WHAT THE COMPANIES ARE DOING
The results of the survey indicated that the programs are primarily focused on achieving improvement in cost, quality, and cycle time. Over 80% of the respondents said that their programs have been in place for less than three years. According to the survey, the number of full-time resources dedicated to operations excellence ranged from one to 20. The survey also showed that most programs are designed around Lean concepts, with a much smaller number incorporating elements of Six Sigma.STATE OF OPERATIONS EXCELLENCE
Unfortunately, the results of these programs have not been stellar. About 66% of respondents admitted only marginal success in meeting management expectations. Several themes applied to most of the companies driving these programs, which helped us understand the current state of operations excellence in the industry. Some of these themes included:
Evolution Versus Transformation
Starting with Manufacturing
Most pharmaceutical companies began their operations excellence programs in the manufacturing area, probably because most of the methodologies were developed in other manufacturing industries. Nevertheless, more successful organizations have applied these tools more broadly and included quality, supply chain, and engineering. A focus on research and development (R&D) is still missing, however, because of political and cultural challenges. Nonetheless, R&D related improvements are high on the list of priorities for senior executives (see Manufacturing: BioPharmaceutical Operations Roadmap 2007 in the April 2007 issue of BioPharm International).
There is a Lack of Business Imperative
Although management supports these programs, there is a feeling that a business imperative is not yet there to make these programs transformational rather than incremental. The threats of direct competition, price controls, stricter regulatory requirements, and biosimilars are on the horizon, but the companies have not felt the need to act in anticipation of these challenges.