ISO TS 16949 Update.ppt

,ISO/TS16949Update,AGENDAISO/TS16949UpdateISO9001:2000UpdateISO14001UpdateEnhancedSurveillanceAuditsHighlightsofIASGSanctionedQS-9000:98Interpretations(Nov.1,1999)AQSRReviewRegistrationProcessQuestionmoreexplicitaboutqualitypolicyobjectives,ISO/TS16949,.3QualityresponsibilityManagementwithresponsibilityandauthorityforcorrectiveactionshallbepromptlyinformedofproductsorprocesseswhichbecomesnon-compliantwithspecifiedrequirements.Personnelresponsibleforqualityshallhavetheauthoritytostopproductiontocorrectqualityproblems.*notechangedintoarequirement,ISO/TS16949,.2ShiftresourcesEspeciallyconcerningtheproductionprocess,alltheshiftsshallbestaffedwithpersonnelinchargeof,ordelegatedresponsibilityforquality.*newrequirement,ISO/TS16949,Managementreview-supplementalThesereviewsshallincludeallelementsofthequalitysystemanditsperformance(see4.2.8)overtimeasanessentialpartofthecontinuousimprovementprocess.Partofthemanagementreviewshallbethemonitoringofstrategicqualityobjectives,andtheregularreportingandevaluationofthecostofpoorquality.NOTEManagementreviewshouldbeconductedwithsufficientfrequencytoensurethattheestablishedqualitysystemiseffective.*moreexplicitaboutwhattoreview,ISO/TS16949,4.1.5AnalysisanduseofcompanyleveldataThesuppliershalldocumenttrendsinquality,operationalperformance(productivity,costsofpoorquality,efficiency,effectiveness)andcurrentqualitylevelsforkeyproductandservicefeatures.NOTETheseshouldbecomparedwiththoseofcompetitorsand/orappropriatebenchmarks.,ISO/TS16949,4.1.5AnalysisanduseofcompanyleveldatacontdTrendsindataandinformationshallbecomparedwithprogresstowardoverallbusinessobjectivesandleadtoactiontosupportthefollowing:a)developmentofprioritiesforpromptsolutionstocustomer-relatedproblems;b)determinationofkeycustomerrelatedtrendsandcorrelationtosupportstatusreview,decisionmakingandlongertermplanning;,ISO/TS16949,4.1.5Analysisanduseofcompanyleveldatacontdc)aninformationsystemforthetimelyreportingofproductinformationarisingfromusage.*item“c”isnew,ISO/TS16949,4.1.6Employeemotivation,empowermentandsatisfactionThesuppliershallhaveaprocessformotivationofemployeestoachievequalityobjectivesandtomakecontinuousimprovements.Theprocessshallincludepromotionofqualityawarenessonalllevels.NOTEQualityreviewsshouldbeconductedtoprovideappropriateinformation,suchas“plan/actual”comparisonandimprovementsuggestions.,ISO/TS16949,4.1.6Employeemotivation,empowermentandsatisfactioncontdThesuppliershallhaveaprocessformeasurementofemployeesatisfactionandemployeeunderstandingofappropriatequalityobjectives.*newsub-element,ISO/TS16949,Productsafety-Duecareregardingproductsafetyandmeanstominimizepotentialriskstoemployees,customers,usersandtheenvironmentshallbeaddressedinthesuppliersqualitypolicyandpractices,especiallyindesigncontrol(see4.4)andprocesscontrol(see4.9)proceduresandpractices.Thesuppliershallpromoteinternalawarenessofsafetyconsiderationsrelativetothesuppliersproduct.*QS-9000:98;moreexplicit,ISO/TS16949,Regulations-Thesuppliershallhaveaprocesstoensurecompliancewithallapplicablegovernment,safetyandenvironmentalregulations,includingthoseconcerningstorage,handling,recycling,eliminatingordisposingofmaterials.*QS-9000:98;moreexplicit,ISO/TS16949,ProductrealizationInthisTechnicalSpecification,qualityplanningactivitiesofallpre-launchphaseshavebeenintegratedunderthenewheading“Productrealization”.Forsupplierswithproductdesignresponsibility,productrealizationalsoincludesproductdesign(see4.4).Productrealizationinthecontextofqualityplanningisdiscussedin4.2.4.Thestructureisoutlinedonthenextslide:,ISO/TS16949,ProductRealizationcontd4.2.3QualityplanningQualityplanning-ISO9001:199Qualityplanrequirements4.2.4ProductrealizationGeneralMeasurementsReviewcycleMultidisciplinaryapproachToolsandtechniquesComputer-aideddesign,ISO/TS16949,ProductrealizationcontdSpecialcharacteristicsFeasibilityreview4.2.4ProductrealizationcontinuedManagementofprocessdesign.1General.2Processdesigninput.3Processdesignoutput.4Processverification0Controlplan1Productapprovalprocess*Renumberedandsomenewrequirements,ISO/TS16949,4.2.8QualitysystemperformanceThesuppliershallevaluatetheperformanceofthequalitysystemtoverifytheeffectivenessofitsoperation.Resultsshallberecordedtoprovide,asaminimum,evidenceoftheachievementof:a)objectivesspecifiedinthequalitypolicy(see),b)objectivesspecifiedinthebusinessplan(see4.1.4),c)customersatisfactionwithproductsupplied.Theresultsshallbeusedforcontinuousimprovementorcorrectiveactionasappropriate.*moreexplicit,ISO/TS16949,4.10.6LaboratoryrequirementsWhereinspection,testingandcalibrationservicesareconductedbyasupplierslaboratoryfacilityshallcomplywithISO/IEC17025,includinguseofalaboratoryscope.NOTEAccreditationofsupplierfacilitiestoISO/IEC17025ornationalequivalentisnotrequiredby,nordoesitsatisfy,allqualitysystemrequirementsspecifiedinthisTechnicalSpecificationforalaboratory.Therefore,thelaboratoryshouldbeincludedintheon-siteaudits.,ISO/TS16949,4.10.6LaboratoryrequirementscontdCommercial/independentlaboratoryfacilitiesusedforinspection,testorcalibrationservicesbythesuppliershallbeaccreditedtoISO/IEC17025ornationalequivalent.*newrequirementwithrespecttoISO/IEC17025,ISO/TS16949,ProcessauditThesuppliershallaudittheproductrealizationandproductionprocessestodeterminetheeffectivenessofprocessperformance(seeA.43)*newrequirement,ISO/TS16949,A.43processauditonsiteverificationactivityusedto:-verifyconformancetospecifiedrequirements,suchascontrolplan,workinstructions,-ensurethatqualityobjectivesaremet,-verifythatspecifiedrequirementsforprocesscapability/performancearemet,-assesstheeffectivenessofactivitiesandrelatedresults,ISO/TS16949,4.17.3AuditorqualificationThesuppliershallcomplywithcustomerrequirementsforinternalsystemandprocessauditorqualification.*newrequirement,ISO/TS16949,AuditProcessThescopeofcertificationshallincludeallproductssuppliedtocustomerssubscribingtothecertificationtoISO/TS1649.Any“site”mayelecttopursuethirdpartycertificationtoISO/TS16949,however,such“sites”shallhavedemonstratedcapabilitytoconformwithallISO/TS16949requirements,includingcustomerspecific.RemotelocationsshallbeauditedastheysupportasitebutcannotobtainindependentISO/TS16949certification.,ISO/TS16949,AuditProcesscontdCertificationbodychecklistsshallincludeallquestionscontainedinthe“ChecklisttoISO/TS16949.”QualitysystemsshallnotberegisteredtoISO/TS16949ifopenminorormajornonconformitiestoISO/TS16949exist.Aftercertification,whenanonconformityisidentifiedbythecertificationbody,thenthedecertificationprocessshallbeinitiated.NOTE:Suchidentificationcanoccurasaresultofacustomercomplaint.,ISO/TS16949,AuditprocesscontdTheauditplanshallincludeevaluationofallsupplierqualitysystemelementsforeffectiveimplementationofISO/TS16949requirementsaswellasforeffectivenessinpractice.Assessmentshallevaluatetheeffectivenessofthesystem,itslinkages,itsperformanceanditsrequirements.Partoftheevidencerequiredistheresultofatleastonecompleteinternalauditandmanagementreviewcycle.NOTE:Effectivenessofthesystemshouldconsiderhowwellthesystemisdeployed.,ISO/TS16949,AuditprocesscontdEachon-siteaudit,includinginitialandsurveillanceaudits,shallincludeareviewof:customercomplaintsandsupplierresponse,supplierinternalauditandmanagementreviewresultsandactions,progressmadetowardcontinuousimprovementtargets,effectivenessofthecorrectiveactionsandverificationsincethelastsurveillanceaudit.Elements4.1,4.2,and4.4fordesignresponsiblesuppliershallbereviewedatleastonceduringanon-siteauditwithineachconsecutive12-monthperiod.,ISO/TS16949,AuditActivitiesContractbetweencertificationbodyandsupplierAnalysereadinessforon-siteauditReadinessforon-siteaudit(Incaseofdoubts,thecertificationbodyandthesuppliermaydecidetoexecuteapre-audit).Inthisphase,thecertificationbodycanperforma“pre-audit”atthesupplierssites.Documentreview,ISO/TS16949,AuditActivitiescontdPre-auditThepre-auditshallnotbeconsideredaspartoftheinitialcertificationaudit.Timededicatedtothepre-auditwillnotreduceauditdaysrequirement(seeAnnex3)Ifthereisinsufficientreadinesstoconducttheinitialaudit,theSuppliercanstoptheprocess,inconsultationwiththecertificationbody.,ISO/TS16949,AuditActivitiescontdThecertificationbodyshallrecordthisfactinitsdatabase.Theinitialauditshallbecompletedwithina3monthperiodfromthedocumentreview.Multiplevisitsforinitialauditarenotpermitted.Teamof2auditorsminimumifauditor-daysrequirementsexceed4.,ISO/TS16949,AuditMandaysforcertificationtoISO/TS16949,ISO/TS16949,AuditActivitiesRequirementsonauditmandaysInitialAudit(On-siteMandays)cannotincludepre-auditand/ordocumentreview.On-sitereviewofcorrectiveactionsarisingfromtheinitialauditwillbeadditionaltothespecifiedauditmandays.TheonlydeviationspermittedfromthischartisanupgradefromthecurrentthirdpartycertificationstoAVSQ,EAQF,QS-9000orVDA6.1.,ISO/TS16949,AuditActivitiescontdEachauditshallincludeauditingonallshifts.Ifweekendcrewsarededicatedandnon-rotating,thenauditingoftheweekendshiftsisalsorequired.Nondesigncapablesuppliersmayreduceon-siteauditmandaysby15%.Thecertificationbodyshallpreparemonthlyauditschedule(toforwardtoA/BandIATFcommondatabase).Siteaudit+reports,ISO/TS16949,AuditActivitiescontdInitialcertificationauditactivitiesshallbeconductedaccordingtothefollowingrules:Useofthe“ChecklisttoISO/TS16949”Checklisttobecoveredineachsiteincludedincertificationscope(nositesamplingallowed)RevieweffectivenessoftheimplementationoftheISO/TS16949requirementsandforeffectivenessinpractice,relatedtoplannedandachievedqualityperformance.,ISO/TS16949,AuditActivitiescontdMajornonconformitiesmayprovideabasisforterminationoftheauditbythesupplierinconsultationwiththeauditteamleader.Inthiscaseauditteamleaderwillstopthecertificationprocessimmediately:areportwillbepreparedforthecertificationbody(copyfortheSupplier)ThecertificationbodywillrecordthereasonsforterminationintheirdatabaseandreporttoIATF.Whenthisoccurs,anyre-auditshallcommencefromthebeginningoftheprocess.,ISO/TS16949,AuditActivitiescontdAttheendofthesitevisit,theLeadauditorconductsthefinalpresentationandreleasesadraftreportincluding:descriptionofallnonconformitiesopportunitiesforimprovementauditteamrecommendationstocertificationcommitteeUndernocircumstancescananonconformitybeidentifiedasanopportunityforimprovement.,ISO/TS16949,AuditActivitiescontdAuditteamleaderwithin15workingdaysaftertheendofthesitevisitwillsendtothesupplierandthecertificationbodythefinalreport:Scope-products-customerspecificrequirementswithissuelevelSummaryofauditedelementsandrelatedresultsNonconformitiesasevidencedduringtheauditprocessOpportunitiesforimprovement,ISO/TS16949,AuditActivitiescontdAuditteam(plusadditionaltechnicalexpertsifany)Cross-referencestosupplierqualitysystemdocumentationNonconformitiesshallbeacknowledgedbythesupplier.Theauditorshallrecordallnonconformitiesidentifiedontheauditreportevenifthecorrectiveactionisimplementedimmediately.,ISO/TS16949,AuditActivitiescontdForeachnonconformitytheSuppliershallperformcorrectiveactionwithinthreemonthsfromtheendofthesitevisit.Thesupplierwillinformtheauditteamofcorrectiveactionsandtargetdateforimplementation.Uponverificationofcorrectiveaction,asupplementaryreportshallbeissuedbytheauditteamtoaccompanythefinalauditreport.,ISO/TS16949,AuditActivitiescontdTheauditteammayproposetothecertificationbodyafollow-upvisitinordertoverifytheimplementationofcorrectiveactions.Certificateswillbeissuedonlyifthereis100%compliancetorequirementswhichmeansthatnonconformitiesfoundduringtheauditare100%resolvedwithinthreemonthsofthestartoftheon-siteaudit.,ISO/TS16949,AuditTeamTheauditteamshallprovideafullreportontheoperationsauditedtothesupplierwithin15workingdaysofeachinitialandsurveillanceauditunlessotherwiseagreedbythesupplier.Auditorsshallidentifyopportunitiesforimprovementwithoutrecommendingspecificsolutions.Theseopportunitiesshallbeincludedinthereporttothesupplier.Authorizationtoprovidethefinalreportshallbespecifiedinthecertificationcontractbetweenthecertificationbodyandthesupplier.,ISO/TS16949,OtherRequirementsConsultantstothesuppliercannotparticipateintheaudit.CertificationbodiesshallnotifytheIATFofallscheduledauditsincludingwitnessauditsandshallallowIATFmembers,ortheirdesignates,toattend.CertificatestoISO/TS16949shallonlybeissuedbyIATFcontractedcertificationbodyofficesforamaximumvalidityofthreeyears.,ISO/TS16949,OtherRequirementscontdUpgradingofacurrentautomotivecertificate,AVSQ,EAQF,QS-9000,VDA6.1,byoneoftheIATFcontractedcertificationbodieswillbetakenintoaccountpriortotheinitialassessmenttoISO/TS16949,asfollows:Ifthescopeisunchanged,atleast50%oftherequiredauditmandaysforinitialauditshallbeapplied.TheauditmustfullyincludetheISO/TS16949elements4.1,4.2and4.14andthecustomerspecificrequirements,andassesstheremainingISO/TS16949requirementsonasamplingbasis.,OtherRequirements,OtherRequirementscontdIfthescopeischanged,100%oftherequiredauditmandaysfortheinitialauditshallbeapplied.TheauditmustfullyincludeallISO/TS16949requirements,includingcustomerspecificrequirements;samplingofISO/TS16949requirementsisnotpermitted.IATFreservestherighttosendadelegatetotheexecutivemanagementcommitteeofthecertificationbodyconcerningcertificationdecisionsregardingISO/TS16949.,ISO/TS16949,OtherRequirementscontdIfacertificationbodyplacesanexistingISO/TS16949certifiedcompanyonsuspensionbecauseofqualitysystemnonconformitiesoraviolationoftherulesofregistration,thecertificationbodyshallnotifyIATF,within10workingdays.,ISO/TS16949,Goingforward,IATFplansto:beginworkonarevisedISO/TS16949toalignwiththeISO9001year2000text;2000-2001:ISO9000:2000or-ThesupplierisnotifiedbyFordof“Q-1Revocation”,byDaimler-Chryslerof“NeedsImprovement”(“QualityRatingonly-notTotalRating”),orbyGeneralMotorsof“NewBusinessHold”;or-Minornon-conformancecorrectiveactionisnotverifiedbytheRegistrarasbeingeffectivelyimplementedwithin60daysofthedateidentified.,IASGSanctionedQS-9000Interpretations,*Probationisdefinedasnoticegivenasupplierbytheirregistrarthatfailuretotakecorrectiveactiontoeliminatethemajororminornonconformitieswithinthespecifiedtimeperiodwillresultinasupplierscertificatebeingrevokedbytheirregistrar(refertoclauseR3.D,R3.E,R3.F).*TheQSAstates“numberofminornonconformitiesagainstonerequirementwhichwhencombinedcanrepresentatotalbreakdownofthesystemandthusbeconsideredamajornonconformity.”,IASGSanctionedQS-9000Interpretations,Additionally,minornonconformances,whichoccuronsuccessivesurveillanceassessments,shouldbeviewedasapattern.Ifapatternofminornonconformitiesoccursoversuccessiveassessments,itmayrepresentatotalbreakdownofthesystemandamajornonconformanceshallbeissued.A.Ifprobationresultsfromtheissuanceofamajornonconformance,theregistrarwillnotifythesupplierinwritingoftheprobationwithinfivedaysoftheissuanceofthemajornonconformance(whetherornotanappealisinitiated.,IASGSanctionedQS-9000Interpretations,B.Ifprobationiswarrantedforanyotherreason,writtennotificationwillbeprovidedtothesupplierimmediately.C.Ifthecertificationis“corporate”thenallsitesunderthecorporatecertificationmustbeplacedonprobation.Ifa“corporate”probationfromQS-9000,“new”locationsmaybeaddedtothecorporateregistration,oralocationwithinacorporatecertificationmayberemovedifsuchlocationiscompletelyclosed.,IASGSanctionedQS-9000Interpretations,D.Ifasupplierfilesanappealwiththeirregistrar,thesupplierandregistrarwillhave30daysfromnotificationtocompletetheappealprocess.Atthecompletionofthis30-dayperiod,ifthesuspensioniscontinued,theregistrarwillnotifytheASQdatabaseoftheresult,andthesupplierwillnotifythosecustomersthathaverequiredthemtoobtainQS-9000registration.E.Beforeanyprobationcanbelifted,theregistrarwillconductanon-siteassessmentofappropriatelengthtoverifyeffectiveimplementationofallcorrectiveactions.,IASGSanctionedQS-9000Interpretations,F.Ifaprobationisnotliftedwithinfourmonthsofitsissuance,asupplierscertificatemustberevokedbytheregistrar.Exceptionstothismustbejustifiedbytheregistrarinwritingandagreementobtainedfromtheaccreditationbody(s)whosemarkappearsonthecertificate.Theregistrarmustprovidethesupplierinquestionacopyofthisjustification.ThesuppliermustprovidesamecopytotheirOEMcustomer(s).G.RegistrarswillnotifytheASQdatabaseofallprobations,andofallregistrationde-listingsforfailureofthesuppliertocomplywithQS-9000requirements.,IASGSanctionedQS-9000Interpretations,H.Ifasuppliertransfersregistrationservicesfromoneregistrartoanotherwhileaprobationispendingresolution,theacceptingregistrarcannotregistersamesupplieruntiltheacceptingregistrarhasconductedacompleteregistrationassessmentforwhichtheon-siteregistrationdurationcannotbelessthanshownintheman-daytableofAppendixH-regardlessofthereasonforthetransfer.I.Registrarsmaywaitforaperiod,nottoexceedfiveworkingdays,afteranauditevent,beforeissuingamajornon-conformancetoasupplier.,AQSR,CorporateUpdate,AQSRProfile,InternationalManagementSystemsRegistrar:ProvidingaccreditedthirdpartymanagementsystemregistrationCoreQualityISO9000-QualityAutomotiveQualityQS-9000,TESupplement,ISOTS16949,VDA6.1AerospaceQuality(AS9000&AS9100)TL-9000ISO14000-Environment,AQSRProfile,Over1500CertificatesofRegistrationissuedWorldwideNorthAmericaSouthAmericaEuropeAsia,AQSRProfile,HIGHLIGHTSTop2registrarformarketgrowth(NorthAmerica)Ranked#4*(inafieldof39registrars)forthelevelofknowledge,serviceandvalueprovidedtoclientsA“top10”registrarforQS-9000Oneof31registrarscapableofprovidingISO/TS16969registrationworldwide*2000QualityDigestsurveyofregisteredcompanies.July2000publicationdate,AQSRProfile,InternationalAQSRGroupOfficesCanada-Mississauga,OntarioUnitedStates-AnnArbor,MichiganTimperleyUKGoshiem,GermanyMexicoCity,MexicoVelenciaVenezuelaTiapai,TaiwanShanghai&DongGuong,China,AQSRProfile,AccreditedbySCC-CanadaRABU.S.SENCAMER-VenezuelaDAR/KBA-GermanyScopeofAccreditationBroadbaseofexperienceinmostIAFScopeCategoriesinbothManufacturingandServiceSectors,AQSRProfile,ServiceExperienceEngineeringServices,ProjectManagement,AirportManagement,Employment&Staffing,ConstructionandRelatedCompanies,Transportation,Wholesa