104年度檢驗機構能力試驗結果分析

Analysis of Proficiency Testing Results in 2015

104年度食品藥物管理署（下稱食藥署）舉辦檢驗機構對於食品及藥物化粧品認證領域之認證項目檢驗能力試驗，包括食品領域16場次、藥物化粧品領域5場次，計有21場次。兩領域之能力試驗場次，測試類別包括食品及中藥製劑攙西藥成分、食品天然毒素、農藥殘留、動物用藥殘留、食品添加物、化粧品類等，測試項目計有60品項，參與測試之檢驗機構計有384家次，包括22縣市衛生局、食品領域50家民間檢驗機構及藥物化粧品領域13家民間檢驗機構。各能力試驗場次皆以評定原則為判定標準，若測試項目屬定性者，則測試結果以檢出/未檢出、陽性/陰性作判定；屬定量者係以Robust-Z、回收率（即相對於添加值之差異值）或測試值之合格範圍擇優者為評定結果，評定結果分為「滿意」、「應注意」及「不滿意」。透過能力試驗，可知104年參與測試之檢驗機構整體測試結果滿意率為80%，其中認證檢驗機構之整體測試結果滿意率為88%，顯示認證檢驗機構之檢驗能力表現大致良好。能力試驗提供檢驗機構間檢驗技術能力比對之機會，測試結果可作為檢驗機構持續改進其品質管理系統之參考，以及食藥署監控認證檢驗機構檢驗品質依據之一。

In 2015, 21 proficiency tests (PT) on the analysis of food, drugs and cosmetics were distributed to 384 participating laboratories, including 22 local health bureaus, 50 private food laboratories and 13 private drug and cosmetic laboratories. The participants were required to analyze the samples according to the standard procedures used routinely in their laboratories. The PT results were evaluated in this study to assess the participants' competencies. Qualitative tests were evaluated based on the results of presence/ absence or positive /negative. Quantitative tests were analyzed by statistic approaches such as Robust-Z, percentage recovery or value range. Robust-Z was categorized as follows: |Z| ≦ 2 is satisfactory; 2 ＜ |Z| ＜ 3 is acceptable; |Z| ≧ 3 is unsatisfactory. The results of this study showed that accredited laboratories performed well qualitatively and quantitatively. 80% of the participating laboratories achieved satisfactory results, including 88% of accredited laboratories. The accredited laboratories that attained unsatisfactory results were required to perform a second test and provide corrective action reports. Proficiency testing provides a tool for laboratories to assess their performance and improve their quality systems based on the test results. It also allows interlaboratory comparison and provides a basis for the TFDA to monitor the performance of accredited laboratories.