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。
Abstract
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.
关键词
批签发实验室 /
管理评审 /
输入信息 /
多层模式
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Key words
lot release laboratory /
management review /
input information /
multi-layer mode
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李睿, 缪宁梅, 曹玲.
疫苗实验室管理评审多层输入模式的构建与实践[J]. 中国药学杂志, 2021, 56(18): 1456-1458 https://doi.org/10.11669/cpj.2021.18.003
LI Rui, MIAO Ning-mei, CAO Ling.
Construction and Practice of Multi-Layer Input for Lab Management Review[J]. Chinese Pharmaceutical Journal, 2021, 56(18): 1456-1458 https://doi.org/10.11669/cpj.2021.18.003
中图分类号：
R917
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参考文献
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[6] ISO/IEC 17025:2017. Accreditation criteria for the competence of testing and calibration laboratories [S]. 2017.
[7] RB/T 214-2017. Competence assessment for inspection body and laboratory mandatory approval-General requirements for inspection body and laboratory [S]. 2017.
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