ISPE 中国COP实践交流会在天津大学圆满落幕
主题：基于风险的制药设施确认体系构建
厂房设计
时间：17th Mar, 2012
地点：天津大学
嘉宾：谢京军
孙小兵
精彩剪影
ISPE China office
Tel: +86 21 23123640
Fax: +86 21 2312 3699
Email: china@ispe.org
ISPE China office
Tel: +86 21 23123640
Fax: +86 21 2312 3699
Email: china@ispe.org
ISPE China office
Tel: +86 21 23123640
Fax: +86 21 2312 3699
Email: china@ispe.org
ISPE China office
Tel: +86 21 23123640
Fax: +86 21 2312 3699
Email: china@ispe.org
ISPE 中国区社区讨论组（COPs）线下活动在上海圆满落幕
主题：Applying Lean to Pharmaceutical Manufacturing + Lean Leadership
时间：10th Jan. 2012 (one day)
地点：上海
As process industries Pharmaceutical manufacturers often strive to reduce batch sizes, reduce set up
times and maximize productivity and overall equipment effectiveness. Increasingly supply chains for
Pharmaceutical are global and highly complex and opportunities exist to simplify supply chains,
reduce cost and working capital.
TXM has significant experience in FMCG and Pharmaceutical. We have enabled customers to
increase line outputs by up to 50% and reduce product waste by 75% in environments as diverse as
tablet manufacturing, fruit juice, paint, firearms ammunition, fresh vegetable process and baking.
We have also helped customers design complex global and regional lean supply chains that have
reduced lead times and working capital by up to 50%.
Our practical 5S approach and SPED ™ system for Structured Problem Solving also complements the
GMP and compliance efforts of our clients and leads to a clean, clear visual workplace producing
consistent high quality products.
Learning Objectives
•
What is different about pharmaceutical manufacturing and the challenges of implementing
lean in this environment?
•
Lean principles and how they are relevant to pharmaceutical manufacturing.
•
shift.
Engaging people in a pharmaceutical manufacturing environment - particularly continuous
•
Steps to implement lean in a pharmaceutical manufacturing environment.
About Trainer
Anthony Clyne – Principal Lean Consultant
Anthony has a deep understanding of lean thinking and an ability to explain and apply the concepts
in many different processes. Anthony joined TXM in 2007 with an impressive record of lean
manufacturing experience in a range of industries including pharmaceutical, food, automotive,
minerals processing and transactional processes. As a graduate Engineer at the Ford Motor Company,
Anthony was initially taught standardized work using yamazumi by Japanese-based Mazda engineers.
This project won the President’s Award for innovative tooling. After numerous line re-layouts at Ford
in Australia, Anthony received further training from the US-based Toyota Sensei and worked with
automotive suppliers to reduce costs. He was also mentored locally by a highly respected TMCA Lean
ISPE China office
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Fax: +86 21 2312 3699
Email: china@ispe.org
Sensei (Teacher). Since partnering with TXM in 2007, Anthony has worked with a range of
pharmaceutical customers along with process based companies.
精彩剪影
Q&A
Q. What's Different About Introducing Lean in Pharmaceutical?
问：制药行业实施精益有何不同？
A. The culture of leadership in Pharmaceutical is traditionally focused on quality compliance.
Change is seen as a risk and is a barrier to implementing improvements. The forum discussed the
need to evaluate risk to enable low risk small changes to be implemented and not prevented by
blanket policies.
答：制药行业的传统领导文化是专注于质量遵循。改变就被视作一个风险，而且是一个实施改
进的障碍。研讨会讨论了需要评估风险，确保改变时的低风险，不被政策所阻止。
ISPE China office
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Fax: +86 21 2312 3699
Email: china@ispe.org
Q. What do you do with people freed up after lean OEE efficiency improvements?
问：当公司通过精益改进效率后，多出来的人怎么办？
A. Lean is difficult to implement when workers are dismissed after an efficiency improvement. The
best practices in lean deployment are to reskill and redeploy these people to new areas. In the work
place were many people leave regularly there is no need to let workers leave. It is important to re
assure workers at the start of lean that nobody will lose their job as a result of the improvements.
答：精益会很难实施，如果效率改进后会辞人。精益实施的最佳实践是对多出来的员工进行再
培训并用到新的区域中去。如果员工离职率较高的地方，就没有必要辞退工人了。在开始实施
精益的时候，非常有必要向员工保证没有人会因为改进了而被失业的。
Q. What is the benchmark OEE in Pharmaceutical Industry?
问：在制药行业的标杆 OEE 是多少？
A. The group shared OEE approximations for various machines, products, processes, for given batch
sizes. The results ranged from 37% to 70% OEE. TXM offered to help the benchmarking part of
Communities Of Practice (COP) to allow like for like comparisons.
答：我们大家分享了 OEE 的大概值，根据机器、产品、工艺和批量而有所不同。结果是从 37%
到 70%。TXM 可以为实践交流成员提供同类比较标杆提供帮助。
Q. How does TPM fit within GMP environment?
问：全员生产维护如何在 GMP 环境下进行？
A. The 8 TPM pillars provide a framework to improve and optimize existing equipment. Initially AM
(autonomous maintenance) engages operators to monitor, clean, check and daily maintain the
machine to prevent defects, make the machine life longer, and find small problems that can be fixed
before causing a breakdown. Finding small problems allows them to be fixed in a timely fashion
fitting with the planned GMP maintenance time. SI (specific improvement) brings together a group
including maintainers and production operators to work on the top causes of downtime. They
review the logged downtime in raw hand written sheets together with the Pareto analysis of the
downtime. The top cause category is then also analyzed in a second level Pareto if required. Best
practice is to analyze the downtime to the three levels using Pareto. PM (planned maintenance) PM
establishes the scheduled Preventive maintenance tasks to prevent failure and extend the
equipment life. Actions are scheduled on time period and run time. Monthly, quarterly, yearly,
along with run time “pop up” checks. The status of the machine is evaluated and predictive
maintenance is carried out. This could use temperature sensing, motor current, vibration
monitoring, listening, or simple feeling to monitor equipment status.
答：TPM 八大支柱提供了一个框架，以改善和优化现有设备。最初 AM（自主保养）让操作工
去监测、清洁、检查和日常维护机器，以防止机器故障，使机器的使用寿命更长，并在造成故
障之前找到可以修复的小问题。寻找小问题，使他们能够及时与计划的 GMP 固定维护时间相
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一致。 SI（个别改善）汇集了一组包括维护人员和生产操作工一起工作来寻找停机原因。他们
在原始的书面停机记录来分析停机原因，做帕累托图分析。对原因进行排列，选择停机最多的
设备和故障原因，最佳实践是对三个层次使用帕累托图分析。PM（计划维护）建立定期的预
防性维护任务，以防止故障和延长设备使用寿命。行动预计在一段时间和运行时间后进行，每
月，每季，每年，随着运行时间“弹出”检查。还有根据机器状态评估和进行的预测性维护。
这可以使用温度传感，电机电流，振动监测，听，或简单的感觉，监控设备状态。
Q. Who need carry out for TPM, Maintenance or production?
问：谁来实施 TPM，维修还是生产？
A. Working together. The maintainers and production need to work together to:
•
Maintainers coach Operators how to do specific tasks
•
Write One Point Lessons for AM (autonomous maintenance)
•
Analyse the SI (specific improvements) to find root cause of downtime and instill 5 why’s
during the breakdown.
•
Feedback result of the PM and allow the operator to help to speed up the maintenance time
and learn about the machine. This will allow many small learning’s about the machine.
•
The production people establish ownership similar to owning a car and look after the
machine. The Maintenance as 4s support provides:
a.
Survey – understand the needs from production. Identify the frustrations caused by the
machine and machine status;
b.
Service – provide scheduled service;
c.
Spare parts – identify the spare parts to be kept online, in the workshop, and at local
suppliers;
d.
Sales – provide the new equipment and training that includes the learning of the site. This
includes the initial control during the commissioning and first 90 days of operation.
•维修指导操作工如何执行特定任务
•为 AM（自主保养）制作一点通课程
•一起进行 SI（个别改善），找到导致的停机的根源，灌输 5 个为什么。
•计划性维护的反馈结果，并允许操作工帮助加快维修时间和及机器调整，并了解机器。这将
有许多对机器的小学习。
•生产建立类似拥有一辆汽车的主人翁精神来照顾机器。
ISPE China office
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Email: china@ispe.org
而维修则像 4S 一样提供支持：
Survey 调查 - 了解从生产的需要, 识别机器和机器状态;
Service 服务 - 提供定期计划性维护服务;
Spare parts 备件 - 确定备件保持在线，在车间，或在本地供应商;
Sales 销售 - 提供了新的设备和培训，包括现场学习。这包括在调试和操作前 90 天的初期控制。
Q. What to include in the supermarket?
问：拉动式生产的超市可以放哪些产品？
A. High frequency products should be kept in the supermarket if single flow is not viable.
答：在单件流不能实现的时候，那些消耗频率高的产品应该放在超市里。
Q. How do I calculate the supermarket stock levels?
问：如何计算超市库存量大小？
A. Assign green, yellow and red area. Green is the economic (or defined) batch size. Yellow is the
consumption amount during the re-order lead time. Red is the safety stock to protect against risks.
Typical risks are breakdown, material supply, and higher demand.
答：设置绿色、黄色和红色区域。绿色是经济批量大小。黄色是再订货期间的消耗量。红色是
安全库存以抵抗风险。典型的风险有停机、供货及高需求等。
ISPE China office
Tel: +86 21 23123640
Fax: +86 21 2312 3699
Email: china@ispe.org
ISPE 中国区社区讨论组（COPs）线下活动在上海圆满落幕
主题：Effective implement and operational MES by quality increasing;
Facility design
时间：3-5 p.m. 27th Jun, 2012
地点：上海
嘉宾：丁之洁女士 河北省石油化工设计院有限公司
林洪女士
西门子工业软件（上海）有限公司
精彩剪影
ISPE China office
Tel: +86 21 23123640
Fax: +86 21 2312 3699
Email: china@ispe.org
ISPE China office
Tel: +86 21 23123640
Fax: +86 21 2312 3699
Email: china@ispe.org
ISPE 中国COP实践交流会在台州学院圆满落幕
主题：制药行业对大学生的期望
无菌原料药的实施和 GMP 认证
时间：17th Jun, 2012
地点：台州
嘉宾：联化科技股份有限公司高级副总裁 叶渊明先生
海正药业验证部经理 陈小彬先生
6 月 17 日下午，规模盛大的国际制药工程协会 COP 实践交流会在台州学院 A5 大教室
举行，联化科技股份有限公司高级副总裁叶渊明先生、海正药业验证部经理陈小彬先生受邀做
演讲，医化学院党总支副书记邱方利主持会议，一百多名师生和企业代表参加交流。
叶渊明先生为大家作“制药行业对大学生的期望”的演讲。叶先生从自身的管理工作经
验，分析了大学生应从七个方面了解制药行业的相关知识，即法律法规、行业发展、生产制造、
供应链，生物、化学及制造科学、工程管理、业务管理等方面的知识。他提出学习力和个人能
力是企业员工发展的关键因素，比竞争对手学得更快的能力也许是唯一能够保持竞争优势的法
宝。
陈小彬先生则与大家分享了“无菌原料药的实施和 GMP 认证”的话题，通过无菌原料
药的结晶和冻干粉针的技术介绍，指出无菌原料药验证对无菌、内毒素和微粒等方面的严格要
求的特点，强调了在药品的生产中保证产品质量的重要性。并通过视频生动形象地向与会人员
展示了无菌原料药的生产工艺流程以及空调、纯化水等公用工程设施。
交流会中安排了自由交流环节，同学们、老师和企业代表针对 ISPE 协会的认证流程、
协会的课程学习考试情况、无菌原料药的应用领域、GMP 的验证方法等方面纷纷提问，两位
受邀专家都一一耐心地做解答。会后，在医化学院会议室，联化科技股份有限公司、海正药业、
浙江新华制药有限公司企业代表与医化学院教师就企业与学校的合作、制药专业的管理和技术
特点、学生的培养和就业、企业对从业人员的需求、大学生在企业的发展等方面进行进一步的
深入交流。
本次国际制药工程协会 COP 实践交流会，结合了化工、制药等相关专业的特点，旨在
帮助学生提高对专业发展前景的认识，为今后更好的就业打下基础，活动也拓宽了学生视野，
增强了学生的专业与学科素养。
ISPE China office
Tel: +86 21 23123640
Fax: +86 21 2312 3699
Email: china@ispe.org
精彩剪影
ISPE China office
Tel: +86 21 23123640
Fax: +86 21 2312 3699
Email: china@ispe.org
ISPE China office
Tel: +86 21 23123640
Fax: +86 21 2312 3699
Email: china@ispe.org
ISPE China office
Tel: +86 21 23123640
Fax: +86 21 2312 3699
Email: china@ispe.org