Risk Revolution

What does it really mean for an employee to be qualified, and is completing training the same as demonstrating competence? In this episode of Risk Revolution, Lori Richter welcomes learning and development expert Nathan Profehl to explore how pharmaceutical and life sciences companies can use risk-based principles to build more effective employee qualification programs. They discuss why traditional “read and understand” training often falls short, how to distinguish procedural notifications from meaningful training, and why qualification should focus on demonstrating the knowledge and skills employees need to perform their jobs successfully.Following the interview, Lori and co-host Val Mulholland examine the broader risks associated with onboarding, employee development, and knowledge retention. They discuss the importance of tailoring training to individual experience, involving frontline employees in designing qualification programs, and creating procedures that serve the people using them rather than simply satisfying auditors. The conversation also highlights how effective knowledge management, thoughtful hiring practices, and risk-based training can improve employee performance, strengthen quality systems, and protect organizations from losing critical institutional knowledge.Show NotesAdditional resources discussed in this episode: eBook: Biopharmaceutical Training — Designing Effective Adult-Learning–Based Programs Integrating Knowledge Management into QMS for Early Stage Companies: A Practical Approach for Improved Business Performance and Growth, Part 1 Integrating Knowledge Management into QMS for Early Stage Companies: A Practical Approach for Improved Business Performance and Growth, Part 2

AI is already moving into GxP, sometimes through purpose-built AI applications and sometimes as new AI capabilities within software organizations already use. But how do we know when an AI application is trustworthy enough for a regulated use? And is traditional computer system validation even the right starting point? Val talks with Andy O’Connor of Phanero about why “AI” is not one single technology and why the first question should perhaps not be “How do we validate it?” but “What are we asking it to do?” SHOW NOTES:  Phanero Blog: https://blog.phanero.ai/   ICH Q9 (R1) Training Materials: https://www.ich.org/page/quality-guidelines  EMA Annex 22 AI Expert Workshop June/July 2026: https://www.ema.europa.eu/en/events/good-manufacturing-practice-multistakeholder-workshop-expert-contributions-artificial-intelligence-guidance-development-annex-22?utm_source=chatgpt.com  Risk Revolution Episode 28: Quality Theatre to Quality Science,  Jeremiah Genest’s Playbook:https://www.youtube.com/watch?v=93cx5r3ub5I&list=PLY5Gm6o-46FUtColQY_vz4O5NzmRGzlay&index=11 

Quality risk management should be more than a compliance exercise or another spreadsheet to complete. The real opportunity is to make it risk-based. They cover:  Why the industry is still struggling to fully embrace ICH Q9(R1)   The shift from reactive risk assessments to proactive risk-based decision-making   Why leadership, knowledge management, and organizational culture are critical to effective QRM   How the new ISPE QRM Guide was designed as a practical handbook and toolkit for practitioners   Why defining the right risk question should come before choosing a risk assessment tool   How organizations can determine the appropriate level of formality for different risk scenarios   The growing role of QRM in product availability and supply chain resilience   Why practitioners should look beyond FMEA and consider different or combined risk tools   How QRM can become an integrated part of strategic decision-making rather than simply a compliance requirement  The key takeaway: the future of QRM is not about doing more risk assessments. It is about creating a risk mindset where managing uncertainty becomes part of everyday decision-making across the organization. When risk management is integrated with knowledge, strategy, and business objectives, organizations can move from reacting to problems to identifying and addressing them before they happen. thinking part of how organizations operate, make decisions, and protect patients.In this episode of Risk Revolution, Nuala Calnan welcomes Dr. Alice Redmond, Chief Risk and Quality Officer at CAI and a longtime leader in the quality risk management community. They explore the current state of QRM across the life sciences industry, the persistent challenges following ICH Q9(R1), and the development of the new ISPE Quality Risk Management Guide. 

Some of the most valuable lessons in risk management don't come from regulations or templates. They come from books that challenge how we think, make decisions, communicate, and lead.In this special Book Club edition of Risk Revolution, hosts Nuala Calnan, Valerie Mulholland, and Lori Richter share the books that have most influenced their thinking about quality risk management, decision making, organizational culture, and leadership. They discuss practical lessons from Thinking, Fast and Slow, Upstream, Surrounded by Idiots, The Talent Code, and Deciding, while exploring how these ideas can improve risk assessments, strengthen decision making, and build more effective organizations. The episode also features Celeste Theberge of Takeda, who shares how her company's "Risky Reads" book club is helping develop quality risk management capability across the organization. They cover:  Why psychology and behavioral science matter in quality risk management   The difference between reactive problem solving and preventing issues before they occur   How cognitive bias and AI can influence decision-making   Why communication styles can strengthen or weaken cross-functional teams   Practical ways to build a stronger quality risk management culture through discussion and shared learning   Lessons from Takeda's "Risky Reads" quality risk management book club   Why assumptions should be challenged before important decisions are made   The books every quality and risk professional should consider adding to their reading list 

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

 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. 

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 practiceLink to ICH E8 R1Link to ICH E6R3 PDA Southeast Chapter QRM Practical Workshop Registration Link 

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 wayShow 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