By the time a consent decree comes along, it’s no longer a
discussion about responses to 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 fresh
coat of paint.
Regardless of the huge effort and expense 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 often-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.
