The Global Food Safety

Initiative:

Guidance Document

First Edition

Guidance Document First Edition 18 October 2001

 CONTENTS

Page N°

1 Introduction 3

1. Introduction – the Global Food Safety Initiative 3

2. Aim 3
3. Scope 3
4. Definitions 4
5. Overview of the Guidance Document 6
[Link] for an endorsed food safety scheme 7

Part I

6.1 Key Elements Quality Management Systems 7

6.2 Key Elements GAP, GMP, GDP 9

6.3 Key Element HACCP System 11

Part II

7 Requirements and guidance for Certification Bodies 12

Part III

8 Procedure for the application and endorsement of

food safety schemes and logo use 22

Annex 1 Key Element GAP/GMP/GDP 25

Annex 2The principles of the HACCP system

and guidelines for its application 36

Guidance Document First Edition 18 October 2001 2

 1 Introduction

The Global Food Safety Initiative (GFSI)

The Global Food Safety Initiative (GFSI) co-ordinated by CIES - The Food Business Forum in co-
operation with the Food Marketing institute (FMI), was launched in May 2000. It is a retail-led
network of over 40 food safety experts and their trade associations world-wide.

The objectives of the Global Food Safety Initiative are to

Ø enhance food safety;
Ø ensure consumer protection;
Ø strengthen consumer confidence.;
Ø harmonise requirements of food safety systems;
Ø improve cost efficiency throughout the food supply chain.

This group or Task Force has developed a standardisation project to achieve these objectives.

2. Aim of the Guidance Document

The aim of this document is to ensure food safety throughout the food supply chain and promote
customer confidence in products supplied by certified companies through the application of endorsed
food safety schemes.

3. Scope

This Document sets out the key elements for production of food under the Global Food Safety
Initiative as requirements for food safety schemes and gives guidance on how to seek endorsement of
such a scheme. It is a framework in which food safety schemes can be endorsed as appropriate and
effective.

Furthermore it sets out the requirements for the certification of schemes to be approved. It also
contains guidance on the operation of certification processes.

The food safety standards endorsed can be applied by food suppliers in the whole supply chain. It is at
the discretion of retailer and supplier for which products standards will be applied. Over the world this
will differ depending on:

– Company policies;
– General regulatory requirements;
– Product liability and due diligence regulations.

Guidance Document First Edition 18 October 2001 3

 4. Definitions
Accreditation
Procedure by which an authoritative body gives formal recognition of the competence of a certification
body to provide certification services, against an international standard.

Accreditation body
Agency having jurisdiction to formally recognise the competence of a certification body to provide
certification services.

Allergen
Food causing an adverse reaction that is mediated by an immunological response

Audit
Systematic and functionally independent examination to determine whether activities and related
results comply with standardised requirements.

Certification
Procedure by which accredited certification bodies, based on an audit provide written or equivalent
assurance that food control systems conform to requirements.

Certification body
Provider of certification services, accredited to do so by an accreditation body.

Endorsement
Procedure by which a food safety-related standard is approved of under the Global Food Safety
Initiative.

Food intolerance
A reproducible, adverse reaction that is not psychologically based and not immunological, caused by
food

Food sensitivity
An adverse reaction in humans either caused by allergens or as a result of food intolerance. The
following food and products derived from them are considered to be allergens or causing food
intolerance:
• Peanuts;
• Tree nuts (almonds, brazils, cashews, chestnuts, hazelnuts, macadamia nuts, pecans, pine nuts,
pistachios, walnuts);
• Eggs;
• Fish;
• Cows’milk;
• Crustacea, molluscs, shellfish;
• Sesame seeds;
• Soya;
• Sulphite;

Guidance Document First Edition 18 October 2001 4

• Cereals containing gluten (wheat, rye, barley, oats, spelt or their hybridised strains).
Inspection
Examination of systems for control of food safety, in order to verify that they conform to requirements.

Inspection body
Provider of inspection services.

Primary production
Food product that is similar in nature to its natural state, but may have been
Ø Packed
Ø Washed
Ø Trimmed (not cut into pieces)
Ø Undergone any process not defined under the definition of "processed food”

Processed food
Food product which has undergone any of the following processes:
Ø Aseptic filling
Ø Baking
Ø Bottling
Ø Brewing
Ø Canning
Ø Coating/Breading/ Battering
Ø Cooking
Ø Curing
Ø Cutting/Slicing/Dicing
Ø Distillation
Ø Drying
Ø Extrusion
Ø Fermentation
Ø Freeze Drying
Ø Freezing
Ø Frying
Ø Hot Filling
Ø Irradiation
Ø Microfiltration
Ø Microwaving
Ø Milling
Ø Mixing/Blending
Ø Packed in modified atmosphere
Ø Pasteurisation/Sterilisation
Ø Pickling
Ø Roasting
Ø Smoking
Ø Steaming
Ø Packed in Vacuum Packing

Requirements
Criteria set down in an endorsed standard related to food safety.

Guidance Document First Edition 18 October 2001 5

 5. Overview of the Guidance Document
5.1 Key Elements (Part I)

5.1.1 Basis for the Key Elements

The Key Elements cover the whole range of food safety standard criteria, including Quality
management systems for food safety, Good Practices and Hazard Analysis and Critical Control Point
(hereafter, HACCP) principles, as defined by the Codex Alimentarius Commission. They form the
reference basis for the endorsement procedure of food safety standards and are in addition to any legal
requirements for food in the country of production and consumption. They are not intended to replace
the requirement of any legislation, where this legislation requires a higher standard. In consequence it
is necessary that any food safety scheme accepted for application under this framework be in
compliance with all requirements of the Key Elements, except for the Key Element ‘good practices’,
where it suffices to comply with either Good Agricultural Practices, Good Manufacturing Practices or
Good Distribution Practices.

5.1.2 Elaboration of Certification Criteria

The Key Elements structure has been developed by the GFSI with the assistance of retailers,
manufacturers and other relevant stakeholders. These Key Elements will be periodically reviewed in
the light of new scientific knowledge so as to ensure a regime of continuous improvement.

5.2 Certification Procedures

The requirements for the certification of schemes to be approved can be found in chapter 7 (Part II).
Guidance on the operation of certification processes, based mainly on ISO/IEC Guide 65, are included
in chapter 7.4.

5.3 Endorsement procedure

The procedure for the application and endorsement of food safety standards are included in Chapter 8
(Part III).

5.4 GFSI Logo

The GFSI Logo Usage rules and recommendations are included in Chapter 9. This chapter identifies
the owner and controller of the GFSI Logo, those having the rights to use the GFSI Logo, the nature of
claims represented by the GFSI Logo, in what kind of communication the GFSI Logo can be used and
the restrictions with regard to the reproduction of the GFSI Logo in printed and published forms.

5.3.1 General Rule

A common collective Logo is registered and owned by the GFSI. The Logo can be used as a
communication tool between suppliers and their customers. The logo shall not be used on any product,
product packaging or advertising.

Guidance Document First Edition 18 October 2001 6

 Part I
6. Requirements for an endorsed food safety scheme (Key Elements)

6.1 KEY ELEMENT: QUALITY MANAGEMENT SYSTEMS

6.1.1. General requirements

The endorsed scheme (hereafter, the scheme) shall require that the elements of the supplier’s Quality
Management System with respect to food safety be documented, implemented, maintained and
continually improved.
The quality management system shall:
a) identify the processes needed for the quality management system;
b) determine the sequence and interaction of these processes;
c) determine criteria and methods required to ensure the effective operation and control of
these processes;
d) ensure the availability of information necessary to support the operation and monitoring of
these processes;
e) measure, monitor and analyse these processes, and implement action necessary to achieve
planned results and continual improvement.

6.1.2. Quality Policy

The scheme shall require the supplier to have a clear, concise and documented quality policy statement
and objectives, that specifies the extent of the organisation's commitment to meet the safety and quality
needs of its customers.

6.1.3. Quality Manual

The scheme shall require the supplier to have a Quality Manual or documented system, having a scope
appropriate to the range of business activity to be covered, including documented procedures or
specific reference to them, and describing the interaction of the related processes.

6.1.4. Customer Focus

The scheme shall require that the supplier’s senior management will ensure that their customer’s needs
and expectations are determined, converted into requirements and fulfilled with the aim of achieving
customer satisfaction.

6.1.5. Management Responsibility

The scheme shall require the supplier to establish a clear organisational structure, that unambiguously
defines and documents job function, responsibility and reporting relationships, or at least those staff,
whose activities affect product safety and quality.

6.1.6. Management Commitment

The scheme shall require that the supplier’s senior management demonstrate its commitment to the
development and improvement of the quality management system.

Guidance Document First Edition 18 October 2001 7

6.1.7. Management Review (including HACCP Verification)
The scheme shall require that the supplier’s senior management will review the verification of the
quality management system and HACCP Plan, at planned intervals, to ensure its continuing suitability,
adequacy and effectiveness. Such review shall evaluate the need for changes to the supplier’s quality
management system, including the quality policy and quality objectives.

6.1.8. Resource Management

The scheme shall require that the supplier’s senior management determine and provide, in a timely
manner, all the resources needed to implement and improve the processes of the quality management
system, and to address customer satisfaction.

6.1.9. General Documentation Requirements

The scheme shall require that the supplier prepare documented procedures to demonstrate compliance
with the specified scheme and will ensure that all records required to demonstrate the effective
operation and control of its processes are securely stored and readily accessible when needed.

6.1.10. Documentation Control

The scheme shall require that the supplier ensure that all documents, records and data critical to the
management of product safety effectively controlled, securely stored and readily accessible when
needed.

6.1.11. Specifications
The scheme shall require that the supplier ensure that for all items and services purchased/provided
and having effect on product safety documented specifications are prepared, securely stored and
readily accessible when needed.

6.1.12 Procedures
The scheme shall require that the supplier will prepare and implement detailed procedures/instructions
for all processes and operations having effect on product safety.

6.1.13. Record Keeping

The scheme shall require that the supplier ensure that all records in relation to product safety are
effectively maintained, securely stored and readily accessible when needed.

6.1.14 Internal Audit

The scheme shall require that the supplier have in place an internal audit system in relation to all
systems and procedures, which are critical to product safety.

6.1.15 Corrective Action

The scheme shall require that the supplier will ensure that procedures for the determination and
implementation of corrective action in the event of any significant non-conformance relating to
product safety are prepared and documented and that all such documentation is securely stored and
readily accessible when needed.

6.1.16 Control of Non-conformity

The scheme shall require that the supplier ensure that product which does not conform to requirements
is clearly identified and controlled to prevent unintended use or delivery. These activities shall be
defined in a documented procedure that is securely stored and readily accessible when needed.
6.1.17 Product Release
The scheme shall require that the supplier will prepare and implement appropriate product release

Guidance Document First Edition 18 October 2001 8

procedures to ensure that product is not released until all specified requirements are met.

6.1.18 Purchasing
The scheme shall require that the supplier control purchasing processes to ensure that all externally
sourced items conform to requirements.

6.1.19 Supplier Performance Monitoring

The scheme shall require that the supplier operate procedures for approval and continued monitoring
of its suppliers. The results of evaluations and follow-up actions shall be recorded.

6.1.20 Traceability
The scheme shall require that the supplier develop and maintain appropriate procedures and systems to
ensure:
Identification of the source of any out-sourced product, ingredient or service;
Record of purchaser and delivery destination for all product supplied.

6.1.21 Complaint Handling

The scheme shall require that the supplier prepare and implement an effective system for the
management of complaints.

6.1.22 Product Recall

The scheme shall require that the supplier prepare and implement an effective product recall procedure
for all products it supplies, which is tested regularly.

6.1.23 Control of Measuring and Monitoring Devices

The scheme shall require that the supplier identify the measurements critical to food safety and the
measuring and monitoring devices required to assure product safety.

6.1.24 Product Analysis

The scheme shall require that the supplier prepare and implement a system to ensure that
product/ingredient analyses critical to the confirmation of product safety is undertaken and required
and that such analyses conforms to publicly recognised standards.

6.2 KEY ELEMENT GOOD AGRICULTURAL PRACTICES, GOOD MANUFACTURING

PRACTICES, GOOD DISTRIBUTION PRACTICES

6.2.1 Introduction
This clause sets out the requirements good practice in agriculture (Good Agricultural Practices,
hereafter GAP), manufacturing (Good Manufacturing Practices, hereafter, GMP) and distribution
(Good Distribution Practices, hereafter GDP). An example of more detailed requirements can be found
in Annex 1.
The scheme shall include consideration of the following items in relation to GAP/GMP/GDP where
appropriate.

6.2.2 Facility Environment

The site or facility shall be located and maintained so as to prevent contamination and enable the
production of safe (primary) products (GAP/GMP/GDP).

6.2.3 Local Environment

Guidance Document First Edition 18 October 2001 9

All grounds within the site or facility shall be finished and maintained to an appropriate standard
(GAP/GMP/GDP).

6.2.4 Facility Layout and Product Flow

Premises, site and/or plant shall be designed, constructed and maintained to control the risk of
(primary) product contamination (GAP/GMP/GDP).

6.2.5 Fabrication (raw material handling, preparation, processing, packing and storage areas)
The fabrication of the site, buildings and facilities shall be suitable for the intended purpose
(GAP/GMP/GDP).

6.2.6 Equipment
Equipment shall be suitably designed for the intended purpose and shall be used so as to minimise the
risk of contamination (GAP/GMP/GDP).

6.2.7 Maintenance
A system of planned maintenance shall be in place covering all items of equipment, which are critical
to product safety (GAP/GMP/GDP).

6.2.8 Staff Facilities

Staff facilities shall be designed, and should be operated, so as to minimise the risk of product
contamination (GAP/GMP/GDP)

6.2.9 Physical and Chemical Product Contamination Risk

Appropriate facilities and procedures shall be in place to control the risk of physical or chemical
contamination of (primary) product (GAP/GMP/GDP).

6.2.10 Segregation and Cross-contamination

Procedures shall be in place to prevent the cross-contamination of raw materials, packaging and
finished (primary) product (GAP/GMP/GDP).

6.2.11 Stock Management

Procedures shall be in place to ensure materials and (primary) products are used in the correct order
and within the allocated shelf life (GAP/GMP/GDP).

6.2.12 Housekeeping, Cleaning and Hygiene

Appropriate standards of housekeeping, cleaning and hygiene shall be maintained at all times and
throughout all the stages (GAP/GMP/GDP).

6.2.13 Water Quality Management

The quality of water that comes in contact with food, shall be regularly monitored and shall present no
risk to product safety (GAP/GMP):
Extra GAP: Water for post harvest washing shall be potable.
Extra GMP: Potable water shall be used and checked for contaminants at an appropriate frequency.

6.2.14 Waste Management

Adequate systems shall be in place for the collation, collection and disposal of waste material
(GAP/GMP/GDP).

6.2.15 Pest Control

Guidance Document First Edition 18 October 2001 10

A system shall be in place for minimising the risk of pest infestation on the site or facilities
(GAP/GMP/GDP).

6.2.16 Veterinary medicine

The utilized drugs shall be appropriate to their purpose and should not be banned in the destination
country (GAP).

6.2.17 Pesticide, Herbicide and Fungicide Control

An Integrated Crop Management or equivalent system shall be in place to control the use of these
chemicals during growing and post harvest treatment (GAP).

6.2.18 Transport
All vehicles used for the transportation of raw materials (including packaging), intermediate/semi
processed (primary) product and finished (primary) product shall be suitable for the purpose,
maintained in good repair and be in a hygienic condition (GDP).

6.2.19 Personal Hygiene, Protective Clothing and Medical Screening

Documented and trained hygiene standards based on risk of product contamination shall be in place.
Suitable and appropriate protective clothing shall be provided.
A medical screening procedure shall be in place.
In all cases this shall also apply to contractors and visitors (GAP/GMP/GDP).

6.2.20 Training
A system shall in place to ensure that all employees are adequately trained, instructed and supervised
commensurate with their activity (GAP/GMP/GDP).

6.3 KEY ELEMENT HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP)

The submitted scheme shall require for a Hazard Analysis and Critical Control Point (hereafter,
HACCP) system, or equivalent, to demonstrate food safety management. The described HACCP
system shall be systematic, comprehensive and thorough and shall be based on the Codex Alimentarius
HACCP principles (the hazard analysis, where appropriate, shall include allergens). The 7 HACCP-
principles shall apply to all suppliers. Any supplier who is not a primary producer shall additionally
comply with the guidelines for its application in formulating its HACCP plan in reference with these
guidelines.

The scope and extent of the HACCP-system shall be required to be defined per product, per process
line/or process-location and the position within the food chain.

The supplier’s HACCP-system shall be able to demonstrate management commitment and shall be
supported through the supplier’s quality management system.

Note: The principles of the HACCP system as adopted by the Codex Alimentarius Commission and
guidelines for its application can be found in Codex Alimentarius as an Annex to CAC/RCP 1-1969.
For reference and guidance they can also be found in Annex 2 to this Guidance Document. It is
urgently recommended that users of this Guidance Document ensure that they are fully informed of the
content of the relevant document in Codex Alimentarius and of any changes thereto.

Guidance Document First Edition 18 October 2001 11

 Part II
Requirements and Guidance for certification bodies

7.1 Introduction
In recognition that the procedures and methodology for assessment and certification are pre-
established, purpose of this chapter is to identify a minimum number of requirements, necessary to
focus the certification process on food safety. In addition, for convenience, this chapter includes
guidance for certification bodies seeking accreditation to ISO/IEC Guide 65 for the scope of the
Global Food Safety Initiative.

7.2 AUDITOR QUALIFICATIONS, TRAINING AND EXPERIENCE

Entry level
Qualifications
The auditor shall have a minimum of secondary education (as defined in ISO 19011), or equivalent, as
mentioned in clause 7 of ISO 19011, in a food or bioscience related discipline.

Training
The auditor shall have successfully completed a QMS lead assessor course and have undergone a
supervised period of training in practical assessment. He or she shall also have successfully completed
training in HACCP based on the principles from Codex Alimentarius (Alinorm 97/13) and be able to
demonstrate competence in the understanding and application of HACCP principles.

Note: The training course should be recognised by the industry (and its stakeholders) as being
appropriate and relevant. For example, approval or certification by an independent body with the
relevant expertise can provide some assurance that a course meets specified criteria.

Experience
The auditor shall have a minimum of five years experience relevant to the food industry. This shall
involve work in Quality Assurance or food safety functions within manufacture, retailing, inspection
or enforcement.

An auditor shall perform a minimum of five audits per year to maintain his qualification.

Training and Experience for specific fields

Certification bodies shall be able to demonstrate that every auditor has appropriate training and
experience for the particular fields for which they are considered competent. Competence shall be
recorded (clause 5.6.c of ISO 19011) at least at the level of each field and its first sub-division as
indicated in chapter 7.5.

It is difficult to be prescriptive as to the specific training required in the absence of nationally

recognised training modules. Necessary training and experience shall be judged on the risk and the
particular technical demands of the field

Guidance Document First Edition 18 October 2001 12

7.3 List of minimum requirements for audit reports
An audit report shall contain the following as a minimum.

1 General information
- Name of the company
- Address
- Name of certification body
- Address
- Name of factory
- Address
- Accreditation details
- Date(s) of assessment
- Date of previous assessment
- Name of the food safety standard
- Scope of assessment (detailed description processes / products)
- Product category / product rating
- List of key personnel present at assessment
- Name /signature company
- Name / signature assessor
2. Summary of results
- Description HACCP / QMS system
- Description existing certificates / approvals company
- Overview of assessed processes
- Conclusion of the assessment
- Expiry date of certificate
3. List of non conformances
- Closed

- Outstanding

- New

4. Detailed assessment report/sampled items

- HACCP requirements - Results per key element
-
-
- QMS requirements - Results per key element
-
-
- GMP/GAP/GDP - Results per key element
requirements
- Other relevant remarks -

Guidance Document First Edition 18 October 2001 13

7.4 Guidance for certification bodies seeking accreditation to ISO/IEC Guide 65 for the
scope of the Global Food Safety Initiative

7.4 Introduction.
[Link] The general requirements for accreditation are laid down in the International Standard ISO/IEC
Guide 65 – IAF (International Accreditation Forum) Guidance on the Application of General
Requirements for Bodies Operating Product Certification Systems. These requirements apply to all
types of certification and therefore need to be interpreted in respect of food safety requirements and the
fields of food technology concerned.

[Link] This document provides general guidance on the application of ISO/IEC Guide 65 to food
certification. It has been produced by the GFSI. It provides amplification of ISO/IEC Guide 65 where
guidance is necessary when applied to food certification. It does not cover all the requirements of
ISO/IEC Guide 65, and certification bodies are reminded of the need to comply with all of the
requirements of the publication.

7.4.2 Scope

[Link] The guidance below is intended to apply to the certification of the “process” which supplies
food products to assure their safety.
The term “process” is used in the widest sense and should include all the processes and services, which
come together to make up the end user food product. This requires the adoption of the elements of a
documented quality management system in relation to food safety, control of GAP (Good Agricultural
Practices)/GMP (Good Manufacturing Practices)/GDP (Good Distribution Practices) standards and the
HACCP principles or equivalent,.

[Link] The GFSI endorsed standard used by a Certification Body shall have undertaken the GFSI
endorsement procedure, which includes the key elements defined by the GFSI, the auditor
qualifications, training and experience, the assessment reporting format and duration of initial and
surveillance visits.

7.4.3 Definitions

[Link] Certification and Certification Body are defined in chapter 4. Clarification is given below on
some other terms, some have gained common usage in the food industry in a way that conflicts with
the Accreditation definition. Another source of confusion is the 3-way relationship between food
producer, food purchaser and Certification Body. Care should be taken in standards, policies and
procedures to ensure clarity of meaning.

[Link].1 Accreditation
The procedure by which an authoritative body gives formal recognition of the competence of a
certification body to provide certification services, against an international standard.
The International Accreditation Forum, Inc. (IAF) brings together a number of bodies from around the
world with the aim of providing global accreditation coverage, in this case, for process certification.
Further information on member bodies with an MLA-status of the IAF can be obtained by contacting
the IAF Secretariat at the address detailed in the back of ISO/IEC Guide 65.

[Link].2Audit
A systematic and functionally independent examination to determine whether activities and related

Guidance Document First Edition 18 October 2001 14

results comply with standardised requirements.
Used in the food industry to mean evaluation of a process and the process controls. But see also
internal quality audit. (Quality audit has a more specific meaning within ISO9000).

[Link].3 Client
In the context of ISO/IEC Guide 65, the client is the party that commissions work from the
Certification Body.

[Link].4 Consultancy
Participation in an active creative manner in the development of the processes to be assessed. For
example by:

a). Preparing or producing manuals handbooks or procedures.

b) Participating in the decision making process on management system matters.
c) Giving specific advice towards the development of facilities and the implementation of
processes.

Consultancy may prejudice the impartiality of the Certification Body in breach of clause 4.2 (o) of the
standard. Further guidance is given at the appropriate point in this document.

[Link].5 Fields of Certification

The scope of accreditation shall be precisely defined in terms of the field type and range of
certification.

[Link].5.1 Field
Of certification will be the specific area of the food chain. Sub-divisions are indicated in chapter 7.5.

[Link].6 Internal quality audit

(In the context of ISO/IEC Guide 65) a planned and documented audit, conducted by or on behalf of
the Certification Body, of the implementation of the procedures and systems of the Certification Body
to verify compliance with the criteria of ISO/IEC Guide 65 and the effectiveness of the quality system.
(See sub-clause [Link])

7.4.4 Certification body

[Link] General Provisions

(Reference 4.1.3). The criteria against which the process of a supplier is evaluated shall be those
outlined in the standards endorsed by the GFSI for companies supplying Retailer Branded Food
Products. A full list of endorsed standards will be available from the GFSI secretariat.

[Link] Organisation
(Reference 4.2. c). The Certification Body shall clearly define its management structure for
i) day to day operation of the business and certification activities
ii) the ongoing governance of the business and certification activities by an impartial and
independent group of appointed stakeholders. This group should be selected from
sources who have interest in the certificated product. Individuals appointed must
represent particular stakeholder interest. For food certification bodies the stakeholders
may include representation from:
primary producers;
manufacturers;

Guidance Document First Edition 18 October 2001 15

 wholesalers and distributors;
retailers;
consumers;
Letters of appointment for the governing board must be held by the certification body,
along with details to verify that appointment as a particular stakeholder.
iii) in specific cases a certification body may refer to stakeholders of the
GFSI

(Reference 4.2.e). The range of certification services offered by a body may be wider than
those accredited. In this case the limits of accreditation shall be made clear. Services that are
outside the scope of the accreditation shall be distinguished from those that are accredited.

(Reference 4.2.h). Liability insurance shall include, Employers Liability, Public and Product
Liability and Professional Indemnity. Certification Bodies should be able to demonstrate
adequate arrangements both financially and geographically for its activities.

(Reference 4.2.i). Financial stability for the operation of the certification system shall be
demonstrable through audited accounts.

(Reference 4.2.p). Handling of complaints, appeals and disputes received from clients or other
parties, shall be documented in accordance with the timescale requirements of the GFSI
Protocol.

[Link] Operations
The certification body shall evaluate the process on the basis of a site visit according to the guidelines
mentioned in Annex 3 (Guidance for bodies providing certification to GFSI endorsed standards). The
evaluation shall encompass all the elements of the GFSI endorsed standard. Personnel conducting the
evaluation shall be recognised as competent by the certification body within the requirements defined
in chapter 7.2.

[Link] Subcontracting
No additional comments on this clause.

[Link] Quality System

(Reference 4.5.2). The quality system of the certification body shall appropriately reflect the
requirements of the GFSI endorsed standard.

[Link] Conditions and procedures for granting, maintaining, extending, suspending and
withdrawing certification.
i) The conditions for granting, maintaining, extending, suspending and withdrawing certification
shall be in accordance with the criteria described in the standards endorsed by the GFSI
[Link] Internal Audits and Management Reviews

[Link].1 Internal audit shall ensure that all elements of the accreditation standard and the GFSI
endorsed standard criteria are included. Internal audits shall be undertaken at a minimum of once per
year and should be conducted based on the requirements of ISO 19011, Guidelines on Quality and
Environmental auditing.

[Link].2 The certification body management shall review it’s quality system at a minimum of
once per year.

Guidance Document First Edition 18 October 2001 16

[Link] Documentation

[Link].1 The certification body shall clearly define to all interested parties all criteria, as listed in
ISO/IEC Guide 65, and:

a) the criteria under which the GFSI endorsed standard operates;

b) the criteria of the GFSI endorsed standard;
c) the agreement signed up with the accreditation body;

Much of this information can be included in business terms and conditions as part of the contract with
the client.

[Link].2 Document control shall include all documents and data related to certification activity,
including:

i) in-house quality manual and procedures;

ii) working instructions and record forms;
iii) normative documents ;
iv) accreditation documents ;
v) food safety legislation and Codes of Practice.

[Link] Records

Certification data and records shall be kept for a minimum of five years

[Link] Confidentiality
No additional comments on this clause.

7.4.5 Certification Body personnel/ Qualification criteria

The minimum relevant criteria for the competence of personnel as defined by the certification body
shall be in accordance with the qualifications, training and experience defined in Annex 4.2 of this
document.

7.4.6 Changes in the certification requirements

Changes to certification requirements shall include any criteria as implemented by the GFSI for their
endorsed standards. Such changes shall be implemented by the certification body from the date of
publication by the GFSI or as authorised by the GFSI.

7.4.7 Appeals, complaints and disputes

Certification personnel investigating appeals, complaints or disputes shall be suitably independent

from the activities under investigation.

7.4.8 Application for certification

[Link] Information on the procedure
[Link].1 The certification body shall provide to the client full up-to-date details of the
certification process appropriate to the scheme, rules of the scheme, fees to be paid and any other
information deemed appropriate by the GFSI Protocol.

Guidance Document First Edition 18 October 2001 17

[Link] The application for certification
[Link].1 The certification body shall provide an official application form for the client prior to
the evaluation process which will require the following information:
a) the client company name, address and locations to be site visited
b) the scope of the desired certification defined in terms of the field and sub-field of
food technology for the product(s) being manufactured
c) a clear definition of the process to be certified
d) the client’s consent to abide by the rules of the certification scheme

This application form, which the client signs, shall also include any other contractual requirements
including the reporting timescale, that exist between the certification body and the client as described
in the GFSI protocol.

7.4.9 Preparation for evaluation

[Link] The certification body shall prepare and monitor the plan for any certification activity to
include:
a) A proposal for a site visit date, mutually acceptable to client and certification body
b) A proposal for an auditor to undertake a site visit, mutually acceptable to client and
certification body
c) The duration and frequency of site visits according to the guidelines mentioned in Annex 4.3

[Link] Following the proposed plan the certification body shall formally assign an appropriate auditor
and confirm all arrangements in writing or whatever way with the client.

7.4.10. Evaluation

The certification body shall evaluate the process against all the criteria specified in the GFSI endorsed
standard. The auditor shall record sufficient contemporaneous data to support the findings as will be
reported in the evaluation report. The auditor may collect objective evidence to support the findings .
At the closing meeting the auditor shall present also in a written form the findings to agree to a
proposed corrective action plan and time scales for implementation. The auditor may propose a
recommendation for certification status, but the final decision must remain that of the certification
body itself.

7.4.11. Evaluation Report

The evaluation report shall be prepared by the auditor and include all the requirements listed in the
GFSI Protocol (Annex 4). The report shall be submitted to the certification body for review.
Corrective action proposals are considered and the Certification Body shall inform the client of the
non-conformities that need to be discharged in order to comply with the certification scheme
requirements. Verification of corrective action undertaken by the client must be demonstrated in
writing to the certification body.

7.4.12. Decision on Certification

No additional comments on this clause.

Guidance Document First Edition 18 October 2001 18

7.4.13. Surveillance

7.4.13.1The certification body shall have documented procedures for surveillance, which reflect the
requirements of the GFSI protocol with regard to certification status and product rating.
7.4.13.2Surveillance frequencies may differ from the GFSI protocol when a client informs the
certification body of intended modifications to the certified product, manufacturing process or the
quality system, which may affect the conformity of the process/product.

7.4.14. Use of licences, certificates and marks of conformity.

No additional comments on this clause.

See chapter 8 for the use of the Global Food Safety Initiative logo.

7.4.15. Complaints to suppliers

The certification body must ensure that during the evaluation process the complaint record to the
client is evaluated.

Guidance Document First Edition 18 October 2001 19

[Link] CERTIFICATION – FIELDS AND TYPES

Fields
Six broad fields have been identified. Within those six fields that of raw meat and fish has been
categorised into six further fields, as listed below. Some further sub-categorisation for specific fields is
defined. Where applicable the GFSI product category has also been included. Organisations applying
for accreditation or extensions of scope should use these fields in their applications.

Food Processing GFSI Product Category

Raw Meat & Fish
Red Meat ~ Slaughter & cutting 2
Poultry Meat Slaughter & cutting 3
Fish ~ Chilled and frozen 4
Raw meat products and preparations 7
Raw fish products and preparations 8
Produce (Fruit & Vegetables)
Fresh & frozen 5
Dairy
Chilled and frozen 6
Egg 1
Ready to eat or heat (chilled & frozen) ~
including cooked meat/ cooked fish products 10
Ambient stable, heat preserved, hermetically sealed packs 9
Ambient Stable Foods (Other):
Beverages 11
Bakery products ~ ambient 12
Dried foods 13
Confectionery 14
Snacks and breakfast cereals 15
Oils & fats 16
Food ingredients 17

Guidance Document First Edition 18 October 2001 20

7.6 DURATION AND FREQUENCY OF VISITS
7.6.1 Initial visits
The duration of an initial visit has to be determined by the certification body with due regard to:
• the type of process used to manufacture the product;
• the conditions under which the product is stored and sold;
• the method of preparation of the food by the consumer;
• the number of sites and products;
• the number of employees related to food safety

During the initial visit it should be determined whether activities and related results comply with
agreed requirements. Therefore all the elements of a GFSI endorsed standard should be covered by
reviewing the suppliers’ manual and related procedures together with an assessment of the production
facilities.

7.6.2 Surveillance visits

Surveillance visits should be executed at a minimum of once per year.
During a surveillance visit the certification body should provide written assurance that food control
systems are still conforming to requirements.
The duration of a surveillance visit has to be determined by the certification body with due regard to:
• the method of preparation of the food by the consumer;
• the number of sites and products;
• the number of employees related to food;
• the size of the random sampling;
• the number of outstanding non conformances

7.6.3 Follow-up visits

Depending on the grading and the number of non conformances the certification body should have a
provision for follow-up visits on a short interval base.

Guidance Document First Edition 18 October 2001 21

 Part III
8. Procedure for the application and endorsement of food safety schemes and logo
use
8.1 Procedure for the application and endorsement of food safety schemes.

Any food safety scheme accepted for inclusion in the GFSI framework shall be endorsed by the Global
Body. The procedure is as follows:

[Link] The submission of certification scheme, with a written request from the owner of a scheme,
for the scheme to be formally assessed and endorsed shall be on paper and also in electronic
form to allow it to be posted on the GFSI web page. This allows for public comments.

[Link] The scheme prepared in accordance with chapter 6 shall at least contain the following
items:
• A standard;
• A clearly defined scope;
• Requirements for the qualification of auditors;
• A table stating duration and frequency of visits;
• The minimum content of the audit report;
The conditions and procedures for granting, maintaining, extending, suspending and
withdrawing certification

8.1.2 The scheme is forwarded to the Expert Committee, which assesses conformity of the scheme
with the requirements in Chapter 6. To this end, a technical committee may be appointed. The
assessors shall not have any vested interest in the application.

8.1.3 In cases where minor alterations are required, the Expert Committee can discuss these in
writing directly with the applicant, so changes can be made.

8.1.4 The Expert Committee is required to prepare a report for the Director of the Global Body, who
possesses delegated authority from the Board of Directors, within a target time of 8 weeks, so a
decision can be made on the conformity of certification scheme. A copy of the report will also
be sent to the applicant.

8.1.5 In the case where the Director of the Global Body finds that a certification scheme conforms, a
decision to endorse the scheme will be made.

8.1.6 In the case where the Director of the Global Body finds that a certification scheme does not
conform, the applicant is informed. The applicant can then either revise the scheme and apply
again or appeal to the Board of Directors.

8.1.7 If endorsed the scheme will be permitted to use the GFSI logo, in accordance with the
requirements of Annex 6. This will be announced on the GFSI web page.

8.1.8 Minor alterations to an approved scheme will need to be submitted to the GFSI secretariat so
these can be assessed to ensure continuing compliance with the Key Elements. The Expert

Guidance Document First Edition 18 October 2001 22

 Committee is empowered to approve minor alterations on behalf of the Director of the Global
Body. Major alterations will need to be approved by the Director as before.

8.1.9 Each applicant is responsible for meeting the costs incurred by the assessment process.

8.1.10 The GFSI needs to ensure that the scheme meets the Key Elements. As the scheme will need to
be implemented by certification bodies accredited by a national accreditation service, it is up to the
applicant to ensure that the scheme is capable of meeting any of its requirements.

8.2 Procedure for logo use

8.2.1. PURPOSE
The purpose of this procedure for logo use is to establish the rules which specify who the owner and
governor of the logo is, who has the right to use the GFSI logo and trademark, what kind of claims are
included in the logo, in what kind of communication the logo can be used and what the specifications
are as regards the reproduction of the GFSI logo in printed and published form. The logo shall not be
used on any product, product packaging or advertising.

8.2.2. DEFINITION OF THE GFSI LOGO COVERAGE

The GFSI logo is designed to show compliance with a GFSI endorsed food safety standard. It shall
therefore only be used on endorsed standards and certificates issued under such a standard, provided
all requirements in this document are met.

8.2.3. OWNERSHIP AND USAGE OF THE LOGO

The GFSI logo is copyright material and is a registered trademark, owned by the GFSI Global Body.
The initials “GFSI” are covered by copyright and are registered. Unauthorised use of this copyright
material is prohibited and may lead to legal action. The usage of the GFSI logo is regulated and
governed by the GFSI Global Body. A fee for logo usage may be levied in accordance with Article …
of the Statutes of the GFSI Global Body.

8.2.4. LOGO USERS

Three categories of logo users are identified:

Category 1.
Standard owners are permitted to use the logo on their standards, once endorsed under the
requirements in this document.

Category 2.
Certifying bodies are permitted to use the logo on certificates issued under the requirements of an
endorsed standard.

Category 3.
Organisations and other bodies that are willing to promote or advertise the GFSI scheme for
educational purposes only and are permitted to do so by the GFSI Global Body.

8.2.5. GFSI REGISTRATION AND CODING SYSTEM

Register of Logo Users
It is the GFSI Global Body’s responsibility to keep an up-to-date register of all the on- and off- product
logo users in different countries.

Guidance Document First Edition 18 October 2001 23

8.2.6. LOGO USAGE FEE
The fee for the use of the logo is €100 per annum.

8.2.7. MONITORING AND REPORTING

The GFSI logo usage is subject to monitoring carried out by the GFSI Global Body, an accreditation
body or an accredited certification body.

8.2.8 SANCTIONS
In case of unauthorised use of the logo, the Global Body preserves right to claim damages.

Guidance Document First Edition 18 October 2001 24

 Annex 1
KEY ELEMENT

GOOD AGRICULTURAL
PRACTICES, (GAP)

GOOD MANUFACTURING
PRACTICES, (GMP)

GOOD DISTRIBUTION
PRACTICES (GDP)

Guidance Document First Edition 18 October 2001 25

 Annex 1 – KEY ELEMENT GOOD AGRICULTURAL PRACTICES, GOOD
MANUFACTURING PRACTICES, GOOD DISTRIBUTION PRACTICES

The following Good Agricultural Practices (GAP), Good Manufacturing Practices (GMP), or Good
Distribution Practices (GDP) are an example of how they could be developed under the requirement of
the related Key Element (Chapter 6.2).

Facility Environment

GAP
• Facility should be appropriate for the purpose
• Uncontrolled sewage water flow into irrigation facilities and other water basins should be
prohibited.

GMP
• Adequate security arrangements should be in place
• Site boundaries should be clearly defined
• Pest control of the periphery should be in place
• Adequate drainage should be in place

GDP
• Adequate security arrangements should be in place
• Site boundaries should be clearly defined
• Pest control of the periphery should be in place
• Adequate drainage should be in place

Local Environment

GAP
• All new sites should be risk assessed for environmental pollutants and flooding
• Periodic assessment of potential food safety impact from and to local environment should be
performed

GMP
• All new sites should be risk assessed for environmental pollutants and flooding
• Periodic assessment of potential food safety impact from and to local environment should be
performed

GDP
• All new sites should be risk assessed for environmental pollutants and flooding
• Periodic assessment of potential food safety impact from and to local environment should be
performed

Facility Layout and Product Flow

GAP
• Not Applicable

Guidance Document First Edition 18 October 2001 26

GMP
• Process flow should be logical and a one way flow system
• High/ low risk production areas should be suitably segregated
• Process flow should be designed to prevent contamination
• There should be segregated equipment washing facilities
• On site laboratory, where there is a potential food safety risk, should be sited away from
production areas

GDP
• Process flow should be logical
• Process flow should be designed to prevent contamination

Fabrication

GAP
Not Applicable

GMP
• Design and construction to minimise accumulation of dirt/debris should be in place
• Walls, floors and ceilings should have easy access and be easy to clean and impervious
• False ceilings should have adequate access to void for cleaning and pest management
• Adequate covered drainage should be in place, which flows away from high risk areas
• Lights should be protected, preferably glass should be absent
• Windows in production areas to be avoided but where present should be protected and secured if
designed to be opened
• Air should be filtered where necessary
• Pressure differentials should exist between high and low risk production areas
• Adequate ventilation should be in place to prevent condensation
• Adequate dust control where necessary
• Adequate lighting should be provided
• External doors linked to production areas need to be close fitting and adequately proofed

GDP
• Design and construction to minimise accumulation of dirt/debris should be in place
• Walls, floors and ceilings should be easy to clean and impervious
• Adequate covered drainage should be in place
• Lights should be protected, preferably glass should be absent
• Windows to be avoided but where present should be protected and secured if designed to be
opened
• Adequate lighting should be provided
• External doors should be close fitting and adequately proofed

Equipment

GAP
• Equipment should be designed for purpose intended and easily cleaned
• Condition of equipment should be frequently assessed

Guidance Document First Edition 18 October 2001 27

GMP
• Equipment should be designed for the purpose intended and easily cleaned
• Equipment should be sited to allow ease of access for cleaning and maintenance
• Condition of equipment should be frequently assessed

GDP
• Equipment should be designed for purpose intended and easily cleaned
• Equipment should be sited to allow ease of access for cleaning and maintenance
• Condition of equipment should be frequently assessed

Maintenance

GAP
• Planned maintenance programme should be in place
• Contractors and in-house maintenance teams should be aware of and adhere to company hygiene
standards

GMP
• Planned maintenance programme should be in place
• Contractors and in-house maintenance teams should be aware of and adhere to company hygiene
standards

GDP
• Planned maintenance programme should be in place
• Contractors and in-house maintenance teams should be aware of and adhere to company hygiene
standards

Staff Facilities

GAP
• Toilets should be available

GMP
• Staff facilities should be suitably sited for direct entry to production areas
• Adequate lockers/storage facilities should be provided
• Adequate hand wash facilities should be provided
• Appropriate protective clothing, footwear and head gear should be provided
• Rest areas and catering facilities should be provided
• Smoking should only be permitted in designated areas
• Toilets should be available, but not open directly into production areas
• Entry to high risk production areas should be via a specifically designated changing facility and
follow specified procedures

GDP
• Adequate lockers/storage facilities should be provided
• Adequate hand wash facilities should be provided
• Appropriate protective clothing, footwear and head gear should be provided
• Rest areas and catering facilities should be provided
• Smoking should only be permitted in designated areas

Guidance Document First Edition 18 October 2001 28

• Toilets should be available but not open directly into warehouse areas

Foreign body/ Chemical Contamination Risk

GAP
• Chemicals used on mechanical equipment should be managed and controlled

GMP
• Systems to control hazards should be in place
• Metal detection should be in placewhere there is risk
• If metal detector is used, it should have automated rejection into a locked container.
• Issue of knives/blades should be controlled and their condition regularly checked
• Glass control and breakage procedures should be in place
• Glass register should be available and inspected appropriate to risk
• Filters and sieves should be inspected regularly
• Maintenance sign off procedures should be in place
• Incoming goods should be inspected based on risk of contamination
• Rework should be controlled
• Chemicals should be stored in a secure area
• Chemicals should be used by trained personnel
• Where feasible, wood should be avoided in production areas
• All measures in place should be carried out at an appropriate frequency and fully documented

GDP
• Systems to control hazards should be in place
• Glass control and breakage procedures should be in place
• Glass register should be available and inspected appropriate to risk
• Maintenance sign off procedures should be in place
• Incoming goods should be inspected based on risk for contamination risks
• Chemicals should be stored in a secure area
• Chemicals should be used by trained personnel
• All measures in place should be carried out at an appropriate frequency and fully documented

Housekeeping, Cleaning and Hygiene

GAP
• Where relevant cleaning schedules and records should be in place
• Chemicals used should be appropriate for the purpose intended

GMP
• Cleaning schedules and records should be available
• Chemicals used should be appropriate for the purpose intended
• Hygiene inspections should be carried out and recorded
• Methods for verification of cleaning and corrective action procedures should be in place
• Where appropriate, cleaning equipment should be clearly identified and segregated

GDP
• Cleaning schedules and records should be available in place

Guidance Document First Edition 18 October 2001 29

• Chemicals used should be appropriate for the purpose intended
• Hygiene inspections should be carried out and recorded

Water Quality Management

GAP
• Potable water for post harvest washing should be available

GMP
• Potable water should be used and where appropriate checked for contaminants at an appropriate
frequency
• Adequate ventilation to minimise condensation build up should be in place
• Quality of ice, when used in processing, should be managed to prevent cross-contamination

GDP
• Not Applicable

Waste Management

GAP
• Waste should be controlled to prevent contamination of water and soil
• A programme for the adequate disposal of waste and chemical containers should be in place

GMP
• Systems should be in place to minimise waste
• Waste management should be effective
• External waste containers should be covered and removed at appropriate frequencies
• Waste containers for internal and external purposes should be clearly identified and cleaned
regularly

GDP
• Systems should be in place to minimise waste
• Waste management should be effective
• External waste containers should be covered and removed at appropriate frequencies

Pest Control

GAP
• The effect of chemicals used in previous harvests on soil and water should be assessed
• Pest control should be carried out by a reputable organisation or by trained in-house personnel

GMP
• Pest control should be carried out by a reputable organisation or by trained in-house personnel
• Inspections should include the periphery and internal and external buildings
• A bait map should be available
• Inspections should be carried out to a frequency based on risk.
• Inspections, recommendations and corrective action should be documented
• Where appropriate correctly sited, permanently operational electric fly killers should be in place
• All incoming goods should be inspected for pest infestation

Guidance Document First Edition 18 October 2001 30

• The building should be adequately proofed

GDP
• Pest control should be carried out by a reputable organisation or by trained in-house personnel
• Inspections should include the periphery and internal and external buildings
• A bait map should be available
• Inspections should be carried out to a frequency based on risk.
Inspections, recommendations and corrective action should be documented
• Where appropriate correctly sited, permanently operational electric fly killers should be in place
• All incoming goods should be inspected for pest infestation
• The building should be adequately proofed

Personal Hygiene

GAP
• Documented and trained hygiene standards, based on risk should be in place
• Adequate covering of cuts, grazes and boils should be in place
• Adequate hand washing should be required

GMP
• Documented and trained hygiene standards, based on risk, should be in place for all persons
entering the facility and should include:
− Hand washing
− Cuts, grazes and boils
− Dedicated smoking areas
− Eating and drinking in segregated areas
− Jewellery and watches
− Cosmetics
− Medical screening procedures
− Also see: protective clothing

Guidance Document First Edition 18 October 2001 31

GDP
• Documented and trained hygiene standards, based on risk, should be in place for all persons
entering the facility and should include:
− Hand washing (unwrapped products)
− Cuts, grazes and boils (unwrapped products)
− Dedicated smoking areas
− Eating and drinking in segregated areas
− Medical screening procedures (unwrapped products)
− Also see: protective clothing

Training

GAP
• Adequate training for the required skills should be established .

GMP
• Personnel should be trained commensurate with their responsibilities/activities
• Verification of training should be in place
• Review of training needs should be in place
• Training records should be kept
• Adequate supervision of new personnel should be in place

GDP
• Personnel should be trained commensurate with their responsibilities/activities
• Verification of training should be in place
• Review of training needs should be in place
• Training records should be kept
• Adequate supervision of new personnel should be in place

Protective Clothing

GAP
• When applicable, appropriate protective clothing should be provided for personnel

GMP
• Appropriate protective clothing should be provided for personnel, contractors and visitors
• Clean protective clothing should be used and changed at an appropriate frequency
• Protective clothing should be hygienically laundered
• Protective clothing should be designed to prevent product contamination
• Captive footwear should be worn in high risk production areas

GDP
• Appropriate protective clothing should be provided for personnel, contractors and visitors
• Clean protective clothing should be used and changed at an appropriate frequency
• Protective clothing should be hygienically laundered internally or by an approved contractor

Cross Contamination Risks

Guidance Document First Edition 18 October 2001 32

GAP
• Cross-contamination by extraneous packaging should be avoided

GMP
• There should be separation of raw and cooked products and utensils in high/low risk production
areas
• Nuts and other allergens should be identified and controlled to prevent cross contamination
• Rework should be controlled

GDP
• Not Applicable

Segregation

GAP
• Products types should be segregated to avoid cross contamination risks

GMP
• Products types should be segregated to avoid cross contamination risks
• There should be quarantine area for all reject/on hold products

GDP
• Products types should be segregated to avoid cross contamination risks
• There should be quarantine area for all reject/on hold products

Stock Management

GAP
• Where appropriate availability of health certificates for purchased nursery stock
• There should be control of harvested crop to ensure correct rotation

GMP
• Raw materials, work in progress, packaging and finished goods should be adequately labelled to
allow effective stock rotation based on first in first out principle
• Raw materials, work in progress, packaging and finished goods should be checked for micro-
biological contamination to be within agreed levels

GDP
• Products should be despatched on a first in first out principle

Medical Screening

GAP
• When appropriated a medical screening procedure should be in place for employees and
contractors.
• Where appropriate sickness reporting and return to work procedure should be in place

Guidance Document First Edition 18 October 2001 33

GMP
• A medical screening procedure should be in place. This should also apply to contractors and
visitors
• Where appropriate sickness reporting and return to work procedure should be in place

GDP
• A medical screening procedure should be in place. This should also apply to contractors and
visitors
• Where appropriate sickness reporting and return to work procedure should be in place

Veterinary Medicine

GAP
• The drugs utilized should be appropriate for the treatment/control required and used in the
prescribed quantities
• Drugs that are banned in the destination country should not be used
• Protection against diseases and pests should be achieved with minimal amount of drugs

GMP
• Not Applicable

GDP
• Not Applicable

Pesticide/ Herbicide/ Fungicide Control

GAP
• Integrated Crop Management techniques should be in place to minimise chemical use
• When appropriate training for the admission and use of pesticides, herbicides and fungicides
should be in place

GMP
• Not Applicable

GDP
• Not Applicable

Post Harvest Treatment

GAP
• The chemicals utilized should be appropriate for the treatment/control required.
• Potable water should be used.

GMP
• Not Applicable

GDP
• Not Applicable

Guidance Document First Edition 18 October 2001 34

Feedstuff

GAP
• Materials not released for human consumption should be avoided
• Fresh ingredients should be heat treated before use
• The composition of feed should be regularly assessed

GMP
• Not Applicable

GDP
• Not Applicable

Guidance Document First Edition 18 October 2001 35

 Annex 2

The principles of the

HACCP system and
guidelines for its
application

Guidance Document First Edition 18 October 2001 36

 Annex 2 –The principles of the HACCP system and guidelines for its application

I. Principles of the HACCP system

The HACCP system consists of the following seven principles:

1. Conduct a hazard analysis.

2. Determine the Critical Control Points (CCPs).
3. Establish Critical Limits.
4. Establish a system to monitor control of the CCP.
5. Establish the corrective action to be taken when monitoring indicates that a particular CCP is not
under control.
6. Establish procedures for verification to confirm that the HACCP system is working effectively.
7. Establish documentation concerning all procedures and records appropriate to these principles and
their application.

II. Guidelines for the application of the HACCP system

The application of HACCP principles consists of the following tasks.

1. Assemble HACCP team

The food operation should assure that the appropriate product specific knowledge and expertise is
available for the development of an effective HACCP plan. Optimally, this may be accomplished by
assembling a multidisciplinary team. Where such expertise is not available on site, expert advice
should be obtained from other sources. The scope of the HACCP plan should be identified. The scope
should describe which segments of the food chain is involved and the general classes of hazards to be
addressed (e.g. does it cover all classes of hazards or only selected classes.
2. Describe product

A full description of the product should be drawn up, including relevant safety information such as:
composition, physical/chemical structure (including Aw, pH, etc.), microcidal/static treatments (heat-
treatment, freezing, brining, smoking, etc.), packaging, durability and storage conditions and method
of distribution.

3. Identify intended use

The intended use should be based on the expected uses of the product by the end user or consumer. In
specific cases, vulnerable groups of the population, e.g. institutional feeding, may have to be
considered.
4. Construct flow diagram
The flow diagram should be constructed by the HACCP team. The flow diagram should cover all steps
in the operation. When applying HACCP to a given operation, consideration should be given to steps
preceding and following the specified operation.

5. On-site confirmation of flow diagram

The HACCP team should confirm the processing operation against the flow diagram during all staged
and hours of operation and amend the flow diagram where appropriate.

Guidance Document First Edition 18 October 2001 37

 6. List all potential hazards associated with each step, conduct a hazard analysis, and
consider any measures to control identified hazards.
(see Principle 1)

The HACCP team should list all of the hazards that may reasonably expected to occur at each step
from primary production, processing, manufacture, and distribution until the point of consumption.

The HACCP team should next conduct a hazard analysis to identify for the HACCP plan which
hazards are of such a nature that their elimination or reduction to acceptable levels is essential to the
production of safe food.

In conducting the hazard analysis, wherever possible the following should be included:
• the likely occurrence of hazards and severity of their adverse health effects;
• the qualitative and/or quantitative evaluation of the presence of hazards;
• survival or multiplication of microorganisms of concern;
• production or persistence in foods of toxins, chemicals or physical agents;
• conditions leading to above.
•
The team must then consider what control measures, if any, exist which can be applied for each
hazard.

More than one control measure may be required to control a specific hazard(s) and more than one
hazard may be controlled by a specified control measure.

7. Determine Critical Control Points

(see Principle 2)

There may be more than one CCP at which control is applied to address the same hazard. The
determination of a CCP in the HACCP system can be facilitated by the application of a decision tree
(e.g. Diagram 2), which indicates a logic reasoning approach. Application of a decision tree should be
flexible, given whether the operation is for production, slaughter, processing, storage, distribution or
other. It should be used for guidance when determining CCPs. This example of a decision tree may not
be applicable to all situations. Other approaches may be used. Training in the application of the
decision tree is recommended.

If a hazard has been identified at a step where control is necessary for safety, and no control measure
exists at that step, or any other, then the product or process should be modified at that step, or at any
earlier or later stage, to include a control measure.

Step 8: Establish critical limits for each CCP

(see Principle 3)

Critical limits must be specified and validated if possible for each critical control point. In some cases
more than one critical limit will be elaborated at a particular step. Criteria often used include
measurements of temperature, time, moisture level, pH, Aw, available chlorine, and sensory
parameters such as visual appearance and texture.

9. Establish a monitoring system for each CCP

Guidance Document First Edition 18 October 2001 38

 (see Principle 4)

Monitoring is the scheduled measurement or observation of a CCP relative to its critical limits. The
monitoring procedures must be able to detect loss of control at the CCP. Further, monitoring should
ideally provide this information in time to make adjustments to ensure control of the process to prevent
violating the critical limits. Where possible, process adjustments should be made when monitoring
results indicate a trend towards loss of control at a CCP. The adjustments should be taken before
deviation occurs. Data derived from monitoring must be evaluated by a designated person with
knowledge and authority to carry out corrective actions when indicated. If monitoring is not
continuous, then the amount or frequency of monitoring must be sufficient to guarantee that the CCP is
in control. Most monitoring procedures for CCPs will need to be done rapidly because they relate to
on-line processes and there will not be time for lengthy analytical testing. Physical and chemical
measurements are often preferred to microbiological testing because they may be done rapidly and can
often indicate the microbiological control of the product. All records and documents associated with
monitoring CCPs must be signed by the person(s) doing the monitoring and by a responsible reviewing
official(s) of the company.

10. Establish corrective actions

(see Principle 5)

Specific corrective actions must be developed for each CCP in the HACCP system in order to deal
with deviations when they occur.

The actions must ensure that the CCP has been brought under control. Actions taken must also include
proper disposition of the affected product. Deviation and product disposition procedures must be
documented in the HACCP record keeping.

11. Establish verification procedures

(see Principle 6)

Establish procedures for verification. Verification and auditing methods, procedures and tests,
including random sampling and analysis, can be used to determine if the HACCP system is working
correctly. The frequency of verification should be sufficient to confirm that the HACCP system is
working effectively. Examples of verification activities include:

• Review of the HACCP system and its records;

• Review of deviations and product dispositions;
• Confirmation that CCP's are under control.
•
Where possible, validation activities should include actions to confirm the efficacy of all elements of
the HACCP plan.

12. Establish Documentation and Record Keeping

(see Principle 7)

Efficient and accurate record keeping is essential to the application of a HACCP system. HACCP
procedures should be documented. Documentation and record keeping should be appropriate to the
nature and size of the operation.

Guidance Document First Edition 18 October 2001 39

Documentation examples are:
• Hazard analysis;
• CCP determination;
• Critical limit determination.

Record examples are:

• CCP monitoring activities;
• Deviations and associated corrective actions;
• Modifications to the HACCP system.

Guidance Document First Edition 18 October 2001 40