SGS食品行业验厂资料
GUIDELINES
FOR
FOOD PROCESSING PLANT 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 designe d to indicate a processing plant’s compliance with the Good Manufacturing Practices (GMP’s) 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。
GRADE SCORE GRADE SCORE
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.
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SGS Form 3 1/2001
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.
?Actual 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 GMP’s. 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).
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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.
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SGS Form 3 1/2001
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。
AUDITOR’S 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)
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SGS Form 3 1/2001
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. (10points). 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. (15points).
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. (15points).
成品测试及编号程序
?Ingredient tractability program. (10points).
成分追踪程序
?Product recall program. (10points).
产品召回程序
?S.S.O.P’s (35points). 标准安全生产程序
Plant cleaning procedures. 工厂清洁步骤
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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 plant’s 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 (GMP’s) 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 plant’s 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 GMP’s 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 management’s 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 GMP’s. 受聘于食品加工厂的员工必须接受GMP的训练。
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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 employee’s 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 w ill be a reflection of the plant’s 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.
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RAW MATERIAL PURCHASING GUARANTEES: -(15 points).
原料采购保障
The plant’s 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 plant’s 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
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The ability to spot problems before they enter the plant is determined by the thoroughness of the plant’s 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 abus e (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。
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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 plant’s 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
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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 t he plant’s 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 ascertain that the plant has a program and/or in-process controls and that the plant is adhering to this program and controls. 检查官没有义务在进行GMP检查时来落实HACCP程序，或者是加工过程的完善性。检查官只是要确定工厂有一个程序，或加工过程的控制，并且确实跟随这个程序或控制来做。
When examining a H.A.C.C.P. program the auditor is responsible for ensuring that the program has the seven (7) key elements i.e. 在检查HACCP程序时，检查官要保证这个程序有7个主要因素，它们是：
?The hazards are identified. 明确有那些危险品
?The Critical Control Points (C.C.P.’s) in the process for these hazards are identified. 处理这些危险品的过程中的关键控制点要写明。
?The critical limits are set for each hazard. 每种危险品的关键点限值要确定
?There is a monitoring procedure for each hazard. 每种危险品有一个监控程序
?There are written corrective actions to be taken if any hazard’s critical limit is exceeded. 如危险品的关键点限值被超过，必须有一个书面的纠正解决方法。
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?There is a verification procedure to be followed to ensure that the H.A.C.C.P. program is being followed and that it is working as intended. 必须有一个可行的核实步骤来确保
HACCP程序被遵守并且运行正常。
?There are tables to write the results generated by measuring the Critical Control Points. 必须有记录关键控制点测量值的表格。
The importance of having either a H.A.C.C.P. program or in-process 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 combination equal to 15% of the overall audit on this one issue including a possible automatic failure of the audit. 是否有一个HACCP程序或者设计一个加工过程控制程序对于食品安全非常重要，所以这部分占食品安全程序检查的25%的分数，以及占工厂操作检查的50%的分数，综合起来占整个检查的15%的分数，并且有可能导致检查的“自动失败”。
FINISHED PRODUCT TESTING AND CODING PROGRAMS: - (15 points).
成品测试和日期标码
The auditor is judging here if the plant has a program to test the finished product for metal contamination, microbiological contamination (if applicable), and/or certain chemical attributes that would ensure the plant is distributing a safe and wholesome product.
这部分检查的目的是看工厂是否有程序来检测成品有否金属污染，微生物污染(如可行的话) ，以及某些化学品污染。
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，工厂是否具备一个日期标码系统来标记每一批产品，在产品被召回时可以迅速地找到和分离出问题产品。
After conducting the food safety inspection of the plant it may be necessary to re-visit this section to deduct further points.
This would be done if this finished product testing is determined to be inadequate or not being followed. 在完成食品安全检查后，如果发现成品测试做得不充分，可回到这部分来扣
分。
INGREDIENT TRACEABILITY PROGRAM: - (10 points). 成分追踪程序
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? 工厂是否有
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一个追踪程序，能根据原材料和包装材料的批号，从它们的接收，到生产，到完成包装的成品，都能追踪得到。
This is very important in case of a recall caused by a contaminated raw material or packaging material so that the amount of finished product that has to be removed from the marketplace is limited and hence so is the plant’s liability. 这在成品因原材料或包装材料的污染而造成的召回环节中十分重要，因为万一发生这种情况，从市场上挪走的污染产品及工厂的损失就会仅局限于一部分。
?Can the plant track the bulk ingredients? 工厂能否追踪大包装的成分材料？
?Does the plant keep detailed records on re-work? 工厂有无再加工的详尽记录？
?Does the plant test the ability to trace the raw materials and/or the packaging materials at least once per year? 工厂有无每年一次测试追踪原材料/包装材料的能力？
?Is the plant able to account for 100% of a raw material and/or packaging material within 4 hours? 工厂能否在4 小时内查询到任一种原材料/包装材料的全部？
PRODUCT RECALL PROGRAM: - (10 points). 产品召回程序
?Does the plant keep documented shipping records as to which product code dates are sent and to where? 工厂有没有产品的送货记录，哪一个产品日期标号，送到哪里？
?Does the plant have a documented recall program? 工厂有没有召回程序的存档文件？
?Is the program detailed enough to provide sufficient information to do an expeditious recall?
这个程序是否提供足够详细的信息来做一个加快的召回？
?Is the program tested at least once per year? Is this test documented? 这个程序有没有每年至少一次的测试？这个测试有无存档记录？
?Is the plant able to account for the entire product in question within 4 hours? 工厂能否在4小时内查询到全部的产品？
S.S.O.P’s (Sanitation Standard Operating Procedures): - (35 points). 卫生标准操作步骤
The importance of having good documented Sanitation Standard Operating Procedures
(S.S.O.P.’s) cannot be ignored due to their importance in having a sanitary plant and a protected food product. 有良好的卫生标准操作步骤文件的重要性是不容忽视的，因为它们使厂房卫生干净，从而保护了食品的卫生。
In meat and poultry plants and their distributors this is a part of their mandatory H.A.C.C.P. program, so failure to have documented S.S.O.P’s is critical and an automatic failure of the
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audit. 这部分对于肉类和家禽类厂商和供应商而言，是HACCP程序里必须具备的，所以，若不具备一个有文件存档的SSOP的程序，将被列为验厂的“关键问题”和“自动失败”。
For seafood plants and their distributors it is a mandatory pre-requisite to their H.A.C.C.P. program that they be following cleaning procedures and schedules (S.S.O.P.’s) but they do not have to be documented. 对于海产食品的厂商和供应商而言，遵守SSOP要求的清洗步骤和时间安排是它们的HACCP程序的必须前提，但不需要文件存档。
For juice manufacturers it is a proposed requirement to their H.A.C.C. P. program for 2000.
对于果汁生产商而言，这被提议为它们2000年的HACCP 程序里的一项要求。
For other manufacturers it is considered necessary to comply with the GMP’s.
对于其他生产商，这被考虑作为符合GMP要求的必须条件。
The safety of the finished product can greatly be affected by the cleanliness of the equipment and environment on/in, which the product is made. 产品的安全性很大程度上取决于生产设备和环境的干净程度。
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.
不清洁的设备可造成极微量的食品原料交叉污染，使消费者产生的化学过敏
Pathogenic bacteria can become airborne in an unsanitary plant and can contaminate ready-to-eat product causing the consumer to have a foodborne illness. 不卫生的工厂会使治病细菌在空气中滋生，污染熟食产品，令消费者患食物引起的疾病。
The plant needs to have documented cleaning procedures for all pieces of the equipment and the environment so that the employees know how to clean everything. 工厂应有一套关于清洁设备所有部件和环境的文件，这样员工才知道怎样进行清洗。
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 completed by the employees after each task is done. Points in this section should be deducted for: - 此外，还要有一个详尽的清洁时间表，显示多久会清洗所有东西，及员工每次清洗完毕后填写的查核清单。
?Incompleteness of the cleaning procedures. 清洗程序不完整。
?Incompleteness of the cleaning schedule. 清洗时间表不完整。
?Incompleteness of filling in the cleaning schedule check off list after each task is performed.
清洗时间表查核清单填写不完整。
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?Lack of cleanliness of the plant or equipment discovered during the audit and due to an inadequate cleaning procedure or schedule. 因清洁程序或时间表的不完善而造成工厂或设备不够清洁。
?Lack of a requirement to do any microbiological testing for cleanliness of equipment or the environment when manufacturing microbiological sensitive (potentially hazardous) foods. 当生产微生物敏感食品(有潜在危险的) 时，缺乏对设备或环境的清洁度要求作细菌检测。
?Lack of the initials of the person responsible for the cleaning being on the check off list.在清洗查核清单上，没有负责清洗人员的签字。
?Lack of a supervisor’s initials showing verification that the clean up had been completed satisfactorily. 没有上司确认清洗完成和满意的签字。
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.
工厂为了能安全地生产和供应食品，就必须拥有一个无虫害污染食物以至传播疾病的环境。
This section comprises 20% of the audit and the points will be lost due to the presence of pests and/or the lack of the plant’s programs to prevent pest problems.
这个部分占检查总分的20%。如果发现有虫害存在，以及//或者工厂缺乏预防虫害的程序，分数都会被扣减。
To achieve a pest free plant the plant has to have solid programs to prevent the entry of pests into the plant and also a program to catch and eliminate any pests that inadvertently get into the plant. 为了达到无虫害，工厂必须有一个严格的措施来预防虫害进入工厂以及捕获和消灭入侵到工厂里的虫害。
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.
检查的这个部分，就是要判断这些措施的有效程度，及厂房里有没有虫害 (老鼠，蟑螂，苍蝇，鸟类，蚂蚁，等) 的发生。
Programs and conditions which are to be examined and graded out of 200, then expressed as a percentage of 1000 points, are: -
被检查的防虫措施和状况总共是200分，然后表达成1000分的百分比：
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*Any actual adulteration of a product due to pests. (This is an automatic failure of the audit). (200 points).
产品因遭受虫害而成为劣品。(这种情况意为着这项检查自动失败) (200分)
*The presence of any pests in the plant. (This is a critical finding). (60 points).
被发现有任何一种虫害在厂房里。(这是一个关键的发现) 。(60分)
*The interior rodent and insect control programs and their effective implementation. (35 points).
室内老鼠和昆虫的控制措施及其有效的实行。(35分)
The exterior rodent control programs and their effective implementation. (35 points). 室外老鼠的控制措施及其有效的实行。(35分)
*
*The condition of the building for effective pest control including personnel practices. (35 points).
建筑物的状况，包括个人操作在内的防虫的有效性。(35分)
*The ability to be able to do effective pest control inside the plant buildings. (35 points). 在厂房内实行有效防虫的能力。(35分)
ACTUAL ADULTERATION OF A PRODUCT DUE TO PESTS: - (200 points).
因虫害引起劣品
This can be from birds, flies, rodents, stored product pests, ants, cockroaches etc. The presence can be just evidence (i.e. 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 G.M.P.’s and hence is a critical finding and an automatic failure of the audit.
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这可能因鸟类，苍蝇，老鼠，储藏产品虫类，蚂蚁，蟑螂等。存在的可能只是痕迹 (比如老鼠遗留物，死昆虫等) 而不必是活虫。这一条构成了GMP 402(A)3里的劣品条例，因此是关键发现并会造成检查自动失败。
THE PRESENCE OF PESTS IN THE PLANT: - (60 points). 工厂出现虫害
As pests around the raw materials, the packaging materials and the food products can result in a contaminated product this is a critical finding and further investigation can result in an automatic failure of the audit.
虫害如出现在原材料，包装材料和食品里就会造成食品污染，这是一个关键发现，进一步的调查有可能让检查自动失败。
The auditor should not however consider the following conditions critical: -
检测官不应将以下情况作为关键发现：
* A single live mouse caught in a rodent control device. (Serious but not critical).
一只被捕鼠器抓获的活鼠。(严重但不算关键) 。
*The presence of fruit flies. (Indication of poor sanitation and should be judged accordingly).
果蝇的存在。(显示卫生条件差，但不算此列)
*The presence of spiders in a warehouse, where all the food is protected.
仓库里有蜘蛛，仓库的所有食品都是被保护好的。
*The presence of old, dead insects in a warehouse. (Judge under poor housekeeping).
仓库被发现有老，死的昆虫。(算作厂房管理不善)
*The presence of flies in the warehouse, where all the food is protected.
仓库里有苍蝇，仓库的所有食品都是被保护好的。
*The presence of rodent evidence in non-food areas (i.e. boiler rooms, electrical rooms etc.).
非食品区被发现有老鼠 (比如锅炉房，电路房等)
*The presence of old rodent evidence. (Judge under poor housekeeping).
被发现有旧的老鼠的痕迹。(算作厂房管理不善)
Examples of instances that an auditor should consider critical are: -
检查官应列入关键问题的例子有：
*Any pests, or fresh pest evidence, in any area where food is exposed (i.e. flies), or food is stored (rodents, cockroaches etc.). 任何虫害或活虫证据被发现于：任何的食品接触区(如苍蝇) ，或食品储藏区(老鼠，蟑螂等)
*Any insect-o-cutors positioned over, or within 15’(4.5 m), of exposed raw materials, f ood, food packaging materials or food processing equipment. 任何捕虫器置于敞开的原材料，食品，食品包装材料，或食品加工设备之上或者少于4。5米的距离。
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*Any birds, or bird evidence, in the warehouse areas or on docks over which the raw materials, the packaging materials or the finished product pass. 发现有任何鸟类，或鸟类痕迹在仓库区，或者在原材料，包装材料和成品经过的卸物台上。
*Any fresh rodent evidence in warehouse areas where the raw materials, the packaging materials or the finished product are stored. 在储藏原材料，包装材料，或成品的仓库有任何新鲜的老鼠的痕迹。
*Any rodent, insect, or bird evidence on the trailers delivering the raw materials or the packaging materials. 在运输原材料或包装材料的拖车上发现有任何老鼠，昆虫，或鸟类的痕迹。
*Any rodent, insect or bird evidence on the trailers being loaded with the finished products. 在装载成品的拖车上发现任何有任何老鼠，昆虫，或鸟类的痕迹。
INTERIOR RODENT AND PEST CONTROL PROGRAMS AND THEIR EFFECTIVE IMPLEMENTATION: - (35 points). 室内防虫措施
In order to prevent having a problem with insects and rodents in a food processing plant it is necessary to have good interior pest control programs in effect and a pest proof plant.
The auditor should judge the following programs and pest proof conditions for adequacy and implementation: -
检查官应审核以下程序和防虫措施的充分性和实行性：
*Incoming goods inspection program with regard to looking for insects, rodents and evidence.
对进料的检验措施，寻找昆虫，老鼠和证据。
*The positioning of the rodent traps (ketchalls, tin-cats, glue boards etc.) against the wall on the inside on either side of all doors leading in from the outside and then every 30’ (9m)
against the inside of all exterior walls in the storage areas, boiler rooms etc. al so every 30’ (9m) against all walls in the coolers. 捕鼠器的摆放：从外通向里的所有门的内侧靠墙，储藏区，锅炉房所有外墙的内侧每隔9米处，并且在冷却器所有墙壁每隔9米处。
*The inspection of these traps weekly and records to support this. 每星期定期检查并记录这些步骤。
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*The availability of a plot diagram showing the location of all the internal and external rodent control devices and of the insect-o-cutors. 可提供图表显示所有室内和室外老鼠控制装置及捕虫器的位置图。
*The presence and the working condition of the insect-o-cutors for fly control and for stored product pest monitoring. 安装为了控制苍蝇和监控储存产品的捕虫器，及其工作情况。*The location of these insect-o-cutors away from exposed food, food packaging materials and food processing equipment. 捕虫器的位置必须远离暴露的食品，包装材料及食品加工设备。
*The program for, and the effectiveness of, servicing of the insect-o-cutors weekly to remove dead insects and to try to identify the source of these insects. 有一个有效的程序来确保捕虫器每周的正常运作，清除死虫且找出这些昆虫的来源。
*The preventive maintenance program to change the insect-o-cutor light tubes at least once annually, and the documentation to show that it is happening. 捕虫器的维护措施，每年至少换一次捕虫器里的灯管，并且文件证明有这样做。
*The documentation of the pest control treatments showing the pesticides used, the amount used and for control of what insect(s). 提供杀虫处理的文件，要显示所使用的杀虫剂，用量，及所控制的哪种昆虫。
*The pest control service reports showing the conditions found and the corrective actions needed to prevent future pest problems. 防虫服务的报告要显示发现的状况，及将来预防进一步虫害问题的改正措施。
EXTERIOR RODENT CONTROL PROGRAMS AND THEIR EFFECTIVE IMPLEMENTATION: - (35 points). 室外老鼠控制
The auditor is judging the plant’s exterior rodent control program as to: -
检查官是这样判断厂房室外老鼠控制程序的：
*The presence of the bait stations positioned every 40’ (12m) against the outside walls of the plant all the way around. 靠着厂房外墙一周，每隔12米要放置一个诱饵装置。
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