As one surveys the Leaning of Pharma, the journey continues — just like any industry. In spite of the gaps in understanding and implementation, Pharma’s late-coming embrace of Lean Six-Sigma may be a blessing in disguise. The disciplines are well understood, but in Pharma, perhaps not quite as much. The industry’s on a learning curve — but an accelerated one — because it can apply best practices outside the Pharma universe and learn from other’s early missteps. Lean done right can be an amazingly sharp tool to achieve cost effective, efficient and profitable operations. Its disciplines and basis in statistical process control are well aligned with cGMP and QbD theory and practice and support empirically provable compliance when it comes to critical processes. As the Pharma industry responds to the global market’s competitive and financial pressures, its success will be increasingly dependent on operations optimized the Lean Six-Sigma way.
Published in the October 2013 edition of Pharmaceutical Manufacturing magazine
Editor’s note: During my reporting for the cover special feature on the leaning of the pharmaceutical industry,
I had a chance to discuss with Bill Faria, Head of Operational Excellence at EMD Millipore, how Lean principles are being embraced by his organization.
PhM: How do you promote/manage process excellence and waste mitigation across your operational (factory floor, R&D, supply chain) ecosystem?
Faria: “Our Operational Excellence organization is responsible for promoting and managing process excellence and waste mitigation across our operational ecosystem. We have team members in most of our sites and functions responsible for partnering with local leadership teams to understand site and/or functional priorities and to align process improvement efforts to those priority areas. The teams lead and mentor process improvement projects while also teaching a variety of problem solving tools and methodologies utilizing Lean & Six-Sigma principles.”
PhM: Are your operational efficiency initiatives based on Lean Six-Sigma principles? How has your organization institutionalized lean concepts and has it evolved to suit your strategic needs operationally and/or competitively.
Faria: “Yes, our operational efficiency initiatives are based on Lean and Six-Sigma principles. We focus on using the right tools at the right times. We have many examples of Lean concepts implemented in many of our sites (5S, kanbans, visual management, visual work instructions, mistake proofing, etc.). Our program has evolved from initially focusing on cost savings opportunities to a more balanced view of cost, supply and quality opportunities to ensure our process improvements are focused in the right areas. “
PhM: Are there particular aspects of your operational continuum that have received recent scrutiny and the application of Lean principles?
Faria: “One area of opportunity where we are aligning our Operational Excellence team is in Supply Reliability, focused on improving our delivery performance to our customers. Looking at the end-to-end supply chain has helped us identify areas of opportunity to align the teams and improve information flow and process hand-offs.”
PhM: Considering that your organization is actively implementing Lean/Six-Sigma principles to improve and sustain efficient waste-free operations across several fronts, how mature would you say your initiatives and culture are?
Faria: “We have been utilizing Lean/Six Sigma principles for eight years and are still in the early stages of our journey to establish a Continuous Improvement culture. We are past the ‘activity’ phase (initial training, forming teams, starting projects) and are well into the ‘process’ phase (end-to-end process view, cross functional projects, mature training program) of a typical process improvement lifecycle, with an ultimate goal of making it part of the ‘culture’ (the way we naturally solve problems across all levels of the organization).”
PhM: What benefits/returns has your organization realized from the institutionalization of Lean-based or other waste-reducing optimization strategies?
Faria: “We have realized many benefits from our Operational Excellence program over the years. From substantial cost savings to improvements in product and process quality to delivery performance gains to customer satisfaction focused projects and initiatives. We constantly look for ways to utilize the program to improve our business in many different areas.”