食品接触包材企业审核需要的文件.doc

FOOD CONTACT PACKAGING MANUFACTURING FACILITIES INSPECTION DOCUMENT
OPERATIONAL METHODS AND PERSONNEL PRACTICES
1. 1.1 All transports/containers and ingredients inspection document during receiving stage, including rejected shipments.针对所有的运输工具/容器及来料的接收检验记录。包括拒收记录。
2. 1.3 Infrequently used raw materials, R&D materials, and packaging supplies routine inspection record, if available. 如果可能，提供不经常使用的原料，R&D用料，及包装的例行检验记录。
3. 1.4 A formal procedure to monitor insect-susceptible raw materials that were stored for more than four weeks. 用来监控储存超过4周的易被害虫污染原材料的正式程序
4. 1.6 A rework procedure.返工程序
5. 1.9 Security seal number verification record for possible bulk handling.对可能散货的封铅号码的验证记录
6. 1.11 Food approval documentation for processing aids. 加工助剂的食品级证明
7. 1.12 Written procedures for transferring and handling packaging materials.包装材料的转移和处理程序
8. 1.15 Written procedures covered operating, monitoring and testing the foreign material control devices. Document of Checks of the devices and Corrective Actions for device failures 异物控制装置的操作，监控及测试的书面程序。装置的检查记录及失效时的纠正措施记录。
9. 1.16 License for Trash disposal contractor.垃圾处理商的营业执照
10. 1.23 Procedures to identify and segregate raw materials, work-in-progress, rework, and finished products to prevent cross contamination. 有明确的程序以确认和区分原材料，在制品和成品，以预防交叉污染。
11. 1.24 Containers and utensils control procedure including constructing, handling and maintaining to prevent contamination. 容器和器具的管控程序包括构造、使用、维护以预防污染
12. 1.26 All shipping vehicles inspecting records prior to loading for cleanliness and structural defects that could jeopardize product integrity. Inspection documentation was maintained and included lot code designation, amounts, and the point of distribution to ensure traceability and recall. 发货前运输车辆洁净度和车况的检验记录， 以防危害产品。要保持检查记录，并要包括批号、数量和分销的初始点，以确保可追溯性和召回
13. 1.29 Hand washing procedure and monitoring records.洗手程序及监控记录
14. 1.30 Glove control procedure if necessary. 需要时，提供手套管控程序
15. 1.33 Effective procedures were in place to ensure that personnel with boils, sores, infected wounds, infections or other communicable diseases were not permitted to come in contact with packaging, as required by law. Metal detectable bandages test document if available. 有有效的程序确保任何有疖子、疮、伤口感染或者任何其它感染或传染性疾病的人员，不允许接触包材。可能时，提供金属可探测的创可贴的测试记录。
16. 1.34 Personnel practices requirements as well as appropriate training and/or medical screening records for all non-facility personnel, including visitors and contractors. 所有外来人员适当的培训和健康询问记录
17. 1.43 Documentation of the purging and cleaning.清洁文件（相同设备生产不同洁净度要求的产品时）
MAINTENANCE FOR PRODUCT SAFETY
18. 2.7 Checklist for all fluorescent light tubes, essential glass, brittle plastics, and ceramics in the facility. 所有荧光灯管、必要的玻璃制品、易碎塑料和陶瓷制品清单
19. 2.8 Maintenance and cleaning records for the possible air intake system, as well as the filters on ventilation system. 空气进风系统，包括通风设施的滤网的维护和清洁记录
20. 2.11 Approval document for food grade lubricants. 食品级润滑油证明
21. 2.13 Facility design standards. 工厂设施设备设计标准
22. 2.15 Written temporary repair program. 书面的临时维修程序
23. 2.18 Compressed air system maintenance records. 压缩空气系统的维修记录
24. 2.19 Transporting equipment maintenance records. 运输设备维修记录
25. 2.21 Water quality monitoring program if necessary. Documentation of water quality reports was maintained. Food approval, using and concentration testing documentation for any chemicals used to treat water, ice, or steam. Checking document for back siphonage or backflow prevention. 如有必要，水质监测计划。水质监测报告。用于处理水，冰及蒸汽的任何化学品的浓度测试记录及食品级证明。反虹吸和回流设施检查记录。
CLEANING PRACTICES
26. 3.2 Food approval documentation for cleaning chemicals and sanitizers used to clean product contact surfaces. Current records documented that cleaning chemicals and sanitizers were used in accordance with the product label. 与产品表面接触的清洁剂，消毒剂的食品级证明。化学消毒剂和清洁剂，依照标签要求使用的记录。
27. 3.5 Master Cleaning Schedule and Written procedures for periodic cleaning tasks.主清洁计划、书面的清洁程序
INTEGRATED PEST MANAGEMENT
28. 4.1 A formal Integrated Pest Management (IPM) Program with written procedures that included requirements of the facility’s Prerequisite Programs. 正式发布的综合虫害管理程序
29. 4.2 An annual facility assessment that addressed all areas inside and outside of the facility as well as the Results and Corrective Actions. 每年对工厂内外部进行的全面评估，结论及整改措施
30. 4.4 A signed contract. 书面合约
Training records for in-house IPM Service provider. 内部IPM负责员工的培训记录
31. 4.5 Current copies of certification or registration documents for all persons providing IPM services for the facility. Current copies of the company license, as well as a copy of the certificate of insurance. Verification of GMP training of the applicators who service the facility. 为工厂进行虫害控制人员的资质证书，并要在有效期内。在有效期内的虫害公司营业执照及保险。虫害控制人员接受工厂GMP要求的培训证据。
32. 4.6 Current copies of the pesticide specimen labels and Material Safety Data Sheets (MSDS) for all pesticides listed as being applied at the facility. 工厂在用的现行的杀虫剂标签和MSDS
33. 4.7 Documentation of all pesticides usage. 杀虫剂使用记录.
34. 4.9 Outside IPM service report after each visit, as well as the Quarterly reviewed reports. 虫害设施外部服务人员每次服务后的记录。季度趋势分析报告。
35. 4.10 A current site map that lists the locations of interior and exterior pest control devices. Temporary device placement was mapped separately. Weekly inspections records of internal traps. 现行的虫害设施布置图，临时监控装置要单独列出。内部防控设施的每周检查记录。
36. 4.11 The service and results of the checks on outside rodent control devices.
37. 4.12 The service and results of the checks on inside rodent control devices. 内部鼠害控制设施的检查结果记录
38. 4.13 A record of the service, cleaning and activity levels of each ILT. The light tubes routine checking records. Documentation of annually replacement of light tubes. 每台灭蝇灯的服务、清洁和虫害活动水平记录，灯管的日常检查记录和每年灯管更换记录。
39. 4.14 Pheromone monitoring devices checking records if necessary. 信息素设施检查记录
ADEQUACY OF PREREQUISITE AND PRODUCT SAFETY PROGRAMS
40. 5.1 Documented policy statement outlining its commitment to produce safe and legal products. Evidence of communication about the policy and training records for supervisory staff and key personnel. 一份承诺生产安全和合法产品的、签署过的书面政策声明。并将此政策对管理人员及关键岗位员工进行沟通及培训的记录。
41. 5.2 A current organizational chart. 现行的组织机构图
42. 5.4 Written procedures to define step-by-step processes to ensure product safety. Programs define job descriptions and alternates/deputies designated to cover in the absence of key personnel. 建立确保食品安全的每一个程序。程序内容要包括职责描述，以及关键岗位人员缺席时的后备人员或付手。
43. 5.5 Specific written procedures for providing food safety training to all personnel, including temporary employees and contractors. Records of new employee training and annual refresher. Exit criteria for competency. 针对所有人员的书面食品安全培训，包括临时工和合同工。新入职员工的培训记录和每年的全员更新/回顾性培训，培训效果验证的合格标准.
44. 5.6 A multidisciplinary Food Safety Committee, as well as the monthly inspections records of the entire facility. 由多学科/部门人员组成的食品安全小组执行对全厂的每月食品安全检查，提供每月的检查记录。
45. 5.7 A risk based audit’s annually reviewing records. 基于风险评估进行的年度审核记录
46. 5.8 A written Program for evaluating Customer, as well as the consumer complaint summary. 顾客投诉程序
47. 5.9 A written Chemical Control Program. 书面的化学品控制程序
48. 5.10 A formal Microbial Program, as well as test records if necessary. 需要时，有正式发布的微生物控制程序及记录。
49. 5.11 A documented Allergen Control Program. 过敏原控制程序
50. 5.12 A written policy stating that no glass, brittle plastics, or ceramics were to be used in the facility, except where absolutely necessary. A list of all essential glass brittle plastics and ceramics, as well as the routine checking records. 有书面政策，明确规定除非必要否则工厂内不得使用玻璃、易碎塑料或陶瓷制品。玻璃、易碎塑料或陶瓷制品清单及检查记录。
51. 5.13 A formal documented Cleaning Program that included a Master Cleaning Schedule (MCS) for periodic cleaning assignments as well as a daily housekeeping. 包括定期清洁计划和每日清洁计划的正式的书面清洁程序
52. 5.14 A formal Preventive Maintenance Program. 正式的预防性维修计划
53. 5.15 Incoming ingredients, packaging, and transports inspection procedures and records. 原料、包材和运输车辆检查程序和记录
54. 5.16 A written Regulatory Affairs and Inspections Program . 法规事务和检查程序
55. 5.17 Evidence of registration under the FDA Bioterrorism Act. Vulnerability Assessment for food defense risks. A documented Food Defense Program . 根据《生物反恐法》进行FDA注册，食品防御风险评估和食品防卫程序。
56. 5.18 A documented Traceability Program. 书面追溯程序
57. 5.19 A written Recall/Withdrawal Program and mock recall records. 书面召回和回收程序、模拟召回记录
58. 5.20 A written Nonconforming Products control program. 不合格品控制程序
59. 5.21 A written program on the evaluation, selection and maintenance of suppliers of goods and. A current and accurate list of approved suppliers. 供应商的评估、选择和维护程序，以及现行的合格供应商清单。
60. 5.22 Appropriate specifications for raw materials, food contact packaging materials, finished products, work in progress and processing aids. 原料、与食品接触的包材、成品、中间产品和加工助剂规格书
61. 5.23 Letters of Guarantee or Certifications for received materials and finished products. 接收原料和成品的保证书或证明书
62. 5.25 A Hazard Analysis Critical Control Point (HACCP) Procedures. Records of conformance, and Corrective Action. Training records. Annually reviewing records. The HACCP plan validation document. HACCP计划，监控记录、纠正措施、培训记录、年度回顾记录、HACCP计划确认文件。
63. 5.27 Where applicable, testing procedures for evaluation of transfer of chemical, odour, and taste to food products that will be packaged using these materials, as well as the Chemical testing records for the finished product indicating chemicals will not migrate into food products above the established tolerances. 包材测试报告，用以评估化学物质的转移性。