CLIENT: This global biopharmaceutical company manufactures prescription pharmaceuticals in several therapeutic areas. The plant implementing this initiative produces solid and injectable pharmaceutical products.

CHALLENGE: In a continuous quest to achieve manufacturing excellence, site managers explored opportunities to reduce the number of investigations as well as the number of days required to close their investigations. The plant did not have a standard, systematic approach to finding the root cause of manufacturing deviations. In fact, engineers and scientists often relied on trial and error approaches that delayed investigations or created recurrences of deviations because true cause was not found and corrected. Site managers believed that by adopting a formal methodology to ensure faster time to closure on investigations, they would be able to reduce the number of investigations and improve investigation results.

RESPONSE: After a rigorous evaluation, a decision was made to implement the Kepner-Tregoe investigation methodology. Site managers developed implementation plans around four major actions:

  1. Create investigation teams based on the type of operation: To help structure the investigation process, teams were formalized and roles and responsibilities were defined.

  2. Redefine investigations according to specific criteria. Instead of using the same approach for all deviations, site managers defined higher impact events and required use of KT methods for these investigations.

  3. Implement KT as the investigation methodology for investigations. 3. A training program introduced all employees to the KT methods for problem solving and developed problem solving and decision making skills in investigations teams. Two employees were trained as instructors and facilitators for the KT approach. SOP s that incorporate the KT methods were created for documentation of all Investigations.

  4. Define business goals for performance. Two goals guided the initiative:

  • Close 90% or more of manufacturing investigations in 30 days or less
  • Reduce the number of investigations by 20%

RESULTS: The work plan to improve the investigation process and incorporate KT as the investigation methodology was completely developed and implemented in less than six months. Within a year of identifying this opportunity for improvement, management and investigations teams reported a new confidence in their ability to conduct investigations quickly and accurately. Comparing year-to-year, investigations fell by 33% using the new approach. When compared with the previous year, closings dropped 13%. As a result of these successes, investigation teams are more focused and disciplined, and systematic KT approaches have been integrated into other business functions to facilitate concerns and critical decision making.