Risk Thinking: From Tools to Judgement

Описание: In this episode, the hosts take a hard look at one of the most persistent challenges in modern quality risk management: why risk thinking feels natural in everyday life—but becomes so difficult at work.

Moving beyond familiar tools like FMEA, heat maps, and scoring tables, the discussion explores what real risk thinking looks like in regulated environments—and why over-reliance on templates can sometimes suppress the very judgment and curiosity needed to manage risk effectively.

Key topics include:

Why completing a risk tool doesn’t necessarily mean risk has been managed
The difference between risk analysis and risk-based decision-making
How compliance pressure, audit defensibility, and organizational culture shape behavior
What “good” risk-based decisions look like when information is incomplete
Practical ways teams can talk about risk without pulling up a template
The importance of humility, uncertainty, and learning from real-world outcomes
The episode also connects today’s challenges to the evolution of ICH Q9 and the industry’s broader shift toward Quality Risk Management—asking whether the original intent has been lost along the way

Show Notes:

Risk management basics: what exactly is it? David Hillson Risk Doctor
Lori's upcoming PDA West Coast Chapter Event
Article: Steps Towards Demystifying Risk-Based Decision Making (Valerie Mulholland and Anne Greene
Valss Course on RBDM.... http://www.gmp.ie
Val’s 8 steps to better Risk Thinking in RBDM