摘要: | 對於物料供應商的評估是製藥廠產品優劣的關鍵因素之一,如果選擇的物料品質欠佳,即使在製程能力和製程設備的方面沒有問題,仍會造成客訴的問題頻繁發生,然而製藥廠 E 廠昔日在選擇物料供應商時,是以成本為唯一考量,故導致每次更換物料供應商時,客訴事件及被通報到不良品中心的案件數會一直頻繁發生,此問題不但會影響到製藥廠本身的商譽及客戶端的使用安全,甚至嚴重點會導致病安事件的發生。所以本研究為了改善產品的品質問題及降低客訴事件的發生率,透過文獻探討及本身製藥廠對於物料供應商需求的特性,最終決定以層級分析法(Analytic Hierarchy Process ,AHP)和品質機能展開(Quality Function Deployment,QFD)的品質屋(House of Quality,HOQ)兩種方法結合,來探討製藥廠對於物料供應商的評估指標有那些需要評估的構面與準則,再配合品質屋對於物料供應商評估指標的分析結果,瞭解到製藥廠對於物料供應商評估指標的權重順序。 本研究透過與廠內的 7 位專家討論後,使用層級分析法(AHP)決定了 5 個評估構面和 18 項準則要素,且整個架構共有三個層級,獲得關於製藥廠 E 廠對於物料供應商需求的權重比,再透過與製藥廠內專家小組的討論後,在製藥廠 E 廠的需求構面與物料供應商的評選指標兩者所構成的關係矩陣表內,填入相對應的關係程度以表示兩者關係的強弱,最後將關係矩陣表中的各符號量化轉換成其量值,配合製藥廠需求構面的相對權重結果(從 AHP 所得到的結果)來計算出技術目標的數值,最終獲得製藥廠 E 廠對 於物料供應商之評估指標的權重大小順序,以作為日後製藥廠 E 廠在選擇新的物料供應商時的評估需求和指標依據。;The evaluation of material suppliers is one of the key factors determining the quality of pharmaceutical products. If the chosen material quality is poor, even if there are no issues with process capability and process equipment, it will still lead to frequent occurrence of complaints. However, in the past, Pharmaceutical Plant E solely considered cost when selecting material suppliers, leading to frequent complaints and cases reported to the Non-Conforming Product Center every time a material supplier was changed. This not only affects the reputation of the pharmaceutical plant itself and the safety of its customers, but could even lead to serious incidents of drug safety. Therefore, in order to improve product quality issues and reduce the occurrence of complaints, this study, through literature review and the characteristics of material supplier requirements of the pharmaceutical plant itself, ultimately decided to combine two methods: Analytic Hierarchy Process (AHP) and Quality Function Deployment (QFD) in the Quality House (HOQ), to explore the evaluation criteria of material suppliers for pharmaceutical plants, understand the aspects and criteria that need to be evaluated, and understand the weight order of the evaluation criteria for material suppliers by the pharmaceutical plant. Through discussions with 7 experts within the plant, this study used the Analytic Hierarchy Process (AHP) to determine 5 evaluation aspects and 18 criteria elements, with a total of three levels in the entire framework. The weight ratios of Pharmaceutical Plant E′s requirements for material suppliers were obtained. After discussions with an expert team within Pharmaceutical Plant E, the relationship matrix table between the requirements aspect of Pharmaceutical Plant E and the selection criteria of material suppliers was filled with corresponding relationship degrees to indicate the strength of the relationship between the two. Finally, the symbols in the relationship matrix table were quantitatively converted into numerical values, and the values of technical objectives were calculated based on the relative weight results of the requirements aspect of the pharmaceutical plant (obtained from the AHP results), ultimately obtaining the weight order of evaluation criteria for material suppliers of Pharmaceutical Plant E, to serve as the basis for evaluation requirements and indicators when selecting new material suppliers for Pharmaceutical Plant E in the future. |