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1、2023/3/5,Process Failure Mode and Effects Analysis过程失效模式及后果分析(PFMEA)PFMEAPFMEA,陶 国,2023/3/5,Proprietary Information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 consulting your management.FMEA
2、(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。,2023/3/5,Forms and Formats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 approval to use an alternate format
3、.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。,2023/3/5,Process FMEA过程FMEA,何谓PFMEA何时作PFMEA何人作PFMEA如何作PFMEA16步工作步骤,2023/3/5,Process FMEA过程FMEA,何谓PFMEA何时作PFMEA何人作PFMEA如何作PFMEA16步工作步骤,2023/3/5,Process FMEA过程FMEA,an analytical tool used by a process design team to identify potential product failures cause
4、d 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。,2023/3/5,formal process正式程序customer focused着眼于顾客uses engineering judgment,and hard data where it is available利用工程经验判断和可靠
5、的数据,Process FMEA过程FMEA,2023/3/5,PFMEA is focussed on the Product PFMEA 关注对产品的影响,Process FMEA过程FMEA,2023/3/5,Process FMEA过程FMEA,何谓PFMEA何时作PFMEA何人作PFMEA如何作PFMEA16步工作步骤,2023/3/5,When 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
6、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,2023/3/5,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？,2023/3/5,It is derived from a DFMEA在DFMEA之后进
7、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PFMEAIt should 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？,2023/3/5,Do a PFMEA(or at least review the
8、 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 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？,2023/3/5,Do a PFMEA(or at least review th
9、e 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？,2023/3/5,Process FMEA过程FMEA,何谓PFMEA何时作PFMEA何人作PFMEA如何作PFMEA16步工作步骤,2023/3/5,Who performs a PFMEA?由谁
10、进行PFMEA？,A cross-functional team should be used由跨部门小组进行The leader should be the process-responsible engineer小组组长应是过程设计责任工程师,2023/3/5,Cross-Functional Team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
11、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Supplier of product and machinery，零件和设备供应商Representatives from the next process,后续工序代表,2023/3/5,Process FMEA过程FMEA,何谓PFMEA何时作PFMEA何人作PFMEA如何作PFMEA16步工作步骤,2023/3/5,How do we do a PFMEA?A Summary怎样进行PFMEA？提要,Assemble the cross-functi
12、onal PFMEA team组建跨部门PFMEA小组List the failure modes,their effects,and their causes列出失效模式，后果以及原因,2023/3/5,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 d
13、o a PFMEA?A Summary怎样进行PFMEA？提要,2023/3/5,Calculate 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RPN,How do we
14、do a PFMEA?A Summary怎样进行PFMEA？提要,2023/3/5,How 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
15、 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,2023/3/5,Process FMEA过程FMEA,何谓PFMEA何时作PFMEA何人作PFMEA如何作PFMEA16步工作步骤,2023/3/5,1.Assemble a team and plan your activities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：indivi
16、dual efforts produce 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,2023/3/5,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
17、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,2023/3/5,2.Develop a process flow diagram 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,2023/3/5,Supplier_Date_Part Num
18、ber_Revision Level_Part Description_Prepared by_,pressure,2.Develop a process flow diagram 绘制过程流程图,2023/3/5,过程流程图,2023/3/5,2023/3/5,3.List the function(s)of each operation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用 State the function as，说明功能为：Verb+Object+Qualifier 动词+宾语+修饰词 mold par
19、t，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,2023/3/5,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,2023/3/5,4.List the quality requirements列出质量要求,a customer want or desire顾客的希望或要求could seriou
20、sly 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,2023/3/5,5.List the potential process failure modes 列出可能的过程失效模式,a 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、
21、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,2023/3/5,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
22、failure modes 列出可能的过程失效模式,2023/3/5,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,2023/3/5,6.Derive the potential effects of each failure 列出每一失效模式的所有可能
23、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 government regulation，法规the next process step，下序,2023/3/5,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 eac
24、h failure 列出每一失效模式的所有可能后果,2023/3/5,An effect can be，后果可能为 complete loss of function，功能完全丧失 degradation of performance or 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,2023/3/5,E
25、ffects 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
26、,6.Derive the potential effects of each failure 列出每一失效模式的所有可能后果,2023/3/5,Effects 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 severity of e
27、ach effect评估每种后果的严重度,2023/3/5,2023/3/5,8.Determine potential cause(s)of each failure mode 确定每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
28、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,2023/3/5,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 record
29、ed 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 develop可利用树形图或鱼刺图,8.Cause(s)of Failure失效原因,2023/3/5,9.Assess the likelihood of occurrence of each cause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
30、and comparison with similar processes利用可靠性模型，与类似的过程进行比较,2023/3/5,9-10Failure 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
31、,9.Assess the likelihood of occurrence of each cause评估每种失效原因产生的可能性,2023/3/5,2023/3/5,Causes and EffectsHarness Clamp,Cause-and-effect chain,tool is worn,tool notreplaced,lack of maintenance procedure,clamp cracksat bend,bundle falls out,rattling noise,CAUSE chain,EFFECT chain,2023/3/5,Causes and Eff
32、ectsWiring Assembly,Effects Tree,Crossed Wire,Nofunction,Fire in Plant,OperatorInjury,DamagedEquip.,Must repair vehicle,2023/3/5,Causes and EffectsWiring Assembly,Causes Tree,Crossed Wire,BoardError,OperatorError,PoorInstruct.,Nottrained,Oper istired,2023/3/5,10.List the Current Process Controls列出现有
33、过程控制,Process 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!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
34、因并找出纠正措施(3)detect the failure mode(s)，检测失效模式,2023/3/5,Assign 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
35、,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,write“None”，若没有，则填“无”。,10.List the Current Process Controls列出现有过程控制,2023/3/5,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
36、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!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,2023/3/5,11.Detecting failure探测度,Detection Rating(D)，探测度评分(D)9-10very remote chance this c
37、ontrol will detect the cause or failure查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),2023/3/5,2023/3/5,12.Calculate the Risk Priority Number(RPN)计算风险顺序数
38、(RPN),RPN=S x O x D=Severity of Effect x Occurrence Rating x Detection Rating=后果的严重度 x 原因可能出现的频度x 探测度Focus on high RPNs关注RPN较高的项目,2023/3/5,Recommended Corrective Action推荐的纠正措施,Aim for PREVENTION rather than detection以预防而非探测为目的Begin with the highest RPN items,从RPN高的项目开始dont set an a priori“cut-off”va
39、lue(i.e.prior to beginning the FMEA)，勿预先设定“分数线”Give serious attention to items with Severity=9 or 10严重度9或10时应特别注意,2023/3/5,What corrective action,if any,should be taken to reduce the，应采取哪些措施以降低 severity(probably need a design change),严重度（可能需修改产品设计）likelihood of occurrence,频度detection rating，探测度?You
40、dont recommend corrective action?Low RPN?你不建议采取纠正措施吗？RPN较低？Dont leave the space on the form blank.Write None不要在表上留下空格不填。应填写“无”,Recommended Corrective Action推荐的纠正措施,2023/3/5,14.Responsibility and Target Dates职责和预定日期,FMEA is action-oriented，FMEA以采取措施为宗旨 Responsibility must be assigned and recorded,wit
41、h dates，确定并记录职责及日期Assign to the person or group best suited for implementation 指定最适合履行职责的个人或小组Person or group assigned should have been on FMEA team被指定的个人或小组应在FMEA小组内工作过,2023/3/5,15.Corrective Action(s)Taken已采取的纠正措施,Recorded on the form，记入表内以便to track progress 追踪进展情况to document due care 说明“应有的注意”Com
42、pletion date and a brief description完成日期和简要说明,2023/3/5,16.Recalculation of RPN重新估计RPN,Evaluate the proposed corrective action评价建议采取的纠正措施Then re-estimate 然后重新评估severity,严重度occurrence,频度detection，探测度,2023/3/5,Recalculate the RPN，重新估计RPNVerify improvement with supporting data!利用支持数据确认改进措施Consequences，结果：May reprioritize the failures有可能对失效重新排序May lead to further corrective actions有可能需要进一步改进,16.Recalculation of RPN重新估计RPN,
