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HowIsAParadigmFormed?,Paradigm:Asetofassumptions,concepts,values,andpracticesthatconstitutesawayofviewingrealityforthecommunity.,(Paradigm=Example),Agroupofscientistsplaced5monkeysinacageandinthemiddle,aladderwithbananasonthetop.,Everytimeamonkeywentuptheladder,thescientistssoakedtherestofthemonkeyswithcoldwater.,Afterawhile,everytimeamonkeywentuptheladder,theothersbeatuptheonewhotriedtogouptheladder.,Aftersometime,nomonkeydaretogouptheladderregardlessofthetemptation.,Scientiststhendecidedtosubstituteoneofthemonkeys.The1stthingthisnewmonkeydidwastogouptheladder.Immediatelytheothermonkeysbeathimup.,Afterseveralbeatings,thenewmemberlearnednottoclimbtheladdereventhoughitneverknewwhy.,A2ndmonkeywassubstitutedandthesameoccurred.The1stmonkeyparticipatedonthebeatingforthe2ndmonkey.A3rdmonkeywaschangedandthesamewasrepeated(beatings).The4thwassubstitutedandthebeatingwasrepeatedandfinallythe5thmonkeywasreplaced.,Whatwasleftwasagroupof5monkeysthateventhoughneverreceivedacoldshower,continuedtobeatupanymonkeywhoattemptedtoclimbtheladder.,Ifitwaspossibletoaskthemonkeyswhytheywouldbeatupallthosewhoattemptedtogouptheladder.Ibetyoutheanswerwouldbe.“Idontknowthatshowthingsaredonearoundhere”Doesitsoundfamiliar?,SothequestionisHowdowekeepfrommakingthesamemistakesoverandoveragain?,The“ArtOfPerfection”WithAWonderfulFMEA,AgendaFMEATrainingSuzhouPlant,Day1FMEAOnteamuntilde-commissioning,Coreteamdefinestaskstocomplete;FunctionalSupv.assignstaskstoextendedteam;Onteamuntilassignedtasksarecompleted.,MustattendFMEA,AttendFMEAasrequiredbyCoreTeam,DesignEngineerOnteamuntilde-commissioning,Coreteamdefinestaskstocomplete;FunctionalSupv.assignstaskstoextendedteam;Onteamuntilassignedtasksarecompleted.,MustattendFMEA,AttendFMEAasrequiredbyCoreTeam,ProcessEngineer&LaunchTeamResponsibleforallaspectsofProcessFMEA,MinimumCoreTeam:LaunchCoordinatorPlantQualityEngineerProcessEngineerOperator,Functionalsupport:AutomationengineerSupervisorEnvironmentalToolingengineerDesignengineer,ProcessFMEATeamStructure,ProcessFMEAteamswithmembersfromdifferentareasbringvaryingdegreesofexperienceandperspectivetotheproblembeinganalyzed.,OrganizingtheTeam,Teammembersshouldhaveexperienceworkingwiththeprocess,ProcessFMEAteamsshouldincludemembersfrom:ManufacturingorlaunchcoordinatorDesignEngineerAQPEngineerProductionSupervisorOperatorProcessEngineeringQualityEngineering,Task:Schedulingmeetings2-3meetingsperweek.FMEAshouldnottakelongerthen8weeks.PlanningtheagendaOnehourmaximumOrientingteamEnsuringcompletion,Facilitatorrole(preferableQuality/ManuEng.),CapabilityTeambuildingCoach,counsel,mentor,continuallyreviewthefocusofyourteammembersandadjustdirection,andmanage/directteammembersGoodwrittenskillsPromotesdetailandfollowsup,UnderstandstheprocessandpotentialprocessfailuresHeisthepersonthatmanagesprocessexpectationsandprocessperformance.UnderstandsprocessrobustnessandprocessflawsManagesandcontrolsallinternalaspectsofcost,timing,deliveryandproductexpectationsLearnedfrompastexperiencepotentialfailures,occurrencesanddetections.Discussopportunitiesofprevention,ifapplicable,RoleofProcess/ManufacturingEngineer,DesignEngineerAttendsForProcessFMEARelatedToAProductOrPart,RoleofDesignengineer,UnderstandscriticalfailuremodesfromDesignFMEAUnderstandsSORorspecificationsoftheproduct.KnowsfitandfunctionofthepartverywellandprovidespotentialfailuremodesProvidespotentialhighriskseverity,PotentialfailuremodesfromdailyandhandsonexperienceProvidepotentialhandlingdefectsHasexperienceandknowledgeoffailureoccurrencePotentiallyyourmostvaluableteammembers,RoleofSupervisor/Operator,RoleofAQPEngineer,AuditsProcessFMEAVerifiesthatfailuremodesareprotectedAssurestheHighSeverity,highemphasizeactionsarecomplete,1Organizingtheteam,2GettingStarted,ProcessFMEA,3AnalyzingPotentialProblems,4IdentifyingCausesandControls,5IdentifyingandImplementingCorrectiveActions,6PitfallsofFMEA,GettingStarted,IdentifyProcessorfunction,ReviewpreviousFMEAs,HaveDesignFMEA,Completeprocesssteps/functions,ConductRiskAnalysis,GettingStarted,IstartandcompletePFMEAatmydesktoshowProcessFMEAtocustomerforPPAP.Checkinthebox,FMEAcompleteforourAQP6gatelaunchprocess,FMEAisawrittendocumentgeneratedbyacrossfunctionalteamtoevaluatethepotentialfailureofaproduct/process/machineandtheeffectsofthefailures,AllFMEAsfocusondesign,regardlessofwhetheritisoftheproduct,machineorprocess,ItisagainstSRGpolicytoprovideacopyofourProcessFMEAstothecustomer,WRONG!,Processflowsincludeallsignificantstepsandaddedvalueontheprocess/product,Whentheriskanalysisisperformed,theteamdetermineswhethereachstepisaHIGH,MEDIUM,orLOWrisk.,1Organizingtheteam,2GettingStarted,ProcessFMEA,3AnalyzingPotentialProblems,4IdentifyingCausesandControls,5IdentifyingandImplementingCorrectiveActions,6PitfallsofFMEAs,1Organizingtheteam,2GettingStarted,ProcessFMEA,3AnalyzingPotentialProblems,4IdentifyingCausesandControls,5IdentifyingandImplementingCorrectiveActions,6PitfallsofFMEAs,1Organizingtheteam,2GettingStarted,ProcessFMEA,3AnalyzingPotentialProblems,4IdentifyingCausesandControls,5IdentifyingandImplementingCorrectiveActions,6PitfallsofFMEAs,ProcessFMEAConsiderations,Potentialfailuremodes,Impactonmanufacturingplant,Impactoncustomers,RootCausesofthePotentialFailure,DetectionOnTheRootCause(NotTheEffect),Abilitytodetectrootcause,Recommendcorrectiveactions,Effectssuchasscratch,dirt,nickelshowarenotfailuremodes,1)PotentialCausesareonthefailuremode,2)Detection,Detectthecause,NOTthefailuremodeoreffectofthefailuremode,PLCstopsmoldwhendryerstopsworking,3)Prevention:whenapotentialcausehappens,processormachinestopsavoidingfailuremode,IdentifyingandImplementingCorrectiveActions,Weshouldaddresscorrectiveactionsbasedonthefollowingcriteria:,ImproveDesignandProcessFMEAwithTop5activityprioritizedwithpreviouscriteria,Implementour“lessonslearned”and“bestpractice”activityandachieveacontinuousimprovementculture,(1)HighSeverity(9or10)Operatorsafety(2)HighImpactofEmphasis:Severity=5to8andOccurrence=4to10.(3)HighRPN,FMEA,DesignFMEAComponentsSubsystemsSystems,ProcessFMEAMachinesWorkStationsToolsProductionlinesGaugesOperatorTraining,Rememberthis,1Organizingtheteam,2GettingStarted,ProcessFMEA,3AnalyzingPotentialProblems,4IdentifyingCausesandControls,IdentifyingandImplementingcorrectiveActions,6PitfallsofFMEAs,FMEAPitfalls,Pitfall:PrioritizesDoesntCorrect:,Pitfall:Effectsfromafailuremodeareconsideredfailuremodes:,AFMEAdoesnotdetecthowwecanavoidsendingadefecttothecustomer.Youmakethedefectbutdontsendittoyourcustomerbyaddingmorelabororspectaculardetectionsystem.Youeatthescrapanyway.AgoodFMEAavoidsmakingadefect.,TheoutputofaFMEAisprioritizingfailuremodes,thisdonteliminatethefailuremode.Additionalactionareneededtoreducethefailuremode,$,FMEAPitfalls,Pitfall:OnlyasGoodastheteam,Pitfall:TimeConsuming:,Ittakestimeanddisciplinetogetintothedetails,IdentifyingfailuremodesisateambrainstormingprocessIftheteamisnotdetailorientedandforgetanimportantfailure,thenthisfailureiswaitingtooccur,Pitfall:NotAccurateRatingScales:,Ratingscalesshouldbemeaningful.AssurethatsimilarratingscalesarealwaysthesamethrutheFMEA.Visualinspectionshouldbea8acrosstheFMEA.Dontcherrypick,withaspurposetokeeptheRPNlow,FMEAPitfalls,Pitfall:NotstartingintheDesignphase,Pitfall:ToprovidethisinaPPAPpackagetocustomer:,TodoaFMEAjusttodoitisuseless.StopwastingyourtimeMakesureaFMEAhasaddedvalueandshouldbecompletedwithaCFTteam.GoodFMEAsshouldnotbeprovidedtothecustomer.,TheearlierinthedesignprocesstheFMEAisstarted,thebetterADesignFMEAcancatchpotentialfailuresstillwhendesigncanbemodified,Pitfall:Notincludingoperators,ExperienceoperatorsshouldbeontheteamtousetheirknowledgeOperatorsoftenhavegoodinformationonfailuremodesandtheeffectivenessofthecontrols.Theycanalsoprovideoccurrences,FMEAPitfalls,Pitfall:Notlookingtopreviousandsimilarproducts,Pitfall:AssumeDetectionControlsarebetterthentheyare:,SomecontrolsarenotrobustandnotverifiedfortheyfunctionDonttestforwhatwethinktheytestfor.,Templatesaregreatbuteveryproducthasitsuniqueissuesorconcerns.UseotherFMEAsbutreviewwiththeCFTteamthatthisproductdoesnthaveotherfailuremodes,Pitfall:NotlinkingwithMistake-Proofing,Sometimesfailuremodecannotbeavoidedanddetectionofthefailuremodeiscritical.THEFMEADOESNTELIMINATETHEFAILUREMODEOREFFECTSBYITSELF,itonlyDETECTSITThenweneedtoapplytoolssuchasmistake-proofing,verifytherobustnessofthemistakeproofingregularly.,FMEAPitfalls,Pitfall:NotTyingIntotheControlPlans,Pitfall:FailingtoUpdatetheFMEA:,Asnewpotentialfailuremodesareidentified,theyshouldbeaddedtotheFMEAandcontrolplan.Thesearelivingdocuments.AddanyQR,PIR,PRR,etcnumberstotheFMEA,Thecontrolplanprovidesusinformationonhowtoreactwhenafailuremodeoccurs.TheFMEAwillnotbealivingdocumentifitisnottiedtothecontrolplan,Pitfall:NolinkagebetweenDesignFMEA-ProcessFMEAandControlPlan,SeverefailuremodesfromtheDesignFMEAshouldbeaddressedintheProcessFMEAandforsurementionedinthecontrolplan,FMEAExample,Previousfailuremode:setupsheetwasa4or3?,Remember:Flashisaneffectfromafailuremode,Whatistherootcause?Clamppressuretolow,Processing,troubleshootingisnotaprocessstep,Notheatedproperlyisanaffectfromafailuremode!,Onlyonerootcause:TemperatureAnvilsnotcorrect:3,Settingsnotcorrect:4,Assemblyisaprocessstepbutisnotdefined,Previousfailuremode:100%Operatorinspectionvaryfrom4to7?,Missingstudsisanaffectfromafailuremode!,rootcauseisnotdefinedMachinefailureormalfunction,Assemblyoperationisaprocessstepbutisnotdefined,HE,Remember:Severitybetween5-8withcombinationofoccurrence4-10areHEfailuremodes,Previousfailuremode:100%detectionwasa7,Remember:Flashisaneffectfromafailuremode,Tomuchcauses:Molddamage=2,Processparameter=3,New/repairedmold=1,Severityonsurfacedefectsshouldhavehigherranking,Similardetectionsarea7:Visualinspectionshouldbea8,Surfacedefectsareeffectsfromafailuremode,Tomuchcauses:Padmark=2,Materialhandling=4Roughsurfaceofdie=2,FMEAbuildingblock,Buildingblocksystem,Usesthepremisesthat:DifferencefromparttopartareminimalMoldingismolding,platingisplating,paintispaint,etc.ProcessimprovementstopartABCwilllikelyapplytopartXYZFocusesontheexception,whatscaresorconcernusabo

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