4 - fssc 22000 presentation food safety forum argentina 091814

Food Safety Forum Food Safety Forum –– ASU ASU –– ArgentinaArgentinaFSSC 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 approvedWithout 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 systemFood safety management system, PRP’s, additional guidance

� Requirements for providing certificationApproval by the Foundation, accreditation, audit process, harmonization, providing guidance and information

� Requirements for providing accreditationAccreditation process, providing information

� Regulation for the Board of Stakeholders

Scheme Requirements

ISO/TSISO/TS2200222002--11

ISO/TSISO/TS2200222002--33

PAS 222PAS 222 ISO/TSISO/TS2200222002--44

ISO/TSISO/TS2200222002--55

ISO/TSISO/TS2200222002--22

ISO/TS ISO/TS PAS 221PAS 221

ISO 22000:2005 - Food Safety Management Systems ISO/TS 22003:2013 -Requirements for bodies providin g 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. USA2. China3. Japan4. India5. 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 experienceo Training logs and audit logs are not always readily

availableo Lack of documented continuous training programo Training certificates often over 5 years oldo Audit logs not complete and up-to-date; required

information not always available or missing


� 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.


� 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


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)


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


� Audit durationo Audit plan supporting the audit time calculation is often

missingo 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


� Certification Audito CB having trouble organizing the Certification Audit or

Upgrade Audit��Upgrade AuditUpgrade 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


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

Enter Manufactures

ISO 22000 – FSSC 22000

� Companies with Multiple Siteso Guidance described in ISO 22003, clause 9.1.5.1o 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


� 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 oo Currently scheduling an FSSC informational meeting on Nov. 19 afCurrently scheduling an FSSC informational meeting on Nov. 19 af ter ter

the Food Safety Consortium Meeting (Nov. 17the Food Safety Consortium Meeting (Nov. 17 --18) in Schaumburg, 18) in Schaumburg, Illinois Illinois

� Global harmonization day for all CBs - an annual, required event oo Amsterdam, October 22Amsterdam, October 22 --23, 201423, 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 GeneralE-mail [email protected]

Phone (+31) 183 645 028www.fssc22000.com

Join us at LinkedIn: Group FSSC 22000Follow us on Twitter: @FSSC22000

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