ISO 22000 Pauline Jones

8/11/2019 ISO 22000 Pauline Jones

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1ISO Workshop on Conformity Assessment, Johannesburg2007-05-10

www.iso.org

International Organizationfor Standardization


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ISO 22 series

by Pauline Jones

Former Technical Programme Manager of ISO/TC 34

ISO Regional Workshop on Conformity Assessment

9 and 1 May 2 7


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Contents

Introduction to food safety problems

ISO 22000 series and TC 34

Codex and HACCP

ISO 22000

ISO/TS 22003

ISO/TS 22004

ISO 22005


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Food safety

Failures in food supply chain can be

dangerous and costly.

Some 65% of ISOs food standards

(700 to date) deal with analysis and

test methods.

ISO standards on food safety

management systems aim to

complement regulatory

requirements and assist in reducing

weak links in the food supply chain.


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Examples of food incidents

glass/razor blades in baby food (depressed market

ca. 100 million)

cross-contamination of Salmonellafrom raw milk

(76 illnesses, one death)

contaminated chocolate (245 people ill; 500 000

cost)

benzene in bottled mineral water (160 million

bottles destroyed: US$ 79 million cost)

$


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ISO 22000 serieson food safety management

ISO 22000:2005, Food safety management systems--Requirements for any organization in the food chain

ISO/TS 22003:2007, Food safety management systems--Requirements for bodies providing audit and certification offood safety management systems

ISO/TS 22004:2005, Food safety management systems --Guidance on the application of ISO 22000

ISO 22005:2007, Traceability in the feed and food chain --General principles and guidance for system design anddevelopment

ISO/TC 34 has prepared a series of international

standards on food safety management systems:


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ISO Technical Committee TC 34,Food products

Standardization in the fields of

human and animal foodstuffs

animal and vegetable propagation materials

terminology, sampling, methods of test andanalysis

product specifications and requirements forpackaging, storage and transport



Participation in ISO/TC 34

Participating members: 45, Observer members: 47

10 A-liaisons (e.g. CODEX, AOAC, UN/ECE, IH&RA)

5 B-liaisons (e.g. OIV, WHO) with international and

regional organizations

Experts from more than 20 countries and from six

other international organizations took part in the

Working Group with 3 new liaisons (e.g. CIES, WFSO)



ISO/TC 34 Liaisons

One of TC 34

s most important liaisons isthe

FAO/WHO Codex Alimentarius Commission

When developing a new ISO standard,

special care is taken of the relevant Codex

documents,

each comment of any Codex Committee is taken intoconsideration during the ISO procedure.


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Codex and ISO activities are complementary

Codex, asan inter-governmental organization(WHO & FAO)

prepares documents to assist governments in their statutory

and regulatory work to protect their citizens from health

hazards caused by food consumption.

ISO, as anon-governmental organization,

prepares consensus-based standards on test methods and

management systems to assist stakeholders along the whole

food chain to fulfil the relevant statutory and regulatory

requirements, as well as customer to supplier requirements

relating to food an feed products.


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HACCP system

Hazard analysis and critical control point (HACCP

system)was developed in the 1980s by Codex.

HACCP plans incorporate issues such as cleaning and

general sanitation which are hard to monitor and even

harder to validate, e.g. hand-washing.

There are often over 20 Critical Control Points (CCPs) per

plan.

HACCP systems in place with differing requirements and

implementations in different countries and for different

foodstuffs


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Advantages of ISO 22000

ISO 22000,Food safety management systems--

Requirements for any organization in the food chain

Constitutes an internationally recognized food safety

management system standard

Incorporates HACCP and goes beyond it

Specifies PreRequisite Programmes(PRPs) in lieu of CCPs

Identifies Operational PRPsas those PRPs which are essential


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Reasons for ISO 22000

Increasing number of national regulations and controls relating to

food safety

Food producers have to comply with different requirements

depending on the country and customer

Retailers are certifying and inspecting food producers and have

set a variety of specific criteria BRC, IFS,)

ISO 22000simplifies the process

Requirements of ISO 22000 are genericand are intended to be

applicable to all organizations in the food chain regardless of size

and complexity


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Food Chain Interactions

Essential:Ensure that the Relevant Food Safety Hazards

are identified and adequately controlled

at each step within the food chain.

Inside theorganization

With customers

With organizations upstream in the food chain

With organizations downstream in the food chain

With suppliers


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Food chain


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What does ISO 22000 do?

ISO 22000specifies the characteristics of a management

system designed to

carry out the hazard analysis,

design the HACCP plan,

identify the prerequisite programmes (PRP), and

select the operational prerequisite programmes


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Definition of PRP

PRP - prerequisite programme

basic conditions and activities that are necessary to

maintain a hygienic environment throughout the

food chain suitable for the production, handling and

provision of safe end products and safe food for

human consumption

The PRPs n eeded depend on the segment of the foodchain in w hich the organization o perates and the typeof org anizat ion.

Docum ents shou ld speci fy how act iv it ies included inthe PRPs are managed.


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Operational PRPs

ISO 22000 reorganizes the traditional concept by

dividing control measures into two groups (PRPs

and CCPs) and introduces the third group, which is

the operational PRPs:

operational prerequisite programme

PRP identified by the hazard analysis as essential in

order to control the likelihood of introducing food

safety hazards, or contamination, or proliferation of

food safety hazards in the products or in the

processing environment

PRPs and operational PRPs


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PRPs andoperational PRPs

What are the main differences between PRPs and operational PRPs?

Purpose of the control measure PRP OPRP

Maintenance

the basic hygienic

conditions and activities

Yes No

Controlling hazards identified by hazard

analysis and need to be controlled

No Yes

Validation is required No Yes

Categorization of Control Measures


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Categorization of Control Measures

Control measures

Prerequisite

programmes

Operational

prerequisite

programmes

HACCP plan and

its critical control

points

Basic conditions and

activities.

PRPs do not need validation

but their effectiveness shall

be verified periodically.

Control measures identified by the hazard analysis.

Both shall be validated and verified.


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Validation of control measure combination

Validation includes such activities as:

reference to validations carried out by others,

experimental trials to simulate process conditions;

biological, chemical and physical hazard data collected

during normal operating conditions;

statistically designed surveys or mathematical modelling

use of a guide approved by competent authorities.


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Literature

Our plans

Are we doing things right?

Verification

Are we doing the right things?

Validation

Our plans Our activities

Verification and validation

ISO 22000 O i


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ISO 22000 Overview

ISO 22000allows an organization (even small or less

developed ones ) to implement an externallydeveloped combination of control measures.

ISO 22000can be applied independently of othermanagement system standards.

However, it can easilybe integrated with existingrelatedmanagement systems.


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ISO 22000 and ISO 9001

The structure of ISO 22000 is aligned with ISO 9001:2000

in order to enhance the compatibility of the two standards

for the benefit of the users.

ross-references between ISO 22000 and ISO 9001 are

provided in Annex A.

An organization already certified to ISO 9001 will find it

easier to obtain certification to ISO 22000.


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M i t f ISO 22000


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Main concepts of ISO 22000

Individual organizations are free to choose the necessary

methods and approaches to fulfil the requirements of ISO

22000.

ISO 22000 is particularly intended for organizations that

seek a more coherent and integrated food safety

management system than is normally required by law.

It is important to note that certification of an ISO 22000

FSMS is a management system certification

and not a product certification.

M i d t f ISO 22000


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Main advantages of ISO 22000

Internationally recognized.

Auditable.

Applicable in varied contexts.

Flexible.

Easily combinable with other management systems

and/or with the HACCP method.

Supported by other ISO deliverables (ISO/TS 22003;

ISO/TS 22004 and ISO 22005).

ISO 22000 is widely implemented


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ISO 22000 is widely implemented

Although ISO 22000 was published only a year

ago, it has already been implemented by morethan 50 countries, and at least 350 companies

have been certified to it.

2

Potential of ISO 22000


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Potential of ISO 22000International coherence among many GMPs

EFSIS

Nestl NQS

FAMI-QS

GMO

ISO 9 1

GMP standard for Corrugated &Solid Board IFS

GFSIGuide

SQF

AG 9000

ISO 14001

McDonalds system

Kraft food system

Eurepgap

Friesland Coberco FSS

DS 3027

BRC-IoP

BRC-Food

Dutch HACCP

Irish HACCP

M&S system

Aldi system

Waiterosesystem

GMP GTP

ISO/TS 22003


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ISO/TS 22003

ISO/TS 22003,

Food safety management systems

Requirements for bodies providing audit and

certificationof food safety management systems

TC 34 needed the assistance of and its liaison

organizations, particularly ISO/CASCO and the

International Accreditation Forum (IAF).

Therefore, a joint working group with ISO/CASCO was

established for the elaboration of ISO/TS 22003.

Reasons for ISO/TS 22003


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Reasons for ISO/TS 22003

Certification of a Food Safety Management System (FSMS)

provides independent demonstration that the FSMS of the

organization

conforms to specified requirements,

is capable of consistently achieving its stated policy

and objectives, and

is effectively implemented.

ISO/TS 22003gives generic requirements for the

certification bodies.

ISO 22000 and Conformity Assessment


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ISO 22000 and Conformity Assessment

The ISO 22000 requirements can be used as the basis of

a food safety management system and assessed under

Supplier

s Declaration of Conformity, 2

nd

party

inspection or 3rd party certification

ISO/TS 22003 adds specific guidance related to assessing

compliance with ISO 22000 to the requirements for the

certification of management systems according to

ISO/IEC 17021

Qualifications of FSMS auditors according to


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gproduct/service category

The FSMS auditors shall

have general knowledge

of microbiology and

chemistry

They shall be educated in

the food industry category

in which they will

conduct FSMS audits

Qualifications of FSMS auditors (cont)


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Qualifications of FSMS auditors (cont)

They shall have successfully

completed training in audit

techniques based on ISO 19011 and

in food safety issues relating to

FSMS (e.g. ISO 22000)

For a first qualification, they shall

have performed within the last

three years at least 12 FSMS audit

days in at least four organizations,

under the leadership of a qualified

auditor.

Annex A: Food chain categories (1)


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Category

codes

Categories Examples of sectors

A Farming 1 (Animals)

animals; fish; egg production; milk production;

fishing; hunting; trapping

B Farming 2 (Plants)

fruits; vegetables; grains; spices; horticulture

products

C

Processing 1 (perishable

animal products) meat; poultry; eggs; dairy and fish products

D

Processing 2 (products with

long shelf life at ambient

temperature)

fresh fruits and fruit juices; preserved fruits;

fresh vegetables; preserved vegetables;

E

Processing 3 (perishable

vegetal products)

canned products; biscuits; snacks; oils;

drinking water; beverages; pasta; flour;

sugar; salt

F Feed production animal feed; fish feed;



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Category

codes

Categories Examples of sectors

G Catering hotels; restaurants

H Distribution retail outlets; shops; wholesalers

I Services

water supply; cleaning; sewage; waste

disposal; development of product, process

and equipment; veterinary services

J Transport and storage transport and storage

K Equipment manufacturing process equipment; vending machines;

L (Bio)chemical manufacturer

additives; vitamins; pesticides; drugs;

fertilizers; cleaning agents; biocultures;

M

Packaging material

manufacturing

packaging material;

Annex B: Audit time


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Guidance is given on the minimum audit timeneeded,depending on the food chain category involved, number of

employees, number of sites, etc.Minimum audit time for single site, Ts:

Ts = D + H + MS + FTE

where D is the basic on-site audit timeH is the audit days for additional HACCP studies

MS is the audit days for absence of relevantmanagement system

FTE is audit days per number of employees.


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ISO/TS 22004

ISO/TS22004,Food safetymanagement sys tems Guidanceon the app licat ion o f ISO 22000

ISO/TS 22004 was published in 2005.

What is the aim of ISO/TS 22004?


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What is the aim of ISO/TS 22004?

It provides users with explanations that will helpin the application of the standard

It provides additional information for smalland/or less developed organizations on how toimplement certain requirements

ISO/TS 22004deals with those parts of ISO 22000

which need special attention.

Guidance in ISO/TS 22004


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Guidance in ISO/TS 22004

The guidance helps:

to avoid misinterpretation of ISO 22000;

to clarify the meanings of its terms; and

to eliminate confusion.

Introduction to ISO/TS 22004


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The design and implementation of the systemare influenced by many varying factors:

the type of food safety hazard;

the products provided;

the processes employed;the size and structure of the organization.

Therefore, only generic guidance can be

given.

Guidance for small and/or less developedorganizations


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organizations

In an organization with only one or two people in the management

structure, an internal audit may be carried out as follows:

The manager steps back from direct involvement in the business

operations and tries to be objective about the audit.

Cooperation of another small business allows each to provide the

internal audit for the other.

External parties (e.g. chamber of commerce, consultant,

inspection agencies) could provide independent auditors.

Assessment and combination of controlmeasures


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measures

The guidance in ISO/TS 22004 lists the informationrequired to assess the effect of a control measure.

More than one control measure is often required to

control specific food hazards

More than one food safety hazard may be controlled

by the same control measure (but not necessarily to

the same extent).

ISO 22000 Checklist


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ISO and the ITC have recently prepared a checklist to facilitate the use

of ISO 22000, namely

ISO 22000 Are you ready?

This comprehensive document:

Quotes a part from ISO 22000.

Raises a question relating to the quoted part.

If the reply is

"Yes"

it says

Go to the next question

If the reply is"No" it says See guidance below

Detailed explanation is then given to assist in answering the question.

The ISO 22000 Checklist comprises a paper version and a CD Rom. It is

available in English, French and Spanish.

Traceability


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y

ISO 22005, Traceability system in the feed and food chain

General principles and basic requirements for system design and

implementation ,will be published in 2007

The traceability of food products "from the farm to the fork"

is an important requirement of ISO 22000.

ISO 22005 will help food producers and manufacturers to

comply with the relevant statutory and regulatory

requirements,

It will also be an important tool to prove the origin of food.

Use of ISO 22005


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Choice of traceability system is influenced by regulations,

product, its characteristics and customer expectations

Implementation by an organization of a traceability

system depends on:

technical limits inherent to the organization and

products

cost/benefits of applying such a system.

ISO 22005 and Codex


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ISO 22005 complements CCFICS (Codex) Principles for

Traceability/Product Tracing as a tool within a Food

Import and Export Inspection and Certification System

ISO 22005 does not specify how or when regulators

require or apply traceability/product tracing

This is the work of Codex

CCFICS participated in the ISO Working Group (via

nominated expert(s) from Codex)


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Thank you for your kind attention!

Thank you

for your

kind

attention

Documents

ISO 22000 Pauline Jones