潜在失效模式及后果分析

单击此处编辑母版标题样式,单击此处编辑母版文本样式,第二级,第三级,第四级,第五级,*,单击此处编辑母版标题样式,单击此处编辑母版文本样式,第二级,第三级,第四级,第五级,*,潜在失效模式及后果分析,第四版,Potential Failure Mode and Effects Analysis,4,th,Edition,Agenda,Introductions,简介,Background,背景,The,“,New,”,Stuff,“,新增加,”,的内容,Development using the,“,new,”,stuff,使用新增加的内容进行,FMEA,开发,Introduction,简介,FMEA,Part of a Family of OEM Documents Published by AIAG,F,MEA-AIAG,发布的,OEM,文件中的一部分,Requirements documents,要求的文件,1,）,ISO/TS16949 Automotive Sector Requirements, ISO/TS16949,汽车行业要求,-,-ISO9001,：,2000 is foundation, ISO9001,是基础,-Standard & Customer Specific Requirements include the implementation of an FMEA process,标准和顾客特殊要求，包括,FMEA,过程的实施,2,）,PPAP: Product Part Approval Process,PPAP:,生产件批准：,-PPAP includes requirements for FMEA implementation and is subject to compliance audit.,-PPAP,包括,FMEA,实施的要求，以及属于审核的一个项目。,3,）,Reference Documents,参考文件：,-FMEA 4,th,ED FMEA,第四版,-APQP 2,nd,ED APQP,第二版,-SPC 2,nd,ED SPC,第二版,-MSA 3,rd,ED MSA,第三版,4,）,Supported by,被支持,-Manuals chartered by the AIAG Quality Steering Committee.,-,符合,AIAG,质量策划委员会的手册,The FMEA Reference Documents,FMEA,参考文件,A reference document is guidance,参考文件是指：,-it is an OEM recommendation, OEM,的建议,-it is not prescriptive,不是强制的,-it is NOT auditable, unless:,不是审核依据，除非,The organization says in its procedures that it will follow the Manual,（,versus be consistent with it,）,or,组织宣称他们的程序按照此手册实施（等同采用）或,A customer explicitly requires that you must (currently TS and the Customer Specific Requirements do not do this,you only have to be consistent with the manual),顾客明确要求你必须使用（目前,TS,和顾客特殊要求不要求,你只能等同采用）,The FMEA Reference Documents,FMEA,参考文件,Usage and Application of FMEAs is included in requirements or compliance documents such as ISO/TS 16949 and PPAP,使用和应用,FMEAs,的要求被包含在,16949,标准或相关文件里面，如,PPAP,。,ISO/TS16949 and PPAP describe “what” is required or the compliance criteria for FMEAs and are subject to audit.,ISO/TS16949,和,PPAP,描述“什么”是被要求的，或,FMEA,的接收准则，并且是作为审核的项目。,FMEA compliance requirements may also be included in CSR,FMEA,的要求可能被包含在顾客特殊要求中。,The FMEA Reference Documents,FMEA,参考文件,The FMEA reference document contains information and guidance for completing and using FMEAs,-the FMEA document describes the,“,how,”,; the implementation tools for effectively developing FMEAs,- it is also a resource for developing procedures and training in FMEA,FMEA,参考文件包括完成和使用,FMEA,的信息和指南,- FMEA,文件描述,“,怎么做,”,，有效开发,FMEA,的实施工具,-,同样它也是,FMEA,开发程序和培训的资源,Background,背景,What is FMEA,？,FMEA,是什么？,FMEA,stands for failure mode and effects analysis,- FMEA is an analytical methodology used to ensure that potential problems have been considered and addressed throughout the product and process development process,-key is having the right people having good discussion about issues and risks in the product and process design, and the mitigation of high risk issues,-this becomes part of the organizations knowledge management,FMEA,表示失效模式后后果分析,- FMEA,是一个分析工具，以确保潜在问题已经被考虑，并且贯穿于整个产品和过程开发中,-,关键是在产品和过程开发中，有资格的人很好的讨论了关键点和风险，并且降低了高风险的发生,-,这成为组织知识管理的一部分,FMEA is a process not a document,-previous version focused primarily on the completion of the FMEA form and the knowledge contained therein.,FMEA,是一个过程，而不是一个文件,-,早期的版本，主要关注到的是,FMEA,的表格完成和里面的概念。,Reinforce that management is an integral part of this process,需要强调的是，管理是这个过程所必需的一部分。,Why a Fourth FMEA,？,为什么发布,FMEA,第四版？,Minimize or Eliminate column shifting,-placing information in the wrong columns thus hindering the analysis and product/process improvement efforts,减少或者消除栏目,-,将信息填入错误的栏目，会阻碍分析和产品,/,过程改进的效果,Why a Fourth FMEA,？,为什么发布,FMEA,第四版？,Why a Fourth FMEA,？,为什么发布,FMEA,第四版？,Minimize or Eliminate sole reliance on the RPN in the evaluation of risk priorities and improvement actions,-Practice of Deflating of the RPN to meet an arbitrary threshold.,减少或消除单一依靠,RPN,值，去评价风险缝隙的优先程度和改进措施。,-,习惯于去刻意降低,RPN,值，以满足某个主观的指标。,Lack of understanding of the role of the FMEA process throughout the APQP phases,-including continual improvement during production; i.e., looking at the FMEA as a static document necessary only for PPAP approval.,缺乏对,FMEA,在,APQP,各阶段中的角色的理解。,包括在生产过程中的持续改进。如，只将,FMEA,视为,PPAP,批准所需的静态文件。,Why a Fourth FMEA,？,为什么发布,FMEA,第四版？,The,“,New,”,Stuff,新内容,Improvements in FMEA 4,th,第四版,FMEA,的改进,Highly Visible Improvements,可见的改进,Changes in format,格式变化,- additional example,增加例子,- better graphics,更好的图形,Changes to S,O, and D ranking tables.,更改了,S,，,O,，,D,值的表格,Alternative Forms,可选的表格,Reduced Emphasis on RPN,减少对,RPN,的强调,- Alternatives to RPN RPN,的可选,Alternative Methods to Analyze Design Risk,可选的方法去分析设计风险,Ease of Reading and Use,更容易的阅读和使用,Change in format,格式的变化,- Similar to that of the SPC and MSA manuals,与,SPC,和,MSA,手册相似,An index is also included to aid in navigating the manual.,增加抬头，以便于索引。,Additional Examples,增加案例,Additional examples and verbiage have been provided to improve the utility of the manual and to provide a closer tie in to the FMEA process as it develops.,所提供增加的案例和内容，以改进手册的效果，以及提供一个更接近的关系去开发,FMEA,过程。,Changes to Risk Ranking Tables,风险等级表格的更改,Improvements to the Severity, Occurrence, Detection ranking tables so that they are more meaningful to real world analysis and usage.,对,S,，,O,，,D,值表格的改进，可以让他们更有意义的去分析真实世界和使用。,Alternative Forms,替换表格,The 3,rd,edition used a single,“,standard,”,form,第三版,FMEA,使用单一的,“,标准,”,表格,- although it allowed for other forms, no examples were provided.,尽管它允许用其他表格，但没有提供例子。,The 4,th,edition identifies alternative example forms,第四版提供了替换表格,- the focus on the,“,standard form,”,has been replaced with several options that represent the current application of FMEA in industry.,关注,“,标准格式,”,已经被替换成代表当前工业领域使用的,FMEA,的多种选择,- Manual identifies the minimum information that should be contained on any form.,手册识别了最低内容，这些内容必须被包括在任何使用的表格中。,- allows for use of the 3,rd,edition form,允许使用第三版的表格。,DFMEA Form Examples,例子,：类似产品的,DFMEA,及,FMA,项目,/,功能,要求,潜在失效模式,潜在失效影响,S,级别,潜在失效起因,O,现行设计控制,预防,现行设计控制,探测,D,RPN,项目,/,功能,要求,潜在失效模式,潜在失效影响,S,级别,潜在失效起因,O,现行设计控制,预防,现行设计控制,探测,D RPN,项目,/,功能,要求,潜在失效模式,潜在失效影响,S,级别,潜在失效起因,现行设计控制,预防,O,现行设计控制,探测,D,RPN,项目,/,功能,要求,潜在失效模式,潜在失效影响,S,级别,潜在失效起因,现行设计控制,预防,O,现行设计控制,探测,D RPN,DFMEA,Reduced Emphasis on RPN,降低对,RPN,的强调,More meaningful methods for evaluating potential design risk,更有意义的方法去评价潜在设计风险,Priorities should not be based on RPN alone.,并不能单独依据,RPN,值的大小来决定采取措施的优先权。,Alternatives to RPN,可供选择的,RPN,S and S * O (Severity times Occurrence),严重度和严重毒乘以频度,SOD (Severity-Occurrence-Detection),严重度乘以频度乘以探测度,Alternative Methods to Analyze Design Risk,多种方法来分析设计风险,Alternative Methods are introduced that are currently being applied in industry.,介绍了多种应用于当前工业的方法,FTA,故障树,FMECA(Failure Mode Effects and Criticality Analysis),失效模式后果和关键性分析,DRBFM(Design Review Base on Failure Mode),基于失效模式的设计评审,FMECA,FMECA is similar to FMEA,与,FMEA,相似,The C in FMECA indicates that the criticality (or Severity) of the various failure effects are considered and ranked. FMECA,中的,C,，指的是：若干个失效影响的关键度（或严重度）已经被考虑和归类。,Today, FMEA is often used as a synonym for FMECA.,今天，,FMEA,经常等同于,FMECA,来使用。,Improvements in FMEA 4,th,改进,Not so easily seen,不能轻易看到：,1)Identification of the need for, and types of, Management Support.,识别了管理层支持的所需和类型。,2)Increased emphasis on the FMEA process,强调了,FMEA,过程,- Alignment with APQP.,和,APQP,的密切关系,- increased emphasis of,“,Team,”,discussion and development,强调了,“,小组,”,讨论和开发,- Increased emphasis on,“,prerequisites,”, Failure modes based on requirements.,强调了,“,前提,”,，失效模式基于要求。,- Linkage between DFMEA and PFMEA DFMEA,和,PFMEA,的联系,Consistent FMEA approach in Chapter 3 and 4(Design and Process),第三章和第四章一样的,FMEA,方法,Reduced Emphasis on RPN,减少了对,RPN,值得强调。,The Need and Type of Management Support,管理层支持的所需和类型,Reinforcement of the need for management support, interest, and review of the FMEA process and results.,增强对管理者支持的所需，兴趣和,FMEA,过程的评审和结果。,“,Management owns the FMEA process. Management has the ultimate responsibility of selecting and applying resources and ensuring an effective risk management process including timing,”,.,管理层拥有,FMEA,过程。管理层具有最终的职责，以选择和提供资源，以及一个包括时机的有效的风险管理过程。,Emphasis on,“,Prerequisites,”,and Team Discussions,强调前提和小组讨论,To minimize or eliminate column shifting, it is recommended.,为了减少或消除列项，建议：,Use separate columns Item/Step,Function, and Requirements.,使用独立的列项：项目,/,步骤，功能，要求。,Base Failure Modes on Requirements, not brain-storming.,制定基于要求的失效模式，而不是头脑风暴。,Linkage Between DFMEA and PFMEADFMEA,和,PFMEA,的联系,Define and Strengthen the understanding of the linkage between DFMEA and PFMEA as well as defining the linkages to other tools.,确定和加强对,DFMEA,和,PFMEA,联系的理解以及和其他工具的联系。,- Main Linkage is how the design can impact manufacturing or assembly and conversely.,主要的联系是设计如何能够影响制造或装配过程，反之亦然。,- Product design risk impacted by manufacturing of design that may be identified during the DFMEA research and analysis process.,产品设计风险被在,DFMEA,调查和分析过程中识别的制造过程设计所影响。,- The effect of a Process failure mode can be a Design failure mode (and all its effects),一个过程失效模式的影响，可能是一个设计失效模式（以及所有它的影响）。,- Also, connections to Control Plans, DVPR,etc,同样的，与控制计划，设计验证的联系,Linkages between Design and Process,设计和过程的联系,Design development,设计开发,- A,“,standard,”,radius specified but hard to manufacture.,一个标准的半径，但是难以加工,- Styling shapes, which look good but are hard and expensive to shape.,一个外形，看着很漂亮，但是难以，和需要昂贵的加工。,- Sharp edges which could injure the operator,尖锐的棱角可能会伤害到操作者,- Characteristics that are critical, excessive variation will cause warranty issues.,对于关键特性，过大的变差会导致保修。,噪音、粗糙、运行不稳、无法运作、外观不良、不适的异味、不稳定、运行减损、间歇运行、发热、泄漏、定期的不符合,System Development,系统开发,- A child failure mode causes a parent failure modes and all its effects.,一个子失效模式，会导致一个母失效模式和它所有的影响。,Process Development,过程开发,- Process Failure mode causes a Design Failure Modes and all its effects.,过程的失效模式，会导致设计失效模式以及它所有的影响。,Conduct a Case Study!,听了这么久，做个案例吧？！,回形针,SCENARIO,案例,You work for Dilbert Wire Forming(DWF), a firm that has long prospered by supplying the automotive industry with formed wire products, such as springs and wire clips.,To become economically more robust, DWF wishes to broaden its product line so that it could move into new markets.,A group is formed consisting of market research, production, sales, and design associates to look into what new product could be made utilizing the company,s experience in wire forming,You are a member of this group.,你为,DWF,公司工作。该公司是一个在汽车行业用成型钢丝产品（ 比如弹簧和电线夹）有着长期成功供货经验的公司。,为了公司的发展，公司希望在其他市场扩大其产品线。,一个由市场调研，生产，销售和设计人员在内的小组已构成，以寻求能基于公司在钢丝产品经验的基础上开发新的产品。,你是小组的成员之一。,The group has identified wire paper clips as a viable new product.,- in recent years the price of paper clips had risen almost three times as fast as the price wire,- demand for the product was up, and,- there appears to be little customer loyalty to any particular brand.,Outlook,- domestic market is estimated to be 500 million paper clips per year,- if the manufacturing costs are $0.0035 per clip, DWF might expect to capture 10 percent of the market,- if the cost is $ 0.0025 per clip domestic sales can expect to be 80 million paper clips and export another 20 million each year.,小组已经识别出了回形针是一个可行的新产品：,-,在最近几年中，回形针的价格涨了三次，比钢丝的价格上涨次数还多,-,产品的需求在上涨，并且,-,显示出，部分顾客对某一特定品牌的忠诚度很高。,展望,-,本地市场，每年估计有,5,亿只需求；,-,如果制造成本是每只,0.0035,美元，那么公司期望能获得,10%,的市场占有率,-,如果成本在,0.0025,美元，那么每年，本地市场预计可以销售,8000,万只，出口达到,2000,万只。,Since the standard-size “Gem” accounts for 90 percent of the market, its overall dimensions used as the design starting point.,To become competitive, your group decided that if the legs could be cut off shorter, up to 10% less total wire would be needed for each paper clip thus,- reducing the cost of raw materials, which represents over half the manufacturing cost,- reflect savings in shipping costs since it would be lighter.,普通标准尺寸的回形针占了,90%,的市场占有率，所以设计的起始点放在产品的外轮廓尺寸上。,为了具有竞争力，小组决定：如果回形针的脚能切短一点，达到钢丝原有用量的,10%,，那么，每一个回形针可以：,-,降低材料成本，并能降低一半的制造成本；,-,因为减轻了重量，则同时降低了运输成本。,Concern: Will the paper clip still,“,Clip,”,?,关注：回形针还能发挥作用吗？,How a paper clip works,回形针如何工作的,Paper clips are small objects, usually constructed from metal wire, that serve to hold several sheets of paper together as a single unit.,回形针是个小物体，通常采用金属钢丝制造，用于夹紧一层纸张。,In effect, a paper clip consists of two metal surfaces that are pressed against one another by the elasticity of the metal wire from which the paper clip is built.,实际上，一个回形针包括两个互相贴合的金属表面，通过金属丝的弹性来夹紧纸张。,As you distort the paper clip away from its equilibrium shape, by spreading the two surfaces apart, it experiences restoring forces.,当你将回形针的两个表面分开，使之变形，会有一个回弹力。,These forces tend to return the paper clip to its equilibrium shape and push the two surfaces together.,这种力量会导致回形针回复到一个平面，并将两个表面合在一起。,A test engineer determined that this change would result in only 2 percent decrease in spring action gripping.,一个测试工程师确定，这种更改只会降低弹力的,2%,。,Basic Customer Requirements for a paper clip,对于回形针，顾客的基本要求。,Basic Function: Holds papers securely,基本功能：安全的夹紧纸张,Maintains integrity of the stack of paper,保持一堆纸张整齐,Does not catch, mutilate, or tear papers,不能卡住或撕破纸张,Holds a thick set of papers,夹紧一摞厚纸,Is easily inserted.,能轻松插入,Safe to use,使用安全,Does not get tangled with other clips in the box,在盒子里，不能和其它回形针发生干涉,is light weight and requires less postage,轻量，并且需要较少的邮费,Is cheap,便宜,Is durable,does not rust,耐用，不能生锈,Block Diagram,简图,DFMEA,Develop a DFMEA to determine what are the risks in using this design with the new changes,开发一个,DFMEA,以确定这个新的更改所产生的设计风险。,DFMEA,Requirement: Does not catch, Mutilate, or tear papers,要求：不能卡住或撕破纸张,Team Exercise,小组测试,Develop the branch in the DFMEA for this requirement of the basic function of the item: paper clip,以以上要求，开发一个,DFMEA,。,DFMEA,Requirement,：,Does not catch, Mutilate, or tear papers.,不能卡住或撕破纸张,Failure Mode: Paper Clip catches, mutilates, or tears papers in normal use, on insertion, or on extraction.,在正常的插入或拔出过程中卡住或撕破纸张,- with small stack of paper: the sharp ends of the clip dig into the papers when it is removed.,对于一小摞纸张：回形针的尖端会戳进纸张,- with large stack of paper: the clip either twists badly out of shape or files off the pile and the sharp ends of the clip dig into the papers.,对于一厚摞纸张：回形针既会弯曲变形，又会让文件散乱，而导致尖端会戳进纸张。,Sharp ends,回形针的尖端,Paper Clip,DFMEA,Process Flow,过程流程,Operation 10: receiving (wire and coatings),材料接收,Operation 20: Receiving Inspection,进货检验,Operation 30: Uncoiling and straightening,展开拉直,Operation 40: Coating,Future,涂覆,后续,Operation 50: Curing,Future,加工,后续,Operation 60: Cutting,切断,Operation 70: Bending,弯曲,Operation 80: Unit Packaging,单只包装,Operation 90: Pack and Ship,包装发运,PFMEA,Exercise,测试,Conduct and Review the PFMEA and Control Plan,实施并评审,PFMEA,和控制计划,Conclusions,结论,The FMEA process is critical in assuring that all areas of the product and process design (including interfaces and environment) have been evaluated and all potential failure modes have been mitigeted.,FMEA,过程决定于确保产品和过程设计的所有区域（包括接口和环境）都被评审，并且所有潜在失效模式都已经被减轻,The 4,th,edition improvement will aid in applying FMEAs at suppliers and reduce some of the auditing issues in relation to FMEAs.,第四版,FMEA,的改进将会帮助供应商对,FMEA,的应用，并且减少一些对,FMEA,相关的审核。,Questions,？ 问题？,感谢您接受本次培训！,如果您对本次培训有任何建议或意见，请向您的培训师提出，我们将认真的考虑您所提出的任何疑问，以不断改进我们的培训质量！,