【正文】 指導(dǎo)書 不足 Not Trained 未培訓(xùn) Operator Error 操作員 錯(cuò)誤 Board Error 電路板 錯(cuò)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(dāng)在産品到達(dá)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(wèi)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(dá)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(yù)防失效的有效程度 63 FMEA ? Aim for PREVENTION rather than detection 目的是 預(yù)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(yù)先設(shè)定“分?jǐn)?shù)線” (例如在開始做 FMEA前 ) ? Give serious attention to items with Severity = 9 or 10 嚴(yán)重度＝ 9或 10時(shí)應(yīng)特別注意 64 FMEA ? What corrective action, if any, should be taken to reduce應(yīng)採取哪些措施以降低 – Severity (probably need a design change) 嚴(yán)重度（可能需修改産品設(shè)計(jì)） – 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(shè)計(jì) FMEA規(guī)則 ? Tool for design engineers and project team to improve the design in a preemptive manner (before failure occur) 是設(shè)計(jì)工程師和項(xiàng)目小組的工具用來提高設(shè)計(jì)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(zhì)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(shè)計(jì) 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(jìn)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(shè)計(jì)中的不足和相應(yīng)的措施 ? Helps evaluate the risk of design changes 幫助評價(jià)設(shè)計(jì)變更的風(fēng)險(xiǎn) 15 FMEA Purpose of Design FMEA 設(shè)計(jì) 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(dòng)態(tài)的文件 – 記錄可選擇的設(shè)計(jì)方案和相應(yīng)的風(fēng)險(xiǎn) ? Establishes bases for manufacturing and quality control plan 建立製造和品質(zhì)控制計(jì)劃的基礎(chǔ) 16 FMEA Design FMEA Inputs and Outputs 設(shè)計(jì) 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(zhì)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(zé)任人的記錄 17 FMEA ? Design 設(shè)計(jì) – Components 元件 – Elements 設(shè)計(jì)要素 Design FMEA looks at physical failure modes of ponents and design elements 設(shè)計(jì) FMEA著眼于 元件及設(shè)計(jì)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(xiàng)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(jìn) ? Dynamic document for continuous improvement 持續(xù)改進(jìn)的動(dòng)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(chǔ) ? 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(fēng)險(xiǎn) 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(tuán)隊(duì)的方式 ? Responsible for Design FMEA – Design Engineer 設(shè)計(jì)工程師負(fù)責(zé)設(shè)計(jì) FMEA ? Responsible for Process FMEA – Manufacturing Engineer 製造工程師負(fù)責(zé)過程 FMEA ? Remended representatives: 推薦人選 : – Design / 設(shè)計(jì) – Manufacturing Engineers / 製造工程師 – Quality Engineers / 質(zhì)量工程師 – Reliability / 可靠性 – Materials / 原材料 – Suppliers / 供應(yīng)商 22 FMEA Definition of Terms 術(shù)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(gè)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(shù)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(dāng)前的控制 (建議的控制 ) – Design elements that ensure function 確保功能的設(shè)計(jì)要素 – Mistake proofing, automated controls, set up instructions, gauges