【Dell的FMEA教材失效模式影响分析】.docx

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Failure Mode Effects Analysis 失效模式影响分析 Objectives 课程目标 By the end of the training, you will be able to: 在本堂课程结束时, 您将能够: 1. Compare and contrast the different types of failure mode effects analysis (FMEA). 比较与对照不同类别的失效模式影响分析 (FMEA). 2. Characterize the differences in questions asked in completing each type of FMEA. 区分在完成不同类别的FMEA过程中所提出问题的特性. 3. Define design FMEA and process FMEA. 定义设计FMEA与流程FMEA. 4. Describe how to apply FMEA to a process map. 了解如何将FMEA运用于流程图. 5. List the steps and components used in building an FMEA. 将建立FMEA的步骤与要件列出. 6. Demonstrate how to assess level of risk. 展示如何评估风险等级. 7. Prioritize risk assessment to drive corrective actions. 排定风险评估优先级以推动矫正措施. FEMA and What is it? 什么是失效模式影响分析 FMEA Could these have been avoided? · The Bhopal tragedy · The Valujet air crash · The contamination of meat at Hudson Foods · The Y2K problem 下列事件原本是否可以避免呢? · 印度波布尔化工厂毒气外泄惨剧 · 美国Valujet 航空公司坠机意外 · 美国Hudson食品公司肉品污染事件 · 千禧虫问题 What is FMEA? 什么是失效模式影响分析 · Disciplined approach to studying failures in - Product - System - Process - Service - Plus causes and effects 有系统的研究下列各种失效 - 产品 - 系统 - 流程 - 服务 - 原因与结果 · Method that quantifies level of risk 用量化评估风险等级的一种方法. · Requirement of QS9000 QS9000 品管系统要求条件之一. · Tool to use on new or existing products, processes, services, etc. 用于新的或现有的产品, 流程, 服务, 等等的工具. When FMEA’s Should Be Conducted 何时该做FMEA Life Cycle Cost 生命週期成本 Stages in Product/Service Life Cycle 產品/服務生命週期之各個階段 FMEA Exercise FMEA练习 FMEA Exercise 1 FMEA练习一 Consider the pager as a communication device. Answer the following questions: 将呼叫器当做一个通讯工具. 回答下列问题: 1. Identify the most serious failure that can occur with a pager. 列出呼叫器可能发生最严重的失效状况 (故障). _______________________________________________________________________________________________________________________________________________________________________________________ 2. What could be the “worst case” effect of this failure? 这个失效状况所能导致的最糟结果是什么? ___________________________________________________________________________________________________________________________________________________________________________________________________________________________ 3. Identify 5 causes that lead to such failure, and rank in order of priority for corrective action. 列出五个导致这个失效状况的原因, 并将它们矫正措施的优先等级列出. Cause 原因 Rank 等级 FMEA Exercise 1, Continued FMEA练习一, 续前页 Points to consider: · What was the basis for allotting the ranks you did? · How sure did you feel about what you were doing? · Do you think your ranking will agree with most other people in the class? Why? · Would a team effort be better or worse? 考虑以下各点: · 您分配优先等级的参考依据是什么? · 您对您的结论有多大的信心? · 您认为这个班里大部份的学员会同意您的评比等级吗? 为什么? · 小组合作的结果会更好或更差? Failure Mode Effects Analysis, Continued FMEA分析, 续前页 Probability of Occurrence – Cause 发生机率 – 原因 Very rare, maybe once in 10 yrs., or <1 ppb 1 非常罕见, 每＋年才可能发生一次, 或小于十亿分之一 Rare, maybe once in 5 yrs., or X00 ppb 2 罕见, 每五年才可能发生一次, 或大约为十亿分之数百 Could occur somewhat frequently, more than once / 2 yrs., or <100 ppm 3 发生频率略高于每两年一次, 或小于百万分之一百 Could occur 1 to 3 times / yr or between 100 and 1000 ppm 4 每年发生一至三次, 或介于百万分之一百至百万分之一干 Definitely more than one occurrence per quarter, or above 1000 ppm 5 发生频率多于每季一次, 或高于百万分之一千 Severity – Effect 严重性 – 影响 Minor inconvenience in personal / work life 1 对个人生活与工作稍有不便 Noticeable impact to work schedule / personal plans 2 对个人与工作计划稍有影响 Affects relationships with boss / family members 3 对上司 / 家人之间的关系有影响 Loss of revenue, relationships, and or reputation 4 对收入, 关系, 或名誉有损失 Could result in injury, / other safety issues 5 导致受伤或其它安全事故 Detection – Failure Mode (or Cause) 侦测能力 – 失效模式 (或原因) Failure or its cause is readily or self evident 1 失效本身或其原因显而易见或自行彰显 Manual inspection or test can easily detect failure / cause 2 人工检验或测试可以轻易侦测到失效或其原因 Failure is hard to detect, special instruments or training req. 3 失效不易侦测, 必须要有特殊仪器或训练 Failure detection will destroy the unit 4 失效侦测过程会损毁产品 Failure can slip by unnoticed 5 无法侦测到失效 Complete the following FMEA Rating Worksheet for the problem in Exercise 1. 将练习一的问题排定FEMA优先等级并填入下表. Product or feature 产品或特性 Failure mode 失效模式 Effect 影响 S Cause 原因 O Current controls 现行管制 D RPN 风险系数 Rank 等级 Failure Mode Effects Analysis, Continued FMEA分析, 续前页 Common types of FMEA FMEA的一般类型 · Design/Product – Focus on product, system, sub-system, or component part 设计/产品 – 重点在产品, 系统, 次系统, 或零附件. · Process – Focus process. Output usually a product 流程 – 重点在流程本身. 其输出通常为产品. · Service – Focus on process, but output is service 服务 – 重点在流程. 但其输出为服务. Design/Product FMEA 设计/产品FMEA Benefits: · Increases robustness of designs · Identifies failure modes · Enables priority setting for corrective action · Supports failure discussion between different groups · Provides a framework for continuous improvement of designs · Identifies often missed failure modes when used at systems level Customers: End user, manufacturing, assembly, service and … 好处: · 更完善的产品设计 · 找出失效模式 · 得以设定矫正措施的优先级 · 支持不同工作小组之间的失效案例讨论 · 提供设计持续改善的工作架构 · 找出在系统阶层经常遗漏的失效模式客户: 最终用户, 制造, 组装, 服务, 与… Process FMEA 流程FMEA Benefits: · Increases robustness of process · Identifies high risk process steps · Identifies process variables controls · Supports failure discussion between different groups · Documents results of process · Provides framework for continuous improvement of processes · … · … Customers: End user, down stream manufacturing / assembly processes, service operations and… 好处: · 更完善的流程设定 · 找出高风险的流程步骤 · 找出流程变量的控制办法 · 支持不同工作小组之间的失效案例讨论 · 经由纸上作业制订流程 · 提供流程持续改善的工作架构 · … · … 客户: 最终用户, 下游制造, 组装流程, 服务作业, 与… Failure Mode Effects Analysis, Continued FMEA分析, 续前页 Service FMEA 服务FMEA Benefits: · Reduces probability of service not meeting expectations · Identifies failure modes · Enables prioritization for corrective action · Pin points high risk steps in service process · Identifies highest value control steps Customers: End user, downstream process owners, and …. 好处: · 降低服务不良的机率 · 找出失效模式 · 得以设定矫正措施的优先级 · 精确指出在服务流程中的高风险步骤 · 找出最高价值的管制步骤客户: 最终用户, 下游流程负责人, 与… Define the scope for the FMEA 定义FMEA的范围 Step 1 Define the boundaries within which the product, process, or service will be studied, identifying the operating assumptions, current conditions, and Constraints’ if any. 步骤一定义要所要研究的产品, 流程, 或服务的研究界限, 确定作业假设条件, 目前状况, 以及可能的限制. The Influence of Level 不同阶层的影响 Radiator Pump, V Belt Diaphragm, Bi Metal Spring Safety, Lubrication Engine, Braking, Exhaust Trans., Cooling Thermostat Example of a Product Level 阶层 Focus 重点 Failure Mode 失效模式 Cause 原因 Effect 影响 System 系统 Car 轿车 Overheating 引擎过热 Cooling system failure 冷却系统失效 Stranded on the road 在途中抛锚 Sub-system 次系统 Cooling system 冷却系统 Inadequate coolant flow 冷却剂循环不当 Thermostat stuck closed 澎胀阀死锁 Car overheating 轿车引擎过热 Sub-assembly 次组合 Thermostat 澎胀阀 Stuck closed 死锁 Bi-metal spring broken 铋金属弹簧断裂 Inadequate coolant flow 冷却剂循环不当 Component 零件 Bi-metal spring 铋金属弹簧 Broken 断裂 Fatigue 金属疲劳 Thermostat stuck closed 澎胀阀死锁 Failure Mode Effects Analysis, Continued FMEA分析, 续前页 Example of a Process 流程举例 Company Plant 4 Plant 3 Plant 2 Plant 1 PCB Line Power supplies FHP Motors Op 250 Op 20 Op 10 FMEA can be conducted at any of these levels; it all depends on your objective 依据您的目的, FMEA可应用于以上任何一个阶层. Op250 Op 240 210 Op 10 Op 120 Op250 OpA20 OpA10 Level 阶层 Focus 重点 Failure Mode 失效模式 Cause 原因 Effect 影响 System 系统 Factory (Plant 2) 工厂 (二厂) Late delivers to customer 交货延迟 Low FPY on Line 2 第二线直通率过低 Lost business 损失订单 Sub-system 次系统 Line 2 (power Supplies) 第二线 (电源供应器) Low FPY 直通率过低 High rework at / after testing 测试后重工率太高 Late deliveries 交货延迟 Operation 作业站 Testing Op 210 第210测试站 High rework 重工率太高 Testing results inconsistent 测试结果不稳定 Low FPY 直通率过低 Important: You must be able to see a cascading of failure modes, causes, and effects. 重要提示: 您必需要能看出失效模式, 原因, 和影响的系列关联. Failure Mode Effects Analysis, Continued FMEA分析, 续前页 Define the scope for the FMEA, cont. 定义FMEA的范围, 续前页 Step 2 Identify team members, customer, and knowledge expert/s Involve the customer in the process. 步骤二确定小组成员, 客户, 与专家. 邀请客户参与作业 Step 3 Develop roles and responsibilities for team members Leverage the strengths of each team member 步骤三指派小组成员职掌充分运用各小组成员之长处 Step 4 Study the product / Process / Service All team members work to familiarize themselves with the product, process, or service 步骤四研究产品 / 流程 / 服务各小组成员致力于熟习产品, 流程, 或服务 Step 5 Develop rating scales for Severity, Occurrence, and Detection 步骤五建立严重性, 发生机率, 与侦测能力的评比等级 Quantifying failure modes, effects and causes 量化失效模式, 影响, 与原因 Causes Failure Modes* Effects 原因失效模式影響 Occurrence Detection Severity 發生機率偵測能力嚴重性 How severe? 有多嚴重? Who has the most info? 誰有較多的資訊? How easy to detect with current controls? 現有的偵測能力有多好? Who has the most info? 誰有較多的資訊? If prevented will effects be eliminated? 預防措施是否可以消除影響? How frequent? 多頻繁? Who has the most info? 誰有較多的資訊? If eliminated, will failure be avoided? 如果消除了發生機率, 失效是否可以避免? Failure Mode Effects AnalysisError! No text of specified style in document., Rating Scales FMEA分析, 评比等级来源于中国最大的资料库下载 Rating scales 评比等级 Example from Design FMEA 设计FMEA举例 Severity 严重性 Occurrence 发生机率 Detection 侦测能力 Effect 影响 Cause 原因 Failure mode or cause 失效模式或原因 1 - No effect 无影响 2 - Minor effect - fit/cosmetics 轻微影响 – 配合 / 外观 3 - Major effect - fit/cosmetics 严重影响– 配合 / 外观 4 - Minor reduction in Function 功能稍受影响 5 - Customer dissatisfied 客户不满意 6 - Major reduction in function 功能大受影响 7 - Totally dysfunctional 功能完全不正常 8 - Presents minor hazard 形成轻微危险 9 - Presents injury hazard 造成受伤危险 10 - Fatal if used 造成致命危险 1 - Remote chance, <1ppm 微乎其微 2 - Very low 1-5 非常低 3 - Very low 5-10 非常低 4 - Moderate 10-100 中等程度 5 - Moderate 100-1K 中等程度 6 - High 1K-10K 高度 7 - High 10K-100K 高度 8 - Very High 100K-1M 非常高 9 - Very High 1M - 10M 非常高 10 - Almost certain 几乎是必然会发生 1 - Certain to be detected 一定能侦测出 2 - Very high chance of detection 非常高的机会能侦测出 3 - high chance of detection 很高的机会能侦测出 4 - Moderately high chance of detection 中高程度的机会能侦测出 5 - Moderate chance of detection 中等程度的机会能侦测出 6 - Low chance of detection 低程度的机会能侦测出 7 - Very low chance of detection 非常低程度的机会能侦测出 8 - Remote chance of detection 微乎其微的机会能侦测出 9 - Very remote chance of detection 非常微乎其微的机会能侦测出 10 - Slips by undetected 无法侦测 Rating scales 评比等级 FMEA; Step by Step FMEA; 逐步展開 5 Develop rating scales for Severity, Occurrence,and Detection Example from Process FMEA: Severity - effect 1 – No effect on operators, users, or current and down stream processes 2 – Minor rework at current step / no dysfunction introduced in product 3 – Rework at current / subsequent steps causing some delayed schedules, or product is rendered partially dysfunctional 4 – Heavy rework at subsequent operation, major delays in schedules, or product function is severely impacted 5 – Risk of injury or fatal Occurrence - cause 1 – Very rare occurrence, X00 ppb or once in 3 to 5 years 2 – Rare occurrence, X to X000 ppm, 2 to 5 occurrences in 3 years 3 – Frequent occurrence, X000 to X0,000 ppm, 1 to 3 occurrences in 1 year 4 – High frequency of occurrence, X0,000 to XM ppm, over 4 occurrences per year 5 – Almost certain Detection – failure mode (or cause in some cases) 1 – Certain to be detected, before any measurable damage is done 2 – Automated inspection / detection or strong process controls exist at current step or within the system boundaries 3 – Sampling plans used for inspection purposes 4 – 100% manual inspection methods used within system boundaries 5 – Defect unlikely to be detected, will slip by unnoticed 5 建立嚴重性, 發生機率, 與偵測能力的評比等級流程FMEA舉例: 嚴重性 – 影響 1. 對作業員, 使用者, 或目前及下游作業無影響. 2. 對該作業步驟輕微重工, 產品功能不受影響. 3. 對該作業 / 後續作業步驟重工而造成進度稍為落後, 或產品功能部份受影響. 4. 對後續作業步驟施以重大重工, 造成進度嚴重落後, 或產品功能嚴重受影響. 5. 有受傷或致命危險. 發生機率 – 原因 1. 發生機率非常罕見. 十億分之數百, 或三至五年發生一次. 2. 發生機率罕見. 百萬分之一至百萬分之數千, 或三年發生二至五次. 3. 發生機率時常. 百萬分之數千至百萬分之數萬, 或一年發生一至三次. 4. 發生機率頻繁. 百萬分之數萬至百萬分之數百萬, 或一年發生多於四次 5. 幾乎是必然會發生. 偵測能力 – 失效模式 (在某些案例中這個項目是原因) 1. 在損失造成前一定可以偵測到. 2. 自動檢驗 / 測試, 或對該流程或系統有週密的流程管制. 3. 依抽樣計劃檢驗. 4. 系統範圍內施行百分之百人工檢驗. 5. 無法偵測. Failure Mode Effects Analysis, Continued FMEA分析, 续前页 Rating Scale Worksheet 评比等级工作表 Severity 严重性 Occurrence 发生机率 Detection 侦测能力 Effect 影响 Cause 原因 Failure Mode or Cause 失效模式或原因 Failure Mode Effects Analysis, Continued FMEA分析, 续前页 Define the scope for the FMEA, cont. 定义FMEA的范围, 续前页 Step 6 Brainstorm failure modes, known and potential Identify as many failure modes as possible. 步骤六运用脑力激荡方法找出已知和可能的失效模式尽可能的找出各种失效模式 Separating Failure Modes, Effects and Causes 區分失效模式, 影響, 與原因 Multiplicity will exist for causes, failure modes, and effects 重複性存在於各個原因, 失效模式, 與影響之間 Failure Modes : Will share causes, and effects 失效模式 : 不同的失效模式會有共同的原因與影響 Causes : The reasons for failure, can be one or many for a given failure mode 原因 : 某個失效的 (多個) 原因, 可能是另一個失效模式中一或多個的原因. Effects : The results of the failure, can be one or many for a given failure mode 影響 : 某個失效的 (多個) 結果, 可能是另一個失效模式中一或多個的結果. Failure Mode 3 Failure Mode 1 Effect 3 Effect 2 Effect 1 Cause 4 Cause 3 Cause 2 Cause 1 Failure Mode 2 Error! No text of specified style in document.Failure Mode Effects Analysis, Continued FMEA分析, 续前页 Define the scope for the FMEA, cont. 定义FMEA的范围, 续前页 Step 7 List the effects, causes, and current controls for each failure mode Include input from customer and knowledge experts 步骤七列出每一个失效模式可能产生的所有影响, 原因, 与目前的管制办法将客户与专家的意见包含在内 FMEA; Step by Step FMEA; 逐步展開 7 List the effects, causes, and current controls for each failure mode 列出每一個失效模式的所有影響, 原因, 與目前的管制辦法 Example: 舉例 Failure Mode Effects Analysis, Continued FMEA分析, 续前页 Define the scope for the FMEA, cont. 定义FMEA的范围, 续前页 Step 8 Assign ratings for Severity, Occurrence, and Detection Work to reach team consensus 步骤八列出严重性, 发生机率, 和侦测能力的评比等级致力于达成小组共识 FMEA; Step by Step FMEA; 逐步展開 8 Assign ratings for Severity, Occurrence, and Detection 列出嚴重性, 發生機率, 和偵測能力的等級 Example: 舉例 Failure Mode Ef

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