105年度檢驗機構能力試驗結果分析

Analysis of Proficiency Testing Results in 2016

廖彩汝(CAI-RU LIAO) ； 羅維新(WEI-HSIN LO) ； 呂在綸(ZAI-LUN LU) ； 林雪如(HSUEH-JU LIN) ； 洪志平(CHIH-PING HUNG) ； 闕麗卿(LI-CHING CHUEH) ； 王淑芬(SHU-FEN WANG) ； 李明鑫(MING-SHIN LEE)

《食品藥物研究年報》 8期 (2017/11) Pp. 170-178

摘要

105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17場次、藥物化粧品領域8場次，計有25場次。兩領域之能力試驗場次，測試類別包括食品一般成分、農藥殘留、食品天然毒素、動物用藥殘留、重金屬、食品攙假、食品添加物、食品微生物、中藥製劑、西藥、化粧品類等，測試項目計有88品項，參與測試之檢驗機構計有483家次，包括22縣市政府衛生局、食品領域57家民間檢驗機構及藥物化粧品領域23家民間檢驗機構。透過能力試驗，可知105年參與測試之檢驗機構測試結果總滿意率為78%，其中認證檢驗機構之測試結果總滿意率為82%，顯示認證檢驗機構之檢驗能力表現大致良好；另地方政府衛生局之測試結果總滿意率為89%，顯示衛生局有持續提升其檢驗品質。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，以及食藥署監督管理認證檢驗機構檢驗品質依據之一。

關鍵字

能力試驗 ； 能力試驗評定原則 ； 認證檢驗機構

並列摘要

The Taiwsn Food and Drug Administration (TFDA) organized a total of 25 proficiency tests (PT) on the analysis of food, drugs and cosmetics in 2016. There were 17 PTs on food analysis and 8 PTs on drugs and cosmetics analysis. The test categories included food content, pesticide residues, natural toxins in food, veterinary drug residues, heavy metals, food adulteration, food additives, food microorganisms, Chinese medicinal products, western medicines and cosmetic products. There were a total of 88 test items and 483 participating laboratories, including 22 local health bureaus, 57 private food laboratories and 23 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 to assess the participants’ competencies. The results of this study showed that 78% of the participating laboratories achieved satisfactory results, including 82% of accredited laboratories. This indicated that accredited laboratories performed well in general. In addition, 89% of the local health bureaus achieved satisfactory results, indicating continuous improvement made on their quality of testing. Proficiency testing provides a tool for laboratories to assess their performance and improve their quality systems based on the test results. It also allows inter-laboratory comparison and provides a basis for the TFDA to monitor the performance of accredited laboratories.

並列關鍵字

proficiency testing ； the rule of proficiency testing ； accredited laboratories