|摘要: ||本研究主要研究目的是針對特殊營養食品工廠導入ISO22000與危害分析重要管制點（Hazard Analysis and Critical Control Points，HACCP）等食品安全管理系統後的執行情況、成效評估及所面臨的問題做一探討。本論文以台南某粉體食品代工廠K公司為個案研究對象，探討其粉狀特殊營養食品代工調配罐裝生產線導入ISO22000與HACCP等食品安全管理系統後之生產狀況，主要收集包括從進料、生產、到包裝儲運之所有階段之成品檢驗報告、生產異常狀況及客訴情況等作為研究資料來源。在導入ISO22000食品安全管?系統後，K公司之粉狀特殊營養食品生產線之製程從原料脫袋、投料、混合攪拌、過震動篩、金屬排出器、充填自動檢重機、人工補正重量、第一捲封、抽真空、充入混合氣體、第二捲封、包裝等加工製程，共區分成前提方案（Prerequisite Programs，簡稱：PRPs）、作業前提方案（Operational Prerequisite Program，OPRP）重要管制點（Critical Control Points，CCP）等管控點，其中共有夾雜異物 （OPRP1）、真空度不足 （OPRP2）等2項OPRP及金屬異物（CCP）等1項CCP。分析2017年K公司之粉狀特殊營養食品之檢驗分析報告、異常狀況及產品客訴狀況，發現從例行性之抽驗結果均正常。但異常狀況主要來自於PRP，其中以原料驗收後發現異常的件數最多。與品質有關的客訴狀況中OPRP1有17件、OPRP2有6件、CCP則有1件，顯然異物摻入是粉狀特殊營養食品加工最大的問題，且在加工製程中最難即時發現管控的。由異常案件作比較，顯示出個案K公司HACCP系統之建立及其完備，但其對於矯正及防止再發措施之執行力，確實宜再加強。|
The study aims to research the implementation, evaluation, and potential problems that special dietary food factories face on its management of food safety after ISO 22000 and HACCP were adopted. The researchers took K Company, a powdered food OEM (original equipment manufacturer) factory in Tainan, to be the case study subject and made an approach to production of its powdered special dietary food OEM canned preparation production line after ISO 22000 and HACCP were introduced into its food safety management system. The research data include material incoming, manufacturing, finished product inspection reports of packaging and storage at all stages, the quality anomaly and customer complaint. The powdered special dietary foods production line including raw material-unpacking, batch charging, intermingling, separator & filtering, metal discharger, automatic filling checkweigher, manual weight correction, first operation seaming, vacuuming, mixture gases filling, second operation seaming, and packaging. The production process is divided into control points including PRPs, OPRP and CCP. Among which, there were determination some control points including OPRP1 (foreign materials incorporation), OPRP2 (insufficient vacuum degree) and CCP (metal substance incorporation). According to certificate of analysis, it was found that the results of routine inspection of the powdered special dietary foods of 2017 were qualified. But the quality anomaly report and customer complaint report were showed some abnormality. The quality abnormality mainly originated from the PRP, of which the number of abnormalities detected after raw material acceptance was the highest. A total of 17 OPRP1, 6 OPRP2 and 1 CCP were found from the quality related consumer complaint status. Apparently, the incorporation of foreign substances is the most significant problem in the processing of powdered special dietary food, and it is also difficult to discovered and controlled in time during process. After the comparisons among abnormality case, the establishment and completeness of HACCP system in subject K Company are well shown; however, for its implementation on correction and recurrence prevention, remains much room for improvement.