FailureModeEffectsAnalysis（FMEA）

FailureModeEffectsAnalysis(FMEA)Abbr.VersionDTQS-NPQJuly2000ProprietaryMaterialofDuracellGlobalBusinessManagementGroup2FAILUREWhat’sthefailureFailureclassFailureoccurrenceWhat’sthereasonforfailureProprietaryMaterialofDuracellGlobalBusinessManagementGroup3Questions?FAILUREProprietaryMaterialofDuracellGlobalBusinessManagementGroup4FailureModeEffectsAnalysisFMEAAsystematicgroupofactivitiesintendedto:Recognizethepotentialfailure(s)ofaproductorprocessandtheseverityofeffectofthatfailure(s).Identifycriticalcharacteristics.Rankorderpotentialdesignandprocessdeficiencies.Identifyactionsthatcaneliminateorreducethechanceofthepotentialfailurefromoccurringandreachingthecustomer.Documenttheprocess.ProprietaryMaterialofDuracellGlobalBusinessManagementGroup5FMEAPurposeToeliminatethecauseoffailure…ifthisisnotpossiblereducehowoftenthefailureoccursimprovetheabilitytodetectthefailurebeforeitreachesthecustomerProprietaryMaterialofDuracellGlobalBusinessManagementGroup6FMEAHistoryandTypesHistory50’FighterPlaneDesign60’ApolloPlan70’Automobile/MedicalInstrument80’Micro-electronic90’QS9000,ISO9000TypesDFMEAPFMEAProprietaryMaterialofDuracellGlobalBusinessManagementGroup7ProcessFMEAFormProcessProcessResponsibilityPage1of1CellSizeFMEADueDatePreparedbyCellChemistryFMEANumberFMEADate(Orig.)(Rev.)ActionResultsProcessFunctionPotentialFailureModePotentialEffect(s)ofFailureSevClassPotentialcause(s)ofFailureOccCurrentControlsDetS*ORPNRecommendedAction(s)Area/IndividualResponsible&CompletionDateActionsTakensevoccdetS*ORPNProcessProcessResponsibilityPage1of1CellSizeFMEADueDatePreparedbyCellChemistryFMEANumberFMEADate(Orig.)(Rev.)ProprietaryMaterialofDuracellGlobalBusinessManagementGroup8ProcessFMEAFlowTeamSelectionCalculateRiskNumbersDefineProcessDetailFailureModeCausesEffectsBuildParetoChartDevelopRecommendedActionsProprietaryMaterialofDuracellGlobalBusinessManagementGroup9ProcessFMEAFlowTeamSelectionCalculateRiskNumbersDefineProcessDetailFailureModeCausesEffectsBuildParetoChartDevelopRecommendedActionsProprietaryMaterialofDuracellGlobalBusinessManagementGroup10ProcessFMEATeamSelectionCrossFunctionalandMultilevelOperators,Mechanics,Engineers,LeadersTeamLeaderDesignatedRecommendedtobeProcessOwnerMustbeEmpoweredtoimplementactionsFunctionalexpertscanbepulledinasneededSmaller“Core”groupmaybeusefulinitiallytoprovideframework.ProprietaryMaterialofDuracellGlobalBusinessManagementGroup11ProcessFMEAFlowTeamSelectionCalculateRiskNumbersDefineProcessDetailFailureModeCausesEffectsBuildParetoChartDevelopRecommendedActionsProprietaryMaterialofDuracellGlobalBusinessManagementGroup12ProcessFMEADefineProcessDevelopaProcessFlowdiagramthatisrepresentativeoftheprocessasittrulyis.DecidetheRatingScalesOutlineOperator,Machine,ProductInteractionsOperatorinvolvementisimperativeatthisstep!ProprietaryMaterialofDuracellGlobalBusinessManagementGroup13SeverityRatingSeveritySeverityisaratingcorrespondingtotheseriousnessofaneffectofapotentialfailuremode.NoEffect1Noeffectonsystemoroutputperformanceoronsubsequentprocesses.VerySlightEffect21Customerwillprobablynotnoticethefailure.NuisanceFaultnoticed.SlightEffect3Slighteffectonoutputperformance.Customerslightlyannoyed.Nuisancefaultobvious.MinorEffect4Minoreffectonoutputorprocessperformance.Slightdeterioration.Chronicnuisancefault.ModerateEffect54Moderateeffectonperformance.Customerdissatisfied.Nuisancerepairrequired.SignificantEffect6Performancedegradedbutsafe.Discomfort.Repairrequired.Non-vitalpartnonfunctional.MajorEffect77Rework/Repairsnecessary.Performanceseverelyaffectedbutsafe.Dissatisfiedcustomer.Subsysteminoperable.SeriousEffect8Equipmentdamaged.Systeminoperablebutsafe.Verydissatisfiedcustomer.VerySeriousEffect99Potentiallyhazardousfailure.Safetyrelatedbutgradualfailure.HazardousEffect1010Hazardousfailure.Safetyrelated–suddenfailure,Governmentregulationnon-compliance.ProprietaryMaterialofDuracellGlobalBusinessManagementGroup14OccurrenceOccurrenceisaratingcorrespondingtotherateatwhichafailuremodeoccursbeforeanydetectingmeasuresareapplied.OccurrenceRatingCpkFailureRateNotesAlmostImpossible1Cpk1.675.01in1,500,000Failureunlikely.Similarprocessesorproductsshownofailure.Remote21Cpk1.504.51in150,000Remotenumberoffailureslikely.VerySlight3Cpk1.334.01in15,000Veryfewfailureslikely.Slight4Cpk1.173.51in2000Fewfailureslikely.Low54Cpk1.003.01in400Occasionalfailure.Medium6Cpk0.832.51in80Moderatenumberoffailureslikely.ModeratelyHigh77Cpk0.672.01in20Frequentfailureslikely.High8Cpk0.511.51in7Highnumberoffailureslikely.VeryHigh99Cpk0.331.01in3Veryhighnumberoffailureslikely.AlmostCertain1010Cpk0.3311in3Failuresalmostcertaintooccur.Similarprocesses/productsshowfailures.OccurrenceRatingProprietaryMaterialofDuracellGlobalBusinessManagementGroup15DetectionDetectionisaratingcorrespondingtothelikelihoodthatthedetectionmethodsorcurrentcontrolswilldetectthefailure.AlmostCertain1Reliabledetectioncontrolsareknownwithsimilarprocessesorproducts.Controlsarealmostcertaintodetectthefailuremode.VeryHigh21Hist