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Food Safety Forum ASU ASU Argentina Argentina Food Safety Forum FSSC 22000 Bob Readel , FSSC Regional Inspector, The Americas Global Companies Using or Accepting FSSC 22000 Specifics FSSC 22000 Scheme has 3 required


  1. Food Safety Forum – – ASU ASU – – Argentina Argentina Food Safety Forum FSSC 22000 Bob Readel , FSSC Regional Inspector, The Americas

  2. Global Companies Using or Accepting FSSC 22000

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

  4. Scheme Requirements � 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

  5. ISO 22000:2005 - Food Safety Management Systems ISO/TS 22003:2013 -Requirements for bodies providing audit ISO/TS ISO/TS PAS 222 PAS 222 ISO/TS ISO/TS ISO/TS ISO/TS ISO/TS ISO/TS ISO/TS ISO/TS ISO/TS ISO/TS PAS 221 PAS 221 22002- 22002 -3 3 22002- 22002 -1 1 22002- 22002 -4 4 22002- 22002 -5 5 22002- 22002 -2 2

  6. 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

  7. FSSC 22000 Global Distribution Top 5 countries: 1. USA 2. China 3. Japan 4. India 5. The Netherlands

  8. 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

  9. CB Office Audit Breakdown

  10. Non-Conformities from Office Audits

  11. Non-Conformity Breakdown – Office Audits

  12. 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

  13. 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

  14. 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 area’s requirements.

  15. 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

  16. 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)

  17. 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

  18. 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

  19. 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 � Upgrade Audit � 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

  20. 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

  21. 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

  22. 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

  23. 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 af o Currently scheduling an FSSC informational meeting on Nov. 19 after ter the Food Safety Consortium Meeting (Nov. 17- -18) in Schaumburg, 18) in Schaumburg, the Food Safety Consortium Meeting (Nov. 17 Illinois Illinois � Global harmonization day for all CBs - an annual, required event o Amsterdam, October 22 o 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

  24. 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

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