ABSTRACT
In spite of the demonstrable value of Six Sigma and Lean
Manufacturing programs, there remains considerable
skepticism within the ranks of pharmaceutical engineers
and quality professionals about their validity. At the
same time, many process improvement professionals
attempting to use these tools and methods to reduce
variability and increase process efficiencies are surprised
by how often they are confronted with resistance centered
onoutmodednotions ofwhat itmeans tovalidate pharma-
ceutical processes. Often the very fact that the process has
been validated is used to justify resistance to process
improvement proposals.
