FMEA 培训Training 中英文PPT课件

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

2、缺陷和其影响进行识别,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WHY ? 为什么为什么Page 3第2页/共19页What is a Failure Mode ? 什么是失效模式什么是失效模式Failure Mode:The way in which the

3、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 the effect of a loos

4、e battery cable may be ?Page 4第3页/共19页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 battery cable causesexcessive heat

5、 to be generatedwhich can result in vehicle firePage 5第4页/共19页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. - Predict the impact corrective actions will

6、 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Page 6第5页/共19页Process Map Link to FMEA 工艺流程图与工艺流程图与FMEA的联系的联系Process Step/InputPotential Failure ModePotential Failure EffectsSEVPotential CausesOCCCurrent ControlsDETRPNWhat is the

7、process step/ Input under investigation?In what ways does the Key Input go wrong?What is the impact on the Key Output Variables (Customer Requirements) or internal requirements?How Severe is the effect to the cusotmer?What causes the Key Input to go wrong?How often does cause or FM occur?What are th

8、e existing controls and procedures (inspection and test) that prevent eith the cause or the Failure Mode? Should include an SOP number.How well can you detect cause or FM?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 inputs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 H

9、ow often (发生频率) x What detection rate (可侦测率)Page 7第6页/共19页Process Step/InputPotential Failure ModePotential Failure EffectsRPNActions RecommendedResp.Actions TakenSEVOCCDETRPNWhat is the process step/ Input under investigation?In what ways does the Key Input go wrong?What is the impact on the Key Ou

10、tput Variables (Customer Requirements) or internal requirements?What are the actions for reducing the occurrance of the Cause, or improving detection? Should have actions only on high RPNs or easy fixes.Whose Responsible for the recommended action?What are the completed actions taken with the recalc

11、ulated RPN? Be sure to include completion month/yearIdentify 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 工艺流程图与FMEA的联系第7页/共19页Definition of Terms 各要素各要素定义定义: simple description of th

12、e process step or function being analysed.对工序做简单的描述或功能的分析: the manner in which a specific Process Step could potentially fail 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 pre

13、vious operation or can be associated with a failure in a subsequent operation. 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下道工序的差错有联系.: 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

14、 what the customer might notice or experience in the final product 对客户的影响. 通常是指外部客户, 但也可扩展至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. : 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 is

15、sues if failure occurs. 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frequency with which Failure Mode could occur. Usually refers to the frequency of a Failure Mode 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) methods/devices in place to prevent or detect Failure Modes or Causes (before cau

16、sing effects). Prevention consists of mistake-proofing, SPC, automated control and set-up verifications. 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. ability of current controls to detect: the causes before creating failure mode and or the failure modes before causing effect 当前控制手段下, 在失效模式发生前或

17、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Risk Priority Number (RPN) 风险优先风险优先指数指数F The output of an FMEA is the FMEA的输出就是风险优先指数(RPN).F The 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 mo

18、des,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 ability 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. F It is calculated as the product of three quantitative ratings, each one related to the effects, causes

19、, 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.F The Risk Priority Numbers are then sorted and actions are recommended 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 frus

20、tration 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 (Process 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

21、.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.OK !Its a 9 !Page 12第11页/共19页FMEA Severity rating scalePage 13第12页/共19页FMEA Occurrence ratingPage 14第13页/共19页FMEA Detection RatingPage 15第14页/共19页Dynamics of the RPNSev Occ Det RPN Result Actions

22、 1 1 1 1 Ideal Situation理想的情况 No Action 不采取行动 1 1 10 10 Assured Mastery保证精通 No Action 不采取行动 10 1 1 10 Failure does not reach user 失败并没有达到用户 No Action 不采取行动 10 1 10 100 Failure reaches user 心力衰竭达到用户 Improve Det 提高检测 1 10 1 10 Freq. fails, detectable, costly 频繁发生故障，探测，昂贵 Improve Process 改进工艺 1 10 10 100 Freq. fails, reaches user 频繁的失败，达到用户 Work Det and then Process改善检测，然后工艺 10 10 1 100 Freq. fails w/major impact 频繁的失败，并产生重大影响 Improve Process 改进工艺 10 10 10 1000 Big Trouble! 大麻烦！ New Process 重大改进 Page 16第15页/共19页FMEA Procedure Overview (FMEA 制定步骤概述制定步骤概述)Page 17第16页/共19页Page