药厂设备平均故障间隔时间优化与改进

论文总字数：16576字

摘 要

设备管理和药品生产息息相关,怎样配合GMP（食品、药品、医疗产品生产和质量管理法规）管理条例,确保药品生产的顺利进行,是设备部门首当其冲要去完成的。根据辉瑞总部计划和苏州工厂生产需求，设备的稳定性和可靠性是保证质量生产的重要环节之一，通过开展IMEx-TPM（整合的卓越运作系统-全员生产维护)，帮助解决因设备稳定性和可靠性在生产过程中带来的各项干扰，促使苏州工厂和PGS(参与式保障体系)业务达到世界级水平。

EM(工程部)通过EAMS(企业架构管理系统)系统工单故障定期回顾以及和MFG(生产部)沟通调研发现，生产员工自主维护意识与期望值有一定的差距，EM维修人员忙于应急维修，PM(项目管理)保养维护及PdM(产品数据管理)预见性维护时间不充分，导致设备平均故障间隔时间较短，严重影响生产OEE(设备综合效率), 以TPM(全员生产维护)项目部署作为契机，工厂决定将“提高设备平均故障间隔时间（MTBF）”作为此次的改进项目。最终通过TPM培训和SMT技能培训，员工也对全员生产性维护有了深刻的认识，进而达成了“提高生产设备平均故障间隔时间”的改进目标，同时在设备上提高了设备的可运行时间，提高了设备的可靠性，设备使用过程中的故障能自己调整；在操作过程中车间内维修频率明显降低，提高了设备操作员技能，各个工段对于应急状况的处理更迅速；在部门联系中车间和维修部门紧密配合，EM和MFG的伙伴关系增强，形成了工作流程的完整对接；这些成果都有效的减少了费用，对故障损耗设备的维护更高效。

关键词：生产维护；设备稳定性和可靠性；质量生产；平均故障间隔时间；应急维修

MTBF, the Pharmaceutical Company"s Manufacturing Facility, is Optimized and Improved

Abstract

Equipment management and drug production are closely related, how to cooperate with GMP (GOOD MANUFACTURING PRACTICE)regulations to ensure the smooth progress of drug production, is the equipment sector to be the first to complete. According to the Pfizer headquarters plan and the production needs of the Suzhou plant, the stability and reliability of the equipment is one of the important links to ensure quality production, through the implementation of IMEx-TPM (integrated operational excellence system - full production maintenance), to help solve the equipment stability and reliability in the production process caused by the interference, Suzhou plant and PGS (Participatory Guarantee Systems)business to achieve world-class level. EM(Engineering Management) through the EAMS(Enterprise Asset Management System) system work order failure regular review and MFG(MANUFACTURING) communication research found that production staff self-maintenance awareness and expectations have a certain gap, EM maintenance personnel busy with emergency repair, PM(Project Management) maintenance and PdM(Product Data Management) predictive maintenance time is not sufficient, resulting in the equipment average failure interval is short, seriously affecting the production of OEE(Overall Equipment Effectiveness), TPM(Total Productive Maintenance) project deployment as an opportunity, the factory decided to "improve the average equipment failure interval (MTBF) as an improvement project."Finally, through TPM training and SMT skills training, employees also have a deep understanding of the production maintenance of the whole staff, and then achieve the improvement goal of "increasing the average failure interval of production equipment", and improve the equipment operation time, improve the reliability of the equipment, and adjust the faults in the process of equipment use; During the operation, the frequency of maintenance in the workshop is obviously reduced, and the equipment operator skills are improved, and the emergency situation is handled more quickly in each section; In the department contact, the workshop and maintenance department cooperate closely, and the partnership between EM and mfg is enhanced, forming a complete docking of the work flow; These results effectively reduce the cost and make maintenance of the equipment more efficient.

Keywords: Production and maintenance, equipment stability and reliability, quality production, average time between failures, emergency repair

目 录

摘 要 I

Abstract II

第一章 引 言 1

1.1 背景 1

1.2 意义 1

第二章 现状分析与目标可行性分析 3

2.1 现状调查 3

2.2 目标可行性分析 3

2.2.1 制度优化支持 3

2.2.2 数据分析 4

第三章 要因分析与要因确认 5

3.1 要因分析 5

3.1.1 工作人员疏漏 5

3.1.2 机械故障 5

3.1.3 产品物料问题 5

3.1.4 制度不足 5

3.2 要因确认 6

3.2.1 确认方法 6

3.2.2 要因确认 6

第四章 实施措施 7

4.1 制定措施 7

4.2 措施实施 8

4.2.1 对全员进行为期3天的TPM培训 8

4.2.2 制作点检表和点检记录表，每周车间PT检查完成记录情况 8

4.2.3 保养时间由MFGEM生产计划组协调时间进行 8

4.2.4 关键调整部件设立中心线 8

4.2.5 根据评估结果对设备进行改造复兴或替换 9

4.2.6 对全部生产员工进行TPM培训 9

第五章 项目总结与展望 10

5.1 检查效果 10

5.2 实际结果 11

5.3 经济效益 11

5.4 巩固措施 11

5.5 项目总结 13

5.6 后续优化 14

5.7 展望 14

致 谢 15

参考文献 16

第一章 引 言

1.1 背景

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