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Risk Revolution

Risk Revolution

By: Risk Revolution
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Welcome to Risk Revolution! The goal of this series is to advance the maturity of risk management practices within the industry, by covering topics that challenge quality professionals to seek opportunities to improve and advance the ways in which they perceive and manage risk.

The hosts for this series are Nuala Calnan, Valerie Mulholland, and Lori Richter. Biological Sciences Economics Management Management & Leadership Science
Episodes
  • 34: Is ICH Q9 Training a Reset for Risk Management?

    34: Is ICH Q9 Training a Reset for Risk Management?
    Mar 31 2026

    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.
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    58 mins
  • 33: Beyond ‘Human Error’- Designing for Humans

    33: Beyond ‘Human Error’- Designing for Humans
    Feb 27 2026
    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.
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    1 hr and 3 mins
  • 32: Risk Thinking: From Tools to Judgement

    32: Risk Thinking: From Tools to Judgement
    Jan 30 2026

    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

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    46 mins
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