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An ABC Guide on
Food Safety
Management
SysteDls

June 2007
 QUALITYGuide

June 2007

An ABC Guide on
Food Safety
Management
Systems

This is the second in (I series of booklets produced

by the Quality Programme. as a guide to
understanding the role and importance of relevant
food safety and quality issues.

Produced in the framework of the MEDA Project:

Strengthening Quality Management, Capabilities and Infrastructure
in Lebanon - QUALEB, the Quality Programme, hosted at the
Ministry of Economy & Trade - Europe Aid/117725/D/SV/LB
Edited by the Quality Programme hosted at the Ministry of Economy & nadc . Lebanon
,\zarieh Building - Block 0 I - 8 th Floor - Down Town Beirul

T +961 I 982 357 +961 I 970879 • F +96 I I 982 299 • www.qualcl).org

© QUALEB, The Quality Programme

 TABLE OF CONTENTS
An ABC Guide
on Food Safety Management Systems

I • List of abbreviations p.6

2 • References to Terminology p.7

3 • ABC Guide on Food Safety Management Systems

PART I - Summary of HACCP (HaZard Analysis
Critical Control Points) p. 12

4 • ABC Guide on Food Safety Management Systems

PART 2 - Summary of ISO 22000 Food Safety
Management Systems p.24

5 • Related websites p.35

1 - LIST OF ABBREVIATIONS

• BRC British Retail Consortium

• CIES Global Food Business Forum

• EHEDG European Hygienic & Engineering

Design Group

• Eurepgap European Retailer Produce working group­

Good Agricultural Practice

• FAO Food & Agriculture Organisation

• GAP Good Agriculture Practices

• GMP Good Manufacturing Practices

• GFSI Global Food Safety Initiative

• HACCP Hazard Analysis Critical Control Points

• IFS International Food Standard

• IFIC International Food Information Council

• RASH Rapid Alert System for Food and Feed (European Union)
·WHO World Health Organisation

• WTO World Trade Organisation

• IAF International Accreditation Forum

• ISO International Organisation for Standardisation

• PRP's Pre-Requisite Programmes

• OPRP's Operational Pre-Requisite Programmes

• SPS San itary and Phytosan itary Measures

• SQF Safe Quality Food

• UNIDO United Nations Industrial Development Organisation

• WFSO World Food Safety Organisation

 2 - REFERENCES TO TERMINOLOGY

• Allergens 3-A - Allergens are identified as food

safety hazards and must be considered in the Hazard
Analysis. Sanitary Standards, Inc. (3-A 551) is a non-profit
association (US based) representing equipment manufacturers,
processors, regulatory sanitarians and other public health
professionals. Through many decades of co-operation, these groups
have established a comprehensive inventory of 3-A Sanitary Standards
and 3-A Accepted Practices, now known around the world for dairy and

food processing equipment and systems

• Benchmark - Benchmarked Food Safety Standards by CIES . The C1ES has 4

bench marked standards (BRC, IFS , the Dutch Standard and the SQF 2000),
along with an additional standard for primary producers

• BRC - British Retail Consortium - The British Retail Consortium has developed
the Technical Standard, which is a Checklist, for those companies supplying
Retailer branded food products. The Standard has been developed to assist
Retailers in the fulfillment of their legal obligations and protection of the
consumer, by providing a common basis for the inspection of companies
supplying retailer branded food products. (www.brc.org.uk)

• CE - Conformite Europeenne, a marking on products indicating compliance

with European Directives

• CBI - Centre for the promotion of imports from developing countries into the
EU. Through the access guide (www.cbi.nilaccesguide). the CBI provides the
most recent EU information on legislation regarding imports into the EU

• CIAA - Confederation of the food and drinks industries in the EU

• Codex Alimentarius - A code of food standards for all nations, developed by

the FAO and WHO. The Codex Alimentarius Commission was created in 1963
to develop food standards, guidelines and related texts such as codes of
practice under the Joint FAOIWHO Food Standards Programme. The main
purposes of this Programme are the protection and health of consumers and
ensuring fair trade practices in the food trade and promoting co-ordination of
all food standards work undertaken by international governmental and non­
governmental organisations 0
 • CIES - The Global Food Business Forum is the only independent global food
business network. It serves the CEOs and senior management of 175 retail and 175
supplier member companies in addition to their subsidiaries in over 150 countries

• Certification - ISO Definition of certification

Definition 1

"With certification, a company gives notice, with justified confidence, by

means of a formal statement that a system or a product is in conformance with,
respectively, a predefined standard or specification"
Definition 2
"A procedure by which accredited certification bodies, based on an auuit
provide written or equ ivalent assurance that food control systems conform to
requ irements"

• Eurepgap - The objective of EUREP, which is made up of leading European

food-retailers, is to raise standards for the production of fresh fruit and
vegetables. The prepared document (Checklist) sets out a framework for Good
Agricultural Practice (GAP) on farms, which defines essential elements for the
development of best-practice for the global production of horticultural
products (e.g. fruits, vegetables, potatoes, salads, cut flowers and nursery stock)

• EFSA - The European Food Safety Authority (EFSA) is the keystone of European
Union (EU) risk assessment regarding food and feed safety. In close
collaboration with national authorities and in open consu Itation with its
stakeholders, EF5A provides independent scientific advice and clear
communication on existing and emerging risks

• EC - European Commission

• EHEDG - European Hygienic Engineering & Design Group

Faults in hygienic engineering could have a negative impact on food safety at
the point of consumption - EHEDG provides guidance on the hygienic
engineering aspects of manufacturing of safe and wholesome food. EHEDG's
scope of work focuses on hygienic engineering for food manufacturing
establishments such as equipment and building design and clean ability

8
• EU Guidance document The guidance document explains the implementation
of procedures based on HACCP and facilitation of the implementation of
HACCP principles in the retail food business, as required by EU regulation
852/2004 hygiene of food stuff
http://europa.eu.int/comm/food/food/biosafety/hygienelegislation/guidance_d
oc_haccp_en.pdf

• EU - European Union, made of 27 countries, 490 million people, is a family

of democratic countries commited to working together for peace and prosperity

• FAO - Food & Agriculture Organisation

• FMI - The Food Marketing Institute (FMI) The SQF Programme is owned by
the Food Marketing Institute (FMI) in Washington,DC, USA. At the request of
its retail members, FMI acquired SQF so they could utilise one programme that
meets their requirements and at the same time provides efficiencies for
suppliers. SQF is recognised by the Global Food Safety Initiative (GFSI) as
conformi ng to the highest international standards and uti Iises protocols
recognised by the International Accreditation Forum

• GFSI - Global Food Safety Initiative (GFSI) ClES has facilitated the initiative to
enhance food safety, ensure consumer protection, strengthen consumer
confidence and set requirements for food safety schemes and improve cost
efficiency throughout the food supply chain. Following their lead, the Global
Food Safety Initiative (GFSI) was launched in May 2000. It is based on the
principle that food safety is a non-competitive issue, as any potential problem
arising may cause repercussions in the whole sector

• HACCP - Hazard Analysis & Critical Control Points

• Hazards - HACCP identifies 3 types of food safety hazards with the potential to
cause an adverse health affect: micro biological, physical and chemical

• GMP - Good Manufacturing Practice is a set of regulations, codes, and

guidelines for the control and management of manufacturing and quality
control testing of ingredients and products, especially in the areas of food,
pharmaceutical and medical devices

9
 • IFS - The International Food Standard (IFS) was created by the Federations of
German Distributors (after which it was supplemented by French distributors)
to make possible a systematic and uniform evaluation of food product
suppliers. The IFS standard is based on the philosophy of the ISO 9001 :2000
standard. The IFS standard (a Checklist similar to BRC ) is primarily concerned
with the setting up of the HACCP system

• IFIC - The International Food Information Council - IFIC Foundation is the

educational arm of IFIC. IFIC's mission is to communicate science-based
information on food safety and nutrition to health and nutrition professionals,
educators, journalists, government officials and others providing information
to consumers. IFIC is supported primarily by the broad-based food, beverage
and agricultural industries

• ITC - The technical co-operation agency of UNCTAD and WTO for

operational, enterprise-oriented aspects of trade

• IQ Net - International certification network - IQNet - The International

Certification Network is an Association composed of 38 certification/registration
bodies, with registered offices in Bern/Switzerland

• RASFF - Rapid Alert System for Food and Feed

http://ec.europa.eu/comm/food/food/rapidalert

• Rapid Alert - Rapid Alert (EU) is a system supporting the work of RASFF, to
provide the control authorities with an effective tool for exchange of
information, on measures taken to ensure food safety. Information is classified
under 2 headings of alert and information notifications

• Risk - The function of the probability or chance on an adverse health affect

and the severity of that affect (e.g.: discomfort, hospitalised or even death)

• Traceability - Identification of incoming material from the immediate supplier

and the initial distribution route of the end product to the final consumer

• PORTAL International Portal on Food Safety, Animal & Plant Health facilitates

10
 trade in food and agriculture products and supports the implementation of the
Sanitary and Phytosanitary (SPS) Agreement by providing a single access point
for authorised official international and national information across the sectors
of food safety, animal and plant health

• SQF 1000 - SQF (Safe Quality Food) 1000 code provides the primary
producer with a food safety and quality management certification programme,
tailored to the needs of the primary producer. The Food Marketing Institute
(FMI) in Washington, DC, acquired the rights to the SQF programme

• SQF 2000 - SQF (Safe Quality Food) 2000 code provides the food sector
(primary producers, food manufacturers, retailers, agents and exporters) with
a food safety and quality management certification programme tailored to
requirements which enables suppliers to meet regulatory, food safety and
commercial quality criteria in a cost effective manner. The Food Marketing
Institute (FMI) in Washington, DC, has acquired the rights to the SQF
programme

• Validation - Validation concerns obtaining evidence that the elements of the

HACCP system are effective. Validation ensures that the information
supporting the HACCP system is correct and is useful in the design stage.
Micro biological results can be used as validation to ensure that the control
measures are properly implemented

• Verification - Methods, procedures, tests, reviews and other evaluations,

additional to those in monitoring, to determine compliance with the HACCP
system. Verification is carried out at planned intervals and the frequency of
verification varies from a few days to monthly or even yearly activities

11
 3 - ABC GUIDE ON FOOD SAFETY

MANAGEMENT SYSTEMS

PART 1 SUMMARY OF HACCP

(HAZARD r\''\,IALYSIS CRITICAL CONTROL POINTS)

1) INTRODUCTION
2) BACKGROUND
3) LEGAlISATION IN EUROPE
4) FIELD OF APPLICATION

5) THE HAZARDS
(Microbiological hazards, Chemical hazards, Physical hazards)

6) FACTORS TO BE CONSIDERED
6.1 Motivation
6.2 Preparation
6.3 Commitment
6.4 Management
6.5 Training
7) IMPLEMENTING A HACCP SYSTEM
7.1 Assemble the HACCP team
7.2 Describe Product
7.3 Identify the intended use
7.4 Construct the Flow Chart(s) and Floorplan
7.5 Verify the Flow-Chart
7.6 List all hazards, carry out Risk Assessment
and take preventive measures
7.7 Apply HACCP decision tree
7.8 Establish target levels, tolerances and critical limits for each CCP
7.9 Establish a monitoring system for each CCP
7.10 Establish corrective actions
7.11 Complete verification of the system
7.12 Establish record keeping and documentation system
8) PROBLEMS OCCURRING DURING IMPLEMENTATION
9) CONCLUSIONS
10) RECOMMENDATIONS
11) REFERENCE lITERATU RE

12
1) INTRODUCTION
This document provides general background, a reference guide and
practical information about HACCP (Hazard Analysis Critical Control
Points).

2) BACKGROUND
HACCP was developed for the space programme of NASA, to prevent
any hazards, that could cause illness or injury during space flights. In
1971, the HACCP system was presented to the public for the first time
and was implemented in the food industry in the United States.

During the 70's and early 80's, the HACCP system was implemented
by a number of companies in the food industry. From these initial
experiences, it was concluded that the HACCP system is an approach
which helps to prevent micro-biological, chemical and physical
hazards and was therefore recommended by the Codex Alimentarius.

3) LEGALISATION IN EUROPE
In 1993, the EC-council established the EC-Directive 93/43/EC, in
which the member states commited to implementing Food
Regulations, where-by companies in the food industry are obligated
to implement the HACCP system in their organisations.

In subsequent years, the regulations have becme obligatory in

European Countries, in conformance with the EC Directive 93/43/EC,
which was replaced by the Regulation 852/2004 of the European
Parliament and of the Council of 29 April 2004 on the Hygiene of
Foodstuffs. Today all European companies within the food industry
are obliged to have a quality system based on the HACCP principles.

4) FIELD OF APPLICATION
The objective of the HACCP system is to guarantee food safety, by
implementation of a quality system, which covers the complete food
production chain, from the primary producer up to the final consumer
of the product. This means that the Food Manufacturer is not only
responsible for Good Manufacturing Practices within his organisation,
but must also deal with possible hazards which can occur before
and/or after this step. For example, if there is a possibility that the raw
materials are exposed to certain hazards, then the manufacturer is
responsible to check if and how the supplier of the raw materials
controls these hazards.
13
 On the other side of the chain, the manufacturer must supply the
consumer with sufficient information about handling of the product,
to avoid hazards which can occur during cooking and/or storage of
the product. The HACCP system is principally focused on food safety,
but through th is system, other important aspects such as control Iing
quality and financial features of the product/process, can be monitored
very effectively.

5) THE HAZARDS
Regarding Food Safety, hazards can be defined In the following
categories:
• Microbiological hazards
• Chemical hazards
• Physical hazards

Below are several examples for each hazard category, to explain and
understand the wide range of hazards, which can occur during the
manufacturing of a food product.

Miuobiological hazards
Food can be infected by toxic pathogenic or infectious pathogenic
micro-organisms, in all stages of the food chain. Whether the
contamination of micro-organism will become a hazard depends on
several circumstances during the production of product/material.
These can be related to:
• Hygiene circumstances during production
• Presence of ki II ing-step duri ng production
• Conditions in the product/material regarding possible micro­
biological growth
• Other biological hazards

Other possible hazards of biological origin are insects, rodents and

other vermin, which can contaminate the raw material and/or product
during cultivation, harvesting, storing and/or processing of the
material and lor product

Chemical hazards
The chemical hazards can be divided into 3 categories:
• Intrinsic chemicals, which are already naturally in the food,
14
 e.g. Haemaglutinins in red kidney beans, poisonous mushrooms,
Japanese Fu-gu fish
• Added materials which might cause hazards for the consumer
due to overdoses or reactions with other materials, e.g. Sodium
nitrite (curing agent nitrosamins), coloring agents, preservatives,
pesticides and fungicides
• Technical faults during cultivation, harvesting, transportation
and/or processing might contaminate the food with chemicals,
e.g. due to packaging materials containing poisonous material
in contact with food, cleaning agents, metals dissolving in
product and maintenance materials
Physical hazards
Physical hazards are divided into two basic categories:
• Intrinsic physical hazards which are in the food by nature,
e.g. bones in fish or meat
• Technical faults during cultivation, harvesting, transportation
and processing might cause contamination with physical
material like foreign bodies (metal, glass, plastic) in raw materials,
faulty packaging, engineering problems (nuts, bolts, etc.)

•
The food products belonging to the group of allergens (peanuts, cereals

containing gluten, nuts, eggs, milk, crustaceans, fish, soybeans, celerey,

mustrad, sesame seeds, sulphurdioxide and sulphites and products theroff)

must be considered as part of the Hazard Analysis.

6) FACTORS TO BE CONSIDERED
6.1 Motivation
The implementation of a HACCP system in the EU is mandatory under
Food Regulations, but if this is the only motivation to start
implemetating HACCP, a company will not get the best results from
the HACCP system. Other reasons for implementation include:
• Company policy on continuous quality improvement
• Total Commitment
• Customer requirements
• Guarantees regarding product liability
• Cost reduction and efficient management by a preventive
approach
Important Note: It is essential to see the implementation of HACCP
as a tool rather than an objective.
15
 6.2 Preparation
To follow the sequence of implementation, firstly implement the Pre
Requisites Programmes (PRP's), also called hygiene measures and
Good Manufacturing Practice, prior to starting with HACCP. The Pre
Requisite programme covers the following topics:

Personnel hygiene
• Layout of premises, including workspace and employee
faci Iities

~
• Construction and layout of buildings and associated facilities
• Supplies of utilities like water, energy, air etc.
",:;;" • Supporting services, including waste and waste disposal
,
• Suitability of equipment and its accessibility, maintenance
and preventive maintenance

iD
• Management of purchased raw materials, ingredients, chemical
utilities or supplies, like steam, water and ice, disposal of
waste and sewage along with handling of products (like
storage and transportation)
• Measures to prevent cross contamination
• Cleaning and sanitising
• Pest Control
Some aspects of PRP's and HACCP can be implemented
simultaniously (a gasoline forklift does not need to be replaced by a
forklift on batteries before continuation in implementing HACCP.

6.3 Commitment
To get the best results from the HACCP system, commitment has to be
demanded of all people within the organisation. Accordingly, each
person has to be trained in HACCP.

6.4 Management
Company management must establish a policy, which supports the
implementation and maintenance of the HACCP system.

Management is responsible for emphasising the importance of the

system. Accordingly, management should draw up a formal
'Declaration of Intent', in which the commitment of the management
is stated. This 'Declaration of Intent' is inserted in the HACCP manual
and communicated clearly to the employees. Company management
16
 is also responsible for the allocation of tasks related to the HACCP

system and for the availability of people and the relevant funding and

resources.

6.5 Training
All employees must be trained on hygiene issues and GMP (the PRP's)

and HACCP (make use of photographs showing Conformance and

Non Conformance hygiene and GMP situations with effective

examples and training material.)

It is important to ensure that the company has one or more competent

people to set-up such training programmes and to conduct the

training on the PRP's, and where necessary to appoint a training

officer, ensuring the participaion of Human Resources.

7) IMPLEMENTING A HACCP SYSTEM

The Codex Alimentarius, is an implementing system to be considered,

wh ich consists of 12 stages:

CODEX ALiMENTARIUS

1 •
Assemble the HACCP team
2 •
Describe product
3 •
Identify the intended use
4 •
Construct the flow chart
5 •
Verify the Flow-Chart
6 •
Conduct Hazard Analysis and Hazard Assessment
7 •
Apply HACCP decision tree
8 •
Establish target levels, tolerances and critical limits for
each CCP
9 • Establish a monitoring system for each CCP
10 • Establ ish corrective actions

12 E t bl" h d k .
11 • Complete verification of the system
: ddt t
Comment: the steps from 6 to 12 are the so called 7 principles of the
HACCP system. Steps 1 to 5 are the preliminary steps of the Hazard Analysis.

17
 7.1 Assemble the HACCP team
The Codex Alimentarius, for implementing the HACCP system,
recommends the use of multi disciplinary teams where knowledge is
pooled and practicable, helping to create commitment from all
members of the group

The HACCP team has the following responsibilities:

• Processing the implementation project
• Co-ordination between the different groups
• Implementation of the HACCP system
• On-going maintenance of the system
• Keeping consistent records of discussions and decisions agreed
• Providing the necessary information for all employees

'Quality starts with production': production managers, production

supervisors and key operators should be fully involved in the development
and implementation of HACCP, along wih the subteams.

Step 1 however, includes more: Terms of Reference and the Scope of

the System are included in the very first step.

For practical reasons, it is better to complete a simple HACCP system

first, rather than trying to be over ambitious. A simple system can be
expanded later, instead of starting with a complex system, which may
be never implemented or completed. The terms of reference should be
outl i ned clearly from the start.

Example: Company A is producing dairy products (pasteurised milk,

sour cream butter, yogurt and sour cream). The company receives raw
milk from farmers and distributes the products to various outlets in the
country and the company decides to implement HACCP. The HACCP
team decides to implement HACCP in the milk-reception, processing
and filling departments. At a later stage, it will be implemented in the
butter, yogurt and sour-cream manufacturing departments. The Terms
of Reference or Scope of the Plan is Milk-reception, the
manufacturing of Pasteurised milk up to Cold Storage stage.

18
7.2 Describe product
A fully detailed description is required e.g.: composition, processing,
packaging, technological details (pH, Aw, Salt %, etc.), method of
distribution, storage (i nternal/external), shelf-I ife, etc.. Th is product
analysis is needed to better understand the characterisicts of the
products, in order to carry out the Hazard Analysis and preparation of
technical information to be communicated to the customers.

7.3 Identify the intended use

Consumer usage and methodolgy must be analysed to determine if
there are any abuses during preparation/consumption by the
consumer. Target groups must be identified, so as to identify
particularly vulnerable consumers, like children or eldery persons.

7.4 Construct the Flow Chart

To visualise the Flow of the production process and to make the
process transparent, it is recommended to construct one or more Flow
Charts and a floorplan. The flow chart should include all processing
steps, starting with raw materials, up to and including the
preparation/product consumption, depending on the Terms of
Reference or Scope of the Plan.

Each step of the process should be determined, identifying which

conditions are important in relation to possible hazards. The Flow of
the product will be illustrated in a factory floor plan with an
equipment layout.

7.5 Verify the Flow-Chart

After the construction of the flow chart, every processing step, within
the control of the organisation, must be checked in practice, so non­
conformances of the chart and/or conditions are determined. It is
essential to pay attention to material inputs and outputs and to pay
attention to auxiliaries, rework, waste and even downtime.

Remark: It is necessary to make a small description of each process

step, including existing control measures and parameters applied and
at least explain the objective of the process-step. This information has
to be agreed upon in the HACCP team. At a later stage, while
applying the decision tree, the objective of the process step is already
laid down and this prevents unnecessary discussions.

19
 7.6 List all hazards, carry out Risk Assessment and take preventive
measures (principle 1)
All reasonable hazards must be determined at this step. To determine
a complete list of the relevant hazards, a brainstorming session should
be organised. It is important that all hazards are precisely stated ­
making reference to pathogenic bacteria is not sufficient, though the
specific pathogenic bacteria has to be noted. The HACCP team
conducts a Hazard Analysis, which includes the Hazard Assessment,
(to identify the hazards which must be eliminated or reduced to
acceptable levels, for the production of a safe food. Next to every
hazard, all control measures are identified within the process, to
prevent, eliminate or reduce hazards to an acceptable level. These
control measures belong to the so called Operational Pre Requisite
Programme (OPRP's), according to ISO 22000. Validation objective
evidence is obtained, to ensure that the elements of the HACCP
system are effective - using time/temperature charts for processing
and/or with microbiological results.

7.7 Apply HACCP decision tree (principle 2)

To identify the CCP's, the so-called CCP Decision Tree is used. All
hazards, as determined at step 6, must be evaluated by this CCP
decision tree. Common sense and a discussion amongst the HACCP
team members will eventually decide whether or not the process-step
is a CCP. Make sure that the arguments in the discussion around the
CCP are recorded and documented.

7.8 Establish target levels, tolerances and critical limits for each CCP
(principle 3)
It is essential to set values, targets or norms, target levels, tolerances,
control limits, warning levels or action limits and critical limits,
appropriate for the effective elimination of the hazard. These must be
formally established and specified. This may require some investigations
including quantifying the targets, target levels and critical limits,
which is not always so easily achieved e.g., how to quantify the
effectiveness of cleaning operations.

7.9 Establish a monitoring system for each CCP (principle 4)

The HACCP plan includes monitoring, corrections and corrective
action. Monitoring requires observations and whenever possible,
20
measurements made at each CCP, to ensure that critical limits are not
infringed and targets are maintained. Continuous monitoring is
advised and this process should be monitored closely at the most
likely poi nt of infringement.

7.1 0 Establ ish corrective actions (principle 5)

Correction and corrective actions must be identified for each CCP.
Correction systems must be developed to deal with the affected
product, should critical limits be infringed.

Corrective actions, preferab Iy adj ustments through ind icati ng

tolerance limits, should take place before critical limits are reached,
to bring the process back under control. Each correction and
corrective action should state: who/when/how should act and last but
not least, what actions will be taken with the effected product. To
register the non conformance incident, please apply the procedure
relating to 'Production Non Conformance Report'.

7.11 Complete verification of the system (principle 6)

It is important to verify that the procedures put into effect as part of
the HACCP process, are achieving the desired results or if not, that the
necessary actions are taken to correct the situation. These verification
activities may involve reviewing finished product testing, results on
various audits, review of consumer complaints and non conformance
reports after categorisation, review of sanitising results, validation of
target levels and critical limits. These verification activities must be
carried out periodically in a planned manner to ensure that the
HACCP system is maintained and effective.

The review of the HACCP system, as part of verification, is used to

determine whether the system is still appropriate to the process of
verification. Changes in the process, routing, layout and modification
to process equipment should be adapted in the HACCP system. The
frequency of review is laid down in the procedure of Verification.

7.12 Establish record keeping and documentation system (principle 7)

The Codex Alimentarius recommends that all HACCP documentation
and procedures are organised in a manual. The manual makes
reference to other manuals such as, the manual for product
21
 specifications. This will require proper documentation control and an
appropriate procedure to ensure that the data remains up-to-date. The
manual contains, next to information of each implementation step, a
Time & Event schedule for the subjects to be implemented.
Documentation is a firm requirement by ISO 22000. The table of
contents of the HACCP manual is based on ISO 22000.

8) PROBLEMS OCCURRING DURING IMPLEMENTATION

Potential problems during the implementation include:
• HACCP is introduced before the PRP's are in place. If
requirements related to PRP's are not attained at a sufficient
level, then it will be impossible to control all hazards which
may occur because of the inadequate situation
• HACCP has not sufficient commitment from top management
• HACCP is set up without the involvement and training of
personnel
• Inappropriate person appointed as chairman of the HACCP team
• Under-estimation of required time to implement HACCP, lack
of resources and/or knowledge
• HACCP concepts are not fully understood
• Changes in processing conditions are ignored
• Unimportant hazards are identified and too many CCP's are
introduced

9) CONCLUSION
HACCP is a very effective system to visual ise the processi ng of the
product, to identify potential hazards, to implement control and preventive
measures on these hazards and to have a plan of corrective action for
the identified CCP's. Most important of all is the documentation, necessary
for the entire process.

10) RECOMMENDATIONS
• Management Commitment is a firm requirement which must
be in place
• Staff and employees must be trained on time, especially on
the Pre Requisite Programmes, Hygiene measures and GMPs
• PRP's must be implemented and operational prior to starting
with HACCP - certain elements can be implemented simultaniously

22
 • Apply more than one Flow Chart, if necessary, by making use
of the connectors, rather than making complex Flow Charts
• Control and/or preventive measures have to be taken from the
cause of the hazard and not from the hazard itself - the
Hazard Analysis must include the column for causes
• Make use of multidisciplinary groups rather than one
permanent HACCP team
• Establish a time & event schedule and use this document as
a tool throughout the implementation
• Have procedures, working instructions and checklists
developed in an effective and user friendly way, according to
ISO standards
• Make the production employees accountable and responsible
for what they are doing, giving them the necessary authorisation
• Encourage and/or implement the process control to be carried
out by the production employees
• Pay specific attention to downtime, rework and waste material
• Appoint the appropriate person as chairman of the HACCP team

11) REFERENCE LITERATURE

• Codex AI imentarius CAC/RCP 1-1969, Rev. 4-2003
• Food Hygiene Basic Texts. ISBN 92-5-104619-0 FAO and
WHO 2001
• EC Regulation No 852/2004 of 29 April 2004 on the Hygiene
of Foodstuffs
• ISO 22000 Food safety management systems - Requirements
for any organisation in the Food Chain

23
 4 - ABC GUIDE ON FOOD SAFETY
MANAGEMENT SYSTEMS

PART 2 SUMMARY OF ISO 22000

FOOD SAFETY MANAGEMENT SYSTEMS
REQUIREMENTS FOR ORGANISATIONS
IN THE FOOD CHAIN

1) INTRODUCTION

2) WHY ISO 22000

3) REQUIREMENTS OF ISO 22000

4) WHAT ISO 22000 DELIVERS

5) PRE.REQUISITE PROGRAMMES (PRP's)

6) ISO 22000 CLAUSES

7) MANDATORY PROCEDURES

8) DETAilS OF THE CLAUSES AND MANDATORY PROCEDURES

9) REQUIRED DOCUMENTS AND PROCEDURES
10) OTHER ISO DOCUMENTS RElATED TO THE FOOD INDUSTRY
11) DEVElOPMENT OF ISO STANDARDS

24
1) INTRODUCTION
Over the years, many countries have developed HACCP standards
with different certification levels, subsequently implemented as
HACCP systems, based on these standards. Accordingly, standards
differ from country to country. However ISO 22000 Food Safety
Management requirements for organisations in the Food Chain,
have been developed specifically to harmonise with all the
individual standards.

ISO 22000 is the combined output of working group WG 8 food

safety management systems, ISO technical committee ISOfTC 34
food products, which was formally launched in September 2005.

Experts from 23 countries participated in the working group,

together with international organisations with liaison status. In
addition to the Codex Alimentarius Commission, these included the
Confederation of the Food and Drink Industries of the European
Union (C1AA), the C1ES/Global Food Safety Initiative and the World
Food Safety Organisation (WFSO). They were joined for the
development of ISOfTS 22003 by experts from the ISO committee
on conformity assessment, ISO/CASCO, the International Accreditation
Forum (IAF) and the IQ Net international certification network.

The ISO 22000 standard emphasises the certification requirements

for HACCP and will further contribute to the standardisation and
harmonisation of the HACCP systems worldwide. The standard
incorporates three requisite components:
• Requirements for pre requisites programmes including GMP
• Requirements for HACCP
• Requirements for implementing a management system with
a strong component of interactive communication along
the Food Chain

This ABC Guide on Food Safety Management Systems provides

background information on the reasons for the development of ISO
22000 and more precise details are provided in the ISO standard.

25
 2) WHY ISO 22000
Many HACCP standards have been developed internationally, for
example:
• India uses the Indian Standard - Food hygiene - Hazard
Analysis and Critical Control Points (HACCP) System and
guidelines for its application: ISO 15000 : 1998
• Singapore applies the Singapore Standard 444
• South Africa uses SASS 0330: Code of Practice for the
implementation of a HACCP system
• The Netherlands is using Requirements for a HACCP based
Food Safety System version September 2002
• Ukraine uses the 'National Standard of Ukraine 4161-2003'
Food Safety Management Systems
• Turkey uses the Turkish Standard TS 13001 (March 2003)
• Additionally, the FAOIWHO Codex Alimentarius HACCP
Code of Practice CAC/RCP 1-1969, Rev. 4-2003 has been
applied for certification

HACCP standards and certificates based on these standards, differ

substantially from one country to another. ISO 22000 has been
specifically developed to harmonise all of these individual standards.

It is applicable to all organisations, regardless of size, which are

involved in any aspect of the food chain and who want to implement
systems that consistently provide safe products. This means meeting
any requirements of ISO 22000 can be accomplished through the use
of internal and/or external resources.

3) REQUIREMENTS OF ISO 22000

ISO 22000 specifies requirements for a food safety management
system, where-by an organisation in the food chain needs to
demonstrate its ability, in controlling food safety hazards, in order to
ensure that food is safe at the time of consumption.

ISO 22000 specifies requirements to enable an organisation:

• To plan, implement, operate, maintain and update a food
safety management system aimed at providing products that,
according to their intended use, are safe for the consumer

26
 • To demonstrate compliance with applicable statutory and
regulatory food safety requirements
• To evaluate and assess customer requirements and demonstrate
conformity with those mutually agreed customer requirements
that relate to food safety, in order to enhance customer satisfaction
• To effectively communicate food safety issues to their suppliers,
customers and relevant interested parties in the food chain
• To ensure that the organisation conforms to its stated food
safety policy, to demonstrate such conformity to relevant
interested parties
• To seek certification or registration of its food safety
management system by an external organisation, or make a
self-assessment or self-declaration of conformity to ISO 22000

4) WHAT ISO 22000 DELIVERS

ISO 22000 delivers the following:
• The standard can be used as the basis of any food safety
management system, with or without 3rd party certification
• The standard includes requirements for addressing (assessing
and implementing) food safety concerns of customers (e.g.
retailers) and regulators
• The standard includes Prerequisite programmes (Hygiene and
GMP)
• HACCP ( Hazard Analysis) is included
• System management (ISO 9000 approach)
• Interactive communication along the food chains

5) PRE-REQUISITE PROGRAMMES (PRP's)

The following pre-requisites must be considered:
• Personnel hygiene
• Layout of premises, including workspace and employee
faci Iities
• Construction and layout of buildings and associated facilities
• Supplies of utilities like water, energy, air, etc.
• Supporting services, including waste and waste disposal
• The suitability of equipment and its accessibility, maintenance
and preventive maintenance

27
 • The management of purchased raw materials, ingredien_
chemical, utilities or supplies like steam water and ice
disposal of waste and sewage and handling of products dike
storage and transportation)
• Measures to prevent cross contamination
• Cleaning and sanitising
• Pest control

Pre-requisites should be documented and the documentation of the

pre-requisites depends largely on the size of the companies. The ISO
22000 is designed for both large companies but also for small
enterprises. Large companies are highly recommended to document
PRP's to faci Iitate verification purposes.

6) ISO 22000 CLAUSES

The main clauses of ISO 22000 are:
• Documentation requirements
• Management responsibi Iity
• Resource management
• Planning and realisation of safe products
• Verification, validation and improvement of the Food Safety
Management system

7) MANDATORY PROCEDURES
ISO 22000 identifies the following procedures which must be
documented:
• Documentation
• Records
• Corrections
• Corrective actions
• Recall (which includes traceability)
• Internal auditing

28
8) DETAILS OF THE CLAUSES AND MANDATORY PROCEDURES
The following is some of the more detailed information and clauses
for ISO 22000, where mandatory procedures are relevant:

8.1 Documentation requirements

Documents required by the food safety management system must be
controlled to ensure that all proposed changes are reviewed, prior
to implementation. This will help to determine the impact on food
safety and food safety management system. A documented procedure
(No.1) shall be established to define the controls needed.

Records must be established and maintained to provide evidence of

conformity to requirements and of the effective operation of the food
safety management system. Records s~al[ remain legible, readily
identifiable and retrievable. A document€d procedure (No.2) shall
be established to define the controls needed for the correction,
identification storage protection, retrieval, retention time and
disposition of records.

8.2 Management responsibility

Company top management shall provide evidence of their
commitment to the development and implementation of the food
safety management system and towards continually improving its
effectiveness.

Management responsibilities include the following:

• Management commitment
• Food safety policy
• Food safety management planning responsibility and authority
• Appointment of food safety team leader
• Communications which include:
* External communication
* Internal communication
• Emergency preparedness and response
• Management review
* Review input
* Review output

29
 8.3 Resource management
The organisation shall provide adequate resources for the establishment,
implementation, maintenance and updating of the food safety
management system. Resource management includes the following
subparagraphs:
• Human resources - training is a major component of resource
management
• Infrastructure
• Work environment

8.4 Planning and realisation of safe product

This clause refers more specifically to HACCP, details of which are not
covered in this booklet - see Guidance Document on HACCP principles (EU)
http://europa.eu.intlcomm/food/biosafety/hygienelegislation/guidanc
edochaccpen.pdf
The ISO 22000 standard is an audible standard and the HACCP
system has to comply with the information specified.

The company must plan and develop the processes needed, for the
production of safe products. The company must implement, operate
and ensure the effectiveness of the planned activities and any changes
to those activities. These actions incl ude the prerequisites as well as
the operational pre-requisites.

The planning and production of safe products covers the following

sub paragraphs:
• Pre-requisite programmes
• Preliminary steps to develop the hazard analysis include:
* The Food Safety team
* Raw materials and final product specifications and
their intended use
* Flow diagrams and description of the process steps
and control measures
• Hazard analysis
• Operational pre-requisite programmes
• The HACCP plan which includes:
* The critical control points (CCPs)
* Determination of critical limits for the CCPs
30
 * Monitoring system
* Actions to be implemented when monitoring results
exceeding critical limits
• Updating preliminary information and documents specifying
the pre-requisite programmes and the HACCP plan
• Verification planning
• Traceability system
• Control of non-conformities
* Corrections
The organisation must ensure that when critical
limits for the CCPs are exceeded, or there is a loss of
control of operational PRPs, the end products are
identified and controlled with regard to thei r use and
delivery. A documented procedure (No.3) shall be
established and maintained
* Corrective actions
• The organisation shall establish and maintain a documented
procedure (No.4) that specifies appropriate actions to
identify and eliminate the cause of the detected non
conformities, to prevent a recurrence and to bring the
process or system back into control after non-conformity
is encountered
* Handling of unsafe products
* Withdrawal or product recall
• To enable the complete and timely withdrawal of
implicated lots of end products that have been identified
as unsafe, the organisation must establish and maintain a
documented procedure (No.5) for notification to the
relevant interested parties (regulatory authorities, customers
and/or consumers)

8.5 Validation, verification and improvement of the Food Safety

Management Systems
The food safety team must plan and implement the processes
needed to validate control measure combinations and to verify and
improve the food safety management systems. Validation, verification
and improvement of the food safety management systems covers the
following sub paragraphs:

31
 • Validation of control measure combinations
• Control of monitoring and measuring
• Food safety management system verification/internal audit
• The organisation shall conduct internal audits at planned
intervals
• The responsibilities and requirements for planning and
conducting audits and for reporting results and
maintaining records shall be defined in a documented
procedure (No.6)
• Improvement
• Continual Improvement
• Food safety management updating

9) REQUIRED DOCUMENTS AND PROCEDURES

Next to mandatory procedures, the final ISO 22000 system contains
the following documents and records:
• Management of the pre-requisite programmes
• Characteristics and intended use of the end product
• The HACCP plan
• Product/process flow diagram
• Hazard identification
• Hazard analysis
• Selection of control measures
• Critical limits
• Corrective action records
• Correction records
• Internal audit records
• Cal ibration records
• Traceability records
• Raw material and ingredient records
• Evaluation and handling of potentially unsafe products or
nonconforming product
• Internal and external communication
• Management review
• Monitoring records for operational pre-requisite programmes
and HACCP plan
• Product withdrawal records
• Verification
• Training and knowledge records
• Agreements with external food safety experts
32
10) OTHER ISO DOCUMENTS RELATED TO THE FOOD INDUSTRY
The ISO 9001 :2000 standard can be appl ied for the Food Industry
however this is not a common practice as a single system for the
Food Industry. If used, it is recommended to be used together with
and after HACCP implementation to have a complete Quality
Management System.

Nowadays a single HACCP certificate or a single ISO 9001 :2000

certificate is not enough. It is essential to have components of both.
For this reason, ISO 22000 becomes the ideal standard, as ISO
22000 includes both the ISO 9001 :2000 and HACCP requirements.

The ISO 15161 :2001 standard provides guidelines on the application

of ISO 9001 :2000 for the food and drink industry. This guideline is
based on the ISO 9001 :2000 guideline and includes HACCP.
However this standard is not designed for certification, it is not an
auditable standard but rather a tool for the Food Industry to
implement ISO 9001 :2000 in combination with HACCP.

11) DEVELOPMENT OF ISO STANDARDS

ISO 22000 is one of a series of ISO documents. Presently, ISO is
working under TC 34 Food Products, for various new documents.
These standards will be known as the ISO 22000 family of
standards. Others incl ude:

• ISO 22001 - Guidelines on the application of ISO 9001 :2000

for the food and drink industry, which is a revision of ISO
15161:2001

• ISO 22002 - Quality management systems - Guidance on the

application of ISO 9002:2000 for crop production

• ISOITS 22003 - Food safety management systems ­

Requirements for bodies providing audit and certification of
food safety management systems, wi II give harmon ised
guidance for the accreditation (approval) of ISO 22000
certification bodies and define the rules for auditing a food
safety management system as conforming to the standard

33
 • ISOITS 22004 - Food safety management systems ­
Guidance on the application of ISO 22000:2005 was
published in November 2005 and provides information to
assist organisations including SMEs around the world

• ISO 22005 - Traceability in the feed and food chain ­

General principles and guidance for system design and
development, will be circulated as a draft international
standard

• ISO 22000 - Fitness Checker: this is a practical, easy-to­

use checklist designed to help SMEs to assess their
readiness for ISO 22000 certification, in being prepared in
partnership, with the International Trade Center (ITC)

34
 5 - RELATED WEBSITES

CIAA www.ciaa.be
Codex alimentarius www.codexalimentarius.net
CBI www.cbi.nl
CIES www.ciesnet.com
GFSI www.ciesnet.com
International Organization for Standardization (ISO) www.iso.org
Food and agricultural Organization (FAO) www.fao.org
World Health Organization (WHO) www.who.int
RASSF http://europa.eu.int/comm/food/food/rapidalert
EHEDG www.ehedg.org
EUREPGAP www.eurep.org
EFSA www.efsa.eu.int
IPCS www.who.int/pcs/
IQ net www.iqnet-certification.com
IARC www.iarc.fr
IFIC www.ific.org
IFS www.food-care.info
Portal www.ipfsaph.org/En/default.jsp
SQF www.sqfi.com
WFSO www.worldfoodsafety.org
British Retail Consortium www.brc.org.uk

ADDITIONAL USEFUL E-MAIL ADDRESSES

EU Basic Facts
http://europa.eu.int/comm/publicationslbooklets/eu~lanee/51/index_en.htm I

EU DG SANCO (Directorate General for Health and Consumer safety)

http://europa.eu.int/comm/index_en.html

EU Legal Documents
http://europa.eu.int/eur-lex/RECH_menu.do?ihmlang=en

Healthy Food for Europe's Citizens

http://europa.eu.int/comm/publicationslbooklets/move/20txt_en.pdf

From Farm to Fork - Safe Food for Europe's Consumers

http://europe.eu.i nt/comm/publ icationslbooklets/move/46/en .pdf

Food Rejected by FDA (US Food & Drugs Administration)

http://www.fda.gov/ora/import/default.html

Good Agricultural Practices (GAP)

http://www.fao.orglagimagazine/GAp-vL.-June02.pdf 35
 EU Food Safety
http://europa.eu.int/comm/dgs/health_consumer/library/pub/cv/cv001/cv001-03_en. htm I

World Trade Organisation (WTO)

www.wto.org
EU White Paper on Food Safety (2000)
http://europa.eu.int/comm/dgs.health consumer /Iibrary /pub/pub06 en.pdf
EU Food Safety Training
http://europa.eu.int/commlfooel/traininglwhitepaperen.htm I
General Food Regulations (UK)
http://hmso.gov.uklsi/si2004/200443279.htm I
Food Safety Authority (UK)
www.fooel,gov.uklfooelinelustry/regulationlfoodlawguidebranch
Food Safety (EU)
http://europa.eu.int/scaelplus/leglen/s80000.htm I
Food Safety (EU) Product labeling and Packaging
www.europa.eu.int/scadplus/leglen/s16600.htm I
Veterinary checks, Animal health rules, Hygiene of Food
http://europa.eu.int/scadplus/leglen/s84000.htm I
Animal Health (EU)
http://europa.eu.int/scadplus/leglen/s83000.htm I
Contamination and Environmental Factors (EU)
http://europa.eu.int/scapplus/leglen/s86000.htm I
Organically Grown Agricultural Products and Foodstuffs
http://europa.eu.int/scadplus/leglen/lvb/121097.html
Veterinary and Phytosanitary Inspections (EU)
http://europa.eu.int/scaelplus/leglen/lvb/132038.htm I
Prepacked Products (EU)
http://europa.eu.int/scaelplus/leglen/lvb/132029.htm I
Active and Intelligent Packaging (EU)
http://europa.eu.int/scaelplus/leglen/lvb/121082a.html
Identification of Foodstuffs by lot (EU)
http://europa.eu.int/scadplus/leglen/lvb/121091.html
Foodstuffs treated with Ionising Radiation
http://europa.eu.int/scadplus/leglen/lvb/121117html
Guidance Document on HACCP Principles (EU)
http://eu ropa. eu. int/com m/fooel/b iosa fety/hygi ene IegisIati 0 n/gu ida nceeloch accpen. pdf

Codex Food Hygiene Text

ftp:l/ftp.fao.orglcodex/Publ ica ti 0 ns/Bookl ets/H ygi ene/Fooel Hygi ene2 003 e. pdf
Recommended International Code of Practice of General Principles of Food Hygiene
www.coelexa[imentarius.net/e1ownloael/stanelarelsl2 3/expooi .pelf
36
Example of an EU Inspection Report (Greece)
http://europa.eu.i nticomm/foocVfs/i nspections/vi/reports/greeee/vi repgree92 57-2003 en. pdf

Guidance Document on the Hygiene of Foodstuffs (EU)

http://europa.eu. intlcomm/foocVfoodtbiosafetylhygi enel egi sl ationlguidancedoc852-2 004en.pdf

Guidance Document: Key Questions related to Import Requirements and the New
Rules on Food Hygiene and Official Food Products (EU)
http://europa.eu. intlcom m/food/i nterna ti ona /ltra deli nterp retati on imports. pd f

Other relevant Guidance Documents (EU)

http://europa.eu.intlcomm/foodlfood/foodlaw/guidance/indexen.htm I

Guidelines on the Implementation of the main General Food Law requirements

http://europa.eu.intlcommlfood/food/foodlaw/gu idance/i ndexen. htm I
Benchmarked Standards for the Food Industry
• BRC Standard (British Retail Consortium)

http://www.brc.org.uklstandards/indix.htm I

• IFS (International Food Standard, France & Germany)

http://www.food-care.info

• SQF 2000 (Safe Quality Food)

www.sqfi.com

• Dutch HACCP Code (The Netherlands)

www.foodsafetymanagement.info

Food Nutrition Labelling (EU) Useful Information sources:

• Product Labelling and Packaging

http://europa.eu.intlscadplus/leglen/s16600.htm I

• Labelling, Presentation and Advertising of Foodstuffs

http://europa.eu.intlscadplus/leglen/lvb/121090.html

• Labelling Requirements

www.fas.usda.gov/GainFiles/200508/146130611.pdf

http://useu.usmission.gov/agri/label.htmI

• Canadian Exporters guide to Food Labelling &

• Packaging Requirements of the EU

http://ats-sea.agr.ca/europe/e1429.htm (Note: 2000 Publication)

Nutrition Labelling (EU)

http://europa.eu.intlscadplus/leglen/lvb/121092.html
Ingredient and Allergen Labelling
http://portal.wko.atlwkldoK-detaiUile.wk?AngIO=l &Oocl 0=435488&StI0=215 710
McDonalds list of Allergens
http://www.medonalds.com/app_controller.nutrition.categories.allergens.index.htmI
EU on-line Customs data base
http://europa.eu.intleomm/taxation_customs/dds/en/tarhome.html
List of EU Customs Authorities
http://europa.eu.intlcomm/taxation_customs/databases/bti_en.html

37