5、QSB风险降低.ppt

* BE BRIEF Use the balloons and stay brief 按各气球，简单讲解 * PFMEA Shalls are NOT all inclusive these are the examples to stress PFMEA 的“必须”项目仅举例强调，没有全部包括。 译者： 原文“8.3”系错误，改为“8.2”。 An FMEA is developed by a multi-functional (or cross-functional) team. The team size will depend both on the complexity of the design and the size and organization of the company. Team members need relevant expertise, available time and authority sanctioned by management. (FMEA, 4th Edition, Page 4, “Chapter I General FMEA Guidelines, Impact on Organization and Management”) 译者： * “Tier 2 changes” 翻成“二级供应商的有关变更”。意在强调此处不是改变供应商。 * 翻译：“新产品、工装移地或供应商变更。”，原文“Product from an acquisition, tool move or change in supplier.”，翻译意在表达“PFMEA’s do not exist for a manufacturing process” (refer to GQP-012 “Risk Reduction”, rev Apr 24, 2006, section 5.3.1)。 * 翻译：“久未修订的 PFMEA。”，原文 “PFMEA with oldest revision dates.”，非指 AIAG FMEA 手册版本。 译者： * 翻译：“质量门”，原文：“Quality Gate”，建议理解为Verification Station。 译者： GP-8 (第 4.2 节)：(Rev: May 15, 2005) 4.2 RPN Reduction Process - Suppliers are required to have a formal and documented RPN reduction process which includes: ? A cross functional team that meets regularly and updates FMEA and Control Plans ? Collection of external and internal data relative to rejects (scrap and rework) ? Incorporation of internal data (FTQ, scrap, etc.) and external data (PRR, etc.) into the FMEA and validation that assigned RPN numbers are reasonable and accurate ? A defined strategy for ongoing efforts for RPN reduction ? Identification and implementation of action plans with timing and accountability * Suppliers shall develop an action plan to reduce risk using RPN reduction strategies. If it is a small supplier with a simple process and no quality issues, the list might be a top 5. If the supplier has multiple lines with complex process and parts; the list must be longer.. If the supplier is in Top Focus, Controlled Shipping, or is in Launch, the list may be longer. The number of RPN must be consis