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題名:構建國家科技計畫的品質系統模型:以台灣遠距照護醫療器材為例
作者:張燕妮
作者(外文):Chang, Yen-Ni
校院名稱:國立交通大學
系所名稱:科技管理研究所
指導教授:洪志洋
學位類別:博士
出版日期:2015
主題關鍵詞:科技政策國家科技計畫品質系統風險管理遠距照護產業醫療器材Science &; Technology Policy (S&;T Policy)National Science &; Technology ProjectQuality SystemRisk ManagementTelecare IndustryMedical Devices
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  • 點閱點閱:10
科技政策為促進產業發展與經濟成長的重要領導方針,長久以來都是各國所重視的課題。台灣科技政策的具體執行大多是以國家科技計畫形式實現。根據2002至2014年的施政績效與評核結果的分析顯示:長期以來績效指標的訂定與實際效益間沒有明確的連結,而檢討事項與後續改善情況也沒有確切地追蹤,導致科技政策的產業經濟效益難以忠實地被呈現與評量。本研究為科技計畫提出一以風險管理為核心之品質系統模型,並以遠距照護產業之醫療器材為案例分析。目的在讓科技計畫於規劃之初有一準則與程序可依循,並在風險管理下穩健進行,可提高成功率,也讓科技計畫精準確實滿足社會民生需求、達到科技政策的目的。
Science &; Technology Policy (S&;T Policy) - an important guidance for industry development and economic growth, is always the key issue for most countries in the world for a long time. In Taiwan, S&;T policies are implemented as many National Science &; Technology Projects. However, according to the performance reports and evaluation comments of S&;T ministry from 2002 to 2014, we found that (1) no clear link between performance indicator and real output impact, (2) no reliable tracing evidence between non-conformities and following-up improvements, both situations lead to ambiguous effects of S&;T policies.
In this study, we established an improved Quality System model based on risk management, and the medical devices in telecare industry is described as an example for detailed discussion. This model has the following benefits: Firstly, providing principles and procedures for project planning. Second, assisting the project team to identify, control and monitor critical risks efficiently through the whole process. Finally, the proposed framework can help decision-maker exactly target the needs of society and people. It is also quite in general and can be applicable and expendable for many kinds of S&;T projects.
[1]. Bartoo, G., (2003), “Risk Management”, IEEE Engineering in Medicine and Biology Magazine, July/August 2003, pp.166-172.
[2]. Burton, J., McCaffery, F., and Richardson, I., (2008), “Improving Software Risk Management Practices in a Medical Device Company”, International Conference on Software Process, ICSP 2008, Leipzig, Germany, May 10-11, 2008, Proceedings.
[3]. Bruce H. and Mild, K. H., (2008), “Guidance Note: Risk Management of Workers with Medical Electronic Devices and Metallic Implants in Electromagnetic Fields”, International Journal of Occupational Safety and Ergonomics, Vol.14, No.2, pp.217-222.
[4]. Bush, J. K., Dai, W. S., Dieck, G. S., Hostelley, L. S., and Hassall, T., (2005), “The art and science of risk management – a US research-based industry perspective”, Drug Safety, Vol.28, No.1, pp.1-18.
[5]. CMR, (2006), Pharmaceutical R&;D Factbook, CMR International Co..
[6]. DAPRA (2009), Defense Advanced Research Projects Agency’s (DAPRA) Strategic Plan, http://zh.scribd.com/doc/15833928/Defense-Advanced-Research-Projects-Agency-s-DARPA-Strategic-Plan-May-2009#scribd
[7]. Doctor, R. N., Newton, D. P., Pearson, A., (2001), “Management uncertainty in research and development”, Technovation, Vol.21, No.2, pp.79-90.
[8]. Donn, S. T., (2005), “Medical liability, risk management, and the quality of health care”, Seminars in Fetal &; Neonatal Medicine, Vol.10, pp.3-9.
[9]. EFMN (2009), “Mapping Foresight Revealing how Europe and other world regions navigate into the future”, European Commission, EUR 24041EN, http://ec.europa.eu/research/social-sciences/pdf/efmn-mapping-foresight_en.pdf
[10]. EN ISO 13485, (2012), Medical devices – Quality management systems – Requirements for regulatory purposes.
[11]. EN ISO 14971, (2012), Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
[12]. Flynn, B. B., Schroeder R. G., and Sakakibara, S., (1995), “The Impact of Quality Management Practices on Performance and Competitive Advantage”, Decision Sciences, Vol.26, pp.659-682.
[13]. Gaamangwe, T., Krivoy, A., Kresta, P., (2008), “Applying risk management principles to medical devices performance assurance program-defining the process”, Biomedical Instrumentation Technology, Vol.42, pp.401-406.
[14]. Glenn, J. and Gordon, T. J., (2004), “Future S&;T Management Policy Issues – 2025 Global Scenarios”, Technological Forecasting &; Social Change, Vol.71, pp.913-940.
[15]. Hughes, A. A., (1994), “Medical Device Risk management and Public Safety: Using Cost-benefit as a Measure of Effectiveness”, Health Care Technology Policy, SPIE Vol.2307, pp.318-338.
[16]. IEC 60812, (2006), Analysis Techniques for System Reliability – Procedure for Failure Mode and Effects Analysis (FMEA), 2nd edition.
[17]. IEC 61025, (2006), Fault Tree Analysis (FTA), 2nd edition.
[18]. ISO 13485, (2003), Medical devices-Quality management systems- Requirements for regulatory purposes
[19]. ISO 14971, (2007), Medical devices-Application of risk management to medical devices, 2nd edition.
[20]. ISO 31000, (2009), Risk Management – Principles and guidelines, 1st edition.
[21]. Jordan, P., (2007), “Draft Standard for Risk Management of Medical Devices Netwirks-An Answer to Our Problems”, printed by the IET.
[22]. Keizer, J.A., Halman, J.I.M., Song, M., (2002), “From experience – applying the risk diagnosing methodology”, Journal of Product Innovation Management, Vol.19, No.3, pp.213-232.
[23]. Krewski, D., Hogan, V., and Turner, M. C., (2007), “An Integrated Framework for Risk Management and Population Health”, Human and Ecological Risk Assessment, Vol.13, No.6, pp.1288-1312.
[24]. Lakhal, L., Pasin, F., and Liman, M., (2006), “Quality Management Practices and their Impact on Performance”, International Journal of Quality &; Reliability Management, Vol.23, pp.625-646.
[25]. Lee, J., Veloso, f. M., Hounshell, D. A., Rubin, E. S., (2010), “Forcing technological change: a case of automobile emissions control technology development in the US.”, Technovation, Vol.30, No.4, pp.249-264.
[26]. Lowi, T. J., (1972), Four Systems of Policy, Politics, and Choice. Public Administration Review, Vol.32, No. 4, pp.298-310.
[27]. McCaffery F., Burton, J., and Richardson, I., (2009), “Improving Siftware Risk Management in a Medical Device Company”, INSE Conference. http://eprints.dkit.ie/127/
[28]. Nair, A., (2006), “Meat-analysis of the Relationship between Quality Management Practices and Firm Performance-Implications for Quality Management Theory Development”, Journal of Operations management, Vol.24, pp.948-975.
[29]. O’Connor, G. C., Ravichandran, T., Daniel Robeson, D., (2008), “Risk management through learning: management practices for radical innovation success”, Journal of High Technology Management Research, Vol.19, pp.70-82.
[30]. Perminova, O., Gustafsson, M., Wikstrom, K., (2008), “Defining uncertainty in projects-a new perspective”, International Journal of Project Management, Vol.26, No.1, pp.73-79.
[31]. Pisano, G. P., (2006), “Can science be a business? Lessons from biotech”, Harvard Business Review, Vol.84, No.10, pp.114-125.
[32]. Powell, T. C., (1995), “Total Quality Management as Competitive Advantage: a Review and Empirical Study”, Strategic Management Journal, Vol.16, pp.15-38.
[33]. Preiffer, T., (2002), “Quality Management: Strategies, Methods, Techniques”, Munchen, Hanser Fachbuchverlag, 3rd edition.
[34]. Raz, T., Shenhar, A. J., Dvir, D., (2002), “Risk management, project success, and technological uncertainty”, R&;D management, Vol.32, No.2, pp.101-109.
[35]. Salomo, S., Weise, J., and Gemunden, H.G., (2007), “NPD planning activities and innovation performance: the mediating role of process management and the moderating effect of a product innovations”
[36]. Schmidt, R., (2010), “Risk Assessment in Research Projects”, IEEE.
[37]. Schmuland C., (2005), “Value-Added Medical-Device Risk Management”, Vol.5, No.3, pp.488-493.
[38]. Smith, P. G., and Merritt, G.M., (2002), Proactive risk management: controlling uncertainty in product development., Productivity Press, New York.
[39]. UNESCO, (1970), Science and Technology in Asian Development, 1st edition, Paris, United Nations Educational, Scientific and Cultural Organization.
[40]. UNESCO, (2011), UNESCO’s Global Observatory on Science, Technology and Innovation Policy Instruments GO→SPIN, http://www.unesco.org/new/fileadmin/MULTIMEDIA/HQ/SC/pdf/GO-SPIN_Concept.pdf
[41]. United Nations Educational, Scientific and Cultural Organization 聯合國教育、科學及文化組織http://www.unesco.org/new/en/natural-sciences/science-technology/sti-policy/
[42]. Vanderbyl, S., Kobelak, S., (2008), “Risk management for the biotechnology industry: a Canadian perspective”, Journal of Commercial Biotechnology, Vol.14, No.2, pp.128-140.
[43]. Wang, J., Lin, W., and Huang, Y. H., (2010), “ A Performance-oriented Risk Management for Innovative R&;D Projects”, Technovation, Vol.30, pp.601-611.
[44]. Ward, S., and Chapman, C., (2003), “Transforming project risk management into project uncertainty management’, International Journal of Project Management, Vol.21, No.2. pp.97-105.
[45]. Wilkins, R. D., Holley, L. K., (1998), “Risk Management in Medical Equipment management”, Proceedings of the 20th Annual International Conference of the IEEE Engineering in Medicine and Biology Society, Vol.20, No.6.
[46]. Yu, S., Yang, Q., Liu, J., and Pan, M., (2011), “A Comparison of FMEA, AFMEA and FTA”, IEEE, pp.954-960.
[47]. Zhang, Q., Xiong W., Feng X., (2010), “Exploring the mechanism of how quality management practices impact on firm performance: a theoretical framework”, IEEE.
[48]. Zhao, X. and Bai, X., (2010), “The Application of FMEA Method in the Risk Management of Medical Device during the Lifecycle”, IEEE.
[49]. 中華民國科學技術年鑑,2012年,http://yearbook.stpi.org.tw/html/2012.htm
[50]. 科技部簡介,http://www.most.gov.tw/public/Data/44114371071.pdf
[51]. 行政院國家科學委員會,中華民國科學技術白皮書(民國100年至103年), http://www.most.gov.tw/public/Attachment/18231893271.pdf
[52]. 行政院國家科學委員會,91年度施政績效報告,http://www.most.gov.tw/public/Data/56201223671.pdf
[53]. 行政院國家科學委員會,91年度施政績效報告評核意見,http://www.most.gov.tw/public/Data/56201233171.pdf
[54]. 行政院國家科學委員會,92年度施政績效報告,http://www.most.gov.tw/public/Data/56201245171.pdf
[55]. 行政院國家科學委員會,92年度施政績效評核意見及評定分數,http://www.most.gov.tw/public/Data/562012141471.pdf
[56]. 行政院國家科學委員會,93年度施政績效報告,http://www.most.gov.tw/public/Data/562012173871.pdf
[57]. 行政院國家科學委員會,93年度績效報告評核意見與等第,http://www.most.gov.tw/public/Data/56201218471.pdf
[58]. 行政院國家科學委員會,94年度施政績效報告,http://www.most.gov.tw/public/Data/651910365071.pdf
[59]. 行政院國家科學委員會,94年度施政績效評核意見與等第,http://www.most.gov.tw/public/Data/651910372771.pdf
[60]. 行政院國家科學委員會,95年度施政績效報告,http://www.most.gov.tw/public/Data/76716511071.pdf
[61]. 行政院國家科學委員會,95年度評核意見,http://www.most.gov.tw/public/Data/76716505271.pdf
[62]. 行政院國家科學委員會,95年度施政績效報告,http://www.most.gov.tw/public/Data/851416484071.pdf
[63]. 行政院國家科學委員會,96年度施政績效及評核結果,http://www.most.gov.tw/public/Data/851416493171.pdf
[64]. 行政院國家科學委員會,97年度施政績效報告,http://www.most.gov.tw/public/Data/98279305071.pdf
[65]. 行政院國家科學委員會,97年度施政績效及評核結果,http://www.most.gov.tw/public/Data/98279312371.pdf
[66]. 行政院國家科學委員會,98年度施政績效報告,http://www.most.gov.tw/public/Data/07215574971.pdf
[67]. 行政院國家科學委員會,98年度施政績效及評核結果,http://www.most.gov.tw/public/Data/07215584171.pdf
[68]. 行政院國家科學委員會,99年度施政績效報告,http://www.most.gov.tw/public/Data/25251405771.pdf
[69]. 行政院國家科學委員會,99年度施政績效及評核結果,http://www.most.gov.tw/public/Data/25251423671.pdf
[70]. 行政院國家科學委員會,100年度施政績效報告,http://www.most.gov.tw/public/Data/25251451471.pdf
[71]. 行政院國家科學委員會,100年度施政績效及評核結果,http://www.most.gov.tw/public/Data/25251462571.pdf
[72]. 行政院國家科學委員會,101年度施政績效報告,http://www.most.gov.tw/public/Data/351717103271.pdf
[73]. 行政院國家科學委員會,101年度施政績效及評核結果,http://www.most.gov.tw/public/Data/351717112171.pdf
[74]. 行政院國家科學委員會,102年度施政績效報告,http://www.most.gov.tw/public/Data/46917154271.pdf
[75]. 行政院國家科學委員會,102年度施政績效及評核結果,http://www.most.gov.tw/public/Data/46414574171.pdf
[76]. 行政院國家科學委員會,103年度施政績效報告,http://www.most.gov.tw/public/Data/55281519871.pdf
[77]. 行政院國家科學委員會,103年度施政績效及評核結果,http://www.most.gov.tw/public/Data/55281525271.pdf
[78]. 行政院國家科學委員會,科技部104年度施政目標與重點。
[79]. 科學技術基本法,中華民國92年5月28日公布,http://www.most.gov.tw/public/data/47149592271.htm
[80]. 經濟部產業技術白皮書,1996年至2015年,http://www.moea.gov.tw/Mns/doit/content/Content.aspx?menu_id=5398
[81]. 衛生福利部遠距健康照顧服務網站,http://mohw.telecare.com.tw/HomePage.aspx
[82]. 靖心慈,2000,「美國政府科技政策、制度與官民合作」,經濟前瞻,頁58-62。
[83]. 薛義誠,2004,「國家科技前瞻計畫之策略規劃模型初探」,科技管理學刊,第九卷第二期,頁83-101。new window
[84]. 李煥仁,2008,「我國科技政策的省思與建言」,台灣經濟研究月刊,頁20-24。new window
[85]. 孫智麗,2009,「前瞻2020台灣重要科技發展『新興科技前瞻與社會經濟需求』專家意見量化統計分析」,台灣經濟研究月刊,頁100-107。new window
[86]. 孫智麗,2012,「因應人口結構變遷下之科技發展規劃-論科技前膽與決策支援系統」,台灣經濟研究月刊,第35卷第3期,頁20-40。new window
[87]. 張淑芬,2010,「產業科技政策規劃流程與落實-以歐盟與台灣經驗為例」,台灣經濟研究月刊,頁56-64。new window
[88]. 張曉婷,2009,淺談台灣之遠距照護,台灣老年學論壇,第001期。
[89]. 王睦鈞,2010,「評析我國科技政策運作整合系統」,台灣經濟研究月刊,第33卷第7期,頁23-30。new window
[90]. 蔡璞,殷正華,林海珍,2011,「政策導向之前瞻方法建構—以個人化醫療為例」,科技管理學刊,第16卷第3期,頁53-76。new window
[91]. 柯承恩,孫智麗,吳學良,黃奕儒,鄒篪生,2011,「科技前瞻與政策形成機制:以農業科技前瞻為例」,科技管理學刊,第16卷第3期,頁1-28。new window
[92]. 承立平,吳惠林,2011,「論我國科技政策評估機制與決策支援體系之建構」,科技管理學刊,第16卷第3期,頁77-108。new window
[93]. 邱秀玲,2012,「引領國際運作經驗 提升我國科技續效管理效益」,台灣經濟研究月刊,第35卷第2期,頁26-35。new window
[94]. 許楓靈,2012,「科技政策工具之評估及選用」,台灣經濟研究月刊,第35卷第2期,頁17-25。new window
[95]. 林倖如,2012,「善用E化-精進科技計畫管理效率」,台灣經濟研究月刊,第35卷第2期,頁43-52。new window
[96]. 劉一萍,2012,「績效衡量的尺度-科技計畫效益評估指標的選定與管理」,台灣經濟研究月刊,第35卷第2期,頁36-42。new window
[97]. 吳慈珮,2012,「格局決定佈局,危機就是轉機-淺談韓國科技行政體系再造發展經驗」,台灣經濟研究月刊,第35卷第5期,頁85-93。new window
[98]. 李永正,2012,「公部門應如何進行技術商業化實現突破式創新-以美國『國防先進研究專案署』DARPA為例」,台灣經濟研究月刊,第35卷第7期,頁35-43。new window
[99]. 朱斌妤,高偲凱,2012,「科技政策資訊品質評選架構」,中山管理評論,第20卷第3期,頁811-849.new window
[100]. 莊麗蘭,邱秀蘭,盛淑華,2013,「國聯邦政府績效成果法現代化法(GPRAMA)之探討」,公共治理專刊,第1卷,第2期,頁98-116。
[101]. 羅愛雁,張錦俊,孫瑞臨,莊純琪,陳楚恬,黃財丁,2011,「我國科技政策工具特性與應用研究」,財團法人國家實驗研究院科技政策研究與資訊中心出版。
[102]. 陳明俐,紀凱齡,邱錦田,楊智元,2013,「國家科技發展計畫管考評估機制分析」,財團法人國家實驗研究院科技政策研究與資訊中心。
[103]. 張四明,2009,「行政院施政績效評估制度之運作經驗與改革方向」,研考雙月刊,第33卷第5期。
[104]. 林博文,徐玉梅,2013,「我國科技計畫評估制度分析」,公共治理季刊,,頁18-27.

 
 
 
 
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