Best Practices: Calibrating And Managing Sensing Instruments In GxP-Compliant Applications

Calibration Risk Assessment,
Where Do You Start?

According to ICH-Q9, Risk Assessment involves "the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards." Performing a Risk Assessment for product impact from out-of-specification sensing instruments is now an expectation in regulated environments. To execute a realistic and justifiable Risk Assessment, you need to understand the probability of occurrence of an adverse event, as well as the detectability and severity of the risk event.

To assess risk, we need to imagine a situation where the adverse event has occurred. Then we can study what might be affected.