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1、Failure Modes and Effects Analysis失效模式和影响分析FMEA,学习目标,你将能够:定义“FMEA”理解 FMEA 过程及其和其它质量工具的联系理解失效模式、原因和影响之间的关系能够建立一个FMEA 和相关的行动计划描述 FMEA带来的好处,什么是 FMEA 工具?,用来改进质量的非统计工具,该工具可以用于任何地方,任何“系统”或“过程”！设计、制造、装配、书面工作和管理等等。,故障,哪个项目?,什么是 FMEA?,一种系统方法,用来:识别、分析、排序和记录潜在失效模式确定失效模式对系统、产品和过程的影响确定故障的可能原因确定可以减少风险的行动,FMEA-Exc
2、el 表格,控制图,1,0,2,3,4,0,1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,21,特殊原因,SPC 方法:在特殊原因出现时识别出来并消除。,可靠性方法：在故障发生之前识别主要的失效模式并消除。,使用FEMA的好处,提高产品的质量、产品的可靠性和安全性。帮助增加客户满意度。减少产品开发时间和成本。减少返工、维修和报废的数量。记录并跟踪为减少风险而采取的行动。优先考虑各缺点，关注改进努力。,FMEA的进入层次,过程 层次#1,FMEA 层次#1,FMEA-层次#2,FMEA-层次#3,过程-层次#2,FMEA的类型,设计/产品过
3、程缺陷系统服务项目软件,谁来完成FMEA?,跨功能团队!,过程FMEA 步骤,定义功能,识别潜在的失效模式,描述故障影响,描述产品或过程,步骤 1,步骤 2,步骤 3,步骤 4,确定故障原因,步骤 5,探测方法,步骤 6,计算风险,步骤 7,采取行动,步骤 8,评估结果,步骤 9,部件/产品名称和编号.:,部件/产品所有人:,准备人,过程名称:,过程所有人:,FMEA 日期(原来):(修正.),涉及到的其它方面:,部件/,过程,失效模式,故障影响,S,E,V,原因,O,C,C,控制,D,E,T,R,P,N,行动,计划,p,S,p,O,p,D,p,r,p,n,0,0,0,0,0,0,0,0,0,
4、0,过程流程图用图说明的过程流过程描述表报废&返工 数据内部问题数据客户反馈保证声明,过程知识,步骤 1:描述过程,部件/产品名称和编号.:.:,部件/产品所有人:,准备人,过程名称:,过程所有人:,FMEA 日期(原来):(修正.).),涉及到的其它方面:,部件/,过程,失效模式,故障影响,S,E,V,原因,O,C,C,控制,D,E,T,R,P,N,行动,计划,p,S,p,O,p,D,p,r,p,n,0,0,0,0,0,0,0,0,0,0,步骤 2:定义功能,功能(目的)列表,2,过程流程图,产品规格,步骤 3:识别潜在的失效模式,潜在故障模式列表,Part/Product Name and
5、 No.:,Part/Product Owner:,Prepared By:,Process Name:,Process Owner:,FMEA Date(Orig):(Rev.),Other Areas Involved:,Part/,Process,Failure Mode,Failure Effects,S,E,V,Causes,O,C,C,Controls,D,E,T,R,P,N,Actions,Plans,p,S,p,O,p,D,p,r,p,n,0,0,0,0,0,0,0,0,0,0,3,描述哪些方面可能出现问题,功能是如何实现的呢?,功能,哪些方面可能出现问题?,Part/Prod
6、uct Name and No.:,Part/Product Owner:,Prepared By:,Process Name:,Process Owner:,FMEA Date(Orig):(Rev.),Other Areas Involved:,Part/,Process,Failure Mode,Failure Effects,S,E,V,Causes,O,C,C,Controls,D,E,T,R,P,N,Actions,Plans,p,S,p,O,p,D,p,r,p,n,0,0,0,0,0,0,0,0,0,0,步骤 4a:描述故障影响,故障如何影响功能故障如何影响其它系统、功能、部件等
7、等故障如何影响客户感受除了我们自己的产品外，还有什么影响呢立即的和延迟的影响性能降低所有的故障都必须至少有一种影响,列出故障影响,4a,评定严重性等级,就客户可能注意哪些方面而言:,Part/Product Name and No.:,Part/Product Owner:,Prepared By:,Process Name:,Process Owner:,FMEA Date(Orig):(Rev.),Other Areas Involved:,Part/,Process,Failure Mode,Failure Effects,S,E,V,Causes,O,C,C,Controls,D,E,
8、T,R,P,N,Actions,Plans,p,S,p,O,p,D,p,r,p,n,0,0,0,0,0,0,0,0,0,0,步骤 4b:评定故障严重性等级,4b,评定严重性等级,Part/Product Name and No.:,Part/Product Owner:,Prepared By:,Process Name:,Process Owner:,FMEA Date(Orig):(Rev.),Other Areas Involved:,Part/,Process,Failure Mode,Failure Effects,S,E,V,Causes,O,C,C,Controls,D,E,T,
9、R,P,N,Actions,Plans,p,S,p,O,p,D,p,r,p,n,0,0,0,0,0,0,0,0,0,0,步骤 5a:确定原因,列出故障可能的原因,故障发生的概率,因果关系图,缺点树分析(FTA),Part/Product Name and No.:,Part/Product Owner:,Prepared By:,Process Name:,Process Owner:,FMEA Date(Orig):(Rev.),Other Areas Involved:,Part/,Process,Failure Mode,Failure Effects,S,E,V,Causes,O,C,
10、C,Controls,D,E,T,R,P,N,Actions,Plans,p,S,p,O,p,D,p,r,p,n,0,0,0,0,0,0,0,0,0,0,步骤 5b:评定故障发生的概率,发生,高故障发生概率,中等故障发生概率,低故障发生概率,得分,类别,5(坏),4,3,2,1(好),所列出的原因导致的失效模式发生概率,使用实际的缺陷数据,Part/Product Name and No.:,Part/Product Owner:,Prepared By:,Process Name:,Process Owner:,FMEA Date(Orig):(Rev.),Other Areas Invol
11、ved:,Part/,Process,Failure Mode,Failure Effects,S,E,V,Causes,O,C,C,Controls,D,E,T,R,P,N,Actions,Plans,p,S,p,O,p,D,p,r,p,n,0,0,0,0,0,0,0,0,0,0,步骤 6a:探测/验证 方法,确定控制,评定探测等级,识别验证方法（控制）以证实故障的存在。,计算机数学建模 原型试验 警报 试验 检验,Part/Product Name and No.:,Part/Product Owner:,Prepared By:,Process Name:,Process Owner:,
12、FMEA Date(Orig):(Rev.),Other Areas Involved:,Part/,Process,Failure Mode,Failure Effects,S,E,V,Causes,O,C,C,Controls,D,E,T,R,P,N,Actions,Plans,p,S,p,O,p,D,p,r,p,n,0,0,0,0,0,0,0,0,0,0,步骤 6b:评定探测登记,探测,产品到达“客户”手中发现故障的探测概率低,产品到达“客户”手中发现故障的探测概率中等,产品到达“客户”手中发现故障的探测概率高,得分,类别,5(坏),4,3,2,1(好),评定探测等级,在产品到达“客户”
13、之前通过控制，发现故障的概率,步骤 7:计算风险,Part/Product Name and No.:,Part/Product Owner:,Prepared By:,Process Name:,Process Owner:,FMEA Date(Orig):(Rev.),Other Areas Involved:,Part/,Process,Failure Mode,Failure Effects,S,E,V,Causes,O,C,C,Controls,D,E,T,R,P,N,Actions,Plans,p,S,p,O,p,D,p,r,p,n,0,0,0,0,0,0,0,0,0,0,风险优先
14、数（RPN),严重性等级,故障发生概率等级,X,X,=,Part/Product Name and No.:,Part/Product Owner:,Prepared By:,Process Name:,Process Owner:,FMEA Date(Orig):(Rev.),Other Areas Involved:,Part/,Process,Failure Mode,Failure Effects,S,E,V,Causes,O,C,C,Controls,D,E,T,R,P,N,Actions,Plans,p,S,p,O,p,D,p,r,p,n,0,0,0,0,0,0,实行纠正措施,步骤
15、 8:采取行动,一般设计确认过程(没有采取特殊行动),“回到画图板”,能够减少发生等级吗?,能够减少严重性等级吗?,能够减少探测等级吗?,高风险?,否,是,否,是,是,是,否,否,Part/Product Name and No.:,Part/Product Owner:,Prepared By:,Process Name:,Process Owner:,FMEA Date(Orig):(Rev.),Other Areas Involved:,Part/,Process,Failure Mode,Failure Effects,S,E,V,Causes,O,C,C,Controls,D,E,T
16、,R,P,N,Actions,Plans,p,S,p,O,p,D,p,r,p,n,0,0,0,0,0,0,步骤 9:评估结果,之前,之后,改进,FMEA练习,使用提供的表格对下页的意大利面制作过程其中的一个步骤进行FMEA评估。你将有15分钟来完成作业。每组将有5分钟时间来在班上汇报结果,意大利面制作流程图,投入,输出,面原料平底锅水炉子勺子盐油,煮好的意大利面,盐的数量油的数量盖上或不盖上高度周围温度时间水中的矿物平底锅材料平底锅大小 或 9平底锅条件烧水说明BTU,时间盖上或不盖上面的类别面的数量高度周围温度,水烧开水没有完全开,可控制参数SOP 参数 干扰参数,过程参数(xs)说明,正好
17、没煮熟煮过头,FMEA 练习,FMEA练习,部件/产品名称和编号.:,部件/产品所有人,准备人,过程名称:,过程所有人:,FMEA 日期(原来):(修正.),涉及到的其它方面:,部件,过程,失效模式,故障影响,S,E,V,原因,O,C,C,控制,D,E,T,R,P,N,行动,计划,p,S,p,O,p,D,p,r,p,n,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,什么时候更新 FMEA?,当考虑改变产品制造或装配过程中的设计、应用、环境和材料时应考虑更新FMEA,只要有变化就要考虑更新!,什么时候完成FMEA呢?,设计 FMEA 当原设计或更新的设计投入生产时即完成FMEA
18、。过程 FMEA 永不终止，除非该过程从生产线中去掉。,该工具是什么?电子表格该工具识别/显示什么呢?所有的产品/过程 失效模式故障的相关影响故障原因控制原因的方法行动的风险优先数(RPN)，根据故障严重性故障发生概率故障探测能力行动/计划是为了在减少构成RPN元素,FMEA 总结,总结 成功的关键,清楚具体的目的!理解影响把顾客、客户和供应商考虑进来!与过程图联系用来给各种努力排定优先顺序，分配资源。在预测的影响基础上进行风险评估/风险排序。用来在关于优先问题上达成一致意见。鼓励创新团队工作!计划!提问题!,模块目标,你将能够:定义“FMEA”理解 FMEA 过程及其和其它质量工具的联系理解
19、失效模式、原因和影响之间的关系能够建立一个FMEA 和相关的行动计划描述 FMEA带来的好处,附录 A评级表,严重程度评级,发生概率评级,Rating,Description,1,2,3,4,5,Remote Possibility of happening(10 ppm).where similar parts have been used for similar functions in previous designs or processes and failures have been non-existent.Low failure rate(1000 ppm)with simil
20、ar parts having similar functions in previous designs or processes.High probability of failure(1%)where there is almost certain the failure will occur in major proportions.,探测能力评级,Rating,Description,1,2,3,4,5,Highest probability(99%)of the defect being detected before reaching the customer.Usually d
21、etected prior to the manufacturing process(e.g.,receiving inspection or at the suppliers facility).Very high probability(95-99%)that the defect will be detected before reaching the customer.The defect will most probably be detected during manufacturing and assembly through inspections and tests.Mode
22、rate probability(80-95%)that the defect will be detected before reaching the customer.Tests and inspections during manufacturing and assembly will catch most of the defect units.Rarely will this defect reach a customer.In addition,if this defect did reach the customer,it would be detected on install
23、ation.Lower probability(70-80%)of detection before reaching the customer.Defect will not be detected to a great degree during manufacturing,but testing will detect most of the defects.Normal customer preparation will detect most of the remaining defect units at installation.Lowest probability(70%)th
24、at the defect will be detected before reaching the customer.The customer will probably accept delivery of the system and make a complaint some time after delivery.May be considered a latent defect by the customer or a reliability problem.,附录 BFMEA范例,Assembly Process FMEA,Assembly Process FMEA cont.,
