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1、Failure Modes and Effects Failure Modes and Effects Analysis( FMEA)Analysis( FMEA)潜在失效模式及影响潜在失效模式及影响分析分析Failure Modes and Effects AnalysisA process potential FMEA is an analytical technique utilized by a manufacturing responsible engineer/team as a means to assure that, to the extent possible, poten
2、tial failure modes and their associated causes/mechanisms have been considered and the engineers/teams thoughts (including an analysis of items that could go wrong based on experience and past concerns) as a process is developed. This systematic approach parallels and formalizes the mental disciplin
3、e that an engineer normally goes through in any manufacturing planning process.过程过程的的FMEA是负责是负责制造制造生产的工程师生产的工程师/队伍使用的分析队伍使用的分析技技法，用来法，用来在一定程度在一定程度上上确保确保潜在潜在的的失效模式失效模式和相关的原因和相关的原因/机机制制都已考虑到，都已考虑到，以及以及工程师工程师/队伍的想队伍的想法（包括基于经验和过去的想法得出的可能法（包括基于经验和过去的想法得出的可能失效项目失效项目分析）。这种系统性的方分析）。这种系统性的方法将工程师在任何生产计划过程中通常会
4、碰到的问题法将工程师在任何生产计划过程中通常会碰到的问题标准标准化了化了。2Failure Modes and Effects AnalysisThe Process potential FMEA The Process potential FMEA v Identifies potential product related process failure modes.确认与产品确认与产品有关的过程失效模式有关的过程失效模式v Assesses the potential customer effects of the failures. 评估评估失效对失效对客户客户潜在潜在的影响的影响v
5、Identifies the potential manufacturing of assembly process causes and identifies process variables on which to focus controls for occurrence reduction or detection of the failure conditions. 确定潜在的制确定潜在的制造原因和过程变数，以便加以控制，减少发生造原因和过程变数，以便加以控制，减少发生可能性可能性，增加，增加发现发现到的可能性到的可能性v Develops a ranked list of pot
6、ential failure modes, thus establishing a priority system for corrective action considerations.列出列出潜在失效模式潜在失效模式的排行表，建立一个的排行表，建立一个优先优先系统系统以做出改善行动以做出改善行动v Modify manufacturing or assembly process. 改变改变生产或生产线过程生产或生产线过程3Failure Modes and Effects AnalysisFMEA Step FMEA Step 步骤步骤: : 1. Define the scope fo
7、r the FMEA 定义定义FMEA的范围的范围 2. Identify team members, customer, and knowledge experts 确认队伍成员、客户，和专确认队伍成员、客户，和专家家 3. Develop roles and responsibilities for team members 制定每个成员的任务和职责制定每个成员的任务和职责 4. Study the product / process / service 研究产品研究产品/制程制程/服务服务 5. Brainstorm failure modes, known and potential
8、集体讨论集体讨论已知的和潜在的失效模式已知的和潜在的失效模式 6. List the effects, causes, and current controls for each failure mode 列出影列出影 响、原因和响、原因和失效模式失效模式当前控制情况当前控制情况 7. Assign ratings for Severity, Occurrence, and Detection 给给严重性、发生率、严重性、发生率、发现度发现度的的评评分分 8. Calculate RPN 计算计算RPN 9. Decide on a threshold RPN 制定采取行动的制定采取行动的RP
9、N界限值界限值 10. Prioritize based on RPN and severity,or as required by the customer 优先性要根据优先性要根据RPN，严重性，或客户的要求严重性，或客户的要求 11. Identify corrective actions 确认确认改善行动改善行动 12. Implement and verify effectiveness of corrective action 执行并确认执行并确认改善行动改善行动的有效性的有效性 13. Complete the documentation 完成文件记录完成文件记录4Failure
10、 Modes and Effects Analysis1. 1.Define the scope for the FMEADefine the scope for the FMEA定义定义FMEA的范围的范围5Failure Modes and Effects Analysis2. 2. Identify team members, customer, and knowledge experts Identify team members, customer, and knowledge experts 确认队伍成员、客户和专家确认队伍成员、客户和专家Get the team together
11、, identify the customer and involve them in the process. Some preliminary work must be done to understand the product / process / service, so the right team can be assembled.将成员集合，确认客户并使他们参与进来。为了很好地理解产品将成员集合，确认客户并使他们参与进来。为了很好地理解产品/制程制程/服务，服务，一些先前工作要做一些先前工作要做，已使小组集合起来，已使小组集合起来。6Failure Modes and Effe
12、cts Analysis 3. Develop roles and responsibilities for team members 制定每个成员的任务和职责制定每个成员的任务和职责Who does what on the team. Clearly define the roles and responsibilities for each of the team members.At this time, it is important to consider the strengths of each individual and leverage the same.谁做什么，清楚地定
13、义每个成员的职责。这时，考虑每个人的长处很重谁做什么，清楚地定义每个成员的职责。这时，考虑每个人的长处很重要。要。Example : Team Leader : * Coordinate the activities of the team, and keep on track 例：例： 队长队长 协调队伍的活动，时时追踪协调队伍的活动，时时追踪 * Act as cheer leader, and interface with management 充当鼓舞者与管理相结合充当鼓舞者与管理相结合 * Ensure the decisions are made with consensus 确保
14、和大家一起做决定确保和大家一起做决定 Customer : * Define requirements 定义需求定义需求 客户客户 * Participate in developing rating scales, especially for Severity Knowledge 参与等级制定，尤其是严重性参与等级制定，尤其是严重性 Expert : * As consultant provide info on details of product / 专家专家 process or service 作为顾问提供产品等信息作为顾问提供产品等信息7Failure Modes and Eff
15、ects Analysis4. 4. Study the product / process / serviceStudy the product / process / service 研究产品研究产品/制程制程/服务服务The objective of this step is to acquire as much knowledge as possible. It is highly recommended that all team members delve into this, since there is no other way to familiarize yourself
16、with the product / process / service.此步骤的目的是为了尽可能多的获取知识。此步骤的目的是为了尽可能多的获取知识。高度高度建议所有成员都参与，因为没有其他的方式使你去熟建议所有成员都参与，因为没有其他的方式使你去熟悉产品悉产品/制程制程/服务。服务。8Failure Modes and Effects Analysis5. Brainstorm failure modes,known and potential5. Brainstorm failure modes,known and potential集体讨论集体讨论已知的和潜在的失效模式已知的和潜在的失效
17、模式 * Failure modes should be described in “physical” or technical terms,not as a symptom noticeable by the customer. 失效模式应描述为物理量或技术术语，而不是简单的表面现象失效模式应描述为物理量或技术术语，而不是简单的表面现象* The idea is to identify as many failure modes as possible. This will involve getting all team members and stake holders involve
18、d, however, the proper approach to brainstorming must be used. Defer all judgment, maybe even to a subsequent meeting.确认尽可能多的确认尽可能多的失效模式失效模式，使所有的成员都参与。使用，使所有的成员都参与。使用适当的脑力震荡适当的脑力震荡方法。方法。所有的调节整理留给以后所有的调节整理留给以后的会议的会议。 * The biggest risk in this step is that participants will start mixing up failure mo
19、des with causes,and effects.To prevent this, it is highly recommended that meeting leader do a dry run to familiarize the group with the differences between failure modes,effects,and causes. A listing of the product/process/services specifications, or outputs and requirements will benefit here. 最大的风
20、险是参与者会混淆最大的风险是参与者会混淆失效模式失效模式、原因和影响。建议会议领导者做个排练，使大家熟悉、原因和影响。建议会议领导者做个排练，使大家熟悉失效模式失效模式、原因和影响的差别。产品原因和影响的差别。产品/制程制程/服务的服务的规格规格，产出产出或需求或需求会对此会对此有所帮助。有所帮助。 * Post it pads are a convenient way of collecting this information, and grouping it into logical groups.小纸贴小纸贴是收集此种信息的有效途径，是收集此种信息的有效途径，然后按然后按逻辑分组逻辑分
21、组。 * If you write these on a work sheet, make sure you leave enough space for effects and causes 如果你将此写在工作如果你将此写在工作纸纸上，要确保留出足够的空间上，要确保留出足够的空间填写填写影响和原因。影响和原因。9Failure Modes and Effects Analysis5. Brainstorm failure modes,known and potential5. Brainstorm failure modes,known and potential集体讨论集体讨论已知的和潜在
22、的失效模式已知的和潜在的失效模式Separating Failure Modes,Effects and Causes 分开分开失效模式失效模式，影响和原因，影响和原因Multiplicity will exist for causes, failure modes, and effects失效模式，影响和原因失效模式，影响和原因是是多种多样多种多样的的Failure Modes : Will share causes, and effects失效模式失效模式：有共同的原因和影响：有共同的原因和影响Causes : The reasons for failure,can be one or m
23、any for a given failure mode原因：原因： 不良的原因可以是一个或多个已有的失效模式的原因不良的原因可以是一个或多个已有的失效模式的原因Effects : The results of the failure,can be one or many for a given failure mode影响：不良的结果可以是一个或多个已有的影响：不良的结果可以是一个或多个已有的失效模式失效模式的结果的结果Cause1Cause2Failure Mode 1Effect1Failure Mode 2Effect210Failure Modes and Effects Analy
24、sis6. List the effects, causes, and current controls for each failure mode6. List the effects, causes, and current controls for each failure mode列出影列出影 响、原因和响、原因和失效模式失效模式的当前控制情况的当前控制情况 * To capture the effects, causes, and existing controls if any for the failure mode in question. Input from custome
25、r, knowledge experts will be especially helpful at this step. 专家专家及客户及客户在失效模式的影响、原因，在失效模式的影响、原因，和当前控制和当前控制上尤其能提供帮助。上尤其能提供帮助。 * Caution : Many teams commit errors of wishful thinking here,especially with regard to current controls. You should focus on the current state,and not on what could be done,
26、or what ought to be done. 注意：许多成员由于打如意算盘而犯错误，尤其对当前的控制。我们应该关注当注意：许多成员由于打如意算盘而犯错误，尤其对当前的控制。我们应该关注当前的状况，而不是关注应该做的或可以做的。前的状况，而不是关注应该做的或可以做的。 * Now start documenting on the worksheet,knowing that each failure mode can have multiple effects, and multiple causes.现在开始做文件整理，要意识到失效模式有很多的影响和原因。现在开始做文件整理，要意识到失效
27、模式有很多的影响和原因。11Failure Modes and Effects Analysis6 6 . . List the effects, causes, and current controls for each failure mode List the effects, causes, and current controls for each failure mode 列出影列出影 响、原因和不良型号的当前控制情况响、原因和不良型号的当前控制情况Example举例举例:Load capacity listed列出载重能力列出载重能力Overloaded超载超载Temp Gage
28、Cooling System制冷系统制冷系统Stranded on Road在路上搁在路上搁浅浅Oveheats过热过热Car汽车汽车RPNDCurrent Controls当前控制OCause原因SEffect影响Failure Mode失效模式Product Process or Service产品制程或服务12Failure Modes and Effects Analysis7. Assign ratings for Severity, Occurrence, and Detection7. Assign ratings for Severity, Occurrence, and De
29、tection给给严重性、发生率、严重性、发生率、发现度发现度评分评分 Here we accomplish the conversion of each of these factors into a numerical value. Depending on the quality of the rating scales this step can be very easy or somewhat frustrating. 这里我们将每个因素都转换成相对应的数值。根据质量等级标准，这个步骤可以这里我们将每个因素都转换成相对应的数值。根据质量等级标准，这个步骤可以很简单或很简单或有点烦人有
30、点烦人。 There will be times when the team will disagree on the values assigned to a particular cause, effect, or failure mode.Rather than voting, it is recommended that the team try to reach consensus. In case of disagreements, a knowledge experts opinion can be used to increase understanding, or more
31、data can be sought. In any case the teams decision should prevail.对于任何一个原因、影响或失效模式的等级划分对于任何一个原因、影响或失效模式的等级划分，小组成员之间很多时候，小组成员之间很多时候会意见会意见相左，建议相左，建议多收集数据多收集数据，专家的意见，专家的意见也也可以用以提高理解可以用以提高理解，达成共识，达成共识。13Failure Modes and Effects Analysis7. Assign ratings for Severity, Occurrence, and Detection7. Assign
32、ratings for Severity, Occurrence, and Detection给给严重性、发生率、严重性、发生率、发现度评分发现度评分Example举例举例:Product Process or Service产品制程或服务Failure Mode失效模式Effect影响SCause原因OCurrent Controls当前控制DRPNCar汽车汽车Oveheats过热过热Stranded on Road在路上搁在路上搁浅浅7Cooling System制冷系统制冷系统3Temp Gage4Overloaded超载超载8Load capacity listed列出栽重能力列出栽
33、重能力814Failure Modes and Effects Analysis8. Calculate RPN 8. Calculate RPN 计算计算RPNSimply assigning ratings for Severity, Occurrence, and Detection doesnt help quantify the risk into a single measurable value. Multiplying the rating scores thus fills this gap.Note that in this approach we have maintai
34、ned equal weight for each of the three S,O,D 给给严重性、发生率、严重性、发生率、发现度评分发现度评分并不能将风险变并不能将风险变为一个为一个单一测量的单一测量的数值，数值，把三个分数乘起来填进把三个分数乘起来填进RPN栏栏，注意三个单值的权重，注意三个单值的权重是是一样的。一样的。Product Process or Service产品制程或服务Failure Mode失效模式Effect影响SCause原因OCurrent Controls当前控制DRPNCar汽车汽车Oveheats过热过热Stranded on Road在路上搁在路上搁浅浅7
35、Cooling System制冷系统制冷系统3Temp Gage484Overloaded超载超载8Load capacity listed列出栽重能力列出栽重能力844815Failure Modes and Effects Analysis 9 9. Decide on a threshold RPN 制定采取行动的制定采取行动的RPN界限值界限值 Identify the failure modes you will choose to work on. It may not be practical to address all of them. This critical step
36、must be conducted with customer involvement, and consensus building. 确认你选择确认你选择需要采取行动需要采取行动的失效模式。的失效模式。对所对所有的模式整改是不实际的，这个关键步骤需客户参与有的模式整改是不实际的，这个关键步骤需客户参与 Many teams run into difficulties here, especially when the customer insists all items need to be addressed. It needs to be understood that some el
37、ement of risk will always be present. The question therefore is “ What level of risk is acceptable ” ? 许多许多小组小组都会在这碰到困难，尤其当客户要求所有的都会在这碰到困难，尤其当客户要求所有的项目都要被讨论。风险总项目都要被讨论。风险总是是会会存在的存在的。问题是：。问题是：“什么程度的风险可以接受？什么程度的风险可以接受？” Some of the different approaches that have been used to define the threshold are;
38、Pareto Analysis, Top cause for each failure mode, etc. 一些不同的方法都已被用来定义界限：一些不同的方法都已被用来定义界限：泊泊拉图拉图分析，分析，最最高分等等高分等等Document on FMEA startup form to indicate this was discussed, and agreement reached on the threshold value. 关于关于FMEA的讨论的讨论要写成文件要写成文件，要在界，要在界限值上达成一致。限值上达成一致。16Failure Modes and Effects Analy
39、sis 9 9. Decide on a threshold RPN制定采取行动的制定采取行动的RPN界限值界限值 * Decide on a threshold RPN, without ignoring high severity failure modes决定决定RPN的临界点，不要忽略失效模式的高严重性的临界点，不要忽略失效模式的高严重性 Example using Pareto Chart 用Pareto图表举例:010203040506070809010080% of Cumulative RPNCumulative RPN CurveL累积累积RPN曲线曲线Cause原因原因Cu
40、mulative RPN累积累积RPN17Failure Modes and Effects Analysis1 10. Prioritize based on RPN and severity,or as required by the customer0. Prioritize based on RPN and severity,or as required by the customer优先性要根据优先性要根据RPN，严重性，或客户的要求严重性，或客户的要求 * Arrive at the order in which you will start addressing the fail
41、ure modes and cause for corrective action. Although RPN and severity based prioritization seems the most logical,your decision to proceed must be made with customer input. 订出你对于失效模式和原因整改的顺序。虽然订出你对于失效模式和原因整改的顺序。虽然RPN和和按按先后次序的严重性先后次序的严重性很有逻辑性，你仍然要根据客户的信息来决定。很有逻辑性，你仍然要根据客户的信息来决定。 * This step is easily
42、accomplished by sorting the data, in descending order.You can do this within each failure mode to maintain data integrity.这个步骤根据数据这个步骤根据数据分类分类可以很容可以很容易按降序完成，。每一个失效模式都可以这样做以保证数据的完整。易按降序完成，。每一个失效模式都可以这样做以保证数据的完整。 * Documentation on work sheet is important to ensure the whole team is in sync.相关的文件很重要，可
43、以确保整个队伍工作的相关的文件很重要，可以确保整个队伍工作的同步性。性。18Failure Modes and Effects AnalysisExample of sorted worksheet by RPN within each failure mode失效模式用失效模式用RPN排序的例子排序的例子：1 10. Prioritize based on RPN and severity,or as required by the customer0. Prioritize based on RPN and severity,or as required by the customer优先
44、性要根据优先性要根据RPN，严重性，或客户的要求严重性，或客户的要求844Temp Gage3Cooling System制冷系统制冷系统4488Load capacit listed on side of door在门边列出载重能力在门边列出载重能力8Overloaded超载超载7Stranded on Road在路上搁浅在路上搁浅Oveheats过热过热Car汽车汽车RPNDCurrent Controls当前控制OCause原因SEffect影响Failure Mode失效模式Product Process or Service产品制程或服务19Failure Modes and Eff
45、ects Analysis1 11. Identify corrective actions 1. Identify corrective actions 确认确认改善措施改善措施 * In this step you identify the corrective actions needed to eliminate / control the causes, and reduce the risk level to or below the agreed upon threshold. 这个步骤你要确认消除这个步骤你要确认消除/控制起因的整改方法，去减低风险等级或使之低于规定的控制起因的
46、整改方法，去减低风险等级或使之低于规定的界限。界限。 * There will be times when you cannot work on the root cause; in such case the best course of action will be via addition of controls/ adequate warning devices / mechanisms of impending failure. Re-evaluate the ratings for S,O and D, followed by RPN calculation.很多时候你不能找出根本
47、原因；这时最好的方法就是对未解决的不良进行额外的很多时候你不能找出根本原因；这时最好的方法就是对未解决的不良进行额外的控制控制/足够的提醒装置。根据足够的提醒装置。根据RPN计算结果，重新衡量计算结果，重新衡量S，O，D的等级划分的等级划分。 * Discussion with the customer is important again since the corrective actions will impact them. Knowledge experts may also provide valuable input as to what kinds of corrective
48、action will be best suited for the given cause / failure mode.整改会影响到客户，因此和他们讨论很重要。专家也应提供有用的信息，提议什整改会影响到客户，因此和他们讨论很重要。专家也应提供有用的信息，提议什么样的整改最适合现存的问题。么样的整改最适合现存的问题。 * Finally, from all possible corrective actions, the team may choose one based on cost / benefit analysis, speed of implementation, and the
49、 new level of risk.最后，对所有可能的最后，对所有可能的改善行动，小组可以成本改善行动，小组可以成本/效益分析，执行效益分析，执行快慢快慢，及新的风险，及新的风险等级选择等级选择其中其中一个行动计划一个行动计划20Failure Modes and Effects Analysis1 11. Identify corrective actions1. Identify corrective actions确认整改确认整改Example举例举例:10FebAllTrain in advanced driving techniques提提高驾驶技巧高驾驶技巧3505ABS and
50、 traction controlABS和牵和牵引控制引控制7Driving habit驾驶习惯驾驶习惯30MarRobertTake up matter with city与城市联系与城市联系3505Listen to forecasts听预报听预报7Slick roads潮湿的路潮湿的路 10Accident-injury事故受伤事故受伤Skids刹车刹车None无无844Temp gage3Cooling System制冷系统制冷系统22JanJohnInstall load capacity signs easily visible to driver在司机容在司机容易看到的地方粘易看