摘要
目的探索优质高效的管理评审实施办法,提升疫苗批签发实验室管理体系运行水平。方法以部门报告、专题报告和主题报告的方式组织管理评审输入,经3年实践和改进,形成较为完善的多层输入模式。结果底层全面输入确保输入信息完整性,中层专题汇总提高输入信息针对性,上层深度提炼提升输入信息有效性。结论管理评审的专题报告应包括疫苗批签发检验等专项内容,以评估管理绩效;多层输入模式有助于提升管理评审效能,为管理体系的有效运行和持续改进奠定坚实基础。
OBJECTIVE To explore an efficient way of management review in lot release laboratory management system. METHODS Through three years of practice and improvement, a relatively perfect multi-layer input mode was formed with comprehensive reports, special reports and theme reports. RESULTS The comprehensive input at the bottom level ensured the integrity of input information. The summary process at the middle level improved the pertinence of input information, while the deep processing at the top level improved the effectiveness of input information. CONCLUSION The multi-layer input mode is helpful to lay a solid foundation for the effective operation and continuous improvement of the management system. Testing and lot release of vaccines should be included into special reports in order to evaluate management performance.
作者
李睿
缪宁梅
曹玲
LI Rui;MIAO Ning-mei;CAO Ling(Jiangsu Institute for Food and Drug Control,Nanjing 210019,China)
出处
《中国药学杂志》
CAS
CSCD
北大核心
2021年第18期1456-1458,共3页
Chinese Pharmaceutical Journal
关键词
批签发实验室
管理评审
输入信息
多层模式
lot release laboratory
management review
input information
multi-layer mode