流程导向监管理念下药品检验机构留样的管理与评价

Sample Retention Management and Evaluation in Drug Inspection Agencies Based on Process-oriented Administration Concept

目的:结合流程导向监管理念,为完善药品检验机构留样管理与评价的流程和措施提供参考。方法:从组织管理和控制措施方面探讨健全留样管理制度的措施;从入库检查、存储管理和出库判定、库房管理和信息化等方面探讨完善留样管理的流程和措施;从评价内容和质控措施方面探讨留样管理的评价与持续改进。结果与结论:在组织管理方面,要完善管理程序与流程、确定留样目标与计划、完善岗位配置与管理、完善安全应急预案;在控制措施方面,要完善留样入库状态检查等业务管理措施、调整库房空间分配等条件、完善留样剩余有效期智能提示等措施。留样入库检查、存储空间和条件控制、留样出库判定是入库、存储、出库三大环节的关键,要从这些方面入手完善相关流程和措施。留样管理评价的内容包括管理制度、管理措施和流程、改进与评价三个方面。药品检验机构可采用计划-执行-检查-处理(PDCA)循环来改善留样管理效率、提升其管理质量。

OBJECTIVE:To combine with the concept of process-oriented administration,and to provide reference for improving the process and measures of the sample retention management and evaluation in drug inspection agencies.METHODS:From the aspects of organizational management and control measures,the improvement measures for sample retention management system were investigated.From the aspects of warehouse-in check,storage management and warehouse-out judgment,warehouse management and informatization,the improvement measures for procedures and measures about sample retention management were explored.From the aspects of evaluation content and quality control measures,the evaluation and continuous improvement of sample retention management were investigated.RESULTS&CONCLUSIONS:In the aspect of organizational management,it is necessary to improve management procedures and processes,determine sample retention objectives and plans,improve post allocation and management,and improve safety emergency plans.In the aspect of control measures,it is necessary to improve the business management measures such as warehouse-in status inspection,adjust the conditions such as warehouse space allocation,and improve the intelligent prompt of remaining validity period of samples.The key to the three links of warehouse-in,storage and warehouse-out are warehouse-in check,storage space and condition control,and warehouse-out judgement.The relevant processes and measures can be improved from these aspects.The contents of sample retention management evaluation includes management system,management measures and process,improvement and evaluation.Plan-Do-Check-Action(PDCA)cycle is a measure to improve the efficiency and quality of sample retention management in drug inspection agencies.