摘要
目的:优化国家药品标准工作程序,提高标准制订质量。方法:基于质量管理理论中的PDCA循环模式,针对当前国家药品标准制订工作存在的不足,对国家药品标准的制订程序进行系统总结和优化。结果与结论:当前国家药品标准制订工作存在制订的药品标准整体质量低,制订周期长、效率低,缺乏标准质量管理等问题。应用PDCA循环理论,将整个药品标准工作划分为计划、实施、检查、处理/提高4个阶段,并进一步细分成规划、制/修订标准、颁布实施、宣传贯彻、监督检查、修订提高等环节,既改变了国家药品标准工作中程序不清的积弊,优化了工作程序,又能从管理学理论上对国家药品标准工作的内容进行剖析和阐释,从理论上验证了优化工作程序的合理性。优化国家药品标准工作程序,符合质量管理理论,并对提高标准制订工作的质量、缩短标准制订工作的周期、扩大标准制订工作的绩效具有积极的意义。
OBJECTIVE：To optimize the procedure of national drug standards,and improve the quality of standards.METHODS：Based on PDCA mode of quality management theory,the formulation procedure of national drug standards was summarized and optimized systematically,aiming at the deficiency in present formulation of national drug standards.RESULTS CONCLUSIONS：The problems about the present formulation of national drug standards contain low quality of whole drug standards,long formulation cycle,low efficiency and absence of quality management for standards,etc.The whole work of drug standard can be divided into 4 steps,i.e.planning,formulating,examining and processing/improving,based on the theory of PDCA cycle;the 4 steps were subdivided into planning,developing/revision standard,promulgation and implementation,publicity and implementation,monitoring and supervision,revision and improvement,etc.It not only removes long-standing abuse of unclear procedure and optimizes the procedure of national drug standards,but also analyzes and interprets the contents of national drug standards according to management theory and verifies the rationality of optimization procedure theoretically.The optimization of the procedure of national drug standards meets quality management theory and has a positive meaning for improving the quality of the standard-setting work,shorting the cycle of the standard formulation,expanding the performance of the work.
出处
《中国药房》
CAS
CSCD
2013年第9期778-780,共3页
China Pharmacy
关键词
国家药品标准
PDCA循环
制订
程序
标准管理
National drug standards
PDCA cycle
Formulation
Procedure
Standard management
