GFSI全球市场制造生产协议1.3版GFSI全球市场制造生产协议1.3版GFSI Global Markets Manufacturing Production Protocol Version 1..pdf

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1、GFSI GM MP Basic Level Requirement基础级要求 Intermediat Level Requirement中级要求 No. B.AFood Safety Management Systems (Basic Level)食品安全管理体系（基础级别）食品安全管理体系（基础级别） B.A 1Specifications including product release产品规范和产品放行产品规范和产品放行 The business shall ensure that product specifications are adequate, accurate and e

2、nsure compliance with relevant safety and legislative requirements and customer requirements. The business shall prepare and implement appropriate product release procedures. 供应商应确保产品规范的适宜性和充分性，并确保符合相关安全、法规和顾 客的要求。供应商应建立和执行适宜的产品放行程序。 B.A 1.1 Are specifications available for all product inputs (raw m

3、aterials, ingredients, additives, packaging materials, rework) and finished products? 是否有适用于所有的产品输入（原料，配料，添加剂，包材，返工）和成品 的规范？ B.A 1.2 Are the available specifications compliant with relevant safety and legislative requirements and customer requirements? 这些规范是否能够符合相关安全、法规和顾客要求? B.A 1.3 Are specificati

4、ons up to date, unambiguous and available to relevant staff? 产品规范是否是最新的，清晰的，并提供给相关人员？ B.A 1.4 Are changes to specifications clearly communicated both internally and externally? 产品规范修改是否明确通报给内部和外部相关方？ B.A 1.5 Is a documented Product Release Programme in place and effective to ensure final product mee

5、ts the specification? 是否制定有效的书面产品放行计划以确定成品满足产品规范？ B.A 1.6 Is a designated person responsible for controlling specifications?是否有指定的人负责产品规范控制？ B.A 2Traceability可追溯性可追溯性 The business shall establish a traceability system, which enables the identification of product lots and their relation to batches of

6、 raw materials, primary and consumer unit packaging materials, processing and distribution records. Records shall include Identification of any out sourced product, ingredient or service; Complete records of batches of in process or final product and packaging throughout the production process. Reco

7、rd of purchaser and delivery destination for all products supplied. Record of annual testing of the traceability system. 供应商应建立可追溯系统，以便能确认产品批号以及其相关的原料、主要包 材和消费单元包材的批次，以及加工和分销记录； 记 录应包括： 识别任何外购产品、配料或服务； 整个加工过程的完整记录，包括加工、成品和包装的批次； 所有供应产品的购买者和运输目的地的记录； B.A 2.1 Is a documented traceability system in pla

8、ce for every product that meets regulatory and customer requirements? (Required element Major deduction if missing) 是否为每个产品建立书面的可追溯体系，确保其满足法规和客户的要求？ （必须项-若不满足，主要扣分项） B.A 2.2 Is the traceability system including work in progress, post-treatment and rework fully operational and effective? 可追溯系统是否包括加工、

9、后处理、返工等全部的操作过程，且有效运行？ B.A 2.3 Are records of registration and product identification through all production stages (work in progress, post treatment, rework) available for all raw materials, primary and consumer packaging materials, i.e. from purchase through process to the delivery destination? 登记记

10、录或产品识别记录是否可以获得？适用于加工，采后处理，返工等加工，采后处理，返工等 全部生产阶段，包括原材料、主要包装材料和消费单元包装材料，从购买到 运输目的地的全过程？ B.A 2.4 Is the traceability system tested at least annually and updated as necessary? 可追溯体系是否至少每年测试一次，并进行必要的更新？ B.A 2.5 Is a clear labelling system in place ensuring continuous identification of the product through

11、 all stages of production and delivery? 是否建立一个清晰的标识系统，确保产品在整个生产阶段和运输过程能持续 有效的被确认？ B.A 3Food Safety Incident Management食品安全事件管理食品安全事件管理 The business shall have an effective incident management procedure covering incidents reporting, product withdrawal and recall procedure for all products which shall

12、 include the provision of information to the customer. Record of annual review, testing and verification of the system shall be available. 供应商应有一个有效的事件管理程序，包括事件报告，所有产品的撤回与召 回程序，程序中应有信息提供给客户的条款。年度审查，测试和验证的记录 应可获得； B.A 3.1 Is a documented Incident Management system in place that addresses incident rep

13、orting, product withdrawal and product recall? (Required element Major deduction if missing) 是否建立书面的事件管理体系，包括事件报告、产品撤回和召回？ （必须项-若不满足，主要扣分项） Comp GFSI Global Markets Manufacturing Production Protocol Version: 1.3 - Update Valid from 21.03.2013 for assessments 1 of 8 pages GFSI GM MP Basic Level Requi

14、rement基础级要求 Intermediat Level Requirement中级要求 No. Comp GFSI Global Markets Manufacturing Production Protocol B.A 3.2 Is an effective Communication Plan in place with a designated, responsible person identified to provide information to customers, consumers and regulatory authorities? 是否建立有效的沟通计划，指定专

15、人负责通知客户、消费者和监管部门？ B.A 3.3 Is the Incident Management System reviewed, tested and verified at least once a year? (Required element Major deduction if missing) 事件管理体系是否每年至少审查、测试和验证一次？ （必须项-若不满足，主要扣分项） B.A 3.4 Are all incidents recorded and assessed to establish their severity and consumer risk? 是否记录和评

16、估所有的食品安全事件，并确定其严重程度和顾客风险？ B.A 4Control of non-conforming product不合格品控制不合格品控制 The business shall ensure that any product which does not conform to requirements is clearly identified and controlled to prevent unintended use or delivery. 供应商应确保任何不合格品的确认和控制，防止非预期的使用和运输。 B.A 4.1 Is a documented procedure

17、 in place to identify and manage all non- conforming raw materials, product inputs, semi-finished and finished products, processing equipment and packaging materials? (Required element Major deduction if missing) 是否建立书面的程序识别和管理所有的不合格品，包括原料、产品添加物、 半成品、成品、加工设备和包装材料？ （必须项-若不满足，主要扣分项） B.A 4.2 Is the con

18、trol of non-conforming product managed by competent personnel? 不合格品控制管理是否由有能力的人员负责？ B.A 5Corrective Action整改措施整改措施 The business shall ensure that corrective action be undertaken as soon as possible to prevent further occurrence of non-conformity. 供应商应确保整改措施尽快实施，以防止不符合的再次发生。 B.A 5.1 Is a documented C

19、orrective Action Procedure in place to analyze any complaints and investigate non-conformities to prevent reoccurrence? 是否建立书面的整改程序来分析投诉和调查不符合以避免再次发生？ B.A 5.2 Are corrective actions (i.e. release, rework, quarantine, rejection/disposal) identified and effectively implemented? 整改措施（如：产品放行、返工、隔离、拒收/清理

20、）是否确认并有效实 施？ Chapter A. Food Safety Management Systems (Basic Level)A.食品安全管理体系（基础要求）食品安全管理体系（基础要求） I.AFood Safety Management Systems (Intermediate Level)食品安全管理体系（中级要求）食品安全管理体系（中级要求） I.A 1Management Responsibility管理职责管理职责 The business shall establish a clear organizational structure, which defines an

21、d documents job functions, responsibilities and reporting relationships of at least those staff, whose activities affect product safety. 供应商应建立清晰的组织架构，需明确工作职能、职责和汇报关系，并形成 文件。 I.A 1.1 Is an up-to-date organizational chart outlining the business structure available? 是否有最新的组织机构图表明公司的组织架构？ I.A 1.2 Are d

22、ocumented, clearly defined responsibilities regarding product safety and legality available and communicated to staff? 是否明确定义关于食品安全与法律的相关职责，形成文件，并贯彻到员工？ I.A 2General Documentation Requirements一般文件要求一般文件要求 The business shall establish and implement procedures to ensure that all documents, required to

23、 demonstrate the effective operation and control of its processes and its management of product safety, are maintained and kept up-to-date. Records shall be retained for a time period required to meet customer and/or legal requirements. 供应商应建立程序，保存所有用来证明食品加工和产品安全管理得到控制和 有效运行的最新版文件，并得到实施。 I.A 2.1 Is

24、a written documentation procedure in place and effectively implemented? 是否建立书面程序，并得到有效实施？ I.A 3Procedures程序程序 The business shall prepare and implement detailed procedures/instructions for all processes and operations having an effect on product safety. 供应商应该准备对食品安全有影响的所有过程和操作的详细的程序/指导 书，并实施。 I.A 3.1

25、 Are detailed procedures developed and effectively implemented for all processes and operations that affect food safety? 对食品安全有影响的所有过程和操作是否建立详细的程序，并有效实施？ I.A 3.2 Are procedures clearly communicated to relevant staff?程序是否清楚的传达给相关人员？ I.A 4Complaint Handling投诉处理投诉处理 The business shall prepare and imple

26、ment an effective system for the management of customer/ consumer complaints and complaint data to control and correct shortcomings in food safety. 供应商应准备有效的客户/客户投诉和投诉数据管理体系，以控制和减少食 品安全投诉，并实施。 I.A 4.1 Is a documented complaint management system in place and effectively implemented? 是否建立书面的产品投诉管理体系，并

27、有效实施？ I.A 4.2 Are records of all customer and consumer complaints, investigations and corrective actions maintained? 是否保存了所有的客户、客户投诉、调查和整改措施？ I.A 5Control of Measuring & Monitoring Devices监视与测量设备管理监视与测量设备管理 Version: 1.3 - Update Valid from 21.03.2013 for assessments 2 of 8 pages GFSI GM MP Basic Lev

28、el Requirement基础级要求 Intermediat Level Requirement中级要求 No. Comp GFSI Global Markets Manufacturing Production Protocol The business shall identify measuring and monitoring devices critical to food safety, ensure that they are calibrated and traceable to a recognized standard. 供应商应确定对食品安全起关键作用的测量和监测设备，

29、并确保它们校准， 且符合相应的标准。 I.A 5.1 Are measuring and monitoring devices critical to food safety identified, calibrated and traceable to recognised standards and are they effectively controlled? 对食品安全有重要影响的测量设备，是否得到识别，校准，满足相应的标 准，并得到有效的控制？ I.A 5.2 Are actions taken and recorded when measuring and monitoring

30、devices are found to be outside of specified limits? 当测量和监测设施出现异常时，是否采取措施并记录？ I.A 6Product Analysis产品分析产品分析 The business shall implement a system to ensure that product/ ingredient analyses critical to food safety and legal requirements are undertaken and the business shall ensure that the methods u

31、sed provide valid results (e.g. by procedures set forth in ISO 17025 and/or industry recognized methods). 供应商应建立体系以确保对食品安全关键的、法规要求的产品/配料得以检 测分析；供应商应确保使用的检测方法能提供有效的检测结果（如：使用 ISO 17025规定的程序或者使用行业推荐方法）。 I.A 6.1 Are analysis procedures in place to ensure that all specified product requirements are met,

32、including legal requirements and customer specifications along the whole shelf life? 是否建立分析程序确保满足所有规范的产品要求，包括货架期内的法规要求 和客户的要求？ I.A 6.2 Are methods relevant for food safety used to provide valid results (e.g. by procedures set forth in ISO 17025 and/or industry recognized methods)? 与食品安全有关的检测方法是否确保得出

33、有效结果（如：使用ISO 17025规 定的程序或者使用行业推荐方法）？ I.A 7Purchasing采购采购 The business shall control purchasing processes to ensure that all externally sourced items and services conform to written requirements. 供应商应能控制采购过程，以确保所有外部来源的产品和服务符合书面要求 。 I.A 7.1 Do purchased products and services meet current specification

34、s and contractual agreements? 产品和服务采购是否符合现行规范和合同协议？ I.A 8Supplier Approval and Performance Monitoring供应商认可和监控供应商认可和监控 The business shall operate procedures for approval and continued monitoring of all its suppliers whose products or services may affect product safety. The results of evaluations and

35、follow-up actions shall be recorded. 当下游供应商提供产品和服务会影响到产品安全时，应实施程序来批准和持 续监控所有的下游供应商，应记录评估结果和后续行动。 I.A 8.1 Is a documented supplier approval programme in place and effectively implemented? 是否建立书面的供应商认可计划，并有效实施? I.A 8.2 Is a documented supplier monitoring programme in place and effectively implemented?

36、 是否建立书面的供应商监控计划，并有效实施？ I.A 9Training培训培训 The business shall implement a system to ensure that all personnel are adequately trained, instructed and supervised in food safety principles and practices, commensurate with their activity. 应建立体系确保员工能受到充分的、与其能力相当的、关于食品安全的原则 和实践的培训、指导和监督。 I.A 9.1 Is a docume

37、nted Personnel Training Programme in place and effectively implemented? (Required element Major deduction if missing) 是否建立书面的员工培训计划并有效实施？ （必须项-若不满足，主要扣分项） I.A 9.2 Is a documented HACCP Training programme in place? (Required element Major deduction if missing) 是否建立书面的HACCP培训计划？ （必须项-若不满足，主要扣分项） I.A 9

38、.3 Are adequate training records available? 是否有充分的培训记录？ I.A 9.4 Is a Refresher Training programme documented and implemented?是否制定书面的进修培训计划，并实施？ Chapter A. Food Safety Management Systems (Intermediate Level)A.食品安全管理体系（中级要求）食品安全管理体系（中级要求） B.BGood Manufacturing Practices (GMPs) (Basic Level)良好操作规范（良好操作

39、规范（GMPs）（基础要求）（基础要求） B.B 1Personal Hygiene个人卫生个人卫生 The business shall have processes and procedures in place to ensure the implementation of personnel and visitor hygiene practices. Such practices shall result in sanitary handling and delivery of safe and quality products to customers. The Codex Ali

40、mentarius Commissions recommendation on personal hygiene shall be followed. 供应商应建立流程和程序来保证员工和参观者执行卫生规程，给消费者提供 卫生、安全和高质量的产品，应遵守食品法典委员会关于个人卫生的建议。 Version: 1.3 - Update Valid from 21.03.2013 for assessments 3 of 8 pages GFSI GM MP Basic Level Requirement基础级要求 Intermediat Level Requirement中级要求 No. Comp

41、GFSI Global Markets Manufacturing Production Protocol B.B 1.1 Are personal hygiene requirements in place and applicable to all relevant personnel, contractors and visitors? (Required element Major deduction if missing) 是否建立个人卫生要求，且适用于相关人员、合同方和参观者？ （必须项-若不满足，主要扣分项） B.B 1.2 Are personal hygiene requir

42、ements compliant with legal requirements, if applicable? 如适用，个人卫生要求能否满足法律要求？ B.B 1.3 Are documented communication procedures in place for personnel, contractors and visitors addressing actions to be taken in the case of an infectious disease? 是否在现场有针对员工、合同方和参观者书面的沟通程序，规定发生传染性 疾病时的应采取的措施？ B.B 1.4 Is

43、a qualified person responsible to decide if individuals with a suspect illness may enter food areas and how these individuals are controlled? 是否有合格的负责人决定疑似传染病个体能否进入食品区，及如何控制疑似 传染病个体？ B.B 1.5 Are personnel, contractors and visitors aware of and complying with the personal hygiene requirements? 员工、合同方

44、和参观者是否知道并遵守个人守卫生要求？ B.B 1.6 Are personnel, contractors and visitors aware of and complying with the requirements for the wearing and changing of protective clothing in specified work areas? 员工、合同方和参观者是否知道并遵守进入特定工作区域的穿戴和更换防护 服的要求？ B.B 2Facility Environment设施环境设施环境 The business facilities shall be loc

45、ated and maintained so as to prevent contamination and enable the production of safe products. 供应商设施应布局合理、维护良好、防止污染且适于安全生产。 B.B 2.1 Is the facility located, designed, constructed and maintained to ensure product safety? 公司设施的位置、设计、建造和维护是否能保证食品安全？ B.B 2.2 Is the facility effectively maintained, clean

46、ed and disinfected to prevent physical, chemical and microbiological product contamination? 设施是否维护良好、干净和消毒，能否防止产生物理、化学和微生物的污 染？ B.B 2.3 Is the lighting of the appropriate intensity and design to ensure that food safety practice is effective? 灯光的强度和设计是否能保证食品安全措施的有效性？ B.B 2.4 Are structures, surfaces

47、and materials, particularly those in contact with food easy to maintain, clean and where appropriate disinfect? 建筑物、接触面和材料，尤其与食品直接接触的部分是否便于维护、清洁和 适当的消毒？ B.B 2.5 Are the drainage and waste water systems of equipment locations designed so as not to compromise food safety? 设备布局的排水、废水系统设计是否不危害食品安全？ B.B

48、2.6 Are the grounds and surrounding areas of the facility maintained and kept free of waste and accumulated debris? 地面和设施周边区域是否得到维护，没有废弃物和堆弃的残渣？ B.B 3Cleaning & Disinfection清洁和消毒清洁和消毒 The business shall ensure appropriate standards of cleaning and disinfection shall be maintained at all times and th

49、roughout all the stages. 供应商应确保适用于全部过程的清洁、消毒标准得到实施。 B.B 3.1 Are documented cleaning and disinfection procedures in place and effective, including verification activities, to ensure the cleanliness of the facility, utilities and equipment? 是否建立了有效的书面的清洁、消毒程序，包括验证活动，确保设施、工器 具和设备的清洁？ B.B 3.2 Are cleaning equipment, utensils and chemicals clearly marked, stored in a segregated area away from product, equipment, packaging and suitable for intended use? 清洁用的设备、器具和化学品是否标识清晰，并保存在独立场所，且远离预 期使用的产品、设备和包材？ B.B 3.3 Are qualified, trained personnel used for cle