Risk Revolution

Is the new ICH Q9 training just more guidance—or a reset for how risk should be managed?
In this episode, we break down the latest training materials and what they signal for Quality Risk Management (QRM) in practice.
We cover:

 Why this release feels like a shift in expectations—not just an update

 The gap between risk tools and real decision-making

 Challenges applying dense guidance in real-world settings 

 What organizations may need to rethink in existing QRM programs 

If your team is focused on completing risk assessments rather than improving decisions, this episode will challenge your approach.

In this episode of Risk Revolution, Val and Nuala are joined by Julie Avery and Dominic Furniss, both experts on Human Reliability, to tackle a stubborn challenge in pharmaceutical manufacturing quality: why we keep seeing repeat deviations, repeat CAPAs, and repeat “retraining’.   

Julie and Dominic make a practical case for integrating Human Factors Engineering (HFE) into the PQS in a way that is not only cultural, but structured and auditable. Drawing lessons from other high-hazard industries (including COMAH), they outline what a pharma-focused human reliability guide could look like.  

This conversation isn’t just theory. Julie and Dominic are actively building momentum, and they’re inviting quality leaders, practitioners, and learners to join a growing Community of Practice to share tools, case experiences, and practical ways to bring human reliability into real PQS work. If you’ve ever thought, ‘we keep fixing the symptom,’ this episode is for you.

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

In this episode, Lori and Val explore the proposed update to Chapter 1 of the EU GMPs - Eudralex Volume 4. The update solidifies formality in Quality Risk Management and is clear that it expects subjectivity to be minimized.  Join us as we discuss what this means in reality and how moving these expectations from a guidance to an inspection standard might impact QRM implementation.  

SHOW NOTES:  
The proposed update to Chapter 1 of the EU GMPs 
https://health.ec.europa.eu/consultations/stakeholders-consultation-eudralex-volume-4-good-manufacturing-practice-guidelines-chapter-1_en#respond-to-the-consultation 

Article by Dr Emma Ranmarine on Drug Shortages  
https://www.pda.org/pda-letter-portal/home/full-article/drug-shortage-is-a-wicked-problem 

Article by Dr Marty Lipa on connecting QRM and KM: 
https://prst.ie/wp-content/uploads/2020/11/Knowledge-as-the-Currency-of-Managing-Risk-Uniting-QRM-and-KM-28Oct20-FINAL-for-Level3.pdf

This month, we’re going to discuss Artificial Intelligence with Mike Salem. Mike is an expert in AI with over 15 years of experience. He has a background in mathematics and computer science and has worked in several industries, including defense, education, finance, and more. The design of this podcast is to take us from understanding some general terms and concepts to how this can be leveraged to improve our QRM programs and decision-making, all while keeping humans in the loop. 

Show Notes:

Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle 

Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products 

The EU AI Act 

Learning how to write prompts (3-part video series) – search OpenAI Academy to get started for free