【正文】 finding. 要么有主要的 食品安全問題包括幾個關鍵問題 , 或有被查到自動檢查失敗之處 . CRITICAL ITEMS INCLUDING AUTOMATIC AUDIT FAILURES. 關鍵問題包括自動檢查失敗 Automatic audit failures: 自動檢查失敗 The following conditions discovered during an audit would result in an automatic failure of the audit despite the overall numerical grade of the audit attributed by other factors: 以下幾處情況會造成 自動檢查失敗 ,不管總分多少 . ? Actual adulteration of the product from any cause. (402(A) 3 violation). 任何因素造成的產(chǎn)品有摻雜 , 品質(zhì)低劣 . 違反 402(A) 3 ? Failure to have a . program, if mandated by law. 沒有 HACCP程序 ? Failure to follow a mandatory . program. 沒有按 HACCP程序去做 Numerical audit failure: 得分上的不通過 ? An overall numerical grade of 70%. 總分低于 70% Critical items: 關鍵問題 These findings alone, although very serious, will not automatically result in a failure of the audit but they will result in the overall numerical grade not being any higher than good and in most cases lower than good. 這些問題，雖然不嚴重到自動導致檢查不通過，但會影響總分，令總分達不到良好。 The critical items listed below are not totally enpassing as certain situations may result in the auditor deeming a particular situation to also be critical if it threatens the safety of a food product or a raw material. 下面一些關鍵點會讓檢查員認為會危害產(chǎn)品或原材料安全 . These conditions are all considered to be 402(A) 4 violations of the GMP’s. 這些情形都違反了GMP 的 402(A) 4 條例。 The purpose is to determine if the plant has programs, if they are documented and if, by reviewing the programs, that they are adequate. 目的 : 是否有程序 , 有無相關文件 , 是否齊全 When later reviewing the conditions observed in the plant it may be necessary to revisit this section to adjust the points down due to either inadequacy of a program (remove points against that program) or lack of training of the employees (remove points under employee training) and/or lack of training of management (remove points under management training). 當檢查完畢總結工廠的狀況時，可能有必要重新回到這個部分來調(diào)整分數(shù)：程序不完善 (從程序上扣分 ) ，或員工缺乏訓練 (從員工訓練上扣分 ) ，或管理不善 (從管理培訓上扣分 ) 。 This should include the relationship between their health, hygiene and practices and the possibility of producing contaminated food, the difference between clean and unsanitary equipment and surroundings, and the importance of protecting the product at all times. 這包括關于他們的健康，衛(wèi)生及操作和食品污染的關系，生產(chǎn)設備和環(huán)境中清潔和不衛(wèi)生的區(qū)別，以及在任何時候保護產(chǎn)品不受污染的重要性。 This can be achieved in part by requiring from their suppliers continuing guarantees on the raw materials and the packaging materials and in certain cases certificates of analysis on the raw materials. 要求原料商持續(xù)保證品質(zhì) , 包裝材料亦應有分析報告 . Continuing guarantees are written assurances from the suppliers that the raw materials and the packaging materials meet all the laws regarding food grade, labeling and are as safe as they possibly can be. 持續(xù)保證品質(zhì)是原料商關于原料和包裝材料符合食品級的 商標安全的法規(guī)的書面保 證 Certificates of analysis should be obtained from suppliers on every batch of certain key raw materials showing the presence of particular constituents (% purity) or the absence of certain pathogenic contaminants (. salmonella). 成分分析應是對每批原料進行檢查 , 應包括特殊成分的百分比 (%純度 )或顯示沒有致病菌的污染 (. 沙門氏菌 ) Compliance to this program is extremely important if the plant has a . program and a raw material is identified as being a critical item in this program. 遵守這個要求非常重要，因為 原材料是 HACCP的一個關健點 . The auditor needs to determine the plant’s requirements for this documentation and then the degree to which they are in pliance with their own program. Some plants will rely on their own testing of raw materials to be sure that they are receiving safe and wholesome raw materials. 一些工廠會依賴他們自己的原料檢測體系以保證收到安全和可靠的原料 If the auditor determines that this point is not applicable then mark it (N/A) and remove the total points from 200 and calculate the rest of the category as a percentage of 185 correspondingly. 如果檢查員決定這種方式行不通 , 就會指出并從 200分中扣除 INCOMING GOODS INSPECTION PROGRAM: (15 points). 進料檢查程序 The ability to spot problems before they enter the plant is determined by the thoroughness of the plant’s ining goods inspection program and the implementation of that program. 要有在檢查員驗廠前就應查到工廠的來料檢查程序和完成程序的能力 . The auditor needs to review the documented program as to the requirements for the inspection of both the trailers and the tankers as well as for the inspection of the raw materials and the packaging materials. 檢查官需要查看相關的文件，證明 除了檢查原料和包裝材料外 , 貨柜及運貨小車也會檢查 . A problem stopped from entering the plant is one less problem that the plant has to address inside the plant. 問題在進入工廠之前被發(fā)現(xiàn)和阻止，那工廠里面產(chǎn)生的問題就會減少。 no dirt on the floor of any type。 no temperature abuse (where applicable)。 (袋子沒有損壞或弄臟；罐子完好；溫度適當；沒有無標記產(chǎn)品；沒有不合格產(chǎn)品；等等 ) ? Any requirement for information on the tankers last three (3) loads. 任何要求 前三次貨箱的信息。 Records of the past ining goods inspections can be reviewed at this time or when doing the food safety inspection of the receiving department. 這一步檢查中可查看過往進料的檢驗記錄，或者在檢查來料接受部門的時候查看。 ? Any requirement to follow a FIFO system when supplying production these materials. 供應生產(chǎn) 需用的材料必須遵守先進先出的任何要求 ? The policy on the segregation and the labeling of “onhold“ raw materials pending QA releases. 關于區(qū)格和標記因等待質(zhì)檢放行而 “暫停使用 “的原材料的規(guī)定。 . PROGRAM/ INPROCESS CONTROLS: (50 points). HACCP程序 /加工過程控制 . program: The auditor at this stage of the audit is verifying that the plant has or does not have a formal documented . program. HACCP程序：檢查官在這個環(huán)節(jié)里要核實工廠是否有正規(guī)的 HACCP程序。 In this case the auditor is reviewing the plant’s documented program to achieve this objective. 這種情況下，檢查官會查看工廠的這方面文件。 ? The critical limits are set for each hazard. 每種危險品的關鍵點限值要確定 ? There is a monitoring procedure for each hazard. 每種危險品有一個監(jiān)控程序 ? There are written corrective actions to be taken if any hazard’s critical limit is exceeded. 如危險品的關鍵點限值被超過，必須有一個書面的糾正解決方法。 FINISHED PRODUCT TESTING AND CODING PR