预防维修年度计划

预防性维修年度计划

Th The preventive maintenance annual plan –version 1.0

ti i t l l i 10

08-Jan-2008

及时正确的更新年度预防性维护计划

Updating Updating the PM annual plan correctly on time

the PM annual plan correctly on time

4.1新设备引进

Introduction of new equipment

4.2

预防性维修总计划PM Master plan

4.3

预防性维修实施PM Execution

4.4

定期数据回顾Periodic Data Review

预防性维修总计划概述了由维修小组实施列表中的预防性维修项目。当有需要新的预防性维修内容的新设备时，则更新该计划。为了确保该计划的如实实施，至少每半年回顾该计划次少每半年回顾该计划一次。

The PM Master plan summarises the list of Preventive Maintenance activities to be carried out by the Maintenance team. The plan is updated each time a new piece of equipment which needs PM is added. In order to ensure the plan i f i t hi h d PM i dd d I d t th l corresponds to reality, a complete review will be performed once every 6 months.

更新总计划

The plan is updated

1. 当新设备引进时

During introduction of a new piece of equipment that needs PM 2至少6个月2.

At least every 6 months

以下内容需要每6个月检查

The following checks will be performed every 6 months

1. 对比固定资产设备列表和预防性维修总计划。所有的不同处都需要标注。

Comparison between the list of CAPEX equipment and list of equipment in PM master plan. All differences should be explainable.t l All diff h ld b l i bl 2. 检查预防性维修总计划中的所有设备都有相关SOP

Check that all equipment in the PM Master plan have a PM SOP

预防性维修频率参考点

Points to consider for creating a Preventive Maintenance system

”系统水平评估”的系统分类相对应的维修频率

System classification of “SLIA” is matched with the maintenance frequency as per the following table

预防性维修频率PM frequencyq y

No.

系统分类System classification

N/A in GSKBS *无此设备N/A in GSKBS*无此设备N/A in GSKBS *无此设备

月度month

*存储设备storage system 月度度month

*检测装置check system月度month

*生产设备production machine

1

The system has direct contact with product.系统直接接触产品

The system provides an excipient or produces an ingredient or solvent. 系统为生产提供辅料，产品成分或溶剂The system is used in cleaning or sterilizing.The system is used in cleaning or sterilizing. 系统用于清洁或灭菌

The system preserves product status.系统用于保护产品状态

The system produces data which is used to accept or reject product. 系统所产生的数据用来判断产品合格与否

The system is a process control or analytical system or part of it (PLC, DCS) that may affect product quality and there is no system for independent verification of control system performance in place.

系统会影响产品质量的工艺控制系统，且没有其他系统对其进行复核The system is there for biosafety reason or avoid the risk of cross contamination.

系统用于生物研究安全性和避免交叉污染

2

3

4

5

6

7

N/A in GSKBS *无此设备

预防性维修频率参考点

Points to consider for creating a Preventive Maintenance system

工厂运行设备的预防性维修频率根据维护手册等设置维修频率

The PM frequency of the machine for factory runningmust refer to O&M manual. manual

例如：“污水处理系统”的预防性维修频率为每月，快速卷帘门的预防性维修频率为每季度

For example:The PM frequency of Sewerage system is every month., the PM frequency of fast rolling door is every year.

EHS 系统设备的预防性维修频率根据法律法规和专家的意见设置维修频率The PM frequency of EHS system must refer to Local Policy and expert’s advice