【正文】 Documentation of this training showing time and date of the training, the content of the training and the employee’s signature of attendance is valuable for the auditor to see. 員工衛(wèi)生和健康訓(xùn)練的記錄文件應(yīng)該 有訓(xùn)練的日期和時間 , 訓(xùn)練內(nèi)容和員工參與了訓(xùn)練的簽名 , 以便于檢查員檢查 . Refresher training should be offered on a regular basis of at least a minimum of every 2 years. 每 兩年 應(yīng)該有重新訓(xùn)練 This employee training should also involve cleaning chemical training for the employees, where applicable for their job, and . training for all the employees, if the plant has a . program. 員工訓(xùn)練應(yīng)包括化學(xué)物品訓(xùn)練 , HACCP訓(xùn)練 (針對所有員工 ) After the inspection of the food processing facility, additional points may need to be deducted in this section to reflect the poor or inadequate training of the plant employees. 如果以上條款有違反 ,則會減分 . 在檢查完食品 加工設(shè)施后，如發(fā)現(xiàn)有情況顯示出工廠員工受訓(xùn)不足，這部分的一些分?jǐn)?shù)會被扣除。 The actual implementation of this program will be judged when inspecting the plant and could result in additional points being taken off under this category due to inadequacy of this program or the ineffective implementation of this program. 驗(yàn)廠會對有否真實(shí)實(shí)施這個程序作出評估，如果實(shí)施不當(dāng)，這部分會被扣分。 etc.). 檢查進(jìn)料貨車的清潔情況。 no unlabeled products。 ? Any required Certificates of Analysis. 有無要求任何的證書或分析報(bào)告。 The inpleteness of the records is an indication of either the lack of adequate training, the poor implementation of the program or the lack of good management supervision. Deduct points under the appropriate category. 記錄不全就顯示訓(xùn)練不足，程序?qū)嵤┎簧?，或者缺乏良好的管理監(jiān)督。 ? The policy on the segregation and the labeling of “rejected“ raw materials pending further disposition. 關(guān)于區(qū)格和標(biāo)記因 等待進(jìn)一步處理而標(biāo)有 “被據(jù)使用 “的原材料的規(guī)定。 If the plant is by law required to have a . program and does not, this will be a critical finding and an automatic failure of the audit. 如果工廠在法律上要求具備 HACCP程序而實(shí)際上又沒有的話，這將成 “關(guān) 鍵發(fā)現(xiàn) ”而導(dǎo)致檢查的 “自動失敗 ”。 It is not the responsibility of an auditor when conducting a GMP audit to validate a . program or the adequacy of the inprocess controls. The auditor is only to ascertain that the plant has a program and/or inprocess controls and that the plant is adhering to this program and controls. 檢查官沒有義務(wù)在進(jìn)行 GMP檢查時來落實(shí) HACCP程序，或者是加工過程的完善性。 ? There is a verification procedure to be followed to ensure that the . program is being followed and that it is working as intended. 必須有一個可行的核實(shí)步驟來確保HACCP程序被遵守并且運(yùn)行正常。 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(biāo)碼系統(tǒng)來標(biāo)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。 ? 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(biāo)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(xì)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(biāo)準(zhǔn)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(biāo)準(zhǔn)操作步驟文件的重要性是不容忽視的，因?yàn)樗鼈兪箯S房衛(wèi)生干凈，從而保護(hù)了食品的衛(wèi)生。 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。 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。 ? 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。 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。 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。 (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(shí)行。 (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。 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 old, dead insects in a warehouse. (Judge under poor housekeeping). 倉庫被發(fā)現(xiàn)有老，死的