PFMEA2019/8/21ProcessFailureModeandEffectsAnalysis过程失效模式及后果分析(PFMEA)PFMEAPFMEA陶国PFMEA2019/8/21ProprietaryInformation专有信息YourFMEA(ControlPlan,ProcessCapability,etc.)maybeconsideredproprietaryandshouldnotbesharedwithanyoneoutsidethedivisionwithoutfirstconsultingyourmanagement.FMEA(控制计划、过程能力等)可视为专有信息,在未事先征得管理部门同意之前,不得向部门以外的任何人透露。thisincludesthesharingofinformationwithyourcustomer也不得向顾客透露有关信息。PFMEA2019/8/21FormsandFormats形式和格式Yourcustomermighthaveaspecificformatorformthattheyrequire.Ifso,youwillneedtogettheirwrittenapprovaltouseanalternateformat.顾客可能要求特定的格式或表单。如果是这样,你只有征得他们的书面同意,才能采用其它格式。PFMEA2019/8/21ProcessFMEA过程FMEA何谓PFMEA何时作PFMEA何人作PFMEA如何作PFMEA16步工作步骤PFMEA2019/8/21ProcessFMEA过程FMEA何谓PFMEA何时作PFMEA何人作PFMEA如何作PFMEA16步工作步骤PFMEA2019/8/21ProcessFMEA过程FMEAananalyticaltoolusedbyaprocessdesignteamtoidentifypotentialproductfailurescausedbyfailureofthemanufacturingandassemblyprocesstomeetrequirements,andidentifycorrectiveactionstobetaken是过程设计小组采用的一种分析方法,用于识别由于制造或装配过程的失效而导致的潜在产品失效模式,并确定所应采取的纠正措施。PFMEA2019/8/21formalprocess正式程序customerfocused着眼于顾客usesengineeringjudgment,andharddatawhereitisavailable利用工程经验判断和可靠的数据ProcessFMEA过程FMEAPFMEA2019/8/21PFMEAisfocussedontheProductPFMEA关注对产品的影响PFMEAisfocussedonthePRODUCT.Namely,howthePROCESScancauseflawsorvariationinthePRODUCT.ProcessFMEA过程FMEAPFMEA2019/8/21ProcessFMEA过程FMEA何谓PFMEA何时作PFMEA何人作PFMEA如何作PFMEA16步工作步骤PFMEA2019/8/21WhendowedoaPFMEA?何时进行PFMEA?Whilethereisstilltimetobringaboutchangesintheprocessandintheproduct!当还有时间修改产品及工艺设计时!APFMEAdonesolelytofilloutaformandmeet“requirements”isjustanexercise为了满足QS9000要求而填写PFMEA表格,仅是练习而已PFMEA2019/8/21PFMEAisanoutputoftheProcessDesignandDevelopmentphaseofAPQPPFMEA是APQP中“过程设计和开发”阶段的产物WhendowedoaPFMEA?何时进行PFMEA?PFMEA2019/8/21ItisderivedfromaDFMEA在DFMEA之后进行AnyDFMEAformsandsupportingdocumentsshoudbebroughttothePFMEAmeetingsDFMEA表单和所有相关文件都应带入PFMEAItshouldbeanaturalpartofconceptdevelopment应成为过程设计的一个必要组成部分PFMEAisnever“finished”.itisalivingdocument是动态文件WhendowedoaPFMEA?何时进行PFMEA?PFMEA2019/8/21DoaPFMEA(oratleastreviewtheoldone)if:以下情况需进行PFMEA(或至少评审过去的PFMEA):theprocessisnew是新的过程theproductisnew,orhasneverbeenmadewiththisprocess新产品,或从未用本过程加工的产品anexistingprocesschanges原有的过程发生变化customerrequirementsordesireschange顾客要求或希望发生变化WhendowedoaPFMEA?何时进行PFMEA?PFMEA2019/8/21DoaPFMEA(oratleastreviewtheoldone)if:以下情况需进行PFMEA(或至少评审过去的PFMEA):thecompetitive,business,orlegalenvironmentchanges竞争环境、业务环境或法律环境发生变化PPAPconditionsapply需提交PPAPactualfailuresoccur发生实际失效WhendowedoaPFMEA?何时进行PFMFA?PFMEA2019/8/21ProcessFMEA过程FMEA何谓PFMEA何时作PFMEA何人作PFMEA如何作PFMEA16步工作步骤PFMEA2019/8/21WhoperformsaPFMEA?由谁进行PFMEA?Across-functionalteamshouldbeused由跨部门小组进行Theleadershouldbetheprocess-responsibleengineer小组组长应是过程设计责任工程师PFMEA2019/8/21Cross-FunctionalTeam跨部门小组5-9peoplefrom,5-9人,由从事如下工作的人员组成Design,设计Assembly,装配manufacturing(operators,supervisors),制造(操作工,班组长)Industrial,mfg.Andtoolengineering,工业工程,工艺及工装设计quality,质量管理materialsengineering,材料工程Servicepersonnel,机修Supplierofproductandmachinery,零件和设备供应商Representativesfromthenextprocess,后续工序代表PFMEA2019/8/21ProcessFMEA过程FMEA何谓PFMEA何时作PFMEA何人作PFMEA如何作PFMEA16步工作步骤PFMEA2019/8/21HowdowedoaPFMEA?ASummary怎样进行PFMEA?提要Assemblethecross-functionalPFMEAteam组建跨部门PFMEA小组Listthefailuremodes,theireffects,andtheircauses列出失效模式,后果以及原因PFMEA2019/8/21Assess,评估theseverityoftheeffect(S)后果的严重程度thelikelihoodofthecauses(O)原因出现的可能性andtheabilityofprocesscontrolstodetectfailuremodesand/ortheircauses(D)过程控制探测失效模式和/或原因的能力HowdowedoaPFMEA?ASummary怎样进行PFMEA?提要PFMEA2019/8/21Calculatetheriskprioritynumber(RPN)toprioritizecorrectiveactions计算风险顺序数(RPN)以确定应优先采取的纠正措施Plancorrectiveactionsandassignowner制订纠正措施并落实责任人Performcorrectiveactionstoimprovetheproductorprocess,采取纠正措施以提高产品和过程质量RecalculateRPN重新估算RPNHowdowedoaPFMEA?ASummary怎样进行PFMEA?提要PFMEA2019/8/21HowdowedoaPFMEA?ASuggestion怎样进行PFMEA?建议Doyourworkonscratchpaperfirst;astheteamreachesconsensus,recordtheinformationontheFMEAform先在一张草稿纸上进行分析;当小组达成一致意见后,再将有关信息填在FMEA表上usefishboneandtreediagramsliberally充分利用鱼刺图和树形图tryingtousetheFMEAformasaworksheetleadstoconfusionandmessed-upFMEAs若将FMEA表当做工作单使用,就会造成混乱,使FMEA一塌糊涂PFMEA2019/8/21ProcessFMEA过程FMEA何谓PFMEA何时作PFMEA何人作PFMEA如何作PFMEA16步工作步骤PFMEA2019/8/211.Assembleateamandplanyouractivities成立小组并制订计划PFMEAmustneverbedonebyanindividual,because绝不能由个人单独进行PFMEA,因为:individualeffortsproducebiasedresults,由个人进行会使结果出现偏差anyactionswillrequirebuy-infromvariousgroups进行任何活动,都需要从不同的组织取得信息PFMEA2019/8/21Oneperson(e.g.theleader)shouldbeassignedtomaintainingtheFMEAform应指定一个人(如组长)保管FMEA表格BesuretowritethenamesandfunctionsoftheteammembersontheFMEAform应将小组成员的姓名和职责填入FMEA表格1.Assembleateamandplanyouractivities成立小组并制订计划PFMEA2019/8/212.Developaprocessflowdiagram绘制过程流程图UsetheProcessFlowDiagramformat运用正规的过程流程图identifiesfabricate,move,storeandinspectoperations辨别四种作业类型identifiesKeyCharacteristics辨别关键特性PFMEA2019/8/21Supplier________________Date_______________PartNumber_____________RevisionLevel______PartDescription__________Preparedby_________pressuremoldpartfabmoves