多实验室一体化质量体系运行中不符合项分析报告

Non-Conformity Analysis Report of the Quality Management System in Multi Laboratory

对区域实验室质量管理体系运行中的不符合项进行分析,查找存在的不足,为质量管理体系更好运行提供参考依据。收集2013-2015年间实验室各类质量管理活动中发现并提出的不符合项,进行统计分析。结果显示,3年间共发现并提出不符合项200项,来源于5家实验室的日常质量监督、内部审核、CNAS评审及其他形式的质量监督;按场所区分,档案室和免疫室分别发现不符合项72和62项;按要素分,发现3次以上不符合项的要素有9个,占总不符合项的94%;对发现并提出的不符合项,实验室及时采取有效措施实施纠正并对重点场所或要素实施预防措施加以控制。通过分析得出,日常质量监督对管理体系运行发挥了充分的监督作用,不符合项涉及的要素多而分散、部分相对集中,加强档案管理工作是质量管理工作中的重点;各实验室对不符合项有了充分的认识并能客观对待,不符合项发现与提出逐步减少说明管理水平持续提高。

To search operation problems,the non-conformity of the quality management system have been analyzed in the regional laboratory. And,the work we have done to provide reference for the system run better. From 2013 to 2015 years,the non-conformity which had been found during laboratory quality management activity has been collected for statistical analysis. Results showed that in the past 3 years,200 non-conformities were found,which came from internal audit daily quality supervision,quality supervision and other forms of CNAS review. According to the place,record room and immunology lab were distinguished and were found non-conformities 72 and 62 respectively;and according to factors,more than 3 non-conformities of elements was 9,and the rate was about 94%. Therefore,timely measures and effective preventive measures were implemented to control key sites or elements. Daily quality supervision played a critical role of quality management system. Non conformities of the elements involved in more dispersed and relatively concentrated,and archiving must be focused in the future work. Recently,not conform to the items were full understood and objectively treated. And then not conform to being found less and less gradually predicated continuous improvement of the management.