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1、WHAT?定义定义Failure Mode and Effects Analysis:失效模式与影响分析定义失效模式与影响分析定义A systematic method to qualify the causal relationship within systems,process and designs:对系统,过程和设计中各因素间因果关系进行定量分析的工具Identify,evaluate,and prioritize potential defects(failures)and their effects on their customers对于在客户处存在的潜在的缺陷和其影响进行识别
2、,评估和划分优先等级.Identify actions that could eliminate or reduce the defects(failures)from occuring识别能够预防或减少这些缺陷发生的行动.Document the actions and their potential effects记录这些行动和其潜在影响.Page 2第1页/共19页第一页,编辑于星期五:十九点 四十三分。WHY?为什么为什么Page 3第2页/共19页第二页,编辑于星期五:十九点 四十三分。What is a Failure Mode?什么是失效模式什么是失效模式Failure Mode
3、:The way in which the component,subassembly,product or process could fail to perform its intended function Failure modes may be the result of upstream operations or may cause downstream operations to fail.造成部品,组件和总成的原有功能失去效能的方式.失效模式可能是上道工序的结果或是下道工序失败的原因.Loose Battery CableExampleWhat do you think th
4、e effect of a loose battery cable may be?Page 4第3页/共19页第三页,编辑于星期五:十九点 四十三分。Failure Effects 失效影响失效影响Failure Effect:失效影响The outcome of the occurrence of the failure mode on the system,product or process.The“IMPACT”on the customer.失效模式发生后对系统,产品和工序造成的结果,和对客户的影响.From previous slide loose or corroded batt
5、ery cable causesexcessive heat to be generatedwhich can result in vehicle firePage 5第4页/共19页第四页,编辑于星期五:十九点 四十三分。Why use an FMEA?为什么要使用为什么要使用FMEATo evaluate the design validation plan(Product)and the current control plan(Process)for preventing failures from occurring.为了评估产品/设计计划和当前控制计划(工序),以期预防失效的发生.
6、-Predict the impact corrective actions will have on specific failure modes预测针对特定失效模式的整改行动的效果.-Establish a continuous improvement priority system.建立基于持续改进的优化系统Remember This tool is best used in a proactive manner,but may also be used in Remember This tool is best used in a proactive manner,but may al
7、so be used in a reactive situation.a reactive situation.这是具有前瞻性的工具这是具有前瞻性的工具这是具有前瞻性的工具这是具有前瞻性的工具,同时也用于反应行动的制定同时也用于反应行动的制定同时也用于反应行动的制定同时也用于反应行动的制定.Page 6第5页/共19页第五页,编辑于星期五:十九点 四十三分。Process Map Link to FMEA 工艺流程图与工艺流程图与FMEA的联系的联系Identify failures and impacts(output)识别失效模式和影响识别失效模式和影响(输出输出)Assess input
8、s评估输入因素评估输入因素Prioritise优先等级优先等级RPN=How severe(严重度)x How often (发生频率)x What detection rate(可侦测率)Page 7第6页/共19页第六页,编辑于星期五:十九点 四十三分。Identify output failures and impacts识别失效模式和影响识别失效模式和影响(输出输出)Prioritise优先等级优先等级Determine actions and predict impact决定采用的措施和决定采用的措施和预计的效果预计的效果Page 8Process Map Link to FMEA
9、工艺流程图与FMEA的联系第7页/共19页第七页,编辑于星期五:十九点 四十三分。Definition of Terms 各要素定各要素定义义Process Process Step/FunctionStep/Function:simple description of the process step or function being analysed.工艺步骤工艺步骤/职能职能:对工序做简单的描述或功能的分析Failure Failure ModeMode:the manner in which a specific Process Step could potentially fail
10、 to meet process requirements or intent.It is a description of malfunction at the process step under consideration.The Failure Mode can be associated with a failure in a previous operation or can be associated with a failure in a subsequent operation.失效模式失效模式:在该工序中引起无法满足设定要求的潜在原因,并给予描述.失效模式可能是与上道工序或
11、下道工序的差错有联系.Failure Failure EffectEffect:impact on the customer.Generally external customer focus,but can also include downstream processes affected by the Failure Mode.The effect is described in terms of what the customer might notice or experience in the final product失效影响失效影响:对客户的影响.通常是指外部客户,但也可扩展至
12、下道工序所受的影响.该影响是指客户在产品的使用中会被告知或感受到的.SeveritySeverity:a numeric rating given to a failure effect to describe the importance of the failure effect on the customer.Could also be concerned with potential safety or regulatory issues if failure occurs.(Scale usually 1-10,1=not severe,10=very severe)(Scale u
13、sually 1-10,1=not severe,10=very severe)严重度严重度:按失效模式影响的严重程度以量化的方式进行反映.也可看作失效模式发生会产生潜在的安全性问题Page 9第8页/共19页第八页,编辑于星期五:十九点 四十三分。Occurrence Occurrence:frequency with which Failure Mode could occur.Usually refers to the frequency of a Failure Mode(Scale usually 1-10,1=Not(Scale usually 1-10,1=Not Likely,
14、10=Very Likely).Likely,10=Very Likely).发生频次发生频次:失效模式可能发生的频率(标准1-10,1 频率极低,10 频率极高)Current Current ControlsControls:methods/devices in place to prevent or detect Failure Modes or Causes(before causing effects).Prevention consists of mistake-proofing,SPC,automated control and set-up verifications.当前控制
15、方法当前控制方法:目前用于预防或探测失效模式/原因的方法和设备.预防手段包括防误措施,SPC,自动化控制和核查.Detection(capability of Current ControlsDetection(capability of Current Controls):ability of current controls to detect:the causes before creating failure mode and or the failure modes before causing effect(Scale usually 10-1,1=Very Likely to D
16、etect,(Scale usually 10-1,1=Very Likely to Detect,10=Not Likely to Detect)10=Not Likely to Detect)探测探测(限于当前控制方法限于当前控制方法):):当前控制手段下,在失效模式发生前或失效模式发生影响前的探测能力.(标准1-10,1 探测能力极高,10 探测能力极低)Page 10Definition of Terms 各要素定义第9页/共19页第九页,编辑于星期五:十九点 四十三分。Risk Priority Number(RPN)风险优先指数风险优先指数FThe output of an FME
17、A is the Risk Priority Number(RPN)Risk Priority Number(RPN)FMEA的输出就是风险优先指数(RPN).FThe RPN is a calculated number based on information your team provides regarding RPN指数的计算基于以下内容:the potential failure modes,潜在失效模式 the effects,as seen by the customer(normally end user)失效模式的影响,通常指客户受的影响.the current abil
18、ity of the process to detect the failures before reaching the customer 当前的控制手段在失效影响客户前的探测能力.FIt is calculated as the product of three quantitative ratings,each one related to the effects,causes,and controls:该数字由三个量化指标构成,分别与影响,起因和控制手段相关.FThe Risk Priority Numbers are then sorted and actions are recom
19、mended for the top issues.通过风险优先指数进行筛选,针对风险指数排名高的项目建议实施整改.Page 11第10页/共19页第十页,编辑于星期五:十九点 四十三分。Rating Scales 指数指数Subjectivity in rating 定义Severity customers pain level严重度:客户抱怨的等级 Occurrence process owners frustration level 发生频率:工序操作人员出现差错的等级Detection MSA confidence level探测度:MSA等级Supporting data(Proce
20、ss FMEA)支持性数据支持性数据(Process FMEA)Severity external failure data+feedback from customers&design team严重度:外部失效数据和客户/设计团队的反馈.Occurrence process capability data and internal failure data发生频率:供应能力参数和内部缺陷数据.Detection audit or test data,comparison of internal vs external failure data探测度:审核或检测数据,内部和外部缺陷数据的比较.
21、OK!Its a 9!Page 12第11页/共19页第十一页,编辑于星期五:十九点 四十三分。FMEA Severity rating scalePage 13第12页/共19页第十二页,编辑于星期五:十九点 四十三分。FMEA Occurrence ratingPage 14第13页/共19页第十三页,编辑于星期五:十九点 四十三分。FMEA Detection RatingPage 15第14页/共19页第十四页,编辑于星期五:十九点 四十三分。Dynamics of the RPNPage 16第15页/共19页第十五页,编辑于星期五:十九点 四十三分。FMEA Procedure O
22、verview (FMEA 制定步骤概述制定步骤概述)Page 17第16页/共19页第十六页,编辑于星期五:十九点 四十三分。Page 18 中文译文中文译文FMEA Procedure Overview (FMEA 制定步骤概述)第17页/共19页第十七页,编辑于星期五:十九点 四十三分。FMEA Procedure 程序 Before You Begin 在您开始之前之前 Remember the following 请牢记如下要点:1.It is a team effort use process experts 这是一个团队的努力-运用流程的专家.2.Motivated team m
23、embers facilitated by tool expert 动机的团队成员-灵活运用工具的专家 3.Cross-functional representation on the team 跨职能的团队4.Perform on the“as is”process rather than the“to be”process 遵循“客观存在”的过程,而不是“预计的”过程.5.Treat as a living document,reflect the latest changes 视为一份活的文件,反映最新变化 6.Develop Severity,Occurrence and Detection Scales 不断发展中的严重程度,发生规律及检测标尺7.Recommend actions and assign milestones,inputs to Project Plan,Gantt charts,accountabilities and dates for completion of the action items 提出行动建议,并指定里程碑,投入的项目计划,甘特图表,问责制和竣工日期的行动项目第18页/共19页第十八页,编辑于星期五:十九点 四十三分。感谢您的观看。第19页/共19页第十九页,编辑于星期五:十九点 四十三分。
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