Newsletter #11
The danger of believing stability too long
Jan 24, 2026
5 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.
Why strong performance can hide high risk?
You are a talented, experienced site head — respected by your peers and trusted by your executive leadership. You are known for delivering strong results, quarter after quarter.
In recent years, I have worked alongside several leaders like you. One site, operating in a high-demand market and benefiting from multiple years of continuous growth saw over 30% of its top line at risk of disappearing due to a single, unforeseen supply-chain event.
This was not the result of poor leadership or incompetence. The senior leadership team was strong. But early signals were missed while attention remained focused on growth and past success.
When the KPIs have been green for three quarters, the deviations are at an all-time low, and the culture feels harmonious, a dangerous psychological shift occurs: we begin to believe that the system is stable because it is "fixed." In reality, manufacturing stability is not a static state; it is a temporary equilibrium that requires constant energy to sustain.
What happened at Genzyme Allston?
The fundamental misstep some site leadership make is equating past success with future immunity from failure. The Genzyme site in Allston provides a good illustration. Despite its flagship status, the facility incurred severe FDA violations, including microbial and particulate contamination and inadequate quality systems. This led to a consent decree, a significant $175 million disgorgement of unlawful profits, and critical shortages of essential medicines. This case underscores how regulatory non-compliance and quality failures can result in substantial financial penalties and profound reputational damage. The question one asks is Why? How did this happen?
The primary breakdown occurs when leaders overlook issues that contradict their belief in stability, or exhibit "omission bias," failing to act on early warning signs. This structural flaw allows hidden factory capacity issues and latent compliance risks to fester silently, invisible during your tier meetings and business reviews. This ultimately will compromise the site leadership team's continuous success and can go as far as impacting the career of the team, the patients they serve, and the reputation of their company.
My recommendation is to stay uncomfortably alert...
As a site head, your calendar is probably already full with business reviews, Tier 4 management request, your site Tier 3 meeting, project reviews, updates on the latest contamination, external interactions and much more…
Paradoxically, the better your site performs, the less time you spend looking for fragility and challenging your risk register — precisely when you should be doing so.
Both the FDA and European Medicines Agency highlight major quality failures originating from sites that were fully compliant on paper. Post-inspection findings frequently point to:
Insufficient trend analysis
Over-reliance on periodic reviews
Poor connection of cross-functional data and risks
Early signals identified — but not acted upon
I do not think this is negligence but rather a false perception of security that comes when we have no signals to be alert.
As a site head or member of the SLT, your role is to continuously question good results to ensure they will last…maybe you are already doing this…but if you are not, maybe you could start today. You can simply start with the following:
Ask your SLT : What could surprise us next month? A major deviation, equipment failure?
Where do we rely on suppliers, systems, or assumptions without early-warning controls?
What are the highest-scoring risks in our register — and are remediation plans truly active, or just documented?
Your role is to remain constructively sceptical of a “perfect” Tier review. I often hear, if a KPI has been green too long maybe it is not a good one…get rid of it. I would recommend to create a KPI that will enable you to stay in the green …
When performance is strong, that is exactly when you should dig deeper into the why.
Is it because our systems are genuinely robust — or because the sample bags particulate count is no longer accurate…
Great site leadership is not about enjoying stability, of growth, meeting your targets…It is about challenging stability itself, challenging your people before stability disappears.
What specific area or process on your site needs immediate attention to address the dangerous belief in stability?
Newsletter #11
The danger of believing stability too long
Jan 24, 2026
5 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.
Why strong performance can hide high risk?
You are a talented, experienced site head — respected by your peers and trusted by your executive leadership. You are known for delivering strong results, quarter after quarter.
In recent years, I have worked alongside several leaders like you. One site, operating in a high-demand market and benefiting from multiple years of continuous growth saw over 30% of its top line at risk of disappearing due to a single, unforeseen supply-chain event.
This was not the result of poor leadership or incompetence. The senior leadership team was strong. But early signals were missed while attention remained focused on growth and past success.
When the KPIs have been green for three quarters, the deviations are at an all-time low, and the culture feels harmonious, a dangerous psychological shift occurs: we begin to believe that the system is stable because it is "fixed." In reality, manufacturing stability is not a static state; it is a temporary equilibrium that requires constant energy to sustain.
What happened at Genzyme Allston?
The fundamental misstep some site leadership make is equating past success with future immunity from failure. The Genzyme site in Allston provides a good illustration. Despite its flagship status, the facility incurred severe FDA violations, including microbial and particulate contamination and inadequate quality systems. This led to a consent decree, a significant $175 million disgorgement of unlawful profits, and critical shortages of essential medicines. This case underscores how regulatory non-compliance and quality failures can result in substantial financial penalties and profound reputational damage. The question one asks is Why? How did this happen?
The primary breakdown occurs when leaders overlook issues that contradict their belief in stability, or exhibit "omission bias," failing to act on early warning signs. This structural flaw allows hidden factory capacity issues and latent compliance risks to fester silently, invisible during your tier meetings and business reviews. This ultimately will compromise the site leadership team's continuous success and can go as far as impacting the career of the team, the patients they serve, and the reputation of their company.
My recommendation is to stay uncomfortably alert...
As a site head, your calendar is probably already full with business reviews, Tier 4 management request, your site Tier 3 meeting, project reviews, updates on the latest contamination, external interactions and much more…
Paradoxically, the better your site performs, the less time you spend looking for fragility and challenging your risk register — precisely when you should be doing so.
Both the FDA and European Medicines Agency highlight major quality failures originating from sites that were fully compliant on paper. Post-inspection findings frequently point to:
Insufficient trend analysis
Over-reliance on periodic reviews
Poor connection of cross-functional data and risks
Early signals identified — but not acted upon
I do not think this is negligence but rather a false perception of security that comes when we have no signals to be alert.
As a site head or member of the SLT, your role is to continuously question good results to ensure they will last…maybe you are already doing this…but if you are not, maybe you could start today. You can simply start with the following:
Ask your SLT : What could surprise us next month? A major deviation, equipment failure?
Where do we rely on suppliers, systems, or assumptions without early-warning controls?
What are the highest-scoring risks in our register — and are remediation plans truly active, or just documented?
Your role is to remain constructively sceptical of a “perfect” Tier review. I often hear, if a KPI has been green too long maybe it is not a good one…get rid of it. I would recommend to create a KPI that will enable you to stay in the green …
When performance is strong, that is exactly when you should dig deeper into the why.
Is it because our systems are genuinely robust — or because the sample bags particulate count is no longer accurate…
Great site leadership is not about enjoying stability, of growth, meeting your targets…It is about challenging stability itself, challenging your people before stability disappears.
What specific area or process on your site needs immediate attention to address the dangerous belief in stability?
Newsletter #11
The danger of believing stability too long
Jan 24, 2026
5 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.
Why strong performance can hide high risk?
You are a talented, experienced site head — respected by your peers and trusted by your executive leadership. You are known for delivering strong results, quarter after quarter.
In recent years, I have worked alongside several leaders like you. One site, operating in a high-demand market and benefiting from multiple years of continuous growth saw over 30% of its top line at risk of disappearing due to a single, unforeseen supply-chain event.
This was not the result of poor leadership or incompetence. The senior leadership team was strong. But early signals were missed while attention remained focused on growth and past success.
When the KPIs have been green for three quarters, the deviations are at an all-time low, and the culture feels harmonious, a dangerous psychological shift occurs: we begin to believe that the system is stable because it is "fixed." In reality, manufacturing stability is not a static state; it is a temporary equilibrium that requires constant energy to sustain.
What happened at Genzyme Allston?
The fundamental misstep some site leadership make is equating past success with future immunity from failure. The Genzyme site in Allston provides a good illustration. Despite its flagship status, the facility incurred severe FDA violations, including microbial and particulate contamination and inadequate quality systems. This led to a consent decree, a significant $175 million disgorgement of unlawful profits, and critical shortages of essential medicines. This case underscores how regulatory non-compliance and quality failures can result in substantial financial penalties and profound reputational damage. The question one asks is Why? How did this happen?
The primary breakdown occurs when leaders overlook issues that contradict their belief in stability, or exhibit "omission bias," failing to act on early warning signs. This structural flaw allows hidden factory capacity issues and latent compliance risks to fester silently, invisible during your tier meetings and business reviews. This ultimately will compromise the site leadership team's continuous success and can go as far as impacting the career of the team, the patients they serve, and the reputation of their company.
My recommendation is to stay uncomfortably alert...
As a site head, your calendar is probably already full with business reviews, Tier 4 management request, your site Tier 3 meeting, project reviews, updates on the latest contamination, external interactions and much more…
Paradoxically, the better your site performs, the less time you spend looking for fragility and challenging your risk register — precisely when you should be doing so.
Both the FDA and European Medicines Agency highlight major quality failures originating from sites that were fully compliant on paper. Post-inspection findings frequently point to:
Insufficient trend analysis
Over-reliance on periodic reviews
Poor connection of cross-functional data and risks
Early signals identified — but not acted upon
I do not think this is negligence but rather a false perception of security that comes when we have no signals to be alert.
As a site head or member of the SLT, your role is to continuously question good results to ensure they will last…maybe you are already doing this…but if you are not, maybe you could start today. You can simply start with the following:
Ask your SLT : What could surprise us next month? A major deviation, equipment failure?
Where do we rely on suppliers, systems, or assumptions without early-warning controls?
What are the highest-scoring risks in our register — and are remediation plans truly active, or just documented?
Your role is to remain constructively sceptical of a “perfect” Tier review. I often hear, if a KPI has been green too long maybe it is not a good one…get rid of it. I would recommend to create a KPI that will enable you to stay in the green …
When performance is strong, that is exactly when you should dig deeper into the why.
Is it because our systems are genuinely robust — or because the sample bags particulate count is no longer accurate…
Great site leadership is not about enjoying stability, of growth, meeting your targets…It is about challenging stability itself, challenging your people before stability disappears.
What specific area or process on your site needs immediate attention to address the dangerous belief in stability?