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  • 學位論文

建立醫藥物流作業流程FMEA模式

The Establishment of the FMEA Model on Pharmaceutical Logistics Process

指導教授 : 楊錦洲

摘要


我國加入WTO後,衛生署鑑於提昇國內製藥的水準並與國際接軌,規定國內藥廠須於通過現行優良藥品製造規範(current Good Manufacturing Practices, cGMP) 。然該規範中,並無將醫藥品配送作業規範納入其中,而業界對醫藥品配送的作法是依各藥廠(國外藥廠、國內藥廠、進口貿易商等)委託第三方物流業者(一般物流及貨運業者)進行實體配送,但因藥品的特殊性(如溫濕度、效期等)易造成作業失效,造成無效益配送並增加不良品質成本,因而間接侵蝕企業獲利。 鑑於此,本研究運用FMEA(Failure Mode and Effect Analysis)技術於物流作業流程,符合醫藥品的特性、法律觀點及貨櫃溫度管理,發掘其作業流程的失效模式、效應與原因,以模糊德菲法(Fuzzy Delphi Method)凝聚群體決策共識,評估失效模式風險值,並運用灰關聯分析(Grey Relational Analysis)決定失效模式之改善順序,建立醫藥物流作業流程(Pharmaceutical Logistics Processes)。 在本研究裏,獲得幾項結論,首先,醫藥物流作業在資訊、搬運、疊貨及配送等物流作業規範,較於一般物流作業更為嚴格;再者,醫藥物流作業流程,應加強物流人員訓練,尤其是對於醫藥品的認知與藥品關係到生命安全的觀念;最後則是物流作業流程實施FMEA,可發掘物流作業於醫藥品不足之處,並減少不良之成本,所累積的知識與經驗,可提供新流程設計之參考依據。

並列摘要


After Taiwan joined the WTO, the domestic pharmaceutical manufacturers face the severe challenge to international competition. It is therefore that the department of health (DOH) announced the higher standard of cGMP (current Good Manufacturing Practices). Among the practices, it does not include the pharmaceutical distribution operations. Therefore, various pharmaceutical manufacturers voluntarily engaged physical distribution by third party logistics providers. However, due to the particularities of medicines, (for example temperature/humidity, expiration date), it is possible to cause the operations failure, ineffective distribution, cost of poor quality, ultimately corrode the profits. According to the present situation descriptions, this study combines view of law with pharmaceutical characteristics and temperature management in reefer container to construc the conditions of pharmaceutical logistics. We use Failure-Mode and Effect-Analysis (FMEA) to detect failure modes, effects and causes of third party logistics processes, use Fuzzy-Delphi Method (FDM) to consolidate common view to evaluate risks of failure modes, and Grey-Relational Analysis to sort the improving sequence of failure modes. In this research, we obtain several conclusions. First, the information, transit, stacks and distribution of pharmaceutical logistics is stricter than common logistics; second, pharmaceutical logistics should strengthen personnel’s training, especially ideas of pharmaceutic and the relations between medicine and life; third, FMEA implement can explore the weakness of logistics processes and decrease poor-quality costs. On the side, FMEA can establish the process knowledge library and management mechanism to enhance the know-how technology.

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被引用紀錄


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彭文煌(2007)。醫院病房導入數位化之創新服務 -以互動式STB/RFID為例〔碩士論文,元智大學〕。華藝線上圖書館。https://doi.org/10.6838%2fYZU.2007.00257
劉彩娥(2010)。運用醫療失效模式與效應分析於呼吸管路安全之改善〔碩士論文,中臺科技大學〕。華藝線上圖書館。https://doi.org/10.6822%2fCTUST.2010.00001
黃詠俊(2013)。大範圍淹水地區物資配送系統動力分析-以屏東縣為例〔碩士論文,國立屏東科技大學〕。華藝線上圖書館。https://doi.org/10.6346%2fNPUST.2013.00084
方振宇(2008)。整合HFMEA與VSM於醫療流程之改善〔碩士論文,國立清華大學〕。華藝線上圖書館。https://www.airitilibrary.com/Article/Detail?DocID=U0016-1410200814312463

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