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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 ? 55