3.
3.1
本风险分析报告包含质检、研发楼AHU4-1、AHU4-2、AHU4-3、AHU4-4空调系统所引入的各种风险，包括但不限于：空调系统的设计，安装，使用，验证等项目。
The RA report contain all kinds of risks from new buy P2020-G3 tablet press, including but not limit to: machine and process part,electrical, instrument and control part, safety and maintain part, file part, communication and so on.
Take part in RA and review RA report.
物料部
Material Department
参与风险分析，并审核风险分析报告。
Take part in RA and review RA report.
质量部
Quality Department
起草、审核和批准风险分析报告。
Draft, review and approve RA report.
The purpose to assess to accord qualityriskmanagementprocedureH7-SOP-71002 that it may produce risks from new buy P2020-G3 tablet press.Measures should be taken for hazard in order to minimize risks to an acceptable level. The scope and extent of verification should be determined based on the results of risk assessment; meanwhile, the traceability test must be established to verify the results of risk control.
2.
1、为降低和控制车间洁净区空调系统相关的风险，建立有效的洁净区空调系统质量控制体系，提高产品质量提供风险分析参考。
2、为设计单位提供风险分析参考，以便设计单位采取适当设计措施以规避或将风险控制在可以接受的范围内，更好地设计出符合GMP要求的空调系统，减少可能的设计缺陷。
3、为车间洁净区空调系统的验证确认活动提供风险分析参考。
Table of Contents /目录
1.
为满足公司发展规划，拟在质检研发楼4楼引进上海东富龙德惠净化空调工程安装有限公司的4套净化空调系统（AHU4-1、AHU4-2、AHU4-3、AHU4-4）。
We willbuy 4 HVAC systems from Shanghai Tofflon-Dehui HVAC Co., Ltdfor the AHU4-1, AHU4-1, AHU4-3, AHU4-2 HVAC system in the QC R&D Building ,for the development program of Hisun Animal Company.
3.2
部门名称Department Name
负责范围Responsible
设备部
Equipment Department
参与风险分析，并审核风险分析报告。
Take part in RA and review RA report.
生产部
Product Department
参与风险分析，并审核风险分析报告。
生产部负责人
/Product Responsible
质量部经理
/Quality Manager
批准者Approved by
姓名/职位Name/ Designation
签字Signature
日期Date
质量部总监
/Quality Director
浙江**动物保健品股份有限公司
ZHEJIANG HISUN ANIMAL HEALTHCARE PRODUCTS CO., LTD.
起草者Prepared by
姓名/职位Name/ Designation
签字Signature
日期Date
验证工程师
/Validation Engineer
复核者Checked by
姓名/职位Name/ Designation
签字Signature
日期Date
设备部负责人
/Equipment Responsible
风险评定：按事先议定的风险评定标准对风险的严重性（S）、可能性（P）、可察觉性(D)进行定性或定量/半定量的评定，评定标准如下表所示：
Risk evaluation: Qualitatively or quantificationally /semi quantificationally evaluate of risk serious/ probability/detection according to risk evaluation agreed in advance.
Risk identification: Ensure to every risk what ishazardandor system.
风险分析：对已识别出的风险的后果严重性、可能性以及可察觉性进行分析，得出风险的程度。Risk analysis:Analysis result severity,probability,detectionfor identified risk howdegreeget.
4.
5.1风险管理主要包括：风险识别、风险分析、风险评定、风险控制、风险回顾。
Risk management main include: risk identification, risk analysis, risk evaluation, risk control, risk review.
风险识别：确定出设备或者系统的每一风险点的危害是什么、危害源是什么。