Introduction to FSSC 22000 Food Safety

Management System
April 2015
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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
Current Climate
• 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?
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: Requirements:
- ISO 22000 - ISO 22003
- ISO/TS 22002 - ISO 17021
- PAS 223 - 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
 10

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

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
Mgt
• System Management System
Elements
• Prerequisite programs
HACCP
Principles
(Codex
Alimentarius)

Good Manufacturing
Practices
 20

ISO 22000:2005
• 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
 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

Food Safety Management System
Contracts
PRPs

HACCP Plan
Typical Operating
FSMS Procedures
Documents

Product
Operational PRPs Specifications
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
Who Developed PAS 220:2008/
ISOTS22002-1:2009
• 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

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)
 29

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

 30

FSSC 22000 Initial Certification Cycle

GAP Analysis/ FSSC 22000

Stage 1 Audit Stage 2 Audit
Pre-Assessment Certificate
FSSC 22000 Certification Cycle
Stage
1 Audit
Within 6
months Stage
2 Audit
Within 12
months
Surv. 1

Within next
calendar year
Surv. 2
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
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.
This requires an action plan to be
approved by the auditor for certification
to proceed or be maintained.
Major Non Conformity
assigned at Stage 2, surveillance, and
recertification audits
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 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
 40

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.
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)
What Comes Next?
Apply For Certification
• Application
• Preliminary audit
• Certification audit
• Certification
• Surveillance (compliance) audits
• Triennial (recertification) audit
• Optional activities
Steps to Certification
Application & Review

Initial Certification
Stage 1 Stage 2

Non Conformities
Corrected

Certification

Surveillance Visit
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