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该文建立了一种基于可靠性理论的中药注射剂质量风险分析方法。运用贝叶斯网络分析把风险事件抽象成节点,从而将失效模式与效应分析(FMEA)结果转化成风险网络;并针对系统可靠性问题进行不确定性推理和分析,建立可靠性分析平台。文章进一步阐述了如何运用网络分析工具进行风险分析,发现关键风险因素和系统可靠性的薄弱环节。通过计算某个风险事件对整个质量风险系统的影响,得出各个节点的重要程度,给出合理优化方案,降低质量风险,提高系统可靠性。该文以江苏苏中药业集团股份有限公司的生脉注射剂车间为例,实现了基于FMEA的静态风险分析和基于贝叶斯网络分析技术的动态风险分析与模拟。通过对生脉注射液车间进行相关风险评估,确认潜在风险和应采用的控制措施以最大限度降低风险,保证最终产品质量。
This paper establishes a method of quality risk analysis of traditional Chinese medicine injection based on reliability theory. By using Bayesian network analysis to abstract the risk events into nodes, the failure mode and effect analysis (FMEA) results are transformed into risk networks. And the uncertainty analysis and reasoning of system reliability problems are established to establish the reliability analysis platform. The article further elaborates how to use network analysis tools to conduct risk analysis and find the weak links between key risk factors and system reliability. By calculating the impact of a risk event on the entire quality risk system, the importance of each node is obtained, and the reasonable optimization scheme is given to reduce the quality risk and improve the system reliability. Taking Shengmai injection workshop of Jiangsu Suzhong Pharmaceutical Group Co., Ltd. as an example, this paper realizes the static risk analysis based on FMEA and the dynamic risk analysis and simulation based on Bayesian network analysis technology. Through the Shengmai injection workshop related risk assessment to identify potential risks and control measures should be used to minimize the risk and ensure the quality of the final product.