CGMP文件风险分析格式SOP

1、更多企业学院： 中小企业管理全能版183套讲座+89700份资料总经理、高层管理49套讲座+16388份资料中层管理学院46套讲座+6020份资料 国学智慧、易经46套讲座人力资源学院56套讲座+27123份资料各阶段员工培训学院77套讲座+ 324份资料员工管理企业学院67套讲座+ 8720份资料工厂生产管理学院52套讲座+ 13920份资料财务管理学院53套讲座+ 17945份资料 销售经理学院56套讲座+ 14350份资料销售人员培训学院72套讲座+ 4879份资料文件题目Document Title风险分析的格式SOPSOP - Format of risk ana

2、lysis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 distributed/Code:序号Serial No.部门名称Department Name份数Co

3、pies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 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

4、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 valid

5、ation, 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 analysis when needed.3 职责 Responsibility3.1 QA部负责建立和更新本SOPQA Departm

6、ent 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 sup

7、ervising 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 the 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

8、.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 technology department, a member of quality assurance department and a memb

9、er 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

10、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 must take part in this task. The basis of collecting wrong and key par

11、ameters 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 possible and potential failure (given at Potential Risk on FMEA re

12、cord 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 failure through confirming reasonable failure reason. When making sure t

13、he 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（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

14、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 qualification and validation committee or change control committee,

15、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

16、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 all risk elements

17、 value separately.With the purpose of avoiding disunit ideas,its suggested that to fix evaluating grade standards to facilitate risk evaluation.Format example shows as the table below:风险分析参数：失败的频率 （F）Risk analysis parameter: failure frequency (F)评估 evaluation标准standard1非常低Extremely low2低Low3中等Medium

18、4高High5非常高Extremely high风险分析参数：失败的严重性 （G）Risk analysis parameter: failure graveness (G)评估evaluation标准standard1非常低：失败不影响产品的质量Extremely low: Failure has no influence to product quality.2低：失败不影响产品的质量或以间接的方式对产品质量有非常小的影响Low: Failure has no influence or influent indirectly to product quality 3中等：失败对产品质量有非

19、常小的影响或只是间接影响。产品质量的下降在某种程度上不影响产品放行。Medium: Failure has a fraction of influences or just indirect ones. Quality decline doesnt affect releasing products.4高：失败直接影响产品质量。产品的质量下降会影响产品放行。High:Failure affects product quality directly. Quality decline has impact on product release.5非常高：对法规或指导中涉及的方面应进行评估，以达到所

20、要求的标准。Extremely high: Its needed to evaluate the aspects involved in regulations or guidance to expected standard.风险因数： 察觉失败的可能性 （P）Risk factor: possibility of aware failure (P)评估evaluation标准standard5非常低：失败不可能被察觉，没有定期的检查，没有文件规定要进行符合性研究。Extremely low: Failure cant be perceived, without regular check

21、and documentation to do compliance research. 4低：基本的过程控制检查，失败不易于察觉。设备和仪器的技术性检查仅仅是偶尔进行。Low: It needs basic process control check and its not prone to failure. Just occasionally technical check on equipment and instruments.3中等：定期进行过程控制检查或不连续的监测，失败易于察觉。Medium: It needs regular process control check or i

22、ncontinuous monitoring and failure can be perceived.2高：采取不同的方法进行监测，如工艺参数的监测，有很大可能确定在后续的生产过程中发生的失败。High: It takes various monitoring methods, such as: monitoring on process parameters; it is more likely to confirm failure in the following product process.1非常高：100% 的监测，并可确定在后续的生产过程中发生的明显失败。Extremely h

23、igh: It needs fully monitoring and can confirm obvious failure in the following product process.重要说明：请注意，在此表格中，评估等级是从“5”到“1”。Important note: please notice that evaluating grade is from 5 to 1.4.4 风险追踪 Risk Pursue通过因素的等级评估和三个要素的乘积数，可以确定某一个影响因素的风险评估值。因此，如果出现下列情况，就必须进行风险追踪：- 三个要素的乘积数大于“24”- 三个被评估的要素中，有

24、一项大于或等于“4”。关于风险追踪，至少应考虑该项风险参数是否是与质量相关的。如果有必要进行风险追踪，应提出解决的措施或更进一步的调查研究的内容，以消除可能发生的失败并实施下一步的研究。A risk evaluating value can be obtained from factor grade evaluation and products of three elements.Therefore, risk pursue must be carried through if the following cases happen:-The product of three elements

25、 is greater than 24;-One of the three evaluated elements is greater than or equal to 4.Concerning on risk pursue, it should be taken into consideration that whether the risk parameter is related to quality or not. If risk Pursue is necessary, advance solving measures or make further to survey resear

26、ching contents to get rid of contingent failure and go on next research.4.5 总结 conclusion风险分析以表格的形式加入在各相应的验证文件中，作为文件内容的一部分。范例格式如下所示，Risk analysis is added to corresponding validation document in the form of tables as a part of the document. Format example shows below: 项目Item潜在的风险 / 错误Potential Risk/

27、 Errors失败的频率Frequency of Failure (F)失败的严重性Gravity of Failure (G)察觉失败的可能性Probability to detect Failure (P)风险评估Evaluation of Risk(F×G×P)风险的追踪*Pursue of Risk*项目1Item 1项目2Item 2项目3Item 34.6 风险接受评价 Risk accept evaluation应在采取措施后再进行风险分析，以确定风险已降低至可接受水平内(即三个要素的乘积数小于或等于“24”).同时应对相关的本来在可接受水平内的风险再进行一次

28、风险分析,以确定风险未有增加，仍然在可接受水平内.若依然有风险项目超出控制范围,则应重点对该风险进行分析,提出新的改进控制措施.直至该风险降低到可接受水平. 风险评估的格式如下所示:Conduct risk analysis after pursue measures to ensure risk has been declined to an acceptable level (that product of the three element is less than or equal to 24). At the same time, conduct one more risk anal

29、ysis on related and essentially acceptable risk to make sure that risk doesnt increase and stay acceptable. If there still are risk items out of controllable range, focus on analysis on this risk and put forward new improving control measure until it falls to an acceptable level. The format of risk

30、evaluation is as following: 项目Item潜在的风险 / 错误Potential Risk/ Errors风险的追踪Pursue of Risk失败的频率Frequency of Failure (F)失败的严重性Gravity of Failure (G)察觉失败的可能性Probability to detect Failure (P)风险评估Evaluation of Risk(F×G×P)风险接受评价Risk accept evaluation项目1Item 1项目2Item 2项目3Item 35 风险分析的记录 Risk analysis

31、 record一般来说，风险分析的进行通常和计划的改进措施合并在一起，因此不必要另外编写一份风险分析文件，只需要在相关文件中附加风险分析的记录。如在工艺验证主方案中，风险分析记录需要按照附录1 中“FEMA 记录表”来设计。Generally speaking, risk analysis usually combines with arranged improving measures. So theres no need to compile another risk analysis document but additional risk analysis records in rel

32、ated documents. For example, risk analysis record should be designed according to FEMA record table in appendix 1 in process validation main protocol.6 变更控制程序 Change control process如果本程序需要变更或进行特别的修改，必须按变更控制程序来实行并进行记录。具体操作，请参考变更控制SOP（编码： 7）。If this process needs change or special modification, follow

33、 change control process and make records. Specific operation see “SOP - Change control procedure (code: ).7 风险分析流程图 Flow-chart of risk analysis确认/验证委员会或变更控制委员会会议Qualification/validation committee or change control Meetings 公司FMEA方法的应用Application of corporation FMEA method 错误/关键参数来源的收集Collection of w

34、rong/key parameter sources潜在失败效果的鉴定Identification of potential failure effect根据FMEA方法评估潜在失败的影响Evaluate potential failure influence basing on FMEA method失败的频率 （F）failure frequency (F)失败的严重性（G）failure graveness (G)察觉失败的可能（P）possibility of aware failure (P)对于每一个参数，根据其影响选择从“1”到“5”的评估等级In line with every parameters influ