【正文】 被遵守并且運行正常。 The importance of having either a . program or inprocess control programs that are designed to produce safe food products is so critical that this section carries 25% of the possible points for Food Safety Programs and another 50% of the Plant Practices for a bination equal to 15% of the overall audit on this one issue including a possible automatic failure of the audit. 是否有一個 HACCP程序或者設(shè)計一個加工過程控制程序?qū)τ谑称钒踩浅Ｖ匾?，所以這部分占食品安全程序檢查的 25%的分數(shù)，以及占工廠操作檢查的 50%的分數(shù)，綜合起來占整個檢查的 15%的分數(shù)，并且有可能導(dǎo)致檢查的 “自動失敗 ” 。 In addition does the plant have a program to code date each batch of product so that in the case of a recall the product can be found and isolated quickly. 而且，工廠是否具備一個日期標碼系統(tǒng)來標記每一批產(chǎn)品，在產(chǎn)品被召回時可以迅速地找到和分離出問題產(chǎn)品。 INGREDIENT TRACEABILITY PROGRAM: (10 points). 成分追蹤程序 Does the plant have a program to trace the lot numbers on the raw materials and the packaging materials from their receipt through production into the finished packaged product? 工廠是否有一個追蹤程序，能根據(jù)原材料和包裝材料的批號，從它們的接收，到生產(chǎn)，到完成包裝的成品，都能追蹤得到。 ? Can the plant track the bulk ingredients? 工廠能否追蹤大包裝的成分材料 ？ ? Does the plant keep detailed records on rework? 工廠有無再加工的詳盡記錄？ ? Does the plant test the ability to trace the raw materials and/or the packaging materials at least once per year? 工廠有無每年一次測試追蹤原材料 /包裝材料的能力？ ? Is the plant able to account for 100% of a raw material and/or packaging material within 4 hours? 工廠能否在 4 小時內(nèi)查詢到任一種原材料 /包裝材料的全部？ PRODUCT RECALL PROGRAM: (10 points). 產(chǎn)品召回程序 ? Does the plant keep documented shipping records as to which product code dates are sent and to where? 工廠有沒有產(chǎn)品的送貨記錄，哪一個產(chǎn)品日期標號，送到哪里？ ? Does the plant have a documented recall program? 工廠有沒有召回程序的存檔文件？ ? Is the program detailed enough to provide sufficient information to do an expeditious recall? 這個程序是否提供足夠詳細的信息來做一個加快的召回？ ? Is the program tested at least once per year? Is this test documented? 這 個程序有沒有每年至少一次的測試？這個測試有無存檔記錄？ ? Is the plant able to account for the entire product in question within 4 hours? 工廠能否在 4小時內(nèi)查詢到全部的產(chǎn)品？ ’s (Sanitation Standard Operating Procedures): (35 points). 衛(wèi)生標準操作步驟 The importance of having good documented Sanitation Standard Operating Procedures (.’s) cannot be ignored due to their importance in having a sanitary plant and a protected food product. 有良好的衛(wèi)生標準操作步驟文件的重要性是不容忽視的，因為它們使廠房衛(wèi)生干凈，從而保護了食品的衛(wèi)生。 For seafood plants and their distributors it is a mandatory prerequisite to their . program that they be following cleaning procedures and schedules (.’s) but they do not have to be documented. 對于海產(chǎn)食品的廠商和供應(yīng)商而言，遵守 SSOP要求的清洗步驟和時間安排是它們的 HACCP程序的必須前提，但不需要文件存檔。 For other manufacturers it is considered necessary to ply with the GMP’s. 對于其他生產(chǎn)商，這被考慮作為符合 GMP要求的必須條件。 Chemical allergies in the consumer can be triggered by trace amounts of an allergenic food ingredient being carried from one product into another by means of unclean equipment. 不清潔的設(shè)備可造成極微量的食品原料交叉污染，使消費者產(chǎn)生的化學過敏 Pathogenic bacteria can bee airborne in an unsanitary plant and can contaminate readytoeat product causing the consumer to have a foodborne illness. 不衛(wèi)生的工廠會使治 病細菌在空氣中滋生，污染熟食產(chǎn)品，令消費者患食物引起的疾病。 In addition there needs to be a detailed cleaning schedule showing how frequently everything is to be cleaned and a check off list to be pleted by the employees after each task is done. Points in this section should be deducted for: 此外，還要有一個詳盡的清潔時間表，顯示多久會清洗所有東西，及員工每次清洗完畢后填寫的查核 清單。 ? Inpleteness of the cleaning schedule. 清洗時間表不完整。 ? Lack of cleanliness of the plant or equipment discovered during the audit and due to an inadequate cleaning procedure or schedule. 因清潔程序或時間表的不完善而造成工廠或設(shè)備不夠清潔。 ? Lack of the initials of the person responsible for the cleaning being on the check off list. 在清洗查核清單上，沒有負責清洗人員的簽字。 PEST CONTROL (20%). In order for a plant to manufacture and distribute food safely this has to be done in a pest free environment as pests spread diseases by contaminating the food. 工廠為了能安全地生產(chǎn)和供應(yīng)食品，就必須擁有一個無蟲害污染食物以至傳播疾病的環(huán)境。如果發(fā)現(xiàn)有蟲害存在，以及 //或者工廠缺乏預(yù)防蟲害的程序，分數(shù)都會被扣 減。 In this section the auditor is judging both the effectiveness of these preventive programs as well as the absence of pests (rodents, cockroaches, flies, birds, ants, etc.) in the plant. 檢查的這個部分，就是要判斷這些措施的有效程度，及廠房里有沒有蟲害 (老鼠，蟑螂，蒼蠅，鳥類，螞蟻，等 ) 的發(fā)生。 (這種情況意為著這項檢查自動失敗 ) (200分 ) ? The presence of any pests in the plant. (This is a critical finding). (60 points). 被發(fā)現(xiàn)有任何一種蟲害在廠房里。 (60分 ) ? The interior rodent and insect control programs and their effective implementation. (35 points). 室內(nèi)老鼠和昆蟲的控制措施及其有效的實行。 (35分 ) ? ? The condition of the building for effective pest control including personnel practices. (35 points). 建筑物的狀況，包括個人操 作在內(nèi)的防蟲的有效性。 (35分 ) ACTUAL ADULTERATION OF A PRODUCT DUE TO PESTS: (200 points). 因蟲害引起劣品 This can be from birds, flies, rodents, stored product pests, ants, cockroaches etc. The presence can be just evidence (. rodent droppings, dead insects etc.) and does not have to be a live pest. This constitutes an adulterated product under Section 402(A) 3 of the .’s and hence is a critical finding and an automatic failure of the audit. 這可能因鳥類，蒼蠅，老鼠，儲藏產(chǎn)品蟲類，螞蟻，蟑螂等。這一條構(gòu)成了 GMP 402(A)3里的劣品條例，因此是關(guān)鍵發(fā)現(xiàn)并會造成檢查自動失敗。 The auditor should not however consider the following conditions critical: 檢測官不應(yīng)將以下情況作為關(guān)鍵發(fā)現(xiàn)： ? A single live mouse caught in a rodent control device. (Serious but not critical). 一只被捕鼠器抓獲的活鼠。 ? The presence of fruit flies. (Indication of poor sanitation and should be judged accordingly). 果蠅的存在。 ? The presence of old, dead insects in a warehouse. (Judge under poor housekeeping). 倉庫被發(fā)現(xiàn)有老，死的昆蟲。 ? The presence of rodent evidence in nonfood areas (. boiler rooms, electrical rooms etc.). 非食品區(qū)被發(fā)現(xiàn)有老鼠 (比如鍋爐房，電路房等 ) ? The presence of old rodent evidence. (Judge under poor housekeeping). 被發(fā)現(xiàn)有舊的老鼠的