Keep it Simple (Silly)
I would like to introduce you all to member of the McCormick LifeScience Consultants, LLC team, Jacob Cooper, Quality Systems and Regulatory Operations Consultant. Jacob has worked in Quality Systems and Regulatory Operations for nine years, and has experience implementing simple, scaled to purpose quality systems in three different companies.
Take it away Jake!
Imagine you’re tooling back from your holiday extravaganza in Maine in your sleek new drug development car. It’s a tiny little number, fits just you and Aunt Millie. Boy, will you be able to fly in this! But it has these big “REGULATED” stickers all over it. This means that not only do you have to obey the traffic laws (like you were planning to do), you have to be able to prove that you’ve obeyed them at every step of the way.
You know that if it isn’t written, it didn’t happen.
So you enlist your Aunt Millie to observe every instance of a traffic code that you’ve followed, and write it down. But you need a counter-signature, so you draft your weird Uncle Mert for that. Pretty soon, they get overwhelmed trying to keep up, and in come cousins Marg and Mark to help out, along with their kids.
Suddenly, your two person sports car has becoming a hulking suburban assault vehicle, barely able to stay in the lanes. As everyone jostles around to help, you realize you need some systems in place to keep them in line.
Systems, you think, aha! Now I can really control things.
You start designing away, assigning tasks and sub-tasks and workflows and processes to all of your M-named relatives. There’s suddenly so much work you have to bring in Mary, Martha, Matt, and Max just to make sure everyone’s doing the right thing. And woe betide Nancy if she wants to join – she’ll have to change her name to Mancy, or she won’t be able to work in the systems you’ve set up!
Congratulations, you’ve created a bureaucracy.
Somewhere, the goal of staying in compliance got obscured by the goal of proving it. As quality professionals, we are called on to manage the line that demarcates compliance with federal regulations. The role of quality systems is to enhance and facilitate that management. All too often, quality systems are put in place once the car is already hurtling down the highway, and usually to address an immediate need. The result can be complex, bloated processes that not only make it hard to follow them, but actually increase the risk of a company coming out of compliance.
Since the systems we write for ourselves are a part of our compliance portfolio, if you will, we must stay in compliance with our own systems. A common example is the procedure for completing documentation. How often have you seen company effort expended on minor infractions of this one? Compliance may have been breached against the procedure, but has a regulation? In most cases, probably not.
Beyond this, complicated systems can actually put regulatory compliance at risk. One way this can happen is avoidance. If you have a draconian change management process, you can invite a culture of sidestepping it entirely to avoid the pain of going through it. Better to get a 483 than deal with that, you might hear! Obviously, that’s not something anyone wants to contemplate. So how do we re-think this?
Go back to the basics of what compliance is against.
The regulations, daunting as they can be, can also be surprisingly vague. Documentation, for instance, must be “controlled,” but exactly how that is achieved is left to industry. Through the years, practices have arisen to suit many needs at many scales. Which leads to the second point…
What works at one place won’t necessarily work at another.
As organizations grow, sometimes bureaucracy can be the only tool in the compliance box that does the job. But most companies aren’t there, and a system designed for large companies will simply bury a small one. Finally . . .
Small, simple systems can encourage compliant behavior just by being easy to use.
Fair warning, however; implementing a simple quality system that maintains compliance is actually much more difficult than throwing together a complex one. The logic must be carefully planned, and all the variables still have to be accounted for within a leaner framework. We can define controls in such a way that they are less cumbersome, but we still have to be able, in the end, to prove that we obeyed all the traffic laws.
- Remember the compliance goal of any system, and watch that you’re not adding ones that don’t belong.
- Know your environment, and design for that environment.
- Keep your end user in mind at all times! Quality systems are there to enhance and facilitate compliance, not to keep the Quality Unity busy.