设备部门审核清单 Checklist for Equipment Department

• Site conducted

  Select

• Conducted on

  Date

• Prepared by

• Location
  Address

• 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?

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 1. 是否有粉碎记录？Is there a record of crushing?

  Yes

  No

  N/A

• 2. 粉碎后物料是否可识别？Is the material identifiable after crushing?

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 1. 设备是否有验收单且满足要求？Does the equipment have a receipt and meet the requirements?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 4. 设备标状态识牌是否准确？Is the equipment status identification card accurate?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 6. 设备是否存在于设备台账中？Does the equipment exist in the equipment ledger?

  Yes

  No

  N/A

• 7. 设备是否有年度维护保养计划？Is there an annual maintenance plan for the equipment?

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

• 8. 是否有设备作业指导书？Is there a SOP for equipment?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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？

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

• 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.?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 1. 设备是否有验收单且满足要求？Does the equipment have a receipt and meet the requirements?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 4. 设备标状态识牌是否准确？Is the equipment status identification card accurate?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 6. 设备是否存在于设备台账中？Does the equipment exist in the equipment ledger?

  Yes

  No

  N/A

• 7. 设备是否有年度维护保养计划？Is there an annual maintenance plan for the equipment?

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

• 8. 是否有设备作业指导书？Is there a SOP for equipment?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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？

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

• 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.?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 18. 是否有硅油配比记录？Is there a record of silicone oil mix?

  Yes

  No

  N/A

• 18.1. 硅油配比是否有验证报告？Is there a verification report for the ratio of silicone oil?

  Yes

  No

  N/A

• 18.2. 配比后的硅油是否有标识？Is there a label on the silicone oil after mixing?

  Yes

  No

  N/A

• 19. 油墨是否有标识？Is the ink marked?

  Yes

  No

  N/A

• 1. 设备是否有验收单且满足要求？Does the equipment have a receipt and meet the requirements?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 4. 设备标状态识牌是否准确？Is the equipment status identification card accurate?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 6. 设备是否存在于设备台账中？Does the equipment exist in the equipment ledger?

  Yes

  No

  N/A

• 7. 设备是否有年度维护保养计划？Is there an annual maintenance plan for the equipment?

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

• 8. 是否有设备作业指导书？Is there a SOP for equipment?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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？

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

• 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.?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 1. 设备是否有验收单且满足要求？Does the equipment have a receipt and meet the requirements?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 4. 设备标状态识牌是否准确？Is the equipment status identification card accurate?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 6. 设备是否存在于设备台账中？Does the equipment exist in the equipment ledger?

  Yes

  No

  N/A

• 7. 设备是否有年度维护保养计划？Is there an annual maintenance plan for the equipment?

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

• 8. 是否有设备作业指导书？Is there a SOP for equipment?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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？

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

• 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.?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 1. 设备是否有验收单且满足要求？Does the equipment have a receipt and meet the requirements?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 4. 设备标状态识牌是否准确？Is the equipment status identification card accurate?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 6. 设备是否存在于设备台账中？Does the equipment exist in the equipment ledger?

  Yes

  No

  N/A

• 7. 设备是否有年度维护保养计划？Is there an annual maintenance plan for the equipment?

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

• 8. 是否有设备作业指导书？Is there a SOP for equipment?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

• 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.?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 18. 是否有硅油配比记录？Is there a record of silicone oil mix?

  Yes

  No

  N/A

• 18.1. 硅油配比是否有验证报告？Is there a verification report for the ratio of silicone oil?

  Yes

  No

  N/A

• 18.2. 配比后的硅油是否有标识？Is there a label on the silicone oil after mixing?

  Yes

  No

  N/A

空调 Air Conditioner

• 1. 是否有使用记录？Is there a record of use?

  Yes

  No

  N/A

• 2. 是否有年度维护保养计划？Is there an annual maintenance plan?

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

• 3. 是否有设备验收记录？Are there equipment acceptance records?

  Yes

  No

  N/A

• 4. 是否有设备工单等文件？Is there equipment work order and other documents?

  Yes

  No

  N/A

风机 Air Blower

• 1. 是否有使用记录？Is there a record of use?

  Yes

  No

  N/A

• 2. 是否有年度维护保养计划？Is there an annual maintenance plan?

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

• 3. 是否有设备验收记录？Are there equipment acceptance records?

  Yes

  No

  N/A

• 4. 是否有设备工单等文件？Is there equipment work order and other documents?

  Yes

  No

  N/A

臭氧 Ozone

• 1. 是否有使用记录？Is there a record of use?

  Yes

  No

  N/A

• 2. 是否有年度维护保养计划？Is there an annual maintenance plan?

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

• 3. 是否有设备验收记录？Are there equipment acceptance records?

  Yes

  No

  N/A

• 4. 是否有设备工单等文件？Is there equipment work order and other documents?

  Yes

  No

  N/A

纯化水设备 Purified Water Equipment

• 1. 是否有使用记录？Is there a record of use?

  Yes

  No

  N/A

• 2. 是否有年度维护保养计划？Is there an annual maintenance plan?

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

• 3. 是否有设备验收记录？Are there equipment acceptance records?

  Yes

  No

  N/A

• 4. 是否有设备工单等文件？Is there equipment work order and other documents?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A