质量实验室检验的影响因素与控制措施

The Influencing Factors and Control Measures of Quality Laboratory Testing

为了帮助检验人员提高质量实验室检验的能力,现对质量控制的相关因素进行分析,并深入研究其应对措施。选择2019—2021年出厂成品1863批为对象,对各项影响因素进行回顾性分析,并对影响因素进行总结分析,制定改进措施。分析检验的影响因素主要包括人员因素、样品因素、仪器因素、数据分析、方法标准、环境因素等。文章论述的主要目的在于研究体外诊断试剂的质量检验可能受到的影响因素,以及在此基础上,需要提前制定的相关措施,希望能够通过研究,具体问题具体分析,在不断地发展和研究中,寻求检验技术的进步和水平的提高。

In order to help inspectors improve their quality laboratory testing capabilities,we are now analyzing the relevant factors of quality control and conducting in-depth research on their response measures.Selecting 1863 batches of finished products manufactured from 2019 to 2021 as the object,conducting a retrospective analysis of various influencing factors,summarizing and analyzing the influencing factors,and formulating improvement measures.The influencing factors of analysis and testing mainly include personnel factors,sample factors,instrument factors,data analysis,method standards,environmental factors,etc.The main purpose of this article is to study the factors that may affect the quality inspection of in vitro diagnostic reagents,as well as the relevant measures that need to be formulated in advance based on this.It is hoped that through research,specific problem specific analysis,and continuous development and research,progress in testing technology and improvement in level can be sought.