ISOTS22022-1-2022 食品安全前提方案 食品生产(中英对照)-20221027.docx

ISOTS22022-1-2022 食品安全前提方案 食品生产(中英对照)-20221027 ISO/TS22022-1:2022 食品安全前提方案食品生产（选译）ISO/TS22022-1:2022 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 4 Construction and layout of buildings 4.1 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 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 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 requirements Buildings shall be designed, constructed 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 hazard to the product. NOTE For example, roofs should be self-draining and not leak. 4.2 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 could enter theproduct. The effectiveness of measures taken to protect against potential contaminants shall be periodically reviewed. 4.3 Locations of establishments The site boundaries shall be clearly identified. Access to the site shall be controlled. The site shall 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. 5.1 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 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, shall be designed to protect against potential contamination sources. 5.2 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 加工区域的墙和地面必须可清洗或清洁，对 于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/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/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 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 minimize risk. Openings intended for transfer of materials shall be designed to minimize entry of foreign matter and pests. 5.3 Internal structures and fittings Process area walls and floors shall be washable or cleanable, as appropriate for the process or product hazard. 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 floors 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 when not in use. 5.4 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 facilities 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/mobile premises and vending machines 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 assessed and controlled. 5.7 Storage of food, packaging materials, ingredients and non food chemicals Facilities used to store ingredients, packaging and products shall provide protection from dust, condensation, drains, waste and other sources of contamination. 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 shall 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 (locked 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 公共设施空气、水和能源 6 Utilities air, water, energy 6.1 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 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 如果使用锅炉阻垢剂，必须满足：6.1 General requirements The provision and distribution routes for utilities to and around processing and storage areas shall be designed to minimize the risk of product contamination. Utilitiesquality shall be monitored to minimize product contamination risk. 6.2 Water supply The supply of potable water shall be sufficient to meet the needs of the production process(es). Facilities for storage, distribution 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 culinary 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 quality 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 labelled, 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 chemicals Boiler chemicals, if used, shall be either: 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 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、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 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(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 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 ventilation The organization 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 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 established 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 cleaning, filter changing and maintenance. Exterior air intake ports shall be examined periodically for physical integrity. 6.5 Compressed air and other gases Compressed air, carbon dioxide, nitrogen and other gas systems used in manufacturing and/or filling shall be constructed 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. Where 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 should be as close to the point ofuse as is practicable. 6.6 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 protected to ensure that materials, product or equipment are not contaminated in the case of breakages. 7 废弃物处理7 Waste disposal 7.1 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 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 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 inedible or hazardous 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 cleaned 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 removal Provision shall be made for the segregation, storage and removal of waste. Accumulation of waste shall not be allowed 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 shall be carried out by approved disposal contractors. The organization shall retain records of destruction. 7.4 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 sufficient to remove expected flow loads. Drains shall not pass over processing lines. Drainage direction s