| 杨文凤,张慧文,李薇.食品药品能力验证可疑或不满意结果风险点分析与对策[J].中国药事,2018,32(4):480-484 |
| 食品药品能力验证可疑或不满意结果风险点分析与对策 |
| Analysis of Risk Points and Countermeasures for Suspicious or Unsatisfactory Results of Food and Drug Profciency Test |
| 投稿时间：2017-07-27 |
| DOI：10.16153/j.1002-7777.2018.04.010 |
| 中文关键词: 实验室质量管理 能力验证 可疑结果 不满意结果 整改措施 风险分析 |
| 英文关键词: laboratory quality control profciency test suspicious results unsatisfactory results rectifcation measure risk analysis |
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| 中文摘要: |
| 目的：能力验证是反映实验室质量管理体系有效性的重要手段，对隐藏的风险有预测和预警作用，针对常见的可疑或不满意结果分析原因和案例，汇总自查与整改情况，归纳造成结果偏离的常见原因和关键控制点，据此分析实验室存在的风险点和给出对策。方法：通过举例分析，查找实际检验工作中有代表性的重点、难点，举一反三，总结出经验教训。结果与结论：个别结果偏离虽有一定的偶然性，但也可反映日常检测活动的风险点，高度重视自查与整改过程，实事求是分析失误原因与提出对策，不片面，不避重就轻，从而在检测活动中避免发生相同的错误，这是检验实验室质量保证的一项有益、重要的措施，充分实现能力验证对质量控制和检测水平持续提升的效果。 |
| 英文摘要: |
| Objective: Profciency test is an important means to reflect the effectiveness of laboratory quality management system, which has the function of forecasting and early warning for hidden risks. The objective of the paper was to analyze the causes and cases of common suspicious or unsatisfactory results, to summarize the results of self-examination and rectification, common reasons and key control points that caused deviation of result, and to analyze the risk points and put forward countermeasures accordingly. Methods: Through the analysis of specifc cases, the representative key points and diffculties of the actual testing were found out, inferences were drawn and the lessons learned were summed up. Results and Conclusion: Although the deviation of individual results had a certain chance, could it reflect the risks of routine testing activities. Attention should be paid to the process of self-examination and rectifcation. The causes of failure should be analyzed and countermeasures should be put forward so as to avoid the same mistakes in the testing activities, which was a useful and important measure to ensure the laboratory quality and to achieve the continuous improvement of the levels of the quality control and inspection brought by profciency test. |
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