Many biopharmaceutical companies are transitioning from a strict R&D focus to one that incorporates manufacturing and supply-chain
management capabilities, and it is critical they start thinking about operations excellence.
Increased competition, long development and production lead times, a shortage of qualified personnel, challenging compliance
requirements, the high cost of quality, and the notion that biogenerics are only a few years away are shaping this industry
trend of world-class operations development. Operations excellence will be essential to developing and maintaining a competitive
edge and capitalizing on new product opportunities.
Until recently, biopharmaceutical companies concentrated on the consistent manufacture of their difficult products. Now, after
proving their capabilities, they are attempting to improve overall performance, mostly as it relates to supply-chain management
and quality systems and processes.
One indication of this trend is the formation of the BioPharma Operations Excellence Consortium (www.tefen.com/consortium). This cross-functional group of industry executives and managers, representing manufacturing, the supply chain, quality
assurance, and quality control, meets regularly to informally benchmark operational challenges and propose solutions.
Operations Excellence Consortium
The consortium was founded in April 2002 and serves as a forum for addressing the most effective and efficient cross-functional
business processes related to product development and delivery. This group's purpose, as stated in its charter, is "to share
experiences and surface key challenges facing biotech manufacturing companies and to use the group's collective knowledge
to drive each member company, and the industry as a whole, to world-class levels of operational effectiveness and efficiency."
Tefen Ltd., an operations consulting firm specializing in the biopharmaceutical industry, was selected to lead and facilitate
the consortium's efforts. The group of representatives from more than 25 different companies meets quarterly for a full-day
conference hosted by one of the member companies. To date, Genentech, Amgen, Bayer, Baxter, and Chiron have hosted the consortium.
Each meeting is devoted to a central theme, such as lot release cycle time reduction, contract manufacturing, corrective and
preventive actions (CA/PA), and human errors. The forum atmosphere is informal, and the agenda combines case study presentations
with brainstorming sessions, panel discussions, and vendor demonstrations. Time is always set aside for networking and open
Human Errors Reduction
Chiron Corporation hosted the Consortium's most recent meeting (May 2003), during which members addressed the challenge of
human errors and their effect on cycle time, manufacturing costs, compliance, and overall company performance.
Consortium members agreed that one category of human errors — document errors — has a significant impact on performance. Reducing
such errors and establishing measures to identify nonconformance were a central part of the discussion.
Tefen presented the results of its recently-conducted industry survey on human errors. Different bio/pharmaceutical companies
revealed that the most effective efforts in resolving human errors includes:
increasing the visibility of operator errors
simplifying operator tasks
offering more robust and rigorous operator training
improving the clarity of, or providing additional detail to, batch records and standard operating procedures.
The survey revealed that the most common methods for increasing visibility and publicizing operator errors is by reviewing
them in shift and area management meetings and posting quantities and trends in highly visible public places. It also indicated
that in most organizations, there is a lack of personal accountability in terms of operator error. Only a small portion of
the surveyed companies currently considers errors in the annual employee performance review.