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INLAC 2008 - LABROS BOUKLIS 1

ISO 22000 – Gestión y buenas prácticas en el sector alimentos

Labros Bouklis

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Food Safety

Assurance that food will not cause harm to the consumer when it is prepared and/or eaten according to its intended use.

Source: Codex Alimentarius (WHO)

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Food Safety

Protecting People

Keeping the Employees and Customers

Preventing Food Safety Errors

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Views

“Compromising on food safety is not a way for a farm or a company to reduce costs. It is actually a very dangerous path, not only for consumers, but also for the farm or company itself and for the sector as a whole”.

David Byrne, European Commissioner for Health and Consumer Protection

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Views II

“In a globalized world we all swim in a single microbial sea”

WHO Director General

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Statements:

FOOD SAFETYFOOD SAFETY

““AssuranceAssurance that that foodfood will will not cause harmnot cause harmto the to the consumerconsumer for whom it is for whom it is preparedprepared and/or and/or eateneaten according to its according to its intended useintended use””

WHOWHO

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COMMITMENTCOMMITMENT

“ We, the Heads of State and Government …reaffirm the right of everyone to have access to safe and nutritious food, consistent with the right to adequate food and the fundamental right of everyone to be free from hunger.”

Rome Declaration on World Rome Declaration on World Food Security, 1996Food Security, 1996

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Food Safety – Historical Background

First food law written in 2500 B.C.

Pakistan food laws are dated back 1876.First HACCP system was developed between NASA and Pillsbury in 1971.

Become a regulatory requirements in EU since 1998.US FDA also adopted the HACCP approach as part of control mechanism for food safety.

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Food Safety Management System

Why it is required?

Intense farming and processing of food

Increase in meals consumed outside home

Increase in ready to eat foods

More traveling across the world

Increased amount of exotic imported foods

Increase in number of susceptible people

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Food Safety Management System

FAMI‐QS

GMO

ISO 9001GMP standard for Corrugated &

Solid Board

EFSIS

IFS

GFSI Guide

SQF

AG 9000

McDonalds system

Kraft food system

Nestlé NQS

Eurepgap

Friesland Coberco FSS

DS 3027

BRC‐IoP

BRC‐Food

Ducth HACCP

Irish HACCP

M&S system

Aldi system

GMPGTP

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ISO 22000:2005

A management system designed to enable organizations to control food safety hazards along the food chain in order to ensure that food is safe at the time of consumption

ISO 22000:2005, clause 1

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ISO 22000:2005

Features;First global food safety standard.Harmonizes the voluntary international standards.Employs proven management system principles. Enables a common understanding of what a food safety management system is.

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ISO 22000:2005

Features;

Requires legal compliance checking

Integrates existing good practice

Internal and external monitoring

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ISO 22000:2005

Benefits;Overcomes many of the limitations of traditional approaches to food safety control.Potential to identify all conceivable, reasonably expected hazards.

Capable of accommodating the changes.

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ISO 22000:2005

Benefits;Help to target or manage resources to the most critical part of the food operation.Can promote international trade by equalizing food safety control and by increasing confidence in food safety.

Applicable to whole food chain.

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7.3.2 Food Safety Team7.3.2 Food Safety Team

7.6 Design and redesign of the HACCP

plan

7.6 Design and redesign of the HACCP

plan

7.3.5.2 Description of process steps and control measures

7.3.5.2 Description of process steps and control measures

7.5 Design and redesign of operational PRPs

7.5 Design and redesign of operational PRPs

7.8 Verification planning7.8 Verification planning

7.2 PreRequisite

Programs (PRP)

7.2 PreRequisite

Programs (PRP)

7.3.3 Product Characteristics7.3.3 Product Characteristics

7.3.4 Intended Use7.3.4 Intended Use

7.3.5.1 Flow Diagram7.3.5.1 Flow Diagram

7.4.4 Identification and assessment of control measures

7.4.4 Identification and assessment of control measures

7.4.3 Hazard assessment7.4.3 Hazard assessment

7.4.2 Hazard identification and acceptable levels

7.4.2 Hazard identification and acceptable levels

8.4 Validation of control measure combinations

8.4 Validation of control measure combinations

5

2

3

4

6.b

6.c-7

8-9-10

11

6.a

1

Steps added to Codex Alimentarius

Steps according to Codex Alimentarius

Food Safety Management System Improvement loop

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ISO 22005:2007 – TraceabilitySets out the “general principles and basic requirements for system design and implementation” of traceability system

Uses Codex definition of traceability

Requires food/feed business to:

Set food safety, quality & other objectives

Design a system that meets regulatory & customer requirements & specify the information to be obtained from its suppliers, collected within itself & provided to its customers

Establish procedures, documentation, etc

Implement the system (training, etc)

Monitor the system

Review it regularly & Update

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Food chain

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Entry of Hazards in Food Chain

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Food chain and process approach

Consideration to effect of the food chain on organization’s operation

Identification, application and management of a system of processes within the organization

Ongoing control over linkage, combination and interaction of individual processes within the system of processes

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Plan•What to do?•How to do it?

Do•Do what wasplanned

Check•Did things happenaccording to plan?

Act•How to improvenext time?

Process Approach

A desired result is achieved more efficiently when related resources and activities are managed as a process

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Common ThemeTraceability & Transparency

Processor

Supply ChainBeing able to trace materials & transportation from farmers / growers, to final package, and delivery to receiving company

Grower Suppliers

RetailQSRExport

Distribution

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Process Approach

Resource Processes

Product Design

Process Design

Project Planning

Production

Management Processes

Measurem

ent, Analysis, and Im

provement

OI

IO

I O

I O

I O

I O

I O

I O

Resource Processes

Product Design

Process Design

Project Planning

Production

Management Processes

Measurem

ent, Analysis, and Im

provement

OI

IO

IO

I OI O

I OI O

I OI O

I OI O

I OI O

I OI O

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Process Approach

Benefits;Lower costs and shorter cycle times through effective use of resources

Improved, consistent and predictable resultsFocused and prioritised improvement opportunities

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FSMS Process model

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Key elements

InteractiveCommunication

Systems Approachto FSM

Pre‐requisite Programs

HACCP Principles

ISO 22000:2005

Control Food Safety Hazards

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Increased demand for voluntary international standardsGlobalization of trade in products and services

Outsourcing and foreign investment

Deregulation/privatization of public services

The climate change challenge and energy efficiency mandates

Public demand for consumer safety, environmental protection, corporate social responsibility

Need for international solidarity to face global terrorism, pandemics and natural disasters & pace of innovation and convergence of new technologies

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World Trade Report 2005Section IITrade, Standards and the WTO

Economics of standards and trade

Institutions and policy issues

Standards in the multi-lateral trading system

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ISO/TC 34, Food productsWorking Groups on: Food Safety Management Systems, GMOs, Traceability systems, Food irradiation

Subcommittees (mostly test methods) on: Seeds; Fruits and vegetables; Cereals; Milk; Meat and poultry; Spices; Tea; Microbiology; Animal feeding stuffs; Fats and oils; Sensory analysis; Coffee

711 published standards, 55 participating countries, 49 observer countries

Active liaisons with Codex Alimentarius Commission

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ISO 22000 Family of Standards

New Family – initiated in 2001Four Standards so far:

ISO 22000:2005 – Food safety management system –Requirements

ISO 22003:2007 - Requirements for bodies providing audit and certification of food safety management systems

ISO TS 22004:2005 - Guidance on the application of ISO 22000

ISO 22005:2007 – Traceability in the feed and food chain

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What food businesses were looking for ?

Better planning, less post-process verification

More efficient & dynamic hazard control

Systematic management of prerequisite programs

Better documentation

Communication among trade partners

Resource optimization (internally & along food chains)

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ISO 22000 - OutlineSection 1 – ScopeSection 2 – Normative ReferenceSection 3 – Terms & DefinitionsSection 4 – Food Safety Management SystemSection 5 – Management ResponsibilitySection 6 – Resource ManagementSection 7 – Planning & Realization of Safe ProductsSection 8 – Verification, Validation & Improvement

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Scope: what is ISO 22000:2005 ?A management system standard (based on ISO 9001:2000) & specific to food safety management (not quality, etc)

Based on Codex - HACCP approach with some innovations

Designed for all segments of food chain & all types of food business (micro to global)

Enables a food business to plan, implement, operate, maintain and update a system to provide safe end products and demonstrate conformity with applicable regulatory requirements

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Easy to use Checklist

A new publication, in collaboration with ITC:ISO 22000, Food safety management systems - An easy-to-use checklist for small business - Are you ready?

Enables small businesses to assess their readiness to implement the new ISO 22000 standard

Available in Spanish

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ISO 22000: 2005

Scope

Normative references

Terms and definitions

Requirements

Annex(s)

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Application

All requirements of this International Standard aregeneric and are intended to be applicable to all organisations in the food chain, regardless of type, size and complexity.

This includes organizations directly or indirectly involved in one or more steps of the food chain

The standard allows small and/or less developed organization to implement an externally developedcombination of control measures

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ISO 22000 standard - Requirements

Section 4: Food Safety Management System (FSMS) – General Requirements

Section 5: Management Responsibility

Section 6: Resource ManagementSection 7: Planning and Realization of Safe ProductsSection 8: Validation, Verification and Improvement of the Food Safety Management System

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Section 4 – General Requirements

Scope of the Food Safety Management System

Documentation requirements

More than twenty six types of documents required by ISO 22000:2005

Twenty eight mandatory records required by ISO 22000:2005

Documents needed by the organization to ensure effective development, implementation and updating of the FSMS

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Section 4 – Documentation requirement

Mandatory documented procedures specified by ISO 22000:2005

Control of documentsControl of recordsCorrectionsCorrective actionsHandling potentially unsafe productWithdrawalsInternal audits

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Section 5 – Management Responsibility

Management commitment

Food Safety Policy

Food safety management system planning

Responsibility and authority

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Food safety team leader

External communication– Suppliers and contractors– Customers/consumers– Statutory and regulatory authorities– Other organizations

Internal communication

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Emergency preparedness and response Documented procedures to manage potential emergency situations and accidents

Management ReviewReview input: Food safety related requirements

Review output

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Section 6 – Resource Management

The organization shall provide adequate resources for;

Establishment

Implementation

Maintenance

Updating

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Human ResourceFood safety team and personnel impacting food safety

External experts

Competence, Awareness and Training

InfrastructureBuildingsProcess equipmentUtilitiesSurrounding areasSupporting services

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Work Environment

Measures to prevent cross contamination

Work space requirements

Protective work wear requirements

Availability and location of employee facilities

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Section 7 Planning and Realization of Safe Products

The organization shall plan and develop the processes needed for the realization of safe products

The organization shall implement, operate and ensure the effectiveness of the planned activities and any change to those activities including;

– Pre-requisite programmes ( PRPs)

– Operational PRPs

– HACCP plan

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Section 7 Planning and Realization of Safe Products

Prerequisite programmes (PRPs)

Preliminary steps to enable hazard analysis

Hazard analysis

Establishing the operational prerequisite programmes

(PRPs)

Establishing the HACCP plan

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Planning of safe food

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Decision tree

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Updating PRPs and HACCP plan

The organization shall update the following information;

– Product characteristics– Intended use– Process steps– Control measures– HACCP plan– Procedures instructions specifying PRPs

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Verification planning

Shall define the purpose, methods, frequencies and responsibilities for the verification activities

Output of planning suites to organization’s method of operation

Verification results enables analysis of the result of verification activities

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Traceability system

The system shall enables the identification of product lots and their relation to batches of raw material, processing and delivery records.

The system shall be able to identify incoming material from the suppliers and the initial distribution route of the product.

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Control of non conformity

Corrections

Corrective actions

Handling potentially unsafe products

Evaluation of release

Disposition of Nonconforming products

Withdrawals

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Validation, Verification and Improvement

The food safety team shall plan and implement the processes needed to validate control measures, its combination, and to verify and improve the FSMS.

Validation of control measure combination

Control of monitoring and measuring

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Validation, Verification and Improvement

FSMS verification– Internal audits– Evaluation of individual verification results– Analysis of results of verification activities

Improvement

Updating the Food safety management system

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FSMS Overview

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

ISO22005:2007 Traceability in the feed and food chain - General principles and basic requirements for system design and implementation

ISO 9001:2000. Quality management system-Requirements

Codex Alimentarius Food Hygiene Basic Texts (2001)

Reference websites: http://www.iso.org & http://www.codexalimentarius.net

INTRODUCTION TO ISO 22000:2005 “Food Safety Training Courses on International Standards & Regulations”: A project funded by European Union & implemented by URS

Overview of the ISO 22000 Family of Standards, Kevin McKinley, DOverview of the ISO 22000 Family of Standards, Kevin McKinley, Deputyeputy--SecretarySecretary--General, General, ISO Central Secretariat, Albert Chambers, ISO/TC 34 Working GrouISO Central Secretariat, Albert Chambers, ISO/TC 34 Working Group Expert and Vicep Expert and Vice--Chair, Chair, Canadian Advisory Committee, ISO/TC 34: Canadian Advisory Committee, ISO/TC 34: Joint UNCTAD/WTO Informal Information Joint UNCTAD/WTO Informal Information Session on Private Standards/ 25 June 2007, GenevaSession on Private Standards/ 25 June 2007, Geneva