【正文】 指導書 不足 Not Trained 未培訓 Operator Error 操作員 錯誤 Board Error 電路板 錯誤 Operator Tired 操作人員疲勞 Crossed Wire 交叉的電線 61 FMEA ? Process controls catch the defect before the product reaches the customer /程序控制當在産品到達顧客前發(fā)現(xiàn)缺陷 ! ? There are three types of process controls 程序控制有三種類型 : (1) Prevent the cause of failure, or reduce the rate of occurrence 防止原因出現(xiàn)或降低其出現(xiàn)的可能性 (2) Detect the cause(s) of failure and lead to corrective actions 查明失效的原因並找出糾正措施 (3) Detect the failure mode(s) /檢測失效模式 Assign Currently used process controls to failure modes and causes 針對失效模式或原因列出現(xiàn)行的程序控制手段 62 FMEA ? Detection is an assessment of the probability that 探測度爲下列事件發(fā)生的概率 ? A type 2 control can detect the cause and lead to corrective action 第 2類控制能夠發(fā)現(xiàn)原因並找到糾正措施 ? A type 3 control can detect a failure 第 3類控制能夠在不良品到達顧客前發(fā)現(xiàn)缺陷 ... before the product reaches the customer! ? Detection can also assess how effectively a type 1 control can prevent failure 第 1類控制能夠預防失效的有效程度 63 FMEA ? Aim for PREVENTION rather than detection 目的是 預防 而不是探測 ? Begin with the highest RPN item 從 RPN高的專案開始 – Don’t set an a prior “cutoff” value (. prior to beginning the FMEA) 勿預先設定“分數(shù)線” (例如在開始做 FMEA前 ) ? Give serious attention to items with Severity = 9 or 10 嚴重度＝ 9或 10時應特別注意 64 FMEA ? What corrective action, if any, should be taken to reduce應採取哪些措施以降低 – Severity (probably need a design change) 嚴重度（可能需修改産品設計） – Likelihood of occurrence 發(fā)生的可能性 – Detection rating/ 可探測度 ? You don39。 13 FMEA Rules of Design FMEA 設計 FMEA規(guī)則 ? Tool for design engineers and project team to improve the design in a preemptive manner (before failure occur) 是設計工程師和項目小組的工具用來提高設計的前瞻性 (在問題發(fā)生前 ) ? Used to established Critical to Quality features that effect the performance of the product 用與那些影響產(chǎn)品性能的重要質量特性 ? Used to establish Critical to Life features that effect the life of the product 用於確定影響產(chǎn)品壽命的重要壽命特性 ? Used to establish Critical to safety features 用於確定重要安全特性 14 FMEA Purpose of Design FMEA 設計 FMEA的用途 ? Establishes critical features that must be controlled in manufacturing to satisfy customer requirements 確定那些必須在生產(chǎn)中進行控制的特性以滿足客戶要求 ? Identifies deficiencies in the product design and associated action items 找出產(chǎn)品設計中的不足和相應的措施 ? Helps evaluate the risk of design changes 幫助評價設計變更的風險 15 FMEA Purpose of Design FMEA 設計 FMEA的用途 ? Identifies process development needs 確定開發(fā)工藝流程的需求 ? Dynamic document – documents design alternatives and associated risks 動態(tài)的文件 – 記錄可選擇的設計方案和相應的風險 ? Establishes bases for manufacturing and quality control plan 建立製造和品質控制計劃的基礎 16 FMEA Design FMEA Inputs and Outputs 設計 FMEA的輸入和輸出 ? Product drawings 產(chǎn)品圖紙 ? Product models 產(chǎn)品模型 ? Product specification 產(chǎn)品規(guī)格 ? Identified Critical to Quality failures 確定的重要質量特性 ? Actions to prevent the causes of failures 防止失效原因的措施 ? Actions to detect failure modes 發(fā)現(xiàn)失效模式的措施 ? History of actions and Responsibilities 措施和責任人的記錄 17 FMEA ? Design 設計 – Components 元件 – Elements 設計要素 Design FMEA looks at physical failure modes of ponents and design elements 設計 FMEA著眼于 元件及設計要素 的物理失效模式 18 FMEA Rules of Process FMEA 過程 FMEA規(guī)則 ? Tool for process engineers and project team to improve the manufacturing process in a preemptive manner 是工藝工程師和項目小組的工具 ,用來提高製造工藝的前瞻性 ? Used to prioritize actions to ensure attention to critical processes that effect customers 用與區(qū)分先後順序以確保那些影響客戶的重要工藝 ? Used to document process improvements 用於工藝改進 ? Dynamic document for continuous improvement 持續(xù)改進的動態(tài)文件 19 FMEA Purpose of Process FMEA 過程 FMEA的用途 ? Assists in the analysis of new manufacturing process 幫助分析新的製造工藝 ? Establishes the bases for manufacturing process instructions and control sheets 建立製造工藝文件和控制文件的基礎 ? Identifies new manufacturing process needs 確定新製造工藝的需求 ? Helps evaluate the risk of process changes 幫助評估工藝更改的風險 20 FMEA ? Process 過程 – Manufacturing 制造 – Assembling 裝配 Process FMEA looks at product failures caused by the process failing to meet requirements 過程 FMEA著眼于因加工 過程 不符合要求所造成的 產(chǎn)品 失效 21 FMEA FMEA Team 小組 ? Team approach is necessary. 需要團隊的方式 ? Responsible for Design FMEA – Design Engineer 設計工程師負責設計 FMEA ? Responsible for Process FMEA – Manufacturing Engineer 製造工程師負責過程 FMEA ? Remended representatives: 推薦人選 : – Design / 設計 – Manufacturing Engineers / 製造工程師 – Quality Engineers / 質量工程師 – Reliability / 可靠性 – Materials / 原材料 – Suppliers / 供應商 22 FMEA Definition of Terms 術語 ? Failure Mode – The way in which a specific input requirement fails and if not detected, corrected or removed will cause an Effect to occur. 失效模式 – 一個特殊的輸入要求失敗的方式或者由於未被發(fā)覺 ,糾正或消除而帶來的後果 ? Effect – Impact on customer requirements 後果 – 對客戶要求的影響 23 FMEA Definition of Terms 術語 ? Cause – Source(s) of process variation that causes the Failure Mode to occur. 原因 – 造成失效模式發(fā)生的過程變差的起源 ? Current Control (proposed controls) 當前的控制 (建議的控制 ) – Design elements that ensure function 確保功能的設計要素 – Mistake proofing, automated controls, set up instructions, gauges