Walking the tightrope: Uncertainty and quality risk management

BY DR TIM SANDLE | PHARMACEUTICAL MICROBIOLOGY AND CONTAMINATION CONTROL EXPERT

6th August 2024

Quality Risk Management is an essential part of pharmaceuticals and healthcare, from design to validation, and from change control to deviation impact assessment. Central to all routes is the risk to product quality and hence the risk to the patient. 

There are different conceptions of ‘risk to quality’ and different approaches to risk management, together with different tools. For pharmaceuticals, ICH Q9(R1): 2023 attempts to steer organisations to adopting appropriate tools and processes. Yet the use of risk assessments needs to scientifically sound, data-driven, formal and proportionate.

This article focuses on risk management and general principles for the consideration of conducting risk assessments. The primary area examined is the real-life existence of uncertainty, aka ‘fuzziness’, including ‘fuzzy logic’ approaches.