FMEA失效模式及其影响分析中英文

Click to edit Master title style,Click to edit Master text styles,Second level,*,Failure Mode and Effect Analysis,失 效 模 式 及 其 影 响 分 析,1,Module Objectives,课程目的,Describe FMEA principles and techniques.,描述,FMEA,的法则及技巧。,Summarize the concepts, definitions, application options and relationships with other tools,.,摘要概念、定义、应用的选择和其他工具的关联。,Perform a,FMEA,执行一个,FMEA。,2,FMEA: Failure Modes and Effects Analysis,FMEA,is a systematic approach used to examine potential failures and prevent their occurrence. It enhances our ability to predict problems and provides a system of ranking, or prioritization, so the most likely failure modes can be addressed. FMEA,是用来检查潜在失效和预防它再次发生的系统性方法.它增强了我们预测问题的能力,并提供了一个排序或区分优先次序的系统,因而使得最可能的失效模式得以确定.,FMEA,is generally applied during the,initial stages,of a process or product design.,Brainstorming,is used to determine potential failure modes, their causes, their severity, and their likelihood of occurring. In Six Sigma, we apply FMEA to know failure modes. Our main interests are the cause and likelihood of occurrence, for which we have,actual data,and do not need to rely on brainstorming.,FMEA,通常应用在工艺及产品设计的初期，自由讨论决定潜在失效的模式、原因、严重度及发生的可能性。在6,S,中，我们应用,FMEA,去了解失效的模式。我们主要感兴趣的是原因及发生的可能性。,FMEA,is also a valuable tool for managing tasks during defect/failure reduction projects.,FMEA,也是一个在失效缩小的管理任务的有价值的工具。,FMEA,3,Definition of FMEA,定义,recognize and evaluate,the potential failure modes and causes associated with the designing and manufacturing of a new product or a change to an existing product.,认识和评估,新产品的设计和制造时或对现有产品做出改变时相关的潜在失效模式和原因,identify,actions which could eliminate or reduce the chance of the potential failure occurring,确定,消除或减少潜在失效发生机会的行动,document,the process.,使过程形成,文件,FMEA is a,systematic,design evaluation procedure,whose purpose is to:,是系统的设计评估程序,4,Failure to perform a defined function,执行既定功能的失效,Something occurring that you dont expect, or want,发生了你不希望或不想要的事情,Wrong application,应用错误,A Failure Mode is . . .,失效模式是,5,FMEA Use by Black / Brown / Green Belts,To identify potential failure modes and rate the severity of their effects,To identify critical characteristics and significant characteristics,To rank potential design and process deficiencies,To help all of us focus on eliminating product and process concerns and prevent problems from recurring,Reduce the product development timing and cost,6,Background,Developed in early 60s by NASA to “fail-proof” Apollo missions.,Adopted in early 70s by US Navy .,By late 80s, automotive industry had implemented FMEA and began requiring suppliers do the same. Liability costs were the main driving force.,Used sporadically throughout industry during 1980s.,Adopted by MSI in ?,Six Sigma is the catalyst.,7,NASA used FMEA to identify Single Point Failures on Apollo project (SPF = no redundancy & loss of mission). How many did they find?,420,and we thought we had problems!,8,Types of FMEAs,SYSTEM,DESIGN,PROCESS,System FMEA is used to analyze systems and subsystems in the early concept and design stages.,Design FMEA is used to analyze products before they are released to production,Process FMEA is used to analyze manufacturing, assembly and administrative processes,9,When is the FMEA Started?,“,Do the best you can with,what you have”,AS,EARLY,AS POSSIBLE!,Guideline:,10,When to Start ?,When new systems, products and processes are being designed,When existing designs and processes are being changed,When carry-over designs or processes will be used in new applications or environments,After completing a Problem Solving Study, to prevent recurrence of a problem,11,Beginning and End,12,Effect of FMEA on Process and Design changes,Design,Start,Development,Production,Release,Production,Time,No of Engineering Changes,Traditional approach,FMEA approach,13,Process FMEA Form,14,JL Example,15,Elements of FMEA,Failure Mode,Any way in which a process could fail to meet some,measurable,expectation.,Effect,Assuming a failure does occur, describe the effects. List separately each main effect on both a downstream operation and the end user.,Severity,Using a scale provided, rate the seriousness of the effect. 10 represents worst case, 1 represents least severe.,Causes,This is the list of causes and/or potential causes of the failure mode.,Occurrence,This is a ranking, on a scale provided, of the likelihood of the failure,occurring. 10 represents near certainty; 1 represents 6 sigma. In the case of a Six Sigma project, occurrence is generally derived from defect data.,Current Controls,All means of detecting the failure before product reaches the end,user, are listed under current controls.,Detection,The effectiveness of each current control method is rated on a,provided scale from 1 to 10. A 10 implies the control will not detect,the presence of a failure; a 1 suggests detection is nearly certain.,16,Process Failure Mode,The potential failure mode is the,manner in which the process could fail to perform its intended function.,The failure mode for a particular operation could be a cause in a subsequent (downstream) operation,or an effect associated with a potential failure in a previous (upstream) operation.,FAILURE,MODE,EFFECT,PREVIOUS,OPERATION,CAUSE,NEXT,OPERATION,17,Process Causes,Process FMEA considers process variability due to:,OPERATOR,SET-UP,MACHINE,METHOD,ENVIRONMENT,MEASUREMENT,18,Current Controls,Assessment of the ability of the control to detect the failure before the item leaves the manufacturing area and ships to the customer.,Capability of,all,controls in the process to prevent escapes,SPC,Process Capability,Gage R&R,Sampling,Testing,DOE,19,Types of Measures,SEVERITY,As it applies to the,effects,on the local system, next level, and end user,OCCURRENCE,Likelihood that a specific,cause,will occur and result in a specific failure mode,DETECTION,Ability of the current / proposed control mechanism to detect and identify the failure mode,Typically, three items are scored:,20,Risk Priority Number,RPN = O x S x D,Occurrence x,Severity x,Detection,O,S,D,x,x,=,RPN,21,Shortcomings of RPN,A,8,4,3 96,B,4,8,3 96,SAME RESULT,Failure Mode,Severity,Occurrence,Effectiveness,RPN,22,Severity,23,Occurance,24,Detection,25,It is conducted on a,timely,basis,and,It is applied by a,product,team,and,Its results are,documented,FMEA is Most Effective When,26,What Is A Good Application?,Involve new technology,Have changed from previous,Are chronically in trouble,Have a high degree of operator control,Have a high degree of variation,Choose designs or processes which . . .,Involve new technology,Have changed from previous,Are chronically in trouble,Have a high degree of operator control,Have a high degree of variation,Choose designs or processes which.,27,FMEA Process,Manufacturing,Engineer,Buyer,Process,Operator,Process Knowledge,Previous Experience,Past Problems,Chronic Problems,Reliability,Engineer,Process Functions, Potential Failure Modes,Effects, Causes, Current Controls,Action Priority,Actions to Eliminate or Reduce Failure Mode,Warranty Claims,28,Basic Steps,1.,Develop a Strategy,29,1.,Develop a Strategy,2. Review the design /process,EFFECT,CAUSES,Basic Steps,30,Basic Steps,1.,Develop a Strategy,2. Review the design /process,3. List functions,Develop a Strategy,Review the design/process,List functions,31,1.,Develop a Strategy,2. Review the design /process,3. List functions,4. Brainstorm potential failure,modes,Basic Steps,Basic Steps:,1. Develop a strategy,2. Review the design/process,3. List functions,4. Brainstorm potential failure,modes,32,1.,Develop a Strategy,2. Review the design /process,3. List functions,4. Brainstorm potential failure modes,5. Organize potential failure,modes,Basic Steps,topic,topic,Affinity Diagram,33,1.,Develop a Strategy,2. Review the design /process,3. List functions,4. Brainstorm potential failure modes,5. Organize potential failure modes,6. Analyze potential failure modes,Basic Steps,34,1.,Develop a Strategy,2. Review the design /process,3. List functions,4. Brainstorm potential failure modes,5. Organize potential failure modes,6. Analyze potential failure modes,7. Establish risk priority,VITAL,FEW,TRIVIAL,MANY,Basic Steps,35,1.,Develop a Strategy,2. Review the design /process,3. List functions,4. Brainstorm potential failure modes,5. Organize potential failure modes,6. Analyze potential failure modes,7. Establish risk priority,8. Take action to reduce risk,Basic Steps,36,1.,Develop a Strategy,2. Review the design /process,3. List functions,4. Brainstorm potential failure modes,5. Organize potential failure modes,6. Analyze potential failure modes,7. Establish risk priority,8. Take action to reduce risk,9. Calculate resulting RPNs,Basic Steps,O*S*D=RPN,37,1.,Develop a Strategy,2. Review the design /process,3. List functions,4. Brainstorm potential failure modes,5. Organize potential failure modes,6. Analyze potential failure modes,7. Establish risk priority,8. Take action to reduce risk,9. Calculate resulting RPNs,10. Follow up,Basic Steps,38,Testing the Relationships,IF,THEN,HOW DO,I KNOW?,CAUSE,FAILURE MODE,EFFECT,39,Actions,The design or process must be improved based on the results of the FMEA study.,A well-developed FMEA will be of limited value without positive and effective corrective actions.,40,Module Objectives,Describe FMEA principles and techniques.,Summarize the concepts, definitions, application options and relationships with other tools.,Perform a FMEA,41,Describe FMEA principles and techniques.,Summarize the concepts, definitions, application options and relationships with other tools.,Perform a FMEA,Module Objectives.,42,Organizational Learning and Systems Thinking,组织学习和系统思维,A Management System,43,Building Organizational Memory,Eyelash Learning Curve,ABILITY TO,DO JOB,TIME,OLD EMPLOYEE LEAVES,WITH KNOWLEDGE,NEW EMPLOYEE BEGINS,There is no organizational memory to allow people to start where their predecessors left off,Nothing in place to capture the new or improved methods that produce results,*,44,Rapid Learning Curve,ABILITY TO,DO JOB,TIME,NEW EMPLOYEE COMES ON,AND PICKS UP ALMOST WHERE,PREVIOUS EMPLOYEE LEFT OFF,Organization continues to advance its knowledge by preserving the lessons each learns,Rapid learning = less waste, less complexity, higher customer value, lower costs,*,45,How Do We Create Rapid Learning?,Two key ingredients:,1.,Having best known methods documented,2.,Training people on what those methods are,Who to train?,New employees,Managers,Experienced employees,*,Six Sigma,46,Pros and Cons of Standard Methods,Advantages:,优点,Customer progress is more visible and can be tracked over time,顾客进步更可见而且可以随时间跟踪,Capture and share lessons learned,吸取和分享教训,System itself does not become a source of variation,系统自身不会成为变异的来源,Leads to efficient practices,导致有效率的实践,*,47,Pros and Cons of Standard Methods,Disadvantages:,缺点,Stifle creativity and lead to stagnation,抑制创造力导致停滞不前,Interfere with customer focus,干涉客户的焦点,Add bureaucracy and red tape,助长官僚作风,Make work inflexible and boring,使工作欠缺灵活性，使人容易感到厌烦,Only describe the minimal acceptable output,只描述最小的可接受输出,48,Finding a Balance,寻找平衡,The difficulty we face is . . . .,the arguments for and against standardization are both true,公说公有理，婆说婆有理,To achieve a balance, develop standards judiciously -,where it matters the most,When effectively managed, standards provide the,foundation for improvement,49,Effective Standardization,有效的标准,Companies that use standardization effectively operate very differently:,The company knows why it is developing standards and how they contribute to its overall purpose,Management uses best-known methods themselves and strongly supports and checks usage,Employees understand how different facets of their work affect the products and services,Employees know which elements/functions are critical to producing high-quality output,50,Create Standards Judiciously,明智地创造标准,Leverage Point:,A place where a little change has a great impact,支点：小小的变化就能有巨大的影响的地方。,三两拨千斤？,“ . every job, every process, has within it high-leverage points that we must standardize if we want to achieve consistently high performance, and low-leverage points where standardization is superfluous, serving only to restrict flexibility.”,51,Know What Is and What Is Not Important,“,Knowledge about what is not important is almost as valuable as knowledge about what is important. It frees our attention to better focus on the few things that make a difference.”,“This kind of flexibility shows up in all jobs.”,“As a rule of thumb, keep the degree of standardization as low as possible,but do,not neglect,any leverage points.”,52,Leverage Point Thinking,-,How Do You Turn the Ship?,Knowing the leverage points is critical for determining priorities and strategies for improvement,Vital Few,Trivial Many,Pareto Principle,80% of the problems are caused by only about 20% of the contributing factors,*,53,54,Whats the Connection?,联系,Companies run into trouble because they change their methods before they understand why the methods are there in the first place.,陷入麻烦的公司是因为他们在不了解现有方法存在的原因之前就盲目改变它。,They eliminate safety nets in their processes without controlling the factors that made them essential.,55,Resist the temptation to change until we determine:,Are the documented standards the best?,What is the impact on the rest of the system?,Are the methods actually being followed?,Whats the Connection?,56,Employee Responsibility,员工的责任,Before anyone can be held responsible for the quality of their own work, they must:,1. Know the job,了解工作,Is the job,clearly,documented?,Are goals and targets visible?,Has adequate training been done?,Do workers know how product is used?,2. Know the standard,了解标准,Output must be measurable with immediate feedback on performance.,Dont be vague or require interpretation,(i.e. words like flat, smooth, etc.),57,Employee Responsibility (cont),3.,Have the ability to regulate,拥有调节的能力,When the job does not meet the standard, are there reaction procedures?,Are best practices leveraged?,Must have all 3 - in order!,(See Appendix A for Checklist),58,CAP-Do - Determine the Need for Standardization,1.,Check,Make sure we know,why,the work is being done,See if the purpose is clearly documented,Compare actual practice with documented methods,If no documented methods exist, compare different practices among people doing the work,Compare how the effectiveness of the work is supposed to be checked and how it is actually checked,PLAN,DO,ACT,CHECK,To answer these questions, use the CAP-Do (variation of Demings PDCA - Plan - Do - Check - Act),59,CAP-Do - Determine the Need for Standardization,2.,Act,Reconcile actual practices and,documentation,Change one to match the other as,appropriate,If no standard methods are in place and no one can demonstrate (with data) that consistency among operators exists, simply agree on a method that all will use. This will establish a consistent baseline upon which improvements can be built.,PLAN,DO,ACT,CHECK,60,3.,Plan,Determine how to detect flaws,and potential improvements in,the standard,Conduct a Potential Problem,Analysis (Kepner-Tregoe) to determine,contingencies and triggers for contingencies,Develop a plan for upgrading the,documentation, or for making it more useful,Develop a plan for encouraging the use of the documented standard,CAP-Do - Determine the Need for Standardization,PLAN,DO,ACT,CHECK,61,4.,Do,Train to the new documented,standard,Use the new standard,5. Check,Once again compare actual practices,to documented standards,Investigate inconsistencies,6. Act,Reconcile the actual practice with the documentation,Make changes based on the data!,PLAN,DO,ACT,CHECK,CAP-Do - Determine the Need for Standardization,62,“,The Illiterate of the Year 2000 . . .2000,年的文盲,. . .,will not be the individual who cannot read and write, but the one who cannot learn, unlearn and relearn”,不是不会读和写的人，而是不能学习、再学习和重新学习的人,Alvin Toffler,*,63,