Prioritizing Based on Risk

You probably already practice this but maybe don’t realize it. Every day, you prioritize your tasks and put the most effort into the most important tasks and it’s the same with CAPAs. You can and SHOULD prioritize based on risk. Efforts should be commensurate with risk. You don’t want to expend resources chasing trivial problems. You do want to expend resources when public safety is at stake! Your choice of investigation techniques may differ based on risk.


For example, a more scientific approach such as FMEA or FTA may be warranted when patient harm is involved whereas a “5 Why” approach may be suitable for certain process issues.

We’ve already mentioned that you need to document everything. Here’s a place where it’s very important to document any risk-based decisions you make.