The principle that fear-based relationships are antithetical to progressing quality systems is pivotal as FDA reshapes its quality regulatory approach, CDER Director Janet Woodcock is stressing.
The point was underscored several times by Woodcock in her keynote presentation at the ISPE quality metrics meeting held in Baltimore, Maryland in April. Her remarks have significant implications as she has been driving the quality regulatory changes both conceptually and operationally as CDER’s leader and now in her dual role as Acting Director of the new Office of Pharmaceutical Quality (IPQ October 26, 2014).
Fear of reporting problems internally within a company and fear of negative repercussions from reporting them to the agency drives behaviors that are not just non-productive, but “anti-productive,” Woodcock emphasized.
The CDER/OPQ leader’s message harkens back to a fundamental tenet of quality guru J. Edwards Deming, “drive out fear,” first published as part of his “fourteen points for the transformation of management” in the seminal 1986 book, Out of the Crisis.
While fear is a roadblock on the continuous improvement pathway, measurement is a critical driver, Woodcock said, in explaining why FDA is focusing with industry on the metrics initiative.