【正文】 949 Automotive Sector Requirements, ISO/TS16949汽車行業(yè)要求 ISO9001： 2023 is foundation, ISO9001是基礎(chǔ) Standard Customer Specific Requirements include the implementation of an FMEA process標(biāo)準(zhǔn)和顧客特殊要求，包括 FMEA過(guò)程的實(shí)施 2） PPAP: Product Part Approval Process PPAP: 生產(chǎn)件批準(zhǔn)： PPAP includes requirements for FMEA implementation and is subject to pliance audit. PPAP包括 FMEA實(shí)施的要求，以及屬于審核的一個(gè)項(xiàng)目。 3） Reference Documents 參考文件： FMEA 4th ED FMEA第四版 APQP 2nd ED APQP第二版 SPC 2nd ED SPC 第二版 MSA 3rd ED MSA 第三版 4） Supported by 被支持 Manuals chartered by the AIAG Quality Steering Committee. 符合 AIAG 質(zhì)量策劃委員會(huì)的手冊(cè) The FMEA Reference Documents FMEA 參考文件 A reference document is guidance參考文件是指： it is an OEM remendation, OEM的建議 it is not prescriptive, 不是強(qiáng)制的 it is NOT auditable, unless:不是審核依據(jù)，除非 The anization says in its procedures that it will follow the Manual （ versus be consistent with it） or 組織宣稱他們的程序按照此手冊(cè)實(shí)施（等同采用）或 A customer explicitly requires that you must (currently TS and the Customer Specific Requirements do not do this—you only have to be consistent with the manual) 顧客明確要求你必須使用（目前 TS和顧客特殊要求不要求 —你只能等同采用） The FMEA Reference Documents FMEA 參考文件 ?Usage and Application of FMEAs is included in requirements or pliance documents such as ISO/TS 16949 and PPAP ?使用和應(yīng)用 FMEAs的要求被包含在 16949標(biāo)準(zhǔn)或相關(guān)文件里面，如 PPAP。 ?FMEA pliance requirements may also be included in CSR ?FMEA的要求可能被包含在顧客特殊要求中。 the implementation tools for effectively developing FMEAs it is also a resource for developing procedures and training in FMEA FMEA 參考文件包括完成和使用 FMEA的信息和指南 FMEA文件描述 “ 怎么做 ” ，有效開(kāi)發(fā) FMEA的實(shí)施工具 同樣它也是 FMEA開(kāi)發(fā)程序和培訓(xùn)的資源 Background 背景 What is FMEA？ FMEA 是什么？ ?FMEA stands for failure mode and effects analysis FMEA is an analytical methodology used to ensure that potential problems have been considered and addressed throughout the product and process development process key is having the right people having good discussion about issues and risks in the product and process design, and the mitigation of high risk issues this bees part of the anization’s knowledge management FMEA 表示失效模式后后果分析 FMEA是一個(gè)分析工具，以確保潛在問(wèn)題已經(jīng)被考慮，并且貫穿于整個(gè)產(chǎn)品和過(guò)程開(kāi)發(fā)中 關(guān)鍵是在產(chǎn)品和過(guò)程開(kāi)發(fā)中，有資格的人很好的討論了關(guān)鍵點(diǎn)和風(fēng)險(xiǎn)，并且降低了高風(fēng)險(xiǎn)的發(fā)生 這成為組織知識(shí)管理的一部分 ?FMEA is a process not a document previous version focused primarily on the pletion of the FMEA form and the knowledge contained therein. FMEA是一個(gè)過(guò)程，而不是一個(gè)文件 早期的版本，主要關(guān)注到的是 FMEA的表格完成和里面的概念。 Why a Fourth FMEA？ 為什么發(fā)布FMEA第四版？ ?Minimize or Eliminate column shifting placing information in the wrong columns thus hindering the analysis and product/process improvement efforts ?減少或者消除欄目 將信息填入錯(cuò)誤的欄目，會(huì)阻礙分析和產(chǎn)品 /過(guò)程改進(jìn)的效果 Why a Fourth FMEA？ 為什么發(fā)布 FMEA第四版？ Why a Fourth FMEA？ 為什么發(fā)布 FMEA第四版？ ? Minimize or Eliminate sole reliance on the RPN in the evaluation of risk priorities and improvement actions Practice of Deflating of the RPN to meet an arbitrary threshold. ? 減少或消除單一依靠 RPN值，去評(píng)價(jià)風(fēng)險(xiǎn)縫隙的優(yōu)先程度和改進(jìn)措施。 ? Lack of understanding of the role of the FMEA process throughout the APQP phases including continual improvement during production。 —包括在生產(chǎn)過(guò)程中的持續(xù)改進(jìn)。 Why a Fourth FMEA？ 為什么發(fā)布 FME