山东省药检系统质量体系运行调查

Investigation Report on the Operation of Quality System for Drug Control in Shandong Province

目的研究山东省药检系统质量体系运行存在的问题和发展对策。方法遵循药品检验工作的基本规律,依照国际通用检测实验室管理的先进理念与方法,借鉴全面质量管理(TQC)的思路,进行调研和分析。结果与结论本省药检系统质量保证体系和管理制度日趋完善,有效控制了可能影响检测结果的各种因素,确保了检验结果的准确、可靠。但是还存在着质量意识薄弱、检验人员及装备不足、质量管理不到位等问题。建议进行改进,加强药检系统质量规范化管理,推动全省药检系统质量管理的科学化、规范化、信息化建设。

Objective The purpose of this report is to investigate the problems and development countermeasures of drug quality inspection and supervision system of Shandong province. Methods The current drug control system of Shandong province followed the inherent laws of inspection work that was in accordance with international advanced concepts and methods on inspecting laboratory management theory. Research and analysis were carried out thoroughly by introducing the idea of Total Quality Control （TQC）. Results and Conclusions This investigation has proved that a consummate quality system for drug inspection and management has well-established gradually by providing precise and reliable results. The system played a crucial role in controlling any factor that may affect the performance of drug control. However, problems such as underdevelopment of awareness of quality control, and inadequate personnel, equipments and powerful strength of quality management implementation have also been found during this investigation. Aiming to improve, further suggestions were put forward on the scientific, standardized and information-based management in drug quality inspection and supervision system based on existing problems found in this investigation in the province.