"We are all aware of the heightened emphasis the FDA is placing on risk assessment," comments Andy Barnett, NSF.
ICH Q9, quality risk management was adopted by the FDA in June 2006.
"You might expect, after 11 years, the industry would be fully on board with the practices recommended in this document, but we may not have come as far as one might think in the area of risk estimation" he says.
The two primary principles of quality risk management, per ICH Q9, are:
- the evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient
- the level of effort, formality and documentation of the quality risk management process should be commensurate with the level of risk
Many FDA-regulated companies have adopted a three point rating scale for each category.
For those who prefer words compared to numbers, the scores correspond to low, medium or high risk.
The purpose of the risk prioritisation is to discriminate between risk levels and ensure that higher risk events are subject to a higher standard of due diligence.
But your scoring practices may not deliver the expected results.
Interested in finding out more? Download the full white paper from NSF.
