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| QCC在中药制剂新质量标准不达标分析中的应用研究 |
| Application Study on reducing the non-standard rate of new quality standards of traditional Chinese medicine preparations with QCC |
| 投稿时间：2019-09-23 修订日期：2020-06-12 |
| DOI： |
| 中文关键词: 品管圈 中药制剂 新质量标准 不达标率 |
| 英文关键词: QCC traditional Chinese medicine preparations new quality standard non-standard rate |
| 基金项目:全军医疗机构制剂标准提高科研专项课题项目(编号14ZJZ16-3) |
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| 中文摘要: |
| 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5.8%。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,同时也收获了很多宝贵的无形成果。 |
| 英文摘要: |
| Objective To improve the quality of traditional Chinese medicine preparations, and find out the reasons of the non-standard rate of new quality standards by the use of QCC(Quality Control Circle).Methods Nine special Chinese medicine preparations were selected as research objects. A total of 138 items were inspected in 28 batches, and QCC tools such as Ganttu, Plato, Fish Bone Map, etc., which were used to find out the reasons for not reaching new standards. Then countermeasures were formulated and implemented. Results The actions were identified effective by implementation and result confirmation. The results showed that the non-standard rate of new quality standards after improvement decreased significantly from 15.94% to 5.80%, with the target completion rate of 116.69% and the progress rate of 63.61%. Conclusion This study significantly reduced the non-standard rate of new quality standards, improved the quality of traditional Chinese medicine preparations, and guarantee the clinical efficacy for patients. The application of QCC tools not only improves the ability of group members to find and solve problems, but also improves the quality management system of the department. |
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