以安全為核心的醫療產品生命週期管理 -以電動輪椅為例

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研究生：	方德恩 Te-En Fang
論文名稱：	以安全為核心的醫療產品生命週期管理 -以電動輪椅為例 Safety-based Product Lifecycle Management of Medical Devices – Electric Wheelchair as an example
指導教授：	高信培 Hsing-Pei Kao 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
論文出版年：	2017
畢業學年度：	105
語文別：	英文
論文頁數：	67
中文關鍵詞：	醫療器材、生命週期管理、失效模式及效應分析、糾正預防措施
外文關鍵詞：	Medical devices Industry, Product Lifecycle Management (PLM), Failure Mode & Effect Analysis (FMEA), Corrective Action and Preventive Action (CAPA)
相關次數：	點閱：13 下載：0
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醫療器材產業的範疇十分廣泛，而各國對於產業發展的方向也不盡相同。由於已開發國家邁向高齡化以及對於提升醫療照護品質的訴求，醫療器材產業快速成長。一般而言，歐美醫材產業多以醫院用品為主，台灣則是以消費型醫療產品為主，例如：電動代步車與電動輪椅，而成為全球主要的供應國。
醫療儀器的安全度直接影響病人安全，因此各國政府極為重視醫療器材與產品的控管與審核。對於台灣電動代步車的廠商，如何確保產品在整個生命週期中的安全性，成為極重要的課題。產品生命週期管理的概念在於利用資訊系統以管理與整合與產品相關的各種活動，包括研發、製造、行銷、客服、財會等，而所有活動皆以提升品質與確保安全為核心目標。
本研究將以產品生命週期管理為範疇，電動代步車為例，建構一產品生命週期管理系統。除了界定產品生命週期中各階段的重點活動，並且針對產品的關鍵特性，建議應用失效模式及效應分析(FMEA)以及糾正預防措施（CAPA）等方法，以強化醫療器材的品質與安全。

The scope and the development directions of medical devices industry are varied among the countries. Owing to the ageing society and the high-quality healthcare requirements, rapid medical devices industry growth is occurring. The medical devices industry is mostly of hospital consumer products in Western countries. Comparing to Western, the main market in Taiwan is medical consumer products, like Electric Handicapped Scooter (EHS), and electric wheelchair, etc. It can be expected, Taiwan becomes the main supplier in the world.
Safety of medical devices directly impacts on the patients. Therefore, the government attaches importance among the medical devices, products control, and verification. For the electric handicapped scooter suppliers in Taiwan, how to ensure the safety during the entire product life cycle becomes a major issue. We describe an information system to support the Product Lifecycle Management (PLM) concept holds the product details of supervising, integrating, and the omnigenous processing. Including research, manufacturing, marketing, customer service, financial, etc. Every step aims to enhance quality and safety assurance.
This research illustrates three circumstances. First, we focus electric vehicle wheelchair industry on constructing the PLM system. Furthermore, applying Corrective Action and Preventive Action (CAPA) to inspect the manufacturing procedures. Using Failure Mode and Effect Analysis (FMEA) to find out the potential failure modes and calculate Risk Priority Number (RPN). Using before and after RPN number to know the improving approaches are worth. Finally, strengthen the approaches in CAPA to intensify both the quality and safety of medical devices. It can be applied to any sector, but special attention must be given to each industry particularities in the future.

Table of Contents
中文摘要    i
Abstract    ii
Acknowledgements    iv
Table of Contents    v
List of Figures    viii
List of Tables    ix
Chapter 1 Introduction    1
1.1 The Status of Medical Safety Assessment    1
1.2 The Medical Devices Industry (MDI) in Taiwan    2
1.3 Research Objectives    3
Chapter 2 Literature Review    4
2.1 Medical Device Industry in the World    4
2.2 Product Lifecycle Management (PLM) In Industry    7
2.2.1 The PLM Concept    7
2.2.2 The Current Status of PLM    8
2.2.3 PLM in Industry    8
2.2.4 PLM in Medical Device Industry    9
2.3 CAPA in Industry    13
2.3.1 CAPA Background    13
2.3.2 The Concept and Definition of CAPA    14
2.3.3 CAPA in Industry    14
2.4 Failure Modes and Effect Analysis in Industry    15
2.4.1 Origin and Development of FMEA:    15
2.4.2 The Concept of FMEA    16
2.4.3 FMEA in Industry    16
2.5 Concluding Remark    20
Chapter 3 Topic Propose and Methodologies    21
3.1 Research Framework    21
3.1.1 Research Objective    21
3.1.2 Methodology Framework    22
3.1.3 Research Steps Flow    24
3.2 Corrective Action and Preventive Action (CAPA)    25
3.2.1 The structure of Corrective Action and Preventive Action (CAPA)    25
3.2.2 Corrective Action (CA)    26
3.2.3 Preventive Action (PA)    27
3.3 Failure Mode and Effect Analysis (FMEA)    28
3.3.1 The Structure of Failure Mode and Effect Analysis (FMEA)    28
3.3.2 The Flow of FMEA    30
3.3.3 Risk Priority Number (RPN)    32
Chapter 4 Simulated Example    35
4.1 Electric Vehicle Wheelchairs Industry    35
4.2 Apply the framework in the Simulated Example    38
4.2.1 Applying the framework    41
4.2.2 Simulated Example Results    44
Chapter 5 Research Conclusions and Future Research    50
5.1 Research Conclusions    50
5.2 Review of Research Findings    50
5.3 Limitations of the Research    51
5.4 Recommendations for Future Research    51
References    53
Chinese References    55
Website    55



 
List of Figures
Figure 2: Market Forecast of Global Medical Equipment Industry Analysis Pie Chart (2012)    5
Figure 3: Market Forecast of Global Medical Equipment Industry Analysis Pie Chart (2016)    6
Figure 5: The product lifecycle of medical devices with framework idea    22
Figure 6: Research Framework    23
Figure 7: Research Steps Flow    24
Figure 8: CAPA-CA part in research framework    26
Figure 9: CAPA-PA part in research framework    27
Figure 10: Three categories of FMEA    29
Figure 11: FMEA Flow    31
Figure 12: Five categories of Medical devices in Taiwan    35
Figure 13: Auxiliary devices and remedy devices    36
Figure 14: Electric wheelchair procedure    39
Figure 15: Electric wheelchair procedure-wheelchair part    40
Figure 16: Electric wheelchair procedure with failure modes    42
Figure 17: Electric wheelchair procedure- wheelchair part with failure modes    43
 
List of Tables

Table 1: The Six Target Subsystems    11
Table 2: Different FMEA cases’ target audiences and purposes    18
Table 3: Tools and strategies investigated    19
Table 4: FMEA Table    28
Table 5: FMEA Severity category    32
Table 6: FMEA Occurrence category    33
Table 7: FMEA Detection category    33
Table 8: The results of Case study    44


                                

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