DesignFMEA

1DesignandProcessFMEAFMEAailureode&ffectsnalysisHANDBOOKBySamuelChungHeadofQualityReferenceFQEI2.22DESIGNFMEACHECKLISTDevelopment3DesignFMEAChecklistNo.DesignFMEAChecklistYesNo1Alistofdelegateswithnames,departments,jobtitle(tohelpustounderstandthenatureofresponsibilitywithcross-functionalteam.)2Historicalwarrantydatawithdesign,astherootcause.3Historicaldesign/processcompatibilityprohibitoptimumresult.4DesignFMEAChecklistNo.DesignFMEAChecklistYesNo4Designcharacteristicsthataffecthighrisk?5Designrequiresnewmaterial?6Designrequiresspecialtooling?7Hasassemblybuildvariationanalysisbeenconsidered?8HasDesignofExperimentbeenconsidered?5DesignFMEAChecklistNo.DesignFMEAChecklistYesNo9Isthereaplanforprototypeinplace?10HasadesignFMEAbeencompleted?(Similarproduct)11Haveserviceandmaintenanceissuesbeenconsidered?12HavetheDesignVerificationPlanbeencompleted?(Similarproduct)13Ifyes,wasitcompletedbyacross-functionalteam?6DesignFMEAChecklistNo.DesignFMEAChecklistYesNo14Areallspecifiedtests,methods,andequipmentandacceptancecriteriaclearlydefinedandunderstood?15HavespecialCharacteristicsbeenselected?16Arespecialcharacteristicsproperlydocumented?17Havedimensionthataffectsform,fitandfunction(i.e.placementbythecustomerinthemanufacturingsuchascoplanaryplane,leaddimension,packagesizeorotherconstraint?)7DesignFMEAChecklistNo.DesignFMEAChecklistYesNo18Istestloadingsufficienttoprovideallconditions,i.e.productionandend-user?19Havepartsmanufacturedatminimumandmaximumspecificationsbeentested?20Isthespecifiedtestsamplingsizeandfrequencyfeasible?21Arespecialmaterialcharacteristicsidentified?8DesignFMEAChecklistNo.DesignFMEAChecklistYesNo22Willmaterialsuppliersprovidecertificationwitheachshipment?23IsBillofMaterialcomplete?24Thereferencestandardsidentifiedwithappropriaterevisionlevel?i.e.ANSIGD&T25Arethereferencedimensionsidentifiedtoaddlayoutmeasurement?9DesignFMEAChecklistNo.DesignFMEAChecklistYesNo26Arethecontrolpointsanddatumsurfacesidentifiedtoenabledesignoffunctionalgagesforsignificantcharacteristics?27Theappropriatedesigntolerancesusedcompatiblewithindustrymanufacturingstandards?28Thegovernmentsafety,environmental,ergonomicandemissionconstraintsaddressedinthedesignfeatures?29TheDFMEAaddressedthehigh-riskaffectseverity8?10DesignFMEAChecklistNo.DesignFMEAChecklistYesNo30Thedesignrequiresnewtechnologyandprecisionequipment?Ifyes,identifythespecific..31TheproductdesignedrequiredspecialHandling?Storage?Environmentalcontroltemperatures?32Specialtrainingrequiredformanufacturingpersonnel?11DesignFMEAChecklistNo.DesignFMEAChecklistYesNo33Mistake-proofing?I.e.Keyedforsymmetricalpartsuchasleftandrighttoavoidmistakeassembly?34Characteristicsrequiredspecialtoolsorfixturetoensurecustomersafetyorsatisfaction?35Continuousimprovementfor…12DesignFMEAChecklistNo.DesignFMEAChecklistYesNo363738394013DESIGNFMEA-DevelopmentFlowChartsandBlockDiagramsareusedtoestablish:inputinformationprocess(function)thedeliverablesoroutputTheydemonstrateprimaryrelationshipsandlogicalorderandareattachedtotheFMEA14Workshop1BlockDiagramYouaregoingtobesplitintoteamsTheteamswillbemulti-disciplinedNominateateamleader,“EngineerResponsible”Usethe“BlockDiagramBlank”todevelopablockflowdiagramtorepresentthedesignconsiderationsfor...15Workshop1BlockDiagramACompany®SwitchforXXXXXSomepointsyoumightwishtoconsiderwhoisgoingtouseit?whereisitgoingtobeused?howisittobepowered?expectedlife?16Workshop1BlockDiagramDidyoucompletethekeydetailsatthetop?Anyareaswhereyouneedhelp?Anyadditionalinformationrequired?17THEFMEAFORM__SystemPOTENTIALFAILUREMODEANDEFFECTSANALYSIS(DESIGNFMEA)FMEANumber________Page______of________Subsystem__Component______Customer:DesignResponsibility_______Reviewedby:_______________PreparedBy_________ApprovedBy:_________ModelYear(s)/Vehicle(s)__KeyDate______________FMEADate(orig)_(Rev)_CoreTeam_________________________________________________________________SAMPLE18THEFMEAFORMFMEANUMBER•DocumentnumberforTrackingtheanalysisSystem,Subsystem,Componentnameandnumber•Indicationofthelevelofanalysisbyreferencetothenameandreferencenumberofthesystem,sub-systemorcomponent.DesignResponsibility•Thenameofthegroup,department,supplierorOEM19THEFMEAFORMPreparedby•NameandcontactnumberfortheEngineerwhopreparedtheFMEAModelYear(s)/Vehicle•Theintendedproductmodelandproposedlinespotentiallyaffectedbythecomponentsbeinganalyzed.KeyDate•InitialduedatefortheFMEAnottoexceedthescheduledproductiondesignrelease20THEFMEAFORMFMEADate•ThedatetheoriginalFMEAwascompiledandthelatestrevisiondateCoreTeam•Thoseresponsible,individualsanddepartments,whohavetheauthoritytoidentifyand/orperformtasks•NBteammembersnames,departmentsandcontactreferencesaretobeincludedinthedistributionlist.21THEFMEAFORMPOTENTIALFAILUREMODEANDEFFECTSANALYSIS(DESIGNFMEA)9101112131415161718192022219Item/Function10PotentialFailureModes11PotentialEffect(s)ofFailure22ITEM/FUNCTION9•Name/referenceofitemanalyzed•Referencesasondrawing•Designlevelasondrawing•Useexperimentalnumberpriortoinitialrelease•DetailFunctionandEnvironment•Multiplefun