六西格玛管理法在国家药品标准物质管理中的应用

Application of Six Sigma Methodology in the Management of National Drug Reference Standards

目的:将六西格玛管理法引入国家药品标准物质研制生产管理工作中,以问题导向,将管理流程系统化。方法:基于六西格玛管理法的基本理论,依据定义、测量、分析、改进和控制组成的DMAIC五步法,构建适合国家药品标准物质研制生产工作流程和发展需求的管理模型。结果:应用实践表明,通过改进对研制计划的科学测算及督导、优化流程和时限管理、保障资料安全传递及信息公开等工作程序,使得国家药品标准物质管理工作流程更加清晰合理,控制节点明确,工作效率全面提升。结论:六西格玛管理理论和实际工作相联合,以提高工作效率为核心对国家药品标准物质管理工作进行指导、分析和改进,能够更好地梳理和解决潜在问题,实现挖潜增效的核心目标。

Objective:To introduce Six Sigma methodology applied in the development and production of national drug reference standards and systemize the operation and management process.Methods:Following the concept of Six Sigma methodology and the DMAIC steps(define,measure,analysis,improve and control),the management model and system of national drug reference standards was built.Results:According to the research and application,the management process of national drug reference standards could be more controllable,transparent and efficient by improving the calculation and review of the developing plan,optimizing the process and time management and ensuring the delivery safety and information transparency etc.Conclusion:Six Sigma methodology focuses on working efficiency improvement.With the guidance of Six Sigma applied in daily management to analyze and improve the development and production of national drug reference standards,it can be easier to investigate and solve the hidden problems,so as to improve the producing efficiency.