ISOTS16949QualitySystems(PPT132).pptx
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ISOTS16949QualitySystems(PPT132).pptx
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1AGENDAISO/TS16949UpdateISO9001:
2000UpdateISO14001UpdateEnhancedSurveillanceAuditsHighlightsofIASGSanctionedQS-9000:
98Interpretations(Nov.1,1999)AQSRReviewRegistrationProcessQuestion&Answer2ISO/TS16949QualitySystems3ISO/TS16949Whatisit?
tISO/TS16949isanISOTechnicalSpecificationpreparedbytheInternationalAutomotiveTaskForce(IATF)andrepresentativesfromISO/TC176,QualityManagementandQualityAssurance,anditssubcommittees.ParticularrequirementsfortheapplicationofISO9001:
1994areincorporatedintoISO/TS16949.tISO/TS16949harmonizesthesupplierqualitysystemrequirementsoftheUnitedStates,Germany,Italy,France,withthepurposeofhavingasingledocumentandregistrationschemethattheEuropeanandU.S.automotiveindustrywouldaccept.4ISO/TS16949FIATIVECOPSA(PeugotCitoen)RENAULTFIEVAVSQEAQFADAMOPELAUDIBMWDAIMLERBENZFORDWERKEVWCHRYSLERFORDGMVDA6.1QS-9000TechnicalSpecificationISO/TS16949QualitySystems-AutomotiveSuppliers-ParticularrequirementsfortheapplicationofISO9001:
19945ISO/TS16949tThisdocumentfollowsthesamestructureasISO9001:
1994,withsomeadditionalrequirementsdrawnfromthefollowingdocuments:
QS-9000QualitySystemRequirements,ThirdEditionVDA6,Part1:
QualitySystemAuditAVSQ94Guidaperlapplicazione(guidelinesforuse)EvaluationAptitudeQualitFournisseur(EAQF94)6ISO/TS16949tTheelementsoftheISO/TSarecloselyalignedwiththeelementsofthefourautomotivestandards.tMostoftheelementsoftheISO/TScanbetracedtoaminimumofoneofthefourautomotivestandards-manyelementscanbetracedtoallfourstandards.7ISO/TS16949tThegoalofthisTechnicalSpecificationisthedevelopmentoffundamentalqualitysystemsthatprovideforcontinuousimprovement,emphasizingdefectpreventionandthereductionofvariationandwasteinthesupplychain.8ISO/TS16949Whythenewstandard?
CreateaGlobalQualitySystemLanguageCreateGlobalRecognitionofCertificatesReductioninmultiple3rdpartyregistrationsProvideacompetitiveadvantageAdvantagesforupgradingQM-SystemAdvantagesforglobalsourcing9ISO/TS16949Whatsdifferent?
Numbering(4.1-4.20)remainsthesameAdditional5%requirementsoveratypicaltier1QS-9000systemRegistrationrequirementsaremuch“tighter”thanQS-900010ISO/TS1694911ISO/TS16949ISOvs.QS-9000:
98vs.ISO/TS1694912ISO/TS16949ISOvs.QS-9000:
98vs.ISO/TS1694913ISO/TS16949t4.1.1.2ObjectivestThesuppliershalldefinegoals,objectivesandmeasurementstodeploythequalitypolicy.Objectivesforachievingqualityshallbeincludedinthebusinessplan.NOTEThegoalsandobjectivesshouldaddresscustomerexpectationsandbeachievablewithinadefinedtimeperiod.*moreexplicitaboutqualitypolicyobjectives14ISO/TS169494.1.1.4ContinuousImprovementtContinuousimprovementinquality,service,costandtechnologyshallbeprovidedforintheQualityPolicy.tThesuppliershallidentifyopportunitiesforqualityandproductivityimprovementandimplementappropriateimprovementprojects.tThesuppliershalluseappropriateimprovementmeasuresandmethodologies(see4.2.7).15ISO/TS169494.1.1.4ContinousImprovementcontdNOTE1Thefollowinglistshowsexamplesofpossibletechniqueswhichmightbeused.Theremaybemanyothermethodswhichmeetspecificsupplierneedsmoreappropriately:
-controlcharts(variables,attributes,CUSUM),-designofexperiments(DOE),-theoryofconstraints,-overallequipmenteffectiveness,-partspermillion(PPM)analysistoachievezerodefects,16ISO/TS169494.1.1.4ContinuousImprovementcontd-valueanalysis,-benchmarking,-analysisofmotion/ergonomics,-mistake-proofing.NOTE2GuidelinesforqualityimprovementaregiveninISO9004-4*relocatedfrom4.2.5;moreexplicitaboutqualitypolicyobjectives17ISO/TS169494.1.2.1.3QualityresponsibilitytManagementwithresponsibilityandauthorityforcorrectiveactionshallbepromptlyinformedofproductsorprocesseswhichbecomesnon-compliantwithspecifiedrequirements.tPersonnelresponsibleforqualityshallhavetheauthoritytostopproductiontocorrectqualityproblems.*notechangedintoarequirement18ISO/TS169494.1.2.2.2ShiftresourcestEspeciallyconcerningtheproductionprocess,alltheshiftsshallbestaffedwithpersonnelinchargeof,ordelegatedresponsibilityforquality.*newrequirement19ISO/TS169494.1.3.2Managementreview-supplementaltThesereviewsshallincludeallelementsofthequalitysystemanditsperformance(see4.2.8)overtimeasanessentialpartofthecontinuousimprovementprocess.tPartofthemanagementreviewshallbethemonitoringofstrategicqualityobjectives,andtheregularreportingandevaluationofthecostofpoorquality.NOTEManagementreviewshouldbeconductedwithsufficientfrequencytoensurethattheestablishedqualitysystemiseffective.*moreexplicitaboutwhattoreview20ISO/TS169494.1.5AnalysisanduseofcompanyleveldatatThesuppliershalldocumenttrendsinquality,operationalperformance(productivity,costsofpoorquality,efficiency,effectiveness)andcurrentqualitylevelsforkeyproductandservicefeatures.NOTETheseshouldbecomparedwiththoseofcompetitorsand/orappropriatebenchmarks.21ISO/TS169494.1.5AnalysisanduseofcompanyleveldatacontdtTrendsindataandinformationshallbecomparedwithprogresstowardoverallbusinessobjectivesandleadtoactiontosupportthefollowing:
a)developmentofprioritiesforpromptsolutionstocustomer-relatedproblems;b)determinationofkeycustomerrelatedtrendsandcorrelationtosupportstatusreview,decisionmakingandlongertermplanning;22ISO/TS169494.1.5Analysisanduseofcompanyleveldatacontdc)aninformationsystemforthetimelyreportingofproductinformationarisingfromusage.*item“c”isnew23ISO/TS16949t4.1.6Employeemotivation,empowermentandsatisfactiontThesuppliershallhaveaprocessformotivationofemployeestoachievequalityobjectivesandtomakecontinuousimprovements.Theprocessshallincludepromotionofqualityawarenessonalllevels.NOTEQualityreviewsshouldbeconductedtoprovideappropriateinformation,suchas“plan/actual”comparisonandimprovementsuggestions.24ISO/TS169494.1.6Employeemotivation,empowermentandsatisfactioncontdtThesuppliershallhaveaprocessformeasurementofemployeesatisfactionandemployeeunderstandingofappropriatequalityobjectives.*newsub-element25ISO/TS169494.1.7.1Productsafety-Duecareregardingproductsafetyandmeanstominimizepotentialriskstoemployees,customers,usersandtheenvironmentshallbeaddressedinthesuppliersqualitypolicyandpractices,especiallyindesigncontrol(see4.4)andprocesscontrol(see4.9)proceduresandpractices.Thesuppliershallpromoteinternalawarenessofsafetyconsiderationsrelativetothesuppliersproduct.*QS-9000:
98;4.2.3.4moreexplicit26ISO/TS169494.1.7.2Regulations-Thesuppliershallhaveaprocesstoensurecompliancewithallapplicablegovernment,safetyandenvironmentalregulations,includingthoseconcerningstorage,handling,recycling,eliminatingordisposingofmaterials.*QS-9000:
98;4.6.1.2moreexplicit27ISO/TS16949ProductrealizationtInthisTechnicalSpecification,qualityplanningactivitiesofallpre-launchphaseshavebeenintegratedunderthenewheading“Productrealization”.tForsupplierswithproductdesignresponsibility,productrealizationalsoincludesproductdesign(see4.4).tProductrealizationinthecontextofqualityplanningisdiscussedin4.2.4.Thestructureisoutlinedonthenextslide:
28ISO/TS16949ProductRealizationcontd4.2.3Qualityplanning4.2.3.1Qualityplanning-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-aideddesign29ISO/TS16949Productrealizationcontd4.2.4.7Specialcharacteristics4.2.4.8Feasibilityreview4.2.4Productrealizationcontinued4.2.4.9Managementofprocessdesign4.2.4.9.1General4.2.4.9.2Processdesigninput4.2.4.9.3Processdesignoutput4.2.4.9.4Processverification4.2.4.10Controlplan4.2.4.11Productapprovalprocess*Renumberedandsomenewrequirements30ISO/TS169494.2.8QualitysystemperformancetThesuppliershallevaluatetheperformanceofthequalitysystemtoverifytheeffectivenessofitsoperation.Resultsshallberecordedtoprovide,asaminimum,evidenceoftheachievementof:
a)objectivesspecifiedinthequalitypolicy(see4.1.1.2),b)objectivesspecifiedinthebusinessplan(see4.1.4),c)customersatisfactionwithproductsupplied.Theresultsshallbeusedforcontinuousimprovementorcorrectiveactionasappropriate.*moreexplicit31ISO/TS169494.10.6LaboratoryrequirementstWhereinspection,testingandcalibrationservicesareconductedbyasupplierslaboratoryfacilityshallcomplywithISO/IEC17025,includinguseofalaboratoryscope.NOTEAccreditationofsupplierfacilitiestoISO/IEC17025ornationalequivalentisnotrequiredby,nordoesitsatisfy,allqualitysystemrequirementsspecifiedinthisTechnicalSpecificationforalaboratory.Therefore,thelaboratoryshouldbeincludedintheon-siteaudits.32ISO/TS169494.10.6LaboratoryrequirementscontdtCommercial/independentlaboratoryfacilitiesusedforinspection,testorcalibrationservicesbythesuppliershallbeaccreditedtoISO/IEC17025ornationalequivalent.*newrequirementwithrespecttoISO/IEC1702533ISO/TS169494.17.2.3ProcessaudittThesuppliershallaudittheproductrealizationandproductionprocessestodeterminetheeffectivenessofprocessperformance(seeA.43)*newrequirement34ISO/TS16949A.43processaudittonsiteverificationactivityusedto:
-verifyconformancetospecifiedrequirements,suchascontrolplan,workinstructions,-ensurethatqualityobjectivesaremet,-verifythatspecifiedrequirementsforprocesscapability/performancearemet,-assesstheeffe
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