Make Regulatory Compliance Easy by Not Thinking about It

Companies go through two stages when they try to become compliant with FDA regulations.  Stage one is to write all the procedures that translate the regulations into specific actions for the employees.  That’s hard enough.  In stage two the company has to get all its employees to follow those procedures. 

This is the stage where so many companies get lost in the weeds.  Most companies spend much more effort on stage two than stage one.

The procedures that the employees have to follow are mainly simple.  Why, then, is it so hard for them to just do the job right?  Every error has to be investigated, creating more paperwork.  Managers have been known to grind their teeth to a nub during this stage.

If you find yourself in this position, here is what you can do to make life easier for yourself.  Recognize that your employees have got a lot on their minds when they’re executing a procedure.  Not only do they have to perform that particular task, they have to remember all of the background regulatory requirements for that job.

Of course you have trained the employees on these requirements.  But, the procedures are new, and more importantly, different than what they’re used to.  The new requirements are still competing with the old ways in the minds of the employees.

This means that you need to break old habits, AND you need to instill new habits in your employees.  Make no mistake, this is a daunting prospect. 

Habits can be your best friend, if you understand how to make them work FOR you and not against you.  As Wendy Wood explains in her session at the American Psychological Association's 122nd Annual Convention. "The thoughtful intentional mind is easily derailed and people tend to fall back on habitual behaviors.”  Wood continues, "Habits allow us to focus on other things…Willpower is a limited resource, and when it runs out, you fall back on habits."

Researchers at University College London have found that paying attention can change how the brain allocates its limited energy:  "Our findings suggest that the brain does indeed allocate less energy to the neurons that respond to information outside the focus of our attention when our task becomes harder. This explains why we experience inattentional blindness and deafness even to critical information that we really want to be aware of."  The woman in the image is biting her fingernails and she’s not even aware of it.

If you ascribe an operator's error to 'inattention to detail', beware.  Human beings have a limited amount of attention.  The operator may have been multi-tasking and their focus was elsewhere.  The solution is not to tell the operator to 'pay closer attention'.  Even if you don't totally alienate all of your employees with this corrective action, the operator can, at best, simply re-allocate this limited resource onto a different part of the job.  Something else will then fall into the cracks.

No, the job needs to be re-engineered to reduce the amount of attention that needs to be paid.  That re-engineering can consist of automation, poka yoke, or any number of other changes to ease the cognitive burden on the operator.  One route that should be included in the analysis is quality habits.

Habits are a form of automation.  They allow us to perform tasks even when we're unaware of it.  If you can supplant old, non-compliant habits with new compliant habits, you can start making habits work in your favor.

Good habits can be powerful.  A habit is something that you do automatically.  You don’t think about it.

The question is, how do you embed good habits into a sizeable group of people.  In a business context, you do it like every other improvement that involves large groups.  You set goals and measure your progress toward meeting those goals. 

Most companies set goals for reducing CAPAs or improving yields.  These rarely work, because they are the NEGATIVE OUTPUTS from dysfunctional business processes.

What we found, however, in implementing compliance upgrade projects is that employee teams are most effective when they focus on improving key behaviors that are the POSITIVE INPUTS to these same business processes. 

Let the employees pick the input behaviors that drive good outputs.  Then measure and reward those positive behaviors until they have been repeated enough to become habits.  The employees will then be compliant without thinking about it.

How about you?  Do you have a similar story?  What has worked best for you?  Comment below.

"Nervous" by Maxwell GS on Flickr - http://www.flickr.com/photos/maxwellgs/4267311036/in/photostream/. Licensed under Creative Commons Attribution 2.0 via Wikimedia Commons - http://commons.wikimedia.org/wiki/File:Nervous.jpg#mediaviewer/File:Nervous.jpg