纯化水制备验证方案.doc

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System No.系统编号： Review Approval 审批 Company/Title 公司/职务 Name 姓名 Signature 签名 Date 日期 Written by 起草人 Reviewed by 审核人 Approved by批准人 Revision History版本记载 Rev.版本 Date日期 Change Reason变更原因 00 Initial issuance新制订 Index 目录 1. Introduction介绍 3 2. Purpose目的 3 3. Scope范围 3 4. Responsibility职责 3 5. Abbreviations缩略语 6 6. Regulation and Guidance 法规和指南 7 6.1 Regulation 法规 7 6.2 Guidance 指南 7 7. References 参考文件 8 8. System/Equipment Description系统/设备描述 9 8.1 System/Equipment Use 系统/设备用途 9 8.2 Design and Operation Features 设计和运行特点 9 9. Method of Component Criticality Assessment部件关键性评估方法 9 9.1 Identification of Component Criticality部件关键性的确认 10 9.2 Critical Component Risk Assessment 关键性部件风险评估 11 10. Component Criticality Assessment部件关键性评估 14 10.1 Component Criticality Matrix 部件关键性矩阵 14 10.2 Critical Component Risk Assessment Matrix关键性部件风险评估矩阵 20 10.3 Critical Component Risk Control Matrix 关键性部件风险控制矩阵 25 11. Conclusion结论 32 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 33 Introduction介绍 Co., Ltd. (hereinafter as xxx) has multiple independent plants. This Component Criticality Assessment (CCA) is applied for XXX Plant, and this area is mainly used to manufacture XXX and XXX products.xxx公司（以下简称）拥有多个独立的生产车间，本次进行性评估()的为XXXX车间，将在此区域中主要进行XXX等产品的生产。OSMOSTAR12000C PW generator. The designed yielding capacity is 12m3/h, The quality of produced purified water should comply with the relevant regulations and requirements of current CP 2010. 该纯化水制备系统包含台OSMOSTAR1000C纯化水机，设计产量均为1m3/h，供符合中国现行药典CP 2010版相关规定和要求。Component Criticality Assessment (CCA) will be performed on system which was identified as direct impact system according to System Impact Assessment (SIA) results. This purified water generation system was identified as direct impact system according to SIA, System No.: xxx, see