professional development regarding iso/ts 22003 presented by: scott richter director, program...

Professional Development

regarding ISO/TS 22003

Presented by:

Scott Richter Director, Program Development

March 2007

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© This presentation and any associated training materials are copyrighted by ANAB and may not be reproduced or

used without specific written permission

of ANAB.

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This professional development session is

intended for CB personnel which will

provide program management for an

ANAB-accredited FSMS certification

process.

WARNINGThis program may not

be for all CBs

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ISO/TS 22003

ObjectivesWorking knowledge of 22003Uniqueness of 22003Understanding of specific

sectionsIndustry expectationsConsumer expectations ANAB expectations

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Working Knowledge

OverviewISO/IEC 17021 based5; General requirements6; Structural requirements7; Resource requirements8; Information requirements9; Process requirementsAnnex A; Food categories

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Working KnowledgeISO/IEC 17021 based

Product & service are differentOriginally

Included verbatim wordsEnsure 17021 part of processDecisions based on proposed

timing of 17021 & 22003Co-convener of TG for 17021

also co-convener of JWG 11

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Working KnowledgeISO/IEC 17021 based

CurrentlyNormative reference to

17021 under 5.1Sampling multi-site and

auditor-days are differentJWG felt IAF Annexes 2 & 3

were not statistically sound

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Uniqueness of 22003

More prescriptive than normalIndustry standard modeled after

17021Differentiates food categoriesQualification & competence-

basedAddresses strong contract reviewAddresses strong certification-

granting process

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Uniqueness of 22003

References documented procedures

Law & regulation referencesEncompasses Stage-1 and -2“Does not attest to safety or

fitness of products”“However, … meet all applicable

FS related statutory and regulatory …”

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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 applies17021 seems more prescriptive

with regard to impartiality

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Understanding Section 6 Structural Requirements

Nothing additional than that which is included in ISO/IEC 17021

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Understanding Section 7 Resource Requirements

All of 17021 applies ANDVery prescriptive criteriaAll personnel involved in

certification activities = competentStronger contract review

Training in HACCP principles, hazard assessment and analysis, relevant FSMS standards

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Stronger contract reviewTraining in HACCP principles,

hazard assessment and analysis, relevant FSMS standards

Training in 19011 audit processes

Demonstrate certain capabilities

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Stronger contract reviewDemonstrate certain

capabilitiesFood category classificationsAssessment of applicant …Deployment of FSMS auditor …Determination of audit timeCBs policies & procedures …

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Stronger granting certification processDemonstrate ability to apply:

HACCP principlesUnderstanding PRPsID of food safety hazardsLaws & regulationsRelevant standardsEtc. (a through m)


be for all CBs

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Highly prescriptive auditor criteriaEducationFood safety trainingAudit trainingWork ExperienceAudit experienceCompetencies

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EducationCategories important“courses in the food chain industry

category … conducts audits”Post secondary means training

after graduationCBs can provide post secondary

trainingIncludes microbiology & general

chemistry

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Food safety trainingSuccessfully completed training in:

HACCP principlesHazard assessment & analysisFood safety management

principles, including PRPsCourses ‘should’’ be recognized

by industry & stakeholders

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Audit trainingSuccessfully completed training

in:Audit techniques based on

19011Relevant FSMS standards (e.g.

ISO 22000:2005)

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Work experience5 years full-time work experience

in the food industry2 years work in QA or food safety

functions within …Work experience can be reduced

to 4 years IF …

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Audit experience12 FSMS audit days in last 3

years in 4 different organizationsAll above under leadership of a

qualified auditor6 months work or four FSMS

audits into new category5 external audits/year with 2

FSMS or 4 on-site FSMS / 10 FSMS audit days / year

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CompetenciesRecorded for each category and

sectorEvidence of a successful

evaluationDemonstrate ability to apply

knowledge & skills:Audit principles, procedures &

techniquesTo different auditsEnsure audits are conducted in a

consistent & systematic manner

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Competencies – Audit principlesPlan and organize the work effectivelyConduct the audit in agreed timePrioritize and focus on significanceCollect information effectivelyUnderstand appropriateness of

samplingUnderstand appropriateness of

consequences of samplingVerify accuracy of collected information

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Competencies – Audit PrinciplesConfirm sufficiency of audit evidenceConfirm appropriateness of audit

evidenceAssess factors affecting reliability of

findingsUse work document to record activitiesPrepare audit reportsMaintain confidentiality and security of

infoCommunicate effectively

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Competencies – Mgmt. System & docsApplication of MS to different organizationsInteraction between components of MSFSMS standards & applicable processesRecognizing differences of docsApplication of docs in different situationsInformation systems for authorizationInformation systems for securityInformation systems for distribution of docs

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Competencies – Organizational situationsOrganization’s size, structure,

functionsOrganization’s functional relationshipsGeneral business processes of

organizationRelated terminology of organizationCultural and social customs or auditee

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Competencies – Applicable lawsLocal, regional and national codes,

laws and regulationsContracts and agreementsInternational treaties and conventionsOther requirements to which

organization subscribes

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Competencies – apply terminology, knowledge and skills:In regard to current principles of HACCPIn regard to relevant PRPs for the categoryIdentification of food safety hazardsMethodologies for control measuresAbility to assess effectiveness of selected

control measuresCorrections taken with regard to food safetyAssessment of potential food safety hazards

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Competencies – apply terminology, knowledge and skills:Evaluation of relevance of applicable

PRPsEstablishing or selecting appropriate

evaluation method for these PRPs for category

Products, processes and practices of the sector

Relevant FSMS requirementsRelevant food safety standards

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Technical Experts – think you’ll need some??

EducationCategory being audited or processes

being audited or food safety hazards applicable to category

Work experienceIn their technical area

CompetenciesDemonstrated ability to provide

expertise in their technical area

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Selecting audit teamThe TEAM shall have

competencies in application of PRPs and HACCP as defined by Annex A

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BREAK TIME


be for all CBs

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Understanding Section 8 Information Requirements

Explain sector vs. category

Certification documentsIdentify in detail:

What activity is certified, referring to sectors

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Understanding Section 9 Process Requirements

GeneralThe CB shall precisely define

scope of certificationThe 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.

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GeneralThe 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.

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GeneralCB shall have documented

procedures for:Determining audit timeDetermining time needed to plan

and accomplish auditJustification for the determination

shall also be recorded

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GeneralCB shall consider for audit time

(among other things):Relevant FSMS standard

requirementsSize and complexity of organizationTechnological / regulatory contextOutsourcing activities within scopeResults of previous auditsNumber of sites and multi-site

consideration

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Multi-site organizationsAll sites are of same activityAll sites are in one countryAll sites operating under one centrally

controlled and administered FSMSInternal 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

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Multi-site organizationsMust have more than 20 sitesOnly for categories A, B, G, H

and J in Annex ASampling ratio above 20 sites

shall be at 1:5Must evaluate central location

annually

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GeneralAll 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 CBReport shall include reference to

organization’s PRPs, HACCP methodology used by organization, comment on HACCP team and other relevant issues for organization’s FSMS

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Initial certification - Application

All 17021 Section 9.2.1 applies and

CB shall require organization to provide detailed information:Process linesHACCP studiesNumber of shifts

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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

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Initial certification – Stage 1Know objectives referenced in

9.2.3.1.2CB 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

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CB must review extent to which:Relevant food safety legislation is in placeFSMS is designed to achieve food safety

policy of organizationFSMS implementation program justifies

proceeding to Stage 2Validation, verification and improvement

programs conform to FSMS requirementsFSMS document/arrangements

communicate internally and with relevant suppliers/customer/interested parties

Carried out at organization’s premises

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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

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Understanding Annex A Category

classificationsA 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

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Understanding Annex A Category

classificationsYour system to support

categoriesJudge and record competence by

eachCertificates will reference sectorShould ‘C’ and ‘M’ have equal

on-site days?FF&V is different than eggsJudge and record competence by

each

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Industry Expectations

We’re working in their worldExcellent contract reviewNo sickness due to FSMS errorsNo deaths due to FSMS errorsCredible HACCP studiesHighly competent auditorsRobust decision-makingSincere and credibleCan your activity stand up to

litigation?

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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

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ANAB’s ExpectationsDue diligence with respect to E&O

insurance and risk managementZero 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


be for all CBs

professional development regarding iso/ts 22003 presented by: scott richter director, program...

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