6S管理工具在Ⅰ期临床试验中心的应用  

Application of 6S Quality Management Methods in Phase Ⅰ Clinical Trial Center

作　　者：黄冬香[1] 段炼[1] 黎笑媚 陈思含 戴丽萍 谢志红[1] 李明琰[2] 叶丽卡[1] HUANG Dongxiang;DUAN Lian;LI Xiaomei;CHEN Sihan;DAI Liping;XIE Zhihong;LI Mingyan;YE Lika(Phase I Clinical Trial Center of The Second Afiliated Hospital of Guangzhou Medical University,Guangzhou,Guangdong 510000,China;Cardiology Department of Panyu Branch of the Second Afiliated Hospital of Guangzhou Medical University,Guangzhou,Guangdong 510000,China)

机构地区：[1]广州医科大学附属第二医院Ⅰ期临床试验中心,广东广州510000 [2]广州医科大学附属第二医院番禺院区心内科,广东广州510000

出　　处：《今日药学》2023年第3期231-235,共5页Pharmacy Today

基　　金：广州市科技计划项目(202103000024)。

摘　　要：目的 探讨将起源于企业的6S管理工具应用在医院Ⅰ期临床试验中心的模式和效果。方法 在Ⅰ期病房建设初期即应用6S管理工具从整理、整顿、清洁、规范、素养、安全6个方面形成质量管理基础,通过初期(2019~2020年)与持续改进阶段(2021~2022年)的自身对比,考察6S管理工具的实际应用效果。结果 试验现场6S诊断表评分由初期(87.07±3.08)分上升到持续改进阶段(93.43±2.23)分,成效显著。物品准备和档案查找的操作耗时分别由初期(4.47±0.48)min和(5.36±0.42)min,显著下降到持续改进阶段(1.94±0.31)min和(0.84±0.08)min,显著减少了时间。近100名受试者完成全部筛选流程时间由前期(5.1±0.4)h显著降低到(4.5±0.4)h。结论 通过6S质量管理工具的应用,从领物、存物、摆放、标识、洁净、应用形成全程化管理体系,提高了工作人员行为规范和素养。从而为临床试验安全提供保障。6S质量管理工具的应用保证了临床试验的工作质量和效率,使Ⅰ期临床试验中心在运行中不断发现问题并持续改进,值得推广应用。OBJECTIVE To explore the application and effect of 6S quality management,which originating from enterprises in construction of phase Ⅰ clinical trial center.METHODS The 6S quality management were implanted in the initial construction to control the quality of phase Ⅰ ward from six aspects of arrangement,rectification,cleaning,standardization,literacy and safety.The application effect was evaluated by comparing between the initial(2019-2020)and the improvement stage(2021-2022).RESULTS The score of the 6S diagnostic table increased from 87.07±3.08 in the beginning to 93.43±2.23 in the improvement stage with remarkable results.The time of article preparation and file search operation decreased significantly from(4.47±0.48)min and(5.36±0.42)min in the initial period to(1.94±0.31)min and(0.84±0.08)min in the improvement stage,which significantly reduced the time.The waiting time for screening of the same number of people decreased significantly from(5.1±0.4)h to(4.5±0.4)h.CONCLUSION The application of 6S quality management tools ensures the quality and efficiency of clinical trials,enabling researchers to continuously identify problems and improve in the operation of phase Ⅰ clinical trial center.It is worth of promoting and applying.

关 键 词：6S管理工具 Ⅰ期临床试验 受试者 质量管理 

分 类 号：R95[医药卫生—药学]