Q9+FMEA失效模式效应分析.ppt

AnnexI.2,FailureModeEffectsAnalysis失效模式效应分析(FMEA),I.2:FailureModeEffectsAnalysis失效模式效应分析(FMEA),(seeIEC60812见IEC60812)EvaluationofpotentialfailuremodesforprocessesThelikelyeffectonoutcomesand/orproductperformanceOncefailuremodesareestablished,riskreductioncanbeusedtoeliminate,reduceorcontrolthepotentialfailuresFMEAreliesonprocessunderstandingSummarizetheimportantmodesoffailure,factorscausingthesefailuresandthelikelyeffectsofthesefailuresHowtoperform?Breakdownlargecomplexprocessesintomanageablesteps,ICHQ9,I.2:FailureModeEffectsAnalysis失效模式效应分析(FMEA),(seeIEC60812见IEC60812)工艺的潜在失效模式的评估对结果和产品性能的可能的影响一旦失效模式建立，风险降低行动用于来消除、降低或控制潜在的失效依赖于对工艺的理解概述重要的失效模式，引起失效的因数和失效的可能的影响如何实施?将大的复杂的工艺分解成易处理的步骤,ICHQ9,I.2:FailureModeEffectsAnalysis(FMEA),PotentialAreasofUse(s)PrioritizerisksMonitortheeffectivenessofriskcontrolactivitiesEquipmentandfacilitiesAnalyzeamanufacturingprocesstoidentifyhigh-riskstepsorcriticalparameters,RNP:RiskPriorityNumberC.Kingery,TheSixSigmaMemoryJoggerII,ICHQ9,I.2:失效模式效应分析(FMEA),可使用的潜在领域：Prioritizerisks优先考虑的风险Monitortheeffectivenessofriskcontrolactivities监控风险控制活动的效力Equipmentandfacilities设备和设施Analyzeamanufacturingprocesstoidentifyhigh-riskstepsorcriticalparameters为了识别高风险步骤和关键参数分析一个生产工艺,RNP:RiskPriorityNumberC.Kingery,TheSixSigmaMemoryJoggerII,ICHQ9,I.2:FailureModeEffectsAnalysis(FMEA),Howtoperform?1.Establishateam2.Identifytheknownandpotentialfailuremodes:Developlistsofknownproblemsandbrainstormotherpotentialse.g.ProductnotmeetingspecificationProcessnotmeetingyieldrequirementsMalfunctioningequipmentSoftwareproblemsNewlyidentifiedfailuremodesshouldbeaddedatanytime,I.2:失效模式效应分析(FMEA),如何实施?1.成立一个小组2.识别已知和潜在的失效模式生成已知问题和集体讨论的其他潜在问题的列表例如.产品不符合标准工艺不满足收率需要设备故障软件问题新发现的失效问题应该随时加进来。,I.2:FailureModeEffectsAnalysis(FMEA),Howtoperform?3.Characterisetheseverity,probabilityanddetectabilityAnequalnumberoflevelsissometimeshelpfulSomepreferenceto3,4,5,6or10levelsBut:anevennumberoflevelsavoidsthemidpointUsedifferentscalesLinear:1,2,3,4Exponential:1,2,4,8Logarithmic:1,10,100,1000Selfmade:1,3,7,10Multiplyingdifferentscaleswilldifferentiatetheoutcome,Theaimistocomeupwithamethodofprioritising,I.2:失效模式效应分析(FMEA),如何实施?3.识别严重性、可能性和可检测性一个相当的数字等级常常是很有用的一般优先选择等级3，4，5，6或10但是:一个偶数等级会避免中位数用不同的等级线性的:1,2,3,4直数的:1,2,4,8对数:1,10,100,1000自定义:1,3,7,10不同的等级的乘积将区分结果,目标是提出一个定义优先顺序的方法,I.2:FailureModeEffectsAnalysis(FMEA),Howtoperform?4.Defineactions5.Revisittheranking6.Defineresidualrisk7.PerformashortsummaryScopeDatafromtheassessmentfurthercontrolsrequired,DryingProcess,I.2:FailureModeEffectsAnalysis(FMEA),BasedonTakayoshiMatsumura,EsaiCo.,RPN:RiskPriorityNumber=S*P*D,当RPN大于40采取措施当严重性超过5时采取措施采取措施后保留关键参数;需要进一步控制,干燥过程/工艺,I.2:失效模式效应分析(FMEA),BasedonTakayoshiMatsumura,EsaiCo.,RPN:风险优先因子=S*P*D,I.2:FailureModeEffectsAnalysis(FMEA),Analyseagranulationprocessstepbecauseonlyafewparametersareadjustableandmanyproblemscanoccurbymanualoperations,S.Rnninger,Roche,I.2:失效模式效应分析(FMEA),分析制粒工艺步骤因为仅仅很少的参数可以调整，手工操作许多问题都可能发生。,S.Rnninger,Roche,FailureModeEffectsAnalysis(FMEA),S.Rnninger,Roche,I.2FailureModeEffectsAnalysis(FMEA),S.Rnninger,Roche,I.2:FailureModeEffectsAnalysis(FMEA),Prepareariskprofile,Severity/Consequencesinegligibleiimarginaliiicriticalivcatastrophic,ProbabilityAfrequentBmoderateCoccasionalDrareEunlikelyFveryunlikely,Probability,Consequences,Riskprotectionlevel,S.Rnninger,Roche,Picture:ZurichInsuranceLtd,Switzerland,I.2:失效模式效应分析(FMEA),准备一个风险轮廓,严重性/重要性i可以忽略ii边际iii严重的iv灾难性的,可能性A频繁的B中等的C偶尔的D很少E不太可能F完全不可能,可能性,重要性,风险保护水平,S.Rnninger,Roche,Picture:ZurichInsuranceLtd,Switzerland,I.2:FailureModeEffectsAnalysis(FMEA),Prepareariskprofile:Probability,S.Rnninger,Roche,I.2:失效模式效应分析(FMEA),准备一个风险轮廓:可能性,S.Rnninger,Roche,I.2:FailureModeEffectsAnalysis(FMEA),RiskEvaluationPrepareariskprofile:Consequences,S.Rnninger,Roche,I.2:失效模式效应分析(FMEA),风险评估准备一个风险轮廓:重要性（后果）,S.Rnninger,Roche,I.2:FailureModeEffectsAnalysis(FMEA),RiskEvaluationPrepareariskprofile:Consequences,S.Rnninger,Roche,I.2:失效模式效应分析(FMEA),风险评估准备一个风险轮廓:重要性（后果）,S.Rnninger,Roche,风险评估:风险轮廓Forhighrisks,whicharenotacceptable,riskreductionmeasureshavetobetakenasahighpriority,I.2:失效模式效应分析(FMEA),S.Rnninger,Roche,Highrisk,Lowrisk,RiskEvaluation:RiskProfile对于不可接受的高风险，因为一个高的风险因子风险消减措施必须实施,I.2:FailureModeEffectsAnalysis(FMEA),S.Rnninger,Roche,Highrisk,Lowrisk,I.2:FailureModeEffectsAnalysis(FMEA),Howtoperform?3.Summary(RiskEvaluation)Theeffectsareratedintermsoftheirconsequencesandthecausesareassessedintermsoftheirprobabilitiesa)qualitativeorb)quantitativeBasedontheseresultsariskprofileiscompleted.Inthisprofiletherisksarecomparedwiththeriskprotectionlevel,whichdeterminestheacceptedprobabilityfordefinedconsequencesUseasanaidtoprioritiseactions!,S.Rnninger,Roche,I.2:失效模式效应分析(FMEA),如何实施?3.总结(风险评估)效果在术语后果中评估，原因在术语可能性中评估a)定性或b)定量在这些结果基础上完成一个风险矩阵在这些矩阵中风险使用风险保护水平来比较。为描述的后果来确定可接受的可能性。将预先的措施当作帮助,S.Rnninger,Roche,I.2:FailureModeEffectsAnalysis(FMEA),QRMforfacilities,equipmentandutilitiesAssessanexistingcompressedairsystemOldapproach:60“risks”shouldhavebeensolvedindetailInitialRM-Approach:4sessionsintotal16people153potentialrisksdiscussed34Casesbeyondtheactionlimit30Correctiveactionshavebeenperformed(-50%)ReviewofRM-ApproachafterinspectionDidyouconsiderthishazard?-yes:showandexplainrationale-yes,butstartdiscussionforayes/nodecision-no:revisitinitialriskassessment,I.2:失效模式效应分析(FMEA),厂房设备设施的质量风险管理评估现有的压缩空气系统旧方法:60“风险”应该已经在细节上被解决。最初的风险管理方法:4次会议总共16个人153个讨论的潜在风险34个超过行动限的案例30个纠正措施已经被实施(-50%)检查后风险分析方法的审核你考虑这个是危害吗-是:说明并解释基本原理-是，但是开始讨论做是或不是的决定-不是:重新进行风险评估,I.2:FailureModeEffectsAnalysis(FMEA),ExperiencesEaseofapplicabilityProspectivetoolGoodtoolforoperatorstouseCanbeusedtoidentifycriticalstepsforvalidationMoreobjectivethanFaultTreeAnalysisCoversminorrisks,I.2:失效模式效应分析(FMEA),经验适用性预期工具操作者好使用的工具可以用来识别用做验证的关键步骤比缺陷树分析更多的目标覆盖小的风险,I.2:FailureModeEffectsAnalysis(FMEA),ExperiencesLimitationsCanbetimeandresourceconsumingMitigationplansmustbefollowedupNotagoodtoolforanalysisofcomplexsystemsCompoundfailureeffectscannotbeanalyzedIncorporatingallpossiblefactorsrequiresathoroughknowledgeofcharacteristicsandperformanceofthedifferentcomponentsofthesystemSuccessfulcompletionrequiresexpertise,experienceandgoodteamskillsDealingwithdataredundanciescanbedifficult,BasedonTakayoshiMatsumura,EsaiCo,I.2:失效模式效应分析(FMEA),经验局限性可能耗时和耗资源降低计划必须随后开始不是分析复杂系统的好工具复合的失效效应不能分析合并所有可能的因子需要具有充分的系统的不同组