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研究生： 簡玠
Chieh Chien
論文名稱： 協同設計中以流程導向為架構的風險管理
A Process-Oriented Framework of Risk Management in Collaborative Design
指導教授： 高信培
Hsing-Pei Kao
口試委員:
學位類別： 碩士
Master
系所名稱： 管理學院 - 工業管理研究所
Graduate Institute of Industrial Management
畢業學年度： 96
語文別： 英文
論文頁數： 81
中文關鍵詞： 設計結構矩陣 、協同設計流程 、IDEF3 、風險管理
外文關鍵詞： Collaborative design process, IDEF3, Design Structure Matrix, Risk management
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    • 新產品開發是一連串複雜且充滿風險的流程，其中包含不同領域的知識，以及人員與預算等資源之使用，然而其失敗機率卻非常高。如何使產品設計研發流程成功，遂成為一個重要的議題。
    本研究旨在提出一套方法論，同時對風險與協同設計進行管理，降低協同產品開發過程失敗的可能性。風險管理以一套有系統的方法找到潛在的風險，使我們可以事先防範與規避，以減少風險的影響。本文將以此為基本架構，配合IDEF3與設計結構矩陣(DSM)建立協同產品開發流程，提供分析與回饋。

    Product design and development is a very complex and risky process requiring knowledge spanning different disciplines. Many empirical studies have documented the high failure rates in new product design and development. How to ensure the success of new product development has become a significant issue.
    The methodology will integrate information about the process and risk issue and generate a collaborative design process where risk is considered. Risk management refers to uncovering weaknesses in methods used in development through a structured approach so that timely mitigation actions are initiated afterwards to avoid risk, transfer risk, reduce risk likelihood or reduce risk impact.
    One combines IDEF3 with the Task-based Design Structure Matrix (DSM) to establish context and apply it in the future process of risk management. While DSM provides the resequence the process; IDEF3 could monitor and evaluate the processes easily and have feedback from the process, which will help one to act in advance. Failure Mode and Effect Analysis (FMEA) is a risk identification tool in this thesis which can be used in the early stage of development process.

    List of Figures…………………………………………………vii List of Tables…………………………………………………viii Chapter 1 Introduction 1 1.1 Background 1 1.2 Motivation 2 1.3 Research objectives 2 1.4 Thesis structure 3 Chapter 2 Literature Review 4 2.1 New product development (NPD) 4 2.1.1 Introduction of new product development 4 2.1.2 The process of new product development 5 2.2 Collaborative process 7 2.2.1 Introduction of collaboration 7 2.2.2 Collaborative product development 7 2.3 Risk management 9 2.3.1 Introduction of risk management 9 2.3.2 Risk management process 10 2.3.3 Failure mode and effects analysis 13 2.4 Business modeling tools 17 2.4.1 Integration definition method for process description capture (IDEF3) 17 2.4.2 Design structure matrix (DSM) 21 Chapter 3 Proposed Methodology 28 3.1Proposed Methodology framework 28 3.2 Pre-analysis phase 31 3.2.1 IDEF3 process model 31 3.2.2 Relative table 32 3.2.3 Collaborative matrix 33 3.2.4 Failure mode and effects analysis (FMEA) 34 3.2.5 Different types of FMEA 35 3.3 Construction and analysis DSM matrix 37 3.3.1Map process model and relative table into the matrix 38 3.3.2 Loading the collaborative matrix 38 3.3.3 Risk score 38 3.3.4 Partitioning 39 3.3.5 Converting into IDEF3 process 39 Chapter 4 Illustractive Example 41 4.1 Medical device 41 4.1.1 Definition of medical device 41 4.1.2 The market of medical device 42 4.1.3 Product development process in medical device 44 4.1.4 Regulation in medical device 46 4.1.5 Human factors engineering (HFE) 47 4.2 Description of the case 50 4.2.1 Background of auto-injector 50 4.2.2 New product development process s in Company A 51 4.2.3 Architecture of auto-injector 55 4.3 Demonstration of case implemented by proposed methodology 57 4.3 Implementation of proposed methodology on auto-injector 66 4.3.1 Mapping process and relative table into DSM 66 4.3.2 Loading collaborative company information 67 4.3.3 Loading information of PFMEA 69 4.3.4 Partitioning and construct the new matrix into IDEF3 diagram 71 Chapter 5 Conclusion and Future Research 75 5.1 Conclusion 75 5.2 Future research 75 Reference 77

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