食品药品检验实验室在资质认定评审中的不符合项分析

Analysis on Non-conformance Terms in Assessments of Mandatory Approval of Food and Drug Testing Laboratory

目的通过对本院2019年至2021年接受的7次资质认定现场评审开具的不符合项汇总分析,发现原因,提出整改措施。方法对不符合进行要素、部门分布情况分析,针对性的分析原因并做出整改。结果不符合项在管理体系要求方面占比例最大,为47.8%,设施设备要求方面的不符合项占比其次,为19.1%,人员和场所环境也均有不符合项。不符项涉及较多的科室与本次分析的资质认定评审所涉及的科室检测领域相关。结论针对外审过程中发现的不符合项认真分析产生原因,举一反三,制定好纠正措施,切实落实纠正完成情况,从而保障实验室质量管理体系的持续改进。

OBJECTIVE To analyze the non-conformance terms found in 7 assessments of mandatory approval from 2019 to 2021,analyze the causes,and put forward the improvement measures.METHODS The method was to analyze the distribution of requirements and departments of nonconformities,find out the causes and make rectification.RESULTS The non-conformance terms accounted for the largest proportion in the management system requirements,accounting for 47.8%,followed by the non-conformance terms of facilities and equipment requirements,accounting for 19.1%,and there were also non-conformance terms in personnel and place environment.The non-conformance terms involve more departments related to the field of department testing involved in the qualification evaluation of this analysis.CONCLUSION Carefully analyze the causes of non-conformance terms found in the process of external assessments,and formulate corrective measures to ensure the continuous improvement of laboratory quality management system.