Deming Institute Advisory Board Chairman Kelly Allen maintained at a PDA/FDA Pharmaceutical Quality System (ICH Q10) Workshop on Quality Risk Management that the pharmaceutical industry has, in general, been missing 80% of the power of Deming’s management methods, which involve understanding: ● the organization as a system ● variation ● the theory of knowledge, and ● human psychology.
The workshop was held in Baltimore, Maryland in November 2014 and was co-chaired by CDER Office of Compliance Office of Manufacturing Quality Associate Director for Risk Science Rick Friedman and Sanofi Pasteur Chief Quality Officer Anders Vinther. It brought industry and regulatory thought leaders together to discuss and share examples of quality risk management (QRM) and knowledge management (KM) as enablers for a proactive pharmaceutical quality system (PQS).
Allan maintained in his presentation at the workshop that the approaches the pharmaceutical industry is focusing on, such as the use of QRM, KM and PQS, are what he would categorize as a “powerful, important, necessary 20%” of the Deming methodology.
“And you are getting that,” he emphasized. That 20% is easier to grasp, well-known, “and it changed the world already. But there is another 80% there that is mostly unknown and untapped. And it is the next big thing for competitive advantage.”
Included in the “untapped” 80% is Deming’s “fourteen points for the transformation of management” (see box below). CDER Director Janet Woodcock underscored one of the Deming principles, which is to “drive out fear,” several times in a recent presentation in which she stressed that fear-based relationships are antithetical to progressing quality systems (IPQ April 25, 2015).