PFMEATraining-En

PreparedByLeoYuSep28,2014AccordingtoPOTENTIALFAILUREMODEANDEFFECTSANALYSIS(FMEA)ReferenceManualFourthEditionPFMEATraining1Notice2FMEADevelopmentHistoryTimeline1950s-FMEAwasinitiatedinAmericanGulamanAircraftCompany,appliedtodesignnewnavyfighterjetscontrolsystem.Mid-1960s，FMEAtechnologywasofficiallyusedintheaerospaceindustry(Apolloprogram);1974-ThestandardoftheUnitedStatesNavyvesselsequipment〈failuremodeandeffectanalysisofnavalvesselsequipmentprocedure〉,it’sthefirsttimethatFMEAwasusedinmilitaryprojectcontract.1976-TheUnitedStatesDepartmentofdefensehasissuedtheFMEA'smilitarystandards,butonlyintermsofdesign.Late1970s-TheautomobileindustrytookFMEAaspartoftheprojectreviewofcomponentdesignandmanufacture.Early1980s-Productliabilitycostsskyrocketedandcourtprosecutioneventsoccurredconstantly,theFMEAbecameanimportanttoolforaccidentreduction.FMEAwasappliedinmorethan500companiesatbeginningthenexpandedtotheirsuppliers.Mid-1980s-TheautomotiveindustrybegantoapplytheprocessFMEAtoconfirmthemanufacturingprocess.1988-TheUnitedStatesFederalAviationAdministrationissuedadvisorybulletinrequiringFMEAmustbeusedinallthedesignandanalysisoftheaviationsystem.1991-ISO-9000RecommendedusingFMEAtoimprovethedesignofproductsandprocesses.1993-Includingthreemajorautomobilecompanies(GM,Ford,Chrysler)intheUnitedStates,theAmericanAssociationforqualitymanagementandautomotiveindustryactiongroup(AIAG)organizationpreparedandappliedFMEAreferencemanual.1994-FMEAbecameQS-9000certificationrequirements1999-FMEAhasbecomeanessentialrequirementforTS16949certification.Currently,FMEAmanualhasbeenupgradedtothefourthedition.3ManagementPhilosophyWhyyoucouldnotachievetheexpectedgoalsbyimplementingFMEA？Firstlyyoushouldaskyourselfsomequestions:•Didyoureceivesufficienttrainingandunderstandalltheconceptofthistoolwell?•Didyoureallyunderstandthistoolsandimplementitbycorrectmethods?•Doyouthinkit’snecessarythatuseaprecisenessandscientificmethodofanalysisandcontroltoidentifyandcontrolsimplequalityandprocessissues?4TheTypeofFMEASystemSub-SystemComponentManufacturingAssemblyDFMEAPFMEAFMEADFMEA•Toreduceoreliminatetheeffectofsystemfailuremode•ToreduceoreliminatetheeffectofdesignfailuremodePFMEA•Toreduceoreliminatetheeffectofprocessfailuremode5TheTimelinessofPFMEAFMEAisadynamicprocess!PFMEAshouldbeinitiatedbeforetoolingormanufacturingequipmentisdevelopedandpurchased.FMEAisa“before-the-event”action,notan“after-the-fact”exercise.6TheTimelinessofPFMEATherearethreebasiccasesforwhichFMEAprocessistobeapplied,eachwithadifferentscopeorfocus:Case1:Newdesigns,newtechnology,ornewprocess.ThescopeoftheFMEAisthecompletedesign,technology,orprocess.Case2:Modificationstoexistingdesignorprocess.ThescopeoftheFMEAshouldfocusonthemodificationtodesignorprocess,possibleinteractionsduetothemodification,andfieldhistory.Thiscanincludechangesinregulatoryrequirements.Case3:Useofanexistingdesignorprocessinanewenvironment,location,application,orusageprofile(includingdutycycle,regulatoryrequirements,etc.).ThescopeoftheFMEAshouldfocusontheimpactofthenewenvironment,location,orapplicationusageontheexistingdesignorprocess.7IdentifytheTeamIdentifyFMEATeamFMEAdevelopmentistheresponsibilityofamulti-disciplinary(orcross-functional)teamwhosemembersencompassthenecessarysubjectmatterknowledge.ThisshouldincludefacilitationexpertiseandknowledgeoftheFMEAprocess.FMEAdevelopmenttopicRelevantResourcesorExpertiseScopeProgramManagement,Customer,Integrationresponsibleindividual(s)Functions,requirementsandexpectationsCustomer,ProgramManagement,Integrationresponsibleindividual(s),ServiceOperations,Safety,ManufacturingandAssembly,Packaging,Logistics,MaterialsPotentialfailuremode–thewayaprocessorproductmightfailCustomer,ProgramManagement,Integrationresponsibleindividual(s),ServiceOperations,Safety,ManufacturingandAssembly,Packaging,Logistics,Materials,QualityEffectsandconsequencesofthefailure–toboththeorganization’sprocessesortoadownstreamcustomer.Customer,ProgramManagement,Integrationresponsibleindividual(s),ServiceOperations,Safety,ManufacturingandAssembly,Packaging,Logistics,Materials,QualityCausesofthepotentialfailureCustomer,ManufacturingandAssembly,Packaging,Logistics,Materials,Quality,Reliability,EngineeringAnalysis,EquipmentManufacturer,MaintenanceFrequencyofoccurrenceofpotentialfailureCustomer,ManufacturingandAssembly,Packaging,Logistics,Materials,Quality,Reliability,EngineeringAnalysis,StatisticalAnalysis,EquipmentManufacturer,MaintenanceApplicationofcurrentcontrols-preventionManufacturingandAssembly,Packaging,Logistics,Materials,Quality,EquipmentManufacturer,MaintenanceApplicationofcurrentcontrols-detectionCustomer,ManufacturingandAssembly,Packaging,Logistics,Materials,Quality,MaintenanceRecommendedactionsrequiredCustomer,ProgramManagement,Integrationresponsibleindividual(s),ManufacturingandAssembly,Packaging,Logistics,Materials,Quality,Reliability,EngineeringAnalysis,StatisticalAnalysis,EquipmentManufacturer,Maintenance8PrerequisitesPrerequisitesAPFMEAshouldbeginwiththedevelopmentofinformationtounderstandthemanufacturing