新版DFMEA

◎引導參訓人員更進一步瞭解 FMEA。
◎引導參訓人員瞭解新版FMEA主要的變化點，快速掌握關鍵。
◎學習製作符合標準的 FMEA，以達風險評估/管理、法規/標準 & 客戶要求。
◎透過工具的介紹應用與演練，強化理論與實務應用面的連結，提升效率。

《企業內部開課》

課程單元	單元內容	進行方式
一、FMEA 的基本思考因果邏輯	※Potential Problem Analysis	►講授法 ►互動問答 ►案例分享 ►小組討論 ►小組發表 ►工具應用 ►實作演練 ►講師回饋 ►Q&A
二、FMEA	※FMEA 與 NUDD, IATF 16949, VDA 6.3, ISO 60601, ISO 14971 的關聯性
三、解碼新版 FMEA	1.Project Planning 5T: Team, Timing (in APQP Phases), Intent, Tool, Task 2.DFMEA Causes and PFMEA Alignment: Product Specifications Variation,    Environment, Changes over Time, System Interactions, Customer Use 3.6-Step DFMEA Process: a. Scope Definition b. Structure Analysis, c.    Function Analysis, d. Failure Analysis, e. Risk Analysis, and f. Optimization —Step 1.範圍定義Scope Definition：Company Name, System/Subsystem/Component/Part, Customer Name, Model Year/Platform, Subject, DFMEA Start Date, Cross-Functional Team, DFMEA Revision Date, DFMEA ID Number, Design Responsibility, Confidentiality Level —Step 2.結構分析Structure Analysis：System FMEA, Component FMEA, Block/Boundary Diagrams (physical/logical relationships between components), Structure Trees (System/System Element/Component Element). —Step 3.功能分析Function Analysis：Input->Function of System Element->Output and Interface, Requirements, Product Characteristic, P-Diagram —Step 4. 失效分析Failure Analysis：Types of Failures, Failure Chain (FE-FM-FC), Failure Effects, Failure Mode (Component Level Failure Modes, System-Level Failure Modes), Failure Cause (Inadequate design, system interactions, changes over time, external environment, user behavior, variation within tolerance, lack of robust design for manufacturing, software issues...), Failure Structure at different levels —Step 5.風險分析Risk Analysis：Rating SOD for failure chain and AP with PC/DC, Current Prevention Controls (PC, EMC directives, simulation, published design standard, best practices, lesson learned, Error-Proof, Non-NUDD,..), Current Detection Controls (DC, Function check, Burst test, Environmental test, endurance test, hardware/software, DOE, voltage output lab measurements..), Evaluations: Severity (S), Occurrence (O), Detection (D), Action Priority (AP) —Step 6.優化改進Optimization：Assessment of Action Effectiveness: Prevention Action, Detection Action, Responsible Person, Target Completion Date, Status, Action Taken with Prior to Evidence, Completion Date, SOD, AP, Continual Improvement
四、Project Assignment	※Project Assignment
五、Case Study & Presentation	1.EE Group：汽車/醫療 2.ME Group：汽車/醫療 3.Firmware Group：汽車/醫療

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