制程失效模式及后果分析培训

What is an FMEA? 什麼是FMEA?
Group of activities 系統化的活動 • Recognize & evaluate potential failure of product/process
认可并评价产品/过程中的潜在失效
• Identify actions to reduce the chance of the failure occurring 确定能消除或减少潜在失效发生机会的措施
• Reviewing Design/Process FMEA, special FMEA applications and control plan
对设计/过程FMEA、FMEA的特殊应用以及控制计划进行评审
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When to update of FMEA? 何時更新FMEA？
•FMEA is a living document and should always reflect the latest level, latest relevant actions, including those occurring after the start of production. FMEA是一份动态文件,始终反映最新水平以及最近的相关措 施，包括生产以后发生的。
尋找方 法及解 決問題 預防
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FMEA Implementation FMEA的实施
Because of the general industry trend to continually improve products and processes whenever possible, using the FMEA as a disciplined technique to identify and help minimize potential concern is as important as ever. Studies of vehicle campaigns have show that fully implemented FMEA programs could have prevented many of the campaigns. 因为一般的企业趋向于使用FMEA确定和帮助使潜在问题最小化来达到产 品和制程持续改善的目的.汽车行业的研究表明FMEA的执行将能防止很 多问题.
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FMEA Implementation FMEA的实施 Key Success Factors 成功因素 • Timeliness 时间性 “Before the event” Not “After the fact” “事件发生前”不是“事实出现后”
• Follow up 跟踪
Ensure all actions have been implemented • 确保所有行动已执行
情形1:新设计、新技术或新制程.范围是全部的设计、技术或制程.
Case 2:Modifications to existing design or process.The scope should focus on the modification to design or process,possible interactions due to the modification. 情形2:对现有设计或制程的修改.范围是侧重于对设计和制程的修改及修改可能带来 的相互作用. Case 3:Use of existing design or process in a new environment,location,or application, The scope is the impact of the new environment,location on the existing design or process. 情形3:将现有的设计或制程用于新的环境、场所或应用,范围是新的环境、场所对现 10 有设计和制程的影响.
• Initially adopted in the automotive industry in the 1970s focusing on safety issues.最初於20世紀70年代應用於汽車工業，主要針對安全問題
• In 1994, all automotive suppliers were required use of FMEA under QS9000 standard. It is a major element of Advanced Product Quality Planning Process. 1994年，所有汽車行業處於QS9000標準下的供應商均被 要求使用FMEA。 FMEA 是產品質量先期策劃的一個主要部分 • Now adopted by many other industries.現已被許多其它工業應用
PROCESS FAILURE MODE AND EFFECT ANALYSIS TRAINING 制程失效模式及後果分析培訓
April ,2010 TM-002 , Rev:00 Prepared By : HenryLi
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HISTORY OF FMEA FMEA的歷史
• It was formalized in the aerospace industry during the Apollo program in the 1960s.形成於20世紀60年代航空工業的阿波羅計劃
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How to follow Up
怎樣跟踪
The responsible engineer has several means of assuring that recommended actions are implemented. They include,but are not limited to the following:责任工程师有几种方 法但不局限于下列几种方法来确保建议的措施被执行. •Reviewing designs, processes and drawing to ensure the recommended actions have been implemented. 对设计、过程及图样进行评审以确保建议的措施被执行 • Confirming the incorporation of changes to design/assembly/manufacturing documentation 确认更改已纳入到设计/装配/制造文件中
• is a summary of the team’s thoughts as a process is developed. 是制程開發過程中小組思想的總結 • it includes an analysis of items that could go wrong based on experience past performance,and quality performance indicators (i.e yield,In-process QA & OQA LAR/PPM, Cpk, etc.) •它對可能會出錯的項目進行分析，這些分析以經驗、以往性能和質量性能指 標（如產量、制程QA和去貨QA的批量接收率/每百萬壞品率、制程能力指標 等）为基礎 • it formalizes the mental discipline that an engineer normally goes through in any manufacturing planning process. 它總結了一般情況下工程師在策劃任一個制程時所要經歷的邏輯順序和背景
• Document entire process
将全部过程形成文件
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COPQ at different stages 各阶段纠正问题的成本
成本 1000 100 10 1
Customer complaint客戶投訴 Manufacturing & Assembly製造及裝配 Design Approval 設計核準 FMEA Product planning Design Manufacturing Application 產品策劃 設計 製造 應用 時間
Who Edit FMEA ? 誰編制FMEA？
• Although responsibility for the preparation of the FMEA usually
assigned to individual, FMEA input should be a team effort. FMEA的编制责任通常都指派到某个人，但是FMEA的输入应是工作小組的努力
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PFMEA简介
A process potential FMEA is an analytical technique used by a manufacturing /assembly-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.An FMEA is a summary of the team’s thoughts. 过程FMEA是由负责制造/装配的工程师/小组主要采 用的一 种分析技术，用以最大限度地保证各种潜在的失效模式及其 相关的起因/机理已得到充分的考虑和论述。 FMEA是团队思 想的总结。
recommended actions have been implemented or adequately addressed.
责任工程师负责确保所有的建议措施都得到实施或充分的强调 • A thoroughly thought-out and well-developed FMEA will be of limited value without positive and effective preventive/corrective actions. 一个经过彻底思考、周密开发的FMEA，如果没有积极有效的预防/纠正 措施，其价值将是非常有限的。