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:

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

1. Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle
2. Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products
3. The EU AI Act
4. Learning how to write prompts (3-part video series) – search OpenAI Academy to get started for free