基于精益六西格玛的制药工艺设备故障预防研究  

Research on Fault Prevention of Pharmaceutical Process Equipment Based on Lean Six Sigma

作　　者：谢圣尧 王富东[1] Xie Sheng-yao Wang Fu-dong

机构地区：[1]苏州大学机电学院,江苏苏州215123

出　　处：《今日自动化》2020年第4期97-100,共4页Automation Today

摘　　要：目前某生物制药公司新建厂房刚投入运行,而工艺设备由于故障导致的停机较多,极有可能延误生产;提供研究工艺设备的故障情况并制定预防措施,保障生产正常开展,为生物制药公司工艺设备的维护提供参考。方法:该生物制药公司有一套工艺设备维护维修工单系统Maximo系统,在系统检索2018年全年工艺设备的维修工单信息,对每条工单进行数据分析。结果:2018年全年维修工单信息总计460条,非关键工艺设备故障75条,占比16.30%;间接影响设备故障177条,占比38.49%;关键影响设备202条,占比43.91%。最后经过一年的改善。2019年开始,参与改善的两类工艺设备月均故障数由0.71和0.38次每台每月,下降到0.41和0.06次每台每月,分别减少了42.25%和84.21%,P值分别为0.02和0.03,均小于0.05,显示出了良好的效果,达到了预期目的。结论:通过对历史故障工单数据的分析,不断了解工艺设备的状态和故障发生的原因,改善维护人员对设备的维护和加强维护人员的培训提供参考,保障生物制药企业正常生产。At present,a new plant of a biopharmaceutical company has just been put into operation,and the process equipment has many downtimes due to failures,which is very likely to delay production;provide research on the failure of process equipment and formulate preventive measures to ensure normal production.Provide reference for maintenance of process equipment of biopharmaceutical company.Method:The biopharmaceutical company has a set of process equipment maintenance work order system Maximo system.The system retrieves the process equipment maintenance work order information for the whole year of 2018 and conducts data analysis on each work order.Results:In 2018,there were a total of 460 pieces of maintenance work order information,75 pieces of non-critical process equipment failures,accounting for 16.30%;177 pieces of indirect impact equipment failures,accounting for 38.49%;202 critically affecting equipment,accounting for 43.91%.Finally,after a year of improvement.Starting in 2019,the average monthly number of failures of the two types of process equipment involved in the improvement has dropped from 0.71 and 0.38 times per month per month to 0.41 and 0.06 times per month per month,a decrease of 42.25%and 84.21%,respectively,with a P value of 0.02 And 0.03,both are less than 0.05,showing a good effect and achieving the expected purpose.Conclusion:Through the analysis of historical failure work order data,we can constantly understand the status of process equipment and the cause of failure,improve the maintenance of equipment by maintenance personnel and strengthen the training of maintenance personnel to provide reference to ensure the normal production of biopharmaceutical companies.

关 键 词：工艺设备 故障预防 精益六西格玛 

分 类 号：F273.2[经济管理—企业管理]