2016—2018年某市疾控中心实验室质量管理体系不符合项分析

Analysis on non-conformities of laboratory quality management system in center for disease control of a city from 2016 to 2018

中文关键词:  实验室  质量管理体系  不符合项

英文关键词:aboratory  quality management system  non-conformities term

中文摘要:

      目的 分析某市疾控中心实验室2016—2018年发现的不符合项, 提出改进建议。方法 根据2016—2018年质量管理活动相关资料, 对不符合项的来源、类别、频次和分布情况等进行统计分析。结果 2016—2018年共发现不符合项126项, 均为一般不符合, 类型以实施性为主, 主要来源于日常监督及内、外部审核, 主要涉及记录控制、人员能力确认和监督、管理体系文件和执行、设备和设施管理等要素, 主要分布在卫生科、理化检验科、质管科等科室。结论 某市疾控中心质量管理体系2016—2018年来运行良好, 不符合项呈减少趋势, 但在强化质量和责任意识, 完善奖惩机制和信息化建设等方面仍亟待加强。

英文摘要:

      Objective To analyze the non-conformities found in the laboratory of center for disease control in a city from 2016 to 2018, and put forward suggestions for improvement. Methods According to the relevant information of quality management activities from 2016 to 2018, the source, category, frequency and distribution of non-conformities were statistically analyzed. Results From 2016 to 2018, a total of 126 non-conformities were found, all of which were general non-conformities. The implementation-oriented type mainly came from daily supervision and internal and external audit, mainly involved such elements as record control, personnel capacity confirmation and supervision, management system documents and implementation, and equipment and facility management, and mainly distributed in such departments as health department, physical and chemical clinical laboratory department, and quality control department. Conclusion The quality management system of a city center for disease control has been running well from 2016 to 2018, and the non-conformities are decreasing. However, it is still urgent to strengthen the consciousness of quality and responsibility, and improve the incentive mechanism and information construction.