德国汽车工业质量标准-vda6.Part 5（Product Audit）

3VDAQualityManagementintheAutomotiveIndustry1stEdition1998ProductAuditPart56ProductAudit1stEdition1998VerbandderAutomobilindustriee.V.(VDA)2ISSN0943-9412Copyright1998byVerbandderAutomobilindustriee.V.(VDA)(AssociationoftheGermanAutomotiveIndustry)QualityManagementCenter(QMC)D-60325FrankfurtamMain,Lindenstraße5Overallproduction:DruckereiHenrichGmbHD-60528FrankfurtamMain,SchwanheimerStraße110Printedonchlorine-freebleachedpaper.3LiabilityexclusionTheVDAvolumesareguidelinesavailableforanyonetouse.Itistheres-ponsibilityofthepersonusingtheguidelinestoensureit‘scorrectuseineachspecificcase.TheVDAvolumestakeintoaccountstateofthearttechnology,currentatthetimeofissue.ByusingtheVDAguideline,nobodyisrelievedoftheresponsibilityfortheirownactions.Eachpersonacts,inthisrespect,attheirownrisk.LiabilitybyVDA,andthosepersonsinvolvedinissuingVDAguidelines,isherebyexcluded.IfduringtheuseofVDAguidelines,errorsorthepossibilityofmisinterpre-tationarefound,itisrequestedthatthesebenotifiedtotheVDAimme-diately,sothatanypossiblefaultscanbecorrected.ReferencedstandardsTheextractsfromstandardsidentifiedwiththeirDINnumberandissuedatearereproducedwiththepermissionoftheDINDeutschesInstitutfürNormunge.V.(GermanInstituteforStandardization).Theversionwiththelatestissuedateisdefinitivefortheuseofthestandard,whichcanbeattainedfromthepublishersBeuthVerlagGmbH,10772Berlin.CopyrightThepublication,includingallit‘sparts,isprotectedbycopyright.Anyuseoutsideofthenarrowboundariesofcopyrightlaw,withoutthewrittenpermissionoftheVDA,isunauthorizedandillegal.Thisappliesinparticulartocopying,translation,microfilmingandthesavingandprocessinginelectronicsystems.45ForewordWithrespecttotechnicalandeconomicprogress,qualityassurancedeter-minesthefutureoftheautomotiveandsupplierindustry.Theproductionprocessconsistingofmanyindividualprocesseshastotakeintoaccountrationalandeconomicaspectsinordertoachieveanoptimuminquality,timeandcosts.Toensurethis,theVDAhasissuedthefollowingguidelinesforthequalitystandardoftheautomotiveindustry:QUALITYSTANDARDOFTHEGERMANAUTOMOTIVEINDUSTRY(VDA6)VDA6VDA6Part1QualitySystemAuditVDA6Part2QualitySystemAuditServicesQualityAuditsVDA6Part3ProcessAuditBasicsVDA6Part5ProductAuditVDA6Part6ProductAuditServicesTheproductauditshalldemonstratethequalityniveauofinternally/exter-nallymanufacturedproductsinaprocesschain.Withknowledgeofthequalityniveau,shortandlongtermconclusionsregardingtheproductionprocessandifnecessary,thequalitysystemarepossible.Theinformationgainedfromproductauditspromotethecontinuosprocessofqualityimprovement,tothebenefitofcustomersandsuppliers.Apracticalrepresentationoftheproductauditwaschosen,tomakethecontentofthepublicationeasilyunderstandable.Guidelinesareprovidedfortheplannerofproductauditsandproductauditors.Thesubject„ProductAudit„isthenroundedoffwithactualexamplesfrompractice.6Wethankthefollowinginvolvedcompaniesandtheiremployeesfortheirinputinthepreparationofthispublication:AktiengesellschaftKühnle,Kopp&Kausch,KirchheimbolandenContinentalAG,HannoverFichtel&SachsAG,SchweinfurtFord-WerkeAG,CologneGLYCO-METALL-WERKEGlycoB.V&Co.KG,WiesbadenDaimler-BenzAG,HamburgWorksTRWDeutschlandGmbH,MotorComponents,BarsinghausenTHYSSENKRUPPSTAHLAG,DuisburgVolkswagenAG,WolfsburgZDH-ZERTe.V.,Bonn.andhope,thatthispublicationfindssuccessfulapplication.Frankfurt/Main,April1998VERBANDDERAUTOMOBILINDUSTRIEE.V.(VDA)7ContentPageForeword51Introduction112DefinitionsandPurposeofaProductAudit132.1Definitions132.1.1QualityAudit(according.toISO8402:1994)132.1.2Product(accordingtoISO8402:1994)132.1.3ProductAudit142.2Purpose153ProductAuditatCarManufacturersandSuppliers163.1DistinguishingaProductAuditfromotherAuditTypes163.2ProcessofaProductAudit184PreparationandPlanningofProductAudits194.1PreconditionsandResponsibilities194.3ReferenceDocumentation204.4Inspection,MeasuringandTestMethodsandEquipment214.5AuditorQualification215ProductAuditQuestionnaire225.1General225.2QuestionstothePhysicalExaminationofaProduct225.2.1ReviewofallDocuments225.2.2RandomSampling226PerformingaProductAudit236.1Responsibility236.2Process236.3Reporting(Documenting)247AnalysisoftheDataandInvestigationofCausesofNonconformities258EvaluationoftheProductAuditResults269ProductAuditReport27810CorrectiveActionsResultingfromtheProductionAudit2810.1General2810.1.1CorrectiveActionsforMajorNonconformities2810.1.2CorrectiveActionsforMinorNonconformities2810.2MonitoringofCorrectiveActions2811CaseExamples2811.1CaseExample–SelectorShaft-Müller+Co.2911.2CaseExampleInputMaterial(Sheetmetal)-ThyssenStahlAG3511.3CaseExampleLaserandMashSeamWeldedTailoredBlanks-ThyssenStahlAG11.3.1SelectingSamplesforInspection4011.3.2ScopeofInspection4011.3.3ProcessandSequenceofOperations4011.3.4ProductAuditReport4111.3.5ProcedureforHandlingNonconformities4111.3.6DispatchAudit4211.3.7Responsibility4211.4CaseExampleBearingBush-AGKühnle,Kopp&Kausch4511.4.1ExplanationSystematicQualityEvaluationProductionandPurchasing(SQPP)4511.4.2CodeNumberSystemforSQPP4711.4.3ProcedureusingBearingBushasanExample4911.5CaseExampleValves-TRWDeutschlandGmbH,MotorComponents5611.6CaseExampleTires-ContinentalAG6111.6.1ScopeandFrequencyofInspection6111.6.2Specifications,Inspection,MeasuringandTestMethods6111.6.3Process6211.6.3.1Auditor6211.6.3.2VisualInspection6211.6.3.3MachineTests6211.6.4Documentation6211.6.5Evaluation6211.6.6Forms6211.6.6.1VisualInspection6211.6.6.2Concentricity62911.7CaseExampleCompleteVehicle-FORDAG6511.7.1CheckofConformity6511.7.2CompleteVehicle6511.8CaseExample–CompleteVehicle-VolkswagenAG7411.9ExampleofaProductAuditProcedure-MercedesBenzAG,HamburgWorks8111.9.1Purpose8111.9.2Scope8111.9.3TermsandDefinitions8111.9.3.1ProductAudit8111.9.4Responsibilities8211.9.4.1ProductAudit8211.9.5Description8311.9.5.1PerformingtheProductAudit11.9.5.2ProductAuditPlan8411.9.6AdditionalNotes8411.9.7ApplicableDocuments8411.9.8FlowChartoftheProductAuditProcess8512Appendix:ReferencetoVDA6.18813Bibliography9113.1Standards9113.1.1DINENISO8402(1995)9113.1.2DINENISO9000,Part1(08/94)9113.1.3DINENISO9000,Part2(03/92)9113.1.4DINENISO9001(08/94)9113.1.5DINENISO9002(08/94)9113.1.6DINENISO9004,Part1(08/94)9113.1.7DINISO10011Part1(06/92)9213.1.8DINISO10011Part2(06/92)9213.1.9DINISO10011Part3(06/92)9213.2Literature9213.2.1VDAPublicationsfortheAutomotiveIndustry9213.2.2Masing,Walter(Publ.)9313.2.3DGQ-Publication11-04(Status1995)9313.2.4DGQ-Publication12-62(Status1991)9313.2.5DGQ-Publication12-63(Status1993)9313.2.6DGQ-Publication13-41(Status1995)9313.2.7DGQ-Publication14-189313.3References9410111IntroductionAproductauditassessestheeffectivenessofqualityassurancethroughtheexaminationofasmallnumberofproductsand/orpartsandconfirmstheirqualitycapabilitybasedonthequalityoftheproduct.Thereby,itischecked,iftheproductcomplieswiththegivenspecifications,orrespectively,withspecialcustomer/supplieragreements.Thefocusoftheevaluationofdeviationsfromthespecificationlies,dependingonthegivenobjective,onitstechnicalsignificance,itssignifi-canceforthesubsequentprocessorcustomerreaction.Duringaproductaudit,theproductpropertiesinnewcondition,andnotafterlongtermuse,aredetermined.Itdoesnotserveasasubstituteforinspectionsduringtheproductionprocess.Productauditsarecarriedoutregularly.Irrespectiveofthis,theycanalsobeadditionallycarriedoutforaspecificreason.Theymustbeplannedandpreparedbyqualifiedpersonnel,beforetheyarecarriedout.Everyaudit,itsresults,improvementmeasures,aswellasresponsibilitiesaretobedocu-mented.Productauditscanbecarriedoutinallbusinessprocesseslike,productdevelopment–productmanufacturing-productmarketing.Thispublicationprimarilydealswithproductauditsinproductmanufac-turing.Theproductauditidentifiesqualitytrendsandnonconformityfocalpoints.Incertaincases,itcanleadtotheconclusionthatsystemfailuresexist,whichtheninitiatesfurtherauditssuchasprocessorsystemauditsbeingcarriedout.ProductauditsareanintegralpartofaqualitysystemaccordingtoVDA6.1.Thecompanymanagementmustidentifywiththedutiesandobjectivesoftheproductaudit.12Thefollowingdecisioncriteriacanbeusefulfortheapplicationofproductauditsinacompany:-checkingthecomplianceofdevelopmentresultswiththeinputs(e.g.prototypes,pilotproductionruns)-verifyingtheuniformityofproduction-recognizingdeviations,changesandtrends-discoveringriskpotential-illustratingcustomerreaction-decisionaidtocustomerexpectationsandrequirements-earliestreactiontofieldproblems-checkingtheeffectivenessofmeasurestaken-legalrequirements.Animportantpreconditionfortheperformanceofproductauditsistheavailabilityofanappropriatelyorganizedstructure,thatallowsauditstobesystematicallyandindependentlycarriedout.Theauditplandefinesatwhichstageintheproductionprocess,productauditsarecarriedout.Intheauditplan,questionsabouttheefficiency,com-plexityoftheproductsandthenumberofproductionpiecesareincluded.132DefinitionsandPurposeofaProductAudit2.1Definitions2.1.1QualityAudit(according.toISO8402:1994)„Systematicandindependentexamination,inordertoascertain,ifthequali-tyactivitiesandrelatedresults,complywithgiveninstructions,andiftheseinstructionsareefficientlyputintoactionandaresuitabletoachievetheirobjectives.„Note:Aqualityauditistypicallycarriedoutonaqualitysystemoranelementthereof,onprocessesorproducts(includingservices),butisnotrestrictedtothese.Suchqualityauditsareoftencalled„systemaudits„,„processaudits„,productaudits„,or„serviceaudits„.Onepurposeofaqualityauditistoassesstheneedforanimprovementorcorrectiveaction.Aqualityauditshouldnotbemistakenwithqualitymonitoringactivitiesorreviews,whicharecarriedoutforprocesscontrolorproductreceivingpurposes.Qualityauditscanbecarriedoutforinternalorexternalpurposes.2.1.2Product(accordingtoISO8402:1994)„Resultofactivitiesandprocesses„.Note:Theterm„product“canincludeaservice,hardware,processedmaterials,softwareoracombinationthereof.Aproductcanbetangible(e.g.assemblies,processedmaterials)orintangible(e.g.knowledgeorconcepts)oracombinationthereof.Aproductcanbeintended(e.g.productofferedtocustomers)orunintended(e.g.pollutantsorundesirableeffects).142.1.3ProductAuditAproductauditistheplanning,performance,evaluationanddocumentationofexaminationsof-quantitativeandqualitativecharacteristicson-materialproductsafter-completionofaproductionstageandbefore-itsforwardingtothenextcustomer(internal/external)onthebasis-ofreferencevaluesthrough-anindependentauditor.Note1:Materialproductsaretheresultofactivitiesandprocessesandare,forexample,rawmaterials,intermediateproductsofalltypesincludingcom-ponents,assemblies,andsubassemblies,aswellasendproducts,whicharetobedeliveredtothecustomer.Duringaproductaudit,thepropertiesinnewconditionandnotafterlongtermuse,aredetermined.Note2:Bothinternalorexternalcustomerscanbemeant.Onecanalsounder-stand„customer“tomeanafurtherprocessorasubsequentproductionmachine.Note3:Theproductauditisgenerallycarriedoutbytheproductmanufacturer(supplier).ItisusefulfortheperformanceofaproductaudittouseDINISO10011Part1.Theauditormustknowtheproductanditsproductionprocess,orhaveaccesstoinformationcarriers.Furthermore,dependingontheobjectives,hehasinformationthatdescribecustomerreactionstononconformities.Theperformanceoftheexaminationsfollowsadefinedauditplan.Note4:AccordingtotheVDApublicationVolume6,Part1,Question15.1thefollowingpointsaretobeestablishedintheproductauditplan:typeandextentofsamplesorparts,typeandnumberofthecharacteristicstobechecked,inspection,measuringandtestmethodandequipment,andeva-luationoftheexaminationresultsincomparisontotheinternaland/orexternalstandardsorspecificationsanddrawings.Note5:Theresultoftheevaluationofaproductauditistoberegardedasareviewofallqualitycontrolmeasures.Whendeviationsfromthespecificationsarefound,correctiveactionsaretobetaken.Immediateactionslikee.g.stoppingorre-sortingtheentireproductionand,ifnecessary,indevelopment,arerequired,whendeviationsfromspecifiedvaluesand/orlimitpatternsofimportantcharacteristics-especiallysafetycharacteristics,arefound.15Note6:Productauditscanbecarriedoutonprototypesandafterallproductionphasesuntildelivery.Auditsatdifferentproductionphasesand,ifapplicable,thedeliveryproductauditperformedfromacustomer’spointofview,aremethodicallyattunedtooneanother.2.2PurposeItisthetaskofaproductaudit,tochecknormallydelivery-readyproductsaccordingtotheauditplanforconformancewiththetechnicaldocuments,drawings,specification,standards,legalrequirementsandfurtherset„qualitycharacteristics“.Thischeckiscarriedoutonfewproducts,butverycomprehensivelyandfromthecustomer’spointofview.Asapriority,systemfaults,nonconformityfocalpointsandlongtermqualitytrendsaretobeascertained.Fortheeliminationmeasurestobeimplemented,recognizednonconformitiesaretobeseparatedintosyste-maticandcoincidentalnonconformities.Inseriouscases,immediateactionsintheproductionprocessareimplemented.Therespectivecheckrepresentsthemomentarysituation.Theauditinit’sentiretyoveratimeperiod,shallillustratethequalitypotentialoftheproduction.Thescopeofinspectionisdeterminedbythecomplexityoftheproductandthenumberofproductionpieces.Thepurposeofaproductaudit,foracompany,istorecognizedeviationsandtoconfirmcompliancewithdrawingrequirementsandcustomerspeci-fications.Theresultsofreliabilitycheckscanalsobeincluded.Knowledgeofallcustomerexpectationsofaproductisnecessaryduringaproductaudit.Theseshouldbeexternallyevaluatedandmethodicallyintegratedintotheproductaudit.Inthisway,forexample,noisescouldbeevaluatedtoseeif,andtowhatextent,theyareregardedasdisturbingbythecustomer.Thesupplierormanufacturergainsacomprehensivepictureofthequalityofhisproductsandtheacceptanceoftheseproductsbythecustomer.163ProductAuditatCarManufacturersandSuppliers3.1DistinguishingaProductAuditfromotherAuditTypesTheproductauditshowsonlypartialsimilaritiestootheraudittypesorwithotherproductassessments.Anexemplarydistinction,whichdoesnotclaimtobeexhaustive,isshowninTable1.ProductAuditSystemAuditProcessAudit100%inspection,measuringandtestingFinalinspection,measurementandtestinginserialproductionInspectionverificationFirstsampleWorksinspectioncertificateSPCPerformancefrequencyacc.toplan,generallyseveraltimesayearacc.toplan,generallyonceayearacc.toplanandasnecessarycontinuouslycontinuouslyacc.tocust.requirementsacc.tocust.requirementscontinuouslyCheckedcharacteristicsselectedacc.tocustomerrequirements/expectationsandimportantprocessandproductcharacteristicselementsofthequalitysystemselected,asnecessaryforprocessevaluationqualitativecharacteristics,incompetentcharacteristicsselected,product–related,acc.tocustomerexpectationsacc.tocust.requirementsselected,andacc.tocust.requirementsselected,asrequiredforprocesscontrolCapabilityparametersshorttermcapabilityoftheproductcharacteristicsonthebasisoftheselectedsample.Feedbacktoproduction(degreeofcompliancewiththesystemobjectives)shorttermcapabilitiesoftheprocessparameters(qualitativecharacteristicse.g.cpk<1,33)shortandlongtermcapabilitiesoftheproductcharacteristicsacc.tocustomerrequirementsautomaticidentificationoftheshortandlongtermcapabilitiesAppliedverificationmethodsselected,specificfortheproductdocumentreviewcomparedtotheobjective,theapplicationinpracticeselected,specificfortheprocessselected,specificfortheproductselectedstandardmethod,specificfortheproductselectedwiththeagreementofthecustomerselected,specificfortheprocessorproductQualificationoftheauditors/inspectorsknowledgeoftheproductandproductionprocess,alsofromthecustomer’spointofviewDINISO10011,Part2+EOQCertificate+VDA6.1Certificateknowledgeoftheprocessknowledgeofthecharacteristicsknowledgeofthecharacteristicsandcustomerexpectationsknowledgeofthecharacteristics,customerrequirementsandrelevantstandardsknowledgeandexperienceofcontrolcardtechnologyNecessarydocumentsdrawings,specifications,workandinspectioninstructions,codingsystemsqualitymanual,proceduresandworkinstructionsprocessplan,processparameters,inspectioninstructionscatalogofdeviationsforqualitativecharacteristics,inspectioninstructionscatalogofdeviationsforqualitativecharacteristics,specifications,drawings,inspectioninstructionsspecifications,drawings,inspectioninstructions,standardsqualitycontrolcards,inspectioninstructionsDocumen-tation/recordsinspectionresults,auditreportresultsaccordingtoquestionnaire,auditreport,nonconformityanalysiswithcorrectiveactionsinspectionrecord,auditreport,nonconformityanalysiswithcorrectiveactionsstatisticstoinspectionresults,nonconformityanalysiswithcorrectiveactionsinspectionrecordandstatisticstoinspectionresults,nonconformityanalysiswithcorrectiveactionsfirstsampleinspectionreportworksinspectioncertificatecontrolcardswithevaluationTable1:Distinctionbetweenaproductauditandothertypesofauditsandinspections183.2ProcessofaProductAuditTheprocessofaproductauditisschematicallyshowninthefollowing.ActionplanCompanyspecificrequirementsKcustomerspecificationsDrawingsFMEAPlanningandpreparationofscheduleauditsAudit-date-responsibleareaInspectioninstructions-characteristics-inspection,measuringandtestequipment-frequencyInternalnonconformityCustomercomplaintsPlanningandunscheduledaudits*)MarketandcustomerinformationDrawingsInspectioninstructionAuditplanProcessInformresponsibledepartmentProductsamplingProductinspectionProtocolEvaluationProductAuditProcessRecordwithauditresultsAuditreportLongtermevaluationProductAuditsatisfactoryNoCorrectiveactionsaccordingtoelement18,VDA6.1NonconformitiesaccordingtoauditreportYesYesNoAuditreportLongtermevaluationInformresponsibledepartentsInclusionofresultsinnextauditplanning*)Unscheduledauditsarespecificallyinitiated.Theymustthereforenotbeincludedinthelongtermevaluation.Ifspecificassesmentsareincludedinthelongtermevaluation,itisdistorted,asaspecificassesmentdoesnotrepresentarandomsample.194PreparationandPlanningofProductAudits4.1PreconditionsandResponsibilitiesAproductauditmustbecarefullyplanned.Therefore,certainpreconditionsmustbemet:a)Inclusionofastatementregardingthecarryingoutofproductauditsinthequalitymanualb)raisingofanauditprogramc)thetranslationofthisintoabindingworkinstructionfortheaudi-tors.Personsresponsiblefortheplanningofproductaudits,arethosefuncunitsinacompanyassignedaccordinglyinthequalitymanual.Itmustbeensuredthatthisareaisindependentoftheproducer.4.2AuditProgramAuditprogramsmustbeestablishedfortheproductsandmustcontainfollowinginformation:-Purposeoftheaudit-Referencedocuments-Productstobeaudited-Codingsystems/Checklists-Date/Frequencyoftheaudit-Auditors-Reportissuerwithdistributionlist-Responsibilitiesforfollowingupofcorrectiveactions.Duringtheraisingoftheauditplandetails,amongstothers,mustbegivenabout:-thecharacteristicstobechecked-quantitativecharacteristics-functionalcharacteristics-materialcharacteristics-lifetimecharacteristics-qualitativecharacteristicsandtheinspectionandtestingmethodsandequipmenttobeapplied.20Theselectionoftheproductsandcharacteristicstobeassessedismadeto,forexample,thefollowingcriteria:-lotsize-customerrequirements-productcomposition-productionline.4.3ReferenceDocumentationForaproductaudit,alltechnicaldocumentscontainingintegralpartsofthequalityrequirementsareconsulted.Withthehelpofthesedocuments,itcanbeassessedifthequalityrequirementsontheproductarebeingcompliedwith.Inparticular,itinvolvese.g.followingdocuments:-Drawingswithamendmentstatus-Specifications-FMEA-Productionprocessplansandprocessdescriptions,-Inspectionandtestingspecifications-Nonconformitycatalogs-Limitpatterns-Instructionstotheanalysismethods-Evaluation/qualitystandardorreferences-Materialsheets-Approvedproductiondeviations(concessions)-Standards-Legalrequirements(e.g.federallaws)-Ifapplicable,nonconformityclassification(ine.g.majorandminornonconformities)withevaluation-Deliveryagreements.214.4Inspection,MeasuringandTestMethodsandEquip-mentWhenselectinginspection,measuringandtestmethodsandequipment,thefollowingbasicsandcommentshavetobeconsidered:-measuringuncertaintyoftheinspection,measuringandtestequipment-withalternativeinspection,measuringandtestmethods,theonetobeselectedshouldbeonenotusedintheserialinspec-tion,inthisway,weaknessesduetoincorrectoruncer