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Food Safety Forum Food Safety Forum – – ASU ASU – – Argentina Argentina

FSSC 22000

Bob Readel, FSSC Regional Inspector, The Americas

Global Companies Using or Accepting 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

Specifics

Without these 3 components it is not FSSC 22000 or GFSI approved Without these 3 components it is not FSSC 22000 or GFSI approved

FSSC 22000

Features of the FSSC 22000 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 guidance and information Requirements for providing accreditation Accreditation process, providing information Regulation for the Board of Stakeholders

Scheme Requirements

ISO/TS ISO/TS 22002 22002-

• 1

1 ISO/TS ISO/TS 22002 22002-

• 3

3 PAS 222 PAS 222 ISO/TS ISO/TS 22002 22002-

• 4

4 ISO/TS ISO/TS 22002 22002-

• 5

5 ISO/TS ISO/TS 22002 22002-

• 2

2 ISO/TS ISO/TS PAS 221 PAS 221

ISO 22000:2005 - Food Safety Management Systems ISO/TS 22003:2013 -Requirements for bodies providing audit

• 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

Current Statistics

Top 5 countries:

• 1. USA
• 2. China
• 3. Japan
• 4. India
• 5. The Netherlands

FSSC 22000 Global Distribution

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

Integrity Program

CB Office Audit Breakdown

Non-Conformities from Office Audits

Non-Conformity Breakdown – Office Audits

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

• Training logs and audit logs are not always readily

available

• Lack of documented continuous training program
• Training certificates often over 5 years old
• 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

• Scope descriptions are far too often too detailed

describing subjects not relevant to the scope description

• Guidance document located on the FSSC website is
• ften overlooked but gives insight into this area’s

requirements.

Desk Reviews / CB Office Audit Summary

Audit report content:

• 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

• 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

• 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

• Audit plan supporting the audit time calculation is often

missing

• CBs are seen designing their own calculation tool that

is not compliant with the requirements.

• Must follow ISO 22003 and the FSSC Scheme

Documents.

• Calculation Tool and Guidance Document are

available on the FSSC Website

Desk Reviews / CB Office Audit Summary

Certification Audit

• CB having trouble organizing the Certification Audit or

Upgrade Audit

• Upgrade Audit

Upgrade Audit : not always clear if it is an upgrade from ISO 22000 to FSSC 22000.

• Certification Audit:

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

Desk Reviews / CB Office Audit Summary

• 1. Validate existing certificate:
• full stage 1 and 2 audit will not be required
• n-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

Enter Manufactures

ISO 22000 – FSSC 22000

Companies with Multiple Sites

• Guidance described in ISO 22003, clause 9.1.5.1
• A single certificate may contain multiple sites

All sites must be physically audited

• Not all sites are audited although the certificate includes

all sites belonging to the legal entity

A certificate must be issued for each site

• One overall report is made for the audit without mention
• f the individual sites

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

Desk Reviews / CB Office Audit Summary

• 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

Enter Manufactures

Technical Updates

• Intensify communication and continue developing guidance
• Increase visibility through regional representation (seminars, events,

etc.) and communication

• Currently scheduling an FSSC informational meeting on Nov. 19 af

Currently scheduling an FSSC informational meeting on Nov. 19 after ter the Food Safety Consortium Meeting (Nov. 17 the Food Safety Consortium Meeting (Nov. 17-

• 18) in Schaumburg,

18) in Schaumburg, Illinois Illinois

• Global harmonization day for all CBs - an annual, required event
• Amsterdam, October 22

Amsterdam, October 22-

• 23, 2014

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

Objectives FSSC 22000 for 2014

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

Keep in touch