变更控制审批表

1、精选优质文档-倾情为你奉上精选优质文档-倾情为你奉上专心-专注-专业专心-专注-专业精选优质文档-倾情为你奉上专心-专注-专业附录1变更申请表Appendix 1: Change Application Form R.QA.047-A编号(No)：变更申请Change Application变更名称Change Name变更级别Change LevelGMP微小level 1 较大 level 2 SHE微小level 1 较大 level 2 变更类别Change Type临时性temporary 永久性permanent 替代substitute 备选alternative 变更简述sho

2、rt description of change变更理由及评估reason and evaluation of change提出者proposer 部门经理depart. manager 日期date指定的变更负责人assigned change owner签字signature 日期date变更客户意见comments of change customer签字signature 日期date相关部门意见comments of relevant depart.签字signature 日期dateSHE经理批准approved by SHE manager签字signature 日期dateQA

3、经理批准approved by QA manager签字signature 日期date总经理批准（仅较大变更）approved by GM (only for level 2)签字signature 日期date在非工作日发生的紧急变更，由当班负责人批准、实施。如有疑问，应与相关部门经理联系确认。紧急变更参与讨论人员签字：persons involved for emergency change紧急变更批准approval for emergency change附录4 变更行动清单Appendix 4: Action List for Change R.QA.044-B变更名称Change

4、 Name: 变更实施前行动Actions before the Implementation序号No.行动内容Action方案Protocol负责人Responsible完成时间Deadline备注Remarks变更实施前的行动全部完成，变更可以实施。The actions before the change implementation are finished; the change can be implemented.变更客户批准Approved by change customer签字Signature 日期Date变更投入使用前行动Actions before the Start

5、 up序号No.行动内容Action方案Protocol负责人Responsible完成时间Deadline备注Remarks变更投入使用前的行动全部完成。Necessary actions before start up have been finished, the change can be used. .变更客户批准Approved by change customer签字Signature 日期Date其他行动Remaining Actions序号No.行动内容Action方案Protocol负责人Responsible完成时间Deadline备注Remarks至此，变更相关的所有行

6、动全部完成。Up to now, all actions for the change have been finished.变更客户批准Approved by change customer签字Signature 日期Date附录5变更评估表 Appendix 5: Evaluation Form of Change R.QA.045-B变更名称Change name:变更评估表Evaluation Form of Change1. 涉及该变更的所有行动已完成。All the actions relevant to the change have been finalized.2. 变更效果

7、简述：Short description of the change result:3. 变更结论：Conclusion of the change:（ ）变更失败终止，采取下列措施恢复原状。The change failed and the following actions are necessary to change back. 序号No.行动内容Action方案Protocol负责人Responsible完成时间Deadline备注Remarks（ ）变更成功，作为临时性变更终止。The change is successful and finished as temporary c

8、hange.（ ）变更成功，作为永久性变更，替换目前的方案。The change is successful and will substitute the current solution as permanent change.（ ）变更成功，作为永久性变更，可以作为备选方案。The change is successful and will be used as alternative solution as permanent change.变更客户change customer签字： 日期：Signature: Date:批准Approved byQA： SHE: GM (level

9、 2):日期Date: 日期Date: 日期Date:附录6较大变更举例 Appendix 6: Examples of Major Change现有产品引入新的生产工艺。Introduction of new process of existing product.变更影响产品的关键工艺参数或质量标准。The change affects critical process parameter or accepted criteria of end product.变更成品有效期或储存条件。The change on shelf-life or storage condition of end

10、 product.影响或潜在影响成品质量的关键设备或设施变更。The change on critical equipment or facility which (potentially) influence the quality of end product.关键物料或供应商的变更。The change on critical material or its suppliers.变更影响到SIL的状况，导致分级改变。The change affects the scenario with SIL and may change the SIL classification.消防系统、应急系

11、统、气体监测系统性的改变，疏散通道的改变。The change on fire control system, emergency response system, monitoring system on hazardous or flammable gases, or emergency exit.生产工艺中引入公司从未使用过的易燃、易爆、有毒、窒息性气体或列入国家安全生产监督管理局危险化学品名录中的物料。或实验室引入新的有毒试剂。Introduction into the process of material which is new to the company and is fla

12、mmable, explosive, toxic or suffocating gas, or included in List of Dangerous Chemicals, issued by National WSA. Or introduction of toxic agent into the lab.生产工艺改变，增加主要溶剂消耗或产生新的三废。The process change with increased consumption of VOC or with generation of new waste.防爆区域划分的改变。The change on area classification.设备或操作方式的改变，可能增加现场溶剂、粉尘暴露、噪声超标，或可能引发外部环境投诉。The change on equipment or operation, which may lead to increased exposure to solvent, dust or noise, or external compliant.现有厂房中增加反应罐、离心机等主体设备，导致整体布局的改变。Introduction to existing plant of cri