1、.1April ,2010TM-002 , Rev:00 Prepared By : HenryLi PROCESS FAILURE MODE ANDPROCESS FAILURE MODE ANDEFFECT ANALYSIS TRAININGEFFECT ANALYSIS TRAINING制程失效模式及後果分析培訓制程失效模式及後果分析培訓.2HISTORY OF FMEAHISTORY OF FMEA FMEA FMEA的歷史的歷史 It was formalized in the aerospace industry during the Apollo program in the 1

2、960s.形成於20世紀60年代航空工業(yè)的阿波羅計劃 Initially adopted in the automotive industry in the 1970s focusing on safety issues.最初於20世紀70年代應用於汽車工業(yè)，主要針對安全問題 In 1994, all automotive suppliers were required use of FMEA under QS9000 standard. It is a major element of Advanced Product Quality Planning Process. 1994年，所有汽車

3、行業(yè)處於QS9000標準下的供應商均被 要求使用FMEA。 FMEA 是產(chǎn)品質量先期策劃的一個主要部分 Now adopted by many other industries.現(xiàn)已被許多其它工業(yè)應用.3INTRODUCTIONINTRODUCTION 簡介簡介 is an analytical technique to ensure that potential failure modes and associated causes/mechanisms are identified and addressed.是一種分析工具，用來確保潛在失效模式及其起因和機理被識別且被解決 is a su

4、mmary of the teams thoughts as a process is developed.是制程開發(fā)過程中小組思想的總結 it includes an analysis of items that could go wrong based on experience past performance,and quality performance indicators (i.e yield,In-process QA & OQA LAR/PPM, Cpk, etc.) 它對可能會出錯的項目進行分析，這些分析以經(jīng)驗、以往性能和質量性能指標（如產(chǎn)量、制程QA和去貨QA的批量接收率

5、/每百萬壞品率、制程能力指標等）為基礎 it formalizes the mental discipline that an engineer normally goes through in any manufacturing planning process.它總結了一般情況下工程師在策劃任一個制程時所要經(jīng)歷的邏輯順序和背景.4TYPES OF FMEATYPES OF FMEA FMEA FMEA的分類的分類 Design FMEA 設計FMEA Process FMEA 制程FMEA.5 What is FMEA? 什么是FMEA? FMEA is complementary to

6、the process of defining what a design or process must do to satisfy the customer.FMEA是對確定設計或過程必須做哪些事情才能使顧 客滿意這一過程的補充。 All FMEAs focus on the design, whether it be of the product or process.所有FMEA都關注設計，無論是產(chǎn)品設計或者是過程 設計。.6 What is an FMEA? 什麼是FMEA?Group of activities 系統(tǒng)化的活動 Recognize & evaluate potenti

7、al failure of product/process 認可并評價產(chǎn)品/過程中的潛在失效 Identify actions to reduce the chance of the failure occurring 確定能消除或減少潛在失效發(fā)生機會的措施 Document entire process 將全部過程形成文件.7 COPQ at different stages 各階段糾正問題的成本成 本1000100預 防1Des i gnAppl i cat i on設 計應 用時 間10尋 找 方法 及 解決 問 題Pr oduct pl anni ng產(chǎn) 品 策 劃Manuf act

8、ur i ng製 造Cus t omer compl ai nt 客 戶 投 訴Manuf act ur i ng & As s embl y製 造 及 裝 配Des i gn Appr oval 設 計 核 準FMEA7.8 FMEA Implementation FMEA的實施Because of the general industry trend to continually improve products and processes whenever possible, using the FMEA as a disciplined technique to identify an

9、d help minimize potential concern is as important as ever. Studies of vehicle campaigns have show that fully implemented FMEA programs could have prevented many of the campaigns.因為一般的企業(yè)趨向于使用FMEA確定和幫助使?jié)撛趩栴}最小化來達到產(chǎn)品和制程持續(xù)改善的目的.汽車行業(yè)的研究表明FMEA的執(zhí)行將能防止很多問題. .9 FMEA Implementation FMEA的實施Key Success Factors 成

10、功因素 Timeliness 時間性“Before the event” Not “After the fact”“事件發(fā)生前”不是“事實出現(xiàn)后” Follow up 跟蹤Ensure all actions have been implemented 確保所有行動已執(zhí)行.10 Three Basic Cases to Generate FMEA 進行FMEA時有的三種基本情形Each with different scope and focus:每種情形都有不同的范圍和側重點:Case 1:New design, new technology or new process.The scope

11、 is the complete design, technology, process.情形1:新設計、新技術或新制程.范圍是全部的設計、技術或制程. Case 2:Modifications to existing design or process.The scope should focus on the modification to design or process,possible interactions due to the modification. 情形2:對現(xiàn)有設計或制程的修改.范圍是側重于對設計和制程的修改及修改可能帶來的相互作用.Case 3:Use of exi

12、sting design or process in a new environment,location,or application, The scope is the impact of the new environment,location on the existing design or process. 情形3:將現(xiàn)有的設計或制程用于新的環(huán)境、場所或應用,范圍是新的環(huán)境、場所對現(xiàn)有設計和制程的影響.11 Who Edit FMEA ? 誰編制FMEA？ Although responsibility for the preparation of the FMEA usually

13、 assigned to individual, FMEA input should be a team effort.FMEA的編制責任通常都指派到某個人，但是FMEA的輸入應是工作小組的努力 The FMEA is initiated by the engineer from the responsible activity. FMEA由負責各個項目的工程師編制. .12 Follow Up of FMEA FMEA的跟蹤 Responsible engineer is in charge of ensuring that all recommended actions have been

14、 implemented or adequately addressed.責任工程師負責確保所有的建議措施都得到實施或充分的強調 A thoroughly thought-out and well-developed FMEA will be of limited value without positive and effective preventive/corrective actions. 一個經(jīng)過徹底思考、周密開發(fā)的FMEA，如果沒有積極有效的預防/糾正措施，其價值將是非常有限的。.13 How to follow Up 怎樣跟蹤The responsible engineer ha

15、s several means of assuring that recommended actions are implemented. They include,but are not limited to the following:責任工程師有幾種方法但不局限于下列幾種方法來確保建議的措施被執(zhí)行.Reviewing designs, processes and drawing to ensure the recommended actions have been implemented. 對設計、過程及圖樣進行評審以確保建議的措施被執(zhí)行 Confirming the incorpora

16、tion of changes to design/assembly/manufacturing documentation 確認更改已納入到設計/裝配/制造文件中 Reviewing Design/Process FMEA, special FMEA applications and control plan 對設計/過程FMEA、FMEA的特殊應用以及控制計劃進行評審.14 When to update of FMEA? 何時更新FMEA？FMEA is a living document and should always reflect the latest level, latest

17、 relevant actions, including those occurring after the start of production.FMEA是一份動態(tài)文件,始終反映最新水平以及最近的相關措施，包括生產(chǎn)以后發(fā)生的。.15 PFMEAPFMEA簡介簡介A process potential FMEA is an analytical technique used by a manufacturing /assembly-responsible engineer/team as a means to ensure that,to the extent possible,potent

18、ial failure modes and their associated causes/mechanisms have been considered and addressed.An FMEA is a summary of the teams thoughts. 過程FMEA是由負責制造/裝配的工程師/小組主要采 用的一種分析技術，用以最大限度地保證各種潛在的失效模式及其相關的起因/機理已得到充分的考慮和論述。 FMEA是團隊思想的總結。.16 Introduction of PFMEA 過程FMEA簡介Identifies the process functions and requ

19、irements and potential product and process related failure mode, 確定過程功能和要求, 確定與產(chǎn)品和過程相關的潛在失效模式； assesses the effects of the potential failures on the end-users, identify the potential manufacturing or assembly process causes and identify process variables on which to focus controls for occurrence red

20、uction or detection of the failure conditions.評價潛在失效對顧客產(chǎn)生的后果；確定潛在制造或裝配過程起因并確定要采取控制來降低失效產(chǎn)生頻度或失效條件探測度的過程變量;.17 Introduction of PFMEA 過程FMEA簡介 Identifies process variables on which to focus process controls; 確定過程變量以此聚焦于過程控制； Develops a ranked list of potential failure modes,thus establishing a priority

21、 system for preventive/corrective action considerations;編制一個潛在失效模式的分級表，以便建立一個考慮預防/糾正措施的優(yōu)選體系； Documents the results of the manufacturing or assembly process記錄制造或裝配過程的結果.18 Identification of Customer 顧客的定義 Usually,it means End-User.通常是指“最終使用者”. It may also be sequential manufacturing/assembly process,

22、rework process or government regulation.也可以是隨后或下游的制造或裝配工序，維修工序或政府法規(guī).19 過程FMEA PFMEA should be initiated ：過程FMEA應： Before or at the feasibility stage ； 在可行性階段或之前進行； Prior to tooling for production ； 在生產(chǎn)用工裝到位之前完成； Take into account all manufacturing operations,from individual components to assemblies

23、考慮到從單個部件到總成的所有的制造工序 .20 過程FMEA Early review and analysis of new or revised processes is promoted to anticipate, resolve, or monitor potential process concerns during the manufacturing planning stages ; 在生產(chǎn)計劃階段對新的或修改的制程的早期評估和分析有助于預見,解決或監(jiān)控潛在制程因素; The process FMEA assure the product as designed will me

24、et the design intent 過程FMEA假定所設計的產(chǎn)品能夠滿足設計要求； 20.21 過程FMEADoesnt rely on product design changes to overcomeweaknesses in the process過程FMEA不依靠改變產(chǎn)品設計來克服過程中的薄弱環(huán)節(jié) But take into consideration a products designcharacteristics relative to the planned manufacturing orassembly process但要考慮與計劃的制造/裝配過程有關部門的產(chǎn)品設計特

25、性21.22 過程FMEA Begin with a flow chart of the general process,this flowchart should identify the product/processcharacteristics associated with each operation過程FMEA應從一般過程的流程圖開始，該流程圖應明確與每一工序相關的產(chǎn)品/過程特性。 In order to facilitate documentation of the analysis ofpotential failures and their consequences,a P

26、FMEAform has been developed.為了便于FMEA的文件化，編制了標準的過程FMEA表供參考.22.23 Process FMEAFMEA #FAILURE MODE AND EFFECTS ANALYSISPage of Item2Process ResponsibilityModel Years(s)Vehicle(s).Key DatePrepared byCore Team:8FMEA Date (Orig.) (Rev.)ProcessCPotentialCurrentCurrentFunctionPotential Potential SLCause(s)/O

27、ProcessProcessDRRecommended Resp. &SODRFailure Effect(s)of EAMechanism(s)CControlsControlsEPActionsTargetActionsECEP RequirementsModeFailureVSof FailureCPreventionDetectionTNDateTakenVCTNS 101112 131415161617 1819202195143Actions Results 2267What are the Functions,Features or RequirementsWhat can go

28、 wrong ?-No Function-Partial/ Over / Degraded Function-Intermittent Function-Unintended FunctionWhat are theEffects?How bad is it ?What are the cause(s) ?How often does it happen? What can be done ?-Design Changes-Process Changes-Special Controls -Changes to Standards, Procedures, or GuidelinesHow c

29、an this be prevented and detected ?How good is this method at detecting it ?.24 編制過程FMEAv 1 FMEA number FMEA編號 Enter the FMEA document number, which may be used for tacking 填入FMEA文件的編號以便查詢v 2 Item 項目 Enter the name and number of the system, subsystem, or component for which the process is being anal

30、yzed 注明正在進行過程分析的系統(tǒng)、子系統(tǒng)或部件的名稱和編號. .25 編制過程FMEAv 3 Process Responsibility 過程責任者Enter the OEM, department, and group. Also includethe supplier name, if applicable 填入制造/裝配產(chǎn)品的車間、部門和小組，若已知，還包括供方v 4 Prepared By 編制人Enter the name, telephone number, and company of theengineer responsible for preparing the FM

31、EA負責編制FMEA的工程師的姓名、電話和所在公司名稱.26 編制過程FMEAv 5 Model Year(s) /Program(s) 車型年/項目Enter the intended model year(s)/program(s) that will use and/or beaffected by the design being analyzed (if know)填入所分析的設計/過程將要應用和/或影響的車型年/項目(若已知)v 6 Key Date 關鍵日期 Enter the initial FMEA due date, which should not exceed thes

32、cheduled start of production date 初次FMEA應完成的時間，該日期不應超過計劃的投入生產(chǎn)日期 In case of a supplier, the initial FMEA due date should not exceed thecustomer required production PPAP submission date.對于供方，初始的FMEA日期不應超過顧客要求的生產(chǎn)件批準過程的提交日期。.27 編制過程FMEAv 7 FMEA Date FMEA日期Enter the date the original FMEA was complied an

33、d the latest revision date 填入編制FMEA原始稿的日期及最新修訂的日期v 8 Core Team 核心小組List the names of the responsible individuals andDepartments(each team numbers name,department,telephone number, address) that have the authority to identify and/or perform tasks列出有權確定和/或執(zhí)行任務的責任部門的名稱和個人的姓名，建議所有參加人員的姓名、部門、電話、地址等都應記錄在一

34、張分發(fā)表.28 9. Process Function/Requirements 過程功能/ 要求 Based on manufacturing and assembly process flow chart 基于制造與裝配過程流程圖 Based on team knowledge 以小組的集體知識為基礎 Whats the process for?這個生產(chǎn)過程要做什么？ Whats the purpose?其目的是什么？ Whats the function?其功能是什么？.29 9. Process Function/Requirements 過程功能/ 要求v Enter a simpl

35、e description of the process or operation being analyzed.Where the process involves numerous operations with different potential modes of failure, it may be desirable to list the operations as separate elements. 填寫過程或操作的簡單說明/目的。如果過程包含許多不同的潛在失效模式的操作，則每一操作分別列出。例如，將多工作機床的每一操作或一臺加工設備的順序過程都列出。 Example:#2

36、0 : drilling 操作#20 : 鉆孔 Example:#30 : Spot welding a to b 操作#30 : 將零件A焊至零件B Example:#40 : Put x into y 操作#40 : 將零件X裝進部件Y.30 10. Potential Failure Mode 潛在失效模式v The manner in which the process could potentially fail to meet the process requirements and/or design intent as described in the process func

37、tion/requirements column, its a description of the nonconformance at that specific operation. 指過程有可能不能滿足過程功能/要求欄中所描述的過程要求和/或設計意圖，是對該特定工序上的不符合的描述。.31 10. Potential Failure Mode 潛在失效模式vit can be a cause associated with a potential failure mode in a subsequent operation or an effect associated with at

38、potential failure in a previous operation 可能是下一工序 的某個潛在失效模式的一個相關起因或是上一工序的某個潛在失效模式的一個相關后果vAssumption: that the incoming parts are correct應假定所接收的零件/材料是正確的。.32 10. Potential Failure Mode 潛在失效模式vList each potential failure mode for the particular operation .The process engineer should be able to pose an

39、d answer the questions：列出每個操作的所有失效模式.過程工程師應提出并回答下列問題： How can the process/part fail to meet requirements?零件/過程怎樣不滿足要求？ Regardless of engineering specification,What would a customer (end user,subsequent operations or service) consider objectionable?無論工程規(guī)范如何，顧客（最終使用者，后續(xù)工序或服務）認為的可拒收的條件是什么？.33 10. Poten

40、tial Failure Mode 潛在失效模式vTypical failure modes ：典型的失效模式可能是但不局限于： Bent彎曲 Burred毛刺 Hole off-location孔錯位 Cracked斷裂 Hole too shallow開孔太淺 Hole missing漏開孔 Handling damage轉運損壞 Dirty臟污 Deformed變形 Hole too deep開孔太深 Surface too smooth表面太平滑 Surface too rough表面太粗糙 Open circuited開路 Short circuited短路 Mislabeled貼錯

41、標簽v Described in physical or technical terms, NOT as a symptom noticeable by the customer 潛在失效模式應以規(guī)范化或技術術語描述，不同于顧客察覺的現(xiàn)象.34 11. Potential Effect(s) of Failure 潛在失效效應v The effects of the failure mode on the customers下游用戶生產(chǎn)過程或最終的客戶那里會注意到或體驗到的后果。v Describe the effects of the failure in terms of what the

42、 customer might notice or experience,remembering that the customer may be an internal customer as well as the ultimate end user.依據(jù)客戶經(jīng)驗來描述失效效應,客戶可能是內部客戶和最終的客戶.35 11. Potential Effect(s) of Failure 潛在失效效應v The customers in this context could be the next operation, subsequent operations or locations,th

43、e dealer and the vehicle owner. Each must be considered when assessing the potential effect of a failure.客戶包括下一個操作或工序，經(jīng)銷商和車主。評估失效效應時應考慮進去。v State clearly if the failure mode could impact safety or cause noncompliance to regulations若失效模式可能影響安全性或對法規(guī)的符合性，要清楚地說明。.36 11. Potential Effect(s) of Failure 潛在

44、失效效應v For the end user, the effects should always be stated interms of product or system performance對于最終使用者來說，失效的后果應一律采用產(chǎn)品或系統(tǒng)的性能來描述，例如： Nose噪音 Rough粗糙 Unstable 不穩(wěn)定 Scrap報廢 Rework返工 Leaks 泄露.37 11. Potential Effect(s) of Failure 潛在失效效應vFor the next operations customer, the effects should always be st

45、ated in terms of process or operation performance.如果顧客是以下工序或后續(xù)工序/工位，失效的后果應用過程/工序性能來描述，例如： Cannot fasten無法緊固 Does not fit不能配合 Cannot mount無法安裝.38 12. Severity(S) 嚴重程度(S)v S: the rank associated with the most serious effect for a given failure mode某一給定失效模式最嚴重的影響后果的等級v REDUCTION only can be effected th

46、rough design change / redesign of process嚴重度數(shù)值的降低只有通過設計更改或重新設計才能實現(xiàn)v The team should agree on an evaluation criteria and ranking system工作組應在使用該表時對每個影響的嚴重程度的等級取得一致意見38.39（客戶影響）（整車廠/制造廠影響）影響級別缺陷導致汽車安全運作及/或包括違反政府法規(guī)（未有警告）或可能危害操作者（機械及裝配人員）（未有警告）沒有警告之危險事件10缺陷導致汽車安全運作及/或包括違反政府法規(guī)（帶有警告）或可能 危害 操作 者（ 機械 及裝 配人員）

47、帶有警告）帶有警告之危險事件9車輛/部件不能（失去基本功能）或 100%產(chǎn) 品 可 能 報 廢 ， 或 車 輛 /部件須在修理站，修理超過1小時以非常高8車輛/部件能動，但功能水平下降，客戶非常不滿?；?產(chǎn) 品 可 能 要 挑 選 及 部 分 （ 100%） 報 廢 ， 或 車 輛 /部 件 在 修 理站修理達（1/2至1小時）高7車輛/部件能動，但為舒適/方便用之部件不能動?？蛻舨粷M或 產(chǎn) 品 /部 件 （ 100%） 可 能 不 需挑 選 而 報 廢 ， 或 車 輛 /部 件 在 線 旁修理但不用進去修理站中等6車輛/部件能動，但為舒適/方便用之部件表現(xiàn)水平下降或 100%產(chǎn) 品 可 能

48、翻 工 ， 或 車 輛 /部件在線旁修理而不用進去修理站低5配合度及表面/異聲雜音不能表達，大部分客戶都能察覺（75%）或產(chǎn)品 可能 挑選 ，沒 有報 廢， 或部分（100%）翻工非常低4配合度及表面/異聲雜音不能表達，大部分客戶都能察覺（大約50%）或產(chǎn)品可能挑選，沒有報廢，或部分（100%）翻工，線上翻工但離開崗位輕微3配合度及表面/異聲雜音不能表達，大部分客戶都能察覺（小于25%）或產(chǎn)品可能挑選，沒有報廢，或部分（100%）翻工，線上翻工而不離開崗位非常輕微2未有顯著影響或對作業(yè)及操作人員做成不便，或沒有影響沒有1要求:影響之嚴重度,當最終用戶及/或整車廠發(fā)現(xiàn)潛在缺陷時，最終用戶應為首要

49、考慮，若兩者同時存在，應選擇較高分數(shù)P PF FM ME EA A嚴嚴重重度度評評估估表表.40 Suggested PFMEA Severity Evaluation Criteria 推薦的嚴重度評價準則v Not recommend to modify criteria for ranking values of 9 and 10.不推薦修改9和10的嚴重度數(shù)值。v Failure modes with a rank of severity should not be analyzed further.嚴重度定級為1的失效模式不應進行進一步的分析。.41 13. Classificati

50、on特性分類v Classification 級別 classify any special product or process characteristics (eg.critical,key,major,significant)特殊產(chǎn)品或過程特性的分級 Highlight high priority failure mode突出高優(yōu)先度的失效模式.42 14. Potential Cause(s)/ Mechanism(s) of Failure 失效的潛在起因失效的潛在起因/機理機理vHow the failure could occur? Described in terms of

51、something that can be corrected or controlled.失效是怎樣發(fā)生的，并應依據(jù)可以糾正或可以控制的原則予以描述v List every failure cause assignable to each potential failure mode, to the extent possible.盡可能列出可歸結到每一失效模式的每一個潛在起因.43 14. Potential Cause(s)/ Mechanism(s) of Failure 失效的潛在起因失效的潛在起因/機理機理v A design of experiments may be consi

52、dered to determine which root causes are the major contributors and most easily controlled. The causes should be described so that remedial efforts can be aimed at those causes which are pertinent. 可以考慮用DOE之類的方法，以明確哪些起因為主要作用，哪些易于控制.應描述出這些原因以便針對這些原因采取相應的應對措施。vOnly specific errors or malfunctions(e.g.

53、,operator fails to install tool)should be listed;ambiguous phrases(e.g.,operator error, machine malfunction)should not be used. 應列出失效和故障（操作員模具安裝不好），不應使用不明確的詞語（操作員錯誤或機器故障）.44 14. Potential Cause(s)/ Mechanism(s) of Failure 失效的潛在起因失效的潛在起因/機理機理vTypical failure causes:典型的失效起因： improper torque - over, un

54、der 扭矩不當-過大或過小 improper weld - current,time,pressure 焊接不當-電流，時間， 壓力improper heat treat - time, temperature 熱處理不當-時間，溫度.45 14. Potential Cause(s)/ Mechanism(s) of Failure 失效的潛在起因失效的潛在起因/機理機理v Typical failure causes:典型的失效起因： part missing or mislocated 零件漏裝/裝錯 worn locator 磨損的定位器 worn tool 磨損的工裝 improp

55、er machine setup 不正確的機器設置.46 15. Occurrence (O) 發(fā)生頻度v The likelihood that a specific cause/mechanism of failure willoccur,with ranking from 1 to 10某一特定起因發(fā)生的可能性，從1-10等級v Only design or process change could reduce Os ranking唯有通過設計更改或過程更改才能降低頻度等級v consistent occurrence ranking system agreed on within t

56、he team小組對分級方法達成一致，保證連續(xù)性 Statistical data, if available, should be used to determine the ranking統(tǒng)計數(shù)據(jù)可用來確定頻度數(shù).47失效機會比例（每千件次）1000.5510500.559200.788100.86750.94621.00511.1040.51.2030.11.302絕少失效0.011.671高：經(jīng)常失效中等：偶爾失效低：相對少失效PFMEA 發(fā)生度評估表PFMEA 發(fā)生度評估表機會率PpK級別非常高：持續(xù)失效.48 16. Current Process Controls 現(xiàn)行過程控制v

57、 Two types of Process Controls ：有兩類過程控制： Preventive：preferred approach 預防：高優(yōu)先權Prevent the cause/mechanism of failure OR the failure mode from occurring, or reduce their rate of occurrence.防止失效的起因或失效模式出現(xiàn)，或者降低其出現(xiàn)的幾率Detection:探測：Detect the cause/mechanism of failure OR the failure mode, and lead to cor

58、rective actions 探測失效的起因或失效模式，導致采取糾正措施.49 17. Detection(D) 探測度(D)v Detection is the rank associated with the best detection control listed in the process control column探測度是與過程控制欄中所列的最佳探測控制相關聯(lián)的定級數(shù) dont automatically presume that the detection ranking is low because the occurrence is low不得因發(fā)生頻度等級低而假定探測

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