Professional Development regarding ISO/TS 22003 Presented by: Scott Richter Director, Program Development March 2007
© This presentation and any associated training materials are copyrighted by ANAB and may not be reproduced or used without specific written permission of ANAB. 2
This professional development session is intended for CB personnel which will provide program management for an ANAB-accredited FSMS certification process. 3
WARNING This program may not be for all CBs
ISO/TS 22003 «Objectives «Working knowledge of 22003 «Uniqueness of 22003 «Understanding of specific sections «Industry expectations «Consumer expectations «ANAB expectations 5
Working Knowledge «Overview «ISO/IEC 17021 based « 5; General requirements « 6; Structural requirements « 7; Resource requirements « 8; Information requirements « 9; Process requirements «Annex A; Food categories 6
Working Knowledge ISO/IEC 17021 based «Product & service are different «Originally «Included verbatim words «Ensure 17021 part of process «Decisions based on proposed timing of 17021 & 22003 «Co-convener of TG for 17021 also co-convener of JWG 11 7
Working Knowledge ISO/IEC 17021 based «Currently «Normative reference to 17021 under 5. 1 «Sampling multi-site and auditordays are different «JWG felt IAF Annexes 2 & 3 were not statistically sound 8
Uniqueness of 22003 «More prescriptive than normal «Industry standard modeled after 17021 «Differentiates food categories «Qualification & competence-based «Addresses strong contract review «Addresses strong certificationgranting process 9
Uniqueness of 22003 «References documented procedures «Law & regulation references «Encompasses Stage-1 and -2 «“Does not attest to safety or fitness of products” «“However, … meet all applicable FS related statutory and regulatory …” 10
Understanding Section 5 General Requirements «Impartiality «“CB and any part of same legal entity …” «“ … Is likely to be considered. . . ” «What about 17021? – all of Section 5. 2 applies « 17021 seems more prescriptive with regard to impartiality 11
Understanding Section 6 Structural Requirements «Nothing additional than that which is included in ISO/IEC 17021 12
Understanding Section 7 Resource Requirements «All of 17021 applies AND «Very prescriptive criteria «All personnel involved in certification activities = competent «Stronger contract review «Training in HACCP principles, hazard assessment and analysis, relevant FSMS standards 13
Understanding Section 7 Resource Requirements «Stronger contract review «Training in HACCP principles, hazard assessment and analysis, relevant FSMS standards «Training in 19011 audit processes «Demonstrate certain capabilities 14
Understanding Section 7 Resource Requirements «Stronger contract review «Demonstrate certain capabilities «Food category classifications «Assessment of applicant … «Deployment of FSMS auditor … «Determination of audit time «CBs policies & procedures … 15
Understanding Section 7 Resource Requirements «Stronger granting certification process «Demonstrate ability to apply: «HACCP principles «Understanding PRPs «ID of food safety hazards «Laws & regulations «Relevant standards «Etc. (a through m) 16
WARNING This program may not be for all CBs
Understanding Section 7 Resource Requirements «Highly prescriptive auditor criteria «Education «Food safety training «Audit training «Work Experience «Audit experience «Competencies 18
Understanding Section 7 Resource Requirements «Education «Categories important «“courses in the food chain industry category … conducts audits” «Post secondary means training after graduation «CBs can provide post secondary training «Includes microbiology & general chemistry 19
Understanding Section 7 Resource Requirements «Food safety training «Successfully completed training in: «HACCP principles «Hazard assessment & analysis «Food safety management principles, including PRPs «Courses ‘should’’ be recognized by industry & stakeholders 20
Understanding Section 7 Resource Requirements «Audit training «Successfully completed training in: «Audit techniques based on 19011 «Relevant FSMS standards (e. g. ISO 22000: 2005) 21
Understanding Section 7 Resource Requirements «Work experience « 5 years full-time work experience in the food industry « 2 years work in QA or food safety functions within … «Work experience can be reduced to 4 years IF … 22
Understanding Section 7 Resource Requirements «Audit experience « 12 FSMS audit days in last 3 years in 4 different organizations «All above under leadership of a qualified auditor « 6 months work or four FSMS audits into new category « 5 external audits/year with 2 FSMS or 4 on-site FSMS / 10 FSMS audit days / year 23
Understanding Section 7 Resource Requirements «Competencies «Recorded for each category and sector «Evidence of a successful evaluation «Demonstrate ability to apply knowledge & skills: «Audit principles, procedures & techniques «To different audits «Ensure audits are conducted in a consistent & systematic manner 24
Understanding Section 7 Resource Requirements « Competencies – Audit principles «Plan and organize the work effectively «Conduct the audit in agreed time «Prioritize and focus on significance «Collect information effectively «Understand appropriateness of sampling «Understand appropriateness of consequences of sampling «Verify accuracy of collected information 25
Understanding Section 7 Resource Requirements «Competencies – Audit Principles «Confirm sufficiency of audit evidence «Confirm appropriateness of audit evidence «Assess factors affecting reliability of findings «Use work document to record activities «Prepare audit reports «Maintain confidentiality and security of info «Communicate effectively 26
Understanding Section 7 Resource Requirements «Competencies – Mgmt. System & docs «Application of MS to different organizations «Interaction between components of MS «FSMS standards & applicable processes «Recognizing differences of docs «Application of docs in different situations «Information systems for authorization «Information systems for security «Information systems for distribution of docs 27
Understanding Section 7 Resource Requirements «Competencies – Organizational situations «Organization’s size, structure, functions «Organization’s functional relationships «General business processes of organization «Related terminology of organization «Cultural and social customs or auditee 28
Understanding Section 7 Resource Requirements «Competencies – Applicable laws «Local, regional and national codes, laws and regulations «Contracts and agreements «International treaties and conventions «Other requirements to which organization subscribes 29
Understanding Section 7 Resource Requirements «Competencies – apply terminology, knowledge and skills: «In regard to current principles of HACCP «In regard to relevant PRPs for the category «Identification of food safety hazards «Methodologies for control measures «Ability to assess effectiveness of selected control measures «Corrections taken with regard to food safety «Assessment of potential food safety hazards 30
Understanding Section 7 Resource Requirements «Competencies – apply terminology, knowledge and skills: «Evaluation of relevance of applicable PRPs «Establishing or selecting appropriate evaluation method for these PRPs for category «Products, processes and practices of the sector «Relevant FSMS requirements «Relevant food safety standards 31
Understanding Section 7 Resource Requirements «Technical Experts – think you’ll need some? ? «Education «Category being audited or processes being audited or food safety hazards applicable to category «Work experience «In their technical area «Competencies «Demonstrated ability to provide expertise in their technical area 32
Understanding Section 7 Resource Requirements «Selecting audit team «The TEAM shall have competencies in application of PRPs and HACCP as defined by Annex A 33
BREAK TIME 34
WARNING This program may not be for all CBs
Understanding Section 8 Information Requirements «Explain sector vs. category «Certification documents «Identify in detail: «What activity is certified, referring to sectors 36
Understanding Section 9 Process Requirements «General «The CB shall precisely define scope of certification «The CB shall not exclude any part of the processes, sectors, products or services from scope of certification having an influence on food safety of end products. 37
Understanding Section 9 Process Requirements «General «The CB shall have a process for choosing audit day, time and season «Organization operating on a representative number of product lines, categories and sectors covered by scope. 38
Understanding Section 9 Process Requirements «General «CB shall have documented procedures for: «Determining audit time «Determining time needed to plan and accomplish audit «Justification for the determination shall also be recorded 39
Understanding Section 9 Process Requirements «General «CB shall consider for audit time (among other things): «Relevant FSMS standard requirements «Size and complexity of organization «Technological / regulatory context «Outsourcing activities within scope «Results of previous audits «Number of sites and multi-site consideration 40
Understanding Section 9 Process Requirements « Multi-site organizations «All sites are of same activity «All sites are in one country «All sites operating under one centrally controlled and administered FSMS «Internal audit has been conducted on each site with 3 years prior of certification «Internal audit carried out on each site within certification period «Internal audit activities comply with ISO 2200 or equivalent «Findings indicative of entire system and correction implemented accordingly 41
Understanding Section 9 Process Requirements «Multi-site organizations «Must have more than 20 sites «Only for categories A, B, G, H and J in Annex A «Sampling ratio above 20 sites shall be at 1: 5 «Must evaluate central location annually 42
Understanding Section 9 Process Requirements « General «All requirements in ISO/IEC 17021 Sections 9. 1. 1 -9. 1. 3, 9. 1. 6 -9. 1. 9 and 9. 1. 11 to 9. 1. 15 apply «A written report based on relevant guidance in 19011 shall be provided for each audit. «Ownership of audit report is retained by CB «Report shall include reference to organization’s PRPs, HACCP methodology used by organization, comment on HACCP team and other relevant issues for organization’s FSMS 43
Understanding Section 9 Process Requirements «Initial certification - Application «All 17021 Section 9. 2. 1 applies and «CB shall require organization to provide detailed information: «Process lines «HACCP studies «Number of shifts 44
Understanding Section 9 Process Requirements «Initial certification – Stage 1 «Determine if organization has an externally-developed combination of control measures «If so, Stage 1 shall review organization’s documentation to determine if measures are suitable to organization, comply with 22000 requirements and are kept updated 45
Understanding Section 9 Process Requirements «Initial certification – Stage 1 «Know objectives referenced in 9. 2. 3. 1. 2 «CB must review extent to which: «Organization has IDd PRPs appropriate to regulatory and statutory requirements «FSMS includes adequate processes, methods for IDing and assessing organization’s food safety hazards and subsequent selection and categorization of control measures 46
Understanding Section 9 Process Requirements « Initial certification – Stage 1 «CB must review extent to which: «Relevant food safety legislation is in place «FSMS is designed to achieve food safety policy of organization «FSMS implementation program justifies proceeding to Stage 2 «Validation, verification and improvement programs conform to FSMS requirements «FSMS document/arrangements communicate internally and with relevant suppliers/customer/interested parties «Carried out at organization’s premises 47
Understanding Section 9 Process Requirements « Initial certification – Stage 1 « 17021 Sections 9. 2. 3. 1. 2 and 9. 2. 3. 1. 3 apply «CB shall inform client results of Stage 1 may lead to postpone or cancel Stage 2 audit «Portions of FSMS found in compliance during Stage 1 may not be audited during Stage 2 if they continue to conform to ISO 22000 requirements «Stage 2 report shall clearly state conformity was been established during Stage 1 48
Understanding Annex A Category classifications «A CB’s scope of operation shall be defined by using Annex A’s categories «Auditor and technical expert technical qualifications and competencies shall be defined by using Annex A’s categories 49
Understanding Annex A Category classifications «Your system to support categories «Judge and record competence by each «Certificates will reference sector «Should ‘C’ and ‘M’ have equal on-site days? «FF&V is different than eggs «Judge and record competence by each 50
Industry Expectations «We’re working in their world «Excellent contract review «No sickness due to FSMS errors «No deaths due to FSMS errors «Credible HACCP studies «Highly competent auditors «Robust decision-making «Sincere and credible «Can your activity stand up to litigation? 51
Consumer Expectations « 3 year old twins Mark and Marsha don’t die from eating « 93 year old grandma doesn’t get sick from eating « No more stories of food-borne sickness « Everyone pays if anyone dies « “I’m gonna own your car, your house, your business, your …. ” « Never-ending confidence in grocery store and café 52
ANAB’s Expectations « Due diligence with respect to E&O insurance and risk management « Zero nonconformances regarding auditor, sales-person, scheduler, staff, decision-maker competencies « Credible audit-day totals with strong justification, unique for each organization – no more ‘standard’ tables « Clean bill-of-health when litigation occurs « Strong internal training effort regarding program 53
WARNING This program may not be for all CBs
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