Conversations That Matter
No deviation’s Takeaways from 2025 ISPE Europe Annual Conference in London
Speakers: Alice Redmond – CAI, Kevin O’Donnell – Health Products Regulatory Authority (HPRA), Graham Carroll – MHRA, Arie Menachem – Novo Nordisk
ICH Q9 isn’t new. Even the revision (R1) is no longer fresh off the press. But the conversations it sparks are more relevant than ever.
At a recent ISPE conference session led by Alice Redmond and a stellar panel of industry and regulatory voices, we dove deep into one of the most critical and often overlooked aspects of Quality Risk Management (QRM): subjectivity—and its close cousin—formality.
Understanding Subjectivity in Risk Assessment
Subjectivity in QRM is the elephant in the cleanroom. Despite structured tools and templates, our risk assessments are influenced by personal experience, education, prior sites, and what some panelists called our “war wounds.” This human element can skew scores, particularly in methods like FMEA, where arbitrary numbers may determine whether action is taken—or not.
The guidance in ICH Q9(R1) acknowledges this and challenges us to build systems that recognize, mitigate, and manage subjectivity through:
• Training on cognitive biases and heuristics
• Structured facilitation during assessments
• Diverse, cross-functional teams to reduce anchoring effects
• Clarity in definitions and scoring criteria
As Kevin O’Donnell pointed out, even regulators are training themselves to inspect through the lens of subjectivity. The field is evolving—and we’re evolving with it.
Formality: Not One Size Fits All
One of the most powerful upgrades in ICH Q9(R1) is the focus on formality as a spectrum, not a binary. The document clarifies that the level of effort, documentation, and oversight should be proportional to the uncertainty, complexity, and importance of the risk.
At No deviation, this resonates deeply. We work with clients across the full project lifecycle—from risk-based design to deviation investigations—and we’ve seen how inappropriate formality can either waste time or overlook critical issues.
Our approach?
- Use simple tools where appropriate.
- Use robust methods where needed.
- Always align the level of formality to the context of the decision.
Better Tools, Not Just More Tools
The session emphasized that while FMEA remains the go-to, it’s not always the right fit. Other tools—like HAZOP, HACCP, or even AI-powered analysis—have valuable roles, especially when combined.
And yes, AI in QRM was highlighted as a frontier to watch. As complexity grows, smart algorithms may help us identify patterns and reduce noise. But formality will be essential here too—especially in evaluating uncertainty in AI decision-making.
What’s Next?
ISPE and regulators are calling for case studies, knowledge sharing, and real-world examples. The industry must support itself, not just wait for regulatory direction.
That’s what we aim to do at No Deviation—share knowledge, sharpen systems, and shape a QRM culture that works in practice, not just on paper.
Let’s move beyond checkboxes. Let’s train facilitators, choose the right tools, and keep the patient at the center of our risk thinking.
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Need help navigating QRM with the right balance of structure and sense?
Get in touch with our expert team at hello@nodeviation.com to explore our QRM services.
