The QbD/Six Sigma Connection, Revisited

I had a good talk a few weeks back with Patheon CEO Wes Wheeler about initiatives he's undertaken to increase performance across all sites, and to use performance indicators to drive marketing for new business. (Article here.) I also e-communicated with Patheon executive VP and CTO Paul Garofolo about the company's Patheon Advantage Lean Six Sigma and its ongoing progress. You can read that Q&A here, but I thought Garofolo's take on the QbD/Six Sigma overlap helpful:

PhM: Where is Patheon in terms of adhering to FDA’s vision of Quality by Design, and what role does QbD play in the PA program?

P.G.: We’re making great progress. It’s all about culture change, on both fronts. The fundamentals of Lean Six Sigma support the fundamentals of QbD. Some tools, particularly Quality Function Deployment, Design for Six Sigma and Design of Experiments are particularly well-matched with QbD. We’re finding that the methods we’re developing and the culture change we’re building with PA support fully our move to QbD.

--Paul Thomas