变更控制评估方案.docVIP

F9.002 (2) – 02 PAGE PAGE 3 变更控制评估方案 Change Control Committee Protocol 编号No.: GZCC-2005-0019 方案填写说明Instruction: 变更申请人需填写以下第1-8项和第19项内容. Proposer must fill in item 1-8 and 19. 对于第8项,只填写本次变更所涉及的内容,请附详细书面证据或试验报告. Regarding item 8, just fill in contents related to current Change Control. Please attach detailed evidence and validation report. 本方案经变更申请部门经理批准后交变更控制委员会协调员(QS主管).Current Change Control should be submit to Change Control Coordinator (QS Supervisor) after approved by manager of proposing department. 方案正文Protocol Details: 变更申请部门/人（签名）Prepared by: Tommy Yuan / Engineering Department 变更申请部门经理（签名）Approved by: Markus Cai / Engineering Department 变更实施日期Date project was initiated: 2005.05.05 变更内容Describe the change in detail: Replace the fan coils and dehumidifiers (refrigerated cooling mode) which are installed in can hopper room/pouch hopper room/Forberg blender room/rework room/sugar milling room/sugar dumping room by new air conditioning units with HEPA filter and rotor dehumidifiers which will be installed outside those rooms. 变更的原因What is the rationale for the change? To reduce EB risk may cause by the above fan coils and dehumidifiers which have condensate water and may leak in the rooms. (可能)受变更影响的产品List all products affected by this proposed change: All products (Enfa brand stage 1-4; Alacta brand stage 1-3 ) (可能)受变更影响的物料List the materials that are affected: NA (可能)受变更影响的供应商List the supplier sites that are affected: NA 变更被认为(应考虑) Changes to be considered: 过程和设备的变更: Process and Equipment Changes: 1. 软件Are software changes involved: NA 2.实际的工艺参数Actual process equipment changes: NA 2. 新配方的生产工艺条件Thermal process conditions programs for new formulations: NA 3. 设备 (新设备，设备改造，安全防护设施) Misc. equipment changes (new, modifications, maintenance): Air conditioning units 3 Sets, dehumidifiers 3 Sets 配方变更: Formulation Changes: NA 新配方: New formulations: 改良配方: Reformulations: 包装材料结构/组成变更 Packaging Component Changes: NA 原材料变更Raw Material Changes: NA 有过敏原问题吗 Ar