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News and Press: MichBio News

biolink Regulatory Column - September 2014

Wednesday, September 24, 2014   (0 Comments)
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Make Regulatory Compliance Easy by Not Thinking About It

Norm Howe, Sr. Partner, Validation & Compliance Institute


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.

Most of the procedures that the employees have to follow are 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." 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 do it. 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 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 INPUTS to these same business processes. Let the employees pick the input behaviors that drive good outputs. Then repeat those behaviors until they become habits. Then they will be compliant without thinking about it.

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