The Harmonization of DMAIC and the PMBOK® Guide for Pharmaceutical Lean Six Sigma Projects

Michael Herskovitz earned a BS in Aerospace Engineering from Penn State, a Master of Science in Engineering Management from Drexel, a Six Sigma Black Belt certification and a Project Management Professional® certification through Villanova. Michael’s career includes experience in aerospace, defense, semiconductor equipment manufacturing, pharmaceutical development and commercialization, and adjunct teaching.

Lean Six Sigma (LSS) and the PMBOK® Guide agree that a project has (i) a distinct life cycle with clearly defined start and end dates, and (ii) it follows a prescribed logical progression from start to end. However, each methodology prescribes a different set of phases to a project’s life cycle. These phases are outlined in Tables 1 and 2. The intent of this paper is to suggest an integration of the objectives of the different phases into a harmonized life cycle roadmap to assist productivity improvement project teams create a project roadmap that leverages the best of both methodologies.

Before the methodologies are compared and harmonization is suggested, it is necessary to acknowledge that pharmaceutical research and development (R&D) processes are unique. The evolution of a drug product requires the integration of diverse scientific and business disciplines over a very long time line and under a highly regulated environment. Recent economic pressures have pushed the pharmaceutical sector to leverage lower cost regions and, in doing so, have further complicated the workflow by adding global touch points for knowledge and data transfer. It is this uniqueness that is often the principal difficulty in introducing LSS to a pharmaceutical R&D organization. However, as this paper will illustrate, the harmonization of DMAIC and PMBOK® Guide

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