ISO 22000:2005

UNIT 11 ISO 22000:2005-CASE STUDIES

Structure
11.0 Objectives
11.1 Introduction
11.2 Implementation in a Typical Food Industry
11.3 Let Us Sum Up
11.4 Key Words
11.5 Answers to Check Your Progress Exercise
11.6 Suggested Reading

11.0 OBJECTIVES
After studying this unit, we shall be able to:
• apply the application requirements of each clause of ISO 22000: 2005 in
any food processing organisations;
• identify the pitfalls and difficulties faced by the consultants as well as the
implementation project team while implementing the standard in an
organisation;
• appreciate the motive behind the queries which the third party auditor may
raise during audit of the implemented food safety management system; and
• initiate and implement the ISO 22000:2005 in any food processing
industry.

11.1 INTRODUCTION
We have studied and understood the contents of earlier units in block 3, and
are ready and eager to be capable of giving consultancy to a food processing
organisation in due course on implementation of ISO 22000:2005.
The typical sequence to be followed (by the consultant and the organisation)
during system implementation is as follows:
1) Kick-off meeting.
2) Awareness training of the members of the organisation w.r.t. standard.
3) Guidance for documentation.
4) Review and revision of the documentation.
5) Guidance during ongoing practice of the standard and the documentation.
6) Training of the members of the organisation w.r.t. conduction of internal
audits w.r.t. ISO 19011:2002.
7) Conduction of internal audit.
8) Closure of corrective actions w.r.t. non-conformities observed during
internal audits.
9) Conduction of Management review meeting.
10) Conduction of third party audits (stage 1 and stage 2).
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 ISO 22000:2005-
11.2 IMPLEMENTATION IN A TYPICAL FOOD Case Studies
INDUSTRY
Kick-off meeting
Implementation in any organisation will start with the kick off meeting in
which key personnel of the organisation including the top management and
departmental heads are present. The meeting will begin with the address of
the top management wherein the top management will explain the purpose of
implementation, the time-frame and tentative scope (in their mind) keeping
in view the current cluster of activities as well as the likely new
areas/products/sites which may become operational during implementation
but before certification audit (by third party) is to take place.
This will be followed by the address of the consultant wherein the broad
introduction will be made to food safety management system. The address will
summarize the evolution of food safety related standardization work starting
with NASA-Pillsbury efforts to ISO 22000:2005. The need for standardization
especially in India in the wake of consumerization-globalization-liberalization
scenario will be stressed upon the participants. The audience will be briefed
w.r.t. Codex efforts for standardization through spread of awareness of
implementation of HACCP philosophy in food safety organisation. A brief
introduction will be done w.r.t. efforts put in by the ISI (now BIS) in terms of
publishing of many related standards in this sector. Various standards of
national/regional origin will be listed (e.g. IS 15000, IFS, SQF, RVA etc.), and
it will be explained as to why the need for preparing and publishing the ISO
22000 standard was felt by the international body. Here the role of
international organisation for standardization will be clearly explained,
stressing that India is very much part of the ISO, so that the alienation factor
likely to take alarming proportion in the mind of the audience (who are ‘real’
implementers) is nipped in the bud itself, in the sense that let them understand
that ISO 22000:2005 is very much the Indian standard as it is international.
The role of technical committee ‘ISO/TC 34, Food products’ in drafting the
standard will be stressed. It will be explained as to how this standard is not a
stand-alone standard but a part of the series of standards like ISO 22004 and
ISO 22005 etc.
Introduction to the standard
This will be followed by the introduction of the standard i.e. the philosophy
and principles behind the standard, the contents including the terms used and
their specific meaning in the context of the standard will be explained. The
scope of the standard will be explained viz. the entire food supply chain in the
food sector including the service providers. The role of the organisation in the
food chain will be discussed and subsequently the suppliers and customers of
the organisation will be discussed and finalized e.g. the supplier to a dairy will
be farmers or collection centres and the customers either milk product
producers or direct consumers. Once the perspective is clear it will be followed
by clause by clause explanation of the standard including new key concepts
like communication, emergency preparedness, OPRP, control measure
assessment etc. as compared to other food safety management standards. The
FSMS documentation structure will be explained (could be in three tiers or
more depending on number of sites, number of product lines and the
complexity of the constituent processes). The application of five HACCP pre-
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ISO 22000:2005 steps and seven HACCP principles will be explained based on which the
further implementation steps are to be taken. Food safety policy and
measurable food safety objectives should be established. Following are typical
examples of both.
Food safety policy
We are committed to manufacturing of safe aseptically packed mango pulp by
and adhering to strict hygiene and quality norms during procurement of raw
fruits, processing, storage and dispatch.
We are responsible constituent of the food chain and will undertake only those
actions that improve the standards of hygiene, safety and quality in the final
product.
We are focused on the needs, and sensitive to the expectations of customers
and are dedicated to research in fruit processing, upgradation of process
technologies and development of our personnel to guarantee better products.
We will be keeping our suppliers and customers in a closed communication
spiral w.r.t. food safety related aspects of products, process and system.
Typical food safety objectives
1) Reduce aseptic bag losses to 2% by 31.12.2008.
2) Reduce the fruit spoilage losses to 5% by 31.12.2008.
3) Reduce the down time to 0.5 % by 31.12.2006.
4) Reduce diesel consumption per mt. by 2 % by 31.12.2008.
5) Implement fifo (first in first out) system for packing material and
ingredients by 31.12.2008.
Formation of food safety team
A food safety team will be formed. This will consist of a food safety team
leader and food safety members [i.e. representatives of all key departments
(like production, QC laboratory, purchase, raw material and packaging
material stores, maintenance, finished goods stores, Research and development
etc.) in that food industry]. Here the consultant has to keep in mind that he
should conduct specific training of the food safety team (if required in local
language) in coordination with the food safety team leader. The entire team as
a unit should have sufficient knowledge and experience of organisation’s
products, processes, equipments and associated food safety hazards.
The competence of the team members varies from organisation to organisation
and region to region. Though now many new and sophisticated food industries
are setting up their plants in various regions of India and the personnel working
therein are technically competent yet the majority of the industries remain
rooted in traditional clusters like mango processing in Chittur, part of
Maharashtra and Gujarat, fish industry in coastal area.
The food safety team leader should be a well qualified person having sufficient
experience in that organisation or that type of industry. He should have good
communication and motivation skills. He should be knowledgeable in food
safety principles and practices. He should have good management skills like
planning, coordinating, controlling etc. He should ensure that the food safety
team has relevant expertise w.r.t. identification of possible hazards w.r.t. food
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processing steps and sequence followed by that organisation. If required he ISO 22000:2005-
Case Studies
should recommend top management to hire the services of external consultant
to participate and guide the food safety team’s working. The relevant clauses
of the standard are 5.4, 5.5 and 7.3.2. Records should be maintained to
demonstrate that the food safety team has required multi-disciplinary
knowledge and experience.
This is called as competence assessment or mapping w.r.t education, training,
and skills. This exercise is to be done and records of the results of the exercise
as well as the actions taken thereon (to ensure achievement of required
competence by one and all in the organisation) is to be maintained not only for
the members of the food safety team but for all operating and management
team members of the organisation e.g. right from those who are responsible for
selection of suppliers through incoming inspection and production personnel
(many of them may be contract workers, if the food processing organisation is
seasonal in characteristic) to those who load the finished goods in vehicles like
containers (for export may be). The relevant clause is 6.2.2.
Typical Minimum Qualifications Criteria for Food Safety Team Leader and Members in
Aseptic Mango Processing Organisation

Role in the Food Required Minimum Required Minimum Required

Safety Team Qualifications Expertise Minimum
Experience
1. Working
experience of
Aseptic and canning
processing

Food safety team B.Tech (Food) 2. Good Knowledge of

leader food safety and 10 years
microbiological
concepts
3. Good
communication and
managerial skills
1. Working experience
of Aseptic
processing
Food safety team B.Tech (Food) / 2. Good Knowledge of
member, production B.Sc. (Chem) food safety and
05 years
microbiological
concepts
3. Knowledge of
operation of
machines
1. Good Knowledge of
Microbiology
2. Knowledge of food
Food safety team B.Sc. processing industry
member, QA (Microbiologist)
3. Knowledge of
chemical, 05 years
Microbiological
analysis and
methods
4. Good Knowledge of
food safety concept

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ISO 22000:2005 Role in the Food Required Minimum Required Minimum Required
Safety Team Qualifications Expertise Minimum
Experience
1. Working experience
of Aseptic
processing
2. Good knowledge of
Machinery
Food safety team D.E.E / D.M.E./ operation
member, maintenance,
D.I.E cleaning used in
maintenance 05 years
food processing
industry
3. Knowledge of
Calibration
Techniques
4. Basic Knowledge of
food safety
1. Good knowledge of
Post harvest fruit
handling and
management
Food safety team B.Sc. (Agri) 05 years
member, raw 2. Basic Knowledge of
material food safety
3. Good Worker
management skills

Description of product and its intended use

The term product has a specific loaded meaning in the standard. It means
anything which is the result of a process. Hence it covers the broad spectrum
starting with raw material, ingredients, primary and secondary packaging
through semi finished goods to finished goods. In a dairy industry it will cover
raw milk, processed milk and milk filled in pouches, the film-rolls used for
preparing pouches etc. In a packaged water plant it will include the preforms
used to blow into bottles, caps to be tightened on bottles, raw water (usually
sourced from bore-wells), RO water and filled water. In a fruits and vegetables
processing industry it will include the fruits like mangoes, guavas, vegetables
like ladies fingers, potatoes, okra etc. retorted product, mango pulp, sugar,
citric acid, cans used for filling the processed pulp etc.
The details required to be described w.r.t. raw material, ingredients and
product-contact material are given in clause number 7.3.3.1 of the standard. It
covers the aspects like characteristics, composition, origin, method of
production, packaging, delivery, storage, shelf-life, pre-processing and
specifications w.r.t. intended. Statutory and regulatory requirements w.r.t.
above should be identified e.g. usage %, method of production etc.
The details required to be described w.r.t. end products are given in clause
7.3.3.2. It covers the aspects like identification, characteristics, composition,
storage, shelf-life, packaging, labelling, distribution method and intended use
(including potential mishandling and misuse). Statutory and regulatory
requirements w.r.t. above should be identified e.g. w.r.t weight declaration,
nutritional information etc.
A sample end product characteristics is shown below.
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 End Product Characteristics ISO 22000:2005-
Case Studies
Product Name Aseptic fruit Pulp

Raw Materials and Fruit, Citric and Ascorbic Acid (If required)
Ingredients Used

Specific Product Colour, Flavour, Taste

Specifications (as per product specifications)

General Product Refer to Product Specifications

Specification
(Appearance, etc.)
Preservation Method Pasteurization and Aseptic Filling
Primary Packaging Aseptic Bags
Secondary Packaging Virgin Polythene Liners in White Epoxy Coated / Painted
M.S.Drum

Shelf Life One year from the Manufacturing Date

Labelling Instructions Name of the product, Batch Code, Drum Number, Net wt.,
Gross wt., Date of Manufacture, Date of Expiry, FPO No.,
Exporter’s Address and other as per Customers requirement
Applicable Legislation(s) FPO, Weights and Measures Act and PFA. Applicable
legislation of the importing country
Potential Mishandling of Rough handling, rolling of drums
the Product
Keeping in downright position
Storage at High temperature
Storage under Direct sunlight
Use of leaky and puff bags

The product specifications may form part of the characteristics.

The clause 7.7 states that both raw material as well as end product
characteristics should be kept updated as per changing statutory and regulatory
requirements as well as any allowable changes which the organisation
incorporates therein.
PRP (Pre-requisite programme)
PRPs are to be implemented to assist in controlling likelihood of occurrence of
hazards and their levels in product and product processing environment as well
as contamination of product and possible cross contamination between
products. Clause 7.2.3 says that Codex alimentarius commission recommended
international code of practice general principles of food hygiene (CAC/RCP 1-
1969, Rev 4-2003) to be followed for PRP. It contains PRPs (as required by
clause 7.2.3) divided into eight categories viz.

PRP Category PRP aspects

Primary 1) Environmental Hygiene
production 2) Hygienic production of food sources
3) Handling, storage and transport
4) Cleaning, maintenance and personnel hygiene at primary
production

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ISO 22000:2005
PRP Category PRP aspects
Establishment 1) Location
design and 2) Premises and rooms
Facilities
3) Equipment
4) Facilities
Control of 1) Control of food hazards
Operation 2) Key aspects of hygiene control systems
3) Incoming material requirements
4) Packaging
5) Water
6) Management and supervision
7) Documentation and records
8) Recall procedures
Establishment 1) Maintenance and cleaning
Maintenance and 2) Cleaning programmes
Sanitation
3) Pest control systems
4) Waste management
5) Monitoring effectiveness
Establishment 1) Health status
Personal Hygiene 2) Illness and injuries
3) Personal cleanliness
4) Personal behaviour
5) Visitors
Transportation 1) General
2) Requirements
3) Use and maintenance
Product 1) Lot identification
Information and 2) Product information
Consumer
Awareness 3) Labelling
4) Consumer education
Training 1) Awareness and responsibilities
2) Training programmes
3) Instruction and supervision
4) Refresher training

Flow diagrams, process steps and control measures

A detailed flow diagram should be prepared w.r.t. products and processes
under food safety management system. Each step in the flow diagram should
be numbered. Description of each step should be done in a table form
including the parameters to be controlled and current status of control
measures applied to each step. This is a critical step since accuracy and
significance of all further steps like hazard analysis will depend on this step.
The clause number 7.3.5.1 states the details which should be included in the
flow chart. A sample flow chart for raw material (for aseptic mango pulp
processing) is shown below.
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 ISO 22000:2005-
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1
Receiving of Raw
Fruits

2
Inspection of Raw Not Ok Return to Supplier
Fruits

CR 3
Unloading and
transfer of Fruits
Damaged SW
to Ripening

Guava &
Pomegranate 4 Empty Crates
Ripening

5 Unripe / Semiripe
CR Sorting
Spoiled Fruits SW

Ripe Fruits

6
Ripe Fruit
Storage area

7
Infeed
Empty Crates
conveyer belt

8b
8
Spolied fruits, CR
Inspection of
paddy straws in
Fruits
crates

Air 9
SW
PW 1st Fruit
Cl2 Washer
Water recirculation
through Water
Filter
CM 10 PW : Process Water
2nd Fruit PW CR : Criteria for
Washer
Grading/Sorting
SW : Segregated Waste
CM : Control Measures
C
C : Continue

While describing each step also describe the control measures and their level
vis-à-vis the ideal possible level of applying the control measures. The flow
diagram and associated description should be verified by the food safety team.
The verified flow diagram should be maintained as a record.
Hazard Analysis
Each step in the flow diagram should be analyzed w.r.t. possible physical,
chemical and microbial hazards most likely to occur in that step. The hazard
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ISO 22000:2005 identification should be based upon experience, the current status of
implemented prerequisite program, the scientific and technical literature
available, additional information from the relevant food chain w.r.t. the
organisation. The hazard analysis consists of two steps viz. risk assessment and
hazard assessment. The following is the suggested methodology for the same:

Methodology used to conduct Hazard Analysis

Identify and list all potential hazard associated with each process step
(including raw material, packaging material) and post production step
Label the hazards as B (Biological), C (Chemical) or P (Physical)
Identify the related Hazard Category for each.
Determine the Likelihood of occurrence:
A High Risk is likely to happen – Give it a rating of 10
A Medium Risk could happen – Give it a rating of 5
A Low Risk is rarely likely to happen – Give it a rating of 3
Determine the severity of each hazard:
A Critical Severity will automatically result in an unsafe product – Give it a
rating of 10
A Serious Severity will most likely result in an unsafe product – Give it a
rating of 8
A Major Severity could result in an unsafe product – Give it a rating of 5
A Minor Severity will rarely result in an unsafe product – Give it a rating of 3
Determine the Risk Rating by multiplying Likelihood of Occurrence by the Severity
of Impact.
List current PRP level (control measures) to control hazards.
Also list the explanations / justifications for arriving at the risk rating.
Determine the significant hazards. Any hazard with a risk rating of 30 or above
is significant. (S..significant, NS..non-significant).
Following are some typical examples of hazard assessment in a typical food
processing organisation resulting into classification of hazards as significant
and non-significant. Significant hazard means further planned special control
measures need to be applied and assessment of those control measures done (as
per clause 7.4.4) to classify them into operational PRP and CCPs to be treated
as per the clause number 7.5 and 7.6.
Sample hazard analysis (receiving of fruits in aseptic mango processing
organisation)
1.Ingredient / 1. Hazard type Risk Current PRP Is Hazard
Processing Step (B/C/P) Analysis level / Signifi-
Name B..Biological 1.Lhd Occ Explanation / cant ?
2.Step Number C..Chemical 2.Sev Imp Justification S / NS
P..Physical 3.Risk Rtg.

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 2.Details of Hazard ISO 22000:2005-
Identified that Case Studies
could be
introduced,
controlled or
enhanced at this
step

1. B 1.3 1. Ensuring NS
cleanliness of
2. Chances of trucks and
2.3
contamination tarpaulins
with
pathogenic 3.9 2. Inspection of
bacteria like Fruits as per
E.coli, Salmonella Raw Fruits
etc. and fungus specifications
like Aspergillus and
niger, Candida inspection
1. Receiving of albicas etc., due to and test plan
Raw Fruits unclean truck,
tarpaulin.
2. Step No. 1 1. B 1.10 1. Sorting and S
Washing of
2. Chances of 2.3 fruits with
Microbiological chlorinated
contamination due 3.30 water.
to surface micro
flora like E.coli, 2. Inspection of
Salmonella, etc., Fruits as per
and fungus like raw fruits
Aspergillus niger, specifica-
Candida albicas tions.
etc.,
1. Receiving of 1.C 1.3 1. Ensuring NS
Raw Fruits 2. Chemical cross transport
contamination due 2.5 condition of
2. Step No. 1 to residues of truck.
hazardous 3.15
chemical during 2. Instructions
loading/ transport to suppliers
while
loading of
raw fruits in
trucks.

3. Inspection of
fruits as per
raw fruits
specs.

1. C 1.3 1. Instructions NS
to suppliers
2. Chances of 2.5 about
chemical pesticides.
contamination due 3.15 2. Washing of
to pesticide fruits for
sprayed on fruit cleaning
just before fruit surfaces
harvesting. to remove
residues as
per SOP for
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ISO 22000:2005 first and
second fruit
washing.

3. External lab
analysis for
pesticides
residues of
finished
products as
per
inspection
and test plan.

1. P 1.3 1. Sorting of NS
fruits while
2. Cross 2.3 unloading as
contamination per SOP for
with foreign 3.9 sorting.
materials like
wood, stones,
1. Receiving of 2. Cleanliness of
leaves, dirt, etc.
Raw Fruits trucks as per
inspection
2. Step No. 1 and test plan.

3. Washing of
Fruits as per
SOP for first
and second
fruit washer.

Here we have analyzed only step number of receiving of fruits in a typical fruit
processing organisation. Similarly all steps are to be analyzed to find out
significant hazards, assuming that the non-significant hazards are addressed
properly by implemented PRP.
All such significant hazards will be collected together to be further treated for
control measure assessment i.e. we have to determine and classify the
applicable measures into OPRP and CCP and then prepare plan for OPRP and
HACCP plan. Following is a typical collection significant hazards found in a
aseptic fruit pulp processing organisation.
List of significant hazards ready for control measure assessment
1. Step name 1. Type of hazard Current CM Is this Will a
2. Step number 2. Description of (Control process step subsequent step
hazard Measure) at specifically eliminate the
this stage designed to identified hazard
eliminate / or reduce its
reduce the likely
likely occurrence to an
occurrence acceptable level?
of the
identified
hazard to an
acceptable
level?

1. Receiving of 1. B Cleaning and No Yes

Raw Fruits disinfection
2. Chances of of 1. Sorting and
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2. Step No. 1 bacterial equipments washing of ISO 22000:2005-
contamination due fruits with Case Studies
to surface micro chlorinated
Use of
flora on fruits water
chlorinated
water and 2 Inspection of
checking fruits as per
chlorination raw Fruits
levels specifications

First fruit 1. B Checking of No Yes

washer– Step 2. Chances of acidity and
No. 9 Bacterial pH against
contamination due specifications Pasteurization
to unclean using
washer, elevated calibrated
conveyor, unclean equipments
environment and
surface microflora
from fruits.
Contamination
due to Micro-
organisms such as
E.coli, coliforms,
Salmonella spp.
etc., through
water.

System 1. B System is Yes

Sterilization – sterilized
For Step No. 2. Improper before
28 to 31 – Step Sterilization may pasteurized
No. 28a lead to product is
microbiological introduced
contamination of unless the
the product system is
sterile, the
system will
not go in
production
mode

Pasteurization 1. B Temperature Yes

and Holding– and time
Step No. 29 2.Improper (Flow rate)
pasteurization and can be
holding time may controlled by
lead to survival the operator
and growth of
spoilage causing
organisms

Aseptic 1. B Temperature Yes

Filling– Step is controlled
No. 32 2. Microbiological by operator
cross and filling
contamination in automatically
filling chamber stops if
due to low head temperature
temperature falls below
during filling in set values.
aseptic bags.

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ISO 22000:2005 Pre-shipment 1. B Visual Yes
Inspection– inspection is
Step No. 37 2. Damage to filled done
bag due to
improper handling
of the drums
causing bacterial
growth.

Control measure assessment

The control measures described above are subjected to assessment based upon
the criteria given in clause 7.4.4 viz.
a) Effect of CM on hazard at current level of applied strictness.
b) Monitoring feasibility of CM.
c) Place of CM within system vis-à-vis others.
d) Likelihood of failure in functioning of CM.
e) Severity of consequences in case of failure of CM.
f) Is CM specifically established to impact hazard?
g) Synergistic effect of CM (in combination with other CMs).
The application of above criteria [using a model (by allocating marks or
grades) which will take into consideration all above factors from a to g] results
into classifying the CMs as:
1) Those which are to be controlled critically are called as CCPs and are to be
controlled by HACCP plan as per 7.6.1.
2) Others are called OPRPs (operational pre-requisite programme) and are to
be controlled as per OPRP plan as per 7.5.
Let us see a typical OPRP and a typical HACCP plans below for the aseptic
fruit pulp processing organisation.
Operational pre-requisite program plan (OPRP plan)
1. Step name Current CM Monitoring Corrections / Verification
2. Step (Control Measure) corrective
number at this stage actions
3. Type of
hazard
4. Descrip-
tion of
hazard
1. Receiving 1. Instructions to What: On Product: What:
of Raw suppliers about Microbiological Rejection & Chemical
Fruits pesticides. Contamination disposal of lot. Contamination
due to fruit On due to pesticide
2. Step No. 1 2. Washing of fruits damages & Equipment: Residue.
for cleaning fruit Pesticides NA How:
3. C surfaces to Residues. 1. Visual
Records:
remove residues How: Inspection &
Product Non
4. Chances of as per SOP for 1. By visual Record
Conformity
chemical first and second inspection verification
Record.
contami- fruit washing 2. By chemical When:
nation analysis of 1. At the time
due to 3. External lab finish of arrival &
pesticide analysis for products from or
sprayed pesticides external lab randomly.
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 on fruit residues of When: Where: ISO 22000:2005-
just finished products 1. During arrival 1. Raw material Case Studies
before as per Inspection of fruits. section
harvesting and test plan 2. After finished 2. QA
product is department.
ready Who:
Where: 1. Asst. manager
1. Raw Material Commercial,
(RM) Section 2. Officer QA,
2. External lab 3. Plant
Who: manager
1. Supervisor Record:
(RM) 1. RM
2. External lab inspection
authority record,
Record Name: 2. External Lab
1. Fruit analysis
Inspection report
Record
2. External Lab
Analysis
Report

HACCP plan (Hazard Analysis and Critical Control Plan)

1. Step name Current CM Monitoring Corrections/ Verification
2. Step number (Control corrective
3. Type of hazard Measure) at actions
4. Description of hazard this stage
5. Critical limits
1. Pasteurization and Ensure What: On Product: What:
Holding sufficient Rejection, Record &
Temperature
pasteurization & time of rework & or temperature/
2. 29 temperature disposal time Graph
pasteuriza-
and time. tion & On How:
3. Biological Controlling and holding Equipment: Checking &
monitoring of How: Resterlization verifying
4. Insufficient Sterlizer and & or When: After
Temperature & Time Visually &
aseptic filler by Calibration, every
of pasteurization & PLC control
PLC m/c Production
holding may lead to Monitoring maintenance Cycle.
biological hazard. Device: Man,
Who: Where:
PLC
5. From X to Y °C Production Sterlizer &
When:
officer Aseptic Filler
6. Aseptic processing After every Section
Record
handbook by 1 hr.
Name: Who:
Ranganna page no XX manually &
continuously 1. Log sheet Production
by PLC of Sterlizer Manager /
& aseptic Executive
Where:
filler Production,
Sterlizer & Plant
2. Calibration
aseptic filler Manager
record
Who: Officer Record:
Production
1.Log sheet
Record of sterlizer
Name: & aseptic
Log sheet of filler
Sterlizer & 2. Tempera-
aseptic filler ture graph
3. Calibra-
tion record
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ISO 22000:2005 Verification of food safety management system
Verification plan should be prepared defining verification aspect, method,
frequency and responsibilities for verification. Verification records should be
maintained. Following is a sample verification plan. All columns are not filled
fully. The student may take it up as an exercise to complete the plan.
Verification plan
Aspect 1. Frequency Method
2. Responsibility
Product Description 1. Yearly Reviewing the adequacy
w.r.t. customer complaints,
2. Food safety team
changes in statutory and
regulatory requirements.
Flow Diagram 1. Yearly or event driven Verifying whether
basis like changes in the flow diagram
infrastructure, installation is in congruence
of new machines with the ground
reality

2. Food safety team

Hazard Analysis Worksheet
Assessment &
categorization of Control
Measures
OPRP plans
CCP plan
Plant layout
Organisation chart
Applicable legislations and
Regulations
All SOPs and formats
Traceability test (Mock
Test)
Internal audit
Pest control schedule /
checklist
Communication activities
(external)
Results of external audits
Emergency situations
PRP document
OPRP records
CCP records
Training records
Calibration records
Validation reports
Recall / withdrawals records

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 ISO 22000:2005-
Aspect 1. Frequency Method
Case Studies
2. Responsibility
Customer complaints
Specifications for raw
materials, final products,
packaging materials

Traceability system
Identification of product lots and their relationship with batches of raw
material, processing and delivery record should be maintained. Traceability
system should identify incoming material from immediate suppliers and initial
distribution route of the end product.
Mandatory procedures
Following procedure should be documented:
1) Control of documents
2) Control of records
3) Handling of potentially unsafe product
4) Procedure for correction
5) Procedure for corrective action
6) Withdrawal
7) Internal audit
Validation of control measure combinations
It is to be ensured that standards, experience, research, experiments,
competence of personnel etc., validate the selected control measures and their
combination w.r.t. hazard control. (hazard elimination, prevention or reduction
below the acceptance level)
Control of monitoring and measurement
Adequacy of monitoring and measuring methods as well as calibration of
measuring equipment should be done in a planned manner with national or
international traceability. Records of calibration should be maintained.
Emergency preparedness
Emergency procedures should be established, implemented and maintained to
manage potential emergency situations and accidents that can impact food
safety. Following is a (partially filled) suggested format for the external
communication. The students may fill it as an exercise.

Emergency Preparedness Response to the Emergency

Situation & Accidents
Emergency Category : Fire
1. Keep fire extinguisher in identified places. 1. Announce an evacuation of the building if
2. Announce evacuation procedure. there is a fire.

3. Turn off gas valves/pumps with emergency 2. Inform all the staff members to meet at the
shut off switch. predetermined assembly area.

4. Emergency fire stations contact details will 3. Verifying according to the work schedule,
be collected. that all employees are outside the building.
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ISO 22000:2005 Emergency Preparedness Response to the Emergency
Situation & Accidents
5. Make sure that finished goods stores 4. Discard products that have been near a fire.
including raw material. Cold stores are Products exposed to fire can be damaged
properly closed (seal should be air tight). by the heat of the fire, smoke fumes, and
chemicals used to fight the fire.
6. Left over products in the production area
should be covered properly to protect 5. Discard any raw material if it is exposed to
against the fire. fire or fumes of fire.

7. Check the expiry date of fire extinguisher. 6. If the finished store is not airtight, then
fumes can get inside, such food will be
thrown away.

7. Utensils/equipments exposed to fire

fighting chemicals can be decontaminated
by washing in hot soapy water and
sanitized using proper sanitizer.

Emergency Category : Power Shutdown

1. Plant Engineer / Maintenance head is 1. Inform the maintenance operators to

responsible to handle the generator. switch on the generator immediately.

2. For emergency (in case of failure of 2. Discard if the product remains for
internal generator), external generator prolonged time in Chutney cooker / pickle
provider contacts will be obtained. filling tank.

3. If the product remains in chutney 3. If the pickle bottles are half filled, recover
cooking/pickle filling tank product will be the product and re-fill it.
recovered and reprocessing will be done /
discarded if it is unfit for end use. 4. If internal generator is working seek the
help of external generator supplier.
4. Cover all the left over foods in the
utensils/equipments with SS cover.

5. Ask the power house to provide the power

shut down schedule for area.

Emergency Category : Flood

1. Monitor the weather radio or local news
broadcast.

2. Informed to the factory manager regarding

damage of food due to flood water.

3. Make proper drainage facilities for water.

4. Affected product will be discarded to avoid

the contamination.

5. Inform all the operators to cover the left

over product with SS lid.

Emergency Category : Vehicle Breakdown

1. Back up container.

2. Contact numbers of all emergence team

members.

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External communication ISO 22000:2005-
Case Studies
Regulatory bodies, suppliers, contractors, customers, consumers and others in
the food chain should be kept in communication loop w.r.t. food safety related
requirements, issues and changes therein. Following is a (partially filled)
suggested format for the external communication. The students may fill it as an
exercise.
Broad Category Food Safety Aspect Who Communicates?
• Certificate of analysis Purchase manager
• Product specification details
• Complaints regarding raw material
• Products ingredient details
Raw material • Regarding suppliers approval
Supplier certification
• Packaging material for the raw
materials
• Method of transportation
• Method of storage
• Certificate of analysis Purchase manager
• Product specification details
• Nature of material and Food grade
Packing material certificate
Supplier
• Complaints relating to the packaging
• Mode of transportation
• Method of storage
• Scope of accreditation for the test to QC manager
External testing be done
laboratories
• Test details (Report)
• MSDS (Material Safety Data Sheet) QC manager
for the pesticides used
• Pest control annual maintenance
Contract
• Procedure of spraying
Pest control • Effectiveness and safety measures of
spraying
• Concentration of sprays used
• Investigation regarding species of flies
and lifecycle studies
• Layout of pest control activities
Machine and Maintenance manager
equipment suppliers
Construction Management
contractors
Transporter Purchase manager

Internal communication
Food safety team should be informed and kept updated in a timely manner
w.r.t. number of food safety related aspects and changes therein. Following is a
(partially filled) suggested format for the external communication. The
students may fill it as an exercise.
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ISO 22000:2005 Broad Category Food Safety Aspect Associated Who
FSMS
Communicates?
element
Product or New 1. Process modification details SOP for new New
Products 2. Issues about ingredients or product
product
food additives development
development
3. Issues about labelling manager

4. Packaging material
specifications
5. Hazard analysis reviews
6. New raw material
specification
7. New product information
Change of recipe 1. Issues about ingredients or SOP for new New product
in Existing product food additives product development
development manager
2. New raw material
specification
Change in Raw • Suppliers contacts relating • S.O.P for Purchase
Materials, food safety purchase
Manager
Ingredients and
suppliers • Certificate of analysis • New
Supplier
• Product specification details Evaluation
and
approval
form
Production
Systems and
Equipments
Production
Premises, Location
of Equipment,
Surrounding
Environment
Cleaning and
Sanitation
Programs
Packaging,
Storage and
Distribution
Systems
Personnel
Qualification
Levels/Allocation
or Responsibilities
and Authorizations
Statutory and
Regulatory
Requirements
Complaints 1. Severity of complaints 1. SOP for QC/Production
Associated with customer Managers
2. Traceability of complaints
the Product feed back
3. Investigating the nature of and
complaints
2.Complaint
handling
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 Broad Category Food Safety Aspect Associated Who ISO 22000:2005-
Case Studies
FSMS
Communicates?
element
3. Recall and
traceability
procedures
4. Food Safety
manage-
ment
system
manual
Other Conditions 1. Pest control operations 1. MSDS of Production
that have impact all Manager
2. Pesticides used
on food safety pesticides
3. Power failure used
4. Flood 2. Pest Annual
mainte-
5. Fire nance
6. Bioterrorism contract
3. Food Safety
manage-
ment
system
manual
4. Emergency
prepared-
ness
procedure

Management Reviews
Periodic management reviews should be conducted to ensure adequacy,
suitability and effectiveness of FSMS at planned intervals as per clause 5.8, it
should result into continual improvement and updation of the FSMS.

Check Your Progress Exercise 1 "

Note: a) Use the space below for your answers.
b) Compare your answers with those given at the end of the unit.

1) List any four production (processing) related categories and aspects

covered there in CAC/RCP 1 1968 Rev 4-2003 w.r.t. PRPs?
…………………………………………………………………………….
…………………………………………………………………………….
…………………………………………………………………………….
…………………………………………………………………………….

2) Which are the essential elements of OPRP plan?

…………………………………………………………………………….
…………………………………………………………………………….
…………………………………………………………………………….
…………………………………………………………………………….
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ISO 22000:2005 3) Which are the essential elements of HACCP plan?
…………………………………………………………………………….
…………………………………………………………………………….
…………………………………………………………………………….
…………………………………………………………………………….
4) List the aspects to be considered while assessing control measures (CMs)?
…………………………………………………………………………….
…………………………………………………………………………….
…………………………………………………………………………….
…………………………………………………………………………….

5) List any six key elements of product characteristics?

…………………………………………………………………………….
…………………………………………………………………………….
…………………………………………………………………………….
…………………………………………………………………………….
6) List any six elements to be covered as a part of verification plan?
…………………………………………………………………………….
…………………………………………………………………………….
…………………………………………………………………………….
…………………………………………………………………………….

11.3 LET US SUM UP

ISO 22000:2005 standard is generically applicable to all types of food
processing enterprises irrespective of their type (food processing e.g. dairies,
meat processing, fruit and vegetable processing, caterers, restaurants, hotels to
food related service providers, transport and storage operators, producers of
pesticides, fertilizers, veterinary drugs, producers of equipment, producers of
cleaning and sanitizing agents, producers of packaging material etc.), size and
number of people employed by them (micro-scale to MNC), type of customers
they cater to (consumers or secondary food manufacturers or retailers).
Following are the broad guidelines for planning the characteristics and
structure of ISO 22000:2005 system in organisation of any type.
• The system should be relevant to the outcomes and the business operations
of the organisation.
• The system should reflect the major processes and procedures of the
organisation and the way people work.
• The system should include mechanisms for feedback, evaluation, customer
satisfaction and improvement.
• The system should highlight critical activities and risk-associated issues.
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• The system should aid management control within the organisation. ISO 22000:2005-
Case Studies
• The system should be an effective aid to good communications between
individuals and departments, customers, suppliers and regulatory
organisations.
• The system should not result in excessive paperwork and bureaucracy.

11.4 KEY WORDS

Corrective : Action to eliminate the cause/s of a detected non-
Action conformity or other undesirable condition.
CCP (critical : Steps at which control can be applied and is essential to
control point) prevent or eliminate food safety hazard or reduce it to
acceptable limits.
Correction : Action to eliminate a detected non-conformity.
Critical : Criterion which separates acceptability from
Limit unacceptability.
Control : Food safety action or activity that can be used to prevent
Measure or eliminate food safety hazard or reduce it to acceptable
limit.
End Product : Product that will undergo no further processing or
transformation by the organisation.
Flow : Schematic and systematic presentation of the sequence
Diagram and interaction of steps.
Food Chain : Sequence of the stages and operations involved in the
production, processing, distribution, storage and handling
of a food and its ingredients, from primary production to
consumption.
Food Safety : Concept that food will not cause harm to the consumer
when it is prepared and/or eaten according to its intended
use.
Food Safety : Biological, chemical or physical agent in the food, or
Hazard condition of food, with a potential to cause an adverse
health effect on the consumer.
Food Safety : Overall intentions and direction of an organisation related
Policy to food safety as formally expressed by top management.
Monitoring : Conducting a planned sequence of observations or
measurements to assess whether control measures are
operating as intended.
OPRP : PRP identified by the hazard analysis as essential in order
(operational to control the likelihood of introducing food safety
prerequisite hazards to and/or the contamination or proliferation of
program) food safety hazards in the product or in the processing
environment.
Prerequisite : (Basic conditions and activities that are necessary to
Program) maintain a hygienic environment throughout the food
chain suitable for the production, handling and provision
of safe end products and safe food for human
consumption.
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ISO 22000:2005
Updating : Immediate and/or planned activity to ensure application of
the most recent information.
Validation : Obtaining evidence that the control measures managed by
the HACCP plan and by the operational PRPs are capable
of being effective.
Verification : Confirmation, through the provision of objective
evidence, that specified requirements have been fulfilled.

# 11.5 ANSWERS TO CHECK YOUR PROGRESS

EXERCISE
Your answer should include following points:
Check Your Progress Exercise 1
1) a) Establishment : design and facilities
1. Location
2. Premises and rooms
3. Equipment
4. Facilities
b) Control of operation
1. Control of food hazards
2. Key aspects of hygiene control systems
3. Incoming material requirements
4. Packaging
5. Water
6. Management and supervision
7. Documentation and records
8. Recall procedures
c) Establishment: maintenance and sanitation
1. Maintenance and cleaning
2. Cleaning programmes
3. Pest control systems
4. Waste management
5. Monitoring effectiveness
d) Establishment: Personal Hygiene
1. Health status
2. Illness and injuries
3. Personal cleanliness
4. Personal behaviour
5. Visitors
2) a) Food safety hazard to be controlled
b) Control measures
c) Monitoring (procedures)
d) Corrections and corrective actions
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 e) Responsibilities and authorities ISO 22000:2005-
Case Studies
f) Records of monitoring
3) a) Food safety hazard to be controlled
b) Control measures
c) Critical limits
d) Monitoring (procedures)
e) Corrections and corrective actions
f) Responsibilities and authorities
g) Records of monitoring
4) a) Effect of CM on hazard at current level of applied strictness
b) Monitoring feasibility of CM
c) Place of CM within system vis-à-vis others
d) Likelihood of failure in functioning of CM
e) Severity of consequences in case of failure of CM
f) Is CM specifically established to impact hazard
g) Synergistic effect of CM (in combination with other CMs)
5) a) Raw Materials and Ingredients Used
b) Product Specifications
c) Preservation Method
d) Packaging
e) Shelf Life
f) Applicable Legislations
6) a) Product Description
b) Flow Diagram
c) Hazard Analysis Worksheet
d) Assessment & Categorization of Control Measures
e) OPRP records
f) CCP records

11.6 SUGGESTED READING

http://www.iso.org
ISO 19011: 2002 - Guidelines for Quality and /or Environmental Management
Systems Auditing.
ISO 22004: 2005 - Food Safety Management Systems Guidance on Application
of ISO 22000:2005.
ISO 10012:2003 - Quality Assurance Requirements for Measuring Equipment.
ISO 15161: 2001 – Guidelines on the Application of ISO 9001: 2000 in the
Food and Drink Industry.

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