Food Safety Forum ASU Argentina

FSSC 22000
Bob Readel, FSSC Regional Inspector, The Americas

Global Companies
Using or Accepting FSSC 22000

Specifics
FSSC 22000
Scheme has 3 required components:
1.ISO 22000 (Food Safety Management System) provides
a common framework across the entire supply chain to
manage requirements, communication internally &
externally, and continually improve the system
2.Sector specific Pre-Requisite Programs (BSI PAS/TS
standards)
3.FSSC 22000 adds specific requirements to ensure
consistency, integrity, and provide governance
Without these 3 components it is not FSSC 22000 or GFSI approved

Scheme Requirements
Features of the FSSC 22000 scheme
Scope, content, references, terms & definitions
Requirements for the food safety management system
Food safety management system, PRPs, additional
guidance
Requirements for providing certification
Approval by the Foundation, accreditation, audit
process, harmonization, providing guidance and
information
Requirements for providing accreditation
Accreditation process, providing information
Regulation for the Board of Stakeholders

ISO 22000:2005 - Food Safety Management Systems

ISO/TS 22003:2013 -Requirements for bodies providing audit

PAS 222

ISO/TS
2200222002-3

ISO/TS
2200222002-1

ISO/TS
2200222002-4

ISO/TS
2200222002-5

ISO/TS
2200222002-2

ISO/TS
PAS 221

Current Statistics
8000 certificates
96 licensed CBs globally
Food scope (ISO 22002-1)
77 CBs with full license
16 CBs with provisional license, working on accreditation
Packaging scope (ISO 22002-4)
22 CBs with a full license
23 CBs with provisional license
1000 certificates
Feed scope (PAS 222): first CB applied
1,500 auditors
146 countries
Database with certified organizations
15 licensed training organizations

FSSC 22000 Global Distribution

Top 5 countries:
1. USA
2. China
3. Japan
4. India
5. The Netherlands

Integrity Program
FSSC 22000 has an integrity program in place to review the
performance of all licensed certification bodies
Continuous monitoring program
Integrity Manager, independent expert and regional inspectors
The integrity program is risk based and covers:
Stringent acceptance procedure of the CBs
The review of audit reports
CB office and witness audits
Screening audit data
Auditor database
Sanction policy & appeal and complaint procedure

CB Office Audit Breakdown

Non-Conformities from Office Audits

Non-Conformity Breakdown Office Audits

Desk Reviews / CB Office Audit Summary

Top 5 Non-conformities:
Auditor qualification, training and experience
Audit scope/certificate scope
Audit report content
Audit duration
Certification audits

Desk Reviews / CB Office Audit Summary

Auditor qualification, training and experience
o Training logs and audit logs are not always readily
available
o Lack of documented continuous training program
o Training certificates often over 5 years old
o Audit logs not complete and up-to-date; required
information not always available or missing

Desk Reviews / CB Office Audit Summary

Audit scope/certificate scope
o Scope descriptions are far too often too detailed
describing subjects not relevant to the scope
description
o Guidance document located on the FSSC website is
often overlooked but gives insight into this areas
requirements.

Desk Reviews / CB Office Audit Summary

Audit report content:
o CBs often design their own narrative audit report
making it difficult to assess compliance to the basic
FSSC requirements. Areas of concern include:
An FSSC audit is always a full audit as outlined in FSSC
Scheme Document Part II, Appendix IIB
The Result Area is to contain Compliance or Non-Compliance
items
The Summary Section, positive evidence of confirming
compliance shall be provided

Desk Reviews / CB Office Audit Summary

o Description of Non-Conformities not being identified as
per the FSSC Scheme Documents and ISO
Standards.
Only 3 types are identified
Opportunity for Improvement FSSC Part I
Minor Non-Conformity
Major Non-Conformity
Area of Concern Non-Conformities identified during a
Stage 1 Audit (ISO 17021)

Desk Reviews / CB Office Audit Summary

o Opportunities for Improvement (OFI)
Audit reports having more than 5 OFIs not
acceptable
OFIs in excess of 5 even if found in different areas
generally indicate a systemic breakdown which should be
noted as a Minor or a Major depending on the severity and
risk to Food Safety.

OFIs are not severe enough to be called out as a

Minor NC but still need to be brought to the
attention of the organization
Seek guidance on the FSSC Website

Desk Reviews / CB Office Audit Summary

Audit duration
o Audit plan supporting the audit time calculation is often
missing
o CBs are seen designing their own calculation tool that
is not compliant with the requirements.
o Must follow ISO 22003 and the FSSC Scheme
Documents.
o Calculation Tool and Guidance Document are
available on the FSSC Website

Desk Reviews / CB Office Audit Summary

Certification Audit
o CB having trouble organizing the Certification Audit or
Upgrade Audit
Upgrade Audit : not always clear if it is an upgrade from ISO
22000 to FSSC 22000.
Certification Audit: not always noted in Stage 2 that all of
the NCs from Stage 1 are assessed and closed
Have seen Stage 1 and Stage 2 audits combined and this is
not allowed and CB procedures are not always clear on this

Enter Manufactures
ISO 22000 FSSC 22000
1. Validate existing certificate:
full stage 1 and 2 audit will not be required
on-site audit is mandatory
including verification of auditor qualification and audit
duration against FSSC 22000 rules

2. Do a full FSSC 22000 audit including ISO

22000, the applicable technical specification for
sector PRPs and the additional FSSC
requirements

Desk Reviews / CB Office Audit Summary

Companies with Multiple Sites
o Guidance described in ISO 22003, clause 9.1.5.1
o A single certificate may contain multiple sites
All sites must be physically audited

o Not all sites are audited although the certificate includes

all sites belonging to the legal entity
A certificate must be issued for each site

o One overall report is made for the audit without mention

of the individual sites
An individual report is required for each site
NCs are not always referenced to the individual site

Enter Manufactures
Technical Updates
ISO 22003: 2013 introduces a new set of
designations for the categorization
Revised scope Guidance has been published
PAS 223 vs ISO 22002-4 - Packaging
Multisite guidance is outlined in the standard
Classification of non conformities guidance on
NC grading and time frame to close NCs has
been published

Objectives FSSC 22000 for 2014

Intensify communication and continue developing guidance
Increase visibility through regional representation (seminars, events,
etc.) and communication
o Currently scheduling an FSSC informational meeting on Nov. 19 after
the Food Safety Consortium Meeting (Nov. 17-18) in Schaumburg,
Illinois

Global harmonization day for all CBs - an annual, required event

o Amsterdam, October 22-23, 2014

Continue to seek cooperation with authorities

Extension of the scheme to other food supply chain sectors
Continued strong involvement in GFSI programs and representation on
their working groups
Strength the integrity program

Keep in touch
Cornelie Glerum, Secretary General
E-mail info@fssc22000.com
Phone (+31) 183 645 028
www.fssc22000.com
Join us at LinkedIn: Group FSSC 22000
Follow us on Twitter: @FSSC22000