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1. 背景Background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 will buy 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. 2. 目的 Purpose 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。 Thepurpose to assess to accord quality risk management procedure H7-SOP-71002 thatit may produce risks from new buy P2020-G3 tablet press. Measures shouldbe taken for hazard in order to minimize risks to an acceptable level. Thescope and extent of verification should be determined based on the results ofrisk assessment; meanwhile, the traceability test must be established to verifythe results of risk control. 3. 范围与职责 Scope and duty3.1 范围 Scope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 reportcontain all kinds of risks from new buy P2020-G3 tablet press, including butnot limit to: machine and process part, electrical, instrument and controlpart, safety and maintain part, file part, communication and so on.
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