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目的探讨失效模式与效应分析对降低非PVC软袋输液生产废品率的效果。方法选择159批氯化钠注射液计算生产废品率,其中流程改善前73批为改善前组,行常规生产;流程改善后86批为改善后组,采用失效模式与效应分析法对输液生产过程中可能导致废品产生的所有环节和关键工序、操作方法等因素进行评估,找出高风险项和关键点后,进行针对性整改,计算改善前后的风险优先数值,使用统计学方法比较两组的废品率。结果改善后组风险优先数值较改善前组显著降低,废品率显著下降(P<0.05)。结论失效模式与效应分析法能起到降低输液生产废品率的作用。
Objective To explore the effect of failure mode and effect analysis on reducing the rejection rate of non-PVC soft bag infusion production. Methods 159 batches of sodium chloride injection were selected to calculate the rate of production rejects, of which 73 batches before the process improvement were for improving the former group and routine production. After the process improvement, 86 batches were for the improved group. The failure mode and effect analysis Which may lead to all aspects of the waste generated and key processes, methods of operation and other factors to assess, identify high-risk items and key points, the targeted rectification, risk improvement before and after the calculation of the value of the use of statistical methods to compare the two groups Rejection rate. Results The risk priority of the improved group was significantly lower than that of the former improvement group, and the rejection rate was significantly decreased (P <0.05). Conclusion Failure mode and effect analysis can play a role in reducing the rejection rate of infusion production.