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1、过程失效模式及后果过程失效模式及后果分析分析(PFMEA)(ppt)中中英文英文PFMEAProprietary Information专有信息专有信息wYour FMEA(Control Plan,Process Capability,etc.)may be considered proprietary and should not be shared with anyone outside the division without first consulting 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
2、的任何人透露。Ethis includes the sharing of information with your customer也不得向顾客透露有关信息。PFMEAForms and Formats形式和格式形式和格式wYour customer might have a specific format or form that they require.If so,you will need to get their written approval 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
3、式。PFMEAProcess FMEA过程过程FMEAw何谓PFMEAw何时作PFMEAw何人作PFMEAw如何作PFMEAw16步工作步骤PFMEAProcess FMEA过程过程FMEAw何谓何谓PFMEAPFMEAw何时作PFMEAw何人作PFMEAw如何作PFMEAw16步工作步骤PFMEAProcess FMEA过程过程FMEAwan analytical tool used by a process design team to identify potential product failures caused by failure of the manufacturing an
4、d 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。PFMEAwformal process正式程序wcustomer focused着眼于顾客wuses engineering 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FMEAPFMEAwPFMEA is
5、focussed on the Product PFMEA 关注对产品的影响Process FMEA过程过程FMEAPFMEAProcess FMEA过程过程FMEAw何谓PFMEAw何时作何时作PFMEAPFMEAw何人作PFMEAw如何作PFMEAw16步工作步骤PFMEAWhen do we do a PFMEA?何时进行何时进行PFMEA？wWhile 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！wA PFMEA done solely to f
6、ill 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PFMEAwPFMEA 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?何时进行何时进行PFMEA？PFMEAwIt is derived from a DFMEA在DFMEA之后进行EAny DFMEA forms and supporting doc
7、uments shoud be brought to the PFMEA meetingsDFMEA表单和所有相关文件都应带入PFMEAwIt should be a natural part of concept development 应成为过程设计的一个必要组成部分wPFMEA is never“finished”.it is a living document 是动态文件When do we do a PFMEA?何时进行何时进行PFMEA？PFMEADo a PFMEA(or at least review the old one)if:Do a PFMEA(or at least
8、review the old one)if:以下情况需进行以下情况需进行以下情况需进行以下情况需进行PFMEA(PFMEA(或至少评审过去的或至少评审过去的或至少评审过去的或至少评审过去的PFMEA)PFMEA)：+the process is newthe process is new 是新的过程是新的过程是新的过程是新的过程+the product is new,or has never been made with this the product is new,or has never been made with this processprocess新产品，或从未用本过程加工的产品
9、新产品，或从未用本过程加工的产品新产品，或从未用本过程加工的产品新产品，或从未用本过程加工的产品+an existing process changesan existing process changes原有的过程发生变化原有的过程发生变化原有的过程发生变化原有的过程发生变化+customer requirements or desires changecustomer requirements or desires change顾客要求或希望发生变化顾客要求或希望发生变化顾客要求或希望发生变化顾客要求或希望发生变化When do we do a PFMEA?何时进行何时进行PFMEA？PF
10、MEADo a PFMEA(or at least review the old one)if:Do a PFMEA(or at least review the old one)if:以下情况需进行以下情况需进行以下情况需进行以下情况需进行PFMEA(PFMEA(或至少评审过去的或至少评审过去的或至少评审过去的或至少评审过去的PFMEA)PFMEA)：+the competitive,business,or legal environment changesthe competitive,business,or legal environment changes竞争环境、业务环境或法律环境发
11、生变化竞争环境、业务环境或法律环境发生变化竞争环境、业务环境或法律环境发生变化竞争环境、业务环境或法律环境发生变化+PPAP conditions applyPPAP conditions apply需提交需提交需提交需提交PPAPPPAP+actual failures occuractual failures occur发生实际失效发生实际失效发生实际失效发生实际失效When do we do a PFMEA?何时进行何时进行PFMFA？PFMEAProcess FMEA过程过程FMEAw何谓PFMEAw何时作PFMEAw何人作何人作PFMEAPFMEAw如何作PFMEAw16步工作步骤P
12、FMEAWho performs a PFMEA?由谁进行由谁进行PFMEA？wA cross-functional team should be used由跨部门小组进行wThe leader should be the process-responsible engineer小组组长应是过程设计责任工程师PFMEACross-Functional Team跨部门小组跨部门小组w5-9 people from，5-9人，由从事如下工作的人员组成 EDesign，设计 EAssembly，装配Emanufacturing(operators,supervisors)，制造(操作工，班组长)EI
13、ndustrial,mfg.And tool engineering，工业工程，工艺及工装设计Equality，质量管理Ematerials engineering，材料工程EService personnel，机修ESupplier of product and machinery，零件和设备供应商ERepresentatives from the next process,后续工序代表PFMEAProcess FMEA过程过程FMEAw何谓PFMEAw何时作PFMEAw何人作PFMEAw如何作如何作PFMEAPFMEAw16步工作步骤PFMEAHow do we do a PFMEA?A
14、Summary怎样进行怎样进行PFMEA？提要？提要wAssemble the cross-functional PFMEA team组建跨部门PFMEA小组wList the failure modes,their effects,and their causes列出失效模式，后果以及原因PFMEAwAssess，评估 Ethe severity of the effect(S)后果的严重程度Ethe likelihood of the causes(O)原因出现的可能性Eand the ability of process controls to detect failure modes
15、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怎样进行怎样进行PFMEA？提要？提要PFMEAwCalculate 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wPlan corrective actions and assign owner制订纠正措施并落实责任人wPerform corrective actions to improve the product or p
16、rocess,采取纠正措施以提高产品和过程质量wRecalculate RPN重新估算RPNHow do we do a PFMEA?A Summary怎样进行怎样进行PFMEA？提要？提要PFMEAHow do we do a PFMEA?A Suggestion怎样进行怎样进行PFMEA？建议？建议wDo 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Euse
17、 fishbone and tree diagrams liberally 充分利用鱼刺图和树形图Etrying to use the FMEA form as a worksheet leads to confusion 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PFMEAProcess FMEA过程过程FMEAw何谓PFMEAw何时作PFMEAw何人作PFMEAw如何作PFMEAw1616步工作步骤步工作步骤PFMEA1.Assemble a team and plan your activities成立小组并制订计划成立小组并制
18、订计划wPFMEA must never be done by an individual,because 绝不能由个人单独进行PFMEA，因为：Eindividual efforts produce biased results,由个人进行会使结果出现偏差Eany 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PFMEAwOne 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
19、EBe 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FMEA表格1.Assemble a team and plan your activities成立小组并制订计划成立小组并制订计划PFMEA2.Develop a process flow diagram 绘制过程流程图绘制过程流程图wUse the Process Flow Diagram format 运用正规的过程流程图Eidentifies fabricate,move,store and inspec
20、t operations 辨别四种作业类型Eidentifies Key Characteristics辨别关键特性PFMEA Supplier_Date_Part Number_Revision Level_Part Description_ Prepared by_pressuremold partfabmove store inspstepoper.descr.item#KPCitem#KCCinspect partfor flashstore part in containercarry parts to assy area1no flash112342.Develop a proce
21、ss flow diagram 绘制过程流程图绘制过程流程图PFMEA过程流程图过程流程图过程流程图过程流程图mold part注塑零部件注塑零部件fab加工加工move搬运搬运store存放存放insp检验检验step步骤步骤oper.descr.作业说明作业说明item#编号编号KPCitem#编号编号KCCinspect partfor flash检验零件有无飞边检验零件有无飞边store part in container将零部件放入周转箱内将零部件放入周转箱内carry parts to assy area将零部件送往装配区将零部件送往装配区1no flash无飞边无飞边pressu
22、re压力压力11234PFMEAPFMEA3.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wA function is what the operation does 功能系指该操作所起的作用 wState the function as，说明功能为：Verb+Object+Qualifier Verb+Object+Qualifier 动词动词+宾语宾语+修饰词修饰词 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example
23、s例如PFMEAwDont 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PFMEA4.List the quality requirements列出质量要求列出质量要求wa customer want or desire顾客的希望或要求wcould seriously affect customer perception有可能严重影响顾客的看法 wcould lead to a custome
24、r complaint 有可能导致顾客投诉PFMEA5.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wa defect,flaw,or other unsatisfactory condition 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Efailure modes should be written in terms of the cond
25、ition of the product失效模式体现在产品上PFMEAwTypical Failure Modes，几种典型失效模式Ediameter out of spec.，直径超差Emissing seal，漏装密封垫Ecut strands，切破线皮Emisoriented part，部件方向错Einsufficient solder，焊剂不足Etoo much solder，焊剂过量ENFO，未充满EFlash，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PFMEAwNote，注 EAssume
26、 that incoming product and materials are correct假设来料没问题EAssume that the product as designed will meet requirements假设产品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列出可能的过程失效模式PFMEA6.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wThe ramifications of fai
27、lure后果是失效模式的衍生事件 wThe effect can be on，可能影响Ethe ultimate customer，最终用户Eor intermediate customer(OEM,etc.)，中间用户Ea government regulation，法规Ethe next process step，下序PFMEAwCustomer 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
28、每一失效模式的所有可能后果PFMEAwAn effect can be，后果可能为 Ecomplete loss of function，功能完全丧失 Edegradation of performance or quality，质量或性能降低Edamage of process equipment，设备受损Einjury to an operator，员工受伤Eshut-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PFMEAwEf
29、fects of failure often show up as a chain of events,from immediate effect to the ultimate effect 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wIt 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Euse a tree diagram运用树形
30、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PFMEAEffects on the process，对过程的影响:w9-10may endanger machine or operator，可能导致设备或人员受损w6-8scrap，报废w4-5sort and rework，检验、返工w2-3rework on-line，线上返工w1no effect，无影响consider also the effects on the customerconsider also the effe
31、cts on the customer还要考虑对顾客的影响还要考虑对顾客的影响7.Assess the severity of each effect评估每种后果的严重度评估每种后果的严重度PFMEACriteria:Severity of EffectThis 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 fi
32、rst.If both occur,use the higher of the two sevHazardous-without warning10Very high severity ranking when a potential failure mode affects safe vehicle operation and/or involves noncompliance with government regulation without warning.Or may endanger operator(machine or assembly)without warning.Haza
33、rdous-with warning9Very high severity ranking when a potential failure mode affects safe vehicle operation and/or involves noncompliance with government regulation with warning.Or may endanger operator(machine or assembly)with warning.Very High8Vehicle/item inoperable(loss of primary function).Or 10
34、0%of product may have to be scrapped,or vehicle/item repaired in repair department with a repair time greater than one hour.High7Vehicle/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/it
35、em repaired in repair department with a repair time between a half-hour and an one hour.Moderate6Vehicle/item operable but Comfort/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
36、 department with a repair time less than a half-hour.Low5Vehicle/item operable but Comfort/Convenience item(s)operable at reduced level 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 it
37、em does not conform.Defect noticed by most customers(greater than 75%).Or the product may have to be sorted,with no scrap,and a portion(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 t
38、o be reworked,with no scrap,on-line but out-of-station.Very Minor2Fit&Finish/Squeak&Rattle item does not conform.Defect noticed by 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 effec
39、t.Or slight incovenience to operation or operator,or no effect.PFMEA8.Determine potential cause(s)of each failure mode 确定每一失效模式的可能原因确定每一失效模式的可能原因wA cause of failure is how the failure can occur in the process，失效原因：过程为何会失效EShould be written in terms of something in the process that can be corrected a
40、nd controlledcorrected and controlled，应表述为可纠正或可控制可纠正或可控制可纠正或可控制可纠正或可控制的因素EConsider 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的相互作用PFMEAwCauses 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
41、根本原因wIt 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Euse a tree or fishbone diagram to develop可利用树形图或鱼刺图8.Cause(s)of Failure失效原因失效原因PFMEA9.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wUse h
42、istorical data(as a baseline)，利用历史资料ETake improvements into account，并考虑所作的改进 wUse statistical models and comparison with similar processes利用可靠性模型，与类似的过程进行比较PFMEA9-10 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 occ
43、asional 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评估每种失效原因产生的可能性评估每种失效原因产生的可能性PFMEAOccurence(O)ProbabilityLikely Failure Rates*Very High:Persistent Failures=100 per thousand piecesVery High:Persistent F
44、ailures50 per thousand piecesHigh:Frequent Failures20 per thousand piecesHigh:Frequent Failures10 per thousand piecesModerate:Occasional Failures5 per thousand piecesModerate:Occasional Failures2 per thousand piecesModerate:Occasional Failures1 per thousand piecesLow:Relatively Few Failures0.5 per t
45、housand piecesLow:Relatively Few Failures0.1 per thousand piecesRemote:Failure is Unlikely=0.010 per thousand pieces10987654321PFMEACauses and EffectsHarness ClampCause-and-effect chainradius out of spectool is worntool notreplacedlack of maintenance procedureclamp cracksat bendbundle falls outrattl
46、ing noiseCAUSE chainEFFECT chainPFMEACauses and EffectsWiring AssemblyEffects TreeCrossed WireNofunctionFire in PlantOperatorInjuryDamagedEquip.Must repair vehiclePFMEACauses and EffectsWiring AssemblyCauses TreeCrossed WireBoardErrorOperatorErrorPoorInstruct.NottrainedOper istiredPFMEA10.List the C
47、urrent Process Controls列出现有过程控制列出现有过程控制wProcess controls catch the defect before the product reaches the customer，过程控制当在产品到达顾客前发现缺陷!wThere 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 a
48、nd 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PFMEAwAssign currently 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EUsed on similar processes in the past，以前类似过程如何控制ECan be of any Type:1,2,or 3,or any combination，可以是1、2、3类或其组合EType 1 controls
49、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EIf none,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PFMEAwDetection is an assessment of the probability that，探测度为下列事件发生的概率Ea type 2 control can detect the cause and lead to corre
50、ctive action,第2类控制能够发现原因并找到纠正措施Ea 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.before the product reaches the customer!Edetection 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PFMEA11.Detecting failure探测度探测度Detection Rating