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1、文件题目Document Title风险分析的格式SOPSOP - Format of risk analysis文件编号Document Code文件版本号Version Code00 文件种类Category of Document管理标准Management standard发放部门Department of IssueQA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
2、distributed/Code:序号Serial No.部门名称Department Name份数Copies负责人Manager1”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 Contents002011建立文件 File foundation1 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
3、 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 validat
4、ion and equipment qualification (including production process validation, sterilisation process validation and water preparation validation , etc.),its necessary to do risk analysis to validation process on the basis of FMEA；When carrying through important change or inducting new process, use risk a
5、nalysis when needed.3 职责 Responsibility3.1 QA部负责建立和更新本SOPQA 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 valid
6、ation committee sees to implement this process efficiently when supervising validation and qualification .Detailed content can be referred in “Position-related job description - Qualification / Validation committee” (Code: ).4 内容 Content本SOP的内容以FMEA记录表的形式来实施。Contents of this SOP are implemented in t
7、he form of FMEA record tables.本SOP的内容需通过确认/验证委员会或变更控制委员会通过会议讨论来进行实施.在讨论会上，必须至少有一位生产技术部成员，一位质量保证部成员和一位设备部成员参加。This SOP should be implemented after the discussion in the meetings of qualification and validation committee or changing control committee, and there should be a member of production technol
8、ogy department, a member of quality assurance department and a member of equipment department present at least.4.1 错误/关键参数的收集 Collection of wrong and key parameters 需要对所有过程或系统的所有操作/功能参数进行测定，并将各操作项目/功能清楚的列在FMEA记录单中。确认/验证委员会或变更控制委员会的所有在场成员都必须参与此项工作。错误/关键参数收集的基础是：可以导致失败的关键参数或关键步骤的确认。对于每个确认的参数/过程（在FMEA记
9、录单上的参数处给出），应详细评估其可能带来的潜在的失败的影响（在FMEA记录单上的潜在风险处给出）。Its necessary to mensurate all operation and function parameters in all process or system, and list every operation item and function on FMEA record tables .All present members of qualification and validation committee or change control committee mus
10、t take part in this task. The basis of collecting wrong and key parameters is that its qualification of key parameters or key process which may lead to failure. Every confirmed parameter or process (placed at Parameter on the record tables) should be given detailed evaluation on influence brought by
11、 possible and potential failure (given at Potential Risk on FMEA record tables).4.2 潜在失败影响的确定 Confirmation of influence caused by potential failure可能通过确定合理的失败原因来改善对失败所造成的影响的描述和评估。在确定潜在失败所造成的影响和失败原因时，要特别考虑对产品质量造成的影响。It is posible to improve the describtion and evaluation to the effect caused by failu
12、re through confirming reasonable failure reason. When making sure the fluence of potential failure and failure causes, please pay particular attention to fluence on product quality.4.3 潜在失败/关键参数的评估 Evaluation on potential failure and key parameters根据FMEA方法，在风险评估过程中，要对下面三个因素进行评估：- 风险的发生频率可通过“失败的频率”要素
13、（F）来确定。-“失败的严重性”必须由确认/验证委员会或变更控制委员会来评估，它也是风险评估的一个要素。- 还要通过评估“察觉失败的可能性”这一要素对风险进行评估。According to FMEA, in the process of risk evaluation, three factors below should be evaluated:-Risk occurrence can be confirmed by failure frequency element (represented by F)-Failure graveness should be evaluated by q
14、ualification and validation committee or change control committee, and its also one element of risk evaluation. -Risk should be evaluated from the element -possibility of aware failure.以各要素的值为1-5来表示。F值为1，表示发生失败的频率最小，F值为5，表示发生失败的频率最大。同理，G=1，表示严重性最小，G=5，表示严重性最大。依此类推。在必要的情况下，委员会可对所有的风险因素分别确定其评估数值。为了避免委
15、员会成员的意见不统一，建议还是事先确定评估等级标准，以便于风险的评估。范例格式如下表所述：Value of each element is from1 to 5.If F value is 1, it means that failure occurrence is smallest;if its 5,it presents the highest possibility to fail.In the same way,G=1 says that the least graveness ,while G=5 stands for the most importance.The rest can be deduced from this.The committee may ascertain
