【正文】 ? 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。 (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(chǔ)藏產(chǎn)品蟲類，螞蟻，蟑螂等。 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(gè)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。 ? 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(shí)間表的不完善而造成工廠或設(shè)備不夠清潔。 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 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(gè)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(shí)可以迅速地找到和分離出問題產(chǎn)品。 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?zèng)]有義務(wù)在進(jìn)行 GMP檢查時(shí)來落實(shí) HACCP程序，或者是加工過程的完善性。 ? 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。 ? Any required Certificates of Analysis. 有無要求任何的證書或分析報(bào)告。 etc.). 檢查進(jìn)料貨車的清潔情況。 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(shí)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(huì)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(huì)被扣除。 ? Rodents in the plant but not in the products. (Not to include a freshly caught rodent). 廠里有老鼠等動(dòng)物但產(chǎn)品里面沒有 . (不包括剛抓到的 ) ? Insects in the plant but not in the products. (Not to include fruit flies in a processing area, or a fly or spiders in a storage area). 廠里有昆蟲但產(chǎn)品里面沒有 . (不包括在生產(chǎn)區(qū)的果蠅 , 或儲(chǔ)存區(qū)的蒼蠅 等 .) ? Flaking paint or other materials over exposed product, raw materials or packaging materials. 片狀涂料或油漆或其它材料在產(chǎn)品 , 原材料 ,或包裝材料上 ? Rust on food contact or food packaging contact surfaces. 食品或包裝上有銹 . ? Dripping oil, condensate, and grease over exposed product, raw materials or packaging materials. 油滴 , 冷凝物 , 油膏在產(chǎn)品 , 原材料 ,或包裝材料上 ? Rest rooms either opening directly into, or being vented into, areas where food, raw materials or packaging materials are stored or processed. 廁所 直接開于，或通風(fēng)于食品，原材料或包裝材料的儲(chǔ)存或加工區(qū)。 ? Poor employee hygiene that could result in contamination of the food products or raw materials. (. handling food or raw materials with bare, unsanitized hands). 員工衛(wèi)生問題會(huì)造成產(chǎn)品或 原材料污染 (如用未消毒的手去接觸食物 ) ? Employees eating, drinking, chewing or smoking around exposed food, exposed raw materials or exposed packaging materials. 員工在產(chǎn)品 , 原材料 ,或包裝材料區(qū)吃喝抽煙 ? Unhealthy employees working with exposed food exposed raw materials or exposed packaging materials. 生病員工在 原材料 ,或包裝材料上工作 ? Lack of backflow preventers on potable water lines or on product lines where the possibility of backflow can cause food safety issues. 缺少阻止水回流 (會(huì)造成食品安全問題 )的設(shè)施 . ? Blocked sewers and/or drains causing unsanitary conditions where food, raw materials or packaging materials are stored or processed. 下水道阻塞 , 會(huì)造成有產(chǎn)品 , 原材料 ,或包裝材料區(qū)的污染 . ? Mold on walls or equipment where food, raw materials or packaging materials are stored or processed. 墻或 用來儲(chǔ)存和加工食品，原材料或包裝材料的 設(shè)備 上 有霉 . NOTE: All critical items identified in the audit need to be: 注意： 所 有在檢查中被發(fā)現(xiàn)的關(guān)鍵問題應(yīng)作以下處理： ? Summarized at the beginning of the report. 在 報(bào)告的開頭總結(jié) ? Identified with bold type in the correct section of the report. 用黑體字在報(bào)告正確部分標(biāo)記 ? All points need to be deducted against the particular item. 所有分?jǐn)?shù)必須從相應(yīng)項(xiàng)目上扣去 ? Overall grade cannot be higher than good and in many cases will generally be lower than good. 總分不能高于良好。 GMP MONTHLY SELFINSPECTIONS PROGRAM: (15 points). GMP每月自檢程序 The plant conducting every month a GMP selfinspection to identify any food safety problems and to put into effect corrective actions achieves progress towards total food safety and the prevention of regression. 每月應(yīng)有一次 GMP自檢以找出 食品安全問題并放入有效的改正措施中 . These inspections need to be documented and kept on file along with documentation of the corrective actions. 這種檢查應(yīng)有記錄并和更正記錄保存在一起 . The amount of points deducted will be a reflection of the plant’s adherence to doing these inspections monthly and with following up on noted deficiencies. 這部分扣除的分?jǐn)?shù)顯示出工廠每月自檢的遵守程度及有沒有改進(jìn)不足之處。 (沒有老鼠，昆蟲或它們存在的痕跡；沒有氣味；地面上沒有灰塵，等等 ) ? The criteria for the inspection of tankers. 檢驗(yàn)貨箱的標(biāo)準(zhǔn) ? The criteria for inspecting the raw materials and the packaging materials upon receipt. (No torn or stained bags。 ? Any requirements to hold a product on a tanker while the