Operation Exellence | The Quality Function: Best Practices in Pharmaceutical Quality | Pharmaceutical Manufacturing.

Aug. 2, 2006

Regulatory changes and increased scrutiny continue to challenge pharmaceutical companies to improve their quality functions. In confronting mounting FDA rigors, the consensus among world-class pharmaceutical companies is that the greatest defense against regulatory difficulties, production shutdowns, and recalls is a well- developed auditing function. Accordingly, pharmaceutical leaders strive to bolster the knowledge of their quality staff to foster innovation while consistently winning commitment of appropriate resources to support the functionality.

As captured in the benchmarking report, The Quality Function: Structure, Staffing and Execution, Best Practices, LLC, a leading benchmarking research and consulting firm, reveals strategic best practices in quality harnessed from survey responses and in-depth interviews with seven top pharmaceutical and medical device company leaders. A complimentary excerpt is available at http://www3.best-in-class.com/rr730.htm.

Indeed, executives from Abbott Labs, Lilly, J&J, GSK, Wyeth and others shared wisdom and key insights for honing elite quality functions within their organizations. A sampling of their tactics and best practices include:

  - Heighten intra- and inter-company transparency:  Disseminate
      information among quality staff about weak areas within the company and
      competitor companies, reflected in regulatory consent decrees and
      warning letters obtained from F-D-C publications and Gold/Green/Pink
    - Establish action-triggering metrics:  Develop reporting mechanisms that
      bring performance measurements and deviation reports before the eyes of
      senior management.
    - Focus quality personnel on activities and results not measures:  Employ
      integrated improvement charts to effectively communicate important
      measures to focus actions by responsible parties.  E.g., 3-in-1 charts

Quality managers and executives seeking to improve the quality function within their organizations will find this report invaluable for learning and emulating how the best in the world do it.

To download a free excerpt of "The Quality Function: Structures, Staffing, and Execution" visit http://www3.best-in-class.com/rr730.htm. For more information, contact Dorris Huffstetler at (919) 767-9259 or . [email protected]


Best Practices, LLC, is a benchmarking research firm that conducts work based on the simple yet profound principle that organizations can chart a course to superior economic performance by studying the best business practices, operating tactics and winning strategies of world-class companies. For over 12 years, our highly credentialed research staff has conducted primary research across every functional corporate area on almost every business challenge imaginable. Please visit our website at http://www3.best-in-class.com.