食品藥物化粧品認證檢驗機構品質評估分析

Evaluation of the Quality of TFDA-Accredited Food, Medicinal Products and Cosmetics Laboratories

為瞭解國內由食品藥物管理署所認證的食品藥物化粧品檢驗機構品質，食藥署逐年參照國際標準ISO／IEC 17025：2005辦理認證實驗室之實地查核。本研究統計自104至106年度之實地查核缺失項目，並依上述標準之章節進行分類，探討認證實驗室常見的缺失項目。截至106年底，共有食品認證實驗室87家1,131認證項，及藥物化粧品認證實驗室37家372認證項。經統計結果顯示三年期間共計執行實地查核450場次，實地查核場次逐年上升；另三年期間共計開出2,780項缺失，分別於第四章管理要求：4.13章節「紀錄管制」有165項缺失、其次為4.3章節「文件管制」計有139項缺失及於第五章技術要求之5.4章節「測試與校正方法及方法確認」共有1,073項缺失最多，其次為5.9章節「測試與校正結果品質之保證」計有644項缺失，上述缺失均已請實驗室完成改善。本研究實地查核的結果，除列為食藥署加強監督管理認證實驗室之評估外，並供實驗室作為持續改善品質之參考。 In order to verify the quality of TFDA-accredited food, medicinal products and cosmetics laboratories, TFDA performs in situ inspections based on international standard ISO/IEC 17025: 2005 yearly. This study reviewed in situ inspection non-conformance reports (NCRs), and categorized them according to ISO/IEC 17025: 2005. As of the end of 2017, 87 food laboratories (1,131 test items) and 37 medicinal products and cosmetic testing laboratories (372 test items) were accredited. Four hundred and fifty in situ inspections were performed over three years, with an increase in the number of inspections each year. Out of a total of 2,780 NCRs reported. 165 NCRs were related to ＂Control of records＂ (Session 4.13), followed by 139 NCRs to ＂Document control＂ (Session 4.3), concerning ＂Management requirements＂ (Chapter 4). As to technical requirements (Chapter 5), 1,073 NCRs were related to ＂Test and calibration methods and method validation＂ (Session 5.4), followed by 644 NCRs to ＂Assuring the quality of test and calibration results＂ (Session 5.9). All the NCRs were subsequently corrected by the laboratories. The results of the inspections serve to enhance the supervision and management of the accredited laboratories, as well as provide them as references to continuously improve the quality of their works.