I4-1DesignforSixSigmaFailureModeandEffectAnalysis(FMEA)I4-2DesignforSixSigmaLearningObjectivesåDescribeFMEAprinciplesandtechniquesåSummarizetheconcepts,definitions,andtypesofFMEAandunderstandhowFMEAfitswithinDesignforSixSigmaåPerformaDesignFMEAI4-3DesignforSixSigmaIdentifyPhaseIdentifyCustomersIdentifyandPrioritizeCustomerRequirements(CTQ’s)DevelopaProjectCharter•purpose,scope,goals,timelineIdentifyandPrioritizeGaps•technological(performance,measurement,competitive,etc.)•logistical(timing,partavailability,equipment,vendors,etc.)•functional(resources,stakeholders,regulatory,etc.)•failuremodesandeffectsEstablishDeliverablesfortheValidatePhaseandDevelopaStrategicPlanMoveontoDESIGNIdentifyTranslateCTQ’sintoObjectiveMeasureswithTargetandSigmaGoalsBusinessCaseChampionI4-4DesignforSixSigmaTranslatingtheVoiceoftheCustomer…QualityFunctionDeployment(QFD)EngineeringRequirementsFailureModeandEffectAnalysis(FMEA)QFDandFMEACustomerSatisfactionCustomerDissatisfactionI4-5DesignforSixSigma1.recognizeandevaluatethepotentialfailuremodesandcausesassociatedwithdesigningandmanufacturinganewproductorchanginganexistingproduct,2.identifyactionswhichcouldeliminateorreducethechanceofthepotentialfailuresfromoccurring,3.documenttheprocess.FMEAisasystematicdesignevaluationprocedurewhosepurposeisto:DefinitionofFMEAI4-6DesignforSixSigmaFMEAbeginswithadefinitionoftheFUNCTIONSanitemissupposedtoperform.Theinputsmustcomefromseveralsourcestobeeffective:ManufacturingEngineerSupplierQualityReliabilityEngineerDesignEngineerProgramManagementProductionFMEAisFunctionDrivenI4-7DesignforSixSigmaDevelopedinearly60’sbyNASAto“fail-proof”Apollomissions.Adoptedinearly70’sbyUSNavy.Bylate80’s,automotiveindustryhadimplementedFMEAandbeganrequiringsuppliersdothesame.Liabilitycostswerethemaindrivingforce.Usedsporadicallythroughoutindustryduring1980’s.AdoptedbyMSIin2000.BackgroundI4-8DesignforSixSigmaSYSTEMDESIGNPROCESSSystemFMEAisusedtoanalyzesystemsandsubsystemsintheearlyconceptanddesignstages.SystemFMEAisusedtoanalyzesystemsandsubsystemsintheearlyconceptanddesignstages.DesignFMEAisusedtoanalyzeproductdesignsduringdevelopmentbeforetheyarereleasedtoproductionDesignFMEAisusedtoanalyzeproductdesignsduringdevelopmentbeforetheyarereleasedtoproductionProcessFMEAisusedtoanalyzemanufacturing,assemblyandadministrativeprocessesProcessFMEAisusedtoanalyzemanufacturing,assemblyandadministrativeprocessesTypesofFMEA’sWewillfocusourattentionontheDesignFMEA…I4-9DesignforSixSigma•Whennewsystems,productsandprocessesarebeingdesigned•Whenexistingdesignsandprocessesarebeingchanged•Whencarry-overdesignsorprocesseswillbeusedinnewapplicationsorenvironments•Aftercompletingaproblemsolvingstudy,topreventrecurrenceofaproblemWhenToStartI4-10DesignforSixSigmaSTARTCOMPLETESYSTEMAftersystemfunctionsaredefined,beforespecifichardwareisselectedWhentheprojectisturnedovertodesignDESIGNAfterproductfunctionsanddesignconceptsaredefinedbutbeforethedesigniscompleteWhenfinaldrawingsarereleasedPROCESSWhenpreliminarydrawingsareavailablebutbeforetoolingdesigniscompletedWhentheproductreachesendoflifeorisremovedfromproductionWhenToEndI4-11DesignforSixSigmaDesignEngineerProgramManagerProductionProcessKnowledgePreviousExperiencePastProblemsChronicProblemsReliabilityEngineerProductFunctions,PotentialFailureModesEffects,Causes,VerificationActivitiesActionPriorityActionstoEliminateorReduceFailureModeWarrantyClaimsTheFMEAProcess…I4-12DesignforSixSigmaTheFMEAFormProductorSystemName:Preparedby:Page____of____Responsible:FMEADate(Orig)______________(Rev)_____________Function(s)PotentialFailureModePotentialFailureEffectsSEVPotentialCausesOCCDesignVerificationActivitiesEFFRPNActionsRecommendedResp.00000000000000DesignFailureModeandEffectAnalysis(FMEA)ActionsTakenSEVOCCEFFRPN00000000000000DesignFMEATemplate.xlsI4-13DesignforSixSigmaFunctionAllofthefunctionsthatthecomponentorsystemissupposedtoperform.FailureModeAnywayinwhichtheproductcouldfailtomeetsomemeasurableexpectationorfailtoperformsomedefinedfunction.EffectThelikelyeffect(s)ofproductfailureonboththesystem/sub-systemandtheenduser.SeverityThelevelofseverityassociatedwitheacheffect:10representsmostsevere,1representsleastsevere.CauseThepotentialcause(s)ofeachfailuremode.OccurrenceThelikelihoodofthefailuretooccur:10representsnearcertainty,1representsremotelikelihood.VerificationThemeansofdetectingthecauseand/orfailuremodeduringdevelopment.ActivitiesEffectivenessTheeffectivenessoftheverificationactivities:10impliesnomeanstodetectthefailure,1impliesnearcertaindetection.ElementsofFMEAI4-14DesignforSixSigma1.DevelopaStrategyTeamswillbeestablishedtoevaluatetheapplicationofFMEAinareasshownbytheshadingonthefollowingdiagram.EachFMEATeamunderthedirectionoftheFMEAFacilitatorwill:-ESTABLISHastrategyfocusingonnewtechnology,pastissues,neworredesignedcomponents,bothfromtheproduct(design)andprocessperspectives..-PREPAREaDesignandaProcessFMEAfortheselectedcomponentsorsubassemblies..-DETERMINEfunctions,potentialfailuremodes,effects,causes,andverificationactivitiesplannedorin-place..-RECO