基于PDCA循环的制药设备预防性维护分层次管理

发布时间：2019-04-04 12:43

【摘要】：研究制药企业GMP设备预防性维护的具体途径和方法。利用系统影响性评估和部件关键性评估等评估工具对设备系统进行分类、分级,制定分层次的具体维护计划,并在工作中进行PDCA循环。通过评估可将设备分为关键设备、重要设备和次要设备,各设备中的部件可分为关键和非关键两个等级。对关键设备的关键部件进行全面维护,对关键设备非关键部件以及重要设备关键部件进行重点维护,对重要设备非关键部件和次要设备仅需进行日常维护,并进行PDCA循环,提高设备管理GMP水平。
[Abstract]:The specific ways and methods of preventive maintenance of GMP equipment in pharmaceutical enterprises are studied. The equipment system is classified and graded by means of system impact assessment and component critical evaluation, and specific maintenance plans are drawn up at different levels, and PDCA cycles are carried out in the work. The equipment can be classified into key equipment, important equipment and secondary equipment through evaluation. The components in each equipment can be divided into two levels: critical and non-critical. Complete maintenance of critical components of critical equipment, focus maintenance of critical equipment non-critical components and critical equipment critical components, routine maintenance of critical equipment non-critical components and secondary equipment, and PDCA cycling. Improve equipment management GMP level.
【作者单位】：中国药科大学国际医药商学院;
【分类号】：R95

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