标题: 航空货运场站医药物流作业规划与风险评估
Operations Processes Planning and Risk Analysis of Cargo Handling of Pharmaceutical Logistics at Air Cargo Terminals
作者: 谢佳蓉
姚铭忠
Hsieh, Chia-Jung
Yao, Ming-Jong
管理学院运输物流学程
关键字: 医药物流;航空货运场站;失效模式与效应分析;特性要因图;Pharmaceutical Logistics;Air Cargo Terminal;Failure Mode and Effect Analysis
公开日期: 2017
摘要: 为确保药品在运销过程可以维持品质及包装的完整性,国际医药品稽查协约组织(PIC/S)颁布Good Distribution Practice (GDP),台湾卫生福利部亦公告“西药药品优良制造规范(第三部:运销)”以与国际接轨,然台湾航空货站因通关制度与环境之差异,不易取得国内或国际的药品运输认证。
爰此,本研究运用失效模式与效应分析 (Failure Mode and Effect Analysis, FMEA)模式,邀专家学者评估桃园国际航空货站现行药品作业失效风险,确认依相关药品规范及客户需求等标准所提之改善建议,得以管理失效风险,进而提出台湾航空货站医药物流作业环境与流程规划方案。
现行台湾航空货站药品作业潜在有不符药品作业规范、无法启动药品作业及未落实温控程序等严重失效模式,本研究针对相对较高之风险失效因素提改善建议,经与专家学者确认,可有效降低资讯、规范、空间、设备及货站法规等失效发生频率,确保规划之药品作业环境与流程,达到改善现行作业风险,符合药品规范之目标。
To ensure pharmaceutical quality and packaging integrity during transportation, the Pharmaceutical Inspection Convention and Pharmaceutical Co-operation Scheme introduced “Good Distribution Practice-GDP”. Parallel to the international standard, Taiwan Food and Drug Administration enacted “Pharmaceutical Good Manufacturing Practice” to ensure Taiwan’s relevant regulations meet international guidelines. However, constraints due to existing custom clearance requirements prevent Taiwan airport cargo terminals from being certified by international or domestic agencies governing pharmaceuticals handling and transportation.

As such, “Failure Mode and Effect Analysis” (FMEA) is utilized to assess the inadequacies and associated risks based on experts’ survey and suggestions for pharmaceuticals handling processes at Taoyuan International Airport Cargo Terminal. The goal is to identify and manage associated risks and to propose a plan that meets internal and domestic pharmaceutical handling and transportation guidelines, for operational processes in Taiwan’s air cargo terminals.

The FMEA results indicate areas of concern and countermeasures are therefore proposed to mitigate deficiencies and warrant certification by internal and domestic agencies governing pharmaceutical transportation and handling.
URI: http://etd.lib.nctu.edu.tw/cdrfb3/record/nctu/#GT070463624
http://hdl.handle.net/11536/141985
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