Data-Driven FMEA Risk Assessment under ICH Q9(R1)
The updated ICH Q9(R1) guidelines emphasize data-driven FMEA risk assessments in the pharmaceutical sector, reducing reliance on subjective judgment. By using historical data, measurable criteria, and continuous risk reviews, organizations can improve accuracy, consistency, and regulatory compliance. Quantifying severity, leveraging historical RPNs, and maintaining updated risk evaluations help ensure robust quality risk management and better decision-making in manufacturing processes.