Newsletter #9. Leadership is judged on what their manufacturing systems make visible

Curated by Fabrice Gribon, Founder of Gribon & Company
Practical, field-tested insights on operational excellence and business transformation — for Site Heads and Operations Directors.

Does it feel like being stuck on a hamster wheel?

Site heads in biopharma manufacturing are unsung heroes. You're balancing relentless pressure from regulators, customers, and corporate while keeping production running. You must maintain uninterrupted patient supply, ensure compliance, improve financial performance, and firefight whatever breaks down today. It could be a compressor failure on your lyophilizer, a microbial excursion in your aseptic suite, or a supplier quality issue threatening next month's batch release.

A site head in Europe once described his life to me as being stuck on a hamster wheel—always moving but never progressing.

74% of improvement initiatives at manufacturing sites fail or do not sustain the expected improvement. Your teams work hard but produce no measurable or lasting results. Activity becomes the metric. Noise becomes normal. Then a "surprise" event escalates—that equipment vibration you've failed to monitor suddenly becomes a 2-day line stoppage, or that environmental trend you flagged three months ago becomes a contamination event and a global product recall.

Without real-time understanding of what's actually happening on your filling line, in your utilities, across your supply chain, you're managing symptoms, not solving root causes. You're reacting to the alarm, not preventing the failure.

What's broken?

The fundamental misstep is equating effort and reporting with control. Your teams are generating activity—attending meetings, updating spreadsheets and PowerPoint presentations, investigating deviations—but activity isn't visibility.

Here's what's actually broken: Your Quality team sees OOS results in the lab. Your maintenance team tracks equipment performance in their CMMS. Your production team manages batch records in the MES. Your supply chain monitors API inventory in SAP. None of these systems talks to the others.

When your lyophilizer compressor starts showing elevated vibration, log it for maintenance. When sterility assurance sees a minor uptick in viable particle counts, quality investigates it separately. When production reports longer cycle times on that same filling line, they attribute it to operator variability/human errors. Three separate signals. Zero connection. No one sees the pattern until you're facing an aseptic processing failure and a batch rejection.

This fragmentation creates three recurring failure modes:

First, critical risks stay hidden until they become crises. That microbial excursion didn't appear overnight. The environmental monitoring data showed a trend. The HVAC differential pressure was drifting. The gowning qualification results were borderline. But these signals lived in different systems, were owned by different departments, and were reviewed in different meetings.

Second, you can't anticipate what you can't see. Without a unified view of leading indicators across quality, production, utilities, and supply chain, minor deviations compound. A supplier's certificate of analysis shows slight variability. Your incoming inspection flags it, but releases the material. Three batches later, you're investigating an out-of-specification dissolution result and holding finished goods.

Third, accountability disappears. When no one owns the complete picture, everyone owns a piece of the problem. Your site leadership team reviews KPIs monthly; each function presents its green dashboards, while your overall equipment effectiveness slowly degrades and your right-first-time rate erodes.

The result: you're running a hidden factory of inefficiency, unpredictable issues. Rework that shouldn't exist. Investigations that could have been prevented. Capacity you can't access because you don't know it's there.