ISO 22000:2005-

UNIT 8 ISO 22000:2005 - AN OVERVIEW An Overview

Structure
8.0 Objectives
8.1 Introduction
8.2 Key Features of ISO 22000:2005
8.2.1 What Does ISO 22000 Bring to the HACCP Method?
8.2.2 System Components
8.2.3 Communication between Participants in the Food Industry
8.2.4 ISO 22000: A Passport for Exporting?
8.2.5 Why do Companies Commit themselves to an ISO 22000 Approach?
8.3 Who Should Use ISO 22000:2005?
8.3.1 ISO 22000 can be used by:
8.4 Why to Use ISO 22000:2005?
8.5 ISO 22000 and HACCP
8.6 Codex Alimentarius
8.6.1 Commodity Standards
8.7 HACCP
8.8 ISO Family
8.8.1 ISO 22000 is Fully Compatible with ISO 9001:2000
8.9 Key Elements and Benefits of ISO 22000
8.10 Let Us Sum Up
8.11 Key Words
8.12 Answers to Check Your Progress Exercise
8.13 Suggested Reading

8.0 OBJECTIVES
After studying this unit, we shall be able to:
• explain the important features of know establish the relation between the
HACCP and FSMS the ISO 22000: 2005 food safety management system
standard; and
• elaborate HACCP and Codex Alimentarius.

8.1 INTRODUCTION
ISO 22000 is a global food safety management system standard series
consisting of following standards:
ISO 22004:2005 – FSMS guidance on the application of ISO 22000:2005 and
ISO 22005:2007 – Traceability of feed and food chain.
We know that ISO is the International Organisation for Standardization. It was
set up in 1947 and is located in Geneva, Switzerland. Its purpose is to develop
standards that facilitate international trade.
ISO 22000: 2005 was developed by ISO TC 34 (Technical Committee 34). TC
34 is responsible for food products. ISO 22000: 2005 (first edition) was
formally approved during 2005 by over 75% of the ISO member bodies who
participated in the voting process. ISO published this international standard on
September 1, 2005.
ISO 22000 is a generic food safety management system standard. It defines a
set of general food safety requirements that apply to all organisations in the
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ISO 22000:2005 food chain. These requirements are listed in Sections 4, 5, 6, 7, and 8 of ISO
22000.
If your organisation is part of the food chain, ISO 22000 wants you to establish
a Food Safety Management System (FSMS). It then wants you to use this
system to ensure that food products do not cause adverse human health effects.
ISO 22000 is designed to be used for certification (registration) purposes. In
other words, once you’ve established a FSMS that meets ISO’s requirements,
you can ask a registrar to audit your system. If your registrar agrees that you’ve
met the ISO 22000 requirements, it will issue an official certificate that states
that your FSMS meets the ISO 22000 food safety requirements.
However, you don’t have to be certified (registered). ISO does not require
certification (registration). You can be in compliance without being formally
registered by an accredited auditor. You can self assess your system and
simply declare to the world that your FSMS complies with ISO 22000 (if it
does). Of course, your customers and business partners are more likely to
believe that you have an effective FSMS if an independent auditor says so.

8.2 KEY FEATURES OF ISO 22000:2005

The ISO 22000 standard is a management system standard that sets
requirements for results without setting requirements for resources. The
HACCP system is based on organisation and is guided by a policy and
objectives with clearly defined responsibilities, allotted resources, and control
over how objectives are met. This organisation is designed to ensure continual
improvement in food safety. This standard sets out specific requirements for
the five areas shown in the figure at below.

System approach Interactive

(continual communication
improvement)

ISO 22000
Prerequisite Traceability
programmes (crisis
PRP management)

HACCP
Plan

8.2.1 What Does ISO 22000 Bring to the HACCP Method?

PRP, Operational PRP, CCP and Validation
ISO 22000 has made it possible to fill in, a targeted manner, certain gaps that
hindered proper understanding and use of the HACCP method, in particular, by
Introducing Prerequisite Programs (PRP), and operational PRP (oPRP). The
standard makes it possible to prioritize control measures based on criteria
linked to the probably of the occurrence of a certain type of hazard and its
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severity. In addition, ISO 22000 requires that control measures associated with ISO 22000:2005-
An Overview
oPRP and critical control points be validated before they are implemented.

22000

OPRP
PRP

8.2.2 System Components

ISO 22000 has also set up, around the HACCP method, all the system and
organisational components, based on the principle of continual improvement
that made ISO 9001 such a success. In fact, once companies have met the
challenge of setting up an HACCP the first year, they then face a new
challenge.
Keeping it operational over the coming years, something that ISO 22000’s
'PDCA: Plan-Do- Check-Act' system approach makes possible. By providing
system components (procedures, audit, indicators, operating reports,
management reviews, steering committees, etc.), this standard contributes to
efforts to structure and improve management. These measures allow
companies to avoid fixed HACCP systems and move towards systems that
constantly adapt to the situation and to food safety needs. As the first New
Caledonia company to receive ISO 22000 certification reports: ‘Our system
really became dynamic and involves our staff a great deal more’.

P 1. Commit to a food safety policy

2. Plan your objectives

D 3. Implement the programme and
resources
C
4. Check and assess the results and
progress
A
5. Review to improve the system

Food safety
Customer
Act Plan satisfaction and
confidence

Check Do

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ISO 22000:2005 8.2.3 Communication between Participants in the Food
Industry
The requirement for communication about potential hazards, both upstream
and downstream depending on the needs, is a new and major asset of ISO
22000, one that will promote the development of an integrated sector culture
and approach. In the seafood sector, for example, processors will not only have
to have good communications with fishers, packaging suppliers and
transporters but will also have to prove that they fully master the requirements
that they have set with these participants in the food chain. For in-house
communications, emphasis is placed on providing the ISO 22000 team with
timely information on any changes that could affect food safety. A lack of
communication in this area can have a significant impact as has been
demonstrated by recent cases of food poisoning caused by changes in
maintenance or in raw materials or packaging without the ISO 22000 team’s
prior approval.

8.2.4 ISO 22000: A Passport for Exporting?

By selecting an ISO 22000 certification, you are adopting an internationally
recognised system. Whatever the country, you will share a common language
with your customers, suppliers and competent health services. Also, from a
health point of view, the ISO 22000 standard has a great potential to partially
fill the gap between rich importing countries and developing countries that
want to export. In the seafood sector, Thailand was one of the first countries to
benefit from the development of processed product exports by adopting an
effective and internationally recognised food safety Programme. ISO 22000 is
also a good way to reassure consumers who are increasingly wary about the
food they buy. Certified companies demonstrate their food manufacturing
professionalism by guaranteeing better study of and communication about
related hazards.

8.2.5 Why do Companies Commit themselves to an ISO 22000

Approach?
Mainly because some exporting companies want to adopt a common language
to facilitate exchanges. Other companies because they want their hazard
analysis and control techniques to be consolidated, validated and recognised by
an outside agency. And other companies commit to an ISO 22000 approach in
order to complete their ISO 9001, ISO 14001, HACCP plans through the
implementation of an integrated system. In all cases, everyone recognises the
interest of the standard’s managerial dimension in moving their current fixed
HACCP plans towards a well-adapted dynamic system that strongly involves
staff and is constantly improving. In the end, ISO 22000 combines a series of
advantages, involving quality management, external and in-house
communications, designating responsibility, implementing crisis management,
continual improvement, good health practices and differentiating between
PRP, oPRP and CCP

8.3 WHO SHOULD USE ISO 22000:2005?

Since ISO 22000 is a generic food safety management standard, it can be used
by any organisation directly or indirectly involved in the food chain. It applies
to all organisations in the food chain. It doesn’t matter how complex the
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organisation is or what size it is, ISO 22000 can help ensure the safety of its ISO 22000:2005-
An Overview
food products.
The food chain consists of the entire sequence of stages and operations
involved in the creation and consumption of food products. This includes every
step from initial production to final consumption. More precisely, it includes
the production, processing, distribution, storage and handling of all food and
food ingredients.
The food chain also includes organisations that do not directly handle food.
These include organisations that produce feed for animals. It also includes
organisations that produce materials that will eventually come into contact
with food or food ingredients.

8.3.1 ISO 22000 can be used by:

A. Primary producers
• Farms
• Ranches
• Fisheries
• Dairies
B. Processors
• Fish processors
• Meat processors
• Poultry processors
• Feed processors
C. Manufacturers
• Soup manufacturers
• Snack manufacturers
• Bread manufacturers
• Cereal manufacturers
• Dressing manufacturers
• Beverage manufacturers
• Seasoning manufacturers
• Packaging manufacturers
• Frozen food manufacturers
• Canned food manufacturers
• Confectionery manufacturers
• Dietary supplement manufacturers
D. Food service providers
• Grocery stores
• Restaurants
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ISO 22000:2005 • Cafeterias
• Hospitals
• Hotels
• Resorts
• Airlines
• Cruise ships
• Seniors lodges
• Nursing homes
E. Other service providers
• Storage service providers
• Catering service providers
• Logistics service providers
• Transportation service providers
• Distribution service providers
• Sanitation service providers
• Cleaning service providers
F. Product suppliers
• Suppliers of tools
• Suppliers of utensils
• Suppliers of equipment
• Suppliers of additives
• Suppliers of ingredients
• Suppliers of raw materials
• Suppliers of cleaning agents
• Suppliers of sanitizing agents
• Suppliers of packaging materials
• Suppliers of other food contact materials
Of course, the previous catalogue does not exhaust the list of organisations that
could benefit from the use of this standard. ISO 22000 applies to all
organisations directly or indirectly involved in the food chain, not just the ones
listed here.

8.4 WHY TO USE ISO 22000:2005?

ISO 22000 will help you to achieve the following objectives:
A. To establish a food safety management system (FSMS).
(i) to plan and implement a FSMS for your organisation.
(ii) to operate and maintain your organisation’s FSMS.
(iii) to update and improve your organisation’s FSMS.
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B. To ensure that products do not cause adverse health effects. ISO 22000:2005-
An Overview
C. To demonstrate compliance with external safety requirements.
(i) to demonstrate compliance with legal safety requirements.
(ii) to demonstrate compliance with regulatory requirements.
(iii) to demonstrate compliance with statutory requirements.
(iv) to demonstrate compliance with customer requirements.
D. To evaluate your customers’ food safety requirements.
E. To provide safe products and enhance customer satisfaction.
F. To export food products and penetrate international markets.
G. To communicate safety issues throughout the food chain.
(i) to communicate with your organisation’s customers.
(ii) to communicate with your organisation’s suppliers.
(iii) to communicate with other relevant interested parties.
H. To ensure that you comply with your food safety policy.
(i) to demonstrate compliance to all interested parties.
ISO 22000 uses roughly the same basic structure as the ISO 9001 quality
management standard. This should make it a bit easier for ISO 9001 certified
organisations to pursue ISO 22000 certification.

8.5 ISO 22000 AND HACCP

ISO 22000 uses HACCP. HACCP stands for Hazard Analysis and Critical
Control Point. It was developed by the Codex Alimentarius Commission.
HACCP is a methodology and a management system. It is used to identify,
prevent and control food safety hazards. HACCP management systems apply
the following methodology:
A. Pre-Steps
1. Formation of food safety team
2. Description of product
3. Description of end use of product
4. Drafting of process flow chart
5. Verification of process flow chart
B. Seven Principles
1. Conduct a food safety hazard analysis.
2. Identify your critical control points (CCPs).
3. Establish critical limits for each critical control point.
4. Develop procedures to monitor critical control points.
5. Design corrective actions to handle critical limit violations.
6. Create a food safety record keeping system.
7. Validate and verify your system.
This methodology is used to develop an HACCP plan. An HACCP plan is a
document that describes how an organisation plans to manage and control its
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ISO 22000:2005 food safety hazards. An HACCP plan contains at least the following
information:
1. Critical Control Points (CCPs).
2. Hazards that will be controlled at each CCP.
3. Control measures that will be used at each CCP.
4. Critical limits that will be applied at each CCP.
5. Procedures that will be used to monitor CCPs.
6. Actions that will be taken when limits are violated.
ISO 22000 shows organisations how to combine the HACCP plan with
prerequisite programs (or programs) and operational prerequisite programs into
a single integrated food safety management strategy.
Prerequisite programs (PRPs) are the conditions that must be established
throughout the food chain and the activities and practices that must be
performed in order to establish and maintain a hygienic environment. PRPs
must be suitable and be capable of providing food that is safe for human
consumption. PRPs are also referred to as good hygienic practices, good
agricultural practices, good production practices, good manufacturing
practices, good distribution practices, and good trading practices.
Operational prerequisite programs (OPRPs) are prerequisite programs (PRPs)
that are essential. They are essential because a hazard analysis has shown that
they are necessary in order to control specific food safety hazards. OPRPs are
used to reduce the likelihood that products will be exposed to hazards, that
they will be contaminated, and that hazards will proliferate. OPRPs are also
used to reduce the likelihood that the processing environment will be exposed
to hazards.

8.6 CODEX ALIMENTARIUS

Codex Alimentarius was established jointly by FAO and WHO.
The Codex Alimentarius publishes a collection of standards, codes of practice,
guidelines and other recommendations. Some of these texts are very general,
and some are very specific. Some deal with detailed requirements related to a
food or group of foods; others deal with the operation and management of
production processes or the operation of government regulatory systems for
food safety and consumer protection.
Codex standards usually relate to product characteristics and may deal with all
government-regulated characteristics appropriate to the commodity, or only
one characteristic. Maximum residue limits (MRLs) for residues of pesticides
or veterinary drugs in foods are examples of standards dealing with only one
characteristic. There are Codex general standards for food additives and
contaminants and toxins in foods that contain both general and commodity
specific provisions. The Codex General Standard for the Labelling of
Prepackaged Foods covers all foods in this category. Because standards relate
to product characteristics, they can be applied wherever the products are
traded. Codex methods of analysis and sampling, including those for
contaminants and residues of pesticides and veterinary drugs in foods, are also
considered Codex standards.
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Codex codes of practice – including codes of hygienic practice – define the ISO 22000:2005-
An Overview
production, processing, manufacturing, transport and storage practices for
individual foods or groups of foods that are considered essential to ensure the
safety and suitability of food for consumption. For food hygiene, the basic text
is the Codex General Principles of Food Hygiene, which introduces the use of
the Hazard Analysis and Critical Control Point (HACCP) food safety
management system. A code of practice on the control of the use of veterinary
drugs provides general guidance in this area.

Codex guidelines fall into two categories:

• principles that set out policy in certain key areas; and
• guidelines for the interpretation of these principles or for the interpretation
of the provisions of the Codex general standards.
In the cases of food additives, contaminants, food hygiene and meat hygiene,
the basic principles governing the regulation of these matters are built into the
relevant standards and codes of practice. There are free-standing Codex
principles covering:
• Addition of essential nutrients to foods;
• Food import and export inspection and certification;
• Establishment and application of microbiological criteria for foods;
• Conduct of microbiological risk assessment; and
• Risk analysis of foods derived from modern biotechnology.
Interpretative Codex guidelines include those for food labelling, especially the
regulation of claims made on the label. This group includes guidelines for
nutrition and health claims; conditions for production, marketing and labelling
of organic foods; and foods claimed to be “halal”. There are several guidelines
that interpret the provisions of the Codex Principles for Food Import and
Export Inspection and Certification, and guidelines on the conduct of safety
assessments of foods from DNA-modified plants and micro-organisms.

8.6.1 Commodity Standards

By far the largest number of specific standards in the Codex Alimentarius is
the group called “commodity standards”. The major commodities included in
the Codex are:
• cereals, pulses (legumes) and derived products including vegetable
proteins.
• fats and oils and related products.
• fish and fishery products.
• fresh fruits and vegetables.
• processed and quick-frozen fruits and vegetables.
• fruit juices.
• meat and meat products, soups and broths.
• milk and milk products.
• sugars, cocoa products and chocolate and other miscellaneous products.
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ISO 22000:2005 Commodity standards tend to follow a fixed format set out in the Procedural
Manual of the Codex Alimentarius Commission. The format consists of the
following categories of information:
• Scope includes the name of the food to which the standard applies and in
most cases, the purpose for which the commodity will be used.
• Description includes a definition of the product or products covered with
an indication, where appropriate, of the raw materials from which they are
derived.
• Essential composition includes information on the composition and
identity characteristics of the commodity, as well as any compulsory and
optional ingredients.
• Food additives contain the names of the additives and the maximum
amount permitted to be added to the food. Food additives must be cleared
by FAO and WHO for their safety, and the use of food additives must be
consistent with the Codex General Standard for Food Additives.
• Contaminants contains limits for contaminants that may occur in the
product(s) covered by the standard. These limits are based on the scientific
advice of FAO and WHO and must be consistent with the Codex General
Standard for Contaminants and Toxins in Foods. Where appropriate,
reference is also made to the Codex Maximum Limits for pesticide
residues and for residues of veterinary drugs in foods.
• Hygiene makes reference to relevant Codex Codes of Hygienic Practice
for the commodity concerned. In almost all cases it is required that the
product shall be free from pathogenic microorganisms or any toxins or
other poisonous or deleterious substances in amounts that represent a
hazard to health.
• Weights and measures contains provisions such as fill of the container
and the drained weight of the commodity.
• Labelling includes provisions on the name of the food and any special
requirements to ensure that the consumer is not deceived or misled about
the nature of the food. These provisions must be consistent with the Codex
General Standard for the Labelling of Prepackaged Foods. Requirements
for the listing of ingredients and date-marking are specified.
• Methods of analysis and sampling contains a list of the test methods
needed to ensure that the commodity conforms to the requirements of the
standard. References are made to internationally recognized test methods
that meet the Commission’s criteria for accuracy, precision, etc.

8.7 HACCP
Developed with the participation of food sector experts, ISO 22000
incorporates the principles of HACCP, and covers the requirements of key
standards developed by various global food retailer syndicates, in a single
document. “Public sector participation in the development of the ISO 22000
family is also significant,” ISO Secretary-General Alan Bryden commented,
“notably that of the FAO/WHO’s Codex Alimentarius Commission, which is
responsible for the well-known HACCP (Hazard Analysis and Critical Control
Point) system for food hygiene. Thanks to the strong partnership between ISO
and Codex, ISO 22000 will facilitate the implementation of HACCP and the
food hygiene principles developed by this pre-eminent body in this field.”
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Another benefit of ISO 22000 is that it extends the successful management ISO 22000:2005-
An Overview
system approach of the ISO 9001:2000 quality management system standard
which is widely implemented in all sectors but does not itself specifically
address food safety. The development of ISO 22000 was based on the
assumption that the most effective food safety systems are designed, operated
and continually improved within the framework of a structured management
system and incorporated into the overall management activities of the
organisation. While ISO 22000 can be implemented on its own, it is designed
to be fully compatible with ISO 9001:2000 and companies already certified to
ISO 9001 will find it easy to extend this to certification to ISO 22000. To help
users to do so, ISO 22000 includes a table showing the correspondence of its
requirements with those of ISO 9001:2000.

8.8 ISO FAMILY

ISO 22000:2005 is the first in a family of standards that will include the
following documents:
• ISO/TS 22004:2005, Food safety management systems – Guidance on the
Application of ISO 22000:2005, provides important guidance that can
assist organisations including small and medium-sized enterprises around
the world.
• ISO/TS 22003:2007, Food safety management systems – Requirements for
bodies providing audit and certification of food safety management
systems, will give harmonized 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.
• ISO 22005:2007, Traceability in the feed and food chain – General
principles and guidance for system design and development, a Draft
International Standard. In partnership with the International Trade Centre
(ITC) – the technical cooperation agency of the United Nations Conference
on Trade and Development (UNCTAD) and the World Trade Organisation
(WTO) – ISO is also preparing an easy-to-use check-list for small
businesses and developing countries, entitled ISO 22000.
• ISO 22000 and ISO/TS 22004 are the output of working group WG 8,
Food safety management systems, of ISO technical committee ISO/TC 34,
Food products. Experts from 23 countries participated in the working
group, together with international organisations with liaison status.

8.8.1 ISO 22000 is Fully Compatible with ISO 9001:2000

In addition to the Codex Alimentarius Commission, these included the
Confederation of the Food and Drink Industries of the European Union
(CIAA), and the World Food Safety Organisation (WFSO). They have been
joined for the development of ISO/TS 22003 by experts from the ISO
committee on conformity assessment, ISO/CASCO, the International
Accreditation Forum (IAF) and the IQNet international certification network.

8.9 KEY ELEMENTS AND BENEFITS OF ISO

22000
ISO 22000 combines generally recognized key elements to ensure food safety
along the food chain:
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ISO 22000:2005 Interactive Communication
Clear communication along the food chain is essential to ensure that all
relevant food safety hazards are identified and adequately controlled at each
step. This implies communication of the needs of the organisation to
organisations both upstream and downstream in the food chain.
Communication with customers and suppliers, based on the information
generated through systematic hazard analysis, will also assist in establishing
customer and supplier requirements in terms of feasibility, need and impact on
the end product.
System Management
The most effective food safety systems are designed, operated and updated
within the framework of a structured management system and incorporated
into the overall management activities of the organisation. This provides
maximum benefit for the organisation and interested parties. ISO 22000 is
aligned with the requirements of ISO 9001:2000 in order to enhance the
compatibility of the two standards and to ease their joint or integrated
implementation.
Hazard Control
ISO 22000 combines the Codex Alimentarius HACCP (Hazard Analysis and
Critical Control Points) principles and application steps, developed by Codex
Alimentarius, with prerequisite programmes 1) It uses the hazard analysis to
determine the strategy for hazard control.
Benefits for Users
Organisations implementing the standard will benefit from:
• Organized and targeted communication among trade partners;
• Optimization of resources (internally and along the food chain);
• Improved documentation;
• Better planning, less post process verification;
• More efficient and dynamic control of food safety hazards;
• All control measures subjected to hazard analysis;
• Systematic management of prerequisite programmes;
• Wide application because it is focused on end results;
• Valid basis for taking decisions;
• Increased due diligence;
• Control focused on what is necessary, and
• Saving resources by reducing overlapping system audits.
Benefit for other stakeholders
Other stakeholders will benefit from:
• confidence that the organisations which are implementing ISO 22000 have
the ability to identify and control food safety hazards.
Value-adding features

• It is an auditable standard with clear requirements;

• It is internationally accepted;
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• It integrates and harmonizes various existing national and industry-based ISO 22000:2005-
An Overview
certification schemes;
• Food processing industries are waiting for this standard;
• It is aligned with both ISO 9001:2000 and HACCP; and
• It contributes to a better understanding and further development of HACCP
PRP.

Check Your Progress Exercise 1 "

Note: a) Use the space below for your answers.
b) Compare your answers with those given at the end of the unit.
1) List names of ISO 22000 family standards?
…………………………………………………………………………….
…………………………………………………………………………….
…………………………………………………………………………….
…………………………………………………………………………….
2) Give brief information of Codex Alimentarius Commission?
…………………………………………………………………………….
…………………………………………………………………………….
…………………………………………………………………………….
…………………………………………………………………………….
3) List five types of organisations to whom ISO 22000 is applicable?
…………………………………………………………………………….
…………………………………………………………………………….
…………………………………………………………………………….
…………………………………………………………………………….
4) List HACCP pre-steps?
…………………………………………………………………………….
…………………………………………………………………………….
…………………………………………………………………………….
…………………………………………………………………………….
5) List HACCP principles?
…………………………………………………………………………….
…………………………………………………………………………….
…………………………………………………………………………….
…………………………………………………………………………….
6) List the key elements of ISO 22000?
…………………………………………………………………………….
…………………………………………………………………………….
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ISO 22000:2005 …………………………………………………………………………….
…………………………………………………………………………….

8.10 LET US SUM UP

The ISO 22000:2005 standard is a completely new standard published in
September 2005 with the aim to unify principles of the quality systems used in
the food industry. It is an optional standard because it goes beyond the
framework of the GHP/GMP and HACCP requirements. Its range
encompasses (ISO 22000:2005):
• The Prerequisite Program (PRP), i.e. the above-mentioned GHP/GMP
principles and GAP (Good Agricultural Practice), GVP (Good Veterinarian
Practice), GPP (Good Production Practice), GDP (Good Distribution
Practice), GTP (Good Trading Practice),
• The HACCP system,
• The identification system (traceability system), and
• The quality management system ISO 9001:2000.
ISO 22000:2005 integrates both the quality management system (ISO
9001:2000) and HACCP system. There are also cross-references between ISO
22000, ISO 9004 and terms and definitions from ISO. The most effective
system of food quality and safety was designed, which implemented into
existing structure of management, can give profits to both organisation and
other interested party. Furthermore, it may be implemented independently of
other management systems existing into enterprise.

8.11 KEY WORDS

Continual : In the context of ISO 22000, the term continual
Improvement improvement refers to an ongoing need to improve the
effectiveness of a Food safety Management system
(FSMS). The effectiveness of any FSMS can be
continually improved through the use of communications,
management reviews, internal audits, corrective actions,
system updates, verification research, and validation
studies.
Control : Control measures are actions or activities that are used to
Measure manage and control food safety hazards. Control
measures must be capable of preventing or eliminating
food safety hazards or reducing them to an acceptable
level.
Corrections : A correction is any action that is taken to eliminate non-
conformity. In the context of the ISO 22000 standard, a
correction is any action that is taken to deal specifically
with potentially unsafe products (non-conforming
products).
Corrections may include the following types of actions:
reprocessing or further processing of potentially unsafe
products, assigning them to a different use, or simply
destroying them.
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 ISO 22000:2005-
In the context of this standard, a correction is not the An Overview
same as a corrective action (see below). Corrections are
carried out in order to deal immediately with unsafe
products, while corrective actions are designed to prevent
recurrence by addressing causes. Corrective actions often
take a longer-term perspective and tend to take a more
systemic approach.
Corrective : Corrective actions are steps that are taken to eliminate the
Actions causes of an existing non-conformity. The corrective
action process includes causal analysis and is designed to
prevent recurrence.
Critical : A critical control point (CCP) is the point (or step) at
Control Point which a control measure must be applied. It is a point that
(CCP) is critical or essential to safety. It is the point where a
control measure can be used to prevent or eliminate a
food safety hazard or to reduce it to an acceptable level.
Critical limits are set at critical control points.
Critical Limit : A critical limit is a criterion or boundary that is used to
distinguish between what is acceptable (safe) and what is
unacceptable (unsafe). A critical limit is a value of a
parameter or variable.
Critical limits (values) are used to ensure that a process
produces safe food products. When critical limits are
violated or exceeded, products are deemed to be
potentially unsafe.
Critical limits are established at critical control points
(CCPs). They are used to determine whether or not a CCP
is still under control. Whenever critical limits are violated
or exceeded, CCPs are out of control and the associated
products are considered to be potentially unsafe.
End Product : An end product is a finished product. It requires no
further processing or transformation. However, an end
product for one organisation could be an ingredient or
raw material for another (customer) organisation.
Food Chain : The food chain consists of the entire sequence of stages
and operations involved in the creation and consumption
of food products. This includes every step from initial
production to final consumption. It includes the
production, processing, distribution, storage and handling
of all food and food ingredients.
The food chain also includes organisations that do not
directly handle food. These include that produce feed for
animals that will be used as food that will be used as
food. It also includes organisations that produce materials
that will eventually come into contact with food or food
ingredients.
Food Safety : The basic food safety concept is this: food will not harm
the consumer so long as intended use guidelines are
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ISO 22000:2005 followed when it is prepared or eaten. Conversely, food is
potentially harmful whenever it has been exposed to
hazardous agents and intended use guidelines have not
been followed.
Food Safety : A food safety hazard is an agent or condition that could
Hazard potentially cause an adverse human health effect. Agents
can be biological, chemical, or physical. Furthermore, the
condition of the food itself can also be hazardous.
Food safety hazards can also be found in or on animal
feed and feed ingredients. Since these may be transferred
to food through the consumption of animal products, they
can also cause adverse human health effects.
Organisations that do not directly handle food and feed
may also compromise food safety. These include
producers of packaging materials, cleaning agents, and
other products that eventually come into contact with
food or feed. If such products have been exposed to
hazardous agents and they come into contact with food or
feed, adverse human health effects can occur.
Food Safety : A food safety hazard analysis is done in order to
Hazard determine which hazards need to be controlled, how
Analysis much control is needed, and which combination of
control measures should be used in order to make sure
that food is safe. In the context of ISO 22000 (section
7.4), a food safety hazard analysis is carried out in the
following way:
1) Identify your organisation’s food safety hazards.
2) Pinpoint where each hazard may be introduced.
3) Specify acceptable hazard levels for each hazard.
4) Assess each hazard and decide how to control it.
5) Select control measures to control your hazards.
6) Use OPRPs are operational prerequisite programs and
HACCP is hazard analysis critical control point.
Food Safety : A Food Safety Management System (FSMS) is a network
Management of interrelated elements that combine to ensure that food
System does not cause adverse human health effects. These
(FSMS) elements include programs, plans, policies, procedures,
practices, processes, goals, objectives, methods, controls,
roles, responsibilities, relationships, documents, records,
and resources. A FSMS is often one part of a larger
management system.
Food Safety : : A food safety policy statement formally defines an
Policy organisation's commitment to food safety. It expresses, in
general terms, what top management intends to do about
food safety and describes the direction, the organisation
wishes to take.
More precisely, a food safety policy statement should
express an organisation’s commitment to the
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 implementation and ongoing maintenance of its Food ISO 22000:2005-
An Overview
Safety Management System (FSMS). The food safety
policy should drive the establishment of the FSMS and
should also encourage people to update and improve its
overall effectiveness.
Food Safety : A food safety record is a document that contains objective
Record evidence which shows how well food safety activities are
being performed or what kind of results are being
achieved. It always documents what has happened in the
past.
HACCP : HACCP stands for Hazard Analysis and Critical Control
Point. HACCP is a methodology and a management
system. It is used to identify, prevent, and control food
safety hazards.
HACCP was developed by the Codex Alimentarius
Commission.
While we characterize the seven steps as a methodology,
they are traditionally referred to as HACCP principles.
Internal : An internal audit is a systematic evidence gathering
Audit process that is carried out in order to determine how well
a food safety management system (FSMS) meets a set of
expectations. According to Section 8.4.1 of this standard,
your internal audits should determine how well your
FSMS complies with both the ISO 22000 requirements as
well as your organisation’s own requirements and
arrangements. In addition, section 8.4.1 expects internal
auditors to evaluate how well the FSMS has been
implemented and how well it is being updated and
improved.
Management : The purpose of a management review is to evaluate the
Review overall performance of an organisation's food safety
management system and to identify improvement
opportunities. These reviews are carried out by the
organisation's top managers and are done on a regular
basis.
Non- : In the context of ISO 22000, non-conforming products
Conforming are products that are potentially unsafe. They are
Products potentially unsafe because they were produced or
manufactured during a period when critical limits were
violated or exceeded or when an organisation has lost
control of a prerequisite program (PRP) or an operational
prerequisite program (OPRP).
Operational : Operational prerequisite programs (OPRPs) are
Prerequisite prerequisite programs (PRPs) that are essential. They are
Programs essential because a hazard analysis has shown that they
(programs) are necessary in order to control specific food safety
hazards.
OPRPs are used to reduce the likelihood that products
will be exposed to hazards, that they will be
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ISO 22000:2005 contaminated, and that hazards will proliferate. OPRPs
are also used to reduce the likelihood that the processing
environment will be exposed to hazards, that it will be
contaminated, and that hazards will proliferate in that
environment.
Consider using an operational prerequisite program
(OPRP) to manage a control measure:
• If strict control is not needed.
• If your control measure is unlikely to fail in the
future.
• If a control failure would not have severe
consequences.
• If monitoring and rapid corrective action is not
feasible.
• If your control measure does not need to be able to
cope with significant processing variability.
• If your control measure is not designed to eliminate
or reduce the level of a specific food safety hazard.
• If your control measure's place in the system makes it
convenient to make it part of your OPRP.
• If a control measure helps to boost the effectiveness
of another control measure that is also part of your
OPRP.
If the above conditions do not apply to your specific
control measure, consider using your HACCP plan to
manage it.
Note: HACCP plans use critical control points (CCPs)
and critical limits to control food safety hazards, while
OPRPs do not.
Prerequisite : Prerequisite programs (PRPs) are the conditions that must
Programs be established throughout the food chain and the activities
and practices that must be performed in order to establish
and maintain a hygienic environment. PRPs must be
suitable and be capable of producing safe end products
and providing food that is safe for human consumption.
PRPs support HACCP plans.
In order to select the most suitable PRPs, organisations
must consider their type of organisation and their own
unique circumstances, as well as the capabilities of their
suppliers and service providers. In order to select the most
suitable PRPs, they must also consider customer needs
and expectations; they must consider statutory and
regulatory requirements; they must consider good
practices in their segment of the food chain; and they
must consider all relevant standards and guidelines.

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 ISO 22000:2005-
PRPs are also referred to as good hygienic practices, good An Overview
agricultural practices, good production practices, good
manufacturing practices, good distribution practices, and
good trading practices.
Procedure : Procedures control processes or activities. A well-defined
procedure controls a logically distinct process or activity,
including the associated inputs and outputs. Such a
procedure defines the work that should be done, and
explains how it should be done, who should do it, and
under what circumstances. In addition, it explains what
authority and what responsibility has been allocated,
which supplies and materials should be used, and which
documents and records must be used to carry out the
work. While procedures may be documented or
undocumented, ISO usually expects them to be
documented.
Traceability : Traceability is the ability to identify and trace the history,
System location, and application of products and materials. A
traceability system records and follows the trail as
products and materials come from suppliers and are
processed and distributed as end products.
Update : An update is an immediate or planned activity. Its
purpose is to ensure that the most recent information is
being applied.
Validation : Validation is a process that is used to ensure that food
safety control measures are capable of being effective.
The validation process uses evidence to determine
whether control measures are capable of controlling food
safety hazards and ensuring that end products are safe.
Control measures must be validated before they are
implemented. Control measures are implemented and
managed using operational prerequisite programs
(OPRPs) and HACCP plans.
Verification : Verification is a process that uses objective evidence to
confirm that specified requirements have been met. In the
context of this ISO 22000 standard, you are expected to
verify that your food safety management system (FSMS)
has been implemented. More precisely, you are expected
to do at least the following:
1. Verify that your PRPs have been implemented.
2. Verify that hazard analysis inputs are updated.
3. Verify that your hazard levels are acceptable.
4. Verify that OPRPs are implemented and effective.
5. Verify that HACCP plan is implemented and
effective.
6. Verify that procedures are implemented and effective.

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ISO 22000:2005
# 8.12 ANSWERS TO CHECK YOUR PROGRESS
EXERCISE
Your answer should include following points:
Check Your Progress Exercise 1
1) ISO 22000: 2005 - Food Safety Management System.
ISO 22004: 2005 - FSMS guidance on the application of ISO 22000: 2005.
ISO 22005: 2007 - Traceability of feed and food chain.
2) Codex Alimentarius was established jointly by FAO and WHO. The Codex
Alimentarius publishes a collection of standards, codes of practice,
guidelines and other recommendations. Some of these texts are very
general, and some are very specific. Some deal with detailed requirements
related to a food or group of foods; others deal with the operation and
management of production processes or the operation of government
regulatory systems for food safety and consumer protection.
3) Primary producers, Food Processors, Food manufacturers, Food service
providers.
4) • Formation of food safety team
• Description of product
• Description of end use of product
• Drafting of process flow chart
• Verification of process flow chart
5) • Conduct a food safety hazard analysis.
• Identify your critical control points (CCPs).
• Establish critical limits for each critical control point.
• Develop procedures to monitor critical control points.
• Design corrective actions to handle critical limit violations.
• Create a food safety record keeping system.
• Validate and verify your system.
6) Interactive communication, system management and Hazard control.

8.13 SUGGESTED READING

www.iso.org
www.codexalimentarius.net
CAC/RCP- 1 - 1969 (Rev. 4 2003) – Recommended code of practice.
ISO 9001: 2000
Codex Alimentarius – Food hygiene basic text.

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