Newsletter #10
Your KPIs show everything's fine for the last 2 quarters. So why did that incident just happened?
Jan 19, 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.
Everything looks good…
It's Monday noon at a large sterile manufacturing site in France. The SLT is running the site's weekly performance review on their digital dashboard. Everything looks good; batch release rate is at 98%, 95% of deviations were closed within 30 days, Zero overdue compliance activities, Zero accident for the last 11 months.... Everything looks good.
Tuesday morning, a general practitioner in Germany reports a vial (for a major product) with brown discolouration. Contamination...!? The investigation triggers a multi-batch recall affecting thousands of patients...and the reputation of the site and brand, costing the company several 10's of million euros
The root cause analysis reveals a cascade of subtle failures that existed for weeks: gradual degradation of a CIP spray ball reducing cleaning effectiveness, microscopic rubber particulates from ageing gaskets accumulating in the fill needle assembly, slight pH drift in the WFI system just within specification limits, and increasing bioburden counts in routine monitoring—still passing but trending upward. None of these warning signs appeared as red flags on any KPI dashboard at Tier 3, Tier 2 or Tier 1. The performance management system reported success while contamination risk quietly escalated.
This isn't a failure of effort or commitment on the part of the SLT and their respective teams. It's a structural flaw in how we've traditionally measured manufacturing performance.
The hidden danger of lagging green KPIs
I've spent two decades deploying performance management systems across global pharmaceutical companies manufacturing sites. That experience taught me that lagging indicators create a dangerous illusion of control. They tell us what already happened—while the next crisis is silently building up...
Site heads have the toughest job in the industry. One described his week to me, as being permanently on stage, spinning plates that can never stop. Despite large investment in performance management programmes, many leaders still experience that "Oh no...Zut" moment when a serious incident emerges—consuming the entire SLT's time—without any prior warning on the dashboard.
On the vial-filling line at the French plant, all weekly KPIs looked healthy. Monthly trending showed improvement. Yet the Tier meetings failed to escalate what mattered: the convergence of multiple micro-degradations creating a major contamination risk.
CIP effectiveness wasn't monitored between validation cycles.
Gasket wear wasn't tracked until it became visible.
WFI pH drift wasn't analysed directionally.
Bioburden data was reviewed pass/fail—not for patterns signalling a changing microbial ecosystem.
None of these parameters failed individually.
Together, they created fragility.
This isn't solved by working harder, adding more KPIs, or bringing in another wave of consultants. Transforming performance management is neither quick nor simple. There are no shortcuts. It isn't a tick-box programme you implement in a quarter.
It requires engagement from floor operators to executive leadership, a detailed understanding of critical process parameters and their interdependencies, and—most importantly—a shift in how risk is managed: from explaining what went wrong to anticipating what could go wrong.
The real work is moving from reactive firefighting to proactive problem-solving. That means integrating leading indicators and digital insight to achieve true end-to-end operational visibility—systems that surface spray-ball degradation, gasket wear patterns, pH drift, and bioburden trends before they converge into contamination events that reach patients.
This transformation takes years, not months.
But the alternative—relying on lagging indicators that report success right before failure—is a risk no site director can afford.
The visibility problem: why lagging indicators can't prevent what they only report
The fundamental misstep most organisations make is mistaking past performance for future predictability. Organisations over-emphasise lagging indicators—batch success rates, deviation closures, recall statistics—which merely confirm what has already transpired. These metrics are outputs, not precursors, offering little opportunity for intervention.
I came to the conclusions that three structural flaws perpetuate this problem:
Siloed data prevents end-to-end visibility
Many pharmaceutical companies grapple with fragmented data and manual processes, preventing a holistic view of complex manufacturing environments. Subtle shifts in upstream processes or emerging equipment anomalies remain undetected until they manifest as major incidentsCompliance culture inadvertently stifles risk anticipation
While prioritising compliance is essential, the focus on avoiding non-conformance often overshadows the more critical work of actively predicting and preventing issues before they occurAbsence of proactive risk frameworks leveraging leading indicators
Without metrics that signal impending issues—real-time process parameter deviations, maintenance alerts, training adherence rates—teams are left reacting to crises rather than preventing them. Operational risks from equipment failure to human error are inherent in pharma manufacturing; what's missing is the foresight to anticipate them.
What specific operational area in your facility needs immediate attention to address the gap between reported KPIs and actual incident risk?
Newsletter #10
Your KPIs show everything's fine for the last 2 quarters. So why did that incident just happened?
Jan 19, 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.
Everything looks good…
It's Monday noon at a large sterile manufacturing site in France. The SLT is running the site's weekly performance review on their digital dashboard. Everything looks good; batch release rate is at 98%, 95% of deviations were closed within 30 days, Zero overdue compliance activities, Zero accident for the last 11 months.... Everything looks good.
Tuesday morning, a general practitioner in Germany reports a vial (for a major product) with brown discolouration. Contamination...!? The investigation triggers a multi-batch recall affecting thousands of patients...and the reputation of the site and brand, costing the company several 10's of million euros
The root cause analysis reveals a cascade of subtle failures that existed for weeks: gradual degradation of a CIP spray ball reducing cleaning effectiveness, microscopic rubber particulates from ageing gaskets accumulating in the fill needle assembly, slight pH drift in the WFI system just within specification limits, and increasing bioburden counts in routine monitoring—still passing but trending upward. None of these warning signs appeared as red flags on any KPI dashboard at Tier 3, Tier 2 or Tier 1. The performance management system reported success while contamination risk quietly escalated.
This isn't a failure of effort or commitment on the part of the SLT and their respective teams. It's a structural flaw in how we've traditionally measured manufacturing performance.
The hidden danger of lagging green KPIs
I've spent two decades deploying performance management systems across global pharmaceutical companies manufacturing sites. That experience taught me that lagging indicators create a dangerous illusion of control. They tell us what already happened—while the next crisis is silently building up...
Site heads have the toughest job in the industry. One described his week to me, as being permanently on stage, spinning plates that can never stop. Despite large investment in performance management programmes, many leaders still experience that "Oh no...Zut" moment when a serious incident emerges—consuming the entire SLT's time—without any prior warning on the dashboard.
On the vial-filling line at the French plant, all weekly KPIs looked healthy. Monthly trending showed improvement. Yet the Tier meetings failed to escalate what mattered: the convergence of multiple micro-degradations creating a major contamination risk.
CIP effectiveness wasn't monitored between validation cycles.
Gasket wear wasn't tracked until it became visible.
WFI pH drift wasn't analysed directionally.
Bioburden data was reviewed pass/fail—not for patterns signalling a changing microbial ecosystem.
None of these parameters failed individually.
Together, they created fragility.
This isn't solved by working harder, adding more KPIs, or bringing in another wave of consultants. Transforming performance management is neither quick nor simple. There are no shortcuts. It isn't a tick-box programme you implement in a quarter.
It requires engagement from floor operators to executive leadership, a detailed understanding of critical process parameters and their interdependencies, and—most importantly—a shift in how risk is managed: from explaining what went wrong to anticipating what could go wrong.
The real work is moving from reactive firefighting to proactive problem-solving. That means integrating leading indicators and digital insight to achieve true end-to-end operational visibility—systems that surface spray-ball degradation, gasket wear patterns, pH drift, and bioburden trends before they converge into contamination events that reach patients.
This transformation takes years, not months.
But the alternative—relying on lagging indicators that report success right before failure—is a risk no site director can afford.
The visibility problem: why lagging indicators can't prevent what they only report
The fundamental misstep most organisations make is mistaking past performance for future predictability. Organisations over-emphasise lagging indicators—batch success rates, deviation closures, recall statistics—which merely confirm what has already transpired. These metrics are outputs, not precursors, offering little opportunity for intervention.
I came to the conclusions that three structural flaws perpetuate this problem:
Siloed data prevents end-to-end visibility
Many pharmaceutical companies grapple with fragmented data and manual processes, preventing a holistic view of complex manufacturing environments. Subtle shifts in upstream processes or emerging equipment anomalies remain undetected until they manifest as major incidentsCompliance culture inadvertently stifles risk anticipation
While prioritising compliance is essential, the focus on avoiding non-conformance often overshadows the more critical work of actively predicting and preventing issues before they occurAbsence of proactive risk frameworks leveraging leading indicators
Without metrics that signal impending issues—real-time process parameter deviations, maintenance alerts, training adherence rates—teams are left reacting to crises rather than preventing them. Operational risks from equipment failure to human error are inherent in pharma manufacturing; what's missing is the foresight to anticipate them.
What specific operational area in your facility needs immediate attention to address the gap between reported KPIs and actual incident risk?
Newsletter #10
Your KPIs show everything's fine for the last 2 quarters. So why did that incident just happened?
Jan 19, 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.
Everything looks good…
It's Monday noon at a large sterile manufacturing site in France. The SLT is running the site's weekly performance review on their digital dashboard. Everything looks good; batch release rate is at 98%, 95% of deviations were closed within 30 days, Zero overdue compliance activities, Zero accident for the last 11 months.... Everything looks good.
Tuesday morning, a general practitioner in Germany reports a vial (for a major product) with brown discolouration. Contamination...!? The investigation triggers a multi-batch recall affecting thousands of patients...and the reputation of the site and brand, costing the company several 10's of million euros
The root cause analysis reveals a cascade of subtle failures that existed for weeks: gradual degradation of a CIP spray ball reducing cleaning effectiveness, microscopic rubber particulates from ageing gaskets accumulating in the fill needle assembly, slight pH drift in the WFI system just within specification limits, and increasing bioburden counts in routine monitoring—still passing but trending upward. None of these warning signs appeared as red flags on any KPI dashboard at Tier 3, Tier 2 or Tier 1. The performance management system reported success while contamination risk quietly escalated.
This isn't a failure of effort or commitment on the part of the SLT and their respective teams. It's a structural flaw in how we've traditionally measured manufacturing performance.
The hidden danger of lagging green KPIs
I've spent two decades deploying performance management systems across global pharmaceutical companies manufacturing sites. That experience taught me that lagging indicators create a dangerous illusion of control. They tell us what already happened—while the next crisis is silently building up...
Site heads have the toughest job in the industry. One described his week to me, as being permanently on stage, spinning plates that can never stop. Despite large investment in performance management programmes, many leaders still experience that "Oh no...Zut" moment when a serious incident emerges—consuming the entire SLT's time—without any prior warning on the dashboard.
On the vial-filling line at the French plant, all weekly KPIs looked healthy. Monthly trending showed improvement. Yet the Tier meetings failed to escalate what mattered: the convergence of multiple micro-degradations creating a major contamination risk.
CIP effectiveness wasn't monitored between validation cycles.
Gasket wear wasn't tracked until it became visible.
WFI pH drift wasn't analysed directionally.
Bioburden data was reviewed pass/fail—not for patterns signalling a changing microbial ecosystem.
None of these parameters failed individually.
Together, they created fragility.
This isn't solved by working harder, adding more KPIs, or bringing in another wave of consultants. Transforming performance management is neither quick nor simple. There are no shortcuts. It isn't a tick-box programme you implement in a quarter.
It requires engagement from floor operators to executive leadership, a detailed understanding of critical process parameters and their interdependencies, and—most importantly—a shift in how risk is managed: from explaining what went wrong to anticipating what could go wrong.
The real work is moving from reactive firefighting to proactive problem-solving. That means integrating leading indicators and digital insight to achieve true end-to-end operational visibility—systems that surface spray-ball degradation, gasket wear patterns, pH drift, and bioburden trends before they converge into contamination events that reach patients.
This transformation takes years, not months.
But the alternative—relying on lagging indicators that report success right before failure—is a risk no site director can afford.
The visibility problem: why lagging indicators can't prevent what they only report
The fundamental misstep most organisations make is mistaking past performance for future predictability. Organisations over-emphasise lagging indicators—batch success rates, deviation closures, recall statistics—which merely confirm what has already transpired. These metrics are outputs, not precursors, offering little opportunity for intervention.
I came to the conclusions that three structural flaws perpetuate this problem:
Siloed data prevents end-to-end visibility
Many pharmaceutical companies grapple with fragmented data and manual processes, preventing a holistic view of complex manufacturing environments. Subtle shifts in upstream processes or emerging equipment anomalies remain undetected until they manifest as major incidentsCompliance culture inadvertently stifles risk anticipation
While prioritising compliance is essential, the focus on avoiding non-conformance often overshadows the more critical work of actively predicting and preventing issues before they occurAbsence of proactive risk frameworks leveraging leading indicators
Without metrics that signal impending issues—real-time process parameter deviations, maintenance alerts, training adherence rates—teams are left reacting to crises rather than preventing them. Operational risks from equipment failure to human error are inherent in pharma manufacturing; what's missing is the foresight to anticipate them.
What specific operational area in your facility needs immediate attention to address the gap between reported KPIs and actual incident risk?