QCC在中药制剂新质量标准不达标分析中的应用研究

目的:将品管圈(QCC)引入中药制剂质量提升研究中,旨在分析中药制剂新质量标准不达标的原因,以进一步提高中药制剂的质量。方法:针对遴选出的9种特色中药制剂,运用QCC工具和手法,经查找制剂检验原始记录,对28个批次共138个检验项目进行新质量标准不达标的数据统计,并通过甘特图、柏拉图、鱼骨图等进一步分析不达标的原因,在拟定对策并实施检讨后,最终加以效果确认。结果:中药制剂新质量标准不达标率明显下降,由15.94%降至5.80%。目标达标率为116.69%,进步率为63.61%。结论:QCC工具的应用,显著降低了中药制剂新质量标准不达标率,进一步提高了中药制剂的质量,同时在团队凝聚力、沟通协调能力及解决问题能力等方面收获了无形成果。

Application of QCC in Analyzing the Non-standard Rate of New Quality Standards of Traditional Chinese Medicine Preparations

Objective: To improve the quality of traditional Chinese medicine preparations and find out the reasons for the non-standard rate of new quality standards by the use of QCC (Quality Control Circle). Methods: Based on the nine selected special Chinese medicine preparations, the original inspection records of the preparations were searched by using QCC tools and techniques. A total of 138 items in 28 batches were collected and analyzed in non-conformance to the new quality standard. QCC tools such as Ganttu, Plato, Fish Bone Map, etc., which were used to find out the reasons for not reaching new standards. After the countermeasures were formulated and implemented, the actions were identified effective by implementation and result confirmation. Results: The results showed that the non-standard rate of new quality standards after improvement of traditional Chinese medicine preparations has decreased significantly from 15.94% to 5.80%, with the target completion rate of 116.69% and the progress rate of 63.61%. Conclusion: The application of QCC tools significantly reduced the non-standard rate of new quality standards and improved the quality of traditional Chinese medicine preparations. Meanwhile, the invisible achievement was obtained in aspects of cohesiveness, communication, settlement, and so on.