伟创力FMEA培训教材Train-PFMEA-Chinese.ppt

FailureModesandEffectsAnalysis(FMEA)潜在失效模式及影响分析,2,Introduction介绍,AprocesspotentialFMEAisananalyticaltechniqueutilizedbyamanufacturingresponsibleengineer/teamasameanstoassurethat,totheextentpossible,potentialfailuremodesandtheirassociatedcauses/mechanismshavebeenconsideredandtheengineers/teamsthoughts(includingananalysisofitemsthatcouldgowrongbasedonexperienceandpastconcerns)asaprocessisdeveloped.Thissystematicapproachparallelsandformalizesthementaldisciplinethatanengineernormallygoesthroughinanymanufacturingplanningprocess.过程的FMEA是负责制造生产的工程师/队伍使用的分析技法，用来在一定程度上确保潜在的失效模式和相关的原因/机制都已考虑到，以及工程师/队伍的想法（包括基于经验和过去的想法得出的可能失效项目分析）。这种系统性的方法将工程师在任何生产计划过程中通常会碰到的问题标准化了。,3,TheProcesspotentialFMEA,Identifiespotentialproductrelatedprocessfailuremodes.确认与产品有关的过程失效模式Assessesthepotentialcustomereffectsofthefailures.评估失效对客户潜在的影响Identifiesthepotentialmanufacturingofassemblyprocesscausesandidentifiesprocessvariablesonwhichtofocuscontrolsforoccurrencereductionordetectionofthefailureconditions.确定潜在的制造原因和过程变数，以便加以控制，减少发生可能性，增加发现到的可能性Developsarankedlistofpotentialfailuremodes,thusestablishingaprioritysystemforcorrectiveactionconsiderations.列出潜在失效模式的排行表，建立一个优先系统以做出改善行动Modifymanufacturingorassemblyprocess.改变生产或生产线过程,4,FMEAStep步骤:,1.DefinethescopefortheFMEA定义FMEA的范围2.Identifyteammembers,customer,andknowledgeexperts确认队伍成员、客户，和专家3.Developrolesandresponsibilitiesforteammembers制定每个成员的任务和职责4.Studytheproduct/process/service研究产品/制程/服务5.Brainstormfailuremodes,knownandpotential集体讨论已知的和潜在的失效模式6.Listtheeffects,causes,andcurrentcontrolsforeachfailuremode列出影响、原因和失效模式当前控制情况7.AssignratingsforSeverity,Occurrence,andDetection给严重性、发生率、发现度的评分8.CalculateRPN计算RPN9.DecideonathresholdRPN制定采取行动的RPN界限值10.PrioritizebasedonRPNandseverity,orasrequiredbythecustomer优先性要根据RPN，严重性，或客户的要求11.Identifycorrectiveactions确认改善行动12.Implementandverifyeffectivenessofcorrectiveaction执行并确认改善行动的有效性13.Completethedocumentation完成文件记录,5,DefinethescopefortheFMEA定义FMEA的范围,Definetheboundarieswithinwhichtheproduct,process,orservicewillbestudied,identifyingtheoperatingassumptions,currentconditionsandconstraints.定义产品、制程或服务的研究范围，确认运作前提，当前条件和约束。,6,2.Identifyteammembers,customer,andknowledgeexperts确认队伍成员、客户和专家,Gettheteamtogether,identifythecustomerandinvolvethemintheprocess.Somepreliminaryworkmustbedonetounderstandtheproduct/process/service,sotherightteamcanbeassembled.将成员集合，确认客户并使他们参与进来。为了很好地理解产品/制程/服务，一些先前工作要做，已使小组集合起来。,7,3.Developrolesandresponsibilitiesforteammembers制定每个成员的任务和职责,Whodoeswhatontheteam.Clearlydefinetherolesandresponsibilitiesforeachoftheteammembers.Atthistime,itisimportanttoconsiderthestrengthsofeachindividualandleveragethesame.谁做什么，清楚地定义每个成员的职责。这时，考虑每个人的长处很重要。Example:TeamLeader:*Coordinatetheactivitiesoftheteam,andkeepontrack例：队长协调队伍的活动，时时追踪*Actascheerleader,andinterfacewithmanagement充当鼓舞者与管理相结合*Ensurethedecisionsaremadewithconsensus确保和大家一起做决定Customer:*Definerequirements定义需求客户*Participateindevelopingratingscales,especiallyforSeverityKnowledge参与等级制定，尤其是严重性Expert:*Asconsultantprovideinfoondetailsofproduct/专家processorservice作为顾问提供产品等信息,8,4.Studytheproduct/process/service研究产品/制程/服务,Theobjectiveofthisstepistoacquireasmuchknowledgeaspossible.Itishighlyrecommendedthatallteammembersdelveintothis,sincethereisnootherwaytofamiliarizeyourselfwiththeproduct/process/service.此步骤的目的是为了尽可能多的获取知识。高度建议所有成员都参与，因为没有其他的方式使你去熟悉产品/制程/服务。,9,5.Brainstormfailuremodes,knownandpotential集体讨论已知的和潜在的失效模式,*Failuremodesshouldbedescribedin“physical”ortechnicalterms,notasasymptomnoticeablebythecustomer.失效模式应描述为物理量或技术术语，而不是简单的表面现象*Theideaistoidentifyasmanyfailuremodesaspossible.Thiswillinvolvegettingallteammembersandstakeholdersinvolved,however,theproperapproachtobrainstormingmustbeused.Deferalljudgment,maybeeventoasubsequentmeeting.确认尽可能多的失效模式，使所有的成员都参与。使用适当的脑力震荡方法。所有的调节整理留给以后的会议。*Thebiggestriskinthisstepisthatparticipantswillstartmixingupfailuremodeswithcauses,andeffects.Topreventthis,itishighlyrecommendedthatmeetingleaderdoadryruntofamiliarizethegroupwiththedifferencesbetweenfailuremodes,effects,andcauses.Alistingoftheproduct/process/servicesspecifications,oroutputsandrequirementswillbenefithere.最大的风险是参与者会混淆失效模式、原因和影响。建议会议领导者做个排练，使大家熟悉失效模式、原因和影响的差别。产品/制程/服务的规格，产出或需求会对此有所帮助。*Postitpadsareaconvenientwayofcollectingthisinformation,andgroupingitintologicalgroups.小纸贴是收集此种信息的有效途径，然后按逻辑分组。*Ifyouwritetheseonaworksheet,makesureyouleaveenoughspaceforeffectsandcauses如果你将此写在工作纸上，要确保留出足够的空间填写影响和原因。,10,5.Brainstormfailuremodes,knownandpotential集体讨论已知的和潜在的失效模式,SeparatingFailureModes,EffectsandCauses分开失效模式，影响和原因Multiplicitywillexistforcauses,failuremodes,andeffects失效模式，影响和原因是多种多样的FailureModes:Willsharecauses,andeffects失效模式：有共同的原因和影响Causes:Thereasonsforfailure,canbeoneormanyforagivenfailuremode原因：不良的原因可以是一个或多个已有的失效模式的原因Effects:Theresultsofthefailure,canbeoneormanyforagivenfailuremode影响：不良的结果可以是一个或多个已有的失效模式的结果,11,6.Listtheeffects,causes,andcurrentcontrolsforeachfailuremode列出影响、原因和失效模式的当前控制情况,*Tocapturetheeffects,causes,andexistingcontrolsifanyforthefailuremodeinquestion.Inputfromcustomer,knowledgeexpertswillbeespeciallyhelpfulatthisstep.专家及客户在失效模式的影响、原因，和当前控制上尤其能提供帮助。*Caution:Manyteamscommiterrorsofwishfulthinkinghere,especiallywithregardtocurrentcontrols.Youshouldfocusonthecurrentstate,andnotonwhatcouldbedone,orwhatoughttobedone.注意：许多成员由于打如意算盘而犯错误，尤其对当前的控制。我们应该关注当前的状况，而不是关注应该做的或可以做的。*Nowstartdocumentingontheworksheet,knowingthateachfailuremodecanhavemultipleeffects,andmultiplecauses.现在开始做文件整理，要意识到失效模式有很多的影响和原因。,12,6.Listtheeffects,causes,andcurrentcontrolsforeachfailuremode列出影响、原因和不良型号的当前控制情况,Example举例:,13,7.AssignratingsforSeverity,Occurrence,andDetection给严重性、发生率、发现度评分,Hereweaccomplishtheconversionofeachofthesefactorsintoanumericalvalue.Dependingonthequalityoftheratingscalesthisstepcanbeveryeasyorsomewhatfrustrating.这里我们将每个因素都转换成相对应的数值。根据质量等级标准，这个步骤可以很简单或有点烦人。Therewillbetimeswhentheteamwilldisagreeonthevaluesassignedtoaparticularcause,effect,orfailuremode.Ratherthanvoting,itisrecommendedthattheteamtrytoreachconsensus.Incaseofdisagreements,aknowledgeexpertsopinioncanbeusedtoincreaseunderstanding,ormoredatacanbesought.Inanycasetheteamsdecisionshouldprevail.对于任何一个原因、影响或失效模式的等级划分，小组成员之间很多时候会意见相左，建议多收集数据，专家的意见也可以用以提高理解，达成共识。,14,7.AssignratingsforSeverity,Occurrence,andDetection给严重性、发生率、发现度评分,Example举例:,15,8.CalculateRPN计算RPN,SimplyassigningratingsforSeverity,Occurrence,andDetectiondoesnthelpquantifytheriskintoasinglemeasurablevalue.Multiplyingtheratingscoresthusfillsthisgap.NotethatinthisapproachwehavemaintainedequalweightforeachofthethreeS,O,D给严重性、发生率、发现度评分并不能将风险变为一个单一测量的数值，把三个分数乘起来填进RPN栏，注意三个单值的权重是一样的。,16,9.DecideonathresholdRPN制定采取行动的RPN界限值,Identifythefailuremodesyouwillchoosetoworkon.Itmaynotbepracticaltoaddressallofthem.Thiscriticalstepmustbeconductedwithcustomerinvolvement,andconsensusbuilding.确认你选择需要采取行动的失效模式。对所有的模式整改是不实际的，这个关键步骤需客户参与Manyteamsrunintodifficultieshere,especiallywhenthecustomerinsistsallitemsneedtobeaddressed.Itneedstobeunderstoodthatsomeelementofriskwillalwaysbepresent.Thequestionthereforeis“Whatlevelofriskisacceptable”?许多小组都会在这碰到困难，尤其当客户要求所有的项目都要被讨论。风险总是会存在的。问题是：“什么程度的风险可以接受？”Someofthedifferentapproachesthathavebeenusedtodefinethethresholdare;ParetoAnalysis,Topcauseforeachfailuremode,etc.一些不同的方法都已被用来定义界限：泊拉图分析，最高分等等DocumentonFMEAstartupformtoindicatethiswasdiscussed,andagreementreachedonthethresholdvalue.关于FMEA的讨论要写成文件，要在界限值上达成一致。,17,9.DecideonathresholdRPN制定采取行动的RPN界限值,*DecideonathresholdRPN,withoutignoringhighseverityfailuremodes决定RPN的临界点，不要忽略失效模式的高严重性ExampleusingParetoChart用Pareto图表举例:,18,10.PrioritizebasedonRPNandseverity,orasrequiredbythecustomer优先性要根据RPN，严重性，或客户的要求,*Arriveattheorderinwhichyouwillstartaddressingthefailuremodesandcauseforcorrectiveaction.AlthoughRPNandseveritybasedprioritizationseemsthemostlogical,yourdecisiontoproceedmustbemadewithcustomerinput.订出你对于失效模式和原因整改的顺序。虽然RPN和按先后次序的严重性很有逻辑性，你仍然要根据客户的信息来决定。*Thisstepiseasilyaccomplishedbysortingthedata,indescendingorder.Youcandothiswithineachfailuremodetomaintaindataintegrity.这个步骤根据数据分类可以很容易按降序完成，。每一个失效模式都可以这样做以保证数据的完整。*Documentationonworksheetisimportanttoensurethewholeteamisinsync.相关的文件很重要，可以确保整个队伍工作的同步性。,19,ExampleofsortedworksheetbyRPNwithineachfailuremode失效模式用RPN排序的例子：,10.PrioritizebasedonRPNandseverity,orasrequiredbythecustomer优先性要根据RPN，严重性，或客户的要求,20,11.Identifycorrectiveactions确认改善措施,*Inthisstepyouidentifythecorrectiveactionsneededtoeliminate/controlthecauses,andreducetheriskleveltoorbelowtheagreeduponthreshold.这个步骤你要确认消除/控制起因的整改方法，去减低风险等级或使之低于规定的界限。*Therewillbetimeswhenyoucannotworkontherootcause;insuchcasethebestcourseofactionwillbeviaadditionofcontrols/adequatewarningdevices/mechanismsofimpendingfailure.Re-evaluatetheratingsforS,OandD,followedbyRPNcalculation.很多时候你不能找出根本原因；这时最好的方法就是对未解决的不良进行额外的控制/足够的提醒装置。根据RPN计算结果，重新衡量S，O，D的等级划分。*Discussionwiththecustomerisimportantagainsincethecorrectiveactionswillimpactthem.Knowledgeexpertsmayalsoprovidevaluableinputastowhatkindsofcorrectiveactionwillbebestsuitedforthegivencause/failuremode.整改会影响到客户，因此和他们讨论很重要。专家也应提供有用的信息，提议什么样的整改最适合现存的问题。*Finally,fromallpossiblecorrectiveactions,theteammaychooseonebasedoncost/benefitanalysis,speedofimplementation,andthenewlevelofrisk.最后，对所有可能的改善行动，小组可以成本/效益分析，执行快慢，及新的风险等级选择其中一个行动计划,21,11.Identifycorrectiveactions确认整改,Example举例:,22,12.Implementandverifytheeffectivenessofcorrectiveaction执行并确认整改的有效性,*Correctiveactionsidentifiedoughttobeimplementedlikeprojects-withadefinitestartandend.Inmanycasesaprojectteamsmaybeformedtocarryouttheimplementation.TheseprojectteamsmayhavemembersfromoutsidetheFMEAteam,howeveratleastonemembershouldbedrawnfromtheFMEAteam.确认整改方案应该象完成一个项目-有明确的开头和结尾。很多时候一个项目组都已形成以完成方案。这些项目组可以拥有FMEA小组外的成员，至少需有一个属于FMEA的成员。*Acheckontheeffectivenessofthecorrectiveactionisimportant,intheabsenceofwhichyouwillnothaveacloseloopfeedbackonwhatreallytranspired.ThischeckshouldbeconductedbytheFMEAteamafterthecorrectiveactionshavebeeni