洁净厂房306-2区域部件关键性评估
Component Criticality Assessment for 306-2
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目录Content
1 背景 Background    4
2 目的 Purpose    4
3 范围 Scope    5
4 职责 Responsibility    6
5 参考文件 Reference Documents    7
5.1    法规Regulations    7
5.2    指南Guidelines    7
6 定义与缩写 Definitions and abbreviations    8
7 系统描述 System description    6
8 部件关键性评估方法 Method of Component criticality assessment    8
8.1    部件关键性的确认Component criticality qualification    8
8.2    评估成员Asessment members    10
9 部件关键性矩阵Component critical matrix    12
10 结论Conclusion    15
1
背景 Background
Construction contractor is China Electronics System Engineering No.2 Construction Co., Ltd
所有验证活动执行标准为中国GMP、欧盟EU-GM和相关ISO标准。
All the validation actives are based on Chinese GMP & EU-GMP and relevant ISO standards.
所有工程活动执行中国相关国家标准和ISO标准（包含设计、施工、验收、检测）。
All the engineering actives are based on relevance Chinese national and ISO standards (include Design\ Construction \ Acceptance\ Test).
2 目的 Purpose
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。
Component criticality assessment is to assess of the criticality of components in direct impact system. Risk assessment of identified critical components is used to identify all potential hazards and their impact on the product.
本项工作能够有效缩小工作范围，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。它还规定了验证/确认过程中所需进行的活动、操作过程中进行的建议措施等。
This work can effectively reduce the scope of work, so that the critical components need commissioning and qualification, and non-critical components only need commissioning. It also specifies the activities required during the validation / qualification process, the recommended actions taken during the operation, and so on.
3 范围 Scope
本文件规定了对确认306动物房二层306-2区域部件关键性评估的方法和程序。
This document sets out the methods and procedures for the identification of critical assessments of components in section 306-2, floor 2 of the 306 Animal room.
项目范围内：
Project scope:
●洁净室墙板、吊顶、门、窗、地面、照明灯具、紫外灯、地漏、水池、防虫鼠、开关插座、门锁、闭门器、小厨宝、烘手器的安装。
●Clean room wallboard, ceiling, door, window, floor, lighting, UV lamp, Floor drain, sink, pest control rat ,switch socket, door lock, door closers, small kitchen, hand dryer installation.
●
项目范围外：
Outside the scope of the project:
●应急逃生灯的安装；
●Installation of emergency escape lamps;
●门禁系统；position职位
●Access control system;
●洁净电话
●Clean telephone
●灭蝇灯
●Fly-killer lamps
●互锁控制
●Interlock control
4 系统描述 System description
306动物房共分2个区域，一层为CNC区域，二层为洁净区域，洁净等级为D级（7级 ISO标准），其中洁净区域设施包括：洁净室壁板、顶板、洁净门、窗、地面、水池、地漏、开关、插座、照明灯具、紫外灯具、洁净电话、电磁锁等，二层房间信息见下表：
The animal room is divided into two sections, The first floor is CNC area, and the second floor is clean area, The cleanliness level is D (ISO level 7), Clean area facilities include: clean room wall, roof, clean door, window, floor, sink, floor drain, switch, socket, lighting fixtures, UV lamps, clean telephone, electromagnetic lock, etc, Room information is shown in the following table:

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