SGS验厂各部门需要准备的资料

一、公司基本信息

温馨提示：副本和复印件是不同概念，接受副本原件，不接受复印件

2.税务登记证原件（可接受复印件，如营业执照原件无法提供,则必须出示税务登记证原件）（人事部）

3.营业场所土地证原件或房产证原件或租赁合同原件 （人事部）

4.主要产品介绍（实物或产品目录或企业宣传手册） （销售部）

5.组织人事结构图表及各部门人数（人员花名册及工资表或考勤表）,关键人物的简介（员工信息表或个人简介）（人事部）

二、贸易能力

1.对外贸易经营者备案登记表原件或出口批准证书原件 （人事部）

2.前一年度原始的财务报表：如损益表、税务申报表（年度）、审计报告（最新年度）等 （财务部）

3.前一年度和本年度的外贸出口收入 （财务部）

4.外贸业务员列表：包括专业背景、英语水平、外贸经验年限等（业务员简历亦可） （人事部）

5.出口区域、主要客户列表及相关证明文件（复印件即可），如：提单或海关核销单、#5@p、合同 （销售部）

6.供应商选择原则，评估标准与基本流程，合格供应厂商（包括外协厂）名单以及评定记录 （采购部）

7.客户投诉程序和处理记录 （销售、品质部）

8.产品的可追溯性文件及记录 （销售部）

9.是否有对包装后产品的抽检程序，如果有，提供相应的检验标准和最近三个月的记录 （品质部）

三、生产能力和质量管理

1.产品注册商标证书 （人事部）

2.典型产品生产工艺流程图 （工艺部）

3.主要产品前一年度的月度及年度产量统计（最多三种产品） （生产部）

4.来料检验和完成品检验标准（样板），以及最近三个月检验记录 （品质部）

5.产品制造过程控制方法（品质控制流程图） （品质部）

6.制造车间不合格品控制 （品质部）

7.最近三个月的财务凭证（如生产设备折旧台帐、设备购买#5@p、原材料采购合同、人员工资发放记录等）（生产、财务、采购、人事部）

四、行业信息（LED照明行业企业）

1.LED照明行业：产品类型与用途，LED芯片采购合同以及原产地证明，SMT以及测试设备列表，焊接工艺，产品安全测试报告，产品性能测试报告，产品能效测试报告项目 （采购、SMT、工艺、技术）

五、产品设计开发能力 （技术部）

1.研发人员列表：包括专业背景、研发经验、工作职位及工作职责

2.设计开发及更改程序及成功项目的运作记录

3.设计开发部配备的专用仪器，设备及设计软件清单

4.专利证书及企业的资格证书原件（如：特殊行业的资格证书）

六、体系和产品认证 （人事部）

1.体系认证证书以及最近的年度审核证明原件，如ISO9000、ISO14000等

2.产品认证列表及相关代表产品认证证书原件，如CE、CCC、GS、UL、ETL等

3.ROHS、REACH等测试报告

七、财务信用 （财务部）

1.连续三年的会计师事务所出具的审计报告（如选做第七项，必须提供该审计报告）

2.公司开户行信息、银行评定的信用等级

3.针对外销产品，是否有产品保险，如果有，请提供保险合同

八、工作环境 （人事部）

1.营业执照原件（正本/副本均可） （人事部 ）

注：审核需要提供全体员工的花名册，审核员会随机抽查至少5名员工，检查身份证、工资表、考勤表、劳动合同，所有的审核内容须以书面资料为准，不接受口述形式。如果现场不能提供有效的书面资料，评估结果将是不合格的。

1.员工手册或工作管理规定（包括对员工招聘的年龄限制要求、员工工作时间、加班规定等）

2.员工合同及按国家规定的保险

3.员工考勤记录以及工资支付记录

4.新员工上岗要求及培训记录

5.车间劳保用品及急救药品管理

6.消防安全培训

九、环境管理 （人事部）

1.ISO14001环境管理体系证书

2.环保局批准的环境影响评估报告

3.工程建设项目验收报告

4.“三同时”环保验收报告

5.取水许可证

6.空气污染物排放许可证, 空气污染物排放监测记录

7.固体废弃物/危险废弃物的回收/处理方法

8.噪音监测报告

注意事项与审核结果：

审核主体与中国制造网上推广主体必须保持完全一致（以营业执照判定主体），家具/服装/LED照明/水龙头/蓄电池/生产型企业和石材行业的企业可选第四项行业信息。在审核前的会议中，审核员将与被审核公司代表书面确认需要审核的模块。审核日之后5个工作日内，PDF格式的供应商评估报告（内容涵盖所有当天选择并审核的模块）将以邮件形式发送给贵司，同时该报告将在中国制造网贵司的展示厅里全部上传（后续可以选择不上传报告）。请被审核公司代表事先确定好要审核的模块。

只有在审核现场出示的书面规定和记录，才可作为审核的有效依据。报告的所有内容审核员将在现场完成并与被审核公司代表确认，现场确认后，不接受后期报告内容的更改。请被审核公司代表提前作好准备，避免因资料准备不齐全而出现的不符合项。

审核现场将拍照，包括公司大门、内部生产厂区、办公区域、产品以及营业执照、办公场所房产证或租赁合同，组织人事结构图表以及企业证书、执照、证件等。所有照片都将放入SGS出具的供应商评估报告中，作为报告内容的一部分。照片均以审核员现场拍摄的为准，后期不予更换，请尽量保持审核现场的整洁。

审核日之后30日内，SGS将向贵司寄送正本纸质报告。

审核员于2015-01-06到贵司进行现场审核工作。请在该日前提供的《认证供应商审核文件清单》做好审核准备。并请在审核开始前出示您回传的服务函原件给审核员核对。

另外，我们的审核过程主要包括四个阶段：

1. 准备会议

2. 文件审核

3. 现场审核

4. 总结会议

第二篇：SGS食品行业验厂资料

GUIDELINES

FOR

FOOD PROCESSING

PLANT AUDITS

These guidelines are the property of SGS US Testing and cannot be reproduced in any form without written permission from SGS US Testing.

.

食品生产检查指南

(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 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 等级

SCORE 分数

GRADE 等级

SCORE 分数

Superior 优秀 Good 良好 Failure 不及格 95.0 - 100 % 80.0 - 89.9 % < 70.0 %

Excellent 优良 90.0 - 94.9 % Fair 中等 70.0 - 79.9 %

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. 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. 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.

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. SGS

1

Form 3 1/2001

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. 关键问题包括自动检查失败

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

? An overall numerical grade of < 70%. 总分低于70%

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).

SGS

厂里有老鼠等动物但产品里面没有. (不包括刚抓到的) 2 Form 3 1/2001

? 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.

SGS

3 Form 3 1/2001

? Mold on walls or equipment where food, raw materials or packaging materials are stored or

processed.

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。

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.

检查指南

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SGS

4 Form 3 1/2001

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.P’s (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

SGS

5 Form 3 1/2001

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。

(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。

(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。

SGS

6 Form 3 1/2001

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。

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 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.

SGS

7 Form 3 1/2001

(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

(15 points). 进料检查程序

SGS

8 Form 3 1/2001

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 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。

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9 Form 3 1/2001

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。

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。

(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。

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10 Form 3 1/2001

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 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。

? 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。

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11 Form 3 1/2001

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” 。

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。

(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SGS

12 Form 3 1/2001

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？

(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？

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 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。

SGS

13 Form 3 1/2001

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20xx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。

? 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。

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14 Form 3 1/2001

? 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。

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：

? 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) SGS

15 Form 3 1/2001

? 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)

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.

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。

(60 points). 工厂出现虫害

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16 Form 3 1/2001

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, food, 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。

? 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。

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17 Form 3 1/2001

? 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。

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. also 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。

? 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。

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18 Form 3 1/2001

? 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。

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。

? Whether these bait stations are anchored to the ground, tamper resistant and in good condition. 不管这些诱饵装置是否固定在地上，它们必须防捣和性能良好。

? That there is a regular inspection of these bait stations at least every 3 weeks, with a completed inspection sticker under the lid. 诱饵装置每三个星期有一次常规检查，检查完毕的标签贴于装置盖子底下。

? The presence of fresh bait inside these bait stations. 诱饵装置里要有新鲜的诱饵。 SGS

19 Form 3 1/2001

? Lack of rodent burrows around the outside of the plant. 厂房外周不能有老鼠洞。

35 points). 工厂建筑物设计

Rodents, flies, birds and other pests can only be kept out of food plants if the plant is maintaining a pest proof building. 防虫合格的工厂 才能防止老鼠，苍蝇，鸟类和其他虫害进入工厂。

The auditor should be judging the following: - 检查官要检验以下事项：

? The employee practices as to the leaving of doors open so providing possible rodent, fly and/or bird entry points into the plant. 员工有没有忘记关门以至老鼠，苍蝇和/或鸟类进入厂房的可能性。

? The presence and condition of the gaskets around the dock levelers and their ability to reduce all gaps to less than 0.25” (6mm) so as to prevent rodent entry. 货物装卸台水平器的四周要有良好的垫片，它们可把缝隙减少到少于6毫米，防止老鼠进入。

? The tightness of all the doors leading to the outside so that there are no gaps bigger than 0.25” (6mm) at the bottom so as to prevent rodent entry. 为防止老鼠入侵，通往外面的门要密封，门底距离地面不能超过6毫米的距离。

? The presence of air curtains on all doors into sensitive areas so as to exclude flies. 所有进入敏感地带的门口要挂防蝇帘驱蝇。

? The lack of trees, overhanging beams or ledges to discourage the birds from roosting around the plant. 为防止鸟类在厂房四周扰害，工厂周围不能有树木，垂吊的横梁或棚架。

? The presence of screens on windows that can be opened, to keep flies out. 窗户上有可打开的防蝇纱窗。

35 points). 厂房内部

In this section the auditor is judging: - 检验事项

SGS

20 Form 3 1/2001

? The maintenance of an 18” (45cm) perimeter around the walls of the storage areas so as to facilitate the ability to do pest control. 围绕储物区四周墙壁要保持有45CM的距离，以便加强虫害控制的能力。

? The overcrowding of the storage areas so inhibiting effective pest control. 储藏区过于拥挤以至限制虫害控制。

? The use of a licensed and insured pest control company (if applicable). 使用有执照有保险的杀虫公司 (如可行的话)

? The use of properly trained and licensed pest control technicians, whether internally employed or externally hired. 不管内部或外部俜用的，使用经过合适训练及有执照的杀虫技术员。

In this section of the audit the auditor is judging the conditions that are found when examining the handling of the raw materials and the packaging materials, the processing of the product and the

protection of the finished product. 在这部分的检查内容里，检查官会检查原材料，包装材料的处理，产品加工过程和成品的保护措施。

This section does not include either the condition of the building and equipment or the cleanliness of the equipment or building, these are both reviewed in later sections of the audit. 这个部分不包括建筑物和设备的状况，或者它们的卫生情况。这些会在后面检查的内容里包括。

Conditions which are to be examined and graded out of 200, then expressed as a percentage of 1000 points, are: - 检查事项有

? The storage, rotation and handling of the raw materials and the packaging materials. (15 points). 原材料，包装材料的储存，轮换和处理。

? The processing conditions under which the product is manufactured including the in-process controls. (H.A.C.C.P.). (100 points). 生产产品的加工条件包括生产当中的控制。(HACCP)

? The employee’s health, hygiene and practices. (25 points). 员工的健康，卫生和操作。

? The procedures for handling of any re-work. (25 points). 处理再加工的步骤。 SGS

21 Form 3 1/2001

? Protection of the finished product against any possible contamination and

temperature abuse (if applicable), during storage and shipping. (25 points). 防止成品在储存和运输过程中被污染的可能性及温度对产品的损害。

? The shipping of the finished product. (10 points). 成品的运输。

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 seriousness of violations/deficiencies as related to the total protection of the product. 括号里的分数只作参考，而不是严格的要求，因检查官有权对食品保护的违反/不足的严重程度作出评判。

points).

The auditor is to judge in this section the conditions under which the raw materials and the packaging materials are examined on receipt, (i.e. tested - if applicable), stored in storage areas, rotated using FIFO and protected against contamination. 在这项检查中，检查官会检验在收到原材料和包装材料时，它们有没有被检测，存放在存放区，以先到先出的原则轮换以防污染。 The auditor should be examining and judging the following: - 检查官会检查下列事项

? If the plant’s receiving program, or H.A.C.C.P. program, requires a raw material to be analyzed on receipt prior to use, is this happening? 工厂有没有一个程序，或HACCP 程序，要求收到的原材料在被使用前要被检测？

? Are the raw materials placed on hold pending the receipt of this analysis? 原材料被检测期间是否被占时搁置不用。

? Are the raw materials and the packaging materials stored correctly? (Off of the floor on pallets or shelving a minimum of 6” (15cm) above the floor, using proper temperature control, no hazardous raw ingredients over non-hazardous ingredients, etc.).(扣15分) 原材料和包装材料是否存放得当。(在栈板上离地放置或者存放于离地至少15CM的货架上，适当的温度控制，有害成分不能放于非有害成分之上。

? Are the raw materials and the packaging materials free of dust, condensate etc.? in closed containers ? 原材料和包装材料是否无尘，无沉积物？在密闭容器里？

? Are the raw materials and the packaging materials dated as to date of receipt? 原材料和包装材料标记有接收日期？

SGS

22 Form 3 1/2001

? Is a FIFO system being followed for the raw materials and for the packaging materials? 原材料和包装材料先到先出的原则是否被遵守？

? Are all the “on-hold” raw materials and the “on-hold” packaging materials clearly labeled and

segregated? Is this process under control? 所有“占时不用” 的原材料和包装材料被清楚地标记和区隔开？

? Are all the raw materials in sound condition and free from spoilage? 所有原材料是否品质良好并没有腐坏？

? Are all the coolers at 41 F (5 C) or below and all the freezers at 0F (-18 C) or below?(扣10分) 是否所有冷藏箱的温度低于5摄氏度，所有冰冻箱的温度低于零下18摄氏度？

(100 points).

In this section of the audit the auditor is judging the conditions under which the product is processed from the handling of the raw materials in production, through the entire manufacturing process to the filling of the finished product and the handling of the packaging materials.

If the plant has a H.A.C.C.P. program then the auditor will be assessing if the plant is adhering to their H.A.C.C.P. program.

Conditions to be judged in this section are: -

? The handling of the raw materials (sieving, straining, filtering, weighing, recording lot numbers, keeping off of the floor, etc.) And the handling of the packaging materials during processing (recording lot numbers, keeping off of the floor, etc.) (20 points).

? The product processing conditions? (60 points) (Adhering to their H.A.C.C.P. program and/or all of their processing controls).

? Are there effective measures to prevent any cross-contamination and/or contamination of the in-process product and the finished product? (20 points).

The handling of the raw materials and the packaging materials during processing: - (20 points).

SGS

23 Form 3 1/2001

The handling of the raw materials during processing is important in protecting the finished product against possible contamination and the recording of lot numbers is vital in tracing the raw materials and the packaging materials in the case of a problem.

Items to be checked in this part of the audit are: -

? Are the raw materials and the packaging materials stored off the floor and protected against contamination in the processing area?

? Are the raw material lot numbers recorded on the production record sheets? Does this also include the bulk raw materials?

? Are the packaging material lot numbers recorded on the packaging department’s production sheets? ? Are the raw material bags brushed off prior to dumping? Or is the outer bag removed?

? Are the powder and liquid raw materials sieved, strained or filtered as they are used?

? Is there a system in place to prevent the “on-hold” raw materials and “on-hold” packaging materials from being used?

? Are the scales used to weigh the raw materials accurate? And regularly calibrated?

? Is there a check off system for adding the raw materials? Particularly for any restricted ingredients. ? Is the water used in the product filtered prior to use? Is the water tested for potability a minimum of once a year?(扣20分---特别是井水)

Product processing conditions: - (60 points).

In this section the auditor is auditing the processing conditions and the parameters for manufacturing the plant’s products.

If the plant has a H.A.C.C.P. program then this is used as the guide for this part of the audit.

If the plant by law is required to have a H.A.C.C.P. program and it does not this is a critical finding and an automatic failure of the audit.(QS系列产品必须通过)

If the plant is required to have a H.A.C.C.P. program by law and is not following their H.A.C.C.P. program then this is a critical finding and an automatic failure of the audit.

If the plant has a H.A.C.C.P. program and is not documenting its corrective actions then this is a serious deficiency. How serious this deficiency is depends on the auditor’s judgment of whether the problem is the lack of documentation (serious) or the lack of performing a corrective action (critical). SGS

24 Form 3 1/2001

If the plant does not have a H.A.C.C.P. program and it is manufacturing an unsafe product (i.e. under pasteurizing a dairy product, etc.) then this is a critical finding and an automatic failure of the audit. Is the plant measuring the key processing parameters? At the frequency shown in the documented process?

If the plant is not adhering to their processing parameters (i.e. pH is out of specification but product was allowed to continue without adjustment) and the product is still safe for consumption by the end user then this is a critical finding but not an audit failure.

Any problems due to unclean equipment are to be judged under the audit section “ Cleanliness of the equipment and the plant “.

Are there effective measures to prevent any cross contamination and/or contamination of the in-process product and the finished product? (20 points).

In this section the auditor should be looking for any areas where the product is being exposed to possible contamination.

? Are the lids on the processing tanks being kept closed when not necessary to be open ? ? Does the process avoid the finished product coming into contact with the raw materials?

? Is the packaging materials protected as they are conveyed in the plant prior to filling? (I.e. are there covers over conveyors carrying upright empty cans to a filler, etc.?).

? If the plant fills into a glass container does the plant have a glass breakage policy?

? Is there any condensate, fumes, odors that could contaminate the product or the packaging materials?

? Are there any cross-connections between different pieces of the equipment that could result in the backflow of one product into another product?

? Are the utensils, shovels, paddles etc. washed after use in a product prior to being used in another product?

points).

The employees in the plant are generally the plants greatest assets when it comes to manufacturing a safe product but they can also be the greatest liability to achieving this safe objective.

SGS

25 Form 3 1/2001

The auditor needs to be judging the employee and management’s adherence to the GMPs. ? Are the employees wearing light colored, clean clothing around the exposed food?

? Are the employees wearing effective hair and beard restraints around the exposed food?

? Are the employees washing their hands and, where applicable, sanitizing them when working with the exposed food? (Bare, unsanitized, hand contact with a ready to eat food is a critical finding). ? If the plant is using gloves, are these being kept in a sanitary condition?

? Are the employees, who are working with the exposed food, healthy? (It is a critical finding if the employee has a communicable disease i.e. Hepatitis A, Salmonella typhi, Shigella, E. coli O157:H7.) (It is serious if the employee has an open infected sore, diarrhea, flu etc. and this is critical if the employee is touching the exposed food).

? Is eating, drinking, chewing, and smoking restricted to the designated areas? (This is a critical finding if done around exposed food or exposed food-packaging materials).

? Are the employees removing all their jewelry, watches, items in top pockets etc. when working with the exposed food?

? Are the employees sitting or standing on case or bags of raw materials, packaging materials or finished products?

? Are the employees doing anything that could result in contaminating the exposed food or the packaging materials?

NOTE: - If the auditor feels that the poor employee practice is due to lack of training then points need to be also removed in the section Food safety programs - employee training.

If the auditor feels the poor employee practice is due to inadequate management supervision then

additional points should be removed in the section Food safety programs - management training.

A critical finding is minus all 25 points in this category.

(25 points).

As the use of any contaminated re-work in a finished product can result in this causing the finished product to be contaminated then it is important that the plant have a documented program to handle all of the re-work.

SGS

26 Form 3 1/2001

The auditor should judge the following: -

? Does the plant sieve, strain, filter or otherwise screen the re-work?

? Does the plant record the lot numbers of the re-work product on the batch sheets?

? Does the plant keep a record of the percentage (%) of re-work being used in all products? ? Does the plant analyze any returned products prior to re-working them?

? Does the plant have a policy to break the re-work cycle by not re-working some product? (I.e. one day per week not using any re-work).

NOTE: - If the plant has a policy not to rework any product at all then this is N/A and the auditor needs to remove 25 points from the total of 200 points in this category and express the total score in this section as a percentage of 175 points.

(25 points).

The auditor should assess in this section how the plant is handling the finished packaged product to protect it against contamination and also the plant’s ability to be able to recover the finished product if it becomes necessary.

? Is the finished product being stored at the correct temperatures?(扣分:15分)

? Is the product stored up off of the floor on either pallets, or shelving a minimum of 6” (15 cm) off of the floor?

? Is the product stored away from the walls?

? Is the product clearly coded so that the date of manufacture can be seen? (扣分:15分)

? Is the product being shipped out using a FIFO system?

? Are the code dates of the product being shipped being recorded on the bill of lading so as to assist in a possible product recall?

? Is all “ on-hold “ product clearly labeled and segregated from other products?

SGS

27 Form 3 1/2001

? Is the finished product to be re-worked clearly labeled and segregated from other products? (扣分:25分)

(10 points).

? Is perishable product shipped out on pre-cooled refrigerated trailers (扣分:10分)capable of

maintaining the product frozen or refrigerated, as appropriate, to its destination?

? When shipping bulk liquid or powder products are the tankers inspected for cleanliness prior to

loading? Is information available on the tankers last three loads?

? If tankers and/or trailers are sealed on shipping what is the program for recording the seal

numbers?

? Is the finished, packaged product shipped out on trailers that are clean and in good repair?

In this section the auditor is judging the overall condition and maintenance of the buildings, the processing equipment and the packaging equipment.

Conditions which are to be examined and graded out of 200, then expressed as a percentage of 1000 points, are: -

? Walls, windows, doors and dock levelers: - (15 points).

? Floors, platforms, mezzanines etc.: - (10 points).

? Ceilings/roofs, lights, overhead pipes, walkovers etc. (50 points).

? Processing equipment, racking, pallets, etc.: - (100 points).

? Miscellaneous: - (25 points). (Lighting levels, water, garbage, outside grounds, battery charging, restrooms, personal belongings storage, compressed air etc.)

SGS

28 Form 3 1/2001

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 conditions found and their ability to produce a safe, uncontaminated product.

(15 points).

The condition of the doors, the dock levelers and the windows to exclude rodents, birds, flies etc. was judged under the section Pest Control.

All the windows in the areas where the raw materials, the finished or the in-process product are

exposed need to be in good repair and not cracked so that glass cannot get into/onto items stored near them.

The walls in the processing areas should be smooth, sealed and easily cleaned.

There should be no flaking or peeling paint on the walls where the product, the raw materials or the packaging materials are exposed. (If over the product this is a critical finding). (扣分:15分) (10 points).

All the floors, the platforms, the mezzanines etc. need to be in good repair so that they can be kept clean and free of areas for insects to harbor.

The condition of the floors in the processing areas need to be in good enough condition that they can be kept clean and sanitary.

If the floors are tiled the grouting needs to be intact so that water is not getting under these floor tiles. All the mezzanines and the platforms need to be rust free and made of materials that can be cleaned (i.e. no wood).

points).

The conditions of the ceilings/roofs, the lights, the overhead pipes and any walk-overs in processing areas are more critical than the floors and the walls, unless a mezzanine, as items can drop from these into/onto the raw materials, the finished product or the packaging materials below.

SGS

29 Form 3 1/2001

Ceilings/roofs and the bottom of mezzanines need to be in good repair with no flaking paint, no rust, no holes from the outside, no holes from the floors above unless protected against objects or dirt falling through them, etc.

Lights in all areas where the product or the packaging materials are exposed need to be protected against breakage by both using plastic tubes and end caps, safety lights or by other means.

The level of lighting also needs to be sufficient to be able to see properly to clean and do the rodent control. (裸露食品上方的危害--(扣分:50分)

All overhead pipes in areas where the product, the raw materials or the packaging materials are either directly stored or processed under them need to be protected against leakage. (I.e. insulated, or catch pans under them, etc.).

This includes: -

Roof drains, water pipes, sewer lines, mezzanine or upper floor drains, freezer and cooler coils, etc. These pipes also need to be in good repair with no flaking paint, exposed insulation, rust etc.

Platforms or ladders that allow people to walk over the exposed product or the unsealed, exposed packaging need to have a solid base and a kick-lip so as to prevent foot dirt falling into/onto the product or the packaging below.

100 points).

In this section the auditor is judging the condition of the processing, packaging and conveying equipment and the cold storage facilities with regards to their ability to protect the product and the ability to be able to be cleaned.

Also being examined is the reliability and accuracy of instrumentation used to process the product and to give a safe finished product.

In addition the condition of the storage racking, shelving and pallets needs to be judged.

? Are all the processing and the packaging equipment able to be cleaned and is it in good repair? ? Are all the thermometers, the temperature recorders on coolers, freezers, pasteurizers etc. accurate?

SGS

30 Form 3 1/2001

? Are all coolers at 41 F (5 C) or below?(温度不符合要求—扣分:25---50分)

? Are all freezers at 0 F (-18 C) or below?

? Are all the recording charts installed properly on recorders? (I.e. showing the correct time of day, the correct day, etc.).

? Are all the thermometers, the pH meters and any other measuring equipment calibrated on a regular basis?

? Is the use of wood in the processing and the storage areas being avoided accept for pallets? ? Are the wooden pallets in good repair and hence not a source of possible contamination?

? Is the equipment generating steam, grease, fumes or odors that are not being removed properly? ? Is there any equipment, where necessary, to remove the steam, the grease etc.?

? Does the equipment have temporary repairs that have become “permanent”?

? Is the equipment rusty on the food contact surfaces (critical) or on the outside of the equipment? (设备生锈问题—扣分:25---50分)

? Is the equipment in good repair? Not cracked, chipped etc.?

? Do all the motors over equipment, conveyors and/or exposed food have catch pans underneath them to prevent any oil drops from getting into/onto the product or the packaging materials? (有润滑油污染产品扣分:50---100分)

? Are all the overhead conveyors that go over the exposed product and/or the exposed packaging materials protected against anything dropping down on the items below?

? Is there any dripping oil or grease on the equipment? (Critical if over exposed product or packaging materials).

? Are all icing making and ice storage bins free of rust?

? Is all the racking and/or shelving in good repair?

? Are the pallets in good repair?

Any critical finding is a minimum of minus 25 points.

: - (25 points).

? Is all glass, apart from lights in areas, where the product and/or packaging is exposed protected against breakage?(针对产品和包材储存区)

SGS

31 Form 3 1/2001

? Is there sufficient space to process the product safely, to store the product and to keep the storage areas sanitary?

? Are there separate areas for employee’s personal belongings?

? Is the lighting adequate in all areas to operate safely, to see to clean etc.?

? Are all the water lines protected against possible backflow protection? (Critical).(水回流装置: 扣分25分)

? Is the compressed air, if it contacts the product or the packaging materials, filtered to remove bacteria, water and oil droplets etc.?

? Is the steam, if it is injected into the product, culinary?

? Outside grounds - are they being taken care off?

? Free of any litter and debris.

? No standing water.

? Compactors/dumpsters are being kept closed and are not leaking on the ground.

? No weeds and/or overgrowth next to the buildings.

? Equipment stored outside the plant is up off of the ground and away from the buildings. ? Restrooms: -

? Are the restrooms being kept in good repair?

? Are they adequately supplied with soap, towels, warm water (110 F (43 C))?

? Are there wash hand signs in the restroom and over every hand wash sink in processing areas? ? Do the restrooms open directly into production? (Critical).

(Not a problem if there is a double door entrance to the restroom or a negative air pressure in restroom).

? Are there floor drains, where needed, for clean up?

? Are there any blocked floor drains? (Critical).

? Is the plant’s water source being tested for potability?

? Is the recharging of the forklift batteries being conducted where either the fumes or the acid can contaminate the food products?

(对critical外,其它每一项扣5分)

A critical finding is minus 25 points. SGS

32 Form 3 1/2001

The maintenance of a clean plant and equipment is essential to producing and storing a safe food product.

Conditions which are to be examined and graded out of 200, then expressed as a percentage of 1000 points, are: -

? The cleanliness of the processing and packaging equipment (100 points). ? The cleanliness of the processing and packaging areas (30 points).

? The cleanliness of the storage areas, restrooms, etc. and general housekeeping (30 points).

? The correct use of the cleaners, sanitizers and the cleaning equipment (25 points).

? The protection of the raw materials, the packaging materials and the finished product during cleaning. (5 points).

? The record keeping and the monitoring of the results of sanitation (10 points).

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 conditions found and their ability to cause an unsafe, contaminated product.

(100 points).

This is generally done visually and when dealing with potentially hazardous products by additional microbiological methods. (i.e. bioluminescence, or swabbing and plating).

The lack of cleanliness of the food contact surfaces is to be judged more critically than the outside of the equipment.(扣分:50-100分)

It is necessary to examine equipment when it is empty and clean. Therefore certain equipment will need to be taken apart prior to the start of the food processing so that the following can be evaluated for cleanliness: -

SGS

33 Form 3 1/2001

? In line filters and screens.

? The interior of the product pumps.

? The interior of the processing pipes.

? In line magnets.

? Inside of the silos and the bulk storage tanks. (If applicable).

? Inside of ice storage bins. (If applicable).

Also all not in use equipment should be stored clean and covered and preferably out of the food processing department if no longer used in production.

(30 points). The cleanliness of the environment under which a product is processed and package is very important to protecting the product against airborne contamination.

Pathogenic bacteria (i.e. Listeria, Salmonella etc.) have been found in finished products due to airborne contamination from the plant’s environment.

The auditor needs to be inspecting for cleanliness the following areas: -

? Drains in the processing and packaging areas. (Dirty drains are generally the source of fruit flies, Listeria etc.).

? Cooling coils, drip pans and drainage piping on cooling condensers in processing and packaging areas. (This is another source of possible Listeria in the plant).

? Overhead beams, ductwork, pipes, ledges etc.

? Floors, walls etc. in processing and packaging areas.

? Mold on the walls in the processing and the packaging areas. This is critical as this can contaminate the product with airborne mold spores.

A critical finding is minus 25 points.

SGS

34 Form 3 1/2001

( 30 points)

Storage areas :-

The storage areas need to be judged for cleanliness under the shelving, under the pallets, around the perimeter, in the aisles, etc.

Also examine the cleanliness of the cooling coils, drip pans and drainage piping on cooling condensers in the coolers and freezers.

Any mold on the walls in the coolers is critical as this can lead to a contaminated product due to airborne mold spores.

Restrooms :-

All the restrooms should be clean, odor free and sanitary.

General housekeeping: -

The auditor should judge in this section the following: -

? Are all the spills being picked up promptly?

? Are the internal transport vehicles clean?

? Is there equipment to perform all the general cleaning?

? Is the cleaning equipment put away between uses? (I.e. mop buckets emptied, mops hung up to dry, etc.).

? Is there any old rodent evidence found in any areas?

? Are there spider webs in the warehouse that indicate poor housekeeping?

? Are there fruit flies in any area indicating poor sanitation?

A critical finding is minus 25 points.

points ).

SGS

35 Form 3 1/2001

Cleaners :-

The cleaning of the equipment and the environment is acheived by using the correct cleaning chemical, at the correct concentration and under the right conditions. Failure to follow the correct procedures can result in unclean and possibly rusty equipment. The use of the sanitizers is greatly affected by dirt left on the equipment as this dirt inhibits the effectiveness of the sanitizers.

The auditor needs to evaluate in this section the adherence to the cleaning procedures for the plant as to the chemical specified and its recommended strength to that being used by the sanitation crew. If the equipment is not coming visually clean yet the written procedure and schedule frequency are being followed then the sanitation procedure is inadequate or the cleaning schedule is insufficient and the points need to be removed under foodsafety programs - S.S.O.P’S - cleaning procedures or cleaning schedules, whichever applies.

If the employee is not following either the documented cleaning procedure and/or the frequency of cleaning per the cleaning schedule then the auditor should remove additional points under either food safety programs - employee training or food safety programs - management training. Sanitizers: -

The incorrect use of sanitizers on the clean equipment can result in either insanitary equipment or a chemical residue being left on the equipment that can get into the next food product processed on this equipment.

For the sanitizers to be effective they need to be used at the correct strength and at, or above, the minimum recommended temperature for two (2) minutes of contact time.

The following sanitizers, which are generally used in the food industry, need to be used on a food contact surface between the following minimum strengths and the maximum strengths. If they are to be used with a potable water rinse to follow then the maximum strength requirements do not have to be adhered to.

If used on non-food contact surfaces then the maximum strength can be exceeded at any time and without the requirement for a potable water rinse. Chlorine Iodine

50 ppm

200 ppm 25 ppm 200 ppm Varies

75 F (24 C) 75 F (24 C) 75 F (24 C)

12.5 ppm

Quat 200 ppm Acid(s) Varies

SGS

36

Form 3 1/2001

? If the processing room temperatures are lower than 75 F (24 C) then the exposure time to the sanitizer has to be increased from two minutes to compensate for the lower temperature.

? Do not exceed 120 F (49 C) for chlorine and iodine sanitizers due to the volatility of these sanitizers at this temperature.

Use of chemical sanitizers over the maximum allowed strength if not followed by a potable water rinse is a critical finding.

The plant needs to have the ability to test the strength of the sanitizers in use either by using test strips or a test kit.

It is also legal and satisfactory to use hot water at a minimum of 180 F (82 C) to sanitize clean

equipment surfaces as long as the contact time of the hot water is sufficient to raise the temperature on the food contact surface of the equipment to 160 F (71 C) for a minimum of 30 seconds.

A critical finding is minus 25 points.

Colored brush program: -

It is recommended that as a part of the plant’s cleaning program and to avoid another possible source of cross contamination that the plant adopts a different colored brush for different cleaning tasks.

The following is only a recommendation as to the possible colors to use for each task. If in the judgment of the auditor the plant’s current color scheme is satisfactory then no points are lost in this section.

WHITE

RED

YELLOW

GREY

BLACK

SGS

All food contact surfaces - processed product areas only. All food contact surfaces - raw product areas only. All equipment non-food contact surfaces. All environment surfaces (Floors, walls, beams etc.). All drains. 37 Form 3 1/2001

(5 points).

It is essential when performing the cleaning of the equipment or the building that the raw materials, the packaging materials, the in-process products etc. be removed from the area or adequately protected against contamination.

Any observed contamination is a critical finding and could result in an automatic failure of the audit if it involves the finished product.

points).

Record keeping: -

The importance of good record keeping as a part of the total sanitation program is very important as it shows that tasks have been performed.

The records should include against each task the day performed and the initials of the person performing the task. In addition there should be the initials of a supervisor verifying that all cleaning tasks have been performed according to the schedule.

F.S.I.S. (USDA) has made record keeping of the S.S.O.P’s for meat and poultry plants a mandatory part of the plant’s H.A.C.C.P. program.

Therefore if these records are not complete at meat and poultry plant then this is a critical finding. (Minus all 10 points).

For other plants the lack of records, or there incompleteness is serious and the auditor should remove points according to how incomplete the records are.

Additional points may need to be removed under either food safety programs - employee training or management training.

Monitoring: -

To ensure that the cleaning tasks have been performed properly and that the clean surface is also

sanitary, it is necessary to do some microbiological testing either by using bioluminescence or swabbing and plating.(此项扣5分)

The results of these testing needs to be reviewed especially if the plant manufactures a potentially hazardous food.

SGS

38 Form 3 1/2001

Auditor should also look for documented corrective actions taken when the swabbing showed the surfaces not to be sanitary.

If the monitoring is only visual then the results of this visual inspection need to be documented especially as it is a requirement of the S.S.O.P’s whether it is a part of a H.A.C.C.P. program or just a pre-requisite.

Lack of monitoring is a critical finding if the plant is under mandatory government imposed H.A.C.C.P. (i.e. Meat and Poultry plants, Seafood plants, and in fall of 1999 for all Fruit juice plants).

(Minus 10 points).

These guidelines are the property of SGS and cannot be reproduced in any form without the written permission of SGS.

SGS

39 Form 3 1/2001