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1、WCC 17.6.6,过程确认,Choose Certainty, Add Value,WCC 17.6.6,引言,医疗器械的两大原则： 安全、有效国外发展水平： 管理体系：风险管理体系(RMS) 组织结构：首席风险官(Chief Risk Office, CRO)中国企业的现状；,WCC 17.6.6,5.4Risk control measures and evaluation,某公司的风险管理报告,微生物增值曲线,Bacteria can grow outside the body in moist conditions. They can divide into 2 every 2-3
2、0 minutes under the right conditions. One bacterium can give rise to diseases such as boils, septic wounds, urinary infections, pneumonia.,0d 1d 2d 3d 4d 5d 6d 7d 8d,微生物倍增,问题！,尽管执行了灭菌过程确认，但是依然存在灭菌失效的可能， 原因何在？对于计划开发高端产品（高风险）的医疗器械企业， 究竟应该如何应该如何开展风险管理？,WCC 17.6.6,Choose Certainty, Add Value,RISK MANAGE
3、MENT,Based on ISO 14971:2007,WCC 17.6.6,Content 内容,Part A introduction of ISO14971:2007 介绍新标准 Interpret the Clauses of ISO 14971:2007 解释标准的条款 Part B example of vessel stent RM 实例：血管支架的风险管理, 内容包括： 1. 风险管理计划； 2. 危害分析法 PHA； 3. 失效模式和效应分析FMEA；,WCC 17.6.6,Part A introduction of ISO14971:2007,WCC 17.6.6,th
4、e best way to minimize risk:控制风险的最好途径是 1. complying with ISO 14971:2007, the international standard in device risk management, 符合ISO 14971:2007标准的规定 2.developing a solid risk management plan and performing it. 制定详细的风险管理计划并有效执行objective of risk management:风险管理的目标 NOT to eliminate all risk, 不是消除所有的风险
5、But rather to reduce risk to an acceptable level while maintaining feasibility and functionality. 而是在保证器械功能的基础上将风险控制在合理的水平,No MD is entirely free of risk! 风险无处不在,WCC 17.6.6,ISO14971风险管理的国际标准,ISO 14971:2007Published 2007-03-012007-03-01正式推出第二版The second edition of the risk management standard for med
6、ical devicesprovide a better model for implementing a risk management systembetter aligns with the requirements of ISO 13485:2003,WCC 17.6.6,Structure of the ISO 14971标准的结构,Scope范围Terms and definitions术语和定义 General requirements一般要求Risk analysis 风险分析Risk evaluation 风险评价Risk control 风险控制Evaluation of
7、overall residual risk acceptability 剩余风险评价Risk management report 风险管理报告Production and post-production information 生产/上市后信息Annex A-J (Methods of risk management)附录A-J,WCC 17.6.6,1 Scope范围,ISO14971:2007 specifies a process / （procedure ）for a manufacturer to identify the hazards associated with medica
8、l devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.新标准为医疗器械制造商规定了风险管理的全过程。The requirements of this International Standard are applicable to all stages of the life-cycle of a medical device.本标准的要求适用于医疗器械寿命周期的所有阶段,WCC 17.6
9、.6,2 Terms and definitions术语和定义,Harm损害 physical injury or damage to the health of people, or damage to property or the environmenthazard危害 potential source of harmRisk风险 combination of the probability of occurrence of harm and the severity of that harmrisk analysis风险分析 systematic use of available in
10、formation to identify hazards and to estimate the risk,WCC 17.6.6,Terms and definitions术语和定义,risk estimation风险估计 process used to assign values to the probability of occurrence of harm and the severity of that harmrisk evaluation风险评价 process of comparing the estimated risk against given risk criteria
11、 to determine the acceptability of the riskrisk assessment风险评定 overall process comprising a risk analysis and a risk evaluationrisk management风险管理 systematic application of management policies, procedures and practices to the tasks of analysing, evaluating, controlling and monitoring risk;,WCC 17.6.
12、6,3 General requirements 一般要求,Risk management process风险管理过程Management responsibilities管理职责Qualification of personnel人员资质Risk management plan风险管理计划Risk management file( more documentation shall be maintained in the risk management file)风险管理文件,WCC 17.6.6,3.1 Risk management process风险管理过程,WCC 17.6.6,3.
13、2 Management responsibilities管理职责,3.2 the manufacturer shall:制造商应该 a) define and document the policy for determining criteria for risk acceptability, 定义风险可接受标准的方针 b) ensure the provision of adequate resources,提供足够的资源 c) ensure the assignment of qualified personnel for risk management， 确保从事风险管理人员具有相应
14、的资质 d) review the suitability of the risk management process at planned intervals to ensure continuing effectiveness of the RM process. 按策划的时间进行风险管理有效性的评审 documented and recorded in the risk management file.保留相关记录,WCC 17.6.6,3.3 Qualification of personnel人员资质,Persons performing risk management tasks
15、 shall have the knowledge and experience appropriate to the tasks assigned to them. These shall include, where appropriate, knowledge and experience of the particular medical device and its use, the technologies involved or risk management techniques. 应该确保执行风险管理的人员具有相应的知识和经验，包括特定器械本身的知识和经验，器械的使用和相应的风险管理技术； Records of the appropriate qualifications shall be maintained.保留有关的记录,
