105－108年度第二級品管驗證執行成果與常見缺失分析

Certification of Second Tier Quality Control in Food Industry, 2016-2019

連耿汶(KENG-WEN LIEN) ； 洪祥瑜(SHIANG-YU HONG) ； 尤瀞萩(CHING-CHIU YU) ； 楊紓榕(SHU-JUNG YANG) ； 邱雅琦(YA-CHI CHIU) ； 羅維新(WEI-HISN LO) ； 呂在綸(TSAI-LUEN LUE) ； 遲蘭慧(LAN-HUI CHIH) ； 李明鑫(MING-SHIN LEE)

《食品藥物研究年報》 11期 (2020/12) Pp. 365-372

摘要

食品藥物管理署依據食品安全衛生管理法第八條規定，推動食品業者衛生安全管理系統驗證，透過結合第三方機構的專業稽核人員，進行食品業者衛生安全管理系統的驗證工作，以確保食品業者落實自主管理制度，並達到政府強化食品安全之政策目標。依據食品衛生安全管理系統驗證機構認證及驗證管理辦法，迄今已強制納入具工廠登記之10類食品製造業強制執行食品衛生安全管理系統驗證。包括罐頭食品製造業、食品添加物製造業、特殊營養食品製造業、應符合食品衛生安全管制系統之乳品加工食品業及資本額3,000萬以上之食用油脂、澱粉、麵粉、糖、鹽、醬油製造業，截至108年底共計有486家業者應強制執行食品衛生安全管理系統驗證。經統計分析，歷年通過率皆在8成以上，其中，在食品良好衛生規範準則部分之缺失，集中於食品製程之品質管理及量測儀器未確實校正等情況。而在食品安全管制系統部分之缺失，則主要為加工流程圖與現場實際作業流程不一致。上述缺失雖尚未對食品安全產生立即性危害或嚴重影響，惟仍期藉由驗證制度，提早協助食品業者發現廠區問題，使整體食品衛生安全更加精進。

關鍵字

第二級品管 ； 食品衛生安全管理系統驗證機構認證及驗證管理

並列摘要

According to the ＂Act Governing Food Safety and Sanitation＂, Taiwan Food and Drug Administration promotes the certification of food industry's health and safety management system. With professional auditors from third-party institutions, the food industry's health and safety management system is verified to ensure the implementation of their self-management system, and achieve the government's policy goal of strengthening food safety. According to ＂Accreditation of Certification Body and Sanitation and Safety Control of Food Businesses of Certification Regulations＂, canned food products manufactures, special nutrient foods manufactures, dairy products manufactures, and food additive industries, edible oil, sugar, salt, flour, starch and soy sauce industries with capital more than 30 million NT dollars are required for certification. As at end of 2019, a total of 486 businesses should enforce food hygiene and safety management system verification. Through statistical analysis, the passing rate was higher than 80% in the past years. Among them, the nonconformity of good hygiene practice maninly on quality management of food process and the measuring instruments calibration. Although those deficiencies didn't cause serious impact on food safety, through the verification system, problems in the factory can be found in advance, to further improve overall food hygiene and safety.

並列關鍵字

second tier quality control ； certification of food sanitation and safety management systems