Maybe I can start, Pam.
Thank you, Chair, for the question.
The term “risk-based” is something that, in the regulatory space especially, confines enforcement. You will hear us speak to it often. It directs much of our decision-making.
What we mean when we say “risk-based” is that when we are looking at a situation to determine the level of risk, we apply a fairly lengthy but consistent set of criteria. We look at the nature of the non-compliance, although all are important. We look at whether it is a labelling issue versus contamination, the type of non-compliance and what risk that represents. We then look at the target population of a product. Perhaps it's a vulnerable sub-population or something of that nature. We will look at the compliance history of the party we're dealing with.
What we do to ensure it is risk-based is to consistently apply those criteria. That dictates what action we take and how quickly. It really directs all of our decision-making.
Pam, do you have anything to add?