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5. QUALITY ASSURANCE (Continued)

5.2. APPLICATION OF THE ISO-9000 SERIES AND CERTIFICATION
This Section is prepared by Professor Mogens Jakobsen

5.2.1. Definition of ISO quality standards

The International Standards Organization (ISO) is located in Geneva, Switzerland, and is a federation of
national standard bodies representing almost 100 countries.

Based on the good experience gained with the British Standards (BS) 5750 series published in 1979 they were
adopted by ISO, and the ISO 9000 series were published in 1987 aiming at providing an international
acknowledgement of quality efforts. Today, more than 50 countries have adopted the ISO 9000 series which is
equivalent to the BS 5750 standards as just mentioned. In the United States, the standards are published as the
ANSI/ASQC Q 90 series and in the European Community they are published as the European Norm (EN)
29000 Series.

The ISO 9000 series include 5 separated standards as shown in Table 5.15.

Table 5.15. ISO 9000 Series.

ISO Standard Field of application
ISO 9000 Selection of the appropriate ISO 9000 standard
ISO 9001 Quality system requirements for product development, production, delivery and after sales functions
ISO 9002 Quality system requirements for production and delivery
ISO 9003 Quality system requirements for final inspection and testing
ISO 9004 Guidelines for ISO 9000, quality system elements

ISO 9001, 9002 and 9003 are three specific standards describing the elements and requirements of a quality
system to be implemented in a company in connection with a contractual situation, i.e. the supplier - customer
relation. They standardize and outline how companies can establish efficient Quality Systems, and they form the
background for obtaining a Quality System Certificate issued by an approved, independent organization
(certifying body).

As seen from Table 5.15, ISO 9001 is the most comprehensive standard containing most of the elements
described in the guidelines given in ISO 9004. Compared to ISO 9002 the most important difference will be that
it includes development of new products and processes. The ISO 9003 is used in situations where requirements
to the producer only comprise final product inspection and testing and this standard only contains a minor part
of the elements of ISO 9004.

For food processing companies, the most relevant standards will be ISO 9001 and 9002 containing the
elements shown in Table 5.15 and described briefly in the following paragraphs.

However, it shall be mentioned that the combined use of standards can be advantageous. For small enterprises
like a fishing boat, one could use ISO 9003 and add the relevant elements of ISO 9002. This can lead to the
most appropriate system manageable by such a small entity. In such a case the official certification as
mentioned above, will be according to the ISO 9003.

5.2.2. Elements of the quality system

The various elements of the ISO 9000 standards are shown in Table 5.16 and shall be commented briefly in the
following.

Management responsibility is the first and overall most important system requirement mentioned. Full

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commitment of the company top management is a must, and the entire system must be under management
control and review. Management shall define the objectives and the policy of the system, and it bears the full
responsibility for ensuring that the policy is understood, implemented and maintained at all levels in the
company. Responsibility and authority of all personnel who manage, perform and verify work affecting quality,
shall be defined by the management, and adequate resources should be provided.

If the HACCP concept is applied, it shall be stated in the company quality objective and policy.

Requirement No. 2, which has the heading, Quality System, refers to the documented system ensuring that
products comply with the specified requirements. It states that management shall ensure the presence of
documented procedures and instructions in accordance with the ISO 9000 standard in question as well as
efficient implementation of the Quality System procedures and instructions. As mentioned later and shown in
Figure 5.4, the system will often be organized in three levels comprising the Quality Manual, Procedures and
Instructions. If the HACCP concept is incorporated with the more narrow quality objective, e.g. with Salmonella
as the defined risk, only procedures and instructions for control of Salmonella as defined in the objective of the
system will be included.

In Contract review Requirement No. 3, it is laid down that the producer shall review and evaluate all contracts
to ensure that he can supply a product which meets the customer's specified requirements and expectations,
e.g. the product shall conform to specified requirements which for Salmonella, could be “absence in 25 g frozen
shrimps” in each of a certain number of packages according to the sampling plan agreed upon.

Obviously, this element is very important in the ISO 9000 system designed to deal with supplier - customer
relations. It is also stipulated that records of such contract reviews shall be maintained.

For product development Requirement No. 4, the supplier shall establish and maintain procedures which
control and verify all phases of product development to ensure that the specified requirements are met. Using
HACCP and Salmonella as an example, this means that the system shall ensure that new products and
processes are not implemented unless they provide safety against Salmonella as laid down in the quality
objective of the system. This is a complicated, demanding element of the standard, difficult to implement as well
as maintain in the company. For the example used, it requires profound microbiological expertise.

Documentation is a vital part of the system, and so is Document Control as mentioned in Requirement No. 5.
This control shall ensure that all necessary documents (procedures, instructions, forms, etc.) are available where
needed, and obsolete documents promptly removed from all locations.

It is a key point of ISO 9000 that Purchasing (Requirement No. 6) only takes place from approved suppliers
which have been selected on the basis of previous performance and an effective control system as well as their
ability to meet the specified requirements. When applying the HACCP concept for the Salmonella in farmed
frozen shrimp, it means that feed for the farm should only be purchased from feed mills producing feeds which
do not contain Salmonella according to the specifications agreed upon. The standard reaches even further in
demanding mutual cooperation and a contractual understanding with the feed mill; the mill shall be assessed to
be included in the list of approved suppliers established according to ISO 9000 requirements. The feed mill shall
be audited just like all other suppliers on the list, and purchased products shall be inspected on receipt, and
feed-back on performance at all points shall be ensured. The very obvious reasons for these detailed
requirements for purchasing obviously will be the inevitable effect of raw materials, machines, cleaning agents,
services, etc. on the quality of the final product.

Procedures for product identification and traceability during all stages shall be established, maintained and
recorded as stated in Requirement No. 7. If required, each batch, package, etc. shall be provided with a unique
identification which shall be recorded.

Process Control (Requirement No. 8) shall ensure that all processes influencing the quality of the final product
shall be specified and documented to ensure and verify that they are carried out under controlled conditions.
This involves documented work instructions, including cleaning and disinfection procedures, use of appropriate
equipment, machines, material and arrangement of processing facilities as well as monitoring of products and
processes.

This element will be the key area for the HACCP concept with the Hazard Analysis, identification of Critical
Control Points (CCPs) and monitoring of CCPs, as described in Section 5.1.

A schedule for testing and inspection of raw materials, intermediate and final products shall be established
(Requirement No. 9). For the HACCP system, the schedule must be based on CCPs as identified in the hazard
analysis. Test methods must be defined. Responsibilities for sampling and testing, reporting and control of
non-conforming products shall be defined and reference made to the appropriate specifications.

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The test equipment used shall be selected to demonstrate acceptable compliance with the defined
specifications for the products and shall be calibrated at regular intervals against nationally recognized standard
references (Requirement No. 10).

Proper identification of the inspection and test status shall be ensured with untested, tested, approved or
rejected products being clearly marked (Requirement No. 11).

Procedures and instructions shall be established for control of non-conforming products (Requirement No.
12). In the present example, shrimp containing Salmonella will be a non-conforming product according to the
specifications agreed upon. Such a product shall be identified, placed and labelled in a way that clearly isolates
it and prevents it from being supplied as Salmonella-free by mistake. The responsibility for making decisions on
disposition of non-conforming products shall be defined and documented. A non-conformity report shall be
worked out stating the nature of the non-conformity, the disposition decided, and the corrective action to be
initiated for resolving the non-conformity as described in the following.

The corrective action system (Requirement No. 13) is concerned with revising work operations etc. to try to
eliminate the causes of failure. This is the system requirement that helps a company getting better and better by
aiming at doing everything right the first time. To control all the activities required in the corrective action, forms
containing the following points shall be applied: Clear statements of the non-conformity, responsibilities, action
to be taken, date of implementation, verification and recording of the resulting new procedures.

Handling, storage, packaging and delivery (Requirement No. 14) is obviously very important for foods, to
prevent damage or deterioration of the products. Temperature control including monitoring and recording shall
be mentioned as examples to illustrate the importance of this requirement which obviously apply to all stages
from raw materials, throughout production and delivery, and to the point of consumption. Determination and
control of shelf life is needed, and so is full traceability with respect to the risk of product recall.

As mentioned several times in the above, recording is required with the purpose of demonstrating the
achievement of the required quality and to demonstrate that the quality system is effective. This is stated in
Requirement No. 15 Quality Records and the meaning of it will be seen from the following examples of records
to be included: inspection reports, analytical results, calibration reports, audit reports and corrective action
reports.

It is also demanded that the systembe internally audited on a regular basis (Requirement No. 16, Internal
Quality Audits). An appropriate audit plan shall be worked with ensuring that all elements (not necessarily all
details) are audited e.g. once a year. Audit teams shall be formed and it must be assured the members are
independent of the activities being audited. The audit report shall be included in the quality records as mentioned
above.

Management shall carry out its own independent review and evaluation of the Quality System. This has to be
carried out on a regular basis e.g. twice per year and it should be based on the above international audit reports
mentioned above as well as evaluation of the overall effectiveness of the system in achieving the quality
objectives stated. Needs for updating, new strategies etc. should also be indicated. It all has to be documented
in a report. This again demonstrates the very active role to be played by the management of the company.

Training (Requirement No. 17) is a vital part of the ISO 9000 standards. Of similar importance to food
companies are cleaning and disinfection and personal hygiene. These subjects have been included as separate
requirements (No. 18 and 19)in Table 5.15 to emphasize their importance and they have been used for the
following illustration of the structure of the system with its various types of documents.

Table 5.16 Quality system elements.

Quality System Contents
Requirements
1 Management Define and document commitment, policy and objec- tives, responsibility and authority,
responsibility verification resources and personnel. Appoint a management representative and conduct
regular reviews of the system
2 Quality system Establish and maintain a documented quality system ensuring that products conform to
specified requirements
3 Contract Review Ensure that customer's contractual requirements are evaluated and met
4 Product development Plan, control and verify product development to ensure that specified requirements are met
5 Document control System for control and identification of all documents regarding quality, e.g. procedures,
instructions, and specifications
6 Purchasing Ensure that purchased products conform to specified requirements
7 Product identification and System to identify and control traceability of product at all stages from raw materials
traceability through production to the final product as delivered to the customer

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8 Process control Ensure and plan the control of production which direct- ly effects quality by documented
work instructions, monitoring and control of processes
9 Inspection and testing Inspect and test incoming products, intermediate and final product; establish product
conformance to speci- fied requirements and identify non-conforming pro- ducts; maintain
inspection and test records
10 Inspection, measuring Selection and control of equipment to ensure reliability and accuracy in measuring data
and test equipment
11 Inspection and test For the whole process the products shall be identified and clearly marked concerning test
status status, including indication of conformance or non-conformance
12 Control of non-confor- Identification, documentation, evaluation, isolation (if possible) and disposition of
ming products non-conforming products
13 Corrective actions Prevention of reoccurrence of failures (non-conforman- ce)
14 Handling, storage Protection of the quality of the product during hand- ling, storage, packaging and delivery
packaging and delivery
15 Quality records Records, including those which demonstrate that the specified requirements have been met,
shall be control- led and maintained
16 Internal Quality Audits Regular, planned internal audits shall be carried out, documented and recorded to verify the
effectiveness of the quality system
17 Training Training requirements at all levels shall be identified and the training planned, conducted and
recorded
18 Cleaning and Disinfection Although not required by the ISO 9000 standards, these two points should be given special
attention in all food companies
19 Personal hygiene

5.2.3 The documented quality system

As mentioned above (Table 5.16, Requirement No. 2) the ISO 9000 standards require a documented quality
system.

The three-level structure of documentation shown in Figure 5.4 has proved effective in the food industry as well
as in other industries.

Level 1 is described in the Quality Manual. It is normally a short easy-to-read manual briefly stating the
company's quality objectives and policies. All requirements of the appropriate ISO Standard will be addressed.
The Quality Manual need not contain confidential information, and it is intended to be handed out to potential
customers and others, to inspire confidence in the company being able to satisfy customers' expectations. In
the example chosen, a proposal for Chapter 18, Cleaning and Disinfection, is shown in Table 5.17 for the plant
producing frozen shrimps. The Table also shows the various formal requirements for the documents of the
Quality System. Normally, the individual pages of the Quality Manual will be signed by the managing director or
by the chairman of the board to demonstrate the commitment of the top management.

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Figure5.4. Typical structure of the Quality System.

The second level will comprise procedures, describing how the statements of the Quality Manual are deployed
and implemented in the company. Persons responsible, as well as where and when will be stated. An example
of a procedure is shown in Table 5.18. The above mentioned Chapter 18 of the Quality Manual underlies this
procedure which could be issued by the QC-Manager and approved by the Technical Director.

The third level will comprise the work instructions giving all details on how the contents of the procedures are
accomplished. Table 5.19 shows an instruction linked with the procedure featured in Table 5.18.

In levels 2 and 3, appropriate references will be given to various forms to be filled out e.g. the list of approved
suppliers mentioned earlier and being part of the system documentation. An overview of the categories of
documents included in a Quality System is given in Table 5.20. The Table almost speaks for itself and it clearly
underlines the requirements for documentation including record keeping.

Table 5.17. Example of company policy (cleaning and disinfection). Quality manual, Chapter 18, level 1. Figure
5.4.

CLEANING AND DISINFECTION

QUALITY MANUAL CHAP. 18 REVISION NO: 3 DATE: 1993-03-16

EDITION:1 1993–01–15 PAGE: 1 of 1

CLEANING AND DISINFECTION

It is the policy of Company XX to maintain a high standard of hygiene.

Procedures and instructions will be maintained to ensure that the high standard is in accordance with the
requirements specified.

Detergents and disinfectants shall be selected and disinfection procedures worked out to ensure that the plant is
free from Salmonella after cleaning and disinfection

ISSUED BY: APPROVED BY:

Table 5.18. Example of Procedure, Cleaning and Disinfection. Level 2, Figure 5.4.

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CLEANING AND DISINFECTION

PROCEDURE NO.: P 18 10 05 REVISION NO.:3 DATE: 1993-03-16

1. EDITION: 1993-01-15 PAGE:1of1

CLEANING AND DISINFECTION

1.0 OBJECTIVE

Description of the procedure for cleaning and disinfection to ensure that the processing plant is visibly clean and
Salmonella non-detectable after cleaning and disinfection.

2.0 RESPONSIBILITIES

The Technical Director is responsible for implementing and maintaining this procedure.

3.0 AREA OF APPLICATION

This procedure is valid for all areas, equipment, etc. where shrimp are handled within Company XX.

4.0 CLEANING AND DISINFECTION

With reference to the Technical Director, the foreman of the various sections of the processing plant are
responsible for cleaning and disinfection.

Cleaning and disinfection is carried out at the end of each working day. The QC-Manager shall select and
organize the use of cleaning agents and disinfectants in order to eliminate Salmonella, to prevent the buildup of
scales or other residues as well as resistant microbial populations.

The QC-Manager is responsible for control and monitoring of the effectiveness of the cleaning and disinfection
performed.

5.0 REPORTING

The QC-Manager and the foreman shall report their findings to the Technical Director

ISSUED BY: APPROVED BY:

Table 5.19. Example of work instruction for cleaning and disinfection. Level 3, Figure 5.4.

CLEANING AND DISINFECTION

INSTRUCTION NO.: P 18 10 05 REVISION NO.: 3 DATE: 1993-03-16

1. EDITION: 1993-01-15 PAGE: 1 of 2

CLEANING AND DISINFECTION

CLEANING AND DISINFECTION OF COOLER AND CONVEYER FOR COOKED SHRIMP

1.0 OBJECTIVE

It is the objective of this instruction to describe the cleaning and disinfection of cooler and conveyer for cooked
shrimp carried out at the end of each working day, and before production in case the plant has not been in
operation for more than two days.

2.0 RESPONSIBILITY

The Technical Director is responsible for implementing and maintaining this instruction.

The Foreman of Processing Hall C is responsible for carrying out this instruction.

3.0 AREA OF APPLICATION

This instruction is valid for Processing Hall C.

4.0 WORK DESCRIPTION

1. Preparations Cooler and conveyer are emptied and dismantled to allow cleaning of all parts.

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2. Rinse Hosing with cold water

3. Cleaning Alkaline detergent “ZZ” is applied to all surfaces. Dosage: 3 l in 50 l cold water. pH: 12.5 Contact
time: 15 min.

4. Rinse 60°C water; hosing until all detergent is removed

5. Visual inspection All cleaned surfaces are inspected. If residues are observed steps 2, 3 and 4 are repeated.
The inspection is recorded in the Logbook of Hall C.

6. Disinfection Chlorine (YY) is applied to all surfaces. Dosage: 1 l to 50 l of cold water. Free chlorine level: >
200 ppm. Contact time: 10–15 min.

7. Rinse Hosing with cold water

8. Inspection Before start of production a visual inspection is carried out and the result is recorded in the
logbook of the Process Hall C.

9. Reporting Inspection result are reported by the Foreman to the Technical Director, who decides on the
corrective actions to be initiated.

ISSUED BY: APPROVED BY:

Table 5.20. Overview of the categories of documents included in a Quality System.

DOCUMENTS
SYSTEM DOCUMENTATION
SPECIFICATIONS
DOCUMENTATION OF RESULTS
- QUALITY MANUAL - INSPECTIONS - RECIPES
- PROCEDURES - ANALYTICAL CONTROL - QUALITY
- INSTRUCTIONS - PROCESS CONTROL - SPECIFICATIONS
- FORMS - NON-CONFORMANCE - PROCESS-
- CORRECTIVE ACTION SPECIFICATIONS

5.2.4. Establishment and implementation of Quality System

The work involved in establishing and implementing a Quality System e.g. ISO 9001 or 9002 should not be
underestimated. It is a very demanding project both in terms of man-hours and of resources. Proper planning
including well defined project organisation and very often with assistance from outside consultants is a necessity
for a successful result. Further, full commitment and motivation as well as intensive training of all employees are
indispensable requirements.

Table 5.20 and Figure 5.5 illustrate the various activities involved as well as a time schedule for a smaller
company. To initiate the project and as responsible for its completion, a Quality Management Group will
normally be formed. For food industries this Group may comprise the following persons: Managing Director,
Technical Director, R & D Manager, Sales Manager and Head of Laboratory. The key functions of the Group
can be summarized as follows:

Definition of quality policy and objectives.

Definition of responsibilities.

Decision on time schedule for the project from start to certification.

Allocation of resources required.

Information and motivation of all staff members.

Training of all employees.

Follow-up on time schedules.

Resolving differences of opinions, argumenting etc.

The various phases and activities following the formation of the Quality Management Group are shown in Table
5.21 and Figure 5.5 which almost speak for themselves. The time required i.e. about 1–2 years or more, for the
implementation and certification of the system in a medium size company, should be noticed.

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Table 5.21. Phases of a quality system approach.

Formation of a quality management group

Hazard Analysis

Audit of present system elements

Estimation of resources and total period of time required for the project including certification

Formation of project organisation

Preparation of Quality Manual (level 1)

Training of all staff members

Definition of procedures and instructions (levels 2 and 3) to be included in departmental manuals i.e. table of
contents

Decision on time schedule for preparation of departmental manuals

Establishment of working groups for the preparation of the individual procedures and instructions

Commenting, reviewing, approving and issuing procedures and instructions

Implementation of procedures and instructions

First approach to certifying body

Internal auditing

Corrections, adjustments etc.

Further training of staff

Certification

Figure 5.5. Time schedule for establishing and implementing a quality system in a small size food processing
plant.

5.2.5. Advantages and disadvantages experienced by ISO 9000 certified companies

An analysis encompassing one hundred ISO 9000 certified companies showed that they all had experienced
significant advantages. Marketing merits, reduced quality costs, and higher efficiency were the main advantages
mentioned, all contributing to a higher profitability. Findings which agree very well with the general opinion within
the food industry in Europe. As regards quality costs, Figure 5.6 shows how profit is typically created when
Quality Management is implemented in a company. The reduction in quality costs observed in practice can be
as much as 5–15% of the company turnover, and investment in Quality Management have proved to be

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profitable.

The disadvantages experienced appear to be too much bureaucracy and lack of flexibility, which are inherent
parts of the ISO standards, together with the significant amount of paper work involved.

The main objective of Quality Management according to the ISO 9000 series can be defined as meeting the
agreed requirements of the customer. This underlines that the quality of a company's products is the key factor
in the performance of the company. ISO 9000 is clearly a system seeing quality from the industry's point of
view.

The response from the food industry has been slow compared to other industries. However, a rapidly increasing
interest is now seen in Denmark and several other European countries. The interest is not limited to food
processing plants; all links from primary production to the final product are becoming involved. One may expect
that in the near future the whole chain from the primary producer to consumers will be covered by certified
quality systems. Projects on certification of farms are in progress in Denmark, and fishing boats have already
been certified according to ISO 9000.

This development will form a proper background for meeting the worldwide trend towards more stringent
customer expectations.

Figure 5.6 Economical benefits from introducing a quality system.

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