A transformation in quality systems is needed to liberate the power of information, digital, manufacturing and analytical technologies and accelerate the next generation of medical products reaching the patient, Johnson & Johnson Chief Quality Officer Francois Sallans affirmed in his keynote address at the opening of the ISPE/FDA/PQRI Quality Manufacturing Conference in June.
Quality systems (QS) have evolved from being centered around quality control through lab testing, to a focus on quality assurance, and now to quality culture. Noting that making culture the QS cornerstone is “a game changer,” Sallans explained that the question that presents itself – and one that ISPE has been focused on – is “how we measure it and what do we do with it.”
He cited a comment from an FDA drug compliance official during a panel discussion that a change in a manager can make a difference between the site being “compliant and good, to a site becoming all of a sudden non-compliant and bad.”
In looking to the future, Sallans emphasized, “it is important to start thinking about how we use technology and artificial intelligence to make our quality systems and operations agnostic of culture and variability between the people who manage the systems…. The way it is articulated, the way it is controlled, the way we have oversight in each and every [moment] of our execution, has to be fundamentally different going forward. And unless we start today, we will never get there.”