I am pleased to introduce myself as Tefen's new contributor to this regular column. During my tenure with Tefen, I have had
the opportunity to support a number of the industry's largest firms as they struggled with the challenge of changing their
culture and their way of doing business. This month's column will focus on the current state of the industry, regarding operations
excellence, as well as provide an update on the 2006 BioPharmaceutical Operations Excellence Consortium meetings.
As the primary facilitator of the event over the past four years, I have seen a broad spectrum of presentations that highlight
challenges the industry is facing within their operations. At the same time, I have witnessed some great success stories in
dealing with these challenges. Where have we seen the most success within the industry over the past four years?
When initiating operations excellence programs, most companies select "Lean" concepts and tools as the primary strategy for
launching the improvement process. The most popular consortium meetings have focused on the successful use of these tools
to drive improvement in areas like cycle time reduction, deviation reduction, and improved production efficiency. The results
from the projects are clear and measurable, and prove that even in a regulated industry, change can occur rapidly.
As a single measure, the disposition time of production lots can indicate the health of a biopharmaceutical organization.
Issues in manufacturing, quality assurance, and quality control all contribute to the complexity of lot disposition. As a
result, many companies place a significant focus on fixing and accelerating this process. Lot disposition time averaged 85
calendar days in the BioBenchmark study Tefen conducted in 2002. Recent reports found companies consistently achieving dispositions
in 50 days or less, with low variability. Projects that drove this improvement focused primarily on accelerating the deviation
management processes, the primary inhibitor of product release. Companies have more QA resources in production, performing
more real time review and investigation work for problem lots. As a result, companies are more successful in meeting market
Even with the success the industry has experienced over the past several years, there are still some key areas for improvement.
These areas will most likely appear on the agendas of future consortium meetings, and include the topics described below.
Although progress has been made in accelerating overall lot disposition, process deviations for many companies are still a
significant problem. Disposition time reduction programs have resulted in better categorization of events and faster identification
of Corrective and Preventive Actions (CAPAs). However, in the interest of providing rapid review and CAPA identification,
the quality of investigations has suffered. A focus for companies moving forward is how to quickly advance this process while
ensuring that the true root cause has been established.
OPERATIONS EXCELLENCE MOVES INTO R&D
Most operations excellence programs have been initiated in production, with a manufacturing focus. When one examines the concerns
of top industry executives, though, how well are these improvement programs supporting their goals? Some companies have been
aggressively exploring the application of operations excellence tools, such as Design for Six Sigma in the research and development
organizations. Although driving operations improvement into R&D is a dramatic cultural shift for the scientists working in
and running these organizations, it is not new. Most industries have incorporated best practices from Lean and Six Sigma as
a way to drive more success into the manufacturing areas. The benefits target top line growth — they drive more products through
the pipeline faster, with fewer problems in manufacturing. These are good excuses for starting the process.
IMPROVED PROCESS UNDER-STANDING AND CAPABILITY
One of the key challenges facing production groups is the capability of the process reaching the production floor. Historically,
the pressure for rapid development and product launch has resulted in development operations being less focused on "Design
for Manufacturability" concepts. Once processes were transferred into the commercial line, or scaled up, operators were left
with batch records that were difficult to understand and follow. The resulting deviations cause disposition delays and supply
With newer information technologies such as Manufacturing Execution System, Distributed Control System, and Electronic Batch
Records becoming more common, the necessary data and tools for better process understanding should improve the way companies are
attacking process improvement.