FMEA-N

©CaymanSystemsRevisionN980815(513)777-3394:10/12/98FailureModeandEffectsAnalysis©CaymanSystemsRevisionN980815(513)777-3394:10/12/98Don’tLetThisHappenToYOU!©CaymanSystemsRevisionN980815(513)777-3394:10/12/98PotentialFailureModeandEffectsAnalysisProcessFailureModeAndEffectsAnalysisLow-HighProcess:OutsideSuppliersAffected:Engineer:1-10PrimaryProcessResponsibility:ModelYear/Vehicle(s):PartNumber:OtherDiv.OrPeopleInvolved:ScheduledProductionReleased:PFMEADate:Rev.Approvals:QualityAssuranceManagerQualityAssuranceEngineerOperationsManagerSeniorAdvisorPartNameOperationNumberProcessFunctionPotentialFailureModePotentialEffectsOfFailurePotentialCauseOfFailureCurrentControlsOccuredSeverityDetectionRPNRecommendedActionsAndStatusActionsTakenOccuredSeverityDetectionRPNResponsibleActivitySIRTakeTPPEWrongMaterialFragmentedContainerInsufficientSupplierControlMaterialCertification19218ContainerMaterialHeldInUnpredictableDeploymentImproperHandlingRequiredWithEach1StorageAreaMisidentifiedMaterialShipmentReleaseVerificationOutOfSpecFragmentedContainerSupplierProcessControlPeriodicAuditOf310390MaterialUnpredictableDeploymentSupplierMaterialContaminatedFragmentedContainerOpenBoxesVisualInspection19763MaterialUnpredictableDeploymentMaterialFragmentedContainerEngineeringChangeReleaseVerification110770CompositionUnpredictableDeploymentSupplierChangeGreenOKTagChangeCustomerNotification2MoveToUnreleasedFragmentationUntrainedLTOCheckForGreenOK510150ApprovedUntrainedPersonnelTagAtPressStorageTraceCardCheckListTraining©CaymanSystemsRevisionN980815(513)777-3394:10/12/98PotentialFailureModeandEffectsAnalysis©CaymanSystemsRevisionN980815(513)777-3394:10/12/98CourseGoals•TounderstandtheroleandfunctionoftheFMEA•TounderstandtheconceptsandtechniquesofDesignFMEAandhowtoapplyit•TounderstandtheconceptsandtechniquesofProcessFMEAandhowtoapplyit•TounderstandtheroleandfunctionofFTA•TounderstandtheconceptsofZeroQualityControlorMistake-Proofing(e.g.Poka-Yoke)anditsimplicationsforFMEA©CaymanSystemsRevisionN980815(513)777-3394:10/12/98LiabilityIssues©CaymanSystemsRevisionN980815(513)777-3394:10/12/98HowFMEAFitsWithElementsofTQM•CustomerRequirements•EngineeringSpecifications•SystemandComponentsSpecifications•ProcessandSupplierRequirementsandControl•DevelopSystemDesignandProcessFMEA•EliminatePotentialFailures•ImproveUponDesignandProcess•DesignisTheCriticalElement©CaymanSystemsRevisionN980815(513)777-3394:10/12/98WhatIsAnFMEA?AnAdvancedQualityPlanningtoolusedtoevaluatepotentialfailuremodesandtheircauses.•PrioritizesPotentialFailuresaccordingtotheirRiskanddrivesactionstoeliminateorreducetheirlikelihoodofoccurrence.•Providesadiscipline/methodologyfordocumentingthisanalysisforfutureuseandcontinuousprocessimprovement.•Byitsself,anFMEAisNOTaproblemsolver.Itisusedincombinationwithotherproblemsolvingtools.‘TheFMEApresentstheopportunitybutdoesnotsolvetheproblem.’©CaymanSystemsRevisionN980815(513)777-3394:10/12/98FMEAsHaveFailureModes?•TheteamdevelopingtheFMEAturnsouttobeoneindividual.•TheFMEAiscreatedtosatisfyacustomerorthirdpartyrequirement,NOTtoimprovetheprocess.•TheFMEAisdevelopedtoolateintheprocessanddoesnotimprovetheproduct/processdevelopmentcycle.•TheFMEAisnotreviewedandrevisedduringthelifeoftheproduct.Itisnottreatedasadynamictool.•TheFMEAisperceivedeitherastoocomplicatedorastakingtoomuchtime.©CaymanSystemsRevisionN980815(513)777-3394:10/12/98Origins•FMECA•FailureModeEffectsandCriticalityAnalysis•1950’sOrigin-Aerospace&USMilitary•Tocategorizeandrankforfocus•Targetedpreventionasacriticalissue•Addressedsafetyissues•FMEA•FailureModeandEffectsAnalysis-1960’sand70’s•Firstnoticed&usedbyreliabilityengineers•Systemofvariousgroupactivitiesprovidedthroughdocumentationofpotentialfailuremodesofproductsand/orprocessesanditseffectonproductperformance.•Theevaluationanddocumentationofpotentialfailuremodesofaproductorprocess.Actionsarethenidentifiedwhichcouldeliminateorreducethepotentialfailure©CaymanSystemsRevisionN980815(513)777-3394:10/12/98AnEarlyFMEA©CaymanSystemsRevisionN980815(513)777-3394:10/12/98WhereandWhy•AutomotiveQS9000paragraph4.2CitedintheAIAGAPQPManual•ProcessSafetyManagementAct(PSM)CFR1910.119999999liststheprocessFMEAasoneofabout6methodstoevaluatehazardsExample:ICIExplosives-Hazard