【正文】 管制 －標準，程 序書或指引 更FMEA的實施 (FMEA Implementation) 7. FMEA Process Sequence: FMEA的實施 (FMEA Implementation) Subsystem Function Reqt?s Potential Failure Mode Potential Effect(s) of Failure S E V C L A S S Potential Cause(s)/ Mechanism(s) of Failure O C C U R Current Controls D E T E C R. P. N. Remended Action(s) Responsibility Target Completion Date Action Results Actions Taken S E V O C C D E T R. P. N. Prevention Detection What are the Functions, Features or Requirements? What can go wrong? No Function Partial /Over /Degraded Function Intermittent Function Unintended Function What are the Effect(s)? How bad is it? What are the Cause(s)? How often does it happen? How can this be prevented and detected? How good is this method at detecting it? What can be done? Design Changes Process Changes Special Controls Changes to Standards, Procedures, or Guides 8. 實施 FMEA的三種時機 There are three basic cases for which FMEA?s are generated,each with a different scope or focus. 、新技術或新製程 New design, new technology, or new process Modifications to existing design or process 、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) 9. FMEA的推動雖由指定專人負責 ,但其作業(yè)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 is usually assigned to an individual, FMEA input should be a team effort. 10. 即使產(chǎn)品 /製程是一致的，不同小組的比較及評價是不適宜的。 End items, along with every related system, subsystem, and ponent, should be evaluated. ? FMEA是設計小組想法的摘錄 (包括依據(jù)經(jīng)驗更可能失效事項之分析 )。 During the initial Design FMEA process, the responsible engineer is expected to directly and actively involve representatives from 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 ponent. 設計 FMEA是一份動態(tài)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(chǎn)品開發(fā)各階段中，當設計更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 development ? 在最終產(chǎn)品加工圖樣完成至製迼模具之前全部結束。 The designresponsible 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 do and what it is expected not to do, ., 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(chǎn)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。 System, Subsystem, or Component Name and Number: Indicate the appropriate level of analysis and enter the name and number of the system, subsystem, or ponent being analyzed. FMEA小組必頇決定那些是系統(tǒng)、子系統(tǒng)或零組件，基本上，這三者的區(qū)分是相當主觀的。 A Subsystem FMEA is generally a subset of a large system. 例如：前懸吊子系統(tǒng)是底盤系統(tǒng)的下一層系統(tǒng)。 Design Responsibility: Enter the OEM, department, and group. Also include the supplier name, if applicable. 4. 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。 FMEA Date: Enter the date the original FMEA was plied and the latest revision date. 設計 FMEA填寫說明 設計 F M E A 填寫說明 8. 核心小組 (Core Team): 列出被授權參與或執(zhí)行這項工作的負責個人和單位。 Enter the name and other pertinent information (., 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 (., 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。 Potential failure mode is defined as the manner in which a ponent, subsystem, or system could potentially fail to meet or deliver the intended function described in the item/function column (., intended function fails). The potential failure mode may also be the cause of a potential failure mode in higherlevel subsystem or system, or be the effect of one in a lowerlevel ponent. 設計 F M E A 填寫說明 設計 F M E A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。 List each potential failure mode associated with the particular item and item function. The assumption is made that the failure could occur but may not necessarily occur. A remended starting point is a review of past thingsgonewrong, concerns, reports, and group brainstorming. Potential failure modes that could occur only under certain operating conditions (., hot, cold, dry, dusty, etc.) and under certain usage conditions (., aboveaverage 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。也就是，失效模式一旦發(fā)生時，對系統(tǒng)或設備以及操作使用的人員所造成的影響。 Typical failure effects could be but are not limited to: Noise, Rough, Erratic, Operation, Inoperative, Poor Appearance, Unpleasant Odor, Unstable, Operation Impaired, Intermittent Operation, Thermal Event, Leaks, Regulatory NonCompliance. 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。 Note: 1. It is not remended to modify criteria ranking values of 9 and 10. Failure modes with a rank of severity 1 should not be analyzed further. 2. 高嚴重度者，更時可藉由設計修改來降低失效的嚴重度，例如「平胎行駛」可減輕瞬間輪胎爆裂造成的嚴重度，而「安全帶」可以減輕車輛撞毀時人員的傷害。 The likelihood of occurrence ranking number has a relative meaning rather than an absolute value. 藉由設計變更或設計過程變更 (如設計查核表、設計審查、設計指南 )才是降低發(fā)生率的唯一方法，才是降低發(fā)生率的唯一方法 . Preventing or controlling the causes/mechanisms of the failure mode through