FMEA_training

FMEAPotentialFailureModeandEffectsAnalysisDesignandProcessFMEAHeribertNuhn,QMS,Qualitäts-Management-SystemeFMEA;Version2017.3QMSHeribertNuhnReferenceMaterial•PotentialFailureModeandEffectsAnalysisReference-Manual(FourthEdition,June2008)•VDA4.2(SecondEdition,2009/2010)•VDAMaturityLevelAssurance(2ndedition,2009)•APQP&CPReferenceManualSecondEdition(2008)•PPAPFourthEdition(2006)3HeribertNuhn,QMS,Qualitäts-Management-SystemeFMEA;Version2017.3Version2016.2FMEAManual4FMEAHistory•developedmid-1960sintheUS•foraerospaceindustry(Apollo-Program)Present•essentialpartofQM-Systems•aerospace•nuclearenergy•automotiveindustryVersion2016.2FMEAManual5IntroductionThismanualintroducesthetopicofPotentialFailureModeandEffectsAnalysis(FMEA)andgivesgeneralguidanceintheapplicationofthetechnique.Version2016.2FMEAManual6FMEAProcess(1)•APQP:FMEAisananalyticalmethodologyusedtoensurethatpotentialproblemshavebeenconsideredandaddressedthroughouttheproductandprocessdevelopmentprocess•Itsmostvisibleresultisthedocumentationofthecollectiveknowledgeofcross-functionalteamsIntroductionVersion2016.2FMEAManual7FMEAProcess(2)•evaluationandanalysistoassessrisk•conductdiscussionregarding•productandprocessdesign•reviewoffunctions•changesinapplication•resultingriskofpotentialfailureIntroductionVersion2016.2FMEAManual8FMEAProcess(3)•attentiononeverycomponentwithinproductorassembly•criticalorsafetyrelatedcomponentsorprocessesshouldbegivenahigherpriority•importanceoftimelinessofFMEA-Process•before-the-event•notafter-the-factIntroductionVersion2016.2FMEAManual9FMEAProcess(4)•DesignFMEAintheearlystagesofdesign•ProcessFMEAbeforetoolingormanufacturingequipmentisdevelopedorpurchased•FMEAevolvesthroughouteachstageofdesignandeachstageofthemanufacturingdevelopmentprocess•maybeusedinproblemsolvingIntroductionCustomerRequirementsContractReviewSourcingDecisionCraftmanshipD-FMEADVPDesignReviewDesignReviewDesignReviewDesignReviewFacilitiesandToolsMeasurementSystemandGaugesPrototypeBuildsDesignFreezeFeasibilityCommitmentP-FMEAPVPPVP/ProductionValidationTestingProcessFl.ChartMeasurementSystemAnal.Pre-LaunchControlPlanProcessInstructionsLogisticConceptPackagingequipmentProductionTrialRunProductionControlPlanPrel.ProcessCapabilityPSWSOPPrel.FeasibilityComitmentMLA/APQPVersion2016.2FMEAManual10MLA:MaturityLevelAssuranceAPQP:AdvancedProductQualityPlanningVersion2016.2FMEAManual11QualityPlanningLeverProductEngineerManufacturingProcessEngineerManufacturingAssemblyOperationsCustomerService$1ofNetImprovementCustomertakesPossessionLossofControlforManufacturerVersion2016.2FMEAManual12PurposeofManual(1)•describesbasicprinciplesandimplementationofFMEAprocess•coversFMECA:FailureModeEffectsCriticalityAnalysisquantifyingrisks•showsintegrationintoproductandprocessdevelopmentcycle•includesdocumentationofthisprocessIntroductionVersion2016.2FMEAManual13PurposeofManual(2)•showshowtheanalysiscanbeappliedforproductandprocessimprovementinitsearlyandfulldevelopmentstage•providesalternateandsupportingmethodologies•providesguidanceonhowriskcanberepresented,measuredandprioritizedIntroductionVersion2016.2FMEAManual14PurposeofManual(3)Riskevaluation•atooltoidentifytheseverity•atooltoestimatetheprobabilityofoccurrence•broadenstheanalysisbyprovidingameasureofthefailuremode´slikelihood•FMEAisinstrumentalinreliabilityimprovementIntroductionVersion2016.2FMEAManual15PurposeofManual(4)TherearethreebasiccasesforwhichFMEAprocessistobeapplied:•newdesign,newtechnologyornewprocesses•modificationtoexistingdesignorprocess•useofanexistingdesignorprocessinanewenvironment,location,applicationordutycycleIntroductionVersion2016.2FMEAManual16ScopeofManual•Theanalyticalmethodspresentedinthismanualareapplicabletoanyproductorprocess.•However,thismanualwillfocusonthoseapplicationsprevalentwithintheautomotiveindustryanditssuppliers.IntroductionVersion2016.2FMEAManual17ImpactonOrganizationandMgmt.FMEA•isanimportantactivitywithinanycompany•mustbewellplannedasamulti-disciplinedactivity•musthaveaprocessownerand•seniormanagementcommitmentVersion2016.2FMEAManual18ImpactonOrganizationandMgmt.FMEAImplementationwillvarydependingonsizeandstructureofthecompanyconcerned,althoughthesameprincipleswillapply•producedbyorganizationandmulti-tiersuppliers•addressesDesignandProcessFMEA•FMEAprocessisanintegralpartofAPQP•partofengineeringtechnicalreviews•partofsign-offandapprovalforproductandprocessdesignVersion2016.2FMEAManual19ImpactonOrganizationandMgmt.FMEAdevelopedbymulti-functional(orcross-functional)team•teamsizedependingon•complexityofthedesign•sizeandorganizationofthecompany•teammembersneed•relevantexpertise•availabletimeand•authoritysanctionedbymanagementVersion2016.2FMEAManual20ImpactonOrganizationandMgmt.Comprehensivetrainingsprogramincluding•managementoverview•trainingfor•user•supplier•facilitatorUltimately,managementhastheresponsibilityandownershipfordevelopmentandmaintenanceoftheFMEAsVersion2016.2FMEAManual21FMEAExplainedFMEAareanintegralpartofmanagingriskandsupportingcontinualimprovement.•FMEAiskeytoproductandprocessdevelopment•AP