ISOTS16949QualitySystems(PPT132).ppt

AGENDAISO TS16949UpdateISO9001 2000UpdateISO14001UpdateEnhancedSurveillanceAuditsHighlightsofIASGSanctionedQS 9000 98Interpretations Nov 1 1999 AQSRReviewRegistrationProcessQuestion Answer ISO TS16949QualitySystems ISO TS16949 Whatisit ISO TS16949isanISOTechnicalSpecificationpreparedbytheInternationalAutomotiveTaskForce IATF andrepresentativesfromISO TC176 QualityManagementandQualityAssurance anditssubcommittees ParticularrequirementsfortheapplicationofISO9001 1994areincorporatedintoISO TS16949 ISO TS16949harmonizesthesupplierqualitysystemrequirementsoftheUnitedStates Germany Italy France withthepurposeofhavingasingledocumentandregistrationschemethattheEuropeanandU S automotiveindustrywouldaccept ISO TS16949 FIATIVECO PSA PeugotCitoen RENAULTFIEV AVSQ EAQF ADAMOPELAUDIBMWDAIMLERBENZFORDWERKEVW CHRYSLERFORDGM VDA6 1 QS 9000 TechnicalSpecificationISO TS16949QualitySystems AutomotiveSuppliers ParticularrequirementsfortheapplicationofISO9001 1994 ISO TS16949 ThisdocumentfollowsthesamestructureasISO9001 1994 withsomeadditionalrequirementsdrawnfromthefollowingdocuments QS 9000QualitySystemRequirements ThirdEditionVDA6 Part1 QualitySystemAuditAVSQ 94Guidaperl applicazione guidelinesforuse EvaluationAptitudeQualit Fournisseur EAQF94 ISO TS16949 TheelementsoftheISO TSarecloselyalignedwiththeelementsofthefourautomotivestandards MostoftheelementsoftheISO TScanbetracedtoaminimumofoneofthefourautomotivestandards manyelementscanbetracedtoallfourstandards ISO TS16949 ThegoalofthisTechnicalSpecificationisthedevelopmentoffundamentalqualitysystemsthatprovideforcontinuousimprovement emphasizingdefectpreventionandthereductionofvariationandwasteinthesupplychain ISO TS16949 Whythenewstandard CreateaGlobalQualitySystemLanguageCreateGlobalRecognitionofCertificatesReductioninmultiple3rdpartyregistrationsProvideacompetitiveadvantageAdvantagesforupgradingQM SystemAdvantagesforglobalsourcing ISO TS16949 What sdifferent Numbering 4 1 4 20 remainsthesameAdditional5 requirementsoveratypicaltier1QS 9000systemRegistrationrequirementsaremuch tighter thanQS 9000 ISO TS16949 ISO TS16949 ISOvs QS 9000 98vs ISO TS16949 ISO TS16949 ISOvs QS 9000 98vs ISO TS16949 ISO TS16949 4 1 1 2ObjectivesThesuppliershalldefinegoals objectivesandmeasurementstodeploythequalitypolicy Objectivesforachievingqualityshallbeincludedinthebusinessplan NOTEThegoalsandobjectivesshouldaddresscustomerexpectationsandbeachievablewithinadefinedtimeperiod moreexplicitaboutqualitypolicyobjectives ISO TS16949 4 1 1 4ContinuousImprovementContinuousimprovementinquality service costandtechnologyshallbeprovidedforintheQualityPolicy Thesuppliershallidentifyopportunitiesforqualityandproductivityimprovementandimplementappropriateimprovementprojects Thesuppliershalluseappropriateimprovementmeasuresandmethodologies see4 2 7 ISO TS16949 4 1 1 4ContinousImprovementcont dNOTE1Thefollowinglistshowsexamplesofpossibletechniqueswhichmightbeused Theremaybemanyothermethodswhichmeetspecificsupplierneedsmoreappropriately controlcharts variables attributes CUSUM designofexperiments DOE theoryofconstraints overallequipmenteffectiveness partspermillion PPM analysistoachievezerodefects ISO TS16949 4 1 1 4ContinuousImprovementcont d valueanalysis benchmarking analysisofmotion ergonomics mistake proofing NOTE2GuidelinesforqualityimprovementaregiveninISO9004 4 relocatedfrom4 2 5 moreexplicitaboutqualitypolicyobjectives ISO TS16949 4 1 2 1 3QualityresponsibilityManagementwithresponsibilityandauthorityforcorrectiveactionshallbepromptlyinformedofproductsorprocesseswhichbecomesnon compliantwithspecifiedrequirements Personnelresponsibleforqualityshallhavetheauthoritytostopproductiontocorrectqualityproblems notechangedintoarequirement ISO TS16949 4 1 2 2 2ShiftresourcesEspeciallyconcerningtheproductionprocess alltheshiftsshallbestaffedwithpersonnelinchargeof ordelegatedresponsibilityforquality newrequirement ISO TS16949 4 1 3 2Managementreview 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 5Analysisanduseofcompanyleveldatacont dTrendsindataandinformationshallbecomparedwithprogresstowardoverallbusinessobjectivesandleadtoactiontosupportthefollowing a developmentofprioritiesforpromptsolutionstocustomer relatedproblems b determinationofkeycustomerrelatedtrendsandcorrelationtosupportstatusreview decisionmakingandlongertermplanning ISO TS16949 4 1 5Analysisanduseofcompanyleveldatacont dc aninformationsystemforthetimelyreportingofproductinformationarisingfromusage item c isnew ISO TS16949 4 1 6Employeemotivation empowermentandsatisfactionThesuppliershallhaveaprocessformotivationofemployeestoachievequalityobjectivesandtomakecontinuousimprovements Theprocessshallincludepromotionofqualityawarenessonalllevels NOTEQualityreviewsshouldbeconductedtoprovideappropriateinformation suchas plan actual comparisonandimprovementsuggestions ISO TS16949 4 1 6Employeemotivation empowermentandsatisfactioncont dThesuppliershallhaveaprocessformeasurementofemployeesatisfactionandemployeeunderstandingofappropriatequalityobjectives newsub element ISO TS16949 4 1 7 1Productsafety Duecareregardingproductsafetyandmeanstominimizepotentialriskstoemployees customers usersandtheenvironmentshallbeaddressedinthesupplier squalitypolicyandpractices especiallyindesigncontrol see4 4 andprocesscontrol see4 9 proceduresandpractices Thesuppliershallpromoteinternalawarenessofsafetyconsiderationsrelativetothesupplier sproduct QS 9000 98 4 2 3 4moreexplicit ISO TS16949 4 1 7 2Regulations Thesuppliershallhaveaprocesstoensurecompliancewithallapplicablegovernment safetyandenvironmentalregulations includingthoseconcerningstorage handling recycling eliminatingordisposingofmaterials QS 9000 98 4 6 1 2moreexplicit ISO TS16949 ProductrealizationInthisTechnicalSpecification qualityplanningactivitiesofallpre launchphaseshavebeenintegratedunderthenewheading Productrealization Forsupplierswithproductdesignresponsibility productrealizationalsoincludesproductdesign see4 4 Productrealizationinthecontextofqualityplanningisdiscussedin4 2 4 Thestructureisoutlinedonthenextslide ISO TS16949 ProductRealizationcont d4 2 3Qualityplanning4 2 3 1Qualityplanning ISO9001 19944 2 3 2Qualityplanrequirements4 2 4Productrealization4 2 4 1General4 2 4 2Measurements4 2 4 3Reviewcycle4 2 4 4Multidisciplinaryapproach4 2 4 5Toolsandtechniques4 2 4 6Computer aideddesign ISO TS16949 Productrealizationcont d4 2 4 7Specialcharacteristics4 2 4 8Feasibilityreview4 2 4Productrealizationcontinued4 2 4 9Managementofprocessdesign4 2 4 9 1General4 2 4 9 2Processdesigninput4 2 4 9 3Processdesignoutput4 2 4 9 4Processverification4 2 4 10Controlplan4 2 4 11Productapprovalprocess Renumberedandsomenewrequirements ISO TS16949 4 2 8QualitysystemperformanceThesuppliershallevaluatetheperformanceofthequalitysystemtoverifytheeffectivenessofitsoperation Resultsshallberecordedtoprovide asaminimum evidenceoftheachievementof a objectivesspecifiedinthequalitypolicy see4 1 1 2 b objectivesspecifiedinthebusinessplan see4 1 4 c customersatisfactionwithproductsupplied Theresultsshallbeusedforcontinuousimprovementorcorrectiveactionasappropriate moreexplicit ISO TS16949 4 10 6LaboratoryrequirementsWhereinspection testingandcalibrationservicesareconductedbyasupplier slaboratoryfacilityshallcomplywithISO IEC17025 includinguseofalaboratoryscope NOTEAccreditationofsupplierfacilitiestoISO IEC17025ornationalequivalentisnotrequiredby nordoesitsatisfy allqualitysystemrequirementsspecifiedinthisTechnicalSpecificationforalaboratory Therefore thelaboratoryshouldbeincludedintheon siteaudits ISO TS16949 4 10 6Laboratoryrequirementscont dCommercial independentlaboratoryfacilitiesusedforinspection testorcalibrationservicesbythesuppliershallbeaccreditedtoISO IEC17025ornationalequivalent newrequirementwithrespecttoISO IEC17025 ISO TS16949 4 17 2 3ProcessauditThesuppliershallaudittheproductrealizationandproductionprocessestodeterminetheeffectivenessofprocessperformance 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 AuditProcesscont dCertificationbodychecklistsshallincludeallquestionscontainedinthe ChecklisttoISO TS16949 QualitysystemsshallnotberegisteredtoISO TS16949ifopenminorormajornonconformitiestoISO TS16949exist Aftercertification whenanonconformityisidentifiedbythecertificationbody thenthedecertificationprocessshallbeinitiated NOTE Suchidentificationcanoccurasaresultofacustomercomplaint ISO TS16949 Auditprocesscont dTheauditplanshallincludeevaluationofallsupplierqualitysystemelementsforeffectiveimplementationofISO TS16949requirementsaswellasforeffectivenessinpractice Assessmentshallevaluatetheeffectivenessofthesystem itslinkages itsperformanceanditsrequirements Partoftheevidencerequiredistheresultofatleastonecompleteinternalauditandmanagementreviewcycle NOTE Effectivenessofthesystemshouldconsiderhowwellthesystemisdeployed ISO TS16949 Auditprocesscont dEachon 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 atthesupplier ssites Documentreview ISO TS16949 AuditActivitiescont dPre auditThepre auditshallnotbeconsideredaspartoftheinitialcertificationaudit Timededicatedtothepre auditwillnotreduceauditdaysrequirement seeAnnex3 Ifthereisinsufficientreadinesstoconducttheinitialaudit theSuppliercanstoptheprocess inconsultationwiththecertificationbody ISO TS16949 AuditActivitiescont dThecertificationbodyshallrecordthisfactinitsdatabase 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 AuditActivitiescont dEachauditshallincludeauditingonallshifts Ifweekendcrewsarededicatedandnon rotating thenauditingoftheweekendshiftsisalsorequired Nondesigncapablesuppliersmayreduceon siteauditmandaysby15 Thecertificationbodyshallpreparemonthlyauditschedule toforwardtoA BandIATFcommondatabase Siteaudit reports ISO TS16949 AuditActivitiescont dInitialcertificationauditactivitiesshallbeconductedaccordingtothefollowingrules Useofthe ChecklisttoISO TS16949 Checklisttobecoveredineachsiteincludedincertificationscope nositesamplingallowed RevieweffectivenessoftheimplementationoftheISO TS16949requirementsandforeffectivenessinpractice relatedtoplannedandachievedqualityperformance ISO TS16949 AuditActivitiescont dMajornonconformitiesmayprovideabasisforterminationoftheauditbythesupplierinconsultationwiththeauditteamleader Inthiscaseauditteamleaderwillstopthecertificationprocessimmediately areportwillbepreparedforthecertificationbody copyfortheSupplier ThecertificationbodywillrecordthereasonsforterminationintheirdatabaseandreporttoIATF Whenthisoccurs anyre auditshallcommencefromthebeginningoftheprocess ISO TS16949 AuditActivitiescont dAttheendofthesitevisit theLeadauditorconductsthefinalpresentationandreleasesadraftreportincluding descriptionofallnonconformitiesopportunitiesforimprovementauditteamrecommendationstocertificationcommitteeUndernocircumstancescananonconformitybeidentifiedasanopportunityforimprovement ISO TS16949 AuditActivitiescont dAuditteamleaderwithin15workingdaysaftertheendofthesitevisitwillsendtothesupplierandthecertificationbodythefinalreport Scope products customerspecificrequirementswithissuelevelSummaryofauditedelementsandrelatedresultsNonconformitiesasevidencedduringtheauditprocessOpportunitiesforimprovement ISO TS16949 AuditActivitiescont dAuditteam plusadditionaltechnicalexpertsifany Cross referencestosupplierqualitysystemdocumentationNonconformitiesshallbeacknowledgedbythesupplier Theauditorshallrecordallnonconformitiesidentifiedontheauditreportevenifthecorrectiveactionisimplementedimmediately ISO TS16949 AuditActivitiescont dForeachnonconformitytheSuppliershallperformcorrectiveactionwithinthreemonthsfromtheendofthesitevisit Thesupplierwillinformtheauditteamofcorrectiveactionsandtargetdateforimplementation Uponverificationofcorrectiveaction asupplementaryreportshallbeissuedbytheauditteamtoaccompanythefinalauditreport ISO TS16949 AuditActivitiescont dTheauditteammayproposetothecertificationbodyafollow upvisitinordertoverifytheimplementationofcorrectiveactions Certificateswillbeissuedonlyifthereis100 compliancetorequirementswhichmeansthatnonconformitiesfoundduringtheauditare100 resolvedwithinthreemonthsofthestartoftheon siteaudit ISO TS16949 AuditTeamTheauditteamshallprovideafullreportontheoperationsauditedtothesupplierwithin15workingdaysofeachinitialandsurveillanceauditunlessotherwiseagreedbythesupplier Auditorsshallidentifyopportunitiesforimprovementwithoutrecommendingspecificsolutions Theseopportunitiesshallbeincludedinthereporttothesupplier Authorizationtoprovidethefinalreportshallbespecifiedinthecertificationcontractbetweenthecertificationbodyandthesupplier ISO TS16949 OtherRequirementsConsultantstothesuppliercannotparticipateintheaudit CertificationbodiesshallnotifytheIATFofallscheduledauditsincludingwitnessauditsandshallallowIATFmembers ortheirdesignates toattend CertificatestoISO TS16949shallonlybeissuedbyIATFcontractedcertificationbodyofficesforamaximumvalidityofthreeyears ISO TS16949 OtherRequirementscont dUpgradingofacurrentautomotivecertificate AVSQ EAQF QS 9000 VDA6 1 byoneoftheIATFcontractedcertificationbodieswillbetakenintoaccountpriortotheinitialassessmenttoISO TS16949 asfollows Ifthescopeisunchanged atleast50 oftherequiredauditmandaysforinitialauditshallbeapplied TheauditmustfullyincludetheISO TS16949elements4 1 4 2and4 14andthecustomerspecificrequirements andassesstheremainingISO TS16949requirementsonasamplingbasis OtherRequirements OtherRequirementscont dIfthescopeischanged 100 oftherequiredauditmandaysfortheinitialauditshallbeapplied TheauditmustfullyincludeallISO TS16949requirements includingcustomerspecificrequirements samplingofISO TS16949requirementsisnotpermitted IATFreservestherighttosendadelegatetotheexecutivemanagementcommitteeofthecertificationbodyconcerningcertificationdecisionsregardingISO TS16949 ISO TS16949 OtherRequirementscont dIfacertificationbodyplacesanexistingISO TS16949certifiedcompanyonsuspensionbecauseofqualitysystemnonconformitiesoraviolationoftherulesofregistration thecertificationbodyshallnotifyIATF within10workingdays ISO TS16949 Goingforward IATFplansto beginworkonarevisedISO TS16949toalignwiththeISO9001year2000text 2000 2001 ISO9000 2000 ISO16949 2ndEdition harmonizedUS European andJapaneseStandard Thefollowing3slidesrepresentacommuniqu issuedtoallregistrarsonNovember8 2000 200020012002200320042005 ImplementationofcertificationtoISO TS2ndedition relativetoISO9001 2000transition ISO9001 1994 ISO9001 2000 ISO TS16949 1999 ISO TS16949 2002 Standardslifetime Certificationvalidity toISO9001 1994 toISO9001 2000 toISO TS16949 1999 toISO TS16949 2002 3yearsmax seeIAF TC176communique IATFCommunique October4th2000 IATFCommunique October4th2000 Inaccordancewithitsplan theInternationalAutomotiveTaskForceisworkingonthealignmentofISO TS16949 1999withISO9001 2000 TherevisedversionofISO TS16949isexpectedtobepublishedbyMarch2002 inaccordancewiththerequirementsforreviewofanISOTechnicalSpecificationwithinthreeyears ThetransitionfromthecurrentversionofISO TS16949willalignwiththearrangementsforintroductionofISO9001 2000 whicharedefinedbyIAF ISO TC176andISO CASCOintheircommuniquedatedSeptember27 1999 referenceISO TC176N488 CertificationtoISO TS16949 1999 inaccordancewiththeIATFregistrationscheme willcontinuetoberecognisedbysubscribingmemberstoIATFthroughoutthetransitionperiodforISO9001 1994toISO9001 2000 TherearenoplanstorevisetheexistingautomotivecataloguesAVSQ94 EAQF94 QS9000 andVDA6 1duringthisperiod IATFCommunique October4th2000 Ques