PFMEATraining-En.ppt

PreparedByLeoYuSep28,2014AccordingtoPOTENTIALFAILUREMODEANDEFFECTSANALYSIS(FMEA)ReferenceManualFourthEdition,PFMEATraining,Notice,FMEADevelopmentHistory,Timeline,1950s-FMEAwasinitiatedinAmericanGulamanAircraftCompany,appliedtodesignnewnavyfighterjetscontrolsystem.Mid-1960s，FMEAtechnologywasofficiallyusedintheaerospaceindustry(Apolloprogram);1974-ThestandardoftheUnitedStatesNavyvesselsequipmentfailuremodeandeffectanalysisofnavalvesselsequipmentprocedure,itsthefirsttimethatFMEAwasusedinmilitaryprojectcontract.1976-TheUnitedStatesDepartmentofdefensehasissuedtheFMEAsmilitarystandards,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.,ManagementPhilosophy,WhyyoucouldnotachievetheexpectedgoalsbyimplementingFMEA？Firstlyyoushouldaskyourselfsomequestions:Didyoureceivesufficienttrainingandunderstandalltheconceptofthistoolwell?Didyoureallyunderstandthistoolsandimplementitbycorrectmethods?Doyouthinkitsnecessarythatuseaprecisenessandscientificmethodofanalysisandcontroltoidentifyandcontrolsimplequalityandprocessissues?,TheTypeofFMEA,DFMEAToreduceoreliminatetheeffectofsystemfailuremodeToreduceoreliminatetheeffectofdesignfailuremodePFMEAToreduceoreliminatetheeffectofprocessfailuremode,TheTimelinessofPFMEA,FMEAisadynamicprocess!PFMEAshouldbeinitiatedbeforetoolingormanufacturingequipmentisdevelopedandpurchased.FMEAisa“before-the-event”action,notan“after-the-fact”exercise.,TheTimelinessofPFMEA,TherearethreebasiccasesforwhichFMEAprocessistobeapplied,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.,IdentifytheTeam,IdentifyFMEATeamFMEAdevelopmentistheresponsibilityofamulti-disciplinary(orcross-functional)teamwhosemembersencompassthenecessarysubjectmatterknowledge.ThisshouldincludefacilitationexpertiseandknowledgeoftheFMEAprocess.,Prerequisites,PrerequisitesAPFMEAshouldbeginwiththedevelopmentofinformationtounderstandthemanufacturingandassemblyoperationsbeinganalyzedanddefinetheirrequirements.TheprocessflowdiagramisaprimaryinputtothePFMEA.Theflowdiagramisusedasatooltohelpestablishthescopeofanalysisduringmanufacturingsystemdesign.,ProcessFlowDiagramandlinkagetoPFMEA,Aprocessflowdiagramdescribestheflowoftheproductthroughtheprocessfromincomingtooutgoing.Thisshouldincludeeachstepinamanufacturingorassemblyprocessaswellastheirrelatedoutputs(productcharacteristics,requirements,deliverables,etc.)andinputs(processcharacteristics,sourcesofvariation,etc.).,ProcessFlowDiagramandlinkagetoPFMEA,ThePFMEAshouldbeconsistentwiththeinformationintheprocessflowdiagram.Thescopeoftheprocessflowdiagramshouldincludeallmanufacturingoperationsfromprocessingofindividualcomponentstoassembliesincludingshipping,receiving,transportationofmaterial,storage,conveyors,labeling,etc.ApreliminaryriskassessmentusingtheprocessflowdiagrammaybeperformedtoidentifywhichoftheseoperationsorindividualstepscanhaveanimpactontheproductmanufacturingandassemblyandshouldbeincludedinthePFMEA.,ToolsandInformationSources,TheinputofPFMEAOthersourcesofinformationthatareusefulinprovidingtheteamwithwaystofocusandcapturediscussionsontherequirementsoftheprocessinclude:DFMEADrawingsanddesignrecordsBillofProcessInterrelationship(Characteristic)matrixInternalandexternal(customer)nonconformances(i.e.,knownfailuremodesbasedonhistoricaldata)QualityandReliabilityHistory,Interrelationship(Characteristic)matrix,Interrelationship(Characteristic)matrixCharacteristicmatrixisananalysismethodologytoshowtheinterrelationshipbetweenproduct/processcharacteristicsandworkstations.,PFMEAPrinciple,DesignConsiderationsTheteamshouldassumetheproductasdesignedwillmeetthedesignintent.MaterialConsiderationsTheteamshouldassumethematerialfromupstreamisacceptable.ScopeConsiderationsTheinspectionstepshouldnotbeanalyzedbytheteam.Buttheanalysisscopeshouldcoverallthestepwhichareincludedinprocessflowdiagram.,DefineCustomer,Whoisyourcustomer?ENDUSEROEMASSEMBLYandMANUFACTURINGCENTERS(PLANTS)SUPPLYCHAINMANUFACTURINGREGULATORS,PFMEAForm,SamplePFMEAFormwithMinimalInformationElementsRiskPriorityNumber(RPN)(j)OneapproachtoassistinactionprioritizationhasbeentousetheRiskPriorityNumber:RPN=Severity(S)xOccurrence(O)xDetection(D)WithinthescopeoftheindividualFMEA,thisvaluecanrangebetween1and1000.TheuseofanRPNthresholdisNOTarecommendedpracticefordeterminingtheneedforactions.,PFMEA表格讲解,RiskEvaluation;ApplyingthresholdsassumesthatRPNsareameasureofrelativerisk(whichtheyoftenarenot)andthatcontinuousimprovementisnotrequired(whichitis).Forexample,ifthecustomerappliedanarbitrarythresholdof100tothefollowing,thesupplierwouldberequiredtotakeactiononthecharacteristicBwiththeRPNof112.,Inthisexample,theRPNishigherforcharacteristicBthancharacteristicA.However,thepriorityshouldbetoworkonAwiththehigherseverityof9,althoughitsRPNis90whichislowerandbelowthethreshold.,PFMEA表格讲解,RecommendedAction(s)(k)Ingeneral,preventionactions(i.e.,reducingtheoccurrence)arepreferabletodetectionactions.ToReduceSeverity(S)Ranking:Onlyadesignorprocessrevisioncanbringaboutareductionintheseverityranking.ToReduceOccurrence(O)Ranking:Toreduceoccurrence,processanddesignrevisionsmayberequired.Areductionintheoccurrencerankingcanbeeffectedbyremovingorcontrollingoneormoreofthecausesofthefailuremodethroughaproductorprocessdesignrevision.ToReduceDetection(D)Ranking:Thepreferredmethodistheuseoferror/mistakeproofing.Aredesignofthedetectionmethodologymayresultinareductionofthedetectionranking.,PFMEA表格讲解,Responsibility&TargetCompletionDate(l)Enterthenameoftheindividualandorganizationresponsibleforcompletingeachrecommendedactionincludingthetargetcompletiondate.Theprocess-responsibleengineer/teamleaderisresponsibleforensuringthatallactionsrecommendedhavebeenimplementedoradequatelyaddressed.,PFMEA表格讲解,ActionResults(m-n)ThissectionidentifiestheresultsofanycompletedactionsandtheireffectonS,O,DrankingsandRPN.Action(s)TakenandCompletionDate(m)Aftertheactionhasbeenimplemented,enterabriefdescriptionoftheactiontakenandactualcompletiondate.Severity,Occurrence,DetectionandRPN(n)Afterthepreventive/correctiveactionhasbeencompleted,determineandrecordtheresultingseverity,occurrence,a