Compliance is Complacency in Disguise

The path is perilous.

Compliance is the lowest rung on the ladder for any company in a regulated industry. You’ve had a couple of successful submissions. A favorable inspection. A new certificate hanging in the lobby. First few installs went fairly well.

We The Best!

Then demand kicks up, sweet! A few complaints come in, awe. All good, the team will rally, push through and get everything done.

Demand hockey-sticks, reactive measures are taken to address inefficiencies. It’ll be fine.

Oops, a failure on arrival…

and another one.

Another one! We’re not the best!

LOT Contained. Field Corrections. Mo’ Products, Mo’ Problems.

What happened to our “Compliant” Quality Management System?

It was all good just a week ago.

You were caught hanging from the lowest rung of the ladder, feet dangling, struggling to reach for the next without leverage. You didn’t build a robust, optimized quality system with well defined contingency plans to deal with failure or success. Both realities will disrupt, distract and disable your teams quick, fast and in a hurry.

You can’t plan for everything but you need to plan for more than compliance and cross your fingers. You need to be ready for anything. Design best-case/worst-case scenarios, develop plans to react, and define roles/responsibilities. Then practice, practice, practice and practice some more (Yes, we’re talking about practice). Continue to improve your plan as the team learns. Ensure your team knows what to do when everything goes live. Their panic will cost you more than the practice did.

Compliance is only as good as your ability to ship.