklifts, hand trucks, or pallets that are used for handling wrapped packaging products. Introduction or occurrence of a contaminant in packaging material or environment. Contamination does include: physical, chemical, biological contamination. Contamination can also mean correlation of packages among themselves. (Food safety) action or activity that can be used to prevent or eliminate a food safety hazard or reduce it to an acceptable level. Acceptable levels may be derived from; regulatory requirements; industry standards; scientific information; customer requirements; risk assessments. A manufacturer that takes raw materials and converts them into a usable package or package component. The period in which a product may be processed/converted before being considered unsuitable for the purpose. Company. Action to eliminate a detected non-conformity or deviation. Action to eliminate the cause of a detected non-conformity or other undesirable situation. Identified by the hazard analysis as essential in order to control the likelihood of introducing or proliferation of food safety hazard in the product and/or the environment. A CP can be considered as an OPRP (Operational Prerequisite Program), as defined in ISO 22000. A customer is a business company or person to whom products are sold either as finished product or as a semi-finished part of the finished product.

Biological hazards Buyer/filler Calibration

Carrier CCP Critical Control Point Chemical hazards

Cleaning Company Competent employee Contact surfaces

Contamination

Control measure

Converter Converting time Corporate Correction Corrective action CP Control point

Customer

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Deviation

Non-compliance with a requirement but there is no impact on food safety related to products and processes. In the IFS, deviations are requirements scored with a B, C or D and KO requirements scored with a B. Any building or surrounding area in which packaging material and/or product is handled manufactured, or converted, and is under the control of the same management. The process of forming a thermoplastic film, container, or profile by forcing the polymer melts through a shaped orifice. The extruded plastic is immediately chilled. Buildings and other physical structures used for or in connection with the manufacturing and converting of packaging material and product. Factory inspection covers specific subjects and can be carried out by any appropriate person. That means regular visits in any areas, for any purposes, to check the conformity (hygiene, pest control, product control, fabrication, foreign material hazards, surrounding control etc.). First InFirst Out: an inventory system of product rotation, where the oldest product is shipped first. A systematic representation of the sequence of steps or operations used in the production or manufacture of a particular packaging material item. Assurance that food will not cause harm to the consumer when it is prepared and/or eaten according to its intended use. Exhaustive description of quantity and quality of raw materials to be used to process the products, as required in customer specifications. Formula can also include technological parameters and specific know-how on the process. Food Safety Enhancement Program. The FSEP is the Canadian Food Inspection Agencys (CFIA) approach to encourage and support the development, implementation and maintenance of Hazard Analysis Critical Control Point (HACCP) systems in all federally registered establishments of the meat, dairy, honey, maple syrup, processed fruit and vegetable, shell egg, processed egg and poultry hatchery sectors. Government and food industry developed FSEP jointly in 1991 in consultation with consumer groups. (http://www.inspection.gc.ca/english/fssa/polstrat/haccp/haccpe.shtml) Any of various strong adhesive substances; especially: a hard protein chiefly gelatinous substance that absorbs water to form a viscous solution with strong adhesive. An organism, with the exception of human beings, in which the genetic material has been modified otherwise than natural multiplication or natural recombination. The practices that prevent and minimize the biological, chemical and physical contamination of packaging material and product during receiving, manufacturing, converting, storage and transportation, to ensure food safety. EU: (EC) No 2023/2006 of 22 December 2006 on good manufacturing practices for materials and articles intended to come into contact with food. US: 21 CFR 174 - 21 CFR 190. A system which identifies evaluates and controls hazards which are significant for packaging material safety. A biological, chemical or physical agent in, or condition of, packaging material with the potential to cause an adverse health effect. The process of collecting and evaluating information on hazards and conditions leading to their presence to decide which are significant for packaging material safety and therefore should be addressed in the HACCP plan. Assessment of the Conformity Assessment Body Head Office.

Establishment

Extrusion Facility Factory inspection (versus Internal audits)

FIFO Flow diagram Food safety Formula

FSEP

Glue

GMO GMP Good Manufacturing Practices GMP regulation (EU/US) HACCP (risk assessment) Hazard Hazard analysis

Head office assessment (for accreditation bodies)

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Hygiene Inert Integrity Program

Conditions and measures that are required to ensure that packaging material and product is safe. Material without active chemical properties. Program implemented by IFS in order to: Monitor, as preventive actions performance of auditors and certification bodies as well as audited companies, Manage, as corrective actions, any complaints addressed to IFS. General process of audit, for all the activity of the company. Conducted by or on behalf of the company for internal purposes. Internal auditing is an independent, objective assurance and consulting activity designed to add value and improve an organizations operations. It helps an organization accomplish its objectives by bringing a systematic, disciplined approach to evaluate and improve the effectiveness of risk management, control, and governance processes. A process of plying layers of stock to a given thickness. The packaging product manufactured during a period of time or according to a specific code. A testing process designed to find unintended holes or voids that allow air or fluid to pass through packaging materials. For labeled products, leak test is conducted prior to labeling in order to avoid concealing any leaks. Organisms too small to be seen by the naked eye that include yeasts, moulds, bacteria, and viruses. The act of conducting a planned sequence of observations or measurements of control parameters to assess whether a CP is under control. See also Codex Alimentarius, General principles of Food hygiene, Guidelines for the application of the HACCP system, section 9. The safety data sheet information is principally intended for use by professional users and must enable them to take the necessary measures as regards the protection of health, safety and the environment at the place of work. The safety data sheet may be supplied on paper or electronically, provided that the addressee has the necessary means of receiving it. Non-fulfilment of a specified requirement. Non-conformity can be given in nonrespect of legislation, law, packaging material safety, internal dysfunctions and customer issues. In the IFS, defined non-conformities are Majors and KOs scored with a D. Food Defense is the collective term used by the US Food and Drug Administration (FDA), United States Department of Agriculture (USDA), Department of Homeland Security (DHS), etc. to encompass activities associated with protecting the nations food supply from deliberate or intentional acts of contamination or tampering. This term encompasses other similar verbiage (i.e., bioterrorism (BT), counter-terrorism (CT), etc.), The USDA Food Safety and Inspection Service define Food Defense as the protection of food products from intentional adulteration by biological, chemical, physical or radiological agents. The definition also applies on packaging materials. Any animal or insect such as birds, rodents, cockroaches, flies, and larvae that may carry pathogens and can contaminate packaging material and product. Physical components (e.g. wood or glass chip, metal piece, etc.) and foreign matter that can cause illness or injury. This includes pests and their components. Air containing less than 1,000 viable colony-forming units of total micro-organisms per cubic meter of air. Air containing less than 200 viable colony-forming units of bacteria and 200 viable colony-forming units of fungi in a cubic meter of air. Users should check with authority having local jurisdiction for limits pertaining to chemical and other contaminants.

Internal audit

Lamination Lot Leak test

Microorganisms Monitoring

MSDS Material Safety Data Sheet

Non-conformity

Packaging material defense/Food defense (US)

Pest Physical hazards Potable air

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Potable water (CA) Potable water Primary packaging Procedure

Water that meets Health Canadas Canadian Drinking Water Guidelines. (http://www.hc-sc.gc.ca/ewh-semt/pubs/water-eau/doc_sup-appui/index_e.html) Water suitable for human consumption without endangering health. It is immaculate concerning smell, taste and nature. Packaging coming into contact with the packed goods such as PET bottles, cups, plastic closures of packages. Specified way to carry out an activity or process. Procedures shall be implemented and the elaboration of procedures shall be done by documents or process description (e.g. flowchart). Result of a process or activities transforming inputs into outputs. Products include services. In the context of this Standard a product is to be considered a packaging material. The creation of products with new or different characteristics that offer new or additional benefits to the customer. Product development may involve modification of an existing product or its presentation, or formulation of an entirely new product that satisfies a newly defined customer who wants a market niche. In the IFS PACsecure Standard, the requirements for chapter product development apply even if there is just a product modification, use of new wrapping materials or modifications of production processes. Any measure aimed at achieving the return of a dangerous product that has already been supplied or made available to consumers by the producer or distributor. Product requirements includes: product safety, product quality, product legality, process and specification. Any measure aimed at preventing the distribution, display and offer of a product dangerous to the consumer. An employee who is qualified (such as certified auditor) and independent of the audited function conducts first-party/internal audit within the organization. One of the parts of a mixture A document describing detailed product features, attributes and processing factors that enable the user or the document (i.e. supplier) to produce or supply material that will fulfil its intended use. Person of the certification body in charge of assessing the IFS PACsecure audits reports before a certification decision is made. The tasks of the reviewer are, at least: To check the overall consistency of the audit reports. To check if the audit reports are properly completed To check if the findings are well described and if the justifications are relevant. To check if the corrective actions proposed by the audited company have been validated by the auditor (or by a representative of the certification body) and are relevant. The review shall be documented. A function of the probability of an adverse health effect and the severity of that effect consequential to (a) hazard(s) in packaging material. Packaging, e.g. films that have no contact with the food. Executive management. See definition of product. A unit of the company. A program designed to ensure raw materials/other material suppliers are in compliance with product specifications and safety or quality requirements. The program often includes elements such as a supplier selection and approval process; supplier auditing and product testing.

Product

Product development

Product recall Product requirements Product withdrawal Qualified employee Raw material Raw material specification (RMS) Reviewer

Risk Secondary packaging Senior management Services Site Supplier Quality Assurance (SQA) Program

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System

Set of interrelated or interacting elements. System is a planned, sustainable structured course of action. Depending on the complexity, documentation is recommended. System includes: documentation, procedure description, control/monitoring, corrective action, site plan. Packaging/wrapping that is used to group secondary packaging together to aid handling and transportation and prevent damage to the products, for example, the pallet and shrink wrap used to transport a number of cardboard outer containing boxes filled with packaging material. Ability to trace and follow a material intended to be, or expected to be incorporated into a packaging material, through all stages of production, converting and distribution. Confirmation through the provision of objective evidences that the requirements for the specific intended use or application have been fulfiled. Confirmation through the provision of objective evidences that specified requirements have been fulfiled. Assessment of the Conformity Assessment Body when it is carrying out conformity assessment services within its scope of accreditation. The auditor who is witnessed shall be accompanied by an observer from the certification body during a complete audit in order to evaluate his/her competence. The observer shall not be part of the audit (as a team member). The observer shall fulfil the same requirements as for trainers or shall be an IFS PACsecure auditor, IFS Food auditor or IFS HPC auditor. This witness audit shall be a product safety audit and/or an audit under ISO/IEC 17065. On the application file of the auditor (sent afterwards to the IFS offices), the certification body shall specify the name of the company, audit date and name of the person who observed the auditor. On request, the certification body shall be able to provide minutes of the witness audit. The auditor who is witnessed shall be accompanied by an observer from the certification body during a complete IFS PACsecure, IFS Food, IFS HPC, or another GFSI recognized packaging material safety scheme audit, in order to evaluate his/her competence. The observer shall not be part of the audit (as a team member). The observer shall fulfil the same requirements as for trainers or shall be an IFS PACsecure, IFS Food or IFS HPC auditor. For the observer, relevant product scope(s) approval, in relation to the products/processes of the audit, is not mandatory. The certification body shall specify the name of the observer in the participants list of the IFS PACsecure audit report and shall be able to provide, on request, minutes of this witness audit. See tertiary packaging.

Tertiary packaging

Traceability

Validation Verification Witness assessment (by accreditation bodies) Witness audit before applying to IFS examinations

Witness audit, to be performed every 2 years, for IFS PACsecure approved auditors

Wrapping

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Part 3: Requirements for Accreditation Bodies, Certification Bodies and Auditors

IFS accreditation and certification process 0 Introduction

IFS PACsecure certification is a product and process certification. All bodies involved shall comply with the international rules and IFS-specific requirements described in this document. Part 3 of the IFS PACsecure Standard deals mainly with accreditation bodies, certification bodies and auditors.

1
1.1

Requirements for the Accreditation Bodies

General requirements

The accreditation bodies shall fulfil the requirements of the ISO/IEC 17011 norm Conformity assessment General requirements for Accreditation Bodies accrediting conformity assessment bodies , and shall have signed the MLA (Multilateral Agreement) for Product Certification of the EA or IAF . As soon as it will come into force, the accreditation bodies shall also fulfil the GFSI Requirements for the Application of ISO/IEC 17011:2004, which is complementary of the below requirements. In order to ensure interactive communication, the accreditation body shall appoint an IFS contact person within their organisation.

1.2

The training of the accreditation committee (or competent person)

In general, all accreditation body personnel engaged in IFS PACsecure accreditation activity shall have sufficient knowledge of the IFS PACsecure scheme, related normative documents and food or packaging industry. Decisions on accreditation can only be made following a recommendation of a competent person or accreditation committee. The person in charge, or at least one member of the accreditation committee, shall
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have taken part in an IFS PACsecure training course organised by IFS or shall be able to demonstrate equivalent knowledge level as confirmed by IFS. In case of a committee, the trained person provides the other members of the accreditation committee with the necessary information. This information is based on the main points of the IFS PACsecure training course with the main emphasis on Part 1 (IFS PACsecure audit protocol), Part 3 (requirements for accreditation bodies, certification bodies and auditors), Part 4 (audit report, certificate) and the auditors approval process for IFS.

1.3

Competences of the assessor of the accreditation body

The assessor(s) of the accreditation bodies is responsible for the following: accompanying IFS PACsecure auditors during registered IFS PACsecure audits (witness assessment), assessing the head office of the certification body (head office assessment) according to the ISO/IEC 17065 rules and IFS-specific requirements. In general, the assessor(s) shall meet ISO/IEC 17065 and IFS requirements. Witness assessors shall, at a minimum: Have taken part in the IFS PACsecure training course, or shall be able to demonstrate an equivalent knowledge level as confirmed by IFS, Have taken part in a HACCP course or other course related to hazard analysis and assessment of associated risks, Have a minimum of two (2) years of experience in the packaging material industry sector. Head office assessors shall, at a minimum: Have specific knowledge in the IFS PACsecure scheme, Have specific knowledge of the related normative documents.

1.4

Frequency of the assessments of certification bodies

For initial assessment, a head office assessment (with review of at least one full certification process) and at least one witness assessment shall be performed. The certification body is allowed to perform maximum 5 audits before getting accreditation. In this case, at least one of the audits shall be
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assessed by the accreditation body (witness assessment) and all audits (including at least one full certification process) shall be reviewed by the accreditation body during the initial headquarter assessment. For renewal assessment, a head office assessment (with review of at least one full certification process) and at least one witness assessment shall be performed. During the surveillance of the accreditation cycle: A minimum of one head office assessment a year, A minimum of one witness assessment every two (2) years shall take place. Remark: a flexibility of three (3) months at the maximum can be allowed for the interval between two (2) assessments, according to the accreditation body rules. During head office assessments, the following documentation shall be sampled and assessed, as a minimum: At least 10 % or two (2) IFS PACsecure auditor files, whichever is greater, At least two (2) site files or 2 % of delivered audits, whichever is greater. For consecutive witness assessments, the accreditation body shall, wherever possible, select two different certification bodys IFS PACsecure auditors with different scopes.

1.5

Accreditation of an internationally-active certification body

The witness assessments shall cover the typical activities (including international activities and critical locations) of the certification body. If the accreditation body subcontracts an assessment, the subcontracted accreditation body shall be a signatory to the IAF MLA for Product Certification. IAF GD 3 Cross Frontier Policy shall apply.

1.6

Conditions for recovering accreditation after withdrawal or suspension

In case the accreditation body decides to withdraw or suspend accreditation, certification bodies shall stop performing IFS PACsecure audits and issuing IFS PACsecure certificates. To recover accreditation after withdrawal, the same conditions as for initial assessment apply. In case of accreditation suspension, IFS and accreditation body will jointly determine requirements to remove suspension.
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1.7

Transfer of certification

In case one certification body decides to transfer its certification activities to another one, the new certification body shall verify all current IFS PACsecure certificates, in order to decide if further actions (e.g. withdrawal of recent certificates or additional IFS renewal audit) will be necessary.

Requirements for the Certification Bodies

Certification bodies intending to perform IFS PACsecure audits shall comply with the following rules. The prescribed tender procedure for certification bodies is supplied by IFS.

2.1

ISO/IEC 17065 IFS accreditation process

The certification body shall be accredited according to ISO/IEC 17065 for the scope of IFS PACsecure by an IAF or EA recognised accreditation body (see section 1). Certification bodies in the process of IFS accreditation to ISO/IEC 17065 may organise the witness assessment(s) before having achieved accreditation status. They shall demonstrate that they are actively applying for ISO/IEC 17065 accreditation. Note: In case of withdrawal or suspension of the ISO/IEC 17065 accreditation of the scope of IFS PACsecure for the certification body, the whole certification process is stopped and the certification body is no longer allowed to issue any IFS PACsecure certificates. In particular, the certification body cannot issue IFS PACsecure certificates from the date of withdrawal or suspension, even for the audits which have been already performed but which are still in the certification process (review of the report, certification decision, etc.).

2.2

Signing of contract with the proprietor of IFS

After having applied and then gained IFS accreditation to ISO/IEC 17065, in order to be allowed to perform IFS PACsecure audits, the certification body shall sign a contract with IFS in which it commits to meet all IFS requirements. The certification body is not authorised to perform IFS PACsecure audits (except the first witness assessment(s) during the accreditation process) before having signed this contract.

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2.3

Certification decision

The person in charge of assessing the audit reports (reviewer) shall be either an approved IFS PACsecure auditor, an IFS PACsecure trainer or shall fulfil the following rules: To have a food or packaging university degree and two (2) years professional experience in the food safety/packaging material safety and quality related professions To have attended (as auditor or observer) at ten (10) complete audits (related to other packaging material safety schemes) in the last five (5) years To have participated in a hygiene training course To have participated in IFS PACsecureTrain-the-trainer course To be different of the person who performed the audit. The review shall be documented. The decision concerning the certification can only be made following the recommendation of a competent person or a certification committee. Furthermore, decision can only be made by a person different from the person who performed the audit.The competent person for the certification decision or at least one of the members of the certification committee shall be an IFS PACsecure auditor, an IFS PACsecure trainer or an IFS PACsecure reviewer. According to ISO/IEC 17065, the final certification decision shall be made by the certification body and shall not be subcontracted.

2.4

Certification bodies responsibilities for IFS PACsecure trainers and the IFS PACsecure auditors (including freelancers)
To facilitate witness audits (by accreditation bodies and/or by Integrity Program). To ensure that at least one member of their staff is an IFS PACsecure trainer who has taken part in an IFS PACsecure Trainthe-trainer course. The trainer is responsible for the in-house training of all auditors, intending to become IFS PACsecure auditors or who already are IFS PACsecure auditors. Persons intending to become IFS PACsecure trainers shall meet the requirements mentioned in 2.5. Note: for a certification body which is starting IFS activities, this in-house training can be organised by IFS, on request.

Certification bodies have the following responsibilities:

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To ensure that the auditor is competent for the scope of the audit and its execution and is able to access and to apply relevant laws and regulations, based on IFS and internal certification bodys requirements; the certification body shall maintain these competences (continuous supervision by the certification body) and shall monitor audit execution by on-site witness audit. Every auditor shall be monitored by an IFS PACsecure (or IFS Food, IFS HPC or other GFSI recognized packaging material safety) on-site witness audit at least once every two (2) years, and the results of this witness audit shall be documented. The observer shall be an IFS PACsecure, IFS Food or IFS HPC approved auditor or shall follow the same rules as for trainers (see section 2.5). To maintain records of auditor competences. To ensure that no auditor has either acted against IFS rules, for example acting as a consultant, or has been active in and/or on behalf of the company being audited during the previous two (2) years. That is to say, during the certification process, no other commercial and/or personal relationships are permitted between the auditee and the auditor. To ensure that no auditor shall perform more than three (3) consecutive IFS PACsecure audits of the same production site (only applies for complete audits, whatever the time between them; follow up and extension audits are not concerned by this rule). To ensure that an auditor is employed by only one IFS certification body for performing IFS PACsecure audits and this for a period of not less than 12 months. In special cases, IFS offices shall be contacted and may allow exceptions. To sign an audit order for each audit, this includes a statement accepting all the above-mentioned requirements. To organise a 2-day training session for IFS PACsecure auditors once a year for the purposes of sharing experience, calibration and updating knowledge of relevant legal requirements, etc. The IFS PACsecure trainer shall lead a part of the training course. To perform an on-site witness audit of an auditor during a product safety audit and/or an audit under ISO/IEC 17065 accreditation to ensure the auditors competence (see glossary) before he/she has applied for the IFS examinations. The certification body shall state the date, the name of the audited company where the on-site witness audit took place, and the name of the observer in the IFS examination application file.The minutes of the on-site witness audit shall be provided on request to the IFS in English, French or German. The observer for the on-site witness audit of an auditor applying for IFS examination shall comply with the same requirements as the trainers (see section 2.5) or shall be an IFS PACsecure, IFS Food or IFS HPC auditor.

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To include the name of the observer in the Audit Portal when uploading the audit data, when it has scheduled specific onsite IFS witness audit(s) according to ISO/IEC 17065 on internal audits. The certification body is responsible for choosing an auditor with the corresponding scope(s), language, competence(s), etc. for each IFS PACsecure audit.

2.5

Specific requirements for IFS PACsecure trainers

IFS PACsecure trainers shall have the following profile: Fulfil requirements for IFS PACsecure auditors as described in section 3.2 a), b), c) and d), Have audit experience to GFSI standards or other packaging material safety schemes, Have knowledge of packaging legislation, Have taken part in a IFS PACsecure Train-the-trainer course organised by IFS, Be fluent in writing and speaking the languages they will use during participating in training and leading training; they shall inform the IFS offices about the languages they are able to use when teaching. The IFS PACsecureTrain-the-Trainer course is organised by IFS. In order to keep his/her knowledge of IFS PACsecure up to date, each IFS PACsecure trainer shall take part in a 2-day IFS PACsecure training course every two (2) years. These seminars are organised by IFS and shall be the basis for in-house training to all auditors. IFS PACsecure trainers have the responsibility to: Train new IFS PACsecure auditors before applying to IFS PACsecure exams, Lead (a part or the whole) 2-day training session for IFS PACsecure auditors once a year, for the purposes of sharing experience, calibration and updating knowledge of relevant legal requirements, etc. When a new version of the Standard is published, the certification bodys trainer shall take part in the new IFS PACsecure course organised by IFS and carry out in-house training of all the already IFS PACsecure approved auditors, before performing audits based on new version.The duration of this in-house training shall be at least one day. In case of publication of new doctrines, the trainer shall train all IFS PACsecure auditors before the doctrine comes into force.
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Requirements for IFS PACsecure auditors

In general, the auditors shall meet the requirements of chapters 7.2 and 7.3.1 of ISO 19011. During an IFS PACsecure audit, auditors shall, according to IFS good auditing practices, use relevant samples of products, in order to investigate on-site the auditees production processes and documentation and to check the fulfilment of IFS requirements. In particular, auditors shall perform, during the audit, a traceability test in the company. IFS publishes guidelines which can provide further information on topics to be checked and/or requested to the audited company during the audit.

3.1

Conversion of auditors to get the IFS PACsecure version 1 auditor approval

Auditors being already qualified for PACsecure or other IFS schemes are allowed to audit against the IFS PACsecure version 1, without going through the full qualification process as mentioned in 3.2 and 3.3 if they fulfil the following requirements: If they are PACsecure auditors: they shall have experience in product/process certification (or attend a training on product/ process certification organised by IFS, including verification of acquired knowledge) and additionally attend an IFS PACsecure training organised by IFS. If they are IFS HPC auditors approved for scope 3 (Housekeeping properties): they shall additionally attend an IFS PACsecure training organised by IFS. If they are IFS Food approved auditors, also qualified for a packaging standard related to safety and quality, like GMP FEFCO, ISO 22000 scope M or BRC IoP: they shall additionally attend an IFS PACsecure training organised by IFS. If they are qualified for a packaging standard related to safety and quality (e.g. BRC IoP , ISO 22000 scope M, etc.): they shall attend an IFS PACsecure training organised by IFS and, if relevant, additional training on product/process certification, organised by IFS.

3.2
3.2.1

Requirements for new IFS PACsecure auditors

Requirements before applying for the IFS PACsecure examinations

Before applying for IFS examinations, auditors shall have met the following requirements: They shall have signed a contract with the certification body (see ISO/IEC 17065 norm).
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They confirm to the certification body that, for a period of at least 12 months, they will perform IFS PACsecure audits only for the respective certification body. They may, however, work for several certification bodies on other standards. In special cases, IFS should be contacted and may allow exceptions. They shall have participated at the IFS PACsecure in-house course organised by the certification body. They shall have submitted all the relevant information about their competence to the certification body. The certification body shall have observed and confirmed the professional qualification and competence of the auditors.

3.2.2

General requirements for auditors when applying for IFS PACsecure examinations

Candidates applying for qualification as IFS PACsecure auditors shall meet the following requirements and provide evidence with the application documents. An outline CV is available from IFS. a) Education in the food and packaging material sector 1) A food or packaging-related university degree (bachelors and/or masters degree equivalents) and two (2) years professional experience in the packaging material industry in relation to packaging material production activities (quality, production, R & D, ). or 2) If the candidate started directly as an auditor after completing his/her food or packaging related university degree then the candidate shall have five (5) years professional audit experience in the packaging related industry. or 3) If the candidate has a university degree but not a food or packaging-related one, (bachelors and/or masters degree equivalents) then the candidate shall have five (5) years professional experience in the packaging material industryin relation to packaging material production activities (quality, production, R & D, ). or 4) Professional education in food or packaging processing (high degree) and five (5) years professional experience in the packaging material industryin relation to packaging material production activities (quality, production, R & D, ). b) General audit experience A minimum of ten (10) complete audits shall be performed by the auditor in the packaging material processing industry during the previous two years. The audits shall have been carried out in different companies. c) Food/Packaging hygiene (including HACCP/risk assessment) training Qualified training on the basis of the Codex General Principles for Food Hygiene.
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d) Training in auditing techniques based on Quality Management System or Packaging Material Safety Management System Duration: one week/40 hours or equivalent. e) Specific and practical knowledge for product scopes auditors apply for (see Annex 1 for product scopes) At least two (2) years professional experience in the packaging material industry in relation to packaging activities, for each applied product scope. or At least ten (10) packaging safety audits and/or second party audits including quality and packaging material safety investigations with traceable origin and confirmed by the retailer or by the industry, per product scope. Ten (10) witness audits during IFS PACsecure audits, as observer, are also accepted to qualify the observer on the product scope. Audits shall have been carried out in different companies. f) Language Auditors must be fluent in English. g) IFS PACsecure in-house training IFS PACsecure in-house training materials shall be based on the materials provided by IFS. The auditor shall have taken part in the in-house training (covering IFS, packaging-related legislation, general hygiene requirements, GMP) undertaken by an authorised IFS PACsecure trainer and organised by the certification body. The minimum duration shall be two (2) days. IFS is responsible for the technical validation of the auditors application files before they take part in IFS examinations. If the auditors CV does not meet the above-mentioned requirements, IFS may reject the auditors examination application. If the auditor does not show sufficient evidence for the product scopes he/she is applying for, IFS may reject the applications for the product scopes concerned. All CVs content shall be confirmed by a person from the accredited certification body who shall put his/her name and position on the bottom of the CV. Note: IFS offices have the possibility to withdraw an IFS PACsecure auditor approval or not to accept him/her at the examination, if the information provided in the CV is false. This kind of breach will be also forwarded to the IFS Integrity Program.

3.3

IFS examination process (for new auditors, as specified in chapter 3.2)

Auditors who comply with the requirements mentioned in chapter 3.2 can take part in an IFS PACsecure written examination. If successful, the auditor is officially authorised to perform IFS PACsecure audits. The auditor is registered and a personal IFS PACsecure auditor certificate is issued. Starting from the day of passing the written examination, the auditor is allowed to perform IFS PACsecure audits for the product
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scopes he/she was authorized for by IFS offices until the end of the second calendar year. The IFS PACsecure auditor certificate mentions the duration of validity, the name of the certification body and the auditors product scope(s).

3.4

Maintenance of auditors qualification (for both types of auditors, as specified in chapters 3.1 and 3.2)

The auditor cannot perform IFS PACsecure audits anymore when his/her IFS PACsecure auditor certificate expires. The certification body is responsible to maintain auditors IFS approval so that there are no gaps during the auditor approval. Auditors approval shall be re-assessed before end of validity of the auditor certificates. For maintaining their approval, auditors shall fulfil the following requirements: have performed a minimum number of ten (10) IFS PACsecure audits (5 audits per year), have been trained internally by the certification body on packaging-related legislation, Standard requirements, audit practices, etc. (2 days per year), be monitored by an IFS on-site witness audit (once every two years).This audit can be performed at any time during the year of end of validity of auditors certificate. Witness assessments performed by accreditation bodies during IFS PACsecure audits are accepted as witness audits, have taken part in an IFS PACsecure calibration training course (subsequent to passing the initial examination, the first mandatory calibration training shall be successfully completed in the second calendar year following the date on which the initial examination was successfully completed.Then, the re-approval shall be managed every two (2) calendar years, based on the same rule). Documented evidences shall be provided to IFS offices. Example: Date of initial written examination: 25th of October 2012 Date of end of validity for IFS PACsecure auditor certificate (initial approval): 31st of December 2014 Auditor is authorised to perform IFS PACsecure audits between 25th October 2012 and 31st December 2014. In 2014, if the auditor has performed 10 IFS PACsecure audits (5 per year), if he/she has been trained internally, through a yearly 2 days course, has been witnessed, and has taken part in the IFS PACsecure calibration training, the new end validity date of IFS PACsecure auditor certificate (re-approval) is: 31st December 2016. If any of these three rules are not fulfiled, the auditor shall participate again in the IFS PACsecure initial written examination.
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3.5

Scope extension for IFS-approved auditors

Auditors may, during the validity of their IFS PACsecure auditor certificate, extend their product scopes. Scope extension may not be requested in the first 12 months after the initial IFS PACsecure auditor approval. For extension of product scope(s), they shall provide the same evidence as for the initial approval, based on new experience (new from the initial application). At least ten (10) IFS PACsecure audits in the scope, as a trainee, can also be accepted as evidence. The auditor shall have participated in all steps of the audit (on-site audit, assessment and decision processes). The auditors can only perform IFS PACsecure audits according to the scopes stated by IFS.

3.6
3.6.1

Audit team
General rules

In general, all members of the audit team shall be IFS approved auditors. In case of auditing with teams, the following general regulations apply: An IFS PACsecure audit team consists of IFS PACsecure approved auditors whose product scopes comply with the activities of the audited site. A lead auditor shall always be appointed. Co-auditor(s) shall always be approved for at least one product scope of the audit scope.Two (2) hours of the audit duration are not shareable; this additional time shall be allocated to the team, not to an individual auditor, for common tasks (e.g. opening and closing meeting, discussion about audit findings, etc.) The remaining time can be split as long as the auditor competencies for product scopes are not disconnected during the audit. No crossing over is allowed.This means that, if the lead or co-auditor(s) do not have, individually, all product scopes which are necessary for the audit, they have to audit all parts of the audit related to product scope knowledge together. It shall be clearly indicated in the audit time schedule which auditor did which part of the audit. Auditors without necessary scopes can only take part as trainees. The minimum audit duration shall anyway be respected.

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3.6.2

Specific rules for audit team and auditing 3 consecutive times

For audit teams an additional rule applies as regulation for consecutive audits. As an exceptional case, (if the certification body has no other possibility to combine an audit team in year 46, due to missing approval for product scope of their auditors) the following sequence of auditor planning is possible: Year 13: Lead auditor A + co-auditor B Year 46: Lead auditor B + co-auditor C Year 7: Lead auditor A or C + co-auditor A or C.

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ANNEX 1: Product scopes

1. Flexible packaging 2. Rigid plastic 3. Paper 4. Metal 5. Glass 6. Other natural materials

Multi component packaging materials (e.g.Tetra Pak) have to be assigned based on the material which is the main component of the material.The main component of multi component packaging materials shall be mentioned in the scope of the audit on the report. Materials to be considered as other natural materials are, for example wood, clay, cork, jute, textiles, banana leaves, etc.

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Part 4: Reporting and IFS Audit Portal

0 Introduction

After an IFS PACsecure audit has been performed, a detailed and wellstructured audit report shall be completed. The language of the report shall be English. The IFS PACsecure audit report shall be prepared according to the following format.

1
1.1

Reporting
Audit overview (Annex 1)

The first part of the audit report shall contain the following general information: Audit details The cover page of the audit report shall include: name and address of the certification body the logo of the certification body the certification bodys accreditation details name of the audited company or site date of the audit. These first pages shall give a summary of the most important audit report items and shall include: name and address of the audited site name and address of the company (if headquarters) EAN. UCC Global Location Number, if available COID, as defined in the IFS Portal audit date (in case of a follow up audit the date of the follow up audit shall additionally be defined) time of the audit previous audit date the name of the certification body and the auditor who performed the previous audit details of the version of the Standard
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audit scope (mandatory detailed descriptions of processes/ products) numbers of product scopes list of key personnel present at audit name of the lead auditor if applicable, additional name of the co-auditor if applicable, name of the auditor trainee result of the audit (in case of a follow up audit, to specify that a follow up audit has taken place and that the Major non-conformity has been solved) company profile: some compulsory general information about the company shall be provided, as follows: The year of construction of the plant The registration numbers of the company by authorities if available and/or existing (and GS1 number, if available) The COID (IFS identification code number), in case of renewal audit When the last investment was made in production, product oriented investments concerning quality and safety (construction changes, machines). Specify the kind of investment made in production area The name and contact data (phone/fax/e-mail) of the contact person in case of emergency (e.g. withdrawal/recall) Product groups and products per group produced in the company Complete view of the companys processes If the audited company also has trade products (already processed), specify the kinds products How many employees are there, listed according to full-time and part-time workers (own employees, external companies), shift work The number and names of the sub-companies (sites) of the company (where are they situated, if they are IFS certified), precision about names and kinds of sub-contracted part(s) of the process The site area of the plant in square meters State if the company fulfils the requirements about use of IFS logo, as defined in IFS PACsecure audit protocol (Part 1) If the certification body has decided to decrease audit duration (see rules in chapter 5.3 of audit protocol), explanations about the reasons for decreasing If the site is certified according to other schemes, specify the schemes names
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If there are seasonal breaks in production process, please specify time frame

further explanations regarding scoring and frequency below the company profile: name of the person in charge of assessing the report (reviewer).

1.2

Audit report (Annex 2)

The audit report itself is structured as follows: the result of the audit with level and percentage observations on KOs and Majors (in case of a follow up audit, additional explanation on which requirement the Major has been solved) general summary table for all chapters an overall summary of the audit (of all chapters) a list of all established deviations and non-conformities for each chapter (1 to 6) a description of follow up of corrective actions from the previous audit a separate list (including explanations) of all requirements evaluated with N/A (not applicable) a detailed audit report.

1.3

Action plan (Annex 3)

The certification body/the auditor describes and explains all established deviations and non-conformities (KOs, Majors) in each chapter in the action plan, which has a specified format shown in the annex.

1.4

Minimum requirements for IFS PACsecure certificate (Annex 4)

After successful completion of the IFS PACsecure process, the certification body shall issue a certificate in English language. For the purposes of international recognition, and so as to be understandable, IFS PACsecure certificates awarded by the certification body shall include the following information at a minimum: the name and address of the certification body, including its logo

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the logo of the accreditation body or its name and registration number (requirement mentioned in the ISO/IEC Guide 65, G.12.7.); the logo of accreditation body shall be used in conformity with accreditation bodys rules the name and address of the audited company the COID, as defined in the IFS Portal if the company is a subsidiary, the name of the companys headquarters audit scope (with mandatory detailed descriptions of processes/products and including for instance trade products if applicable). If the list of the products is too long to be specified on the one page certificate, the list shall be specified in an annex and the IFS certificate shall make a reference to that annex. name and number of product scope(s) level achieved audit score in percentage, if required by the customer or by the audited company date of audit (last day of audit) date of follow up audit if relevant next audit to be performed within the time period (renewal audit) certificate issue date certificate expiry date, i.e. 12 months after the date of issue the certificate (the certificate validity date shall remain the same each year as described in the audit protocol, Part 1) place and date of signature name and signature of the certification bodys person(s) responsible for the certification decision as described in Part 3 of the Standard IFS PACsecure logo PACsecure logo.

The IFS Audit Portal and the IFS Database (www.ifs-certification.com)

Every IFS PACsecure audit shall be uploaded to the IFS Audit Portal by the certification body (uploading of report, action plan and certificate). There are 3 user groups which have access to the IFS Database: Certification bodies Certified companies Retailers and other users.
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The different groups access rights are as follows: Certification bodies: manage their certified companies and upload audit reports, action plans and certificates may suspend certificates in specific situations can manage all IFS PACsecure audit dates via the diary function, enabling retailers and companies to have a good overview of the scheduled audits. It is mandatory to upload in the diary function of the Audit Portal all audits dates, at latest 2 weeks before the audit. manage their accounts have the possibility to compare two consecutive audit reports and action plans, for internal auditor training and calibration purposes download the IFS logo(s). Certified companies/suppliers: have access to their own audit data have the possibility to unlock retailers and other users for their achieved percentage, detailed audit report and action plan have the possibility to compare two consecutive audit reports and action plans, for improvement purposes download the IFS Logo(s) manage their certification bodies manage company personnel access (create sub-accounts) to the audit data search for other certified companies manage their suppliers using a favourites option. Access for the headquarters of certified companies A headquarter access for certified companies can be set up which allows a company headquarter to administer all of their certified sites through a single access point. Retailers and other users: search for certified companies manage their certified companies via a favourites option get information via e-mail in case of a certificate suspension of their favourite companies. The user manuals for the IFS Audit Portal are available on the respective secured area for each user group.
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Security of the Database The security system used for the database is based on international recognised and mostly used security systems. The retailer and certified companies access provide general information about all certified companies. If no further authorisation is granted by the certified companies both user groups will be able to see the following information only: the companys name and address the certification bodys name and address the auditors name (including auditor scopes) the scope of the audit the date and duration of the audit the level achieved at the audit the IFS PACsecure certificates date of issue and its validity. By using their secure log-in access the certified companies themselves can give the authorisation for access to the following detailed information: audit report and action plan. The retailers and other users/certified companies automatically receive access to the unlocked data by the certified company after the data has been unlocked. Communication to retailers and other users is via a secure Web process which guarantees that only authorised retailers and other users/certified companies can view specific data of the certified companies/suppliers.

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ANNEX 1
Cover page of the audit report

Logo of the certification body

IFS PACsecure Version 1

Final Audit Report

Audited company: Paper and Plastic Ltd Date of audit: 02. 12./03. 12. 2012

Name and address of certification body Accreditation number of the certification body

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Explanations regarding the audit report

Evaluation of requirements
Result A B (deviation) KO requirement scored with a B C (deviation) D (deviation) Major Explanation Full compliance Almost full compliance Almost full compliance Small part of the requirement has been implemented Requirement has not been implemented When there is a substantial failure to meet the requirements of the Standard, which includes product safety and/or the legal requirements of the production and destination countries. A major can also be given when the identified non-conformity can lead to a serious health hazard. A major can be given to any requirement which is not defined as KO. The KO requirement has not been implemented Points 20 points 15 points 15 points 5 points 20 points 15 % of the possible total amount of points is subtracted

KO requirement scored with a D

50 % of the possible total amount of points is subtracted N/A requirements will be excluded from the final scoring

N/A

Not applicable Requirement not applicable for a company

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Scoring and awarding of certificates

Audit result At least 1 KO scored with D > 1 Major and/or < 75 % of the requirements are fulfilled Max 1 Major and 75 % of the requirements are fulfilled Status Not approved Action company Actions and new initial audit to be agreed upon Actions and new initial audit to be agreed upon Report form Report gives status Report gives status Certificate No

Not approved

No

Not approved unless further actions taken and validated after followup audit

Send completed action plan within 2 weeks of receiving the preliminarily report. Follow-up audit max. 6 months after the audit date Send completed action plan within 2 weeks of receiving the preliminarily report. Send completed action plan within 2 weeks of receiving the preliminarily report.

Report including action plan gives status

Certificate at foundation level, if the Major nonconformity is finally solved as controlled during the follow-up audit Yes, certificate at foundation level, 12 months validity Yes, certificate at higher level, 12 months validity

Total score is 75 % and < 95 %

Approved at foundation IFS PACsecure level after receipt of the action plan Approved at higher IFS PACsecure level after receipt of the action plan

Report including action plan gives status

Total score is 95 %

Report including action plan gives status

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First pages of the audit report IFS PACsecure Version 1, October 2012
Audit Overview
Audit details Lead auditor: Date/time of current audit: Date/time of previous audit:

Mr. Mller
Co-auditor:

02. 12. 2012 (09:0018:00) 03. 12. 2012 (08:3017:30)

07. 12. 2011 (09:0018:00) 08. 12. 2011 (08:3017:30)

CB and auditor of previous audit:

Ms. Lehmann
Trainee:

Mr. Schubert
Name and address of the company (or headquarter)

TEST GmbH/FrankTest

Name and address of the audited site

Perfect Packaging Example street 12345 Witzenhausen Germany

Paper and Plastic Ltd Musterstrae 12346 Berlin Germany

EAN Code/UCC Global Location Number COID

Phone:

Fax:

Phone:

Fax:

0 12 34 56
Scope of audit

01 23 45 67 89

0 12 34 57

01 23 45 67 88

Production of paper and PE foil Product scope(s): 1, 3

Audit participants Name: Position: Opening meeting Documentation review Site assessment (Audit): Closing meeting

Mr. Quality Mr. Manager Mr.Transport

Quality Manager General Manager Transport Manager

X X X

X X

Final Result of Audit

As a result of the audit performed on 02. 12. and 03. 12. 2012, xyz found that the processing activities of Paper and Plastic Ltd for the abovementioned scope of production comply with the requirements set out in the IFS PACsecure, Version 1, at Foundation Level, with a score of XX %.
Company profile

Next audit in 12 months

Compulsory information In case of reduction of audit duration, explanations of the reasons:

Reviewer:

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ANNEX 2
IFS PACsecure Version 1, October 2012
Audit Report
Result: The processing activities of company Paper and Plastic Ltd met the requirements of the IFS PACsecure, version 1. The company passed with a score of XX % at: Foundation (Higher) level % Date of renewal audit: between the XX/XX and the XX/XX. Summary:
Chapter 1 Senior management responsibility Chapter 2 Quality and packaging material safety management system 0 0 0 0 0 0 0 Chapter 3 Resource management Chapter 4 Planning and production process Chapter 5 Measurements, analysis, improvements Chapter 6 Packaging material defense/ Food defense and external inspections 0 0 0 0 0 0

KO

0 0 0 0 0 0

0 0 0 0 0 0 0

0 0 0 0 0 0 0

0 0 0 0 0 0 0

Majors 0 A B C D N/A

Observations regarding KOs and Majors: General summary table for all chapters:
100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0%

Chapter 1 Chapter 2 Chapter 3 Chapter 4 Chapter 5 Chapter 6

Total

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Overall summary of the audit: Description of follow up of corrective actions from the previous audit:

Chapter 1: Senior management responsibility

Summary of all Chapter 1 deviations and non-conformities found:
N 1. 2. Reference 1.1.1 1.1.2 IFS requirements Evaluation Explanation

Report of the N/A evaluations

N 1. Reference IFS requirements Evaluation Explanation

Detailed audit report

N 1. 2. Reference IFS requirements Evaluation Explanation

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ANNEX 3
Action plan
Name and address of the audited company The Corrective Action Plan must be returned to the certification body before: ___________________________________________________________
Requirement number IFS PACsecure requirement Evaluation Explanation (by the auditor) Corrective action (by the company) Responsibility/ Date/Status of implementation (by the company) Release by the auditor

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ANNEX 4

CERTIFICATE
Herewith the certification body

Name of the certification body

being an ISO/IEC 17065 accredited certification body for IFS certification and having signed an agreement with the IFS owner, confirms that the processing activities of

Name of the audited company Address

COID (Headquarter) for the audit scope: (detailed descriptions of processes/products plus, if relevant, trade products)

Name and number of the product scope(s)

meet the requirements set out in the

IFS PACsecure Version 1, October 2012 at Foundation level/Higher Level

with a score of XX % (if required) Certificate register number: ________________________________________________
(If relevant: date of follow up audit)

Audit date:

________________________________________________ ________________________________________________ ________________________________________________

Date of issue of certificate: Certificate valid until:

(specify soonest and latest audit date, according to requirements of audit protocol, Part 1)

Next audit to be performed within the time period: ______________________________

Date and place Name and signature of the responsible person at the certification body Address of the certification body
Logo of the accreditation body or its name and registration number

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CONTACT DETAILS OF THE IFS OFFICES GERMANY | BERLIN IFS Management GmbH Am Weidendamm 1A D-10117 Berlin Phone: +49 (0) 30 72 62 50 74 Fax: +49 (0) 30 72 62 50 79 E-mail: [email protected] FRANCE | PARIS IFS Office Paris FCD 12, rue Euler F-75008 Paris Phone: +33 (0) 1 44 43 99 16 Fax: +33 (0) 1 47 20 53 53 E-mail: [email protected] ITALY | MILAN IFS Office Milan Federdistribuzione Via Albricci 8 I-20122 Milano Phone: +39 (0) 2 89 07 51 50 Fax: +39 (0) 26 55 11 69 E-mail: [email protected] POLAND | WARSAW IFS Office Central & Eastern Europe ul. Serwituty 25 PL-02-233 Warsaw Phone: +4 86 01 95 77 01 E-mail: [email protected] BRAZIL | DOURADOS Repesentante IFS Brasil Caroline Nowak BR-79824 Dourados, MS Phone: +55 (67) 81 51 45 60 E-mail: [email protected] CHINA | HEFEI StarFarm Room 2301, C building, Fortune Plaza No. 278 Suixi Road, 230041, Hefei, Anhui, China Phone: +86 (0) 55 15 66 60 69 Fax: +86 (0) 55 15 68 13 76 E-mail: [email protected] [email protected] USA | ST. LOUIS IFS Americas 1610 Des Peres Road, Suite 150 St. Louis, MO 63131 USA Phone: +1 31 46 86 46 10 Fax: +1 31 46 86 46 02 E-mail: [email protected]

CONTACT DETAILS OF THE PACKAGING ASSOCIATION OF CANADA (PAC) THE PACKAGING ASSOCIATION | CANADA 1 Concorde Gate, Suite 607 Toronto ON M3C 3N6 Canada Phone: +1 41 64 90 78 60 E-mail: [email protected]

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