设备部门审核清单 Checklist for Equipment Department

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I. 缓冲间 Buffer Room

1. 传递间的两侧门没有同时打开？Do the two doors of the transfer not open at the same time?
2. 传递间是否干净整洁？包括：地面、墙面、门窗等。Is the transfer room clean and tidy? Including: ground, walls, doors and windows.
3. 进入洁净区的原辅料是否在传递间拆除外包装？Are the raw and auxiliary materials entering the clean area removed from the outer packaging in the transfer room?
4. 在传递间拆除外包装后，原辅料是否有流转单等可识别物料信息的标识？After the outer packaging is removed in the transfer room, is there a turnover list and other identification marks for raw and auxiliary materials?
5. 拆外包装后的物料是否装在流转箱内或双层包装？Are the unpacked materials packed in turnover boxes or double layers?
6. 周转箱是否及时盖好箱盖以防污染？Are the turnover boxes covered in time to prevent contamination?
7. 压差表是否正常？记录是否满足要求？是否在有效期内？Is the differential pressure gauge normal? Do records meet requirements? Is it within the validity period?
8. 车间回风口、高效出风口是否打开？Are the workshop return air outlet and efficient air outlet open?

II. 粉碎间 Pellet Room

1. 是否有粉碎记录？Is there a record of crushing?
2. 粉碎后物料是否可识别？Is the material identifiable after crushing?
3. 粉碎间是否干净整洁？包括：地面、异物、摆放等。Is the pellet room clean and tidy? Including: ground, foreign body, put, etc.
4. 车间回风口、高效出风口是否打开？Are the workshop return air outlet and efficient air outlet open?

III. 注塑工序（正在运行的设备） Injection Process (Equipment on Working)

1. 设备是否有验收单且满足要求？Does the equipment have a receipt and meet the requirements?
2. 设备是否有说明书等工单？是否存于设备履历文件袋？Does the equipment have manual and other work orders? Is it stored in the equipment resume file?
3. 设备是否有验证方案和验证报告？且在有效期内？Does the equipment have a validation plan and validation report? And within the validity period?
4. 设备标状态识牌是否准确？Is the equipment status identification card accurate?
5. 是否有设备履历？是否存于设备履历文件袋？Do you have equipment resume? Is it stored in the equipment resume file?
6. 设备是否存在于设备台账中？Does the equipment exist in the equipment ledger?
7. 设备是否有年度维护保养计划？Is there an annual maintenance plan for the equipment?
7.1. 设备是否按照年度保养计划进行保养？查看维护保养记录。Is the equipment maintained according to the annual maintenance plan? View maintenance records.
8. 是否有设备作业指导书？Is there a SOP for equipment?
9. 作业指导书是否存于设备区域且员工熟悉指导书位置？Are the SOP stored in the equipment area and familiar by employees?
10. 设备是否有日常维护点检表？点检表悬挂于设备上？Is there a daily maintenance checklist for equipment? Check list hanging on equipment?
10.1. 点检表是否按照日期进行合理记录？Are daily maintenance checklists properly recorded by date?
10.2. 设备的周保养和月保养是否也合理记录？Are weekly and monthly maintenance of equipment properly documented?
11. 是否有《工艺清单》用来指代该设备可用于生产哪些产品？且悬挂于设备上？Is there a process list to indicate which products the equipment can be used to produce? Hanging on the device?
12. 是否使用正确的《工艺参数卡》？且悬挂于设备上？Is the correct process parameter card used? Hanging from the device?
12.1. 《过程工艺参数记录》是否正确填写？且悬挂于设备上？Is the Process Parameter Record filled correctly? And hanging on the equipment？
13. 《设备使用记录》是否合理的填写？且悬挂于设备上？Is the equipment Use Record properly filled out? Hanging on the device?
14. 设备是否有维修记录？且悬挂于设备上？Does the equipment have maintenance records? Hanging on the device?
14.1. 设备维修后是否经过判定？若判定需重新验证，是否有验证报告？Is the equipment determined after maintenance? If revalidation is determined, is there a validation report?
15. 人员着装是否满足要求？包括：洁净服、洁净鞋、口罩、帽子、头发、指甲、饰品等。 Does the dress meet the requirements? Including: clean clothes, clean shoes, masks, hats, hair, nails, accessories and so on.
16. 设备中是否干净整洁？没有有异物或维修工具等？Is the equipment clean and tidy? No foreign bodies or maintenance tools, etc.?
17. 设备维护保养用品是否存于指定位置？无随意放置现象？Are equipment maintenance supplies stored in designated locations? No random placement?

IV. 印刷硅化工序（正在运行的设备） Printing and Silicification Process (Equipment on Working)

1. 设备是否有验收单且满足要求？Does the equipment have a receipt and meet the requirements?
2. 设备是否有说明书等工单？是否存于设备履历文件袋？Does the equipment have manual and other work orders? Is it stored in the equipment resume file?
3. 设备是否有验证方案和验证报告？且在有效期内？Does the equipment have a validation plan and validation report? And within the validity period?
4. 设备标状态识牌是否准确？Is the equipment status identification card accurate?
5. 是否有设备履历？是否存于设备履历文件袋？Do you have equipment resume? Is it stored in the equipment resume file?
6. 设备是否存在于设备台账中？Does the equipment exist in the equipment ledger?
7. 设备是否有年度维护保养计划？Is there an annual maintenance plan for the equipment?
7.1. 设备是否按照年度保养计划进行保养？查看维护保养记录。Is the equipment maintained according to the annual maintenance plan? View maintenance records.
8. 是否有设备作业指导书？Is there a SOP for equipment?
9. 作业指导书是否存于设备区域且员工熟悉指导书位置？Are the SOP stored in the equipment area and familiar by employees?
10. 设备是否有日常维护点检表？点检表悬挂于设备上？Is there a daily maintenance checklist for equipment? Check list hanging on equipment?
10.1. 点检表是否按照日期进行合理记录？Are daily maintenance checklists properly recorded by date?
10.2. 设备的周保养和月保养是否也合理记录？Are weekly and monthly maintenance of equipment properly documented?
11. 是否有《工艺清单》用来指代该设备可用于生产哪些产品？且悬挂于设备上？Is there a process list to indicate which products the equipment can be used to produce? Hanging on the device?
12. 是否使用正确的《工艺参数卡》？且悬挂于设备上？Is the correct process parameter card used? Hanging from the device?
12.1. 《过程工艺参数记录》是否正确填写？且悬挂于设备上？Is the Process Parameter Record filled correctly? And hanging on the equipment？
13. 《设备使用记录》是否合理的填写？且悬挂于设备上？Is the equipment Use Record properly filled out? Hanging on the device?
14. 设备是否有维修记录？且悬挂于设备上？Does the equipment have maintenance records? Hanging on the device?
14.1. 设备维修后是否经过判定？若判定需重新验证，是否有验证报告？Is the equipment determined after maintenance? If revalidation is determined, is there a validation report?
15. 人员着装是否满足要求？包括：洁净服、洁净鞋、口罩、帽子、头发、指甲、饰品等。 Does the dress meet the requirements? Including: clean clothes, clean shoes, masks, hats, hair, nails, accessories and so on.
16. 设备中是否干净整洁？没有有异物或维修工具等？Is the equipment clean and tidy? No foreign bodies or maintenance tools, etc.?
17. 设备维护保养用品是否存于指定位置？无随意放置现象？Are equipment maintenance supplies stored in designated locations? No random placement?
18. 是否有硅油配比记录？Is there a record of silicone oil mix?
18.1. 硅油配比是否有验证报告？Is there a verification report for the ratio of silicone oil?
18.2. 配比后的硅油是否有标识？Is there a label on the silicone oil after mixing?
19. 油墨是否有标识？Is the ink marked?

V. 组装工序（正在运行的设备）Assembly Process (Equipment on Working)

1. 设备是否有验收单且满足要求？Does the equipment have a receipt and meet the requirements?
2. 设备是否有说明书等工单？是否存于设备履历文件袋？Does the equipment have manual and other work orders? Is it stored in the equipment resume file?
3. 设备是否有验证方案和验证报告？且在有效期内？Does the equipment have a validation plan and validation report? And within the validity period?
4. 设备标状态识牌是否准确？Is the equipment status identification card accurate?
5. 是否有设备履历？是否存于设备履历文件袋？Do you have equipment resume? Is it stored in the equipment resume file?
6. 设备是否存在于设备台账中？Does the equipment exist in the equipment ledger?
7. 设备是否有年度维护保养计划？Is there an annual maintenance plan for the equipment?
7.1. 设备是否按照年度保养计划进行保养？查看维护保养记录。Is the equipment maintained according to the annual maintenance plan? View maintenance records.
8. 是否有设备作业指导书？Is there a SOP for equipment?
9. 作业指导书是否存于设备区域且员工熟悉指导书位置？Are the SOP stored in the equipment area and familiar by employees?
10. 设备是否有日常维护点检表？点检表悬挂于设备上？Is there a daily maintenance checklist for equipment? Check list hanging on equipment?
10.1. 点检表是否按照日期进行合理记录？Are daily maintenance checklists properly recorded by date?
10.2. 设备的周保养和月保养是否也合理记录？Are weekly and monthly maintenance of equipment properly documented?
11. 是否有《工艺清单》用来指代该设备可用于生产哪些产品？且悬挂于设备上？Is there a process list to indicate which products the equipment can be used to produce? Hanging on the device?
12. 是否使用正确的《工艺参数卡》？且悬挂于设备上？Is the correct process parameter card used? Hanging from the device?
12.1. 《过程工艺参数记录》是否正确填写？且悬挂于设备上？Is the Process Parameter Record filled correctly? And hanging on the equipment？
13. 《设备使用记录》是否合理的填写？且悬挂于设备上？Is the equipment Use Record properly filled out? Hanging on the device?
14. 设备是否有维修记录？且悬挂于设备上？Does the equipment have maintenance records? Hanging on the device?
14.1. 设备维修后是否经过判定？若判定需重新验证，是否有验证报告？Is the equipment determined after maintenance? If revalidation is determined, is there a validation report?
15. 人员着装是否满足要求？包括：洁净服、洁净鞋、口罩、帽子、头发、指甲、饰品等。 Does the dress meet the requirements? Including: clean clothes, clean shoes, masks, hats, hair, nails, accessories and so on.
16. 设备中是否干净整洁？没有有异物或维修工具等？Is the equipment clean and tidy? No foreign bodies or maintenance tools, etc.?
17. 设备维护保养用品是否存于指定位置？无随意放置现象？Are equipment maintenance supplies stored in designated locations? No random placement?

VI. 包装工序（正在运行的设备） Packaging Process (Equipment on Working)

1. 设备是否有验收单且满足要求？Does the equipment have a receipt and meet the requirements?
2. 设备是否有说明书等工单？是否存于设备履历文件袋？Does the equipment have manual and other work orders? Is it stored in the equipment resume file?
3. 设备是否有验证方案和验证报告？且在有效期内？Does the equipment have a validation plan and validation report? And within the validity period?
4. 设备标状态识牌是否准确？Is the equipment status identification card accurate?
5. 是否有设备履历？是否存于设备履历文件袋？Do you have equipment resume? Is it stored in the equipment resume file?
6. 设备是否存在于设备台账中？Does the equipment exist in the equipment ledger?
7. 设备是否有年度维护保养计划？Is there an annual maintenance plan for the equipment?
7.1. 设备是否按照年度保养计划进行保养？查看维护保养记录。Is the equipment maintained according to the annual maintenance plan? View maintenance records.
8. 是否有设备作业指导书？Is there a SOP for equipment?
9. 作业指导书是否存于设备区域且员工熟悉指导书位置？Are the SOP stored in the equipment area and familiar by employees?
10. 设备是否有日常维护点检表？点检表悬挂于设备上？Is there a daily maintenance checklist for equipment? Check list hanging on equipment?
10.1. 点检表是否按照日期进行合理记录？Are daily maintenance checklists properly recorded by date?
10.2. 设备的周保养和月保养是否也合理记录？Are weekly and monthly maintenance of equipment properly documented?
11. 是否有《工艺清单》用来指代该设备可用于生产哪些产品？且悬挂于设备上？Is there a process list to indicate which products the equipment can be used to produce? Hanging on the device?
12. 是否使用正确的《工艺参数卡》？且悬挂于设备上？Is the correct process parameter card used? Hanging from the device?
12.1. 《过程工艺参数记录》是否正确填写？且悬挂于设备上？Is the Process Parameter Record filled correctly? And hanging on the equipment？
13. 《设备使用记录》是否合理的填写？且悬挂于设备上？Is the equipment Use Record properly filled out? Hanging on the device?
14. 设备是否有维修记录？且悬挂于设备上？Does the equipment have maintenance records? Hanging on the device?
14.1. 设备维修后是否经过判定？若判定需重新验证，是否有验证报告？Is the equipment determined after maintenance? If revalidation is determined, is there a validation report?
15. 人员着装是否满足要求？包括：洁净服、洁净鞋、口罩、帽子、头发、指甲、饰品等。 Does the dress meet the requirements? Including: clean clothes, clean shoes, masks, hats, hair, nails, accessories and so on.
16. 设备中是否干净整洁？没有有异物或维修工具等？Is the equipment clean and tidy? No foreign bodies or maintenance tools, etc.?
17. 设备维护保养用品是否存于指定位置？无随意放置现象？Are equipment maintenance supplies stored in designated locations? No random placement?

VII. 组针工序（正在运行的设备）Needle Assembly Process

1. 设备是否有验收单且满足要求？Does the equipment have a receipt and meet the requirements?
2. 设备是否有说明书等工单？是否存于设备履历文件袋？Does the equipment have manual and other work orders? Is it stored in the equipment resume file?
3. 设备是否有验证方案和验证报告？且在有效期内？Does the equipment have a validation plan and validation report? And within the validity period?
4. 设备标状态识牌是否准确？Is the equipment status identification card accurate?
5. 是否有设备履历？是否存于设备履历文件袋？Do you have equipment resume? Is it stored in the equipment resume file?
6. 设备是否存在于设备台账中？Does the equipment exist in the equipment ledger?
7. 设备是否有年度维护保养计划？Is there an annual maintenance plan for the equipment?
7.1. 设备是否按照年度保养计划进行保养？查看维护保养记录。Is the equipment maintained according to the annual maintenance plan? View maintenance records.
8. 是否有设备作业指导书？Is there a SOP for equipment?
9. 作业指导书是否存于设备区域且员工熟悉指导书位置？Are the SOP stored in the equipment area and familiar by employees?
10. 设备是否有日常维护点检表？点检表悬挂于设备上？Is there a daily maintenance checklist for equipment? Check list hanging on equipment?
10.1. 点检表是否按照日期进行合理记录？Are daily maintenance checklists properly recorded by date?
10.2. 设备的周保养和月保养是否也合理记录？Are weekly and monthly maintenance of equipment properly documented?
11. 是否有《工艺清单》用来指代该设备可用于生产哪些产品？且悬挂于设备上？Is there a process list to indicate which products the equipment can be used to produce? Hanging on the device?
12. 是否使用正确的《工艺参数卡》？且悬挂于设备上？Is the correct process parameter card used? Hanging from the device?
13. 《设备使用记录》是否合理的填写？且悬挂于设备上？Is the equipment Use Record properly filled out? Hanging on the device?
14. 设备是否有维修记录？且悬挂于设备上？Does the equipment have maintenance records? Hanging on the device?
14.1. 设备维修后是否经过判定？若判定需重新验证，是否有验证报告？Is the equipment determined after maintenance? If revalidation is determined, is there a validation report?
15. 人员着装是否满足要求？包括：洁净服、洁净鞋、口罩、帽子、头发、指甲、饰品等。 Does the dress meet the requirements? Including: clean clothes, clean shoes, masks, hats, hair, nails, accessories and so on.
16. 设备中是否干净整洁？没有有异物或维修工具等？Is the equipment clean and tidy? No foreign bodies or maintenance tools, etc.?
17. 设备维护保养用品是否存于指定位置？无随意放置现象？Are equipment maintenance supplies stored in designated locations? No random placement?
18. 是否有硅油配比记录？Is there a record of silicone oil mix?
18.1. 硅油配比是否有验证报告？Is there a verification report for the ratio of silicone oil?
18.2. 配比后的硅油是否有标识？Is there a label on the silicone oil after mixing?

VIII. 辅助设备 Auxiliary Equipment

空调 Air Conditioner

1. 是否有使用记录？Is there a record of use?
2. 是否有年度维护保养计划？Is there an annual maintenance plan?
2.1. 是否按照计划进行维护保养？查看维护保养记录。Is maintenance performed according to the plan? View maintenance records.
3. 是否有设备验收记录？Are there equipment acceptance records?
4. 是否有设备工单等文件？Is there equipment work order and other documents?

风机 Air Blower

1. 是否有使用记录？Is there a record of use?
2. 是否有年度维护保养计划？Is there an annual maintenance plan?
2.1. 是否按照计划进行维护保养？查看维护保养记录。Is maintenance performed according to the plan? View maintenance records.
3. 是否有设备验收记录？Are there equipment acceptance records?
4. 是否有设备工单等文件？Is there equipment work order and other documents?

臭氧 Ozone

1. 是否有使用记录？Is there a record of use?
2. 是否有年度维护保养计划？Is there an annual maintenance plan?
2.1. 是否按照计划进行维护保养？查看维护保养记录。Is maintenance performed according to the plan? View maintenance records.
3. 是否有设备验收记录？Are there equipment acceptance records?
4. 是否有设备工单等文件？Is there equipment work order and other documents?

纯化水设备 Purified Water Equipment

1. 是否有使用记录？Is there a record of use?
2. 是否有年度维护保养计划？Is there an annual maintenance plan?
2.1. 是否按照计划进行维护保养？查看维护保养记录。Is maintenance performed according to the plan? View maintenance records.
3. 是否有设备验收记录？Are there equipment acceptance records?
4. 是否有设备工单等文件？Is there equipment work order and other documents?
5. 是否有设备验证报告？且报告满足要求？Is there an equipment verification report? And the report meets the requirements?