Newsletter #14
Pressure as a diagnostic, not a disruption
Feb 2, 2026
6 min-read
Curated by Fabrice Gribon, Founder of Gribon & Company
Practical, field-tested insights on operational excellence and business transformation — for Site Heads and Operations Directors.
Not another internal audit…
Biopharma operations exist in a state of permanent stress testing, whether you've designed it that way or not. Regulatory audits expose compliance gaps with surgical precision. Aggressive launch timelines compress validation cycles beyond comfortable limits. Unexpected demand increases strain capacity in ways that spreadsheets never predicted. Between 2020-2022, over 30% of FDA warning letters cited internal audit failures—proof that pressure exposes operational weaknesses long before they become enforcement actions.
Consider what happened at a European biologics facility last year. They faced a perfect storm: a pre-approval inspection for a new product, a 40% demand increase for an existing therapy, and findings from their annual internal audit. All at once. The convergence revealed something fascinating—critical gaps in deviation management, incomplete batch records, and inadequate cross-training that had somehow remained invisible during "normal" operations. The site wasn't actually functioning well before the pressure arrived; it had simply never been tested properly. The stress didn't create the problems. It just made them impossible to ignore.
This is where performance is lost…
I leave in England where the weather is fairly bad and I see most organizations treat pressure like bad weather—something to endure until conditions improve. This is precisely backwards. Pressure is information. It tells you where your operation actually works versus where you've convinced yourself it works.
The typical response to audits illustrates the problem beautifully. Companies conduct the same reviews year after year, checking the same boxes, finding roughly the same issues, and implementing roughly the same corrections. Nobody asks why the same problems keep appearing in slightly different forms. This "checkbox mentality" transforms what should be a diagnostic moment into theater—everyone performing compliance rather than pursuing understanding.
Here's what pressure actually reveals when you're paying attention: where processes fail under load, where systems lack genuine resilience, and where culture prioritizes appearance over substance. Most sites lack the framework to translate operational strain into useful intelligence. They know something broke; they rarely understand why it was vulnerable in the first place.
The result? Hidden factories proliferate. Not the dramatic failures that trigger investigations, but the quiet inefficiencies that consume resources invisibly—rework that's become routine, scrap that's been normalized, unplanned modifications that somehow became standard practice. Poor documentation habits embed themselves so thoroughly that nobody remembers they're deviations from the original design. Audit findings get managed within departments rather than becoming fuel for enterprise learning.
There's another costly illusion: the belief that you have visibility because you have data. Data exists, certainly. It arrives in reports, gets discussed in meetings, generates action items. But it arrives too late to prevent problems, only to document them. Sites rely on lagging indicators that describe what already happened rather than leading indicators that signal what's about to happen during launches or demand surges.
I recommend the following 5 steps to build resilience
1. Treat pressure as your most honest consultant
Stop firefighting and start pattern recognition. When audits, launches, or demand surges hit, map what breaks first—not to assign blame, but to understand structural weakness. The European biologics facility discovered that 15% of their manufacturing time disappeared into preventable deviations. That's roughly one day per week lost to problems that shouldn't exist. Document what fails under stress, because those failure patterns reveal your actual constraints, not the ones you think you have.
2. Build early efficient warning systems
Lagging metrics are autopsies—they tell you what killed the patient but offer nothing useful for the living. Leading indicators are different. Track deviation trends by root cause weekly, not monthly. Monitor cycle time variance daily during launches. Watch material flow bottlenecks in real-time, not in retrospective reports. When quality events start clustering, that's your system telling you something is breaking before it fully breaks. These indicators transform pressure from crisis into opportunity for intervention.
3. Reframe audits and launches as deliberate stress tests
Pre-approval inspections terrify most sites, which is precisely why they're valuable. Use the preparation period not to polish surfaces but to stress-test your operation deliberately. Identify bottlenecks before they compromise supply. Treat product launches not as one-time events but as validation exercises under real-world conditions—your chance to test whether your technology transfer, supplier qualification, and analytical methods actually work when it matters. The goal isn't to pass the test; it's to learn what the test reveals.
4. Make the hidden factory visible and dismantle it
During high-pressure periods, track every deviation, every rework loop, every unexplained delay with obsessive precision. Calculate the time cost. The European facility cut first-pass failures by 23% and batch cycle time by 18% within six months, not through capital investment but by eliminating preventable waste that pressure had finally exposed. The hidden factory only stays hidden if you let it. Pressure forces visibility. The question is whether you use that visibility to improve or simply to survive until things calm down.
5. Create pressure response teams with real authority
When audits, launches, or demand surges hit, activate cross-functional teams that include operations, quality, engineering, and supply chain. Here's the critical part: give them authority to make rapid decisions without requiring approval chains that guarantee delays. Document what they learn, because each pressure event should build institutional knowledge for the next one. The most resilient sites aren't the ones that avoid pressure—they're the ones that have learned how to learn from it.
The payoff isn't marginal improvement; it's unlocking capacity you didn't know you had. Enhanced stability, optimized resources, and supply chains that actually absorb shocks rather than amplifying them. In our work across biotech sites, we've seen that operations using pressure as a diagnostic lever consistently outperform those treating it as disruption.
Site heads need to reframe pressure as opportunity. Invest in the data systems and team structures that turn stress into insight, because this ultimately ensures reliable patient supply while improving financial performance. The choice isn't whether you'll face pressure—that's guaranteed. The choice is whether you'll use it to become stronger or simply to survive another day.
How is your site leveraging pressure from audits, launches, or demand surges to reveal hidden weaknesses and drive lasting improvement?
Newsletter #14
Pressure as a diagnostic, not a disruption
Feb 2, 2026
6 min-read
Curated by Fabrice Gribon, Founder of Gribon & Company
Practical, field-tested insights on operational excellence and business transformation — for Site Heads and Operations Directors.
Not another internal audit…
Biopharma operations exist in a state of permanent stress testing, whether you've designed it that way or not. Regulatory audits expose compliance gaps with surgical precision. Aggressive launch timelines compress validation cycles beyond comfortable limits. Unexpected demand increases strain capacity in ways that spreadsheets never predicted. Between 2020-2022, over 30% of FDA warning letters cited internal audit failures—proof that pressure exposes operational weaknesses long before they become enforcement actions.
Consider what happened at a European biologics facility last year. They faced a perfect storm: a pre-approval inspection for a new product, a 40% demand increase for an existing therapy, and findings from their annual internal audit. All at once. The convergence revealed something fascinating—critical gaps in deviation management, incomplete batch records, and inadequate cross-training that had somehow remained invisible during "normal" operations. The site wasn't actually functioning well before the pressure arrived; it had simply never been tested properly. The stress didn't create the problems. It just made them impossible to ignore.
This is where performance is lost…
I leave in England where the weather is fairly bad and I see most organizations treat pressure like bad weather—something to endure until conditions improve. This is precisely backwards. Pressure is information. It tells you where your operation actually works versus where you've convinced yourself it works.
The typical response to audits illustrates the problem beautifully. Companies conduct the same reviews year after year, checking the same boxes, finding roughly the same issues, and implementing roughly the same corrections. Nobody asks why the same problems keep appearing in slightly different forms. This "checkbox mentality" transforms what should be a diagnostic moment into theater—everyone performing compliance rather than pursuing understanding.
Here's what pressure actually reveals when you're paying attention: where processes fail under load, where systems lack genuine resilience, and where culture prioritizes appearance over substance. Most sites lack the framework to translate operational strain into useful intelligence. They know something broke; they rarely understand why it was vulnerable in the first place.
The result? Hidden factories proliferate. Not the dramatic failures that trigger investigations, but the quiet inefficiencies that consume resources invisibly—rework that's become routine, scrap that's been normalized, unplanned modifications that somehow became standard practice. Poor documentation habits embed themselves so thoroughly that nobody remembers they're deviations from the original design. Audit findings get managed within departments rather than becoming fuel for enterprise learning.
There's another costly illusion: the belief that you have visibility because you have data. Data exists, certainly. It arrives in reports, gets discussed in meetings, generates action items. But it arrives too late to prevent problems, only to document them. Sites rely on lagging indicators that describe what already happened rather than leading indicators that signal what's about to happen during launches or demand surges.
I recommend the following 5 steps to build resilience
1. Treat pressure as your most honest consultant
Stop firefighting and start pattern recognition. When audits, launches, or demand surges hit, map what breaks first—not to assign blame, but to understand structural weakness. The European biologics facility discovered that 15% of their manufacturing time disappeared into preventable deviations. That's roughly one day per week lost to problems that shouldn't exist. Document what fails under stress, because those failure patterns reveal your actual constraints, not the ones you think you have.
2. Build early efficient warning systems
Lagging metrics are autopsies—they tell you what killed the patient but offer nothing useful for the living. Leading indicators are different. Track deviation trends by root cause weekly, not monthly. Monitor cycle time variance daily during launches. Watch material flow bottlenecks in real-time, not in retrospective reports. When quality events start clustering, that's your system telling you something is breaking before it fully breaks. These indicators transform pressure from crisis into opportunity for intervention.
3. Reframe audits and launches as deliberate stress tests
Pre-approval inspections terrify most sites, which is precisely why they're valuable. Use the preparation period not to polish surfaces but to stress-test your operation deliberately. Identify bottlenecks before they compromise supply. Treat product launches not as one-time events but as validation exercises under real-world conditions—your chance to test whether your technology transfer, supplier qualification, and analytical methods actually work when it matters. The goal isn't to pass the test; it's to learn what the test reveals.
4. Make the hidden factory visible and dismantle it
During high-pressure periods, track every deviation, every rework loop, every unexplained delay with obsessive precision. Calculate the time cost. The European facility cut first-pass failures by 23% and batch cycle time by 18% within six months, not through capital investment but by eliminating preventable waste that pressure had finally exposed. The hidden factory only stays hidden if you let it. Pressure forces visibility. The question is whether you use that visibility to improve or simply to survive until things calm down.
5. Create pressure response teams with real authority
When audits, launches, or demand surges hit, activate cross-functional teams that include operations, quality, engineering, and supply chain. Here's the critical part: give them authority to make rapid decisions without requiring approval chains that guarantee delays. Document what they learn, because each pressure event should build institutional knowledge for the next one. The most resilient sites aren't the ones that avoid pressure—they're the ones that have learned how to learn from it.
The payoff isn't marginal improvement; it's unlocking capacity you didn't know you had. Enhanced stability, optimized resources, and supply chains that actually absorb shocks rather than amplifying them. In our work across biotech sites, we've seen that operations using pressure as a diagnostic lever consistently outperform those treating it as disruption.
Site heads need to reframe pressure as opportunity. Invest in the data systems and team structures that turn stress into insight, because this ultimately ensures reliable patient supply while improving financial performance. The choice isn't whether you'll face pressure—that's guaranteed. The choice is whether you'll use it to become stronger or simply to survive another day.
How is your site leveraging pressure from audits, launches, or demand surges to reveal hidden weaknesses and drive lasting improvement?
Newsletter #14
Pressure as a diagnostic, not a disruption
Feb 2, 2026
6 min-read
Curated by Fabrice Gribon, Founder of Gribon & Company
Practical, field-tested insights on operational excellence and business transformation — for Site Heads and Operations Directors.
Not another internal audit…
Biopharma operations exist in a state of permanent stress testing, whether you've designed it that way or not. Regulatory audits expose compliance gaps with surgical precision. Aggressive launch timelines compress validation cycles beyond comfortable limits. Unexpected demand increases strain capacity in ways that spreadsheets never predicted. Between 2020-2022, over 30% of FDA warning letters cited internal audit failures—proof that pressure exposes operational weaknesses long before they become enforcement actions.
Consider what happened at a European biologics facility last year. They faced a perfect storm: a pre-approval inspection for a new product, a 40% demand increase for an existing therapy, and findings from their annual internal audit. All at once. The convergence revealed something fascinating—critical gaps in deviation management, incomplete batch records, and inadequate cross-training that had somehow remained invisible during "normal" operations. The site wasn't actually functioning well before the pressure arrived; it had simply never been tested properly. The stress didn't create the problems. It just made them impossible to ignore.
This is where performance is lost…
I leave in England where the weather is fairly bad and I see most organizations treat pressure like bad weather—something to endure until conditions improve. This is precisely backwards. Pressure is information. It tells you where your operation actually works versus where you've convinced yourself it works.
The typical response to audits illustrates the problem beautifully. Companies conduct the same reviews year after year, checking the same boxes, finding roughly the same issues, and implementing roughly the same corrections. Nobody asks why the same problems keep appearing in slightly different forms. This "checkbox mentality" transforms what should be a diagnostic moment into theater—everyone performing compliance rather than pursuing understanding.
Here's what pressure actually reveals when you're paying attention: where processes fail under load, where systems lack genuine resilience, and where culture prioritizes appearance over substance. Most sites lack the framework to translate operational strain into useful intelligence. They know something broke; they rarely understand why it was vulnerable in the first place.
The result? Hidden factories proliferate. Not the dramatic failures that trigger investigations, but the quiet inefficiencies that consume resources invisibly—rework that's become routine, scrap that's been normalized, unplanned modifications that somehow became standard practice. Poor documentation habits embed themselves so thoroughly that nobody remembers they're deviations from the original design. Audit findings get managed within departments rather than becoming fuel for enterprise learning.
There's another costly illusion: the belief that you have visibility because you have data. Data exists, certainly. It arrives in reports, gets discussed in meetings, generates action items. But it arrives too late to prevent problems, only to document them. Sites rely on lagging indicators that describe what already happened rather than leading indicators that signal what's about to happen during launches or demand surges.
I recommend the following 5 steps to build resilience
1. Treat pressure as your most honest consultant
Stop firefighting and start pattern recognition. When audits, launches, or demand surges hit, map what breaks first—not to assign blame, but to understand structural weakness. The European biologics facility discovered that 15% of their manufacturing time disappeared into preventable deviations. That's roughly one day per week lost to problems that shouldn't exist. Document what fails under stress, because those failure patterns reveal your actual constraints, not the ones you think you have.
2. Build early efficient warning systems
Lagging metrics are autopsies—they tell you what killed the patient but offer nothing useful for the living. Leading indicators are different. Track deviation trends by root cause weekly, not monthly. Monitor cycle time variance daily during launches. Watch material flow bottlenecks in real-time, not in retrospective reports. When quality events start clustering, that's your system telling you something is breaking before it fully breaks. These indicators transform pressure from crisis into opportunity for intervention.
3. Reframe audits and launches as deliberate stress tests
Pre-approval inspections terrify most sites, which is precisely why they're valuable. Use the preparation period not to polish surfaces but to stress-test your operation deliberately. Identify bottlenecks before they compromise supply. Treat product launches not as one-time events but as validation exercises under real-world conditions—your chance to test whether your technology transfer, supplier qualification, and analytical methods actually work when it matters. The goal isn't to pass the test; it's to learn what the test reveals.
4. Make the hidden factory visible and dismantle it
During high-pressure periods, track every deviation, every rework loop, every unexplained delay with obsessive precision. Calculate the time cost. The European facility cut first-pass failures by 23% and batch cycle time by 18% within six months, not through capital investment but by eliminating preventable waste that pressure had finally exposed. The hidden factory only stays hidden if you let it. Pressure forces visibility. The question is whether you use that visibility to improve or simply to survive until things calm down.
5. Create pressure response teams with real authority
When audits, launches, or demand surges hit, activate cross-functional teams that include operations, quality, engineering, and supply chain. Here's the critical part: give them authority to make rapid decisions without requiring approval chains that guarantee delays. Document what they learn, because each pressure event should build institutional knowledge for the next one. The most resilient sites aren't the ones that avoid pressure—they're the ones that have learned how to learn from it.
The payoff isn't marginal improvement; it's unlocking capacity you didn't know you had. Enhanced stability, optimized resources, and supply chains that actually absorb shocks rather than amplifying them. In our work across biotech sites, we've seen that operations using pressure as a diagnostic lever consistently outperform those treating it as disruption.
Site heads need to reframe pressure as opportunity. Invest in the data systems and team structures that turn stress into insight, because this ultimately ensures reliable patient supply while improving financial performance. The choice isn't whether you'll face pressure—that's guaranteed. The choice is whether you'll use it to become stronger or simply to survive another day.
How is your site leveraging pressure from audits, launches, or demand surges to reveal hidden weaknesses and drive lasting improvement?