SGS食品行业验厂资料.doc

GUIDELINESFORFOOD PROCESSINGPLANT AUDITS .GUIDELINES FOR FOOD PROCESSING AUDITS.食品生产检查指南GRADING SYSTEM: - (To be used with the Food Processing Food Safety audit form). 平分系统：(与食品加工安全检查表一同使用)The SGS grading system is designed to indicate a processing plants compliance with the Good Manufacturing Practices (GMPs) and, where applicable, H.A.C.C.P. principles and to also provide a comparison with other manufacturing plants.SGS 的平分系统是根据加工工厂遵守GMP(良好生产规范) ，以及HACCP的可适用的原则而规定的，并且可用作与其他生产工厂作比较。GRADESCOREGRADESCORE等级分数等级分数Superior 优秀95.0 - 100 %Excellent 优良90.0 - 94.9 %Good良好80.0 - 89.9 %Fair 中等70.0 - 79.9 %Failure不及格 70.0 %Superior grade (95.0 -100 %): - 优秀This grade is awarded to plants that have no identified food safety problems and very few areas for improvement. 没有安全问题, 几乎没有需要改进之处. Excellent grade (90.0 - 94.9%): - 优良This grade is given to plants that have no critical findings and only a few minor food safety problems. 没发现关键问题, 只有几个小的食品安全问题. Good grade (80.0 - 89.9%): - 良好This grade is awarded to plants that have some food safety problems, possibly including critical findings, but there is no evidence of contaminated product and the plant shows a concern in correcting the problems immediately. 有一些食品安全问题, 或许包括关键发现,但没有污染的产品, 工厂关切立即纠正问题.Fair grade (70.0 - 79.9%): - 中等This grade is awarded to plants that have numerous food safety problems, including critical findings, but does not have any contaminated product. 工厂有许多食品安全问题,包括关键发现, 但没有任何污染的产品. Failed grade ( 70.0%): 不及格This grade is awarded to plants that either has many major food safety problems including several critical items or they have an automatic audit failure finding.要么有主要的食品安全问题包括几个关键问题, 或有被查到自动检查失败之处. CRITICAL ITEMS INCLUDING AUTOMATIC AUDIT FAILURES.关键问题包括自动检查失败Automatic audit failures: - 自动检查失败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: -以下几处情况会造成自动检查失败,不管总分多少. AActual adulteration of the product from any cause. (402(A) 3 violation). 任何因素造成的产品有掺杂, 品质低劣. 违反402(A) 3 Failure to have a H.A.C.C.P. program, if mandated by law. 没有HACCP程序 Failure to follow a mandatory H.A.C.C.P. program. 没有按HACCP程序去做Numerical audit failure: - 得分上的不通过 An overall numerical grade of 70%. 总分低于70%Critical items: - 关键问题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. 这些问题，虽然不严重到自动导致检查不通过，但会影响总分，令总分达不到良好。The critical items listed below are not totally encompassing 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. 下面一些关键点会让检查员认为会危害产品或原材料安全. These conditions are all considered to be 402(A) 4 violations of the GMPs. 这些情形都违反了GMP 的402(A) 4 条例。 Rodents in the plant but not in the products. (Not to include a freshly caught rodent). 厂里有老鼠等动物但产品里面没有. (不包括刚抓到的) 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).厂里有昆虫但产品里面没有. (不包括在生产区的果蝇, 或储存区的苍蝇等.) Flaking paint or other materials over exposed product, raw materials or packaging materials.片状涂料或油漆或其它材料在产品, 原材料,或包装材料上 Rust on food contact or food packaging contact surfaces.食品或包装上有锈. Dripping oil, condensate, and grease over exposed product, raw materials or packaging materials.油滴, 冷凝物, 油膏在产品, 原材料,或包装材料上 Rest rooms either opening directly into, or being vented into, areas where food, raw materials or packaging materials are stored or processed.厕所直接开于，或通风于食品，原材料或包装材料的储存或加工区。 Poor employee hygiene that could result in contamination of the food products or raw materials. (I.e. handling food or raw materials with bare, unsanitized hands).员工卫生问题会造成产品或原材料污染 (如用未消毒的手去接触食物) Employees eating, drinking, chewing or smoking around exposed food, exposed raw materials or exposed packaging materials.员工在产品, 原材料,或包装材料区吃喝抽烟 Unhealthy employees working with exposed food exposed raw materials or exposed packaging materials.生病员工在原材料,或包装材料上工作 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(会造成食品安全问题)的设施. Blocked sewers and/or drains causing unsanitary conditions where food, raw materials or packaging materials are stored or processed. 下水道阻塞, 会造成有产品, 原材料,或包装材料区的污染. Mold on walls or equipment where food, raw materials or packaging materials are stored or processed. 墙或用来储存和加工食品，原材料或包装材料的设备上有霉. NOTE: All critical items identified in the audit need to be: -注意：所有在检查中被发现的关键问题应作以下处理： Summarized at the beginning of the report. 在 报告的开头总结 Identified with bold type in the correct section of the report. 用黑体字在报告正确部分标记 All points need to be deducted against the particular item. 所有分数必须从相应项目上扣去 Overall grade cannot be higher than good and in many cases will generally be lower than good. 总分不能高于良好。AUDITORS INSPECTION GUIDELINES.检查指南FOOD SAFETY PROGRAMS (20%): - 食品安全程序In this section of the audit the auditor is judging the food safety programs under which the plant is operating. 在检查的这个部分，检查官要评估工厂运作中的食品安全程序。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, 有无相关文件, 是否齐全When later reviewing the conditions observed in the plant it may be necessary to re-visit 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). 当检查完毕总结工厂的状况时，可能有必要重新回到这个部分来调整分数：程序不完善(从程序上扣分) ，或员工缺乏训练(从员工训练上扣分) ，或管理不善(从管理培训上扣分) 。A plant needs both good food safety programs and the proper implementation of these programs by adequately trained employees in order to run a safe food plant and to gain the full 20% in this category. 厂家应有好的食品安全程序及适当的实施措施-通过人员训练达到食品安全生产要求才能得20%.分Programs which are to be examined and graded out of 200, then expressed as a percentage of 1000 points, are: -这部分200分(以总分1000分为准) Management food safety training program. (10 points). 管理层食品安全培训 Employee food safety training program. (10 points). 员工食品安全培训 G.M.P. monthly self-inspections program. (15 points).GMP每月自检程序 Raw material purchasing guarantees. (15 points).原料采购保障 Incoming goods inspection program. (15 points).来料检查程序 Raw material handling and testing program (if applicable). (15 points).原料处理及检查程序 H.A.C.C.P. program (if applicable)/in process product controls. (50 points).生产过程中的产品品质控制 Finished product testing and coding programs. (15 points).成品测试及编号程序 Ingredient tractability program. (10 points).成分追踪程序 Product recall program. (10 points).产品召回程序 S.S.O.Ps (35 points). 标准安全生产程序 Plant cleaning procedures. 工厂清洁步骤Plant cleaning schedules. 工厂清洁时间表The points in parenthesis are intended as guidelines and not as rigid requirements as the auditor has to retain the right to judge and grade the programs, or the lack of programs, on the plants ability to produce a safe, uncontaminated product. 括号里的分数只作参考，而不是严格的要求，因检查官有权对工厂的程序能否生产安全，不受污染的食品的能力作出评分。MANAGEMENT FOOD SAFETY TRAINING PROGRAM: - (10 points).管理层的食品安全培训It is essential that the management in a food processing plant be trained in food safety and the Good Manufacturing Practices (GMPs) so that they can identify and correct food safety problems in order to prevent distributing contaminated and possibly harmful products.管理层应在食品安全和GGMP上受训, ，他们才会发现和改正食品安全上存在的问题, 才会防止有污染和可能致病的产品.Management also has to be able to ensure that the employees are following the plants food safety programs and not subjecting the products to possible contamination by their poor health, their poor hygiene or their poor practices. 管理层应保证员工会遵行食品安全条例而不致于因健康, 差的个人卫生或操作造成可能的污染.This management training in food safety and the GMPs should be either conducted on joining the company, or achieved by formal education or by a combination of both. In addition there should be on going and refresher training for management personnel on a regular basis. 这种在食品安全和GGMP上的管理训练应该是在加入公司时就进行, 或者是通过正式授课或两者的结合达到目的.As compliance with the GMP requirement for “competent supervision” is being judged here, the availability of documented training is very valuable. 检查员会评估合付GMP要求的 “完全胜任监督”, 因此所有记录的训练备齐是很有价值的. After conducting the inspection part of the audit of the food processing facility, additional points may be deducted under this category based on the conditions in the plant that reflect unfavorably on management training and/or managements implementation of the food safety programs.在检查完食品加工设施后，如发现缺乏管理层训练或不利于管理实施食品安全程序的情况，可能会从这部分扣分。EMPLOYEE FOOD SAFETY TRAINING PROGRAM: - (10 points). 员工食品安全培训It is essential that employees on hiring into a food processing plant be given training in the GMPs. 受聘于食品加工厂的员工必须接受GMP的训练。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.这包括关于他们的健康，卫生及操作和食品污染的关系，生产设备和环境中清洁和不卫生的区别，以及在任何时候保护产品不受污染的重要性。Documentation of this training showing time and date of the training, the content of the training and the employees signature of attendance is valuable for the auditor to see.员工卫生和健康训练的记录文件应该有训练的日期和时间, 训练内容和员工参与了训练的签名, 以便于检查员检查.Refresher training should be offered on a regular basis of at least a minimum of every 2 years.每两年应该有重新训练This employee training should also involve cleaning chemical training for the employees, where applicable for their job, and H.A.C.C.P. training for all the employees, if the plant has a H.A.C.C.P. program.员工训练应包括化学物品训练, HACCP训练(针对所有员工)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.如果以上条款有违反,则会减分. 在检查完食品加工设施后，如发现有情况显示出工厂员工受训不足，这部分的一些分数会被扣除。GMP MONTHLY SELF-INSPECTIONS PROGRAM: - (15 points). GMP每月自检程序The plant conducting every month a GMP self-inspection to identify any food safety problems and to put into effect corrective actions achieves progress towards total food safety and the prevention of regression. 每月应有一次GMP自检以找出食品安全问题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.这种检查应有记录并和更正记录保存在一起. The amount of points deducted will be a reflection of the plants adherence to doing these inspections monthly and with following up on noted deficiencies. 这部分扣除的分数显示出工厂每月自检的遵守程度及有没有改进不足之处。No monthly GMP self-inspections are loss of all the points.没有GMP每月的自检就会失去所有分数. RAW MATERIAL PURCHASING GUARANTEES: - (15 points).原料采购保障The plants ability to produce a safe product is at times contingent upon their ability to purchase safe raw materials and packaging materials. 工厂生产安全的产品的能力是与它们购买安全的原料和包装材料的能力密切相关的。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. 要求原料商持续保证品质, 包装材料亦应有分析报告. 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.持续保证品质是原料商关于原料和包装材料符合食品级的商标安全的法规的书面保 证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 (i.e. salmonella).成分分析应是对每批原料进行检查, 应包括特殊成分的百分比 (%纯度)或显示没有致病菌的污染(i.e. 沙门氏菌) Compliance to this program is extremely important if the plant has a H.A.C.C.P. program and a raw material is identified as being a critical item in this program. 遵守这个要求非常重要，因为 原材料是HACCP的一个关健点. The auditor needs to determine the plants requirements for this documentation and then the degree to which they are in compliance 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.一些工厂会依赖他们自己的原料检测体系以保证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.如果检查员决定这种方式行不通, 就会指出并从200分中扣除INCOMING GOODS INSPECTION PROGRAM: - (15 points). 进料检查程序The ability to spot problems before they enter the plant is determined by the thoroughness of the plants incoming goods inspection program and the implementation of that program.要有在检查员验厂前就应查到工厂的来料检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.检查官需要查看相关的文件，证明除了检查原料和包装材料外, 货柜及运货小车也会检查.A problem stopped from entering the plant is one less problem that the plant has to address inside the plant. 问题在进入工厂之前被发现和阻止，那工厂里面产生的问题就会减少。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. 验厂会对有否真实实施这个程序作出评估，如果实施不当，这部分会被扣分。Parts of the program to look for are: - 要检查的项目是： The criteria for inspecting for the cleanliness of the incoming trailers. (No rodents, insects or evidence; no odors; no dirt on the floor of any type; etc.). 检查进料货车的清洁情况。 (没有老鼠，昆虫或它们存在的痕迹；没有气味；地面上没有灰尘，等等) The criteria for the inspection of tankers. 检验货箱的标准 The criteria for inspecting the raw materials and the packaging materials upon receipt. (No torn or stained bags; no damaged cans; no temperature abuse (where applicable); no unlabeled products; no non approved products; etc.) 收到的原材料和包装材料的检查标准。(袋子没有损坏或弄脏；罐子完好；温度适当；没有无标记产品；没有不合格产品；等等) Any requirement for information on the tankers last three (3) loads. 任何要求 前三次货箱的信息。 Any required Certificates of Analysis. 有无要求任何的证书或分析报告。 Any requirements to hold a product on a tanker while the laboratory testing are conducted on its contents. 当货物被送实验室检查期间，有无任何要求使货物停留在货箱里。 If a sealed tanker, and/or trailer, what is the program to ensure the seal has not been broken or replaced during transit. 如果货箱和货柜是密封的，有什么程序保证运输期间封口没有被打开或取代。Records of the past incoming goods inspections can be reviewed at this time or when doing the food safety inspection of the receiving department. 这一步检查中可查看过往进料的检验记录，或者在检查来料接受部门的时候查看。The incompleteness 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. 记录不全就显示训练不足，程序实施不善，或者缺乏良好的管理监督。从相应部分减除分数。RAW MATERIAL HANDLING AND TESTING PROGRAM: - (15 points). 原材料的处理和测试程序When examining the plants program for handling the raw materials and the packaging materials look for: - 当查验工厂原材料和包装材料的处理时，要检查以下事项： The policy on any requirement to date the raw materials and the packaging materials upon receipt. 任何要求原材料和包装材料标记日期的规定。 Any requirement to follow a FIFO system when supplying production these materials. 供应生产需用的材料必须遵守先进先出的任何要求 The policy on the segregation and the labeling of “on-hold“ raw materials pending QA releases. 关于区格和标记因等待质检放行而“暂停使用“的原材料的规定。 The policy on the segregation and the labeling of “rejected“ raw materials pending further disposition. 关于区格和标记因等待进一步处理而标有“被据使用“的原材料的规定。 Any requirements to test the raw materials for compliance to the specifications prior to release of the raw material to production. 原材料被用于生产前，有无任何要求去检测其是否符合指标。After conducting the inspection of the plant it may be necessary to re-visit this section and deduct further points due to either the inadequacy of this program to control food safety problems in the plant or to remove points under employee or management training if the improper implementation of the program is determined to be the problem. 在检查完工厂之后，可能有必要回到这部分，如果在控制食品安全问题上有不足，员工和管理人员无适当训练，程序实施不恰当，更多分数将被扣除。H.A.C.C.P. PROGRAM/ IN-PROCESS CONTROLS: - (50 points). HACCP程序/加工过程控制H.A.C.C.P. program: - The auditor at this stage of the audit is verifying that the plant has or does not have a formal documented H.A.C.C.P. program. HACCP程序：检查官在这个环节里要核实工厂是否有正规的HACCP程序。If the plant is by law required to have a H.A.C.C.P. program and does not, this will be a critical finding and an automatic failure of the audit. 如果工厂在法律上要求具备HACCP程序而实际上又没有的话，这将成“关键发现”而导致检查的“自动失败”。After auditing the plant the auditor may re-visit this section to deduct further points due to the incomplete implementation of this H.A.C.C.P. program. 检查完工厂之后，如果发现没有完全实行HACCP程序，检查官可回到这个部分扣分。It is important that if a plant that produces and distributes food products does not have a formal H.A.C.C.P. program then it still needs to have in-process controls designed to produce a safe food product. 尽管一个生产供应食品的工厂没有一个正式的HACCP 程序，它仍需要有加工过程控制的设计来保证食品安全。In this case the auditor is reviewing the plants documented program to achieve this objective.这种情况下，检查官会查看工厂的这方面文件。It is not the responsibility of an auditor when conducting a GMP audit to validate a H.A.C.C.P. program or the adequacy of the in-process controls. The auditor is only to