Risk Revolution

Risk Revolution
  • 0.0 (0)
  • Management
  • Monthly

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.

  1. 1 day ago

    When Change Management Becomes the Risk

    Change management is intended to reduce risk—but what happens when the process itself becomes the biggest obstacle to improvement? In this episode of Risk Revolution, Nuala Calnan is joined by Paddy Costello, Senior Director at Lachman Consultant Services, to explore how overly complex change management systems, aging facilities, and ineffective risk oversight can quietly increase risk instead of controlling it. Drawing on experience as both a regulator and industry leader, Paddy shares practical insights into why organizations struggle to implement meaningful change, how leadership teams can better understand their most significant operational risks, and why risk management must move beyond documentation to support better decision-making.  They cover:  Why overly complex change management systems often discourage meaningful improvement   The hidden risks of aging facilities, obsolete equipment, and deferred capital investments   Why rejected changes should be documented—not simply forgotten   How hazard registers can become more effective than traditional risk registers   The importance of Gemba walks in identifying risks that metrics and dashboards often miss   How quality culture influences risk management, change management, and leadership decision-making   Why senior leaders need greater visibility into their organization's most significant risks   Practical ways to simplify risk management while improving product quality, compliance, and patient safety Show Notes:PIC/s Document https://picscheme.org/docview/4294Change Management/Change Control (Enabler or Blocker?) Part 1 of 2Change Management and ICH Q12 - Part 2 of 2 - Lachman Consultants

    42 min

  2. 29 May

    Can Annex 1 Deliver Better Risk Management?

    More than a year after Annex 1 came into force, many organizations are still grappling with the challenge of turning contamination control strategies and risk assessments into meaningful operational practice. Recorded live at the ISPE Ireland Affiliate INSPIRE event in Cork, Nuala Calnan and Valerie Mulholland are joined by Richard Denk to discuss the current state of Annex 1 implementation, the gaps regulators continue to identify, and why the future lies in designing risks out rather than documenting them away. Along the way, they explore contamination control strategies, operator involvement in risk assessments, automation, robotics, and the evidence needed to demonstrate that risk controls are truly effective.

    43 min

  3. 1 May

    From Protocol to Performance: Applying QRM to Improve Clinical Trial Quality

    What does good risk management actually look like in clinical trials—and why are so many organizations still getting it wrong? In this episode of Risk Revolution, the team explores how the latest update to ICH E6(R3) is reshaping clinical trial design and execution, with a deeper focus on risk-based thinking, patient-centricity, and quality-by-design. Joined by clinical quality expert Joy Whitsett, the discussion moves beyond theory to examine how risk management is really being applied—and where gaps still exist. They cover:  Why risk management in clinical trials is often performed, but not truly integrated  The shift toward quality by design at the protocol level  How sponsors and CROs misalign on risk ownership and priorities  Why many risk assessments fail to focus on what actually matters: patient safety and meaningful data  The role of ICH E6(R3) in driving a more structured, risk-based approach   How patient experience and feasibility should shape trial design   Why over-reliance on templates, tools, and “check-the-box” processes can dilute real risk thinking   Practical ways to implement risk-based decision-making without adding complexity The key takeaway: effective risk management isn’t about doing more—it’s about focusing on what matters most, earlier in the process, and aligning teams around real-world outcomes. For professionals working across clinical, quality, and regulatory functions, this episode offers a clear look at how risk thinking is evolving—and what it takes to apply it in practice Link to ICH E8 R1Link to ICH E6R3 PDA Southeast Chapter QRM Practical Workshop Registration Link

    1hr 10min

  4. 31 Mar

    Is ICH Q9 Training a Reset for Risk Management?

    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.

    58 min

  5. 27 Feb

    Beyond ‘Human Error’- Designing for Humans

    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.

    1hr 3min

  6. 30 Jan

    Risk Thinking: From Tools to Judgement

    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

    46 min

  7. 31/12/2025

    EU GMP Chapter 1 Update: The quiet rewrite that may change QRM auditability.

    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

    37 min

  8. 01/12/2025

    Utilizing AI to improve QRM

    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

    1hr 12min
See All (35)

About

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.

Information

  • Creator
    Risk Revolution
  • Years Active
    2022 - 2026
  • Episodes
    35
  • Rating
    Clean
  • Show Website
    Risk Revolution

You Might Also Like