Saturday, March 12, 2011

Consent Decrees—It’s about Sustaining Compliance


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.


John Snyder
The QA Pharm

The QA Pharm is a service of John Snyder & Company, Inc.

John Snyder & Company, Inc., provides consulting services to companies regulated by the Food and Drug Administration. We help our clients to build an effective Quality Management System to enable reliable supply of quality products to their patients. We also help our clients to develop corrective action plans to address regulatory compliance observations and communication strategies to protect against accelerated enforcement action.


Contact us at john@john-snyder.com.

2 comments:

  1. Where have you been? Only one post in March?? We miss you.

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  2. Dear Anonymous,

    I can't tell you how nice it is to be missed! Sometimes I wonder whether I am just writing to myself for cathartic reasons.

    The nature of my work (while I exhaust the waning years of my life) is to answer when the Red Phone rings. However, now that I am energized by your personal message, I will not disappear into the sunset.

    Thank you for being there and listening to my rambles.

    With best regards,
    The QA Pharm

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