為瞭解食品添加物業者經過第三方單位的查核及輔導兩種方式對於業者自主管理能力的提升是否有助益，因此，本研究查核75家及輔導65家台灣地區食品添加物業者，以食品安全衛生管理法及食品良好衛生規範準則(Good Hygiene Practice, GHP)為依據，執行1次查核、1次複查以及2次輔導、1次確認改善情況，探討食品添加物業者對安全衛生改善程度、食品添加物相關規範瞭解程度及自主管理之影響。衛生自主管理指標係以查核及輔導紀錄表單內容為主，查核表及輔導單分為兩個部分:(1)衛生自主管理部分 (2)食品添加物相關規範部分。研究結果顯示，第一次查核及輔導調查結果發現食品添加物業者對於「員工健康檢查」、「食品添加物專櫃管理」、「原料區隔離地擺放」與「病媒防治措施」是前十大共同不符合之項目，而經過二次查核(23.5%)與輔導(40.9%)改善後，前十大不符合項目之不符合率平均下降了32.2%，顯示查核與輔導方式皆能提升業者法規落實程度。就不同業別而言，製造與輸入業者對於查核及輔導方式是合適的，而販售業別則顯示出查核(Q3:44.8、median:44、Q1:40.3)優於輔導(Q3:48.5、median:39、Q1:28. 5)的方式。
其結果與基本資料的關聯性來看，衛管人員、參與教育訓練、是否有工廠登記證有正面相關性，但是資本額大小以及是否有食品工廠登記證是無相關性的。由此建議衛生單位在查核業者前應先教導業者法規相關規範如何執行，提供食品法規諮詢窗口或新法案宣導專線，並依據查核及輔導結果來適時改善作業方式，促使食品添加物業者能符合法規及遵循相關食品添加物要求，以提升業者自主管理能力。

In order to improve sanitization process for food additive industry, the third-party unit's audit and consultation are crucial to enhance the industry's self-management ability. We audit 75 food additive industry and consultations 65 food additive industry in Taiwan. Based on the Act Governing Food Safety and Sanitation and the Good Hygiene Practice (GHP), 2 audits and 3 consultations are performed to investigate the impact of food additive industry on the degree of safety and sanitation improvement, the level of understanding of food additives regulations and self-management. The self-management indicators for sanitation are mainly based on the contents of the audit and counseling record form. The checklist and the counseling list are divided into two parts. (1) Sanitation self-management part (2) Relevant specifications of food additives. The first audit and counseling concluded that common top ten non-conformity items were " Labor Health Examinations ", "Exclusive Area for Food Additives", "Materials, Semi-manufactures and Products Compartmentalization" and " Pest Prevention and Control". After the second audit (23.5%) and counseling (40.9%) improved, the non-conformity rate of the top ten non-conformities decreased by an average of 32.2%, indicating that the audit and counseling methods can improve industries the regulations implementation. The manufacturing and importing industries are suitable for auditing and counseling procedures, while sales industry are more adequate for auditing (Q3: 44.8, median: 44, Q1: 40.3) than counseling (Q3: 48.5, median: 39, Q1: 28) 5).
When conducting relationships between audit/counseling improvements and industry profile in general information, food sanitation inspector, participation in education and training, and a factory registration certificate are relevant, but the amount of its capital and a food factory registration certificate is irrelevant. Therefore, it is recommended that the public health bureau firstly educate the industry the relevant and latest regulations, provide a food regulation consultation window or a new law promotion line, and timely improve the operation mode according to the results of the auditing and counseling, so that the food additive industry can meet the requirements. Hence, auditing and counseling could facilitate industry compliance with relevant food additive requirements to enhance the industry's ability to manage its quality independently, further secure food safety and sanitization.

摘要..........................................I
Abstract.....................................II
目次..........................................IV
表次...........................................V
圖次.........................................VII
第一章 研究背景及目的.............................1
第二章 文獻整理..................................4
第一節 食品添加物簡介.............................4
第二節 食品安全相關法規...........................7
第三節 食品安全管理..............................10
第三章 研究內容.................................12
第一節 研究架構.................................12
第二節 研究範圍及對象............................12
第三節 研究工具.................................12
第四節 研究方法與步驟............................15
第五節 資料處理與分析............................17
第四章 結果與討論...............................19
第一節 業者基本資料分布情形.......................19
第二節 查核及輔導結果不符合情形之比較...............20
第三節 查核與輔導結果之比較.......................29
第四節 查核複查與第二次輔導改善結果分數之比較........31
第五節 業者基本資料在查核與輔導得分之差異情形........31
第五章 結論與建議...............................41
第六章 參考文獻.................................88
謝辭..........................................92
附錄..........................................93

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