Introduction to FSSC 22000 Food Safety Management System

April 2015��

Purpose of this Presentation

Discuss who and what is FSSC 22000

Review the benefits of the FSSC 22000 standard

Review the basic elements of the scheme

Describe what is involved in each of the elements of the scheme

Outline how are FSSC 22000 audits are completed

Review how are certificates issued and what is the scoring of the

audit

Discuss how does the FSSC 22000 standard differentiate from

other GFSI standards

Current Climate

• Food safety systems today are not preventing food-borne illness and death

• Businesses face catastrophic consequences from media-hyped adverse

events

• We depend more on imported food products in our global supply chains

• Current regulatory framework and inspection cannot secure the food supply

chain on its own

• Retailers and manufacturers, in response to consumer demand, are driving

a change to a safer, more secure, and sustainable food supply chain

• Food manufacturing is taking a path well travelled by other industries:

Aerospace: How did they make it the safest form of travel?

Automotive: How did they eliminate defects and improve quality?

Electrical: How did they increase safety and reduce deaths?

Forestry: How did they demonstrate environmental responsibility?

Current Climate

Public & Private Sector Responses

• Codex Alimentarius Commission

• HACCP

• Government Initiatives

• Private Sector Schemes

• GFSI Benchmarking

• International Standards System Framework

Current Trends

• Mandated compliance by both retailers and manufacturers in the Americas will continue to grow

• Benchmarking of audit schemes is a good first step

• Further convergence between food safety standards will happen, like in other industries

• GFSI (Global Food Safety Initiative) recognized as a benchmark process for food safety management schemes

• Further inclusion and recognition of 3rd party certification programs in regulation

Standard Owner for FSSC 22000

• The Foundation for Food Safety Certification was founded in 2004

• Non profit organization

• Foundation facilitates and owns the schemes and manages its copyright

• Maintains the license agreements with accredited CBs

• Incorporates:

68 associated Certification Bodies for FSSC 22000

The actual responsibility and authority for the content of the scheme resides with Board of Stakeholders

Foundation for Food Safety

Certification

FSSC 22000

Board of

Stakeholders

Standards:

- ISO 22000

- ISO/TS 22002

- PAS 223

Requirements:

- ISO 22003

- ISO 17021

- GFSI guidance document

What are the benefits of FSSC 22000?

• Fills a gap between ISO 9001:2008 and HACCP

• Contributes to a better understanding and further development of Codex

HACCP

• Auditable standard with clear requirements

• System approach rather than product approach

• Enables the company to demonstrate due diligence

What is FSSC 22000? • FSSC 22000 is a Food Safety System Certification based on ISO 22000 and ISO

TS 22002-1 (PAS 223 for packaging)

• ISO TS 22002-1 gives the requirements for Prerequisite Programs for food

manufacturers.

• This document was added to ISO 22000 to create a system that could be

benchmarked by the Global Food Safety Initiative (GFSI)

• Some large retailers require suppliers to have a GFSI benchmarked scheme

• It provides a single, internationally recognized food safety management system

• Scheme operated by the Foundation for Food Safety Certification based in the

Netherlands

• 7,300 sites globally and 700 in the North America

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Elements of FSSC 22000

• ISO 22000

• ISO/TS 22002-1

• ISO/TS 22003

• PAS 223

What is FSSC 22000? • FSSC 22000 is a Food Safety System Certification based on ISO 22000 and ISO

TS 22002-1 (PAS 223 for packaging)

• ISO TS 22002-1 gives the requirements for Prerequisite Programs for food

manufacturers.

• This document was added to ISO 22000 to create a system that could be

benchmarked by the Global Food Safety Initiative (GFSI)

• Some large retailers require suppliers to have a GFSI benchmarked scheme

• It provides a single, internationally recognized food safety management system

• Scheme operated by the Foundation for Food Safety Certification based in the

Netherlands

• Approximately 1800 certificates with about 300 in the USA

The content of the scheme • Features of the scheme

• Scope, content, references, terms & definitions

• Requirements for the food safety management system

• Food safety management system, PRP’s, additional, guidance

• Requirements for providing certification

• Approval by the Foundation, accreditation, audit process

• Harmonization, providing information

• Requirements for providing accreditation

• Accreditation process, providing information

• Regulation for the board of stakeholders

Who is the scheme for? • FSSC 22000 is designed for manufacturers who supply their products (i.e. national

brands or private label) to major food retailers or their ingredients to food

manufacturers

• Food manufacturers that process or manufacture:

Animal products (meat, poultry, eggs, dairy & fish products) [ISO C]

Perishable vegetal products [ISO D]

Products with a long shelf life [ISO E]

Food ingredients such as additives, vitamins and bio-cultures [ISO L]

Food packaging material manufacturing [ISO M]

• For details see FSSC 22000 guidance document on certification scopes

[www.fssc22000.com/en/page.php]

• Manufacturers already certified against ISO 22000 will only need an additional review

against the ISO/TS 22002-1

Compatibility with Other Management Systems

• ISO 9001 – Quality Management Focused

• ISO 14001 – Environmental Management Focused

• OHSAS 18001 – Occupational Health and Safety

• Codex HACCP etc.

• Annex A and Annex B provide cross references to ISO 9001 and HACCP

Relationship between Food Safety Management Systems and ISO 9001:2008

• A “quality management system” such as ISO 9001:2008 includes all quality elements that form part of an organization’s operation

• The majority of food safety standards adopt many of the quality management

system principles but with a clear focus on issues relating to the food industry

• ISO 9001:2008 and a food safety management system should be regarded as

complementary

• ISO 9001:2008 covers how a business is organized and operates effectively

A Food Safety Management System addresses specific ‘Food Safety’

issues

ISO 22000 Food Safety Management System • ISO 22000 is a Food Safety Management System (FSMS) that uses a management

system approach and HACCP requirements.

• Published August 2005

• Published in response to the proliferation of private food safety standards

• The goal of ISO 22000 is to provide one internationally recognized standard that

can be applied to any organization in the food chain.

• Its structure complements the quality management system requirements defined by

ISO 9001:2008

• Provides an internationally recognized certification program for food safety

management systems

What is ISO 22000:2005?

ISO 22000 combines generally recognized key elements to ensure food

safety along the food chain:

• Interactive Communication

• HACCP Principles

• System Management

• Prerequisite programs

Mgt

System

Elements

HACCP

Principles

(Codex

Alimentarius)

Good Manufacturing

Practices

• Scope

• Normative References

• Terms and Definitions

• Food Safety Management System

• Management Responsibility

• Resource Management

• Planning and realization of Safe Products

• Validation, Verification and Improvement of the Food Safety Management

System

ISO 22000:2005

20

ISO 22000 Standard

• Section 4: Food Safety Management System

• Section 5: Management Responsibility

• Section 6: Resource Management

• Section 7: Planning and Realization of Safe Products

• Section 8: Verification, Validation and Improvement

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PRPs

Typical

FSMS

Documents

Product

Specifications Operational PRPs

HACCP Plan

Operating

Procedures

Contracts

Food Safety Management System

ISO TS 22002-1:2009

• ISO Technical Specification 22002-1:2009 replaces BSI PAS 220 (withdrawn 2012)

• Sets out Prerequisite programs on food safety for food manufacturing

• Provides detail on PRP's to meet ISO 22000 requirement 7.2.3

• Harmonization of food manufacturer’s PRP’s

• Meeting GFSI requirements on PRP’s

• Intended to used in conjunction with ISO 22000 not in isolation

• When combined with ISO 22000 becomes the basis for FSSC 22000, a GFSI recognized scheme

BSI PAS 220:2008 & ISO TS 22002-1:2009

• FSSC 22000 secured GFSI benchmarking based on ISO 22000:2007 &

BSI PAS 220:2008

• ISO TS 22002-1:2009 is PAS 220 elevated to an ISO standard

• BSI PAS 220:2008 has been withdrawn

• ISO TS 22002-1:2009 replaced PAS 220 starting in 2012

• British Standards Institution (BSI) coordinated the development of PAS 220:2008.

• The development of PAS 220:2008 was sponsored by the Confederation of the Food

and Drink Industries of the European Union (CIAA) and the major food

manufacturers, DANONE, Kraft, Nestlé and Unilever, contributed to the development

of the Specification.

• Additionally, the PAS 220:2008 development Steering Group included

representatives from the Food and Drink Federation (FDF), McDonald’s, General Mills Europe (representing the FDF Food Hygiene Committee), the French National

Association of Food Industries (representing CIAA) and certification bodies.

• In 2009, ISO fast-tracked PAS 220 to international status

Who Developed PAS 220:2008/ ISOTS22002-1:2009

ISO 22000 and TS 22002-1

• ISO 22000 set out the principles of food safety management and HACCP,

developed by Codex to identify, prevent and control food safety hazards

• There were several areas where the prerequisites did not meet all the

requirements of the GFSI Guidance Document

• The CIAA (the Confederation of European Food and Drink Manufacturers) took

on the challenge to ‘bridge the gap’ by combining the standard with the prerequisite program PAS 220 released by BSI

• In 2009, ISO published ISO TS 22002-1 elevating PAS 220 to an international

standard

• In 2012, BSI has withdrawn PAS 220 and FSSC 22000 will no longer be using it

as a basis for certificates

FSSC 22000 Food Chain Categories

• C Processing 1 (Perishable animal products) including all activities after

farming, e.g. slaughtering meat, poultry, eggs, dairy and fish products

• D Processing 2 (Perishable vegetal products) fresh fruits and fresh

juices; preserved fruits; fresh vegetables; preserved vegetables

• E Processing 3 (Products with long shelf life at ambient temperature)

canned products; biscuits; snacks; oil; drinking water; beverages; pasta;

flour; sugar; salt

• L (Bio)chemical manufacturing additives; vitamins; pesticides; drugs;

fertilizers; cleaning agents; biocultures

• M Packaging material manufacturing packaging material

*these food chain categories have changed with the release of ISO 22003:2013

Elements of FSSC 22000 Certification

Certification audits

• Stage 1 audits – “readiness evaluation”

• Stage 2 audits – “facility assessment”

• Audit length based on number of HACCP

plans, number of production lines, number

of employees, and presence of an existing

Management System (eg. ISO 9001)

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Elements of FSSC 22000 Certification • Certification is good for 3 years, not 1 like

other GFSI standards

• A surveillance audit must be conducted

12 months after the initial certification

audit.

• A second surveillance is conducted in the

following calendar year

• Surveillance audit length is less than

initial audit time but based on the same

factors for initial audit length

Certification Requirements

• Certification bodies operate in accordance with ISO 17021 and ISO 22003

• Audits carried out in accordance with ISO 19011 auditing practices

• Audit day must see as many product lines being manufactured as possible

• All scheme requirements must be audited at every audit

• Detailed audit report issued with any nonconformities identified

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FSSC 22000 Initial Certification Cycle

GAP Analysis/ Pre-Assessment

Stage 1 Audit Stage 2 Audit FSSC 22000

Certificate

FSSC 22000 Certification Cycle

Stage 1 Audit

Stage 2 Audit

Surv. 1

Surv. 2

Within 6

months

Within 12

months

Within next

calendar year

FSSC Non-Conformities/Areas of Concern

• Area of Concern (AOC): assigned at the Stage 1 audit. Will identify an area of the

system likely to become ‘Non-conformance’ at Stage 2 Audit. Does not require

closure to proceed.

• Opportunity for Improvement: assigned at Stage 1, Stage 2, surveillance, and

recertification audits. Not considered a “non-conformance”, but a statement is made,

which may identify areas for improvement however shall not make specific

recommendation(s). This does not require closure to proceed.

FSSC Non-Conformities/Areas of Concern

Minor Non Conformity Major Non Conformity

assigned at Stage 2, surveillance, and

recertification audits

assigned at Stage 2, surveillance, and

recertification audits

This is an area of the system for which

the client is required to investigate

potential non-conformity that does not

effect the functioning of the system or

the food safety of the product.

Based on objective evidence, the

absence of, or a significant failure to

implement and/or maintain requirements

of the applicable standard.

Such issues may raise significant doubt

as to the capability of the management

system to achieve its intended outputs.

This requires an action plan to be

approved by the auditor for certification

to proceed or be maintained.

This requires evidence of a corrective

action, along with a root cause analysis,

being implemented and functioning to

proceed to certification or maintain

certification.

FSSC Non-Conformities/Areas of Concern

• If during the next audit it is noted that an action plan for a Minor non-

conformity from the previous audit does not resolve the non-conformance;

the auditor will now raise the level of the non-conformity to MAJOR.

• Major non-conformances have to be closed within 90 days for those that

are noted at a Stage 2 audit and 60 days for all other audits.

• In some cases an on site follow-up audit may be necessary to close non-

conformances that cannot be completely verified by the auditor through

email.

FSSC Scoring & Rating • There is no score with this audit

• There is no rating assigned; there is either a recommendation of

maintain/grant certification or suspend/do not grant certification

• As with some non-conformance closure; a follow-up audit can be

conducted so that certification can be granted for audits that are evaluated

as being suspend/do not grant certification

Audit Checklist • There is no set audit checklist for FSSC 22000

• Checklists are created by the certification body but the evaluation must

include all elements of ISO 22000, ISO/TS 22002 or PAS 223, and GFSI

audit requirements

• An audit report is created at the completion of each audit which outlines

the observations made during the evaluations

FSSC 22000 Audit Procedures • Facility must be informed of auditor names prior to the audit

• Audits can be conducted in a team format

• Auditors shall be accompanied during all audits

• If a Stage 2 audit is not conducted within 6 months of the Stage 1

audit, the Stage 1 audit shall be repeated.

Auditor Training

• CB is responsible for auditor training and must justify to accreditation body

• Training requirements listed in ISO/TS 22003

• Training elements

• Education – post-secondary education

• Food safety training

HACCP

Pre-requisite programs

• Audit training

Audit techniques based on ISO 19011 (ASQ)

ISO 22000 standard

• Experience

5 years experience in food chain related industry

At least 12 audit days of food safety management audits within last 3 years

Auditor Competency

• CB must make sure that auditor can demonstrate competency in the

following areas:

Audit principles

Management systems

Organizational situations

Applicable regulations

HACCP

Pre-requisite programs

Identification of food safety hazards

Control measures

Benefits of ISO TS 22002-1:2009 • Food industry driven and developed and supported by key manufacturers

and trade associations.

• Harmonizes prerequisite programs best practice for food manufacturing.

• Meets the PRP expectations and requirements of food manufacturing

stakeholders, including food retailers and foodservice providers.

• Is fully auditable enabling organizations to demonstrate compliance with

industry best practice.

• ISO/TS 22002-1 enhanced initiatives to harmonize global food safety

standards.

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Additional FSSC22000 Requirements

FSSC 22000 Requirements – Part 1

• ISO/TS 22004:2005 – provides guidance

• Definition of “food safety”

• Chain Approach

• Inventory of applicable regulations

• Specifications for services (Appendix 1A)

• Supervision of personnel in application of food safety principles (Appendix

1A)

Apply For Certification

• Application

• Preliminary audit

• Certification audit

• Certification

• Surveillance (compliance) audits

• Triennial (recertification) audit

• Optional activities

What Comes Next?

Steps to Certification

Surveillance Visit

Application & Review

Initial Certification

Stage 1 Stage 2

Non Conformities

Corrected

Certification

How is FSSC 22000 different from other GFSI standards?

How is FSSC 22000 different from other GFSI standards?

• Scope of audit is system based, not product based

• Certification is for 3 years, not 1 year

• Thereeare noe“critical”efindings in the audit

• There is no scoring or rating provided; you are either certified or not

certified

• Corrective actions need only be confirmed for those deficiencies

classified as MAJOR

• Audit duration for surveillance audits less than those for Stage 2 and

recertification audits

• Program is ISO based and does not have scheme specific requirements

that other programs have

THANK YOU