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1、FMEA,Training,目 錄(Contents),一、何謂FMEA(What is an FMEA)二、FMEA的種類(The Type of FMEA)三、FMEA的實施(FMEA Implementation)四、FMEA的持續追蹤(Follow-Up)五、DFMEA填表說明(Design FMEA)六、PFMEA填表說明(Process FMEA),何謂 FMEA(What is an FMEA),FMEA:失效模式與效應分析(Failure Mode and Effects Analysis)FMEA係藉由系統性的小組活動來進行下列工作:An FMEA can be descri
2、bed as a systematic group of activities intended to:a.確認及評估產品/製程潛在的失效模式及其影響 Recognize and evaluate the potential failure of a product/process and effects of that failureb.採取消除或降低潛在的失效發生機率 Identify actions that could eliminate or reduce the chance of the potential failure occurringc.記載全部的過程 Document
3、the entire process,FMEA的種類(The Type of FMEA),DFMEA:D Design設計PFMEA:P Process製程SFMEA:S System系統MFMEA:M Machinery機械設備,將FMEA當作一專門的技術應用，以消除潛在失效為目的。Using the FMEA as a disciplined technique to identify and help minimize potential concern 全面實施FMEA確實能避免許多宣传活动的發生。Studies of vehicle campaigns have shown that
4、 fully implemented FMEA programs could have prevented many of the campaigns.要完成FMEA得依靠小組共同努力。FMEA input should be a team effort.小組成員應由知識或技術豐富人員共同組成而非應付式的派遣單位助理來權充人數。Team member should be knowledgeable and technical expert,and not the assistants combined from each departments.,FMEA的實施(FMEA Implementa
5、tion),適時性是成功實施FMEA的重要因素之一，強調事前的防範，而非事後事故的補救。One of the most important factors for the successful implementation of an FMEA program is timeliness.It is meant to be a“before-the-event”action,not an“after-the-fact”exercise.FMEA不僅是簡單的填表工作，而是藉由對FMEA的瞭解，以消除風險，使計劃獲得適當的管制，藉以達到客戶的滿意。It is not simply a case o
6、f filling out the form but rather of understanding the FMEA process in order to eliminate risk and plan the appropriate controls to ensure customer satisfaction.,FMEA的實施(FMEA Implementation),7.潛在FMEA實施步驟:,FMEA的實施(FMEA Implementation),7.FMEA Process Sequence:,FMEA的實施(FMEA Implementation),What are the
7、 Functions,Features or Requirements?,What can go wrong?-No Function-Partial/Over/Degraded Function-Intermittent Function-Unintended Function,實施FMEA的三種時機There are three basic cases for which FMEAs are generated,each with a different scope or focus.1.新設計、新技術或新製程New design,new technology,or new process
8、 2.當現有設計或製造將要變更時Modifications to existing design or process 3.當現有設計或製程使用新的環境、位置或應用時Use of an existing design or process in a new environment,location,or application,FMEA的實施(FMEA Implementation),FMEA的推動雖由指定專人負責,但其作業展開，應由FMEA小組來完成(一般跨功能小組=FMEA小組)Although responsibility for the preparation of the FMEA
9、is usually assigned to an individual,FMEA input should be a team effort.即使產品/製程是一致的，不同小組的比較及評價是不適宜的。It is not appropriate to compare the ratings of one teams FMEA with the ratings of another teams FMEA,even if the product/process appears to be identical,since each teams environment is unique and thu
10、s the respective individual ratings will be unique.FMEA文件的審查建議應對應於公司品質目標，且包含予公司管理審查會議中。A review of the FMEA document against FMEA quality objectives is recommended,including a management review.,FMEA的實施(FMEA Implementation),FMEA的持續追蹤是非常重要的The need for taking effective preventive/corrective actions,w
11、ith appropriate follow-up on those actions,cannot be overemphasized.負責工程師應確保所有的建議措施均已有效執行The responsible engineer is in charge of ensuring that all recommended actions have been implementation or adequately addressed.FMEA是個隨時需要更新的文件,縱使該產品已經量產,如有設計或工程變更時亦需更新FMEA內容The FMEA is a living document and sho
12、uld always reflect the latest level,as well as the latest relevant actions,including those occurring after the start of production.,FMEA的持續追蹤(Follow-Up),Design Failure Mode and Effects Analysis設計失效模式與效應分析,DFMEA簡介(Introduction),設計FMEA主要是由負責設計的工程師/小組採用的一種分析技術，用來佐證在可能的範圍內已充分地考慮到，並指明各種潛在的失效模式及其相關的起因/機制。
13、A Design Potential FMEA is an analytical technique used primarily by a Design-Responsible Engineer/Team as a means to ensure that,to the extent possible,potential failure modes and their associated causes/mechanisms have been considered and addressed.最終成品及所有相關的系統，子系統及零組件都應納入評估。End items,along with e
14、very related system,subsystem,and component,should be evaluated.,FMEA是設計小組想法的摘錄(包括依據經驗有可能失效事項之分析)。In its most rigorous form,an FMEA is a summary of the teams thoughts(including an analysis of items that could go wrong based on experience)as a component,subsystem,or system is designed.根據潛在失效模式對顧客的影響程
15、度，列出優先順序來，並據以建立設計、改善、開發及驗收測試或分析之優先順序系統。Developing a ranked list of potential failure modes according to their effect on the“customer”,thus establishing a priority system for design improvements,development,and validation testing/analysis.,DFMEA簡介(Introduction),顧客的定義(Customer Defined),設計FMEA中“顧客”的定義，
16、不僅僅是指“最終使用者”，還包括負責車型設計或更高一級裝配過程設計的工程師/小組，以及在生產過程中負責製造、裝配和售後服務的工程師。The definition of“Customer”for a Design FMEA is not only the“End User”but also the design-responsible engineers/teams of the vehicle or higher-level assemblies,and/or themanufacturing/process-responsibleengineers in activities such as
17、 manufacturing,assembly,and service.,小組的努力(Team Effort),在最初的設計FMEA過程中，負責設計的工程師被要求能夠直接地、主動地從所有受到影響的領域，這些領域應該包括，但不限於：裝配、製造、設計、分析/測試、可靠度、材料、品質、服務和供應商，以及負責次一上層或下層組裝、系統、子系統或零組件。During the initial Design FMEA process,the responsible engineer is expected to directly and actively involve representatives fro
18、m all affected areas.These areas of expertise and responsibility should include but are not limited to assembly,manufacturing,design,analysis/test,reliability,materials,quality,service,and suppliers,as well as the design area responsible for the next higher or lower assembly or system,subsystem,or c
19、omponent.,設計FMEA是一份動態文件，且應該：The Design FMEA is a living document and should:在一個設計概念最終形成之時或之前開始；Be initiated before or at design concept finalization在產品開發各階段中，當設計有變更或獲得資訊增加時，要及時、不斷地修改；Be continually updated as changes occur or additional information is obtained throughout the phases of product develo
20、pment在最終產品加工圖樣完成至製迼模具之前全部結束。Be fundamentally completed before the production drawing are released for tooling.,小組的努力(Team Effort),設計FMEA不是靠過程控制來克服設計中潛在的缺陷，但的確要考慮製造/裝配過程中技術的/物質的限制。例如：The Design FMEA does not rely on process controls to overcome potential design weaknesses,but it does take the technic
21、al/physical limits of a manufacturing/assembly process into consideration,for example:必要的拔模斜度(Necessary mold drafts)表面處理的限制(Limited surface finish)裝配空間/工具可加工性(Assembling space/access for tooling)鋼材硬度的限制(Limited hardenability of steels)公差/過程能力/性能(Tolerance/process capability/performance),小組的努力(Team E
22、ffort),設計FMEA也可以考慮到產品維護(售後服務)和資源回收利用技術的/物質的限制。例如：The Design FMEA can also take into consideration the technical/physical limits of product maintenance(service)and recycling,for example:工具加工(Tool access)診斷(Diagnostic capability)材料分類標示(資源回收利用)(Material classification symbols(for recycling),小組的努力(Team
23、Effort),DFMEA的開發(Development),負責設計的工程師擁有許多用於設計FMEA準備工作的文件。The design-responsible engineer has at his or her disposal a number of documents that will be useful in preparing the Design FMEA.設計FMEA的開始將從列出設計希望做什麼？及不希望做什麼？即設計意圖.The process begins by developing a listing of what the design is expected to
24、do and what it is expected not to do,i.e.,the design intent.,可能是透過品質機能展開(QFD)、車輛要求文件、已知的產品要求和/或製造/裝配/服務/回收利用要求等來源，應該綜合地確定顧客要求和需求。Customer wants and needs as may be determined from sources such as Quality Function Deployment(QFD),Vehicle Requirements Document,known product requirements,and/or manufac
25、turing/assembly/service/recycling requirements should be incorporated.期望特性的定義越明確，就越容易識別潛在的失效模式，以採取預防/矯正措施。The better the definition of desired characteristics,the easier it is to identify potential failure modes for preventive/corrective action.,DFMEA的開發(Development),設計FMEA填寫說明,1.FMEA編號：填入FMEA文件編號,以
26、便追蹤查詢。FMEA Number:Enter the FMEA document number,which may be used for tracking.2.系統、子系統及零組件：註明合適的分析等級,並填入系統、子系統或零件名稱和編號。System,Subsystem,or Component Name and Number:Indicate the appropriate level of analysis and enter the name and number of the system,subsystem,or component being analyzed.FMEA小組必須
27、決定那些是系統、子系統或零組件，基本上，這三者的區分是相當主觀的。The FMEA team members must decide on what constitutes a system,subsystem,or component for their specific activities.The actual boundaries that divide a system,subsystem,and component are arbitrary and must be set by the FMEA team.,系統FMEA的範圍(System FMEA Scope):一個系統可由多
28、個不同的子系統所構成，子系統可由不同的小組所設計，典型的系統FMEA可包含下列系統:底盤系統、動力系統或內裝系統等。A system can be considered to be made of various subsystem.These subsystem often have been designed by different teams.Some typical System FMEAs might cover the following systems:Chassis System,or Power train System,or Interior System,etc.因此系
29、統FMEA是用以確保所有構成系統的不同子系統的所有介面，及相互作用以及其他車用系統皆被含蓋在內。Thus,the focus of the System FMEA is to ensure that all interfaces and interactions are covered among the various components that make up the subsystem.,設計FMEA填寫說明,子系統FMEA的範圍(Subsystem FMEA Scope):一般而言，子系統是由較大系統之次一組系統所構成。A Subsystem FMEA is generally a
30、 sub-set of a large system.例如：前懸吊子系統是底盤系統的下一層系統。For example,the front suspension subsystem is a sub-set of the chassis system.因此子系統FMEA之重點在於確保構成子系統的不同零組件的所有介面及相互作用皆能含蓋在內。Thus,the focus of the Subsystem FMEA is to ensure that all interfaces and interactions are covered among the various components th
31、at make up the subsystem.,設計FMEA填寫說明,零組件FMEA的範圍(Component FMEA Scope):一般而言，零組件FMEA是著眼於子系統之次一層結構.A Component FMEA is a generally an FMEA focused on the sub-set of a subsystem.例如，支柱為前懸吊系統的一個零組件。For example,a strut is a component of the front suspension(which is a subsystem of the chassis system.),設計FM
32、EA填寫說明,設計責任：填入OEM、部門和小組，可能的話還應包含供應商名稱。Design Responsibility:Enter the OEM,department,and group.Also include the supplier name,if applicable.準備者：填入負責FMEA準備工作的工程師的姓名、電話號碼和公司的名稱。Prepared By:Enter the name,telephone number,and company of the engineer responsible for preparing the FMEA.,設計FMEA填寫說明,車型/年份/
33、車型類別：填入將使用或/和即將被分析的車型年份及車輛類別(假如知道)。Model Year(s)/Program(s):Enter the intended model year(s)/program(s)that will use and/or be affected by the design being analyzed(if known).關鍵日期：填入FMEA初次預定完成日期,該日期不能超過計劃生產的發佈日期。Key Date:Enter the initial FMEA due date,which should not exceed the scheduled productio
34、n design release date.FMEA日期：填入編制FMEA原始稿的日期,和最新被修訂的日期。FMEA Date:Enter the date the original FMEA was complied and the latest revision date.,設計FMEA填寫說明,設計FMEA填寫說明,8.核心小組(Core Team):列出被授權參與或執行這項工作的負責個人和單位。(建議將所有小組成員名字、單位、電話號碼、地址等資料都紀錄在分發表上)List the names of the responsible individuals and departments
35、that have the authority to identify and/or perform tasks.(It is recommended that each team members name,department,telephone number,address,etc.,be included on a distribution list.),設計FMEA填寫說明,9.項目/功能(Item/Function):填入正被分析的名稱和其他相關資料(如編號、零件等級)。利用工程圖面上標明的名稱並顯示的設計等級。於最初發行之前,應使用臨時性編號。Enter the name and
36、other pertinent information(e.g.,the number,the part class,etc.)of the item being analyzed.Use the nomenclature and show the design level as indicated on the engineering drawing.Prior to initial release(e.g.,in the conceptual phases),experimental numbers should be used.,盡可能簡潔地填入被分析項目的功能使之符合設計意圖。包括這個
37、系統作業相關環境的資訊(如：溫度、壓力、溼度範圍、設計壽命)。如果項目包含一個以上有不同潛在失效模式功能時，則必須列出所有個別功能.Enter,as concisely as possible,the function of the item being analyzed to meet the design intent.Include information(metrics/measurables)regarding the environment in which this system operates(e.g.,define temperature,pressure,humidity
38、 ranges,design life).If the item has more than one function with different potential modes of failure,list all the functions separately.,設計FMEA填寫說明,10.潛在失效模式(Potential Failure Mode):所謂潛在失效模式是指零件、子系統或系統有可能未達到設計意圖的形式。潛在失效模式也可能是較高階子系統或系統失效原因，或較低階零組件的失效效應。Potential failure mode is defined as the manner
39、in which a component,subsystem,or system could potentially fail to meet or deliver the intended function described in the item/function column(I.e.,intended function fails).The potential failure mode may also be the cause of a potential failure mode in higher-level subsystem or system,or be the effe
40、ct of one in a lower-level component.,設計FMEA填寫說明,設計FMEA填寫說明,對一個特定項目及其功能，列出每一個潛在失效模式。大前題是這種失效可能發生的，但不是一定會發生的。建議將以往TGW(錯誤的案例)的研究，問題報告以及小組的“腦力激盪”的檢討作為出發點。潛在失效模式可能發生於某些作業條件下(如：熱、冷、乾、多灰塵的條件)和在某些使用條件下(如：超過平均里程數以上、粗糙不平的地形、僅在市區行駛)。List each potential failure mode associated with the particular item and item
41、 function.The assumption is made that the failure could occur but may not necessarily occur.A recommended starting point is a review of past things-gone-wrong,concerns,reports,and group brainstorming.Potential failure modes that could occur only under certain operating conditions(i.e.,hot,cold,dry,d
42、usty,etc.)and under certain usage conditions(i.e.,above-average mileage,rough terrain,city driving only,etc.)should be considered.,典型的失效模式包含下列各項，但不限於此：破碎的、變形、鬆弛、洩漏、黏著、短路、生鏽、氧化、龜裂。未傳送扭力，打滑(未保持全扭力)不能支撐(結構上的)，不適當的支撐(結構上的)，切入不順，拖勾過快，不足信號，信號間歇中斷，沒有信號，電磁相容性/射頻干擾,偏移。Typical failure modes could be but are n
43、ot limited to:Cracked,Deformed,Loosened,Leaking,Sticking,Oxidized,Fractured,Does not transmit,Slips(does not hold full torque),No support(structural),Inadequate support(structural),Harsh engagement,Disengages too fast,Inadequate signal,intermittent,No signal,EMC/RFI,Drift.註：潛在失效模式應以物理性或技術用語來描述，而非以顧客
44、所看的現象來描述。Note:Potential failure modes should be described in“physical”or technical terms,not as a symptom necessarily noticeable by the customer.,設計FMEA填寫說明,設計FMEA填寫說明,11.潛在失效效應(Potential Effect(s)of Failure):潛在失效效應定義為失效模式對系統功能的影響。也就是，失效模式一旦發生時，對系統或設備以及操作使用的人員所造成的影響。一般在討論失效效應時要清楚說明該功能是否會影響到安全性及法規的符合
45、性並檢討失效發生時對於局部所產生的影響,然後循產品的組合架構層次，逐層分析一直到最高層級人員、裝備所可能造成的影響。Potential effects of failure are defined as the effects of the failure mode on the function,as perceived by the customer.Describe the effects of the failure in terms of what the customer might notice or experience,remembering that the custome
46、r may be an internal customer as well as the ultimate end user.State clearly if the failure mode could impact safety or noncompliance to regulations.The effects should always be stated in terms of the specific system,subsystem,or component being analyzed.Remember that a hierarchical relationship exi
47、sts between the component,subsystem,and system levels.,例如：一個零件的斷裂可能引起總成的震動，進而導致系統運行的中斷，這種狀況會引起性能的下降,可能造成於組合過程的震動，最終導致客戶的不滿。For example,a part could fracture,which may cause the assembly to vibrate,resulting in an intermittent system operation.The intermittent system operation could cause performance
48、 to degrade and ultimately lead to customer dissatisfaction.典型的失效效應包括：噪音、粗糙、操作不規則、無法操作、異味、不穩定、操作不良、間歇性操作、熱現象、滲漏、校準不符。Typical failure effects could be but are not limited to:Noise,Rough,Erratic,Operation,Inoperative,Poor Appearance,Unpleasant Odor,Unstable,Operation Impaired,Intermittent Operation,Th
49、ermal Event,Leaks,Regulatory Non-Compliance.,設計FMEA填寫說明,12.嚴重度(Severity):嚴重度是針對失效模式衍生的嚴重影響所作的等級界定乃一相對的等級評價。Severity is the rank associated with the most serious effect for a given failure mode.只有透過設計變更，才能降低嚴重度的等級。A reduction in the severity ranking index can be effected only through a design change.
50、,設計FMEA填寫說明,建議評估標準(Suggested Evaluation Criteria):小組成員應對評估標準及等級系統有一致的共識，即使是個別產品分析有所修訂，亦應有一致的共識。The team should agree on an evaluation criteria and ranking system that is consistent,even if modified for individual product analysis.註：1.對評估標準9分及10分者，建議不修訂其衡量標準，對評估標準1分，一般不作進一步分析。Note:1.It is not recomme
