药品中需氧菌总数能力验证不满意结果的OOS分析

OOS Analysis of Dissatisfied Results of Proficiency Testing of the Total Aerobic Microbial Count in the Drug

本文对药品中需氧菌总数能力验证中出现不满意结果的原因进行OOS分析,从人员、培养基、菌种、设施和环境条件、设备及结果处理和报告等方面探讨出现不满意结果的原因,并提出纠正措施。结果表明,实验室通过有目的、有计划地参加能力验证,可有效促进实验室管理水平和检验能力的提升。

In this paper,OOS analysis was made on the causes of unsatisfactory results in the total aerobic bacteria capacity verification of drugs,and the causes of unsatisfactory results were discussed from the aspects of personnel,culture medium,bacteria,facilities and environmental conditions,equipment,result processing and reporting,and corrective measures were put forward.The results show that the laboratory can effectively promote the management level and inspection ability of the laboratory by participating in the ability verification purposefully and planned.