部件关键性评估CCA-Report-PW

Component Criticality Assessment Report for Purified Water Generation System

纯化水制备系统部件关键性评估报告

Approval for Report 报告批准

Index 目录

1.Purpose 目的 (3)

2.Scope 范围 (3)

3.Responsibility 职责 (3)

4.Regulation and Guidance 法规和指南 (4)

5.Abbreviations缩略语 (5)

6.Description 系统描述 (5)

7.Reference Documents 参考文件 (6)

8.Method of Component Criticality Assessment部件关键性评估方法 (7)

8.1 Identification of Component Criticality部件关键性的确认 (7)

8.2 Critical Component Risk Assessment关键性部件风险评估 (8)

9.Performance of Component Criticality Assessment 部件关键性评估执行 (11)

9.1 Identification of Component Criticality部件关键性确认 (11)

9.2 Critical Component Risk Assessment关键性部件风险评估 (13)

10.Conclusion结论 (20)

Appendix 1 The summary of planned control actions for the medium and high risks 附录1 中、高级风险控制措施汇总表 ....................................................................................................... 错误！未定义书签。

1. Purpose 目的

An individual component criticality assessment will be performed for the Purified Water Generation System in the XXX Plant of XXX and documented on the following pages. This component criticality assessment is used to assess the criticality of each of the components of the direct impact systems.

Risk assessment will be performed for a component assessed to be critical to identify all the potential risks and their impacts on products. This activity can effectively decrease the scope of qualification activities. Critical components will be subject to commissioning and qualification and non-critical components will be subject to commissioning only. It also defines the qualification activities for the validation/qualification process and the recommended actions during the operation process.

对XXX公司XXX车间纯化水制备系统进行单独的部件关键性评估并记录在如下文件中。本部件关键性评估是评估直接影响系统中各部件的关键程度。对判定为关键性的部件进行风险评估用于确定出所有的潜在危险及其对产品的影响。本项工作能够有效的缩小确认工作的范围，从而对关键性部件进行调试和确认，对非关键性部件仅需进行调试。它还规定出了验证/确认过程中所需进行的活动、操作过程中的建议措施等。

2. Scope 范围

The scope of this component criticality assessment includes the XXX system (Equipment Location No.: XXX) in the XXX Room (Room No.: XXX) on the XXX floor for the XXX Plant of XXXX. The system No. is XXX.

本部件关键性评估的范围为XXX公司XXX车间XXX楼层XXX房间（房间编号：）XXX系统（设备位号：XXX），系统编号：XXX。

3. Responsibility 职责

✓Information collection

信息的收集

✓Supply all procedure, data, manuals, drawing and documentation necessary for the completion of final report

提供为报告编写所需要的所有的规程、数据、手册、图纸和文件

✓Components Criticality Assessment execution

进行部件关键性评估

✓CCA Report compilation

部件关键性评估报告的编写

✓Review and approve the report

报告的审核和批准