AIB内容变化及评分细则.ppt

2009 Consolidated Standards for InspectionPrerequisite and Food Safety ProgramsContent Changes andRating Guidance内容变化及评分细则内容变化及评分细则How Items in a Standard are RatedCritical RequirementsMinor RequirementsBulleted Content Within a RequirementStep-by-step review of:New Technical Content in the StandardsRatings Guidance for new Technical ContentContents 内容内容评分项是如何定级的评分项是如何定级的主要要求/关键要求次要要求/小要求在要求内的粗体内容按部就班的检查按部就班的检查:标准中新的技术内容新技术内容的评分标准Requirement Changes and EnhancementsRequirement Changes and Enhancements Added new program requirementsAdded new program requirements Added new requirements to existing programsAdded new requirements to existing programs Made revisions to existing requirementsMade revisions to existing requirementsLegend 图例图例 要求的改变和强化要求的改变和强化要求的改变和强化要求的改变和强化 补充新的程序要求。

补充新的程序要求补充新的程序要求补充新的程序要求 补充对现有程序的新要求补充对现有程序的新要求补充对现有程序的新要求补充对现有程序的新要求 对现有的要求进行修改对现有的要求进行修改对现有的要求进行修改对现有的要求进行修改For a complete overview of the Standards redesign, see the “Document Design and Rating Process Redesign” presentation.Standards Redesign 标准的重新设计标准的重新设计作为一个完整的标准重新设计的总的看法，参照“文件设计和评分流程的重新设计”的呈现内容Critical Requirements Rating GuidanceCritical items will be rated as an Improvement Needed or Serious unless otherwise explained. “Otherwise explained” may be that the facility has an alternative program in place that meets the intent of the requirement.The critical requirement could also be rated as Unsatisfactory.Rating of Critical Requirements 主要要求的评分准则主要要求的评分准则主要/关键要求的评分准则主要/关键要求项将被定级为“Improvement Needed需改进项” 或者 ”Serious 严重“项，除非有另外的解释”otherwise explained”。

“另外的解释otherwise explained” 是指工厂具有另外一个程序来满足这个项目的要求主要/关键要求也可被定级为”不满意Unsatisfactory”Minor Requirements Rating GuidanceThese will be rated no more severely than a Minor Issues Noted which falls into the range of 180 to 195.Rating of Minor Requirements 小小/次要求的评分次要求的评分小/次要求的评分准则这些项目将被定级为小问题（Minor Issues noted),同时这一大项的分数将被降为180-195Rate bulleted items listed under Critical Requirements as Improvement Needed if they are applicable to the facility and are not included in the facility's Program.If a paperwork-related bulleted item is not current (i.e., a phone number is obsolete), rate as Minor Issues Noted as long as there is no impact on food safety.Review and Rating of bulleted Content Within a requirement 在要求中列出的粗体内容的评分和审查在要求中列出的粗体内容的评分和审查如果在主要/关键要求内列出的粗体内容适用于该工厂，而该工厂的程序中又没有包括这部分内容，那么该项目将被评为“需要改进项 Improvement need”。

如果与文件有关的粗体内容项不是最新的（例如：号码是旧的），只要是不会影响到食品安全的，则评为“小问题”Example:操作方法和个人规范操作方法和个人规范Operational Methods and Personnel PracticesAdded RequirementCritical Requirements▪1.2.1.1 Ingredients are stored and removed from storage in a manner that prevents contamination.▪1.2.1.6 If materials are stored outside, materials are adequately protected against deterioration and contamination.Rating Guidance: Follow the Critical Requirements guidance.1.2 Storage Practices 储存规范储存规范补充要求补充要求补充要求补充要求关键/主要要求▪1.2.1.1 原料的储存和搬运的方式不能污染原材料。

▪1.2.1.6 如果材料存放在外面的，材料要有充分的保护来防止材料的变质或被污染.评分准则：遵守关键/主要要求的准则.修改后的要求关键/主要要求▪1.4.1.1 增加先到期先使用 (FEFO)的原则来确保库存的周转.评分准则：由于这是附加的检查库存周转的方法，不需要另外的准则1.4 Raw Material Inventory 原材料库存原材料库存Revised RequirementCritical Requirements▪1.4.1.1 Added First Expired, First Out (FEFO) as another verifiable means to ensure stock rotation.Rating Guidance: No additional guidance is needed as this is an additional means of verification of stock rotation.Added RequirementMinor Requirements▪1.6.2.1 A break in the rework process is defined. Records demonstrate that the break and clean process is followed.Rating Guidance: Follow the Minor Requirements guidance.1.6 Designated Rework Areas 指定返工的范围指定返工的范围增加的要求小/次要要求▪1.6.2.1 需要定义返工产品如何断开。

需要有记录证实这个断开和随后的清洁工作评分准则：遵守小/次要要求的准则.New Program RequirementCritical Requirements:▪1.11.1.1 All food contact processing aids, such as anti-foam and release agents, are segregated from nonfood materials.▪1.11.1.2 Processing aids are labeled for their intended use.▪1.11.1.3 Food approval documentation for food contact processing aids is on file.1.11 Processing Aids 加工助剂加工助剂新程序的要求关键/主要要求:▪1.11.1.1 所有与食品接触的加工助剂，如消泡剂和脱膜剂, 需要与非食品材料进行有效隔离.▪1.11.1.2 加工助剂需要有标签标识他们的用途.▪1.11.1.3 文件中需要有食品接触加工助剂被批准用于食品的证明材料。

Rating Guidance:If processing aids are used and the requirements are not met, assign a minimum of Improvement Needed.If the facility has not addressed all program elements, assign a minimum of Improvement Needed.1.11 Processing Aids （（Cont.) 加工助剂（续）加工助剂（续）评分准则:如果工厂使用的加工助剂不能满足以上的条件，则至少给予“需要改进项 Improvement Needed”.如果工厂的程序还没有把上述的要求加入，则至少给予“需要改进项 Improvement Needed”.Added RequirementCritical Requirements▪1.13.1.9 Documentation from the supplier states that bag or box materials were sifted prior to packaging.1.13 Ingredient Sifting 原料过筛原料过筛/滤滤增加的要求关键/主要要求▪1.13.1.9 供应商提供的材料中需要声明所有的袋装或者箱装原材料在包装前已经经过过筛处理.Rating Guidance:Documentation may be in the form of a letter; a statement from the manufacturer; or a COA or letter of guarantee. Or evidence can be presented that ingredient sifting is evaluated as part of the supplier approval program.Sifters are a mandatory requirement for all bulk milled grains (Flour, graham flour, corn meal, wheat flour etc.). If there is a bulk milled grain storage system in place and no sifter is provided, a Serious is assigned.For bulk ingredients such as salt or sugar, if there is no type of foreign material control device present (i.e., magnets) assign a Serious. If there is some form of foreign material control device present, assign an Improvement Needed.1.13 Ingredient Sifting (cont.) 原料过筛原料过筛/滤滤(续）续）评分准则:证明材料可以是从供应商来的信件、申明、COA或者是保证书等.或者有证据证明原材料过筛是供应商批准程序的一部分。

对于所有碾磨过的散装谷物原材料（面粉，全麦面粉，玉米粒，小麦粉等）,使用粉筛机是强制要求如果工厂使用的散装原料的系统中没有筛子，那么评分将为“严重Serious”对于散装原料如糖或盐，如果没有控制异物的装置在现场（例如:吸铁石）则评为严重项如果现场有异物控制装置，则被评为”需要改进Improvement Need“Rating Guidance (cont.):For all other bulk materials (such as processing aids), a risk assessment must be conducted to demonstrate that this material does not present a risk of product contamination if there is no sifter present. If the risk assessment is done, assign an Improvement Needed if there are other foreign material control devices (such as magnets) present. If there is no risk assessment, and no foreign material control devices are provided, assign a Serious.1.13 Ingredient Sifting (cont.) 原料过筛原料过筛/滤滤(续）续）评分准则 (续):对于其它的散装原料（如加工助剂），如果没有使用筛子，那么必须有进行一个该原料不会污染我们产品的危险评估来证明该原料的安全。

如果有进行危险评估，且有现场有其他的异物控制装置（例如吸铁石），则评定为”需要改进Improvement Need“如果没有危险评估，且没有其他的异物控制装置，则评定为”严重Serious”Added RequirementCritical Requirements▪1.14.1.2 Strainers are cleaned and inspected for integrity after each load.▪1.14.1.4 Strainer inspections, findings, and Corrective Actions are documented and kept on file.Rating Guidance: If there is no receiving strainer provided, or if inspections are not documented, assign a Serious. If there are gaps in documentation, rate as an Improvement Needed.1.14 Bulk Liquid Ingredients 散装液体原材料散装液体原材料增加的要求关键/主要要求▪1.14.1.2 在每次进料后需对过滤器进行清洁及检查.▪1.14.1.4 对过滤器的检查，检查中发现的异物和修正行动进行记录并存档.评分准则：如果没有接受过虑器或过滤器的检查没有记录，则评为“严重”。

如果记录有缺陷，则评为”需改进项“Added RequirementCritical Requirements▪1.15.1.4 Product rejections or unusual foreign material findings are investigated and Corrective Actions are taken to identify and eliminate contamination sources.Rating Guidance: If not done, assign a minimum of Improvement Needed.1.15 Foreign Material Control Devices 异物控制装置异物控制装置补充的要求关键/主要要求▪1.15.1.4 被剔除的产品或发现有异常的异物需要进行调查分析并制定相应的纠正措施来发现并杜绝污染源.评分准则: 如果没有这么做，那么至少评为需要改进项.Added RequirementCritical Requirements▪1.15.1.5 Foreign material control devices are appropriate to the product or process, and detect metal wear or contamination from the processing equipment.Rating Guidance: If foreign material control devices are not appropriate to the product or process, assign a minimum of Improvement Needed.补充的要求关键/主要要求▪1.15.1.4 产品或加工工艺需要一些适当的异物控制装置，去检测加工设备中产生的金属碎片或污染物.评分准则: 如果产品或加工工艺中没有一些适当的异物控制装置，那么至少评为需要改进项.1.15 Foreign Material Control Devices 异物控制装置（续）异物控制装置（续）Added RequirementCritical Requirements▪1.24.1.4 Snap-off blades are not used in production, packaging, or raw material storage areas.Rating Guidance: If used in production, packaging or raw material storage areas, assign a minimum of Improvement Needed.1.24 Containers and Utensils 容器和器具容器和器具 补充要求关键/主要要求▪1.24.1.4 可以折断的刀具不可以在生产，包装或原材料储存区域使用.评分准则：如果在生产，包装或原材料储存区域使用那么至少评为需要改进项.New Program RequirementCritical Requirements▪1.25.1.1 If cans, bottles, food contact barrels, or other rigid packaging containers are used, the rigid container is inverted and cleaned with an air or water blast before filling to remove foreign material.Rating Guidance: If not done, assign a minimum of Serious. If the device is present and is not working, assign an Unsatisfactory. 1.25 Cans, Bottles, and Rigid Packaging 瓶、罐和刚性的包装瓶、罐和刚性的包装 新的程序要求关键/主要要求▪1.25.1.1 如果使用瓶，罐，食品直接解除的桶或其他刚性包装容器，在装入原料前，需要将容器倒置并用空气或水进行冲洗将异物去除。

评分准则：如果没有这么做，则至少评为严重项如果有装置而不使用，则评为“不满意” Critical Requirements (cont.)▪1.25.1.2 Filtering systems and/or air/water traps are provided for cleaning systems used with rigid packaging.▪1.25.1.3 The filtering systems or air/water traps on cleaning systems used with rigid packaging are regularly monitored and maintained as part of the Preventive Maintenance Program.1.25 Cans, Bottles, and Rigid Packaging 瓶、罐和刚性的包装瓶、罐和刚性的包装 （续）（续）关键/主要要求 (续)▪1.25.1.2 用于清洁刚性材料的水或空气需要有过虑系统.▪1.25.1.3 这些用于清洁刚性材料的水或空气需要有过虑系统需要包含在维修保养程序内进行定期的监控和维护.Critical Requirements (cont.)▪1.25.1.4 After cleaning, rigid packaging is maintained in an inverted position or covered to prevent foreign material contamination until filled and capped.▪1.25.1.5 Box and other liners used in product containers or packaging materials are suitably durable to prevent risk of product contamination.Rating Guidance: Follow the Critical Requirements guidance.1.25 Cans, Bottles, and Rigid Packaging 瓶、罐和刚性的包装瓶、罐和刚性的包装 （续）（续）关键/主要要求 (续) ▪1.25.1.4 清洁后这些刚性容器需要被倒置或者加盖直至装满原料并加盖来防止被异物污染.▪1.25.1.5 在生产线上使用的箱子或容器必须要适当的耐用来预防对产品造成污染的风险.评分准则：遵守主要要求的原则。

补充的要求小/次要要求▪1.26.2.2 需要提供对其进行上密封条或上锁，并且根据各个工厂的或顾客的要求进行记录.评分准则：遵守小/次要要求的准则1.26 Finished Product Transportation 成品的运输成品的运输Added RequirementMinor Requirements▪1.26.2.2 Security seals or padlocks are provided, and their use is documented as per facility or customer requirements.Rating Guidance: Follow the Minor Requirements guidance.Revised RequirementMinor Requirements▪1.28.2.1 Changed the wording in this item from monthly frequency to defined frequency.Rating Guidance: No additional guidance is needed as this is only a change in frequency from the previous standard.1.28 Washrooms, Showers and Locker Rooms 厕所、浴室和更衣室厕所、浴室和更衣室修改的要求小/次要要求▪1.28.2.1 将原标准中的每月一次改为明确的规定的频率.评分准则：不需要附加的准则，因为这仅仅是一个频率的改变。

Revised RequirementCritical Requirement▪1.32.1.1 Added false eyelashes to the list of prohibited items.Rating Guidance: This is an addition to the existing list of prohibited items from the previous standard. Rating of this issue would follow the Critical Requirements guidance.1.32 Personal Items and Jewelry Control 个人物品及饰品的控制个人物品及饰品的控制修改的要求关键/主要要求▪1.32.1.1 把假睫毛加入不许带入工厂的物品中.评分准则：与旧标准比，这是一个新加入原来不许带入工厂的物品清单的，对它的评估程序必须遵守关键/主要要求的准则.Revised RequirementCritical Requirements▪1.33.1.2 Eliminated the color designation for the metal detectable bandage.Rating Guidance: No additional rating guidance is needed as this is only a clarification of language.1.33 Health Conditions 健康状况健康状况修改的标准关键/主要要求▪1.33.1.2 去掉金探可探邦迪的颜色要求.评估准则：由于这个一个语言上的澄清，不需要另外的评分准则。

与食品安全有关的维修保养与食品安全有关的维修保养MAINTENANCE FOR FOOD SAFETYRevised RequirementMinor Requirements▪2.3.2.1 Added perimeter fences, surveillance cameras, locked doors, security guard stations, controlled access, and controlled bulk storage areas as suggested additions to this listing.Rating Guidance: These are only suggested additions to the program to be considered, if practical. Facilities are not required to have all of the listed elements, particularly if the food defense vulnerability assessment does not identify a need for them.2.3 Security Equipment 安全保障设备安全保障设备修改的要求小/次要要求▪2.3.2.1建议将增加外围围墙，监控摄像头，门上锁，安全警卫室，出入口控制和散装原料储存区域列入监控清单内。

评分准则：如果实际可行，这些仅为建议加入程序的部分工厂并不被要求全部拥有以上列出的全部内容，特别是在食品安全保障薄弱环节评估中没有指出有这方面需要的增加的要求关键/次要要求▪2.6.1.2 其他的物品（如松动的保温材料）不会对产品或食品接触面构成威胁.评分准则：评分将根据被发现问题对食品构成威胁的程度来定2.6 Overhead Structures 高空结构高空结构Added RequirementCritical Requirements▪2.6.1.2 Other materials (such as loose insulation) do not threaten food products or food contact surfaces.Rating Guidance: The rating for this item will be based on identified risk to product.Revised RequirementCritical Requirements▪2.10.1.1 The facility prevents, identifies and eliminates leaks and excessive lubrication.Rating Guidance: Issues such as over-lubricated bearings will be identified and rated under this item. The rating will be based on risk to product.2.10 Leaks and Lubrication 渗漏和润滑渗漏和润滑修改的要求次要/主要要求▪2.10.1.1 工厂要能预防，发现和去除渗漏和加过多的润滑油。

评分准则：例如对轴承加过多的润滑油等问题将放在此项下进行评估评分将根据被发现问题对食品构成威胁的程度来定Revised RequirementCritical Requirements▪2.12.1.4 Expanded the requirement to include raw materials storage areas.Rating Guidance: This is an expansion to the current requirements and no additional rating guidance is required.2.12 Cross Contamination Prevention 交叉污染的预防交叉污染的预防修改的要求关键/主要要求▪2.12.1.4 将要求延伸到包括原材料储存区域内的地方.评分准则：这是一个要求的延伸，没有必要增加评分准则.Added RequirementCritical Requirements▪2.15.1.2 Any temporary repairs on food contact surfaces are constructed of food-grade material.Rating Guidance: Food approval documentation will be required for any temporary repair materials used for repair of direct food contact surfaces. If no documentation can be provided, assign a minimum of Improvement Needed.2.15 Temporary Repair Materials 临时用的维修材料临时用的维修材料增加的要求关键/主要要求▪2.15.1.2 任何用于食品接触面的临时性维修用的材料必须是食品级的.评分准则：食品接触面维修用的任何材料必须有食品级的书面材料，如果无法提供，则至少评为需要改进项。

Critical Requirements (cont.)▪2.15.1.3 The facility maintains a record of work orders or repair requests.▪2.15.1.4 The facility follows temporary repair procedures.Rating Guidance: If there is no program for work orders or repair requests, or there are no temporary repair procedures, assign a minimum of Improvement Needed.2.15 Temporary Repair Materials 临时用的维修材料（续）临时用的维修材料（续）关键/主要要求（续）▪2.15.1.3 工厂需保存维修工作单或维修申请记录.▪2.15.1.4 工厂需遵守临时维修的程序.评分准则： 如果没有维修工作单或维修申请记录，或者临时维修程序，则至少评为需要改进项Revised RequirementCritical Requirements▪2.18.1.1 This item was corrected to indicate that particles the size of 5 microns or larger is removed from compressed air applied to food or food contact surfaces.Rating Guidance: Follow the Critical Requirements guidance.2.18 Compressed Air 压缩空气压缩空气修改的要求关键/主要要求▪2.18.1.1 这个条款已修改为用于食品或食品接触面的压缩空气能证明大于或等于5微米的颗粒已被过滤掉.评分准则：遵守主要要求的原则。

增加的要求关键/主要要求▪2.21.1.7 常规的检查需要确认可以预防吸虹和回流的装置工作正常结果需要记录评分准则：遵守主要要求的原则2.21 Waters Quality 水的质量水的质量Added RequirementCritical Requirements▪2.21.1.7 Routine checks verify that back siphonage and backflow prevention units are functioning properly. Results are documented.Rating Guidance: Follow the Critical Requirements guidance.Added RequirementCritical Requirement▪2.22.1.3 Hand washing facilities are labeled and separated from utensil washing facilities.Rating Guidance: Follow the Critical Requirements guidance.2.22 Hand Washing Facilities Design 洗手设施的设计洗手设施的设计增加的要求关键/主要要求▪2.22.1.3 洗手设施需要有标记，并与用于清洗器具的设备分开.评分准则：遵守主要要求的原则。

CLEANING PRACTICES清洁规范清洁规范Revised RequirementCritical Requirements▪3.2.1.5 The facility maintains verification procedures to test chemical concentrations.Rating Guidance: Chemical concentrations must be verified and tested. If there is no verification of concentration or if chemical testing is not consistent with label directions, assign a minimum of Serious. If the facility does not consistently test and verify chemical concentrations, assign a minimum of Improvement Needed.3.2 Food Contact Cleaning Compounds and Sanitizers 用于食品接触面清洁的化学品及消毒剂用于食品接触面清洁的化学品及消毒剂修改的要求关键/主要要求▪3.2.1.5 工厂需要有确认化学品浓度的测试程序。

评分准则：化学品的浓度必须进行确认和测试如果没有对化学品的浓度进行确认或者化学品浓度测试的方法与标签说明的方法不一致，至少是严重项如果没有坚持一直对化学品的浓度进行确认和测试的，则评为需要改进项Added RequirementMinor Requirements▪3.5.2.1 Air hoses with restricted head pressure are used only to clean inaccessible equipment.▪3.5.2.2 Air hoses are used for cleaning when the facility is not in operation in order to prevent potential product contamination.Rating Guidance: Follow the Minor Requirements guidance.3.5 Periodic ( Deep) Cleaning 定期深度清洁定期深度清洁增加的要求小/次要要求▪3.5.2.1 有限定压力的压缩空气枪只能用于清洁难以清洁的地方。

▪3.5.2.2 为了防止潜在的食品安全污染发生，压缩空气只能在不生产时使用评分准则：遵守小/次要要求的准则Revised RequirementCritical Requirements▪3.6.1.2 Non-sealed electrical panels and boxes located in areas that are susceptible to insect development are cleaned and inspected every four weeks.Rating Guidance: This item was clarified to indicate that electrical panels and boxes that are susceptible to insect development must meet the 4 week requirement.3.6 Maintenance Cleaning 维修清洁维修清洁修改的要求关键/主要要求▪3.6.1.2 放置在容易长虫的地方的未密封的电柜或电箱需要每四周检查并清洁一次.评分准则：这个条款阐明了放置在易于昆虫生长区域的电柜和箱子必须每四周进行检查、清洁的要求。

INTEGRATED PEST MANAGEMENT(IPM)虫害综合管理虫害综合管理新的程序要求关键/主要要求▪4.2.1.1 每年对工厂的进行虫害评估▪4.2.1.2 该评估需要包括工厂的内外部▪4.2.1.3 评估的结果和纠正行动需要记录在案，并用于制定和更新虫害综合管理程序▪4.2.1.4 评估由内部或外部受过IPM培训的人员完成4.2 Facility Assessment 工厂评估工厂评估New Program RequirementCritical Requirements▪4.2.1.1 Personnel conduct an annual assessment of the facility.▪4.2.1.2 The assessment evaluates all areas inside and outside the facility.▪4.2.1.3 Assessment results and Corrective Actions are documented and used to develop and update the IPM Program.▪4.2.1.4 Assessments are conducted by internal or external trained IPM personnel.Rating Guidance: If the facility has not completed or scheduled an assessment, assign an Improvement Needed. Rate the facility against the specific element within the Standard with which the facility does not comply. The minimum frequency for training is annually or to meet licensing requirements as defined by regulatory requirements.4.2 Facility Assessment 工厂评估（续）工厂评估（续）评分准则：如果工厂没有完成评估或没有评估计划，则评为需要改进项。

根据标准的具体细则对工厂没有做到的项目进行评分，最低的培训频率为每年或达到按政府规定要求的许可证的要求What is an assessment?On a minimum of an annual basis, those personnel with IPM training and knowledge look at the data that has been recorded over the course of a year to ensure that the program is adequately identifying, addressing, and managing issues. Elements include, but are not limited to: evaluation of pest-sighting logs, pheromone monitoring reports, pesticide application records, labels and MSDS sheets, site maps etc., to ensure that the program is functioning and accurate.4.2 Facility Assessment 工厂评估（续）工厂评估（续）什么是工厂评估?它至少需要每年做一次，经过IPM培训且有IPM知识的人员查看在这一年内的记录数据，来确保该程序能充分的发现，处理和管理这些问题。

工厂评估的内容包括（但不局限于）：评估虫害发现的记录，信息素的监控记录，杀虫剂的使用记录，标签和MSDS，虫害布局图等来确保该程序是起作用的且是正确的New Program RequirementCritical Requirements▪4.3.1.1 IPM Programs established under alternative guidelines (such as organic, green or sustainable) demonstrate effective pest management through the lack of evidence of pest management issues, and by meeting the criteria in the IPM section of this Standard. Rating Guidance: Rate the facility against the specific criteria within the standard with which the facility does not comply. If the facility is organic, for example, state this for informational purposes as part of this element.4.3 Other Guidelines 其他的指导方针其他的指导方针新程序的要求关键/主要要求▪4.3.1.1 IPM 程序确定在可选择的指导方针（如有机的、绿色的或可持续的）通过没有发现有虫害控制的管理问题来证明虫害管理的有效性，同时能达到IPM这一章节的标准。

评分准则：对照本标准中相应的特殊细则，对工厂没有做到的部分进行评估例如：如果这个工厂是生产有机食品的，在这一部分需要把这一信息进行声明Revised RequirementCritical Requirements▪4.4.1.1 Added contract requirements are:▪Facility name▪Facility contact person▪Frequency of services▪Description of contracted services and how they will be completed▪Term of the contract▪Equipment and material storage specifications, where applicable▪Scope of emergency service calls▪Service records to be maintained▪Requirement to notify facility of any changes in service or materials used4.4 Signed Contracts 合同的签署合同的签署修改的要求关键/主要要求▪4.4.1.1 增加的合同要求是:▪工厂的名称▪工厂的联系人▪服务的频率▪对于合同服务内容和如何去操作进行描述▪合同的期限▪如有必要说明设备和杀虫剂的储存要求。

▪紧急联系▪保存服务记录▪当服务方式和所使用的杀虫剂有任何改变时需要通知工厂Revised RequirementCritical Requirements▪4.5.1.2 If regulation does not require certification or registration, IPM service providers are trained in the proper and safe use of pest management materials by attending a recognized seminar or some other documented training. Evidence of training is on file or available electronically.Rating Guidance: If one of the defined elements that is applicable to the facility is missing, assign a minimum of Improvement Needed. The minimum frequency for training is annually or as defined by regulatory requirements.4.5 Credentials and Competencies 4.5 Credentials and Competencies 资格和能力资格和能力资格和能力资格和能力修改后的要求关键/主要要求▪4.5.1.2 如果法规方面没有发证和登记的要求，提供IPM服务的人员可以通过参加一些公认的组织举行的研讨会或者其他书面的培训来给其恰当的如何安全使用虫害控制的材料培训。

培训资料需要存档评分准则：如果缺少以上提到的任何一个基本条件，将至少给需要改进项，操作人员至少每年培训一次，或根据法规的要求执行Added RequirementCritical Requirements▪4.5.1.3 Applicators provide verification of GMP training.▪4.5.1.5 The facility maintains a current copy of the pest management company license issued by the appropriate government body, if required.Rating Guidance: If one of the defined elements that is applicable to the facility is missing, assign a minimum of Improvement Needed. The minimum frequency for training is annually or as defined by regulatory requirements.4.5 Credentials and Competencies 4.5 Credentials and Competencies 资格和能力资格和能力资格和能力资格和能力( (续续续续) )补充的要求关键/主要要求▪4.5.1.3 使用杀虫剂的人员需提供接受GMP培训的证明.▪4.5.1.5 工厂保存政府部分颁发的虫害控制公司的营业照.评分的准则：如果以上提到的事项内缺少任何一项的，至少评为需要改进项。

培训的频率至少每年一次，或根据相关的法规要求执行Added RequirementMinor Requirements▪4.5.2.1 IPM service providers maintain evidence of competency by exam from a recognized organization.Rating Guidance: Follow the Minor Requirements guidance.4.5 Credentials and Competencies 4.5 Credentials and Competencies 资格和能力资格和能力资格和能力资格和能力( (续续续续) )补充的要求小/次要要求▪4.5.2.1 IPM 服务提供商需要提供有公认的机构出具的资格证书.评分准则：按照次要要求执行Revised RequirementCritical Requirements▪4.6.1.1 Added Documentation is available for review on request as hard copy or electronic files.Rating Guidance: Determine if the facility is using hard copy or electronic documentation. In the case of electronic documentation, it must meet the requirements of availability as defined in the Chemical Control Program. Rate the facility on the ability to provide these records when they are requested as part of their stated program.4.6 Pesticide Documentation 4.6 Pesticide Documentation 杀虫剂的记录杀虫剂的记录杀虫剂的记录杀虫剂的记录修改过的要求关键/次要要求▪4.6.1.1 保有增加的文件所需要的资料，可以是复印件或电子文档。

评分准则：工厂需要确定使用复印件还是电子文件如果使用的是电子文件，它必须满足化学品控制程序中的实用性的要求.根据工厂程序内叙述的所需要的记录结果来进行评估Added RequirementMinor Requirements▪4.6.2.1 The language of the country is taken into consideration when providing MSDS, Chemical Safety Data Sheets and labels.Rating Guidance: Follow the Minor Requirements guidance.4.6 Pesticide Documentation 4.6 Pesticide Documentation 杀虫剂的记录杀虫剂的记录杀虫剂的记录杀虫剂的记录( (续续续续) )补充的要求次要要求▪4.6.2.1 提供给工厂的MSDS，化学品安全数据和标签需要考虑到该国的语言.评分准则：遵循次要要求的评分指导.Added RequirementMinor Requirements▪4.7.2.1 The facility keeps a record of additional information that may be required by local regulations, including lot number of product used and the applicator’s certification or registration number.Rating Guidance: Follow the Minor Requirements guidance.4.7 Pesticide Application Documentation 4.7 Pesticide Application Documentation 杀虫剂使用的记录杀虫剂使用的记录杀虫剂使用的记录杀虫剂使用的记录补充的要求次要要求▪4.7.2.1 工厂需要保存法规可能额外需要的信息，包括所使用产品的批号，使用者的证书和农药登记证.评分准则：遵循次要要求的指导原则.Added RequirementCritical Requirements▪4.8.1.5 Pesticides are approved by the designated facility representative before application, and are incorporated into the Chemical Control Program.Rating Guidance: Follow the Critical Requirements guidance.4.8 Pesticide Control 4.8 Pesticide Control 杀虫剂的控制杀虫剂的控制杀虫剂的控制杀虫剂的控制补充的要求关键要求▪4.8.1.5 所有的杀虫剂在使用前必须被工厂制定的人员批准，同时必须符合化学品控制程序.评分准则：遵循关键要求的指导原则.Added RequirementCritical Requirements▪4.9.1.2 When used, the pest-sighting log provides information about the response taken by pest management personnel.▪4.9.1.3 All records pertaining to pest management activities are available as hard copies or electronic files for review on request.Rating Guidance: Follow the Critical Requirements guidance.4.9 Trend Analysis 4.9 Trend Analysis 趋势分析趋势分析趋势分析趋势分析补充的要求关键要求▪4.9.1.2 虫害监控记录提供给虫害管理人员对其进行分析。

▪4.9.1.3 所有与虫害活动有关的记录需要保存复印件或者电子文件以备检查之需评分准则：遵循关键要求的指导原则.补充要求次要要求▪4.9.2.1 虫害监控记录有指定的位置.▪4.9.2.2 虫害监控记录包括：日期、时间、发现害虫的类型，采取的行动，报告人.▪4.9.2.3 虫害管理人员每季度回顾该记录并确定虫害活动的趋势并向工厂指定人员提交所发现的情况报告▪4.9.2.4 对发现的问题所采取的行动报告需存档评分准则：遵循次要要求的指导原则4.9 Trend Analysis 4.9 Trend Analysis 趋势分析（续）趋势分析（续）趋势分析（续）趋势分析（续）Added RequirementMinor Requirements▪4.9.2.1 The pest-sighting log has a designated location.▪4.9.2.2 The pest-sighting log includes: date, time, type of pests observed, actions taken, names of reporting personnel.▪4.9.2.3 Pest management personnel review the log each quarter to identify trends in pest activity. A report of findings is submitted to designated facility personnel.▪4.9.2.4 Corrective Actions are documented for identified issues.Rating Guidance: Follow the Minor Requirements guidance.Added RequirementCritical Requirements▪4.10.1.1 A detailed survey of the entire facility is completed, and the results are documented and used to determine placement of monitoring devices.▪4.10.1.3 Temporary placement of any pest monitoring devices for short-term monitoring is mapped separately. Findings are documented according to the frequency defined by the IPM Program.▪4.10.1.6 Service records in monitoring devices match documentation on file in the facility.Rating Guidance: Follow the Critical Requirements guidance.4.10 Monitoring Device Documentation 4.10 Monitoring Device Documentation 监控装置文件监控装置文件监控装置文件监控装置文件补充要求关键要求▪4.10.1.1 完成一份详细的工厂调查报告，保存该文件并用来决定所使用的监控设备。

▪4.10.1.3 用于短期监控的任何一种临时监控设备需要有单独的图表▪4.10.1.6 监控设备内的记录需要与工厂存档文件记录一致评分准则：遵循关键要求的指导原则.Revised RequirementCritical Requirements▪4.10.1.2 Device placement maps are needed for all insect and rodent control devices. ▪4.10.1.4 The facility records all services performed on all pest monitoring devices.▪4.10.1.5 Added electronic format as an additional means of tracking information.Rating Guidance: Follow the Critical Requirements guidance.4.10 Monitoring Device Documentation 4.10 Monitoring Device Documentation 监控装置文件监控装置文件监控装置文件监控装置文件( (续续续续) )修改后的要求关键要求▪4.10.1.2 所有的虫害和老鼠的监控装置需要在虫害布局图内标示出来。

▪4.10.1.4 工厂记录所有虫害监控装置的工作状态.▪4.10.1.5 额外的电子格式作为一个补充的跟踪信息评分准则：遵循关键要求的指导原则.Revised RequirementCritical Requirements▪4.11.1.2 All exterior monitoring devices are inspected at least monthly. These devices are checked more often when activity levels increase.Rating Guidance: If bait station use is prohibited by local or other regulations, this would be considered as not applicable. Add a comment in the report that the use of bait stations is not allowed per regulation.4.11 Exterior Rodent Monitoring Device 4.11 Exterior Rodent Monitoring Device 外围鼠笼监控装置外围鼠笼监控装置外围鼠笼监控装置外围鼠笼监控装置修改的要求关键要求▪4.11.1.2 所有的外部鼠笼监控装置至少每月检查一次。

当外围的害虫增加时，需增加这些装置的监控频率评分准则：如果当地或其他法规禁止使用诱饵站，那可以考虑不使用但需在报告中说明当地法规禁止使用诱饵站.Revised RequirementMinor Requirements▪4.11.2.1 Areas of high rodent activity may have a higher concentration of devices.Rating Guidance: Follow the Minor Requirements guidance.4.11 Exterior Rodent Monitoring Device 4.11 Exterior Rodent Monitoring Device 外围鼠笼监控装置（续）外围鼠笼监控装置（续）外围鼠笼监控装置（续）外围鼠笼监控装置（续）修改的要求次要要求▪4.11.2.1 老鼠活动密集地区需要增加放置鼠笼的密度评分准则：遵循次要要求的指导原则.Added RequirementCritical Requirements▪4.12.1.2 Based on the detailed facility survey, interior monitoring devices are placed in sensitive areas specific to the rodent species, and other areas of pest activity, including:▪Incoming materials warehouses or primary storage areas for raw materials▪Maintenance areas with exterior access▪Staging areas where materials are placed after delivery from the warehouse▪Finished product warehouse areas▪Areas with the potential for rodent access due to traffic patterns or activities that take place▪Overhead areas when roof rat activity is evident or likely▪High traffic areas▪Both sides of doors that open to the exterior of the facility4.12 Interior Rodent Monitoring Device 4.12 Interior Rodent Monitoring Device 内部鼠笼监控装置内部鼠笼监控装置内部鼠笼监控装置内部鼠笼监控装置增加的要求关键要求▪4.12.1.2 根据工厂详细的调查报告，内部监控装置放置在一些老鼠和其他害虫活动的敏感区域：▪原料收货区或者主要的原材料储存区。

▪从仓库运出后暂时存放货物的地方▪成品仓库▪一些可能成为老鼠进入口的运输线路或有老鼠活动发生的区域▪顶部架空区域（当有屋顶鼠活动迹象或可能有屋顶鼠存在时）▪车辆来往频繁区域▪工厂通向外围门的两侧Added RequirementCritical Requirements▪4.12.1.6 Facilities in countries that prohibit the use of mechanical traps may consider the use of alternative devices on a case-by-case basis. These devices may include:▪Gassing traps▪Live cage traps▪See-saw tubes▪Electrocution traps▪Extended trigger traps that send alert e-mails or text messagesRating Guidance: For any element that is applicable to the facility, assign a minimum of Improvement Needed.4.12 Interior Rodent Monitoring Device 4.12 Interior Rodent Monitoring Device 内部鼠笼监控装置（续）内部鼠笼监控装置（续）内部鼠笼监控装置（续）内部鼠笼监控装置（续）补充的要求关键要求▪4.12.1.6 建在农村的工厂禁止使用机械式捕鼠器，可考虑使用以下代替设备. 这些设备可包括:▪气体诱捕站▪活动的诱捕笼▪翘翘板式的管道▪电击式诱捕站▪扩展式触发陷阱可发送提醒电子邮件或文字讯息评分准则：有以上任何一项存在，至少评为需要改进项。

Revised RequirementMinor Requirements▪4.12.2.1 Monitoring devices are located at the interior and exterior of frequently used doors.Rating Guidance: Follow the Minor Requirements guidance.4.12 Interior Rodent Monitoring Device 4.12 Interior Rodent Monitoring Device 内部鼠笼监控装置（续）内部鼠笼监控装置（续）内部鼠笼监控装置（续）内部鼠笼监控装置（续）修改的要求次要要求▪4.12.2.1 在门两侧的内外鼠笼的监控频率要较频繁评分准则：遵循次要要求的指导原则.Revised RequirementCritical Requirements▪4.13.1.3 Added verbiage regarding inspections being based on seasons or as dictated by climate. The checks must include emptying collection devices, cleaning the units, and repairs.▪4.13.1.4 Shatter-resistant bulbs are used in all units as outlined by the facility’s Glass, Brittle Plastics, and Ceramics Program.▪4.13.1.5 All services provided to light traps are documented. Service records are kept in the device and on file with the pest management documentation. Rating Guidance: For any missing element that is applicable to the facility, assign an Improvement Needed.4.13 Insect Light Traps 4.13 Insect Light Traps 昆虫诱捕灯昆虫诱捕灯昆虫诱捕灯昆虫诱捕灯修改的要求关键要求▪4.13.1.3 基于季节或者气候的变化而改变检查的需要。

这些检查必须包括清空收集装置，清洁诱捕灯和对其进行维修▪4.13.1.4 根据工厂内的玻璃，易碎塑料和陶瓷控制程序的要求使用防爆灯管▪4.13.1.5 所有的诱捕灯的检查需做记录检查记录需要保存在诱捕灯和虫害管理文件内 评分准则：工厂缺少以上任何一项，则评为需要改进项Added RequirementMinor Requirements▪4.13.2.1 Insect light traps are used to monitor flying insect activity at locations that are likely to allow access to the facility.▪4.13.2.3 The facility documents the types and quantities of insects found in light traps, and uses the information to identify and eliminate the source of activity.Rating Guidance: Follow the Minor Requirements guidance.4.13 Insect Light Traps 4.13 Insect Light Traps 昆虫诱捕灯（续）昆虫诱捕灯（续）昆虫诱捕灯（续）昆虫诱捕灯（续）补充的要求次要要求▪4.13.2.1 昆虫诱捕灯安装在飞虫可能进入工厂的地方来监控飞虫的活动情况.▪4.13.2.3 工厂记录在昆虫诱捕灯内发现的昆虫的种类和数量，并使用该些信息来发现并消除其来源。

评分准则：遵循次要要求的指导原则.Revised RequirementMinor Requirements▪4.13.2.2 Annual insect light tube changes are conducted at the beginning of the active season.Rating Guidance: Follow the Minor Requirements guidance.4.13 Insect Light Traps 4.13 Insect Light Traps 昆虫诱捕灯（续）昆虫诱捕灯（续）昆虫诱捕灯（续）昆虫诱捕灯（续）修改的要求次要要求▪4.13.2.2 每年在飞虫高飞季节来临前更换诱捕灯的灯管.评分准则：遵循次要要求的指导原则.New Program RequirementCritical Requirements▪4.14.1.1 Pheromone monitoring devices are installed according to label requirements.▪4.14.1.2 Pheromone monitoring devices are inspected on a defined frequency.▪4.14.1.3 The facility documents the types and quantities of insects found during device inspections and uses the information to identify and eliminate the source of activity.Rating Guidance: For any missing element that is applicable to the facility, rate as an Improvement Needed.4.14 Pheromone Monitoring Devices 4.14 Pheromone Monitoring Devices 信息素监控装置信息素监控装置信息素监控装置信息素监控装置新的程序要求关键要求▪4.14.1.1 根据标签的要求来安装信息素监控装置。

▪4.14.1.2 信息素监控装置需要按固定的频率来检查▪4.14.1.3 工厂需要记录在该控制装置内发现的害虫种类和数量并运用该些信息来发现并消除其来源评分准则：工厂缺少以上任何一项，则评为需要改进项Minor Requirements▪4.14.2.1 Facilities that handle materials prone to stored product infestations (e.g., grains, cereals, spices, or herbs) implement a comprehensive pheromone monitoring program.Rating Guidance: Follow the Minor Requirements guidance.4.14 Pheromone Monitoring Devices 4.14 Pheromone Monitoring Devices 信息素监控装置信息素监控装置信息素监控装置信息素监控装置( (续续续续) )次要要求▪4.14.2.1 工厂倾向于在易受虫害侵袭的产品（例如：谷物、粮食、香料或药草）储存区域广泛运用信息素监控系统。

评分准则：遵循次要要求的指导原则.New Program RequirementCritical Requirements▪4.16.1.1 Wildlife establishing habitat on facility grounds or in the facility are removed in accordance with regulations and local ordinances. Wildlife can include dogs, cats or other domestic animals.Rating Guidance: If the facility is actively trying to eliminate any wildlife or domestic animals that are observed, add a comment in the report and do not rate as long as everything that is legally possible is being done to eliminate the problem. If no corrective actions are being taken, then assign a minimum of Improvement Needed. This may be rated more severely if risk to product is determined.Evidence of animal feces within a facility will be rated as Unsatisfactory.4.16 Wildlife Control 4.16 Wildlife Control 野生动物的控制野生动物的控制野生动物的控制野生动物的控制新的程序要求关键要求▪4.16.1.1 野生动物需要按当地的法规将野生动物建在工厂场地或工厂内的栖息地移走。

野生动物可以包括狗、猫和其他家养动物评分准则：如果有观察到工厂正在积极的消除任何的野生或家养动物，只要所有的事情均合法的来消除该些问题，就在报告中增加备注但不打分 如果没有采取纠正行动，那么则评为需要改进项如果发现有影响产品的危机，则评分将会升级如果有发现动物的粪屎则评为不满意工厂Minor Requirements▪4.16.2.1 Wildlife control measures are considered, where appropriate. Optional devices include: wire, netting, distracting devices, repellents, or materials that prevent entry.Rating Guidance: Follow the Minor Requirements guidance.4.16 Wildlife Control 4.16 Wildlife Control 野生动物的控制（续）野生动物的控制（续）野生动物的控制（续）野生动物的控制（续）次要要求▪4.16.2.1 如果需要的话，工厂应该有控制野生动物的措施，可选择的装置包括：铁丝网、编网，驱赶装置，排除或驱除装置或其他可防止其进入的材料。

评分准则：遵循次要要求的指导原则.充足的食品安全保障程序充足的食品安全保障程序ADEQUACY OF PREREQUISITE AND FOOD SAFETY PROGRAMS补充的程序 关键/主要要求 ▪5.5.1.3 培训需要包括已定义的标准和要求，提高员工的能力，加强他们对已介绍的信息的理解▪5.5.1.5 再次的培训和教育至少每年一次或按需要增加频率评分准则：如果定义标准没有把已定义的标准培训程序，则评为需要改进项5.5 Training and Education 培训和教育培训和教育 Added RequirementCritical Requirements▪5.5.1.3 The training includes exit criteria for competency requirements used to confirm comprehension of the information presented.▪5.5.1.5 Refresher training and education are done at a minimum of annually or more often as needed.Rating Guidance: If exit criteria are not addressed as an element of the training program, assign an Improvement Needed.新的程序要求关键/主要要求▪5.9.1.1 工厂有书面的化学品控制程序且包括工厂内使用的所有化学品（例如：IPM用，维修用，消毒，卫生清洁和实验室用化学品。

5.9 Chemical Control Program 化学品控制程序化学品控制程序 New Program RequirementCritical Requirements▪5.9.1.1 The facility has a written Chemical Control Program that addresses all chemicals used in the facility (i.e., chemicals for Integrated Pest Management, Maintenance, Sanitation, Hygiene, and Laboratories).Critical Requirements (cont.)▪5.9.1.2 Procedures address:▪Chemical approval▪Purchase authority▪Controlled and segregated storage▪Handling▪Labels / Labeling▪Identification of where and how the chemicals are to be used▪Concentration verification▪Training and education▪Actual usage▪Inventory control▪Chemical disposal▪Container disposal▪Spill containment and control▪Material Safety Data Sheet (MSDS) or Chemical Safety Data Sheet archiving▪Contractor chemicals5.9 Chemical Control Program 化学品控制程序化学品控制程序(续续) 关键/主要要求(续)▪5.9.1.2 程序包括:▪批准的化学品▪购买授权▪化学品的控制和分开储存▪化学品的处理▪标签/标示▪确认哪里和如何使用化学品▪浓度的确认▪培训和教育▪实际的使用量▪库存控制▪化学品的处置▪容器的处置▪化学品泄漏的控制和防泄▪MSDS或者化学品安全数据表的存档▪承包商的化学品Rating Guidance: If there is no Chemical Control Program in place, assign a Serious. If any of the listed elements is missing or if all bulleted items, as applicable to the facility, are not addressed, assign a minimum of an Improvement Needed. 5.9 Chemical Control Program 化学品控制程序化学品控制程序(续续) 评分准则：如果没有化学品控制程序，则评为严重项。

如果以上列出项有任何遗漏或有任何工厂在用的化学品没有全部列出则至少评为需要改进项Added RequirementCritical Requirements▪5.10.1.1 If needed, the facility has a written Microbial Control Program that addresses microbiological analysis in the production and packaging environment.▪5.10.1.2 The Microbial Control Program includes monitoring procedures to address: sanitation/hygiene practices, harborage site detection, and Corrective Actions.▪5.10.1.3 Records are maintained of laboratory analyses and/or environmental samples that document compliance with the Microbial Control Program. 5.10 Microbial Control Program 微生物控制程序微生物控制程序 补充的要求关键/主要要求▪5.10.1.1 如有必要，工厂需要有一个书面的微生物控制程序对生产和包装区域的环境进行微生物进行分析。

▪5.10.1.2 微生物控制程序应包括：清洁/消毒工作，发现隐蔽点并采取纠正行动▪5.10.1.3 根据程序的要求对实验室分析结果或环境检查结果存档 Rating Guidance: If a defined Microbial Control Program or any of the defined elements are missing (if a Microbial Control Program is required), assign a Serious. If issues are found with pathogen testing or results documentation, assign an Unsatisfactory. If issues are found with non-pathogen testing or results documentation, assign a Serious.5.10 Microbial Control Program 微生物控制程序微生物控制程序(续续) 评分准则：如果有建立微生物控制的需要的工厂，如果缺少对微生物控制程序的定义或缺少任何需要定义项，评为严重项。

如果有发现致病菌检测或检测结果有关的问题则评为不满意工厂如果不是致病菌检测或检测结果方面的问题，则评为严重项New Program RequirementCritical Requirements▪5.11.1.1 The facility has a written Allergen Control Program that addresses allergens specific to country regulations.▪5.11.1.2 Procedures address:▪Identification and segregation of allergen during storage and handling▪Prevention of cross contact or contamination during processing by using measures such as:Production run schedulingControl of reworkDedicated product linesComprehensive changeover proceduresEquipment and utensils management(5.11.1.2 continued on next slide)•5.11 Allergen Control Program 过敏源控制程序过敏源控制程序 新的程序要求关键/主要要求▪5.11.1.1 工厂有书面的过敏源控制程序，根据国家的法规管理过敏源。

▪5.11.1.2 程序应包括:▪对过敏源在储存和处理过程进行标示和隔离▪使用以下方法来预防交生产过程中叉污染的发生:生产计划安排回料的控制专用的生产线详细的换品种程序设备和工具的管理(5.11.1.2 下一项中继续)Critical Requirements (cont.)▪5.11.1.2 Procedures address (cont.):▪Product label reviews and control▪Personnel awareness training and education▪Verification of cleaning procedures for food contact equipment▪Approved Supplier Program for ingredients and labels▪5.11.1.3 The program is updated when there are changes in: ingredients, processing aids, ingredient suppliers, products, processes, and labeling▪5.11.1.4 Records demonstrating Program conformance and effective Corrective Actions are maintained.•5.11 Allergen Control Program 过敏源控制程序过敏源控制程序(续续) 关键/主要要求(续)▪5.11.1.2程序应包括:(续.):▪产品标签的检查和控制▪让员工的培训和教育▪食品接触面清洁的清洁步骤的检查▪原材料和标签的供应商批准程序▪5.11.1.3 当原料、加工助剂、原料供应商、产品、工序和标签发生变化时，需对程序进行更新。

▪5.11.1.4 记录与程序规定一致，且保存修正行动Rating Guidance: If an Allergen Program is applicable to the facility, assign a minimum of Serious if a Program is not in place. If any of the defined program elements are missing, or an allergen has been missed as part of the analysis, assign a minimum of Serious. If records or observations indicate that the Allergen Control Program was not followed and no Corrective Action was taken, assign an Unsatisfactory. Any evidence of allergen contamination will be considered Unsatisfactory.•5.11 Allergen Control Program 过敏源控制程序过敏源控制程序(续续) 评分准则：如果建立需要过敏源控制程序的工厂，但却没有则至少评为严重项。

任何缺少任何需要的定义项或者漏掉对一个过敏源的分析则至少评为严重项如果记录或观察发现工厂没有按照过敏源控制程序去执行或者没有采取纠正行动，则评为不满意工厂任何的过敏源交叉污染的事件存在将评为不满意工厂Revised RequirementCritical Requirements▪5.12.1.3 Added stored glass, brittle plastics, and ceramics to the criteria to be evaluated.Rating Guidance: Stored glass, brittle plastics, and ceramics include items such as glass or plastic bottles that are packaging materials that will be filled with finished product. Follow the Critical Requirements guidance.•5.12 Glass, Brittle Plastics, and Ceramics • 玻璃玻璃,易碎塑料和瓷器的控制程序易碎塑料和瓷器的控制程序 修改过的标准关键/主要要求▪5.12.1.3 增加储存的玻璃、易碎塑料和陶瓷到被评估的标准中.评分准则：玻璃、易碎塑料和陶瓷以及用于装最终产品的玻璃、易碎塑料瓶的储存。

遵循关键要求的指导准则Revised RequirementCritical Requirements▪5.13.1.3 Expanded the post cleaning evaluation techniques to include preoperative inspections, ATP testing, and equipment swabs with documentation of Corrective Actions required.Rating Guidance: Follow the Critical Requirements guidance.•5.13 Cleaning Program 清洁程序清洁程序 修改的要求关键要求▪5.13.1.3 清洁后评估延伸到包括试车检查，三磷酸腺甙（ATP）测试和设备棉试需要有纠正行动的记录评分准则：遵循关键要求的指导原则Added RequirementCritical Requirements▪5.14.1.2 Procedures address:▪Post-maintenance cleaning▪Notification to production, sanitation, hygiene and/or quality assurance personnel as appropriate▪Tools and parts reconciliation▪Records of evaluation and sign off by authorized personnel▪5.14.1.3 Records indicating compliance are maintained.Rating Guidance: If any of the listed elements are missing or not consistently documented, assign an Improvement Needed.•5.14 Preventive Maintenance Program 维修保养程序维修保养程序 补充的要求关键要求▪5.14.1.2 程序包括:▪维修后的清洁▪通知相关部门：生产、卫生、清洁和质量人员▪工具和零件的核对▪有评估和授权人员签证的记录▪5.14.1.3 记录显示按程序操作并保存记录。

评分准则：如果以上列出的事项缺少任何一项或记录不全，则评为需要改进项Added RequirementCritical Requirements▪5.15.1.5 Added collection of wash tickets or supplier load out guarantees if inspection of top hatches is not possible; and installation of receiving strainers, and inspection after each delivery.▪5.15.1.6 Incoming vehicle procedures include handling LTL (Less Than Load) vehicles.Rating Guidance: If any of the listed elements are missing or not consistently documented, assign an Improvement Needed.•5.15 Receiving Program 接收程序接收程序 补充的要求关键要求▪5.15.1.5 如果无法检查散粉车仓的顶部舱口，则需要收集车辆清洁清洗但或者供应商卸货保证书，需要安装原料接收过滤网，并在每次收货后检查该滤网。

▪5.15.1.6 收货车辆的管理程序应包括对零担车辆的管理评分准则：如果以上列出的事项缺少任何一项或没有持续记录，则评为需要改进项New Program RequirementCritical Requirements▪5.17.1.1 The facility maintains evidence of FDA registration under the Bioterrorism Act. This requirement applies only if the facility manufactures, processes, packs, holds, or exports food for human or animal consumption in the U.S.A.Rating Guidance: If the facility is not registered, assign an Unsatisfactory. If the facility registers during the inspection and proof of registration can be demonstrated, assign a Serious.•5.17 Food Defense Program 食品安全保障程序食品安全保障程序 补充的要求Critical Requirements▪5.17.1.1 工厂保存有针对“反微生物恐怖活动法案”，在FDA进行登记。

这个要求仅仅适用于出口美国的生产、加工、包装和保存食品的企业评分准则：如果工厂没有注册，则评为不满意工厂，如果工厂在接收检查时正在注册并可以提供注册的证据，则评为严重Critical Requirements (cont.)▪5.17.1.2 The facility conducts a Vulnerability Assessment ,and documents the results. Acceptable Vulnerability Assessments may include: Operational Risk Management (ORM), Threat Evaluation Assessment and Management (TEAM), CARVER + Shock, internal assessment form, or C-TPAT.Rating Guidance: All facilities must have a form of evaluation and a program to protect against intentional contamination even if they are not held accountable to the U.S. Bioterrorism regulations. If the facility has not considered food defense or does not have programs in place, assign a Serious.•5.17 Food Defense Program 食品安全保障程序食品安全保障程序(续续) 关键要求(续)▪5.17.1.2 工厂需要进行薄弱环节的评估，并记录所有的结果。

可以接收的薄弱环节评估包括：营运风险管理(ORM)，威胁评估和管理(CARVER + Shock)，内部评估表或C-TPAT.评估准则：不管这个工厂是否已在FDA注册每个工厂必须有一个评估表和一个程序去防止故意的投毒行为如果这个工厂还没有考虑到食品安全保障程序或没有该程序则评为”严重项”Minor Requirements▪5.17.2.1 The written Food Defense Program includes information related to:▪A trained Coordinator▪Food Defense Team members and contact information▪Key regulatory agency representatives and contact information▪First responders and contact information▪Annual documented Food Defense training and education▪Annual Food Defense Program reviewRating Guidance: Follow the Minor Requirements guidance.•5.17 Food Defense Program 食品安全保障程序食品安全保障程序(续续) 次要要求▪5.17.2.1 书面的食品安全保障程序需包括与以下内容有关的信息：▪一个受过培训的协调人▪食品安全保障小组成员和联系信息▪主要的政府部门联系人和联系信息▪每年一次的食品安全保障培训和教育记录。

▪每年一次的食品安全保障程序的回顾评估准则：遵循次要要求的指导原则Revised Requirement – This was previously incorporated as part of the Recall requirement in the previous Standards.Critical Requirements▪5.18.1.1 The facility has a written Traceability Program that is regularly reviewed.▪5.18.1.2 Added requirements for documentation of lot numbers for food contact packaging materials▪5.18.1.3 All finished products are coded and recordedRating Guidance: If any of the listed elements are missing, assign an Improvement Needed.•5.18 Traceability Program 追溯系统追溯系统修改的要求，这个程序是以前召回程序的一部分.关键要求▪5.18.1.1 工厂有书面的追溯程序并定期回顾▪5.18.1.2 与食品接触的保障材料需要有批号（增加的要求）▪5.18.1.3 使用成品需要有代码和记录评分准则：缺少以上任何一项，则评为需要改进项.Added RequirementMinor Requirements▪5.19.2.2 Testing supports the recall to the first level of distribution outside of the control of the facility.▪5.19.2.3 One of the recall tests includes traceability of the ingredient or food contact packaging material.▪5.19.2.4 The written Recall or Withdrawal Program includes information related to:▪Recall / Crisis Management Team contact information: corporate, emergency and after-hours▪Roles and responsibilities for team members▪Location of the Traceability Program▪Key regulatory agency representative emergency contact information▪Supplier (including food contact packaging) and customer emergency contact information▪Sample recall / withdrawal notification letters•5.19 Recall/Withdrawal Program 产品召回程序产品召回程序 补充的要求次要要求▪5.19.2.2 有不在工厂控制范围内的第一级分发中心作支持▪5.19.2.3 其中一个回收测试需要能追踪到原材料或与食品直接接触的包装材料。

▪5.19.2.4 书面的召回程序需要包括以下的信息：▪召回/危机管理组的联系信息：公司的，紧急的和下班后的联系方式▪召回小组成员的职责和角色▪召回程序的存放位置▪政府部门的首要联系人及紧急联系方式▪供应商(包括与食品直接接触的包装袋)和顾客的紧急联系信息▪发召回通知的信件模板Revised RequirementMinor Requirements▪5.19.2.1 Expanded the requirements of the recall testing protocols to include a test trace for ingredients or food contact packaging materials and success rate and test timings.Rating Guidance: Follow the Minor Requirements guidance. •5.19 Recall/Withdrawal Program 产品召回程序产品召回程序(续续) 修改的要求次要要求▪5.19.2.1 把召回测试方案扩展到包括所有原材料或与食品接触的包装材料，包括召回率及测试的实际。

评分准则：遵循次要要求的指导原则Added RequirementCritical Requirements▪5.20.1.2 Procedures address:▪Investigation of the cause of nonconformity, and whether there is a food safety risk▪Time-sensitive Corrective Actions based on the seriousness of the risk identified▪Documentation of actions taken▪Handling and disposal according to the nature of the problem and/or the specific requirements of the customer•5.20 Nonconforming Product Program • 不确定产品控制程序不确定产品控制程序 补充的要求主要要求▪5.20.1.2 程序的内容:▪不管是否是一个食品安全方面的问题，都需要对不确定产品进行调查。

▪根据发现问题的严重情况确定采取纠正行动的时间性▪记录纠正行动▪根据问题的性质或顾客的特殊要求对不确定产品进行处理Critical Requirements (cont.)▪5.20.1.3 Disposition of nonconforming material is traceable for recall or withdrawal.Rating Guidance: If any of the elements are missing or not consistently documented, or if any of the bulleted items included as part of an element are not addressed, assign an Improvement Needed.•5.20 Nonconforming Product Program • 不确定产品控制程序（续）不确定产品控制程序（续）主要要求 (续)▪5.20.1.3 对不确定产品处理需要是可追溯的（为产品召回的需要）评分准则：如果缺少以上任何以下或没有完整的记录/文件，或缺少以上列出的某一项下面小项，则评为需要改进项。

Revised RequirementCritical Requirements▪5.25.1.1 Allergen Control was added to the Prerequisite Program list.▪5.25.1.7 Added: The training targets:▪Responsibility for management▪Awareness for non-management personnel▪Job specific procedures for personnel working at a designated Critical Control Point (CCP)•5.25 HACCP Program HACCP计划计划 修改的要求关键要求▪5.25.1.1 变应源程序加入HACCP必备程序内▪5.25.1.7 增加培训目标:▪管理层的职责▪非管理人员的认知▪为工作在CCP电的人员制定特别的培训程序Added RequirementCritical Requirements▪5.25.1.9 Records are kept one year or two times the shelf life of the product, whichever is longer.Rating Guidance: If any of the listed elements are missing or any of the bulleted items included as part of the element are not addressed, assign a minimum of an Improvement Needed.•5.25 HACCP Program HACCP计划计划 （续）（续） 补充要求关键的要求▪5.25.1.9 选择记录保持较长的一个：1年或2倍于产品保质期的时间评分准则：缺少以上列出的任何一项或大项中的某一小项，则至少评为需要改进项。