Bad Quality Is Contagious: Stop Before It Spreads

By Rosario Quintero-Vives, Sr. Regulatory & Compliance Specialist, RQV Consulting

Disregarding the rules in the regulated industry is like a contagious disease. If you don’t control it in the beginning, you and your organization will be lost. In advanced stages, it could require the termination of many employees with this disease.  When the FDA recommends you hire fresh eyes for quality systems on a warning letter, it actually means your problem is institutionalized. That’s why I recommend a biannual general audit by a third party. Even if you think you can go more than two years without an audit, this bad behavior can grow roots and can infect the quality culture of your organization. Then, when you do receive a visit from the FDA, it will be easier to correct unwanted behaviors and to renew your quality system, if needed.