When you look at regulatory guidance, it is clear there are Key Performance Indicators (KPIs) that would expect to be seen during an inspection. While a guidance can’t be enforced, If your organization doesn’t have KPIs around a process then how do you justify or prove that you are maintaining control?

If something was important enough that you established a goal, how are you proving that you are meeting that goal?

Setting the right KPI is a powerful tool to support a strong quality system, meet your targets, and maintain regulatory compliance.

But how do you set the right ones?