ISOTS22002-1-2009 食品安全前提方案 食品生产(中英对照)-20141027

1、中国检验认证集团福建有限公司 培训资料 iso/ts22002-1:2009 食品安全前提方案 食品生产 1/14 iso/ts22002-1:2009 食品安全前提方案 食品生产（选译） iso/ts22002-1:2009 prerequisite programmes on food safety part 1 : food manufacturing 1. 范围（略） 10. 交叉污染的预防措施 07 2. 标准引用文件（略） 11. 清洗和消毒 08 3. 术语及定义（略） 12. 虫害控制 09 4. 建筑物结构与布局 01 13. 人员卫生和员工设施 10 5. 厂房和工作场所布

2、局 02 14. 返工 13 6. 公共设施空气、水、能源 03 15. 产品召回程序 13 7. 废弃物处理 05 16. 仓储 13 8. 设备的适宜性、清洁和维护 05 17. 产品信息和消费者意识 14 9. 采购材料的管理 06 18. 食品防护、生物预警和生物反恐 14 4 建筑物结构与布局建筑物结构与布局 4 4 construction and layout ofconstruction and layout of buildingsbuildings 4.1 总要求总要求 建筑物的设计、 建造和维护， 必须与拟进行 的加工操作特性、 与这些加工操作相关的食 品安全危害以及来自

3、工厂环境的潜在污染 源相适宜。 建筑物必须是耐用结构，对产品没有危害。 注：例如屋顶应可排雨且无渗漏。 4.2 环境环境 必须考虑来自当地环境的潜在污染源。 注： 食品生产不应在可能引入潜在有害物质的 区域进行。 必须定期评审潜在污染物防护措施的有效 性。 4.3 工厂位置工厂位置 必须清晰识别场地边界。 必须控制场地出入口。 必须保持场地良好秩序。 植被必须养护或清除。 道路、 庭院和停车区必须有排水设施以防止 积水，并加以维护。 4.1 general requirements4.1 general requirements buildings shall be designed, con

4、structed and maintained in a manner appropriate to the nature of the processing operations to be carried out, the food safety hazards associated with those operations and the potential sources of contamination from the plant environs. buildings shall be of durable construction which presents no haza

5、rd to the product. note for example, roofs should be self-draining and not leak. 4.2 environment4.2 environment consideration shall be given to potential sources of contamination from the local environment. note food production should not be carried out in areas where potentially harmful substances

6、could enter theproduct. the effectiveness of measures taken to protect against potential contaminants shall be periodically reviewed. 4.3 locations of establishments4.3 locations of establishments the site boundaries shall be clearly identified. access to the site shall be controlled. the site shall

7、 be maintained in good order. vegetation shall be tended or removed. roads, yards and parking areas shall be drained to prevent standing water and shall be maintained. 5 厂房和工作场所的布局厂房和工作场所的布局 5 5 layout of premises and workspacelayout of premises and workspace 5.1 总要求总要求 内部布局必须设计、 建造和维护以有助于保 持良好卫生和生产

8、规范。 原料、 产品和人员的流动方式以及设备的布 局必须加以设计，以预防潜在污染源。 5.1 general requirements5.1 general requirements internal layouts shall be designed, constructed and maintained to facilitate good hygiene and manufacturing practices. the movement patterns of materials, products and people, and the layout of equipment, sha

9、ll be designed to protect against potential contamination sources. 中国检验认证集团福建有限公司 培训资料 iso/ts22002-1:2009 食品安全前提方案 食品生产 2/14 5.2 内部设计、布局和交通内部设计、布局和交通 建筑物必须具有足够空间， 确保原料、 产品 和人员有序流动， 确保原料与加工区域物理 隔离。 注：物理隔离的例子包括墙、屏障或隔离物或 足以降低风险的足够距离。 物料传递口必须加以设计， 尽可能降低异物 和害虫进入。 5.3 内部结构和装置内部结构和装置 加工区域的墙和地面必须可清洗或清洁， 对 于

10、加工和产品危害是恰当的。 材料必须耐清 洁。 墙和地面的交接处和角落必须加以设计以 便于清洁。 注：建议加工区域的墙和地面交接处为弧形。 地面必须加以设计以避免积水。 湿加工区地面须无渗透并可排水。 排水沟须 装有防虫设施并加盖。 天花板和高架装置的设计应尽量减小灰尘 和冷凝水聚集。 如有对外开的窗、 屋顶通风口或风扇， 必须 装有防虫网。 对外开的门必须关闭或在不用时有纱网。 5.4 设备位置设备位置 设备的设计和布置必须有助于良好卫生操 作和监视。 设备的布置必须适于操作、清洁和维护。 5.5 实验室设施实验室设施/设备设备 在线检测设施/设备必须加以控制，尽可能 减少产品污染的风险。 微

11、生物实验室的设计、 布置和操作必须防止 人员、 工厂和产品的污染， 且门不能直接朝 向生产区域。 5.6 临时临时/移动厂房和售买机移动厂房和售买机 临时结构必须加以设计、 布置和建造， 以避 免害虫藏匿和潜在的产品污染。 关于临时结构和自动售卖机的额外风险必 须加以评估和控制。 5.7 食品、包装材料、原辅料和非食品化学品食品、包装材料、原辅料和非食品化学品 的贮存的贮存 用于贮存原辅料、 包装材料和产品的设施必 须防止灰尘、冷凝物、排水设施、废弃物和 其它污染物的污染。 5.2 internal design, layout and traffic patterns5.2 internal

12、 design, layout and traffic patterns the building shall provide adequate space, with a logical flow of materials, products and personnel, and physical separation of raw from processed areas. note examples of physical separation may include walls, barriers or partitions, or sufficient distance to min

13、imize risk. openings intended for transfer of materials shall be designed to minimize entry of foreign matter and pests. 5.3 internal structures and fittings5.3 internal structures and fittings process area walls and floors shall be washable or cleanable, as appropriate for the process or product ha

14、zard. materials shall be resistant to the cleaning system applied. wall floor junctions and corners shall be designed to facilitate cleaning. note it is recommended that wall floor junctions are rounded in processing areas. floors shall be designed to avoid standing water. in wet process areas floor

15、s shall be sealed and drained. drains shall be trapped and covered. ceilings and overhead fixtures shall be designed to minimize build up of dirt and condensation. external opening windows, roof vents or fan, where present, shall be insect screened. external opening doors shall be closed or screened

16、 when not in use. 5.4 location of equipment5.4 location of equipment equipment shall be designed and located so as to facilitate good hygiene practices and monitoring. equipment shall be located to permit access for operation, cleaning and maintenance. 5.5 laboratory facilities5.5 laboratory facilit

17、ies in-line and on-line test facilities shall be controlled to minimize risk of product contamination. microbiology laboratories shall be designed, located and operated so as to prevent contamination of people, plant and products. they shall not open directly onto a production area. 5.6 temporary/mo

18、bile premises and vending5.6 temporary/mobile premises and vending machinesmachines temporary structures shall be designed, located and constructed to avoid pest harbourage and potential contamination of products. additional hazards associated with temporary structures and vending machines shall be

19、assessed and controlled. 5.7 storage of food, pac5.7 storage of food, packaging materials,kaging materials, ingredients and non food chemicalsingredients and non food chemicals facilities used to store ingredients, packaging and products shall provide protection from dust, condensation, drains, wast

20、e and other sources of contamination. 中国检验认证集团福建有限公司 培训资料 iso/ts22002-1:2009 食品安全前提方案 食品生产 3/14 贮存区域必须干燥并通风良好。 有规定时必 须进行温度和湿度的监控。 贮存区域设计或安排必须使原材料、 半成品 和成品隔离。 所有材料和产品必须离地贮存， 且材料和墙 之间必须留有足够距离， 以确保检查和虫害 控制活动的实施。 贮存区域的设计必须便于维护和清洁， 防止 污染和降低变质。 必须为清洁材料、 化学品和其它有害物质提 供单独、安全(上锁或其它出入控制)的贮存 区域。 在食品安全管理体系中， 散装或

21、农产品贮存 的例外必须记录。 storage areas shall be dry and well ventilated. monitoring and control of temperature and humidity shall be applied where specified. storage areas shall be designed or arranged to allow segregation of raw materials, work in progress and finished products. all materials and products sh

22、all be stored off the floor and with sufficient space between the material and the walls to allow inspection and pest control activities to be carried out. the storage area shall be designed to allow maintenance and cleaning, prevent contamination and minimize deterioration. a separate, secure (lock

23、ed or otherwise access controlled) storage area shall be provided for cleaning materials, chemicals and other hazardous substances. exceptions for bulk or agricultural crop materials shall be documented in the food safety management system. 6 公共设施公共设施空气、水和能源空气、水和能源 6 utilities 6 utilities air, water

24、, energyair, water, energy 6.1 总要求总要求 加工和贮存区域周边公共设施及其通路设 施的设计必须尽量降低产品污染的风险。 必 须监控公共设施的质量以降低产品污染风 险。 6.2 供水供水 饮用水的供给必须充分满足生产加工需要。 水的贮存、配送以及温度控制（适用时）设 施必须加以设计，满足特定水质要求。 注 饮用水应符合世界卫生组织的饮用水质 量指南。 用于产品原辅料的水包括冰或蒸汽(包括烹 调蒸汽)，或与产品或产品表面接触的水， 必须满足与产品相关的特定质量和微生物 要求。 用于清洁，或用于间接与产品接触风险(如 夹层容器、换热器)的水，必须满足相关用 途的特定质

25、量和微生物要求。 当水加氯时， 必须检测， 确保余氯浓度在使 用处满足相关规范的限量要求。 非饮用水必须有单独供水系统并加以标识， 不与饮用水系统连接； 同时， 防止其回流到 饮用水系统。 注 建议与产品接触的水应流经能消毒的管 线。 6.3 锅炉阻垢剂锅炉阻垢剂 如果使用锅炉阻垢剂，必须满足： 6.1 general requirements6.1 general requirements the provision and distribution routes for utilities to and around processing and storage areas shall b

26、e designed to minimize the risk of product contamination. utilities quality shall be monitored to minimize product contamination risk. 6.2 water supply6.2 water supply the supply of potable water shall be sufficient to meet the needs of the production process(es). facilities for storage, distributio

27、n and, where needed, temperature control of the water shall be designed to meet specified water quality requirements. note potable water should conform to the world health organizations guidelines for drinking-water quality. water used as a product ingredient, including as ice or steam (including cu

28、linary steam), or in contact with products or product surfaces, shall meet specified quality and microbiological requirements relevant to the product. water for cleaning or applications where there is a risk of indirect product contact (e.g. jacketed vessels, heat exchangers) shall meet specified qu

29、ality and microbiological requirements relevant to the application. where water supplies are chlorinated, checks shall ensure that the residual chlorine level at the point of use remains within limits given in relevant specifications. non potable water shall have a separate supply system that is lab

30、elled, not connected to the potable water system and is prevented from reflux into the potable system. note it is recommended that water that can come into contact with the product should flow through pipes that can be disinfected. 6.3 boiler chemicals6.3 boiler chemicals boiler chemicals, if used,

31、shall be either: 中国检验认证集团福建有限公司 培训资料 iso/ts22002-1:2009 食品安全前提方案 食品生产 4/14 a) 使用经批准的符合相关添加剂规范的食品 添加剂，或 b) 经相关执法机构批准可安全用于人类消费 用水的添加剂。 在不立即使用时， 锅炉阻垢剂必须贮存于单 独、安全(上锁闭或其它出入控制)的区域。 6.4 空气质量和通风空气质量和通风 对作为产品成分或与产品直接接触的空气， 组织必须制定过滤、相对湿度(rh%)和微生 物的要求。当组织认为温度和/或湿度很关 键，必须建立控制系统并监控。 必须提供通风(自然或机械通风)，以清除多 余或不需要的蒸汽

32、、 灰尘和气味， 并有助于 湿法清洁后的干燥。 必须控制车间空气质量， 以降低气源性微生 物污染的风险。 在适合微生物生长或存活的 裸露产品的区域， 必须建立空气质量监控制 方案。 通风系统的设计和建造必须确保空气不会 从受污染区域或原料区流向清洁区。 必须保 持一定的空气压差。通风系统必须便于清 洁、更换滤网和维护。 必须定期检查外部空气进气口的物理完整 性。 6.5 压缩空气和其它气体压缩空气和其它气体 用于生产和/或灌装的压缩空气、 二氧化碳、 氮气和其它气体系统的建造和维护必须防 止污染。 直接或偶然接触产品的气体(包括用于物 料、 产品或设备的运输、 吹气或干燥的气体) 必须来自许可

33、与食品接触的气源， 并经过滤 去除灰尘、油和水。 压缩机用油时，如果空气可能与产品接触， 则所用油必须是食品级。 注 建议使用无油压缩机。 必须规定过滤、相对湿度（rh %）和微生 物的要求。 注 空气过滤应靠近使用处以便操作。 6.6 照明照明 照明(自然照明或人工照明)必须使人员便 于卫生操作。 注 照度应与操作性质相适宜。 照明灯具必须防护，确保在其破碎时物料、 产品或设备不被污染。 a) approved food additives which meet relevant additive specifications; or b) additives which have been

34、 approved by the relevant regulatory authority as safe for use in water intended for human consumption. boiler chemicals shall be stored in a separate, secure (locked or otherwise access controlled) area when not in immediate use. 6.4 air quality and ventilation6.4 air quality and ventilation the or

35、ganization shall establish requirements for filtration, humidity (rh%) and microbiology of air used as an ingredient or for direct product contact. where temperature and/or humidity are deemed critical by the organization, a control system shall be put in place and monitored. ventilation (natural or

36、 mechanical) shall be provided to remove excess or unwanted steam, dust and odours, and to facilitate drying after wet cleaning. room air supply quality shall be controlled to minimize risk from airborne microbiological contamination. protocols for air quality monitoring and control shall be establi

37、shed in areas where products which support growth or survival are exposed. ventilation systems shall be designed and constructed such that air does not flow from contaminated or raw areas to clean areas. specified air pressure differentials shall be maintained. systems shall be accessible for cleani

38、ng, filter changing and maintenance. exterior air intake ports shall be examined periodically for physical integrity. 6.5 compressed air and other gases6.5 compressed air and other gases compressed air, carbon dioxide, nitrogen and other gas systems used in manufacturing and/or filling shall be cons

39、tructed and maintained so as to prevent contamination. gases intended for direct or incidental product contact (including those used for transporting, blowing or drying materials, products or equipment) shall be from a source approved for food contact use, filtered to remove dust, oil and water. whe

40、re oil is used for compressors and there is potential for the air to come into contact with the product, the oil used shall be food grade. note use of oil free compressors is recommended. requirements for filtration, humidity (rh%) and microbiology shall be specified. note filtration of the air shou

41、ld be as close to the point ofuse as is practicable. 6.6 lighting6.6 lighting the lighting provided (natural or artificial) shall allow personnel to operate in a hygienic manner. note the intensity of the lighting should be appropriate to the nature of the operation. light fixtures shall be protecte

42、d to ensure that materials, product or equipment are not contaminated in the case of breakages. 中国检验认证集团福建有限公司 培训资料 iso/ts22002-1:2009 食品安全前提方案 食品生产 5/14 7 废弃物处理废弃物处理 7 waste disposal7 waste disposal 7.1 总要求总要求 必须建立系统以确保废弃物得到识别、收 集、 清除和处理， 并防止污染产品或生产区 域。 7.2 废弃物和不可食或有害物质的容器废弃物和不可食或有害物质的容器 废弃物和不可食或有害

43、物质的容器必须： a) 清楚识别其用途； b) 位于指定区域； c) 采用易于清洗和消毒的不渗透材料制成； d) 不使用时，密闭； e) 废弃物可对产品造成风险时，上锁。 7.3 废弃物管理和清理废弃物管理和清理 必须有废弃物的隔离、存放和清理设施。 废弃物不得在食品处理或贮存区域堆积。 清 理频率必须避免废弃物堆积，至少每日清 理。 带有标签的物料、产品或印刷包材作废时， 必须外形损毁或销毁， 以确保商标不能重复 使用。 清理和销毁必须由经批准的处理分包 方实施。组织必须保留销毁的记录。 7.4 排水排水 排水的设计、 建造和布置必须避免物料或产 品的污染风险。 排水能力必须足以清除预期 的

44、流动载物。排水不得穿过加工线上方。 排放方向不得从污染区域流向清洁区。 7.1 general requirements7.1 general requirements systems shall be in place to ensure that waste materials are identified, collected, removed and disposed of in a manner which prevents contamination of products or production areas. 7.2 containers for waste and ined

45、ible or7.2 containers for waste and inedible or hazardous substanceshazardous substances containers for waste and inedible or hazardous substances shall be: a) clearly identified for their intended purpose; b) located in a designated area; c) constructed of impervious material which can be readily c

46、leaned and sanitized; d) closed when not in immediate use; e) locked where the waste may pose a risk to the product. 7.3 waste management and removal7.3 waste management and removal provision shall be made for the segregation, storage and removal of waste. accumulation of waste shall not be allowed

47、in food handling or storage areas. removal frequencies shall be managed to avoid accumulations, with a minimum daily removal. labelled materials, products or printed packaging designated as waste shall be disfigured or destroyed to ensure that trademarks cannot be reused. removal and destruction sha

48、ll be carried out by approved disposal contractors. the organization shall retain records of destruction. 7.4 drains and drainage7.4 drains and drainage drains shall be designed, constructed and located so that the risk of contamination of materials or products is avoided. drains shall have capacity

49、 sufficient to remove expected flow loads. drains shall not pass over processing lines. drainage direction shall not flow from a contaminated area to a clean area. 8 设备适宜性、清洁和维护设备适宜性、清洁和维护 8 equipment suitability, cleaning and maintenance8 equipment suitability, cleaning and maintenance 8.1 总要求总要求 食

50、品接触设备的设计和制造必须有助于清 洁、 消毒和维护。 设备接触面不得影响或被 食品或清洗系统所影响。 食品接触设备必须采用可承受反复清洗的 耐用材料制成。 8.2 卫生设计卫生设计 设备必须满足所规定的的卫生设计原则， 包 括： a) 光滑/易接近/易清洁表面， 在湿加工区内带 有自排水； b) 使用的材质与预期产品和清洁或清洗剂相 匹配； c) 框架结构不得穿孔或用螺栓。 8.1 general requirements8.1 general requirements food contact equipment shall be designed and constructed to f

51、acilitate cleaning, disinfection and maintenance. contact surfaces shall not affect, or be affected by, the intended product or cleaning system. food contact equipment shall be constructed of durable materials able to resist repeated cleaning. 8.2 hygienic design8.2 hygienic design equipment shall b

52、e able to meet established principles of hygienic design, including: a) smooth, accessible, cleanable surfaces, self draining in wet process areas; b) use of materials compatible with intended products and cleaning or flushing agents; c) framework not penetrated by holes or nuts and bolts. 中国检验认证集团福

53、建有限公司 培训资料 iso/ts22002-1:2009 食品安全前提方案 食品生产 6/14 管线和管道必须易消洁、可排水且无盲端。 设备设计必须尽量减小操作人员的手与产 品之间的接触。 8.3 产品接触面产品接触面 产品接触表面必须由设计用于食品的材料 制成。 产品接触面必须无渗透， 无生锈或腐 蚀。 8.4 温度监控设备温度监控设备 用于热加工的设备必须能够满足相关产品 规范要求的温度梯度和维持条件。 必须配备温度监视和控制的设备。 8.5 清洗装置、器具和设备清洗装置、器具和设备 湿法和干法清洁方案必须形成文件， 以确保 所有厂房、器具和设备按规定频率清洁。 方案必须规定：清洁对象（

54、包括排水） 、职 责、清洁方法（如原位清洁 cip/cop 异位清 洁） 、专用清洁工具的用法、清理或拆卸要 求和验证清洁有效性的方法。 8.6 预防性维护和故障维修预防性维护和故障维修 必须建立预防性维护方案。 预防性维护方案必须包含用于监测和/或控 制食品安全危害的所有设备。 注 此类装置的例子有筛网和过滤器 （包括空 气过滤器） 、磁铁、金属探测器、x光探测器。 故障维修的实施必须确保邻近生产线或设 备的生产没有污染的风险。 影响食品安全的维护要求必须优先考虑。 临时性维修措施不得对产品安全带来风险。 彻底维修导致的更换要求必须包括在维护 计划中。 润滑剂和导热流体若有直接或间接与产品

55、接触的风险必须是食品级。 维护后设备投入生产的放行程序必须包括 清理、消毒（加工卫生程序规定的要求）和 使用前检查。 本区域前提方案 prp 要求必须适用于维护 区域和加工区域的维护活动。 维修人员必须 受过与其活动有关的产品危害培训。 piping and ductwork shall be cleanable, drainable, and with no dead ends. equipment shall be designed to minimize contact between the operators hands and the products. 8.3 product c

56、ontact surfaces8.3 product contact surfaces product contact surfaces shall be constructed from materials designed for food use. they shall be impermeable and rust or corrosion free. 8.4 temperature control and monitoring8.4 temperature control and monitoring equipmentequipment equipment used for the

57、rmal processes shall be able to meet the temperature gradient and holding conditions given in relevant product specifications. equipment shall provide for the monitoring and control of the temperature. 8.5 cleaning plant, utensils and8.5 cleaning plant, utensils and equipmentequipment wet and dry cl

58、eaning programmes shall be documented to ensure that all plant, utensils and equipment are cleaned at defined frequencies. the programmes shall specify what is to be cleaned (including drains), the responsibility, the method of cleaning (e.g. cip/cop), the use of dedicated cleaning tools, removal or disassem