A Performance Management Tool
PART II.
|
The data required for full lot tracing is stored in the lot traceability system and characteristically is retrieved only when problems arise. The data is in the ownership of the Quality department, and often jealously guarded. It may be seen more as an extension of the laboratory systems than as a management tool. Yet the lot traceability system is the repository of a large amount of data that with care, imagination and sometimes some additional processing will reveal much about the state of health of the manufacturing operation, in general and in detail. It is the contention of this paper that this potential is largely unexploited. Management Performance Information Requirements It has always been clear that a critical performance factor in any manufacturing operation is time. Delivery time to customers, replenishment time to warehouses, manufacturing time level by level, material sampling and analysis time, material purchasing lead time, even information recording time, are all vital components of total lead time. It has also been clear that this total throughput time, or velocity, has not always been seen as a major success factor within pharmaceutical companies. The time-related and hence velocity-related factors likely to be important in a pharmaceutical manufacturing and packing plant, perhaps with upstream active ingredient manufacturing facilities, include (per manufacturing level unless noted): • Planner time (decision and scheduling time) • Documentation preparation time • Material issuing time, individually and in total • Changeover time • Manufacturing or packing time (process time) • Sampling, analysis and approval time
• Cumulative lead time for finished or saleable products
• Campaign duration • Lot size mismatches (capacity mismatches) • Expiry and retest violations • Delays in recording A lot traceability system is inherently unlikely by itself to be able to provide information of a total or cumulative nature but may in many circumstances act as a data resource for extraction and external analysis. Performance Information Available through a Lot Traceability System One of the reasons, or excuses, for companies failing to install or use performance measurement indicators has always been the difficulty of obtaining and analysing the necessary data. This is as true in pharmaceuticals as elsewhere. There is a remedy. This section will examine how each of the specified performance indicators above can be obtained from a lot traceability system. The assumption will be made throughout that the lot traceability system in question is a fully-functional system capable of providing information to satisfy PDA (USA), MCA (UK), etc. requirements and that it operates in conjunction with a similarly fully-functional material control system. The lot traceability system is not a lot planning system (such systems are uncommon and are not mandatory whereas lot traceability systems are effectively mandatory and thus relatively widespread). Planner Time, Documentation Preparation Time Although entirely administrative, Planner Time and Documentation Preparation Time may contribute to the Cumulative Lead Time (q.v.). The lot traceability system has no direct part in them since the process of lot tracing does not begin until materials are actually issued to an order. Material Issue Time There are two relevant aspects of Material Issue Time. The first is the question of whether the materials were issued according to the schedule for the order. This should be answered through the records maintained by the material control system. The second is that of how long the issue process took. This data should be available in the material control system for all materials. If not, the lot traceability system should retain time, date and operator identity for every issue transaction for lot-traced items. The lot traceability system details make it easier to track down causes of delinquency such as late or incorrect issues, particularly where the process instructions demand successive additions of quantities of the same or different materials over a period of time. The lot traceability system may well make available a printed report showing all or a summary of issues by time period or by order or by material. To be Continued STAY CONNECTED To stay current on bullet-proofed manufacturing solutions, subscribe to our free ezine, "The Business Basics and Best Practices Bulletin." Simply fill in the below form and click on the subscribe button. We'll also send you our free Special Report, "Five Change Initiatives for Personal and Company Success." Your
personal information will never Manufacturing leaders have a responsibility to educate and train their team members. Help for developing a self-directed, World Class Manufacturing training program for your people is just a click away:
You are welcomed to print and share this bulletin with your manufacturing teams, peers, suppliers and upper management ... better yet, have them signup for their own copy at: http://bbasicsllc.com/subscribe.htm With the escalating spam-wars, it's also a good idea to WHITELIST our bulletin mailing domain via your filtering software or control panel:
Manufacturing
Knowledge you’ll not find at offsite
Lean
Six Sigma Consulting World
Class Manufacturing Email: Click here Privacy Policy |