By the time a consent decree comes along, it’s no longer a discussion about responses to Form FDA 483s observations replete with well-turned phrases—it’s about a DIY Network renovation—a complete makeover. It’s a “gut-it” approach, as never before, which exposes the cracked foundation and termite-eaten beams weakened over time.
This is because the common element of a consent decree is demonstrating—sustainability. As in “over time.” That takes more than a simple fresh coat of paint.
Regardless of the huge expense and effort to redesign and implement a more robust Quality Management System (QMS), the real test comes afterwards—sustainability.
Long after the consultants have pulled up their tent stakes, the project plans flawlessly executed, the senior management dashboards faded away, the real mettle is yet to be tested—sustainability.
“Sustainability” is an attribute that is difficult to achieve under normal circumstances, not to mention under the supervision of the Department of Justice.
Geesch…can’t a person make an honest mistake anymore?
Is “sustainability” the same thing as “perfection”?
I sure hope not. If it is, we’re all screwed.
I prefer to think about “sustainability” in a more realistic way. Sustainability is the capability of an organization to know when it is veering off course and the ability to make the right decisions and take the right actions to re-center itself (without external intervention) to maintain a state of control.
Like in the human body, it’s an inherent homeostatic mechanism that monitors the manufacturing and quality process signals and responds accordingly to maintain healthy control of product quality.
“Sustainability” touches—nay, embraces—subjects such as values, culture, expected behaviors, empowerment and accountability. These don’t sound much like terms in the CFR. But the demands of sustainability require nothing less than organization transformation: from something, to something else that it wasn’t before—a makeover.
One thing for sure it is not. It’s not the FDA telling one over-and-over again about the same problems. In fact, consent decrees mandate a series of annual inspections performed by a third-party to determine sustainability, so FDA doesn’t have to.
In other words, FDA has already determined the recidivism of the defendant, and now they look for the third-party to spend their time and the defendant’s money to inspect and certify compliance—often for many years—measuring sustainability. Not FDA.
To achieve the attribute of “sustainability” is not easy, but worth pursuing under usual circumstances. Why wait for an injunction? The oft-surprising benefit of the makeover is operating in the “sweet spot” of economic control of quality and providing a continuous supply of quality product.
Consent decrees require an entirely different kind of response than usual, because a different kind of result than usual is expected—sustainability.
Sustainability—and the organizational capability to achieve it—that’s the goal.
Republished and adapted with permission from the QA PharmSUBSCRIBE TO OUR MONTHLY NEWSLETTER>>