过程失效模式及后果分析PFMEA61中英文课件.ppt

1、PFMEA2020/3/23Process Failure Mode and Effects Analysis过程失效模式及后果分析过程失效模式及后果分析(PFMEA)PFMEAPFMEA陶国PFMEA2020/3/23Proprietary Information专有信息专有信息?Your FMEA(Control Plan,Process Capability,etc.)may be considered proprietary and should not be shared with anyone outside the division without first consultin

2、g your management.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。?this includes the sharing of information with your customer也不得向顾客透露有关信息。PFMEA2020/3/23Forms and Formats形式和格式形式和格式?Your customer might have a specific format or form that they require.If so,you will need to get their written app

3、roval to use an alternate format.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。PFMEA2020/3/23Process FMEA过程FMEA?何谓PFMEA?何时作PFMEA?何人作PFMEA?如何作PFMEA?16步工作步骤PFMEA2020/3/23Process FMEA过程FMEA?何谓PFMEA?何时作PFMEA?何人作PFMEA?如何作PFMEA?16步工作步骤PFMEA2020/3/23Process FMEA过程过程FMEA?an analytical tool used by a process de

4、sign team to identify potential product failures caused by failure of the manufacturing and assembly process to meet requirements,and identify corrective actions to be taken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。PFMEA2020/3/23?formal process正式程序?customer focused着眼于顾客?uses enginee

5、ring judgment,and hard data where it is available利用工程经验判断和可靠的数据Process FMEA过程过程FMEAPFMEA2020/3/23?PFMEA is focussed on the ProductPFMEA 关注对产品的影响PFMEA is focuss ed on the PRODUCT.Namely,how the PROCESS can causeflaws or v ariation in the PRODUCT.Process FMEA过程过程FMEAPFMEA2020/3/23Process FMEA过程FMEA?何谓

6、PFMEA?何时作PFMEA?何人作PFMEA?如何作PFMEA?16步工作步骤PFMEA2020/3/23When do we do a PFMEA?何时进行PFMEA？?While there is still time to bring about changes in the process and in the product!当还有时间修改产品及工艺设计时！?A PFMEA done solely to fill out a form and meet“requirements”is just an exercise为了满足QS9000要求而填写PFMEA表格，仅是练习而已PFME

7、A2020/3/23?PFMEA is an output of the Process Design and Development phase of APQP PFMEA是APQP中“过程设计和开发”阶段的产物When do we do a PFMEA?何时进行PFMEA？PFMEA2020/3/23?It is derived from a DFMEA在DFMEA之后进行?Any DFMEA forms and supporting documents shoud be brought to the PFMEA meetingsDFMEA表单和所有相关文件都应带入 PFMEA?It sh

8、ould be a natural part of concept development应成为过程设计的一个必要组成部分?PFMEA is never“finished”.it is a living document是动态文件When do we do a PFMEA?何时进行PFMEA？PFMEA2020/3/23Do a PFMEA(or at least review the old one)if:以下情况需进行 PFMEA(或至少评审过去的 PFMEA)：the process is new是新的过程the product is new,or has never been made

9、 with this process新产品，或从未用本过程加工的产品an existing process changes原有的过程发生变化customer requirements or desires change顾客要求或希望发生变化When do we do a PFMEA?何时进行PFMEA？PFMEA2020/3/23Do a PFMEA(or at least review the old one)if:以下情况需进行 PFMEA(或至少评审过去的 PFMEA)：the competitive,business,or legal environment changes竞争环境、业

10、务环境或法律环境发生变化PPAP conditions apply需提交PPAPactual failures occur发生实际失效When do we do a PFMEA?何时进行PFMFA？PFMEA2020/3/23Process FMEA过程FMEA?何谓PFMEA?何时作PFMEA?何人作PFMEA?如何作PFMEA?16步工作步骤PFMEA2020/3/23Who performs a PFMEA?由谁进行PFMEA？?A cross-functional team should be used由跨部门小组进行?The leader should be the process-

11、responsible engineer小组组长应是过程设计责任工程师PFMEA2020/3/23Cross-Functional Team跨部门小组跨部门小组?5-9 people from，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.And tool engineering，工业工程，工艺及工装设计?quality，质量管理?materials engineering，材料工程?Service personnel，机修?Supp

12、lier of product and machinery，零件和设备供应商?Representatives from the next process,后续工序代表PFMEA2020/3/23Process FMEA过程FMEA?何谓PFMEA?何时作PFMEA?何人作PFMEA?如何作PFMEA?16步工作步骤PFMEA2020/3/23How do we do a PFMEA?A Summary怎样进行PFMEA？提要?Assemble the cross-functional PFMEA team组建跨部门PFMEA小组?List the failure modes,their eff

13、ects,and their causes列出失效模式，后果以及原因PFMEA2020/3/23?Assess，评估?the severity of the effect(S)后果的严重程度?the likelihood of the causes(O)原因出现的可能性?and the ability of process controls to detect failure modes and/or their causes(D)过程控制探测失效模式和/或原因的能力How do we do a PFMEA?A Summary怎样进行PFMEA？提要PFMEA2020/3/23?Calcula

14、te the risk priority number(RPN)to prioritize corrective actions计算风险顺序数(RPN)以确定应优先采取的纠正措施?Plan corrective actions and assign owner制订纠正措施并落实责任人?Perform corrective actions to improve the product or process,采取纠正措施以提高产品和过程质量?Recalculate RPN重新估算RPNHow do we do a PFMEA?A Summary怎样进行PFMEA？提要PFMEA2020/3/23H

15、ow do we do a PFMEA?A Suggestion怎样进行PFMEA？建议?Do your work on scratch paper first;as the team reaches consensus,record the information on the FMEA form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?use fishbone and tree diagrams liberally充分利用鱼刺图和树形图?trying to use the FMEA form as a worksheet leads to confusi

16、on and messed-up FMEAs若将FMEA表当做工作单使用，就会造成混乱，使FMEA一塌糊涂PFMEA2020/3/23Process FMEA过程FMEA?何谓PFMEA?何时作PFMEA?何人作PFMEA?如何作PFMEA?16步工作步骤PFMEA2020/3/231.Assemble a team andplan your activities成立小组并制订计划成立小组并制订计划?PFMEA must never be done by an individual,because 绝不能由个人单独进行 PFMEA，因为：?individual efforts produce

17、biased results,由个人进行会使结果出现偏差?any actions will require buy-in from various groups进行任何活动，都需要从不同的组织取得信息PFMEA2020/3/23?One person(e.g.the leader)should be assigned to maintaining the FMEA form 应指定一个人(如组长)保管FMEA表格?Be sure to write the names and functions of the team members on the FMEA form应将小组成员的姓名和职责填入

18、 FMEA表格1.Assemble a team andplan your activities成立小组并制订计划成立小组并制订计划PFMEA2020/3/232.Develop a process flow diagram 绘制过程流程图绘制过程流程图?Use the Process Flow Diagram format 运用正规的过程流程图?identifies fabricate,move,store and inspect operations辨别四种作业类型?identifies Key Characteristics辨别关键特性PFMEA2020/3/23Supplier_Dat

19、e_Part Number_Revision Level_Part Description_Prepared by_pressuremold partfabmovestore inspstepoper.descr.item#KPCitem#KCCinspect partfor flashstore part in containercarry parts to assy area1no flash112342.Develop a process flow diagram 绘制过程流程图PFMEA2020/3/23过程流程图mold part注塑零部件fab加工move搬运store存放insp

20、检验step步骤oper.descr.作业说明item#编号KPCitem#编号KCCinspect partfor flash检验零件有无飞边store part in container将零部件放入周转箱内carry parts to assy area将零部件送往装配区1no flash无飞边pressure压力11234PFMEA2020/3/23PFMEA2020/3/233.List the function(s)of each operation列出每个操作的功能列出每个操作的功能?A function is what the operation does 功能系指该操作所起的作

21、用?State the function as，说明功能为：Verb+Object+Qualifier 动词+宾语+修饰词mold part，零件成型crimp terminal onto cable 在线端压接端子form bend in part,零件弯曲成型examples例如PFMEA2020/3/23?Dont forget auxiliary functions as well a primary functions基本功能和辅助功能都要考虑3.List the function(s)of each operation列出每个操作的功能列出每个操作的功能PFMEA2020/3/23

22、4.List the quality requirements列出质量要求列出质量要求?a customer want or desire顾客的希望或要求?could seriously affect customer perception有可能严重影响顾客的看法?could lead to a customer complaint 有可能导致顾客投诉PFMEA2020/3/235.List the potential process failure modes 列出可能的过程失效模式列出可能的过程失效模式?a defect,flaw,or other unsatisfactory condi

23、tion in the product that occurs when the process fails to meet the process requirements由于过程未达到要求而导致的产品缺陷、瑕疵等不良状态?failure modes should be written in terms of the condition of the product失效模式体现在产品上PFMEA2020/3/23?Typical Failure Modes，几种典型失效模式?diameter out of spec.，直径超差?missing seal，漏装密封垫?cut strands，切

24、破线皮?misoriented part，部件方向错?insufficient solder，焊剂不足?too much solder，焊剂过量?NFO，未充满?Flash，飞边5.List the potential process failure modes 列出可能的过程失效模式列出可能的过程失效模式PFMEA2020/3/23?Note，注?Assume that incoming product and materials are correct假设来料没问题?Assume that the product as designed will meet requirements假设产品

25、设计能够满足客户需求5.List the potential process failure modes 列出可能的过程失效模式PFMEA2020/3/236.Derive the potential effects of each failure 列出每一失效模式的所有可能后果列出每一失效模式的所有可能后果?The ramifications of failure后果是失效模式的衍生事件?The effect can be on，可能影响?the ultimate customer，最终用户?or intermediate customer(OEM,etc.)，中间用户?a governme

26、nt regulation，法规?the next process step，下序PFMEA2020/3/23?Customer complaints are a useful source of information顾客抱怨是非常有用的信息来源6.Derive the potential effects of each failure 列出每一失效模式的所有可能后果列出每一失效模式的所有可能后果PFMEA2020/3/23?An effect can be，后果可能为?complete loss of function，功能完全丧失?degradation of performance o

27、r quality，质量或性能降低?damage of process equipment，设备受损?injury to an operator，员工受伤?shut-down of an assembly line，停线6.Derive the potential effects of each failure 列出每一失效模式的所有可能后果列出每一失效模式的所有可能后果PFMEA2020/3/23?Effects of failure often show up as a chain of events,from immediate effect to the ultimate effect

28、 on the customer，失效的后果通常表现为从对顾客的直接影响到最终影响等一系列连锁反应?It is recommended that these chains be developed for each failure mode and recorded on the FMEA form建议针对每一种失效模式找出这些连锁反应，并记录在FMEA表上?use a tree diagram运用树形图6.Derive the potential effects of each failure 列出每一失效模式的所有可能后果列出每一失效模式的所有可能后果PFMEA2020/3/23Effec

29、ts on the process，对过程的影响:?9-10may endanger machine or operator，可能导致设备或人员受损?6-8scrap，报废?4-5sort and rework，检验、返工?2-3rework on-line，线上返工?1no effect，无影响consider also the effects on the customer还要考虑对顾客的影响7.Assess the severityof each effect评估每种后果的严重度评估每种后果的严重度PFMEA2020/3/23Criteria:Severity of EffectThis

30、 ranking results when a potential failure mode results in a final customer and/or a manufacturing/assembly plant defect.The final customer should always be considered first.If both occur,use the higher of the two sevHazardous-without warning10Very high severity ranking when a potential failure mode

31、affects safe vehicle operation and/or involves noncompliance with government regulation without warning.Or may endanger operator(machine or assembly)without warning.Hazardous-with warning9Very high severity ranking when a potential failure mode affects safe vehicle operation and/or involves noncompl

32、iance with government regulation with warning.Or may endanger operator(machine or assembly)with warning.Very High8Vehicle/item inoperable(loss of primary function).Or 100%of product may have to be scrapped,or vehicle/item repaired in repair department with a repair time greater than one hour.High7Ve

33、hicle/item operable but at a reduced level of performance.Customer very dissatisfied.Or product may have to be sorted and a portion(less than 100%)scrapped,or vehicle/item repaired in repair department with a repair time between a half-hour and an one hour.Moderate6Vehicle/item operable but Comfort/

34、Convenience item(s)inoperable.Customer dissatisfied.Or a portion(less than 100%)of the product may have to be scrapped with no sorting,or vehicle/item repaired in repair department with a repair time less than a half-hour.Low5Vehicle/item operable but Comfort/Convenience item(s)operable at reduced l

35、evel of performance.Or 100%of product may have to be reworked,or vehicle/item repaired off-line but does not go to repair department.Very Low4Fit&Finish/Squeak&Rattle item does not conform.Defect noticed by most customers(greater than 75%).Or the product may have to be sorted,with no scrap,and a por

36、tion(less than 100%)reworked.Minor3Fit&Finish/Squeak&Rattle item does not conform.Defect noticed by 50%of customers.Or a portion(less than 100%)of the product may have to be reworked,with no scrap,on-line but out-of-station.Very Minor2Fit&Finish/Squeak&Rattle item does not conform.Defect noticed by

37、discriminating customers(less than 25%).Or a portion(less than 100%)of the product may have to be reworked,with no scrap,on-line but in-station.None1No discernible effect.Or slight incovenience to operation or operator,or no effect.PFMEA2020/3/238.Determine potential cause(s)of each failure mode 确定每

38、一失效模式的可能原因?A cause of failure is how the failure can occur in the process，失效原因：过程为何会失效?Should be written in terms of something in the process that can be corrected and controlled，应表述为可纠正或可控制的因素?Consider human error,wear-out of tools,ambient conditions,and interactions of factors，如人的过失，工装磨损、环境条件以及因素间

39、的相互作用PFMEA2020/3/23?Causes of failure often show up as a chain of events,from immediate cause to root cause失效通常是由一连串的原因造成的，从直接原因到根本原因?It is recommended that these chains be developed for each failure mode and recorded on the FMEA form建议针对每一种失效模式，找出原因链，记入 FMEA表?use a tree or fishbone diagram to devel

40、op可利用树形图或鱼刺图8.Cause(s)of Failure失效原因失效原因PFMEA2020/3/239.Assess the likelihood of occurrence of each cause评估每种失效原因产生的可能性评估每种失效原因产生的可能性?Use historical data(as a baseline)，利用历史资料?Take improvements into account，并考虑所作的改进?Use statistical models and comparison with similar processes利用可靠性模型，与类似的过程进行比较PFMEA2

41、020/3/239-10 Failure almost inevitable，失效几乎不可避免7-8Similar processes that have often failed in the past，以前类似过程常常失效4-6Similar processes that have occasional failures，类似过程偶尔失效1-3Similar processes that have experienced isolated failures，类似过程仅有过个别失效9.Assess the likelihood of occurrence of each cause评估每种失

42、效原因产生的可能性评估每种失效原因产生的可能性PFMEA2020/3/23Occurence(O)ProbabilityLikely Failure Rates*Very High:Persistent Failures=100 per thousand piecesVery High:Persistent Failures50 per thousand piecesHigh:Frequent Failures20 per thousand piecesHigh:Frequent Failures10 per thousand piecesModerate:Occasional Failure

43、s5 per thousand piecesModerate:Occasional Failures2 per thousand piecesModerate:Occasional Failures1 per thousand piecesLow:Relatively Few Failures0.5 per thousand piecesLow:Relatively Few Failures0.1 per thousand piecesRemote:Failure is Unlikely=0.010 per thousand pieces10987654321PFMEA2020/3/23Cau

44、ses and EffectsHarness ClampCause-and-effect chainradius out of spectool is worntool notreplacedlack of maintenance procedureclamp cracksat bendbundle falls outrattling noiseCAUSE chainEFFECT chainPFMEA2020/3/23Causes and EffectsWiring AssemblyEffects TreeCrossed WireNofunctionFire in PlantOperatorI

45、njuryDamagedEquip.Must repair vehiclePFMEA2020/3/23Causes and EffectsWiring AssemblyCauses TreeCrossed WireBoardErrorOperatorErrorPoorInstruct.NottrainedOper istiredPFMEA2020/3/2310.List the Current Process Controls列出现有过程控制列出现有过程控制?Process controls catch the defect before the product reaches the cus

46、tomer，过程控制当在产品到达顾客前发现缺陷!?There are three Types of process controls,过程控制有三种类型:(1)prevent the cause of failure,or reduce the rate of occurrence，防止原因出现或降低其出现的可能性(2)detect the cause(s)of failure and lead to corrective actions，查明失效的原因并找出纠正措施(3)detect the failure mode(s)，检测失效模式PFMEA2020/3/23?Assign curren

47、tly used process controls to failure modes and causes，针对失效模式或原因列出现行的过程控制手段?Used on similar processes in the past，以前类似过程如何控制?Can be of any Type:1,2,or 3,or any combination，可以是1、2、3类或其组合?Type 1 controls affect the likelihood of occurrence,if already part of the design，若设计中已有体现，则第1类方法可降低原因出现的频度?If none

48、,write“None”，若没有，则填“无”。10.List the Current Process Controls列出现有过程控制列出现有过程控制PFMEA2020/3/23?Detection is an assessment of the probability that，探测度为下列事件发生的概率?a type 2 control can detect the cause and lead to corrective action,第2类控制能够发现原因并找到纠正措施?a type 3 control can detect a failure，第3类控制能够在不良品到达顾客前发现缺陷

49、.before the product reaches the customer!?detection can also assess how effectively a type 1 control can prevent failure，第1类控制能够预防失效的有效程度11.Detecting failure探测度探测度PFMEA2020/3/2311.Detecting failure探测度探测度Detection Rating(D)，探测度评分(D)9-10very remote chance this control will detect the cause or failure查

50、明失效或其原因的可能性极小7-8remote chance，可能性很小5-6moderate to low chance，可能性不大2-4moderately to very high chance，可能性较大1almost certainly(if the part passes this test,its OK to ship)几乎都可以查到(如能通过这项检测，则可放心发货)PFMEA2020/3/23Detection(D)CriteriaInspectionTypesSuggested Range of Detection MethodsABCAlmost ImpossibleAbso