CCA法与FMEA法在制药纯化水分配系统风险评估中的应用

Application of CCA and FMEA in Risk Assessment of Pharmaceutical Purified Water Distribution System

目的:提高制药企业纯化水分配系统风险管理效率,节约企业资源,降低企业成本。方法:结合南京某制药有限公司纯化水分配系统实例,运用部件关键性评估(CCA)法选出直接影响系统的关键部件,然后运用质量风险管理工具失效模式与影响分析(FMEA)法对其进行风险评估并提出风险管控措施。结果与结论:通过运用CCA法判定标准,可选出直接影响纯化水分配系统的关键部件;通过建立FMEA法评分标准和风险级别判定标准,运用FMEA法风险评估表可对关键部件进行风险评估并制定相应的风险管控措施。两种方法既可提高风险管理效率,也能降低企业成本。但同时,运用FMEA法定量评估风险也存在一定的主观性;以风险优先度(RPN)值来衡量失效模式的风险顺序进而确定改善措施的优先等级,在实际工作运行时存在一定的问题。因此,需结合其他风险管理工具作进一步研究。

OBJECTIVE：To improve the efficiency of purified water distribution system＇s risk management in pharmaceutical enterprise,save resources and reduce enterprise cost. METHODS：According to the instance of purified water distribution system in a pharmaceutical Co.,Ltd. in Nanjing,components critical evaluation（CCA）method was conducted to select the critical components;and failure mode and effects analysis（FMEA）method with quality of risk management tools was conducted to evaluate the risk assessment and put out control measures. RESULTS CONCLUSIONS：The critical components with direct effects on the purified water distribution system could be selected through the CCA standards. The FMEA standards of scoring and level risk criteria and the risk assessment tables were used to evaluate the risk assessment and formulate the risk control measures. It not only enhanced risk management efficiency,but also reduced enterprise cost. However,the application of FMEA on risk quantitative evaluation has certain subjectivity;it remains certain problems in the practical work about RPN values to measure the risk orders of failure mode and to determine the priority levels of improvements. Therefore,it needs further study with the combination of other risk management tools.