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1、PFMEA,2020/3/23,Process Failure Mode and,Effects Analysis,过程失效模式及后果分析,(PFMEA),PFMEA,PFMEA,陶,国,PFMEA,2020/3/23,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
2、 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。,PFMEA,2020/3/23,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 wri
3、tten 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，才能采用其它格式。,PFMEA,2020/3/23,Process 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,PFMEA,2020/3/23,Process 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,PFMEA,2020/3/23,Process
4、 FMEA,过程,FMEA,?,an analytical tool used by a process design,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。,PFMEA,20
5、20/3/23,?,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的数据,Process FMEA,过程,FMEA,PFMEA,2020/3/23,?,PFMEA is focussed on the,Product,PFMEA,关注对,产品,的影响,PFMEA is,focuss,ed on the PRODUCT.,Namely,how the PROCESS can cause,flaws,or
6、v,ariation in the PRODUCT.,Process FMEA,过程,FMEA,PFMEA,2020/3/23,Process 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,PFMEA,2020/3/23,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及工艺设计时！,?,
7、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,PFMEA,2020/3/23,?,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,？,PFMEA,2020/3/23,?,It is deriv
8、ed from a DFMEA,在,DFMEA,之后进行,?,Any DFMEA forms and supporting documents shoud be,brought to the PFMEA meetings,DFMEA,表单和所有相关文件都应带入,PFMEA,?,It 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,？,
9、PFMEA,2020/3/23,Do 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 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
10、 a PFMEA?,何时进行,PFMEA,？,PFMEA,2020/3/23,Do 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、业务环境或法律环境发生变化,PPAP conditions apply,需提交,PPAP,actual failures occur,发生实际失效,When do we do a PFMEA?,何时进行,PFMFA,？,PFMEA,2020/3/
11、23,Process 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,PFMEA,2020/3/23,Who 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-,responsible engineer,小组组长应是过程设计责任工程师,PFMEA,2020/3/23,Cross-Functional Team,跨部门小组,
12、?,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,?,Supplier of product and machinery,，零件和设备供应商,?,Repres
13、entatives from the next process,后续工序代表,PFMEA,2020/3/23,Process 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,PFMEA,2020/3/23,How 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 effects,and th
14、eir,causes,列出失效模式，后果以及原因,PFMEA,2020/3/23,?,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,PFMEA,2020
15、/3/23,?,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 do a PFMEA?,A Summa
16、ry,怎样进行,PFMEA,？提要,PFMEA,2020/3/23,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
17、 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,PFMEA,2020/3/23,Process 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,PFMEA,2020/3/23,1.Assemble a team and,plan your activities,成立小组并制订计划,?,PFMEA must never be done
18、by an individual,because,绝不能由个人单独进行,PFMEA,，因为：,?,individual 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,PFMEA,2020/3/23,?,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,?,
19、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,FMEA,表格,1.Assemble a team and,plan your activities,成立小组并制订计划,PFMEA,2020/3/23,2.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 in
20、spect,operations,辨别四种作业类型,?,identifies Key Characteristics,辨别关键特性,PFMEA,2020/3/23,Supplier_,Date_,Part Number_,Revision Level_,Part Description_,Prepared by_,pressure,mold part,fab,move,store,insp,step,oper.descr.,item#,KPC,item#,KCC,inspect part,for flash,store part in,container,carry parts,to assy
21、 area,1,no flash,1,1,2,3,4,2.Develop a process flow diagram,绘制过程流程图,PFMEA,2020/3/23,过程流程图,mold part,注塑零部件,fab,加工,move,搬运,store,存放,insp,检验,step,步骤,oper,.,descr,.,作业说明,item,#,编号,KPC,item,#,编号,KCC,inspect part,for 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,1,no
22、 flash,无飞边,pressure,压力,1,1,2,3,4,PFMEA,2020/3/23,PFMEA,2020/3/23,3.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 part,，零件成型,crimp terminal onto cable,在线端压接端子,form bend in
23、part,零件弯曲成型,examples,例如,PFMEA,2020/3/23,?,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,PFMEA,2020/3/23,4.List the quality,requirements,列出质量要求,?,a customer want or desire,顾客的希望或要求,?,could seriously affect customer percepti
24、on,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,PFMEA,2020/3/23,5.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、瑕疵等不,良状态,?,fail
25、ure modes should be written in terms of the,condition of the product,失效模式体现在产品上,PFMEA,2020/3/23,?,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,，
26、飞边,5.List the potential process,failure modes,列出可能的过程失效模式,PFMEA,2020/3/23,?,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,PFMEA,2020/3/23,6.De
27、rive the potential effects,of each failure,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 government regulation,，法规,?,the next process step,，下序,PFMEA,2020/3/23,?,Customer complaints
28、 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,PFMEA,2020/3/23,?,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 operato
29、r,，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,PFMEA,2020/3/23,?,Effects 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
30、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,PFMEA,2020/3/23,Effects on the process,，对过程的影响,:,?,9-10,may endanger machine or operator,，,可能导致设备或人
31、员受损,?,6-8,scrap,，报废,?,4-5,sort and rework,，检验、返工,?,2-3,rework on-line,，线上返工,?,1,no 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 each effect,评估每种后果的严重度,PFMEA,2020/3/23,Criteria:Severity of Effect,This ranking results when a potential failure mode results i
32、n 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 sev,Hazardous-without warning,10,Very high severity ranking when a potential failure mode affects safe,vehicle operation and/or involves nonco
33、mpliance with government,regulation without warning.,Or may endanger operator(machine or assembly)without warning.,Hazardous-with warning,9,Very high severity ranking when a potential failure mode affects safe,vehicle operation and/or involves noncompliance with government,regulation with warning.,O
34、r may endanger operator(machine or assembly)with warning.,Very High,8,Vehicle/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.,High,7,Vehicle/item operable but at a reduced lev
35、el 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.,Moderate,6,Vehicle/item operable but Comfort/Convenience item(s)inoperable.,Custo
36、mer 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.,Low,5,Vehicle/item operable but Comfort/Convenience item(s)operable at,reduced level of performance.,Or 100%of
37、product may have to be reworked,or vehicle/item repaired off-line,but does not go to repair department.,Very Low,4,Fit&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 portion(less than,100%)rework
38、ed.,Minor,3,Fit&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 Minor,2,Fit&Finish/Squeak&Rattle item does not conform.Defect noticed by,discriminating cust
39、omers(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.,None,1,No discernible effect.,Or slight incovenience to operation or operator,or no effect.,PFMEA,2020/3/23,8.Determine potential,cause(s)of each failure mode,确定每一失效模式的可能原因,
40、?,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
41、素间的相互作用,PFMEA,2020/3/23,?,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 di
42、agram to develop,可利用树形图或鱼刺图,8.Cause(s)of Failure,失效原因,PFMEA,2020/3/23,9.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 and comparison with similar,processes,利用可靠性模型，与类似的
43、过程进行比较,PFMEA,2020/3/23,9-10,Failure almost inevitable,，失效几乎不可避免,7-8,Similar processes that have often failed in,the past,，以前类似过程常常失效,4-6,Similar processes that have occasional,failures,，类似过程偶尔失效,1-3,Similar processes that have experienced,isolated failures,，类似过程仅有过个别失效,9.Assess the likelihood of,occ
44、urrence of each cause,评估每种失效原因产生的可能性,PFMEA,2020/3/23,Occurence(O),Probability,Likely Failure Rates*,Very High:,Persistent Failures,=100 per,thousand pieces,Very High:,Persistent Failures,50 per thousand pieces,High:,Frequent Failures,20 per thousand pieces,High:,Frequent Failures,10 per thousand pie
45、ces,Moderate:,Occasional Failures,5 per thousand pieces,Moderate:,Occasional Failures,2 per thousand pieces,Moderate:,Occasional Failures,1 per thousand pieces,Low:Relatively,Few Failures,0.5 per thousand pieces,Low:Relatively,Few Failures,0.1 per thousand pieces,Remote:Failure,is Unlikely,=0.010 pe
46、r thousand,pieces,10,9,8,7,6,5,4,3,2,1,PFMEA,2020/3/23,Causes and Effects,Harness Clamp,Cause-and-effect chain,radius out,of spec,tool is,worn,tool not,replaced,lack of,maintenance,procedure,clamp,cracks,at bend,bundle,falls out,rattling,noise,CAUSE chain,EFFECT chain,PFMEA,2020/3/23,Causes and Effe
47、cts,Wiring Assembly,Effects Tree,Crossed,Wire,No,function,Fire in,Plant,Operator,Injury,Damaged,Equip.,Must,repair vehicle,PFMEA,2020/3/23,Causes and Effects,Wiring Assembly,Causes Tree,Crossed,Wire,Board,Error,Operator,Error,Poor,Instruct.,Not,trained,Oper is,tired,PFMEA,2020/3/23,10.List the Curre
48、nt Process Controls,列出现有过程控制,?,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
49、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,PFMEA,2020/3/23,?,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
50、,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,write“None”,，若没有，则填“无”。,10.List the Current Process Controls,列出现有过程控制,PFMEA,2020/3/23,?,Detection is an assessment of the probability,that,，探测度为下列事件发生的概率,?,a ty
