CGM文件风险分析格式so.docVIP

生效日期： Valid from: 版本号： 00 Version code: 页码： PAGE \* MERGEFORMAT 1/9 Page No.: 文件题目 Document Title 风险分析的格式SOP SOP - Format of risk analysis 文件编号 Document Code 文件版本号 Version Code 00 文件种类 Category of Document 管理标准 Management standard 发放部门 Department of Issue QA 人员 Person 类别 Category 姓名/职位 Name /Position 签名 Signature 日期 Date 编写人 Compiled by 审核人 Checked by 批准人 Approved by 文件分发部门/编号：（ ） Department of document distributed/Code: 序号 Serial No. 部门名称 Department Name 份数 Copies 负责人 Manager 1 ” 2 ” 3 ” 4 ” 5 ” 6 ” 7 ” 8 ” 文件变更历史： History of document changing: 版本号 Version Code 变更日期 Changing Date 变更内容摘要 Abstract of Changing Contents 00 2011 建立文件 File foundation 1 目的 Aim 规范风险分析的格式, 和公司内部根据FMEA（失败模式影响分析）方法实施风险分析的方法，最终降低产品的质量风险。 To standardize the format of risk analysis and methods to carry out risk analysis according to FMEA (Failed Mode Effects Analysis) in internal enterprise, finally to reduce the quality risk of product. 2 范围 Scope 在进行工艺验证，设备确认时（包括生产工艺验证、灭菌工艺验证、水制备工艺验证等）时，应根据FMEA方法对验证的过程进行风险分析；在进行重大变更时或引入新的程序时，应根据需要进行风险分析。 During process validation and equipment qualification (including production process validation, sterilisation process validation and water preparation validation , etc.),it’s necessary to do risk analysis to validation process on the basis of FMEA；When carrying through important change or inducting new process, use risk analysis when needed. 3 职责 Responsibility 3.1 QA部负责建立和更新本SOP QA Department takes responsibility on establishing and updating this SOP. 3.2 各部门负责相应范围内的风险分析。 Every department take charge of risk analysis in corresponding areas. 3.3 确认/验证委员会负责监督验证/确认时本程序的有效实施。详细内容请见“确认/验证委员会工作描述”（编码： ）。 Qualification and validation committee sees to implement this process efficiently when supervising validation and qualification .Detailed content can be referred in “Position-related job description - Qualification / Validation committe