醫療器材製造業風險管理系統建置之關鍵成功因素研究

The Implementation of Risk Management System Critical Success Factors in the Medical Devices Manufacturing

陳淑端(Shu-Duan Chen)

指導教授 ： 李培齊

淡江大學/管理學院/管理科學研究所企業經營碩士在職專班/碩士(2009年)

https://doi.org/10.6846/TKU.2009.00881

摘要

風險管理在醫療器材產業中是相當重要一環，數多的國際標準都直、間接的要求此項。IS0 14797為目前國際標準所發行的醫療器材風險管理之應用標準。因此本研究希望能利用專家深度訪談的研究，透過專家豐富的經驗及意見，對建置風險管理系統之經驗看法與觀點來找出，建立此系統之關鍵成功因素，以期能對醫材產業廠商於建置之際，能有效率的完成建置及有效的落實執行。

本研究蒐集資料範圍包括：（一）文獻資料；（二）針對醫療器材產業具權威與專業 之資深顧問、專家學者及企業代表包括國內外專業技術人員，進行深度訪談；（三）觀察及記錄在建置風險管理系統各個階段過程中之訪談情形。本研究透過文獻探討的方式，彙整出導入風險管理系統十六項關鍵成功因素，再依據建置的五個建置階段逐一進行分析、探討：（一）建置風險管理系統的各個建置階段中，哪些關鍵成功因素必須被重視？（二）建置風險管理系統的各個建置階段中，遭遇到哪些困難？因應措施為何？

研究發現結果如下：參與人員能投入專案工作、高階主管的全力支持並參與運作以及參與人員需有產品風險基本觀念以及參與人員接受適當的教育與訓練在所有階段，均是重要的關鍵因素，其他因素僅在部分建置階段為關鍵成功因素。另外本研究顯示組織管理之層面與內部人員層面，此二個層面之因素，是最關鍵之因素。而專業知識層面之關鍵因素亦是相對的關鍵重要。且本研究所彙整出建置風險管理系統之十六項關鍵成功因素，每項因素在不同階段的建置時期，皆有其關鍵成功之因素展現。

關鍵字

風險管理 ； ISO14971 ； 關鍵成功因素

並列摘要

The review of application and Risk Management processes will be driven by the risk of the business processes and environments. Without appropriate knowledge and guidance, organizations run the risk of doing too much or too little. This document’s purpose is sharing the “real world” experience to those enterprises which hope or need to design and assessment of Risk Management controls or lack the necessary skill or management structure to identify and focus on the correct model.
The research to study on the scope of (a) Literature Review-to review relative documents in risk management and critical success factors (b) In-depth interview- to interview of medical devices industry senior consultants, industry experts and representatives of the enterprises at domestic or foreign, (c) Observe and record the build of risk management systems in various stages during the interview activities.
This study explored the way through literature review, and makes a summary of 16 key success factors when built a risk management system. Based on 5-stage of build up a risk management system and 16 key success factors, the research to study (a) What factors caused risk management system build success during the various stages of construction? And what are critical success factors have to pay attention? (B) To build a risk management systems in various stages of construction, what difficulties they met? How to solve?
The research results are as follows: critical success factors: The team member involved the project task force on the first priority. The fully support of top managers and staff involvement in project progress. The participants have the basic concept of products risk management, as well as the appropriate education and training in all stages is very importance. Other factors are only in specific stage showed critical. In addition this study showed that the organization management and enterprise internal member two factors are very critical factors and the entire of 16 factors at different stages to have a different critical success factor.

並列關鍵字

Risk Management ； ISO 14971 ； Critical Success Factors

參考文獻

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