Operations Excellence

Aug 01, 2003

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 discussions.

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.

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