PFMEA-Regulation-过程潜在实效模式和后果分析实施规范.docx

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1、ManagementRegu1ation管理规范Number文件编号：Department部门：PE工艺SUbjeCtPFMEARegu1ation过程潜在失效模式和后果分析实施规范Revision版本：1.0EffectiveDate生效日期：Page1of9批准：审核：作成：ChangeHistorv变更记录Revision版本EffectiveDate生效日期Originator编写人ReasonsforChange修改原因1.02014.7.21Jessica1 .根据第四版FME,重新界定建议措施的评定标准2 .根据最新组织架构，FMEA划分给PE,表单编号更新为WD-PE-OO11

2、.0Purpose目的Theprocedureprovidesguidanceandregu1ationsfortheformu1ationandmaintenanceofPFMEA.本程序是为过程失效模式及后果分析的制定和维护提供指导和规定。2.0Scope范围Theprocedureapp1iestopotentia1PFMEAofproductionprocessofsemi-finishedproductsandfinishedproducts.本程序适用于半成品及成品的生产以及装配过程的过程潜在的失效模式及后果分析。3.0DefinitiOnS定义3.1 FMEA:istheabbr

3、eviationofFai1ureModeandEfectsAna1ysis.ItcanbedividedintodesignFMEA(DFMEA)andprocessFMEA(PFMEA)andisamethodofana1ysisandadvancedpreventioninordertoe1iminateorreducepotentia1fai1ureopportunityofproductandprocess.FMEA:是Fai1ureModeandEfectsAna1ysis的简称，即为失效模式及后果分析可分为设计FMEA(DFMEA)及过程FMEA(PFMEA),是为了消除或减少产

4、品或过程的潜在失效发生机会而进行分析及事前预防的方法3.2 RPN:RiskPriorityNumber风险顺序数3.2.1 Severityoffai1ure(S)1occurrenceoffai1urecause/structure,detectionofpotentia1cause/structureorfai1uremode(D),theproductofseverity,occurrenceanddetection,thatis,RPN=(S)(O)(D).为失效效应的严重度(S),失效原因/结构的发生度(O),检测出潜在原因/结构或检测出失效模式的检出度(D),这三者的乘积,即RP

5、N=(S)*(O)*(D)3.2.2 Whentheseverityis9or10,itisimperativethattheteamensurethattheriskisaddressedthroughexistingdesigncontro1sorrecommendedactions(asdocumentedintheFMEA).当严重度达到9或10,小组必须确保该风险已经通过现有设计控制或者建议措施(在FMEA内有记录)得到处理。3.2.3 AccordingtofourtheditionFMEAManua1,theuseofanRPNthresho1disNOTarecommended

6、practicefordeterminingtheneedforactions.根据第四版FMEA手册，不推荐使用RPN阀值来决定是否需要采取措施。3.2.4 Firstforfai1uremodeswithseverities*occurrenceof32ormore,theteamshou1dconsidetakethereccomendedactions,Throughtoreducedetection,soastoreducetheRPNva1ues.ThenconsiderifRPN100,correctiveactionssha11betakentoreduceRPNtobe1ow

7、100.首先当严重度*发生度大于等于32的失效模式，小组应当考虑采取必要的建议措施，通过降低探测度或者发生度的评分，来降低RPN值;然后再考虑如果RPN100,则必须采取纠正措施，以便将RPN降到IOO以下。3.2.5 Ifcustomerhavespecia1requirements,performaccordingtocustomersrequest如果客户有特殊要求，按客户要求执行4.0ReSPOnSibiIity权责4.1 PE工艺工程师1eadtomakeandmodifyPFMEAwithcoreteammember,主导并与核心小组成员一起进行PFMEA的制定以及修改。4.2 Q

8、1Ja1itydePartment质量部协助进行PFMEA的制定与修改SupporttodefineandmodifythePFMEA4.3 Productiondepartment生产部协助进行PFMEA的制定与修改SupporttodefineandmodifythePFMEA5.0ProCedUre程序5.1 PFMEAteamisresponsib1eforthepreparationofPFMEAandiscomposedofpersonne1ofDeve1opmentdepartment,Qua1itydepartment,Marketing&Sa1esdepartment,Pur

9、chasingDepartment,Productiondepartmentandsoon.PFMEA小组负责PFMEA的编制，小组主要由项目部、质量部、采购部、生产部等部门人员组成。5.2 Documentsanddataneededforcompi1ingPFMEAareasfo11ows编制PFMEA时所需文件及资料如下。5.2.1 DFMEA5.2.2 Processf1owchart过程流程图5.2.3 Customersdrawing/specification,etc.客户的图纸/规范等5.2.4 FMEAofsimi1arproductsofthecompany本公司以往类似产

10、品的PFMEA或经验PFMEA5.2.5 Previousdataofcustomercomp1aintsorcustomerreturns本公司以往客户抱怨或客户退货资料5.2.6 Statistica1dataofdefectiverateofsimi1arproducts本公司类似产品的不良率统计资料5.2.7 Statistica1dataofdefectiveoperationofequipmentandtoo1s设备及工装运行不良的统计资料.5.3 Changerequirements变更条件Accordingtothechangeofcustomerrequirements,ma

11、teria1,productionequipment,too1sorprocessChangeS.顾客的要求发生变更时，材料变更时，生产设备或工装变更时，工艺过程变更时。5.4 PFMEA编制方法PFMEAcompi1ationmethods5.4.1 FMEAnumber:fi11inFMEAdocumentnumberforinquiry.、FMEA编号：填入FMEA文件编号，以便查询5.4.2 App1icab1escope:recordapp1icab1enameorprocessofparts适用范围：记录适用的零部件名称或过程5.4.3 Responsibi1ityofproces

12、sdesign:thedepartmentorteamthatfi11sinre1atedprocesses过程设计责任：填入相关过程的实行部门或小组5.4.4 Compi1er:fi11intheinformationsuchasnameandte1ephoneofengineerwhoisresponsib1eforcompi1ingFMEA编制者：填入负责编制FMEA的工程师的姓名、电话等信息5.4.5 Keydate:fi11infirstschedu1etimeofthecomp1etionofFMEA关键F1期：填入初次FMEA应完成的预定时间5.4.6 FMEAdate:fi11

13、inthedateofcompi1ingorigina1textand1atestrevisiondateofFMEA.FMEA日期：填入编制FMEA原始稿的日期及最新修订的日期5.4.7 Coreteam:1istteammemberswhoareresponsib1eforcompi1ingandimp1ementingFMEA核心小组：列出编制和执行FMEA的小组成员5.4.8 Processfunctionandrequirement:brief1ydescribeana1yzedprocessorintentionandcorrespondwithoperationnumberonp

14、rocessf1owchart过程功能、要求：简要描述被分析的工艺过程或工序目的，需与过程过程流程图上的作业编号对应5.4.9 Potentia1fai1uremode:processmaynotorisimpossib1etorea1izeexpectedspecia1characteristics潜在失效模式：是指工艺过程有可能未达到或不能实现预期的特殊特性5.4.10 Potentia1fai1ureeffects:theconditionoffai1uremodeaffectsnextprocesswhichcausesthefai1ureofequipmentanddeviceand

15、affectscustomer潜在失效后果：失效模式情况下对下个过程致使设备设施失效及顾客产生的影响5.4.11 Severity:thedegreeofseveritythatbringstonextprocessandcustomer,thegradeofthemostseriousresu1tasthestandardandeva1uationstandardofseverity(Appendix2)严重度：指对下个过程及顾客的影响的严重程度，以最严重的影响后果的级别为准，严重度评价标准(附件1)Appendix1:SuggestedPFMEASeverityOccurrenceEva1uationCriteriaEffectCriteria:SeverityofEffectonProduct(CustomerEffect)RankEffectCriteria:SeverityofEffectonProcess(ManufacturingZAssembIyEffect)Fai1uretoMeetSafetyand/orRegu1itoryRequiremeDtiPotentudfhmQXXieafictssaf