結合ANP與FMEA於醫療產品設計階段之潛在失效風險評估

Risk Evaluation of Medical Product Design Using ANP and FMEA

余佳憓(Chia-Hui Yu)

指導教授 ： 任恆毅

元智大學/工程學院/工業工程與管理學系/碩士(2011年)

https://doi.org/10.6838/YZU.2011.00134

摘要

現今高齡化的社會來臨，高品質醫療服務與高品質的醫療器材需求也隨之增加，由於醫療器材涉及人身安全，因此各國政府及其相關法規均制定所屬的特定或嚴格的要求，尤其針對設計與製造醫療器材時所需進行風險分析及管理特別重視，且視為不可或缺的要項之一。風險分析的方法會依實際的需求而有所差別，而FMEA是判定危害與估計風險的重要方法；傳統FMEA的執行過程，並無考量風險因子間的相互影響與差異性，可能造成決策者的疏忽或誤判，本研究係運用因子間關聯性的建構與ANP法一致性檢定來強化FMEA的性能，藉由比對傳統FMEA評價與ANP+FMEA改良式風險評估法的差異，提高對FMEA考量評估因子間可能會相互影響性(依存關係)或影響自我本身(回饋)效益的完整性，使決策者於後續執行風險控制措施時，決定控制措施或優先處理的順序更客觀，從而提升醫療器材安全品質及可靠度。研究結果顯示，透過ANP+FMEA法證明FMEA階層與因子間的連動性是存在的，且其上下階因子的連動性，會受到模型建構的網絡特性與因子間相關性影響。而納入ANP法形成改良式FMEA門檻值(α)判斷，可彌補FMEA因RPN同分項目不易判別風險差異的困擾，具有真實反應現況的「雙重偵測性」效應。

關鍵字

風險分析 ； FMEA ； ANP ； 門檻值

並列摘要

As today’s society rise in age, so does the need for higher quality medical services and equipments. Due to the fact that medical equipment can directly affect the wellbeing of a person, risk analysis on the design and production of the medical device or the management are all highly regarded in governmental regulation and relative standards. Method of risk analysis differs by need, and FMEA is an important tool of analyzing danger and risks.Traditional FMEA does not take the effect and differences among risk factors into consideration, which can lead to negligence and misjudgment by the analyzer.This study applies the ANP method to combine FMEA that will improve the effectiveness of FMEA by taking the Consistency Index (C.I.) with Super matrix and building the characteristics model of function group. Therefore, the threshold value of ANP (α) consists to the weighting risk factors. By comparing with tradition FMEA analysis with ANP+FMEA method, the relative effects of the risk factors among each factors(effects) or itself (feedback) can be analyzed, allowing the analyzer to perform risk control procedures, decide what activities to perform or prioritize more effectively to increase the quality and reliability of the medical device. As the results, it is shown that through ANP+FMEA method it is clear that risk factors are related to one another, and can be affected by the characteristics of the model and network of factors. The threshold value of ANP (α) can be used to make up for the risk differences of FMEA due to RPN, which gives a more realistic reflection on the current status.

並列關鍵字

FMEA ； ANP ； Risk Analysis ； Threshold value

參考文獻

4. ISO (2007). ISO14971:2007 Medical devices-Application of risk management to medical device, 2ed. Switzerland. ISO14971:2007(E).

3. ISO (2003). ISO13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes, 2ed. Switzerland. ISO13485:2003(E).

17. 華強(2009)，應用FMEA於氣動工具產品設計之研究-以衝擊扳手為例，朝陽科技大學工業設計研究所碩士論文，台中縣。

21. 許盛堡(2001)，建構一個 QFD與 FMEA整合架構，元智大學工業工程與管理研究所碩士論文，桃園縣。

26. 衛萬里(2006)，應用分析網路程序法選擇最佳產品設計方案之決策分析模式，國立台灣科技大學設計研究所博士論文，臺北市。