PhM: What have been the most successful aspects of the program, and which Lean Six Sigma tools have worked for you?
P.G.: Patheon Advantage is successful for us because it is based on the principles of Lean Six Sigma: focus on customer value, make decisions based on data, eliminate waste and variation, and engage our people to make change. One of the most valuable Lean Six Sigma tools for us has been value stream mapping. It helps us understand our business “door-to-door,” so we can eliminate the bottlenecks and waste that inhibit responsiveness and increase cost.
PhM: Which aspects haven’t worked as well, or have been deemphasized?
P.G.: Some tools or aspects of PA may seem to work better than others, but it really depends on application. The challenge is matching the method to the matter. If you give a kid a hammer, everything looks like a nail! We give our people a full tool box and teach them how to pick the right tool for the DMAIC phase they’re solving.
PhM: Where is the program in terms of its maturity?
P.G.: Patheon Advantage is heading into the 18th month of deployment, with all 10 Patheon sites fully engaged. We have nearly 150 projects on the books, representing the work of 24 Black Belts and 93 Green Belts, with an average project value approaching $100K. PA is maturing nicely, but as with any culture change process, we’re still learning to lead and manage change effectively. Our greatest challenge is to engage all our associates in change that adds value to our customers and to our business.
PhM: How much outside expertise have you brought in, and what’s been your training strategy?
P.G.: We are working with Ken Somers, a consultant with significant Lean Six Sigma pharma experience, to help us with our training and deployment. We educated our Site Leadership Teams, then trained a Champion, at least two Black Belts, and a small cadre of Green Belts at each site. In their training, the Belts followed the DMAIC process to analyze a product, or value stream, door-to-door. Then the Belts led kaizen events that fundamentally changed the way we executed the value streams. Now we’re applying the lessons learned to other value streams and other sites. We’ve begun a second wave of belt training, with the goal of becoming self sufficient this year.
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.