William Boyd is a favorite author for me, so I was pleased to read The hidden architecture of failure – understanding “zemblanity”. While I’ve read Armadillio, I missed the applicability of the word.

Zemblanity is actually a pretty good word for our field. I’m going to test it out, see if it has legs.

Zemblanity in Risk Management: Turning the Mirror on Hidden System Fragility

If you’re reading this blog, you already know that risk management isn’t about tallying up hypothetical hazards and ticking regulatory boxes. But have you ever stopped to ask whether your systems are quietly hardwiring failure—almost by design? Christian Busch’s recent LSE Business Review article lands on a word for this: zemblanity—the “opposite of serendipity,” or, more pointedly, bad luck that’s neither blind nor random, but structured right into the bones of our operations.

This idea resonates powerfully with the transformations occurring in pharmaceutical quality systems—the same evolution guiding the draft revision of Eudralex Volume 4 Chapter 1. In both Busch’s analysis and regulatory trends, we’re urged to confront root causes, trace risk back to its hidden architecture, and actively dismantle the quiet routines and incentives that breed failure. This isn’t mere thought leadership; it’s a call to reexamine how our own practices may be cultivating fields of inevitable misfortune—the very zemblanity that keeps reputational harm and catastrophic events just a few triggers away.

The Zemblanity Field: Where Routine Becomes Risk

Let’s be honest: the ghosts in our machines are rarely accidents. They don’t erupt out of blue-sky randomness. They were grown in cultures that prized efficiency over resilience, chased short-term gains, and normalized critical knowledge gaps. In my blog post on normalization of deviance (see: “Why Normalization of Deviance Threatens your CAPA Logic”), I map out how subtle cues and “business as usual” thinking produce exactly these sorts of landmines.

Busch’s zemblanity—the patterned and preventable misfortune that accrues from human agency—makes for a brutal mirror. Risk managers must ask: Which of our controls are truly protective, and which merely deliver the warm glow of compliance while quietly amplifying vulnerability? If serendipity is a lucky break, zemblanity is the misstep built into the schedule, the fragility we invite by squeezing the system too hard.

From Hypotheticals to Archaeology: How to Evaluate Zemblanity

So, how does one bring zemblanity into practical risk management? It starts by shifting the focus from cataloguing theoretical events to archaeology: uncovering the layered decisions, assumptions, and interdependencies that have silently locked in failure modes.

1. Map Near Misses and Routine Workarounds

Stop treating near misses as flukes. Every recurrence is a signpost pointing to underlying zemblanity. Investigate not just what happened, but why the system allowed it in the first place. High-performing teams capture these “almost events” the way a root cause analyst mines deviations for actionable knowledge .

2. Scrutinize Margins and Slack

Where are your processes running on fumes? Organizations that cut every buffer in service of “efficiency” are constructing perfect conditions for zemblanity. Whether it’s staffing, redundancy in critical utilities, or quality reserves, scrutinize these margins. If slim tolerances have become your operating norm, you’re nurturing the zemblanity field.

3. Map Hidden Interdependencies

Borrowing from system dynamics and failure mode mapping, draw out the connections you typically overlook and the informal routes by which information or pressure travels. Build reverse timelines—starting at failure—to trace seemingly disparate weak points back to core drivers.

4. Interrogate Culture and Incentives

A robust risk culture isn’t measured by the thoroughness of your SOPs, but by whether staff feel safe raising “bad news” and questioning assumptions.

5. Audit Cost-Cutting and “Optimizations”

Lean initiatives and cost-cutting programs can easily morph from margin enhancement to zemblanity engines. Run post-implementation reviews of such changes: was resilience sacrificed for pennywise savings? If so, add these to your risk register, and reframe “efficiency” in light of the total cost of a fragile response to disruption.

6. Challenge “Never Happen Here” Assumptions

Every mature risk program needs a cadence of challenging assumptions. Run pre-mortem workshops with line staff and cross-functional teams to simulate how multi-factor failures could cascade. Spotlight scenarios previously dismissed as “impossible” and ask why. Highlight usage in quality system design.

Operationalizing Zemblanity in PQS

The Eudralex Chapter 1 draft’s movement from static compliance to dynamic, knowledge-centric risk management lines up perfectly here. Embedding zemblanity analysis is less about new tools and more about repurposing familiar practices: after-action reviews, bowtie diagrams, CAPA trend analysis, incident logs—all sharpened with explicit attention to how our actions and routines cultivate not just risk, but structural misfortune.

Your Product Quality Review (PQR) process, for instance, should now interrogate near misses, not just reject rates or OOS incidents. It is time to pivot from dull data reviews reviews to causal inference—asking how past knowledge blind spots or hasty “efficiencies” became hazards.

And as pharmaceutical supply chains grow ever more interdependent and brittle, proactive risk detection needs routine revisiting. Integrate zemblanity logic into your risk and resilience dashboards—flag not just frequency, but pattern, agency, and the cultural drivers of preventable failures.

Toward Serendipity: Dismantle Zemblanity, Build Quality Luck

Risk professionals can no longer limit themselves to identifying hazards and correcting defects post hoc. Proactive knowledge management and an appetite for self-interrogation will mark the difference between organizations set up for breakthroughs and those unwittingly primed for avoidable disaster.

The challenge—echoed in both Busch’s argument and the emergent GMP landscape—is clear: shrink the zemblanity field. Turn pattern-seeking into your default. Reward curiosity within your team. Build analytic vigilance into every level of the organization. Only then can resilience move from rhetoric to reality, and only then can your PQS become not just a bulwark against failure, but a platform for continuous, serendipitous improvement.