FMEA+4th+手册介绍.ppt

FMEA4th手册介绍 WhatisanFMEA Asystematicgroupofactivitiesintendedto 团队活动 recognizeandevaluatethepotentialfailureofaproductorprocessandtheeffectsofthatfailure识别潜在失效模式和后果recognizeandprioritizeALLpotentialcausesofeachfailure Notelinktofishbone 所有潜在失效原因assessriskthroughouttheentireprocess notjustmanufacturing 评估风险identifyactionsthatcouldeliminateorreducethechanceofthepotentialfailureoccurring采取行动消除潜在失效模式bea living documentthatshouldalwaysbeupdatedtoreflectcurrentconditions includingchanges动态文件 FMEAProcessobjectives目标 TheFMEAdrivesproductandprocessimprovements推动改进Addressesallhighriskfailuremodes识别高风险失效模式Usedtodevelopcontrolplans用于形成控制计划Integratedwithprocessflowdiagramandtheprocesscontrolplan结合流程图和控制计划Considersallmajor lessonslearned i e nonconformingproduct warrantydata customercomplaints correctiveactions etc 获取经验教训 Improvementsinthe4theditionFMEAManual第4版手册的改进 Changesinformatwithindexfornavigation索引目录的改变Newformexamplesforguidance用于解释的新例子Focusonmanagementinvolvementandsupport管理层支持MorefocusonthelinkageofDFMEAandPFMEA强调了DFMEA和PFMEA的联系Improvedexamplesofrankingtables改进了等级打分表Significantlyenhancedguidanceandexamples增加了例子和解释ReducedemphasisonRPN不再强调RPN值Alternativeapproachesandmethods suchasFaultTreeanalysis引入了其它对失效原因和后果供选择的分析方法 如故障树 Chapter1 Introduction FMEAPROCESS Itsmostvisibleresultisthedocumentationofthecollectiveknowledgeofcross functionalteams 跨职能小组的集体知识文件化Timeliness Meanttobea beforetheevent action notan afterthefact exercise 是 事发前 行为 而不是 后见之明 Canbeappliedtonon manufacturingareas也可以运用于非制造区域Thereare3basiccasestoapplytheFMEAProcess三种基本情况 Newdesign technology orprocess新设计 新技术获新过程Modificationstoexistingdesignorprocess修改现有的设计或过程Useofanexistingdesignorprocessinanewenvironment location application etc 在新的环境 地点 应用等中使用现存的设计或过程 ImpactonOrganizationandManagement对组织和管理的影响 Musthaveprocessownerandseniormanagementcommitment 过程所有人和最高管理部门的承诺是很重要的 Acomprehensivetrainingprogramshouldbeimplementedincluding综合培训项目的执行包括 ManagementOverview管理的纵览Trainingforusers对使用者培训Suppliertraining供应商培训Facilitatortraining 建导者培训 Ultimately managementhastheresponsibilityandownershipfordevelopmentandmaintenanceofFMEAs 最终 管理者对FMEA的开发和维护有责任和所有权 FMEAExplained解释 LinkagetoALL5phasesofAPQP同APQP5个阶段紧密联系 TheFMEAanalysisshouldnotbeconsideredasingleevent butalongtermcommitment toensurethatpotentialfailuremodesareevaluatedandactionsaretakentoreducetheirrisk 不是一个单独事件 而是完成产品过程和开发的长期任务 以确保对潜在失效进行了评估 并采取了措施减少风险 ThelanguageusedinFMEAsshouldbeasspecificaspossible e g failuremodesandcauses FMEA语言应明确的陈述 简明扼要的术语 Follow upandContinuousImprovement持续改进 Theneedfortakingeffectivecorrective preventiveactions withappropriatefollo upcannotbeoveremphasized 采取有效的预防和纠正措施 以及后续行动跟踪是需要的 Teamleadershipisinchargeofensuringthatallrecommendedactionshavebeenimplemented 管理层负责所有建议措施得以实施 TheFMEAisalivingdocumentandshouldalwaysreflectthelatestlevel aswellasthelatestrelevantactions FMEA是动态文件 反馈最新状态 包括开始生产之后发生的措施 Chapter2 ManagementResponsibility管理职责 ManagementownstheFMEAprocess Managementhastheultimateresponsibilityofselectingandapplyingresourcesandensuringaneffectiveriskmanagementprocessincludingtiming 管理者拥有FMEA过程 管理者对选择和应用资源 并保证一个包括时间安排得有效的风险管理过程的最大责任 Managementresponsibilityalsoincludesprovidingdirectsupporttotheteamthroughongoingreviews eliminatingroadblocks andincorporatinglessonslearned 管理责任也包括通过持续评审为小组提供直接支持 消除障碍和吸取所学经验 ManagementSupport管理层支持 Mustbelieveintheprocessanditsvalue相信过程和其会产生价值Commitmenttotrainingandcompetenceneeds承诺提供培训Commitmenttoresources承诺提供资源Regularreviewofprocessandresults managementreview 5 6 2 1 定期回顾过程和结果EnsurethattheFMEAprocessisusedtodriveimprovementsversusjustrecordthem确保FMEA用于过程改进而不只是记录 LinkageofDFMEAandPFMEA DFMEA和PFMEA联系Page69 DuringthedevelopmentofthePFMEA theteammayidentifydesignopportunitieswhich ifimplemented wouldeithereliminateorreducetheoccurrenceofaprocessfailuremode Suchinformationmustbeprovidedtotheresponsibledesignengineer 在PFMEA开发过程中 小组可能识别出设计机会 这种设计机会被实施的话 它会消除或降低失效模式发生的频度 这样的信息必须提供给负责的设计工程师 FMEAsareLIVINGdocuments 请记住FMEA是动态文件 Pages64and110 TheDFMEA PFMEAisalivingdocumentandshouldbereviewedandupdatedwheneverthereisaproductorprocessdesignchange FMEA是动态文件 只要有产品设计和过程变更 就应该评审和更新Anotherelementofongoingmaintenanceshouldincludeaperiodicreviewoftherankings withspecificfocusontheOandDrankings withparticlularattentiontowherefieldissuesorproductionissueshaveoccurred 对FMEA中等级进行评审 应放在频度和探测度的等级上 特别是出现售后市场出现问题或生产出现问题Canwefindevidenceofthishappening withalinkagetowarranty fieldandproductionfailuredata 结合已发生的证据 包括三包数据 售后 生产失效件 SignificantlyEnhancedGuidanceandExamples 增加的典型例子和解释 GuidanceandExpectationofimprovedLinkagetoProcessFlowaskeyinput EnhancedGuidanceonRequirementsandPotentialFailureModes EnhancedGuidanceonEffectsofFailureModes ImprovedRankingCriteria ProvidedasexamplesRecommendedtonotmodifycriteriaforseverity9and10Occurrencescalenowprovidesforlessthan1in100 000 was 1 now 3 SPCremovedfromdetectioncriteria Nowconsideredasapreventioncontrol page95Doestheorganizationuserankingcriteriathatbestreflectstheirproductsandprocessesandusestheentireriskscaleof1000 NewPFMEASeverityCriteria NewPFMEAOccurrenceCriteria EnhancedGuidanceforPreventionvs DetectionControls OperatorerrorisNEVERanacceptablerootcause Theprocessallowedtheoperatortomaketheerror Humanbeingsareonlycapableof3errorsperthousandonarepetitivetask NewPFMEADetectionCriteria Enhancedguidanceonrecommendedactions 建议措施的解释Seepages59 63forexamplesofrecommendedimprovementactionstoreduceoccurrenceanddetectionrankingfor59 63页中描述DFMEA减少频度和探测度的建议改进措施 Seepages105 107forexamplesofrecommendedimprovementactionstoreduceoccurrenceanddetectionrankingforPFMEAs 105 107页对PFMEA中减少频度和探测度的建议改进措施Morefocusonusingstudiesandstatisticalmethodstounderstandthesourcesofvariation 关注统计方法理解过程变差的来源Morefocusonmistakeproofinganderrorproofing 推荐采用防错措施Isthecoreteamcompetentontheseconceptsandisthereevidenceoftheireffectiveuse 核心团队能力能够且有效执行改进措施 RecommendedActions建议措施Shouldfocusonreductionof O valuefirst then D 应先降低频度等级然后降低探测度等级Shouldcorrelatewithanycorrectiveorpreventiveactions 采用纠正和预防措施Thereshouldbea loop fromtheseprocessesthroughtheFMEAstoensureaccurateRPNsatalltimes 整个FMEA过程不断循环 保证正确的RPN High SeverityitemsrequirespecialattentionregardlessoftheRPN 对严重度高的要特别关注 不管其RPN值大小 AlternativeForms AppendixB选择的表格 The3rdeditionplacedtoomuchemphasisonthestandardform The4theditionprovidesforalternativeexamples多种选择 Minimumrequirementsaredefined最起码的要求的定义 pages24 74 3rdeditionformisstillacceptable第三版的表格也可接收Hastheorganizationidentifiedthebestapproachfortheirbusiness组织是否识别对口业务中最有效的方法 DoestheFMEAprocessandformsuseddriveimprovementsversusrecordthemFMEA是否有效推动改进 而不只是记录 ExampleofPFMEAFormrecommended SampleReference StopusinganRPNthresholdfordeterminingactions 不要强调RPN值来决定是否采取改进措施Pages57and103 TheuseofanRPNthresholdisNOTarecommendedpracticefordeterminingtheneedforactions AlternativeRiskAssessments供选择的风险评估 SeeAppendixCforafewexamplesthatmighthelptheteambetterprioritizerecommendedactions附录较多例子解释排列优先等级 SO SeverityxOccurrence focusesonpreventiveactions关注SxO 强调预防措施SOD S 7 O 3 D 5 RPN 105 SOD 735 focusesonseverity thenoccurrence thendete