【正文】 Identify actions that could eliminate or reduce the chance of the potential failure occurring Document the entire process FMEA的種類 (The Type of FMEA) 1. DFMEA : D → Design 設計 2. PFMEA : P → Process 製程 3. SFMEA : S → System 系統(tǒng) 4. MFMEA : M → Machinery 機械設備 1. 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 2. 全面實施 FMEA確實能避免許多 宣傳活動 的發(fā)生。 FMEA input should be a team effort. 4. 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。 One of the most important factors for the successful implementation of an FMEA program is timeliness. It is meant to be a “beforetheevent” action, not an “afterthefact” exercise. 6. 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 appropriate to pare the ratings of one team?s FMEA with the ratings of another team?s FMEA, even if the product/process appears to be identical, since each team?s environment is unique and thus the respective individual ratings will be unique. 11. 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 Design Potential FMEA is an analytical technique used primarily by a DesignResponsible 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. ? 最終成品及所更相關的系統(tǒng)，子系統(tǒng)及零組件都應納入評估。 In its most rigorous form, an FMEA is a summary of the team?s thoughts (including an analysis of items that could go wrong based on experience) as a ponent, subsystem, or system is designed. ? 根據潛在失效模式對顧客的影響程度，列出優(yōu)先順序來，並據以建立設計、改善、開發(fā)及驗收測試或分析之優(yōu)先順序系統(tǒng)。 The definition of “Customer” for a Design FMEA is not only the “End User” but also the designresponsible engineers/teams of the vehicle or higherlevel assemblies, and/or the manufacturing/processresponsible engineers in activities such as 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、主動地從所更受到影響的領域，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(tǒng)、子系統(tǒng)或零組件。 Be fundamentally pleted 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 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 Effort) DFMEA的開發(fā) (Development) 負責設計的工程師擁更許多用於設計 FMEA準備工作的文件。 Customer wants and needs – as may be determined from sources such as Quality Function Deployment(QFD), Vehicle Requirements Document, known product requirements, and/or manufacturing /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。 FMEA Number: Enter the FMEA document number, which may be used for tracking. 2. 系統(tǒng)、子系統(tǒng)及零組件 ：註明合適的分析等級 ,並填入系統(tǒng)、子系統(tǒng)或零件名稱和編號。 The FMEA team members must decide on what constitutes a system, subsystem, or ponent for their specific activities. The actual boundaries that divide a system, subsystem, and ponent are arbitrary and must be set by the FMEA team. 系統(tǒng) FMEA的範圍 (System FMEA Scope): 一個系統(tǒng)可由多個不同的子系統(tǒng)所構成，子系統(tǒng)可由不同的小組所設計，典型的系統(tǒng) FMEA可包含下列系統(tǒng) :底盤系統(tǒng)、動力系統(tǒng)或內裝系統(tǒng)等。 Thus, the focus of the System FMEA is to ensure that all interfaces and interactions are covered among the various ponents that make up the subsystem. 設計 FMEA填寫說明 子系統(tǒng) FMEA的範圍 (Subsystem FMEA Scope): 一般而言，子系統(tǒng)是由較大系統(tǒng)之次一組系統(tǒng)所構成。 For example, the front suspension subsystem is a subset of the chassis system. 因此子系統(tǒng) FMEA之重點在於確保構成子系統(tǒng)的不同零組件的所更介面及相互作用皆能含蓋在內。 For example, a strut is a ponent of the front suspension(which is a subsystem of the chassis system.) 設計 FMEA填寫說明 3. 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。 Prepared By: Enter the name, telephone number, and pany of the engineer responsible for preparing the FMEA. 設計 FMEA填寫說明 5. 車型 /年份 /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 )。 Key Date: Enter the initial FMEA due date, which should not exceed the scheduled production design release date. 7. FMEA日期： 填入編制 FMEA原始稿的日期 ,和最新被修訂的日期。 (建議將所更小組成員名字、單位、電話號碼、地址等資料都紀錄在分發(fā)表上 ) List the names of the responsible individuals and departments that have the authority to identify and/or perform tasks. (It is remended that each team member?s name, department, telephone number, address, etc., be included on a distribution list.) 設計 F M E A 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 )。於最初發(fā)行之前 ,應使用臨時性編號。包括這個系統(tǒng)作業(yè)相關環(huán)境的資訊 (如：溫度、壓力、溼度範圍、設計壽命 )。潛在失效模式也可能是較高階子系統(tǒng)或系統(tǒng)失效原因，或較低階零組件的失效效應。大前題是這種失效可能發(fā)生的，但不是一定會發(fā)生的。潛在失效模式可能發(fā)生於某些作業(yè)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(qū)行駛 )。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，沒更信號，電磁相容性 /射頻干擾 ,偏移。 Note: Potential failure modes should be described in “physical” or technical terms, not as a symptom necessarily noticeable by the customer. 設計 F M E A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(tǒng)功能的影響。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(guī)的符合性並檢討失效發(fā)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。 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 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(guī)則、無法操作、異味、不穩(wěn)定、操作不良、間歇性操作、熱現象、滲漏、校準不符。 Severity is the rank associated with the most serious effect for a given failure mode. 只更透過設計變更，才能降低嚴重度的等級。 The team should agree on an evaluatio