潛在失效模式與效應分析英文版

FailureModeEffectsAnalysis

(FMEA)Abbr.VersionDTQS-NPQJuly2000ProprietaryMaterialofDuracellGlobalBusinessManagementGroup2FAILUREWhat’sthefailureFailureclassFailureoccurrenceWhat’sthereasonforfailureProprietaryMaterialofDuracellGlobalBusinessManagementGroup3Questions?FAILUREProprietaryMaterialofDuracellGlobalBusinessManagementGroup4FailureModeEffectsAnalysisFMEAAsystematicgroupofactivitiesintendedto:Recognizethepotentialfailure(s)ofaproductorprocessandtheseverityofeffectofthatfailure(s).Identifycriticalcharacteristics.Rankorderpotentialdesignandprocessdeficiencies.Identifyactionsthatcaneliminateorreducethechanceofthepotentialfailurefromoccurringandreachingthecustomer.Documenttheprocess.ProprietaryMaterialofDuracellGlobalBusinessManagementGroup5FMEAPurposeToeliminatethecauseoffailure

…ifthisisnotpossible

reducehowoftenthefailureoccursimprovetheabilitytodetectthefailurebeforeit

reachesthecustomerProprietaryMaterialofDuracellGlobalBusinessManagementGroup6FMEAHistoryandTypesHistory50’ FighterPlaneDesign60’ ApolloPlan70’ Automobile/MedicalInstrument80’ Micro-electronic90’ QS9000,ISO9000TypesDFMEAPFMEA

ProprietaryMaterialofDuracellGlobalBusinessManagementGroup7ProcessFMEAFormProprietaryMaterialofDuracellGlobalBusinessManagementGroup8ProcessFMEAFlowTeamSelectionCalculateRiskNumbersDefineProcessDetailFailureModeCausesEffectsBuildParetoChartDevelopRecommendedActionsProprietaryMaterialofDuracellGlobalBusinessManagementGroup9ProcessFMEAFlowTeamSelectionCalculateRiskNumbersDefineProcessDetailFailureModeCausesEffectsBuildParetoChartDevelopRecommendedActionsProprietaryMaterialofDuracellGlobalBusinessManagementGroup10ProcessFMEATeamSelectionCrossFunctionalandMultilevelOperators,Mechanics,Engineers,LeadersTeamLeaderDesignatedRecommendedtobeProcessOwnerMustbeEmpoweredtoimplementactionsFunctionalexpertscanbepulledinasneededSmaller“Core”groupmaybeusefulinitiallytoprovideframework.ProprietaryMaterialofDuracellGlobalBusinessManagementGroup11ProcessFMEAFlowTeamSelectionCalculateRiskNumbersDefineProcessDetailFailureModeCausesEffectsBuildParetoChartDevelopRecommendedActionsProprietaryMaterialofDuracellGlobalBusinessManagementGroup12ProcessFMEADefineProcessDevelopaProcessFlowdiagramthatisrepresentativeoftheprocessasittrulyis.DecidetheRatingScalesOutlineOperator,Machine,ProductInteractions

Operatorinvolvementisimperativeatthisstep!ProprietaryMaterialofDuracellGlobalBusinessManagementGroup13SeverityRatingProprietaryMaterialofDuracellGlobalBusinessManagementGroup14OccurrenceRatingProprietaryMaterialofDuracellGlobalBusinessManagementGroup15DetectionRating*Couldbetimebasede.g.Takesxminutesordaystodetectafailure.ProprietaryMaterialofDuracellGlobalBusinessManagementGroup16ProcessFMEAFlowTeamSelectionCalculateRiskNumbersDefineProcessDetailFailureModeCausesEffectsBuildParetoChartDevelopRecommendedActionsProprietaryMaterialofDuracellGlobalBusinessManagementGroup17ProcessFMEADetailFailureModeCausesEffectsBrainstormfailuremodes.Selectanddefinefailuremodesthatimpactcriticalcharacteristics.Identifyrootcauses.Defineeffectsoffailuremode.Determinehowoftenfailuremodesoccur.Determinecurrentcontrolsabilitytodetect.ProprietaryMaterialofDuracellGlobalBusinessManagementGroup18ProcessFMEAFlowTeamSelectionCalculateRiskNumbersDefineProcessDetailFailureModeCausesEffectsBuildParetoChartDevelopRecommendedActionsProprietaryMaterialofDuracellGlobalBusinessManagementGroup19ProcessFMEACalculateRiskNumbersCalculateRiskPriorityNumber(RPN)foreachfailuremode.RPN=severityxoccurrencexdetection.ProprietaryMaterialofDuracellGlobalBusinessManagementGroup20ProcessFMEAFlowTeamSelectionCalculateRiskNumbersDefineProcessDetailFailureModeCausesEffectsBuildParetoChartDevelopRecommendedActionsProprietaryMaterialofDuracellGlobalBusinessManagementGroup21ProcessFMEABuildParetoChartBuildPareto’sOneforSeverityOneforSeverityxOccurrenceOneforRPN(SeverityxOccurrencexDetection)Identify“VitalFew”FailureModesCanalsouse$ProprietaryMaterialofDuracellGlobalBusinessManagementGroup22ProcessFMEAFlowTeamSelectionCalculateRiskNumbersDefineProcessDetailFailureModeCausesEffectsBuildParetoChartDevelopRecommendedActionsProprietaryMaterialofDuracellGlobalBusinessManagementGroup23ProcessFMEADevelopRecommendedActionsDevelopandimplementactionson“VitalFew”FailureModesProprietaryMaterialofDuracellGlobalBusinessManagementGroup24ProcessFMEAFlowTeamSelectionCalculateRiskNumbersDefineProcessDetailFailureModeCausesEffectsBuildParetoChartDevelopRecommendedActionsProprietaryMaterialofDuracellGlobalBusinessManagementGroup25ProcessFMEAEvaluateeffectofactionstakenonprocessintermsofseverity,occurrenceanddetection.RecalculateRPNandreassessrisknumber.Reprioritizeandrepeat.CalculateRiskNumbersDetailFailureModeCausesEffectsBuildParetoChartDevelopRecommendedActionsProprietaryMaterialofDuracellGlobalBusinessManagementGroup26ProcessFMEAFormat1ListProcessSteps2Whatcangowrong?3Whathappensifitgoeswrong?4RankSeverityHowbadisit?5Safety?6Whatmakesitgowrong?7RankOccurrenceHowoftendoesitgowrong?8Howdowecurrentlycontrolthis?9RankDetectionWhatisourconfidencetofindit?10CalculateSeverityxOccurrence11CalculateRPNSeverityxOccurrencexDetection12DetermineCorrectiveActions13AssignResponsibilities14ActionsCompleted15RecalculaterisknumbersandreprioritizeRPN’sProprietaryMaterialofDuracellGlobalBusinessManagementGroup27ProcessFMEARelationshipsFromthefailuremode,whataretheeffects?Whatistheworstseverityofalleffects?Listallcausesofthefailuremode,notthecausesoftheeffect.Howoftendoeachcauseofthefailuremodeoccur?Listallprocesscontrolsforeachcause.Whatisourconfidenceineachcontroltopreventeachcause,ordetecttheeffect/failuremode?ProprietaryMaterialofDuracellGlobalBusinessManagementGroup28ProcessFMEARelationshipsFormeditedforclarityProprietaryMaterialofDuracellGlobalBusinessManagementGroup29FMEASummaryIdentifyPotentialFailureModeIdentifyCurrentControlsEffectCauseDetermineSeverityDetermineOccurrenceDetermineDetectabilityActionsleadingtoContinuousImprovementCalculateRiskPriorityNumberProprietaryMaterialofDuracellGlobalBusinessManagementGroup30PotentialFailureModeTheproblem,theconcern,theopportunitytoimprove,thefailure,thereject.Thinkofthespecificlossoftheprocessfunction.ExampleQuestions:Howcouldthisprocessfailtocompleteitsintendedfunction?Whycouldthispartberejectedatthisoperation?Whatdoesthecustomer(internalorexternal)findunacceptable?Howwouldthepartnotconformtospecificationsatthisoperation?ProprietaryMaterialofDuracellGlobalBusinessManagementGroup31PotentialEffect(s)ofFailureTheconsequenceofthefailuremodeonthenextprocess,operation,product,customer(internalorexternal)and/orgovernmentregulations.ExampleQuestions:Whatdoesthecustomer(internalorexternal)experienceasaresultofthefailuremodedescribed?Whathappensorwhataretheramificationsofthisfailure?Consequencesmaybetothedesignitself,theproduct,thecustomer,and/orgovernmentregulations.Severityrankingappliestotheeffectonly.ProprietaryMaterialofDuracellGlobalBusinessManagementGroup32PotentialCauseofFailure(s)Theprocessdeficiencythatresultsinthefailuremode.Therootcause.ExampleQuestions:Inwhatwaycanthissystemfailtoperformitsintendedfunction?Why?Why?Why?Why?Why?Whatcircumstancescouldcausethefailure?Howorwhycanthepartfailtomeetitsengineeringspecifications?Occurrencerankingishowoftenthespecificcauseoccurs.ProprietaryMaterialofDuracellGlobalBusinessManagementGroup33CurrentControlsAmethod,procedure,testorengineeringanalysisdesignedtocatchtheproblembeforeitreachesthenextoperationorcustomer.Canbesimple,ex.Audits,sampling,sensors,SPC,operatorchecks,inprocesstests,fixturing.Canbecomplex,ex.FEI,MilStandards,ComputerSimulation,LaboratoryTests.Focusforthedetectionratingisintheeffectivenessofthecontroltocatchtheproblembeforeitreachesthecustomer.ProprietaryMaterialofDuracellGlobalBusinessManagementGroup34RecommendedActionsMaybeasp