| 闫顺华,马国明,王秀霞,叶青.2013-2019年实验室能力验证结果不满意OOS分析[J].中国药事,2020,34(10):1158-1164 |
| 2013-2019年实验室能力验证结果不满意OOS分析 |
| OOS Analysis of Dissatisfied Results of Proficiency Testing of the Laboratory between 2013 and 2019 |
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| DOI：10.16153/j.1002-7777.2020.10.006 |
| 中文关键词: 能力验证 关键控制点 结果不满意 检验结果偏差分析 |
| 英文关键词: proficiency testing key control point unsatisfactory results OOS analysis |
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| 中文摘要: |
| 目的：深入分析能力验证活动中的关键控制点，总结实践经验，不断提高检验检测能力。方法： 对2013-2019年我院参加的能力验证活动情况进行汇总，结合具体实例，对产生可疑结果或不满意结果的原因进行检验结果偏差分析，不断加强和完善实验室的质量管理。结果与结论：各领域能力验证结果的满意率基本呈逐年上升趋势，食品领域的结果满意率最高，接近90%；药品领域位居第二，结果满意率达84%；医疗器械和化妆品领域的结果满意率略低，在70%左右。近年来，我院通过加强人、机、 料、法、环、测等环节的内部质量控制，将质量监督贯穿到日常检验检测的全过程，有效地促进了实验室管理体系的建设和技术能力的提升。 |
| 英文摘要: |
| Objective: To conduct an in-depth analysis of key control points in proficiency testing activities, and sum up practical experience, so as to continuously improve the testing capabilities. Methods: The proficiency testing activities from 2013 to 2019 were summarized, and out of specification (OOS) analysis on the causes of suspicious results or unsatisfactory results were performed to continuously strengthen and improve the quality management of the laboratory. Results and Conclusion: The satisfaction rate of the results of proficiency testing has been increasing year by year. The food field has the highest satisfaction rate which is close to 90%; the pharmaceutical field ranks the second, with a satisfaction rate of 84%; the medical device and the cosmetics fields show relatively lower rates of around 70%. In recent years, our institute has strengthened the internal quality control of human, machine, material, method, environment and measurement, so as to implement quality supervision throughout the entire process of the testing, which promotes the construction of laboratory management system and the improvement of technical capabilities effectively. |
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