Updated: Dec 16, 2020
This is one of my favorite discussions! If compliance is not important in board room discussions then it will be hard to melt into company culture. If compliance is not part of company DNA it can accentuate the "Us Versus Them" mentality between Quality, Operations, and the C-Suite. This creates a vicious cycle which could eventually lead to terrible occurrences, such as companies falsifying records. We all know where this ends (jail).
Here's a few thoughts on how to weave compliance into the company DNA
#1 This starts from the top. Without a strong CEO & executive buy-in compliance culture will not be integrated in the company DNA.
#2 Hire executives from your industry with a proven track record. This seems obvious but having members of the C-Suite who understand how to interpret regulations in a way that makes sense for YOUR company is valuable. They will help guide the compliance ship in the right way. Hiring from other industries such as apparel for a supplement company does not always fit. I discussed this here with Danielle Masterson on her NutraCast podcast.
#3 Understand when to say goodbye to those who don't fit and won't change. Is an executive outspoken about choosing sketchy sales practices over compliance? Is so it's time to say goodbye. 👋
#4 Reinforce good behavior with a monthly compliance award. 👏
#5 Publicize your company compliance best practice culture deck. This is very Silicon Valley but there're some good lessons here. https://www.stitcher.com/show/masters-of-scale/episode/8-why-culture-matters-wnetflixs-reed-hastings-51210066
#6 Ongoing training on FDA/FTC enforcement trends
I would also like to point out that Quality Management Systems (QMS) are best developed with operational efficiency in mind. A QMS can be robust but doesn't allow for company efficient and compliant growth which in turn will hurt the overall business. Since CFR 111 (supplements) has room for interpretation why not develop and implement a QMS that interprets regulations in a way that is #1 compliant, but also streamlines efficiency. It is common for QMS's to be developed in a vacuum that can hinder company efficiency.