FMEA失效模式及其影响分析中英文

Click to edit Master title style,Click to edit Master text styles,Second level,*,Failure Mode and Effect Analysis,失 效 模 式 及 其 影 响 分 析,1,Module Objectives,课程目的,Describe FMEA principlesand techniques.,描述,FMEA,的法则及技,巧,巧。,Summarizethe concepts, definitions, application options andrelationshipswithothertools.,摘,要,要,概,概,念,念,、,、,定,定,义,义,、,、,应,应,用,用,的,的,选,选,择,择,和,和,其,其,他,他,工,工,具,具,的,的,关,关,联,联,。,。,PerformaFMEA,执,行,行,一,一,个,个,FMEA,。,。,2,FMEA:FailureModesandEffectsAnalysis,FMEA,isasystematicapproachusedtoexaminepotentialfailuresandpreventtheiroccurrence.Itenhancesourabilitytopredictproblemsandprovidesasystemofranking,orprioritization,sothemostlikelyfailuremodescanbeaddressed.FMEA,是,用,用,来,来,检,检,查,查,潜,潜,在,在,失,失,效,效,和,和,预,预,防,防,它,它,再,再,次,次,发,发,生,生,的,的,系,系,统,统,性,性,方,方,法,法.,它,它,增,增,强,强,了,了,我,我,们,们,预,预,测,测,问,问,题,题,的,的,能,能,力,力,并,并,提,提,供,供,了,了,一,一,个,个,排,排,序,序,或,或,区,区,分,分,优,优,先,先,次,次,序,序,的,的,系,系,统,统,因,因,而,而,使,使,得,得,最,最,可,可,能,能,的,的,失,失,效,效,模,模,式,式,得,得,以,以,确,确,定,定.,FMEA,isgenerallyappliedduringtheinitialstagesofaprocessorproductdesign.,Brainstorming,isusedtodeterminepotentialfailuremodes,theircauses,theirseverity,andtheirlikelihoodofoccurring.InSixSigma,weapplyFMEAtoknowfailuremodes.Ourmaininterestsarethecauseandlikelihoodofoccurrence,forwhichwehaveactualdataanddonotneedtorelyonbrainstorming.,FMEA,通,常,常,应,应,用,用,在,在,工,工,艺,艺,及,及,产,产,品,品,设,设,计,计,的,的,初,初,期,期,，,，,自,自,由,由,讨,讨,论,论,决,决,定,定,潜,潜,在,在,失,失,效,效,的,的,模,模,式,式,、,、,原,原,因,因,、,、,严,严,重,重,度,度,及,及,发,发,生,生,的,的,可,可,能,能,性,性,。,。,在,在6,S,中，我,们,们应用,FMEA,去了解,失,失效的,模,模式。,我,我们主,要,要感兴,趣,趣的是,原,原因及,发,发生的,可,可能性,。,。,FMEA,isalso avaluabletoolformanagingtasksduring defect/failure reductionprojects.,FMEA,也是一,个,个在失,效,效缩小,的,的管理,任,任务的,有,有价值,的,的工具,。,。,FMEA,3,Definition of FMEA,定义,recognizeand evaluate,thepotential failuremodesand causesassociated withthe designingandmanufacturingofa newproduct or achange to an existing product.,认识和,评,评估,新产品,的,的设计,和,和制造,时,时或对,现,现有产,品,品做出,改,改变时,相,相关的,潜,潜在失,效,效模式,和,和原因,identify,actions which could eliminateorreducethe chanceofthepotential failureoccurring,确定,消除或,减,减少潜,在,在失效,发,发生机,会,会的行,动,动,document,theprocess.,使过程,形,形成文件,FMEA is a,systematic,designevaluationprocedure,whosepurpose is to:,是系统,的,的设计,评,评估程,序,序,4,Failure to performadefined function,执行既,定,定功能,的,的失效,Somethingoccurring thatyou dont expect,orwant,发生了,你,你不希,望,望或不,想,想要的,事,事情,Wrongapplication,应用错,误,误,A FailureModeis. .,失效模,式,式是,5,FMEA UsebyBlack/ Brown /GreenBelts,Toidentifypotentialfailuremodesandratetheseverityoftheireffects,Toidentifycriticalcharacteristicsand significant characteristics,Torank potentialdesignand processdeficiencies,Tohelp allofusfocusoneliminatingproduct andprocess concerns andprevent problems fromrecurring,Reducethe productdevelopmenttiming andcost,6,Background,Developedinearly60,sbyNASA to “fail-proof”Apollomissions.,Adopted in early 70sbyUSNavy.,Bylate 80s, automotiveindustryhad implemented FMEAand began requiringsuppliersdothe same.Liabilitycostswerethemaindriving force.,Used sporadicallythroughout industry during1980s.,Adopted by MSIin?,SixSigmaisthe catalyst.,7,NASA usedFMEAtoidentifySinglePointFailuresonApollo project(SPF= no redundancy&loss of mission).How manydid theyfind?,420,andwethoughtwehadproblems!,8,Typesof FMEAs,SYSTEM,DESIGN,PROCESS,System FMEA isusedto analyzesystems and subsystems in theearly conceptand designstages.,Design FMEA isusedto analyzeproductsbefore they arereleasedto production,Process FMEA isusedto analyze manufacturing, assemblyandadministrativeprocesses,9,Whenis the FMEA Started?,“,Do the best youcanwith,whatyou have”,ASEARLYAS POSSIBLE!,Guideline:,10,Whento Start ?,Whennew systems, products andprocessesarebeingdesigned,Whenexisting designs andprocessesarebeingchanged,Whencarry-overdesigns or processes will beusedin new applicationsor environments,Aftercompleting a Problem SolvingStudy, toprevent recurrence of a problem,11,Beginningand End,12,Effect ofFMEAon ProcessandDesign changes,Design,Start,Development,Production,Release,Production,Time,No ofEngineering Changes,Traditional approach,FMEAapproach,13,Process FMEA Form,14,JL Example,15,Elements of FMEA,Failure Mode,Any way inwhich a process could fail tomeetsome,measurable,expectation.,Effect,Assuming afailure does occur,describethe effects. List separatelyeachmaineffect onbotha downstream operation and theenduser.,Severity,Usinga scale provided, rate the seriousnessof the effect.10 representsworstcase, 1 representsleastsevere.,Causes,Thisis the list ofcauses and/or potential causesof the failuremode.,Occurrence,Thisis aranking, on a scaleprovided,of the likelihood ofthefailure,occurring.10representsnearcertainty; 1 represents6 sigma.In the case ofa SixSigma project,occurrence isgenerallyderived from defectdata.,Current Controls,All meansof detecting the failurebefore productreaches the end,user,arelisted under currentcontrols.,Detection,The effectiveness ofeachcurrent control method is rated ona,provided scalefrom1 to10.A 10implies the controlwillnot detect,the presence ofa failure; a 1suggestsdetectionis nearlycertain.,16,Process FailureMode,The potential failure mode isthe,manner inwhichtheprocess could fail to performits intended function.,The failure mode fora particular operation couldbe acausein asubsequent (downstream)operationor an effectassociatedwitha potentialfailureina previous (upstream) operation.,FAILURE,MODE,EFFECT,PREVIOUS,OPERATION,CAUSE,NEXT,OPERATION,17,ProcessCauses,ProcessFMEAconsiders process variability due to:,OPERATOR,SET-UP,MACHINE,METHOD,ENVIRONMENT,MEASUREMENT,18,CurrentControls,Assessment of the ability ofthecontroltodetect thefailure beforetheitem leavesthemanufacturing areaandships tothecustomer.,Capability of,all,controlsintheprocessto prevent escapes,SPC,ProcessCapability,GageR&R,Sampling,Testing,DOE,19,Types ofMeasures,SEVERITY,As it applies tothe,effects,on the localsystem,next level,andenduser,OCCURRENCE,Likelihood thata specific,cause,willoccur and result ina specificfailuremode,DETECTION,Abilityof the current /proposed control mechanismto detect and identify the failure mode,Typically, threeitems are scored:,20,RiskPriority Number,RPN= Ox Sx D,Occurrence x,Severityx,Detection,O,S,D,x,x,=,RPN,21,ShortcomingsofRPN,A,84,396,B,48,396,SAMERESULT,FailureMode,Severity,Occurrence,Effectiveness,RPN,22,Severity,23,Occurance,24,Detection,25,Itisconductedona,timely,basis,and,Itisapplied by a,productteam,and,Itsresultsare,documented,FMEA is MostEffective When,26,What Is AGoodApplication?,Involve newtechnology,Have changedfromprevious,Arechronicallyintrouble,Have ahighdegreeofoperatorcontrol,Have ahighdegreeofvariation,Choosedesignsorprocesseswhich. .,Involve new technology,Have changed from previous,Are chronically in trouble,Have a high degree of operator control,Have a high degree of variation,Choose designs or processes which.,27,FMEA Process,Manufacturing,Engineer,Buyer,Process,Operator,Process Knowledge,PreviousExperience,Past Problems,Chronic Problems,Reliability,Engineer,Process Functions,Potential FailureModes,Effects,Causes, CurrentControls,ActionPriority,Actions to EliminateorReduceFailureMode,WarrantyClaims,28,BasicSteps,1.,DevelopaStrategy,29,1.,DevelopaStrategy,2.Reviewthedesign/process,EFFECT,CAUSES,BasicSteps,30,BasicSteps,1.,DevelopaStrategy,2.Reviewthedesign/process,3.Listfunctions,Develop a Strategy,Review the design/process,List functions,31,1.,DevelopaStrategy,2.Reviewthedesign/process,3.Listfunctions,4.Brainstormpotentialfailure,modes,BasicSteps,Basic Steps:,1. Develop a strategy,2. Review the design/process,3. List functions,4. Brainstorm potential failure,modes,32,1.,DevelopaStrategy,2.Reviewthedesign/process,3.Listfunctions,4.Brainstormpotentialfailuremodes,5.Organizepotentialfailure,modes,BasicSteps,topic,topic,AffinityDiagram,33,1.,DevelopaStrategy,2.Reviewthedesign/process,3.Listfunctions,4.Brainstormpotentialfailuremodes,5.Organizepotentialfailuremodes,6.Analyzepotentialfailuremodes,BasicSteps,34,1.,DevelopaStrategy,2.Reviewthedesign/process,3.Listfunctions,4.Brainstormpotentialfailuremodes,5.Organizepotentialfailuremodes,6.Analyzepotentialfailuremodes,7.Establishriskpriority,VITAL,FEW,TRIVIAL,MANY,BasicSteps,35,1.,DevelopaStrategy,2.Reviewthedesign/process,3.Listfunctions,4.Brainstormpotentialfailuremodes,5.Organizepotentialfailuremodes,6.Analyzepotentialfailuremodes,7.Establishriskpriority,8.Takeactiontoreducerisk,Basic Steps,36,1.,Developa Strategy,2. Review the design/process,3. Listfunctions,4. Brainstorm potentialfailuremodes,5. Organizepotential failure modes,6. Analyze potentialfailuremodes,7. Establishrisk priority,8. Takeactionto reduce risk,9. Calculateresulting RPNs,Basic Steps,O*S*D=RPN,37,1.,Developa Strategy,2. Review the design/process,3. Listfunctions,4. Brainstorm potentialfailuremodes,5. Organizepotential failure modes,6. Analyze potentialfailuremodes,7. Establishrisk priority,8. Takeactionto reduce risk,9. Calculateresulting RPNs,10.Follow up,Basic Steps,38,TestingtheRelationships,IF,THEN,HOWDO,I KNOW?,CAUSE,FAILUREMODE,EFFECT,39,Actions,Thedesign or process must be improved basedontheresultsof the FMEAstudy.,A well-developedFMEA willbe of limited valuewithoutpositiveand effectivecorrective actions.,40,Module Objectives,DescribeFMEA principlesandtechniques.,Summarize the concepts,definitions,applicationoptionsandrelationships withother tools.,Performa FMEA,41,DescribeFMEA principlesandtechniques.,Summarize the concepts,definitions,applicationoptionsandrelationships withother tools.,Perform aFMEA,ModuleObjectives.,42,OrganizationalLearningandSystemsThinking,组织学,习,习和系,统,统思维,A ManagementSystem,43,BuildingOrganizationalMemory,Eyelash Learning Curve,ABILITY TO,DO JOB,TIME,OLD EMPLOYEE LEAVES,WITH KNOWLEDGE,NEW EMPLOYEE BEGINS,Thereis no organizational memory to allow peopleto start wheretheirpredecessors left off,Nothing inplace tocapture the newor improved methodsthatproduce results,*,44,RapidLearningCurve,ABILITY TO,DO JOB,TIME,NEW EMPLOYEE COMES ON,AND PICKSUP ALMOSTWHERE,PREVIOUS EMPLOYEE LEFT OFF,Organization continues toadvance its knowledge bypreserving thelessons each learns,Rapidlearning= less waste, less complexity,higher customer value, lowercosts,*,45,How Do WeCreate Rapid Learning?,Two key ingredients:,1.Having best known methodsdocumented,2.Training peopleon what thosemethods are,Who to train?,New employees,Managers,Experienced employees,*,Six Sigma,46,Prosand Cons of StandardMethods,Advantages:,优点,Customer progress ismorevisible and can betracked over time,顾客进步更,可,可见而且可,以,以随时间跟,踪,踪,Capture and share lessonslearned,吸取和分享,教,教训,System itself does not becomea source of variation,系统自身不,会,会成为变异,的,的来源,Leadsto efficient practices,导致有效率,的,的实践,*,47,Prosand Cons of StandardMethods,Disadvantages:,缺点,Stifle creativity and lead tostagnation,抑制创造力,导,导致停滞不,前,前,Interferewithcustomer focus,干涉客户的,焦,焦点,Add bureaucracyandred tape,助长官僚作,风,风,Makeworkinflexibleandboring,使工作欠缺,灵,灵活性，使,人,人容易感到,厌,厌烦,Onlydescribe the minimalacceptable output,只描述最小,的,的可接受输,出,出,48,Finding aBalance,寻找平衡,The difficultywe face is. . .,the arguments for and againststandardizationarebothtrue,公说公有理,，,，婆说婆有,理,理,To achievea balance, developstandardsjudiciously -whereit matters themost,Wheneffectively managed,standardsprovide the,foundationforimprovement,49,EffectiveStandardization,有效,的,的标,准,准,Companiesthatusestandardizationeffectivelyoperateverydifferently:,Thecompanyknowswhyitisdevelopingstandardsandhowtheycontributetoitsoverallpurpose,Managementusesbest-knownmethodsthemselvesandstronglysupportsandchecksusage,Employeesunderstandhowdifferentfacetsoftheirworkaffecttheproductsandservices,Employeesknowwhichelements/functionsarecriticaltoproducinghigh-qualityoutput,50,CreateStandardsJudiciously,明智,地,地创,造,造标,准,准,LeveragePoint:Aplacewherealittlechangehasagreatimpact,支点,：,：小,小,小的,变,变化,就,就能,有,有巨,大,大的,影,影响,的,的地,方,方。,三两,拨,拨千,斤,斤？,“.everyjob,everyprocess,haswithinithigh-leveragepointsthatwemuststandardizeifwewanttoachieveconsistentlyhighperformance,andlow-leveragepointswherestandardizationissuperfluous,servingonlytorestrictflexibility.”,51,KnowWhatIsandWhatIsNotImportant,“,Knowledgeaboutwhatisnotimportantisalmostasvaluableasknowledgeaboutwhatisimportant.Itfreesourattentiontobetterfocusonthefewthingsthatmakeadifference.”,“Thiskindofflexibilityshowsu,“As a rule of thumb, keep the degree of standardization as low as possible,but do,not neglect,any leverage points.”,52,LeveragePointThinking-,HowDoYou Turnthe Ship?,Knowing theleveragepointsiscriticalfor determining prioritiesand strategiesfor improvement,VitalFew,Trivial Many,ParetoPrinciple,80%ofthe problems arecausedbyonlyabout20%ofthe contributingfactors,*,53,54,Whatsthe Connection?,联系,Companiesrun intotroublebecause theychange their methodsbefore theyunderstandwhythe methodsare there in thefirstplace.,陷入麻烦,的,的公司是,因,因为他们,在,在不了解,现,现有方法,存,存在的原,因,因之前就,盲,盲目改变,它,它。,Theyeliminate safety nets in theirprocesses without controlling the factors that madethemessential.,55,Resist the temptation tochangeuntil wedetermine:,Arethedocumented standardsthebest?,Whatistheimpact on the rest of the system?,Arethemethodsactuallybeing followed?,What,s the Connection?,56,EmployeeResponsibility,员工的责,任,任,Before anyone can beheld responsible for the quality oftheir own work,they must:,1. Knowthejob,了解工作,Is the job,clearly,documented?,Aregoals and targets visible?,Hasadequatetraining been done?,Do workers knowhowproductis used?,2. Knowthestandard,了解标准,Output mustbe measurable with immediatefeedback onperformance.,Dont bevague or require interpretation,(i.e. wordslikeflat, smooth, etc.),57,EmployeeResponsibility(cont),3.,Havetheabilitytoregulate,拥有调节,的,的能力,Whenthejobdoes not meet the standard,arethere reactionprocedures?,Arebestpractices leveraged?,Musthave all 3- inorder!,(SeeAppendix AforChecklist),58,CAP-Do -Determine the NeedforStandardization,1.,Check,Makesure weknowwhytheworkisbeing done,Seeif the purpose is clearly documented,Compareactual practicewithdocumentedmethods,If no documentedmethodsexist,comparedifferent practicesamong peopledoing the work,Comparehowtheeffectiveness ofthework issupposed tobecheckedandhowit is actually checked,PLAN,DO,ACT,CHECK,To answer thesequestions, use the CAP-Do (variationofDemingsPDCA -Plan- Do -Check -Act),59,CAP-Do -Determine the NeedforStandardization,2.,Act,Reconcile actualpractices and,documentation,Change one to matchtheother as,appropriate,If no standard methods are in placeandno one can demonstrate (withdata) thatconsistencyamong operatorsexists,simply agreeona methodthat all will use.This will establisha consistent baseline uponwhich improvements can be built.,PLAN,DO,ACT,CHECK,60,3.,Plan,Determine how todetectflaws,andpotential improvements in,thestandard,Conducta PotentialProblem,Analysis(Kepner-Tregoe)todetermine,contingencies and triggers for contingencies,Developa plan for upgradingthe,documentation, or for makingitmoreuseful,Developa plan for encouraging the use of the documentedstandard,CAP-Do -Determine the NeedforStandardization,PLAN,DO,ACT,CHECK,61,4.,Do,Train tothenewdocumented,standard,Usethenewstandard,5. Check,Onceagain compare actual practices,to documented standards,Investigateinconsistencies,6. Act,Reconcile the actualpractice with the documentation,Makechangesbased on the data!,PLAN,DO,ACT,CHECK,CAP-Do -Determine the NeedforStandardization,62,“,TheIlliterate of the Year 2000. .2000,年的文盲,. .,willnotbetheindividual who cannot read and write, but the one who cannotlearn,unlearnandrelearn”,不是不会,读,读和写的,人,人，而是,不,不能学习,、,、再学习,和,和重新学,习,习的人,Alvin Toffler,*,63,