我國輸入食品查驗代施檢驗機構品質管理與國際規範合致性探討   全文下載

Investigation of the compliance with international norms for the imported food testing agencies in Taiwan - 2020 and 2021 audit results as an example

為確保代施檢驗機構之檢驗數據品質，確認代施檢驗機構執行內容符合測試與校正實驗室能力一般要求事項（ISO/IEC 17025:2017）及食藥署檢驗機構化學領域檢驗結果之品質管制及微生物領域檢驗結果之品質管制等規範，對代施檢驗機構執行品質確保查核與盲樣測試。彙整分析109年至110年各類別代施檢驗機構之查核意見，並依前述實驗室品質規範之章節進行分類；另統計分析盲樣測試之辦理家次數及測試結果滿意率。2年期間計執行188場次代施檢驗機構查核，總計開立831項查核意見，統計結果顯示查核意見對應章節「7.2方法的選用、查證及確效」者共404項、「7.5技術紀錄」者共217項、「化學品管」者共57項、「7.4樣品的處理」者共28項及「7.7確保結果的有效性」者共27項，此五章節之查核意見數量佔所有查核意見的88%以上，另盲樣測試結果滿意率分別為95.5%及91.7%。此外，針對輸入食品及相關產品代施檢驗機構之檢驗品質管理進行國際規範合致性比較，發現現行要求及管理方式與國際食品法典委員會「從事食品輸出入管控的測試實驗室能力評估指引」之四項品質標準相符。

To ensure the testing processes and data quality of the contracted food testing agencies could meet the requirements of ISO/IEC 17025:2017 and the requirements of quality control of testing results in the chemical field (QC-chemical) and microbiology field (QC-microbiology) announced by the Food and Drug Administration of Taiwan (TFDA), TFDA conducted quality assurance audits and blind proficiency tests for them. The non-conformity records (NCRs) of various testing kinds from 2020 to 2021 were herein summarized and categorized according to the clauses of ISO/IEC 17025:2017. The main clauses of NCRs, the number of contracted agencies who performed the blind tests and the satisfaction rates of the test results were analyzed. A total of 188 audits were carried out with 831 NCRs issued during the period 2020 to 2021. The statistical results showed that there were 404 NCRs corresponding to the clauses “7.2 Selection, verification, and validation of methods”, 217 NCRs corresponding to the clauses “7.5 Technical records”, 57 NCRs corresponding to QC-chemical, 28 NCRs corresponding to the clauses “7.4 Handling of test or calibration items”, and 27 NCRs corresponding to the clauses “7.7 Ensuring the Validity of Results”. The number of NCRs in the aforementioned clauses accounts for more than 88% of all NCRs. The satisfaction rates of blind test results were 95.5% and 91.7% in 2020 and 2021, respectively. In addition, the international standard conformity comparison was conducted on the testing quality management of the contracted food testing laboratories which carried out the imported food and related products tests. The current requirements and management methods applied were found in line with the four quality criteria of the Codex Alimentarius Commission “Guidelines for the Assessment of Competence of Testing Laboratories Engaged in Food Import and Export Control”.