Risk-based validation and verification in medical laboratories: an overview

In the first two articles of this series, we introduced the principles behind risk-based approaches and explored tools like FMEA, FTA, RCA and Process Mapping. These methods help laboratories identify where things might go wrong, understand why, and put controls in place before problems impact patient care.

This third article starts to apply those tools. We’ll look at how risk-based thinking can be applied to method validation and verification and bringing new equipment into service. These are familiar processes – but by approaching them in a risk-based approach, we can make them more patient-focused.

We will also tackle two broader topics. First, we’ll take a closer look at the Sigma metric. It’s a well-known tool for validation and quality control (QC) planning, but how well does it work from a risk perspective? Second, we’ll consider whether a shared, harmonised approach to validation and verification could make things simpler and more consistent across different laboratories.