Newsletter #15
Keeping decisions rational under pressure: A framework for manufacturing leaders
Feb 6, 2026
10 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.
Fast decisions…slow consequences
It's monday morning 7am, a critical filling line is down. At 9am, Quality has flagged a potential non-conformance on a shipment already loaded for delivery…11am, Procurement is warning of a supplier failure that could halt production within 48 hours.
Your phone keeps vibrating, each message demanding a decision, now…
Never mind, you have to rush to a customer meeting right now.
For COOs and site heads, this isn’t a hypothetical scenario. It’s a familiar rhythm for many General managers
Manufacturing is where operational intensity collides with regulatory scrutiny. Decisions are made in minutes, yet judged over months, sometimes years, through audits, investigations, and post-incident reviews. What feels like a technical choice in the moment can quickly become a quality event, a supply disruption, or an executive escalation with enterprise-level consequences.
The real challenge isn’t simply deciding under pressure.
It’s deciding in a way that remains defensible once the pressure has passed.
In the heat of the moment, speed is rewarded. But when the crisis fades, the question inevitably shifts from “Did we act fast enough?” to “Can we explain why we acted this way?”; to regulators, to senior leadership, and to ourselves.
Site heads sit at this uncomfortable intersection: accountable for immediate operational continuity, yet equally responsible for compliance, data integrity, and strategic alignment. Acting too slowly risks production and credibility. Acting too quickly, without the right signals, context, or governance creates exposure that may only surface weeks later.

Five steps to decide well under pressure
Step 1: Pause and categorise the type of decision
Take the time required to first categorise the situation. Is this an immediate safety issue requiring action now, or an urgent issue requiring action within hours?
Be explicit about what is known, what is unknown, and what must be established before a decision is taken.
Vaccine case: The site head convened a 45-minute rapid assessment with Quality, Medical Affairs, and Regulatory. The key question was not “what do we do?” but “what category of risk are we managing?” Discolouration was confirmed, with no reported adverse events. This was a serious quality deviation requiring urgent action. A four-hour window was set to gather critical information before determining recall scope.
Step 2: Define non-negotiable compliance boundaries
Before considering any options, state the regulatory, safety, and quality constraints that cannot be breached. Align with Quality and Regulatory on the compliance baseline, document it, and communicate it before operational discussions begin.
Vaccine case: The site head opened with three non-negotiables: patient safety takes precedence; decisions must be fully defensible to regulators with complete documentation; no GMP shortcuts to accelerate the remediation. Commercial teams argued for completing the investigation before recalling product. Within the defined boundaries, that position was not acceptable. Visible coloured injectable product requires action, not deferral.
Step 3: Apply decision rights and escalate early
Confirm who holds decision authority and escalate immediately if the decision exceeds site mandate. For matters involving regulatory reporting, recalls, or material financial exposure, assume escalation is required.
Vaccine case: The site head recognised that withdrawing eight batches exceeded site authority. Within the first hour, the issue was escalated to the COO with a structured brief: situation summary, compliance boundaries, information being gathered, and a recommendation for precautionary market withdrawal while the investigation continued. The COO retained ownership of the recall decision; the site head owned investigation and corrective actions. Roles were clear. Time was not lost.
Step 4: Test the decision against strategic intent
Before final confirmation, ask a single question: “What does this decision signal about our priorities?” Assess six- and twelve-month implications. If operational convenience conflicts with strategic intent, escalate rather than dilute the position.
Vaccine case: Commercial teams proposed a selective recall, limited to affected batches in order to reduce disruption. The site head tested this against the company’s stated objective of non compromising on patient safety. A selective recall may have been legally defensible, but it weakened that position. The recommendation was a full recall of all eight batches, voluntary regulatory notification, and transparent customer communication. The revenue impact was material. The patient safety and strategic consistency were non-negotiable.
Step 5: Insert a verification checkpoint
Before execution, expose the decision and rationale to a qualified peer who was not involved in the initial discussions. Ask one question: “What have we missed?” Allocate 5–10 minutes.
Vaccine case: Prior to final execution, the COO asked the Chief Medical Officer to review the plan. The review identified a gap: communications covered regulators and customers but omitted public-health authorities reliant on vaccine supply forecasts. A short call corrected this. Proactive outreach to health departments reframed the recall from a disruption into a controlled, transparent response.

The discipline that defines leadership
The vaccine contamination case resolved over 72 intensive hours. The recall was executed. The root cause; a cleaning validation gap introduced during a recent equipment modification was identified and corrected. New batches were manufactured under enhanced oversight. And critically, not a single adverse event was ever reported from the affected batches.
The real outcome wasn't just managing the crisis. It was how the crisis was managed. When regulators audited the decision process months later, they found complete documentation, clear rationale, and decisions that consistently prioritised patient safety over commercial pressure. During the team after-action review, reflecting on what has happened and how they can improve dealing with such situation, they highlighted leadership that didn't abandon process under pressure but relied on it precisely when it mattered most.
Rational decision-making under pressure isn't about eliminating the pressure—that's neither possible nor desirable in a dynamic manufacturing environment. It's about having a disciplined process that functions precisely when instinct wants to take over. IT is not unusual that leaders under high pressure at site level but also from Tier 4 and 5 level would say to me that they are dealing with a few challenges and the only way is to go "through the wall"…whatever this means it does not sound like a good strategy. The leaders who excel in manufacturing aren't those with the fastest reflexes or the loudest voices in the crisis room. They're the ones who've built and practiced a decision framework that works under pressure because it's designed specifically for pressure.
These five steps don't add significant time to your decision process. In the vaccine case, the entire decision framework from first report to recall authorisation took less than four hours—but those four hours of structured thinking prevented months of potential regulatory consequences, customer trust erosion, and strategic misalignment. What this framework adds is structure, and structure under pressure is what separates decisions you'll stand behind from decisions you'll spend months explaining.
More importantly, when your team sees you following a consistent, rational process even in crisis moments, you model the behavior that shapes your entire operational culture. You demonstrate that compliance isn't negotiable, that strategic alignment isn't optional, and that good process isn't something you abandon when things get difficult; it's precisely what you rely on.
The mark of manufacturing leadership isn't perfection in every decision. It's the ability to make defensible decisions under imperfect conditions, decisions that satisfy the immediate operational need while protecting the long-term interests of quality, compliance, and strategic direction. That capability isn't innate; it's built through disciplined practice of frameworks exactly like this one.
When the next crisis comes, you won't need to invent your decision process in the moment. You'll execute the one you've already built.
Newsletter #15
Keeping decisions rational under pressure: A framework for manufacturing leaders
Feb 6, 2026
10 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.
Fast decisions…slow consequences
It's monday morning 7am, a critical filling line is down. At 9am, Quality has flagged a potential non-conformance on a shipment already loaded for delivery…11am, Procurement is warning of a supplier failure that could halt production within 48 hours.
Your phone keeps vibrating, each message demanding a decision, now…
Never mind, you have to rush to a customer meeting right now.
For COOs and site heads, this isn’t a hypothetical scenario. It’s a familiar rhythm for many General managers
Manufacturing is where operational intensity collides with regulatory scrutiny. Decisions are made in minutes, yet judged over months, sometimes years, through audits, investigations, and post-incident reviews. What feels like a technical choice in the moment can quickly become a quality event, a supply disruption, or an executive escalation with enterprise-level consequences.
The real challenge isn’t simply deciding under pressure.
It’s deciding in a way that remains defensible once the pressure has passed.
In the heat of the moment, speed is rewarded. But when the crisis fades, the question inevitably shifts from “Did we act fast enough?” to “Can we explain why we acted this way?”; to regulators, to senior leadership, and to ourselves.
Site heads sit at this uncomfortable intersection: accountable for immediate operational continuity, yet equally responsible for compliance, data integrity, and strategic alignment. Acting too slowly risks production and credibility. Acting too quickly, without the right signals, context, or governance creates exposure that may only surface weeks later.

Five steps to decide well under pressure
Step 1: Pause and categorise the type of decision
Take the time required to first categorise the situation. Is this an immediate safety issue requiring action now, or an urgent issue requiring action within hours?
Be explicit about what is known, what is unknown, and what must be established before a decision is taken.
Vaccine case: The site head convened a 45-minute rapid assessment with Quality, Medical Affairs, and Regulatory. The key question was not “what do we do?” but “what category of risk are we managing?” Discolouration was confirmed, with no reported adverse events. This was a serious quality deviation requiring urgent action. A four-hour window was set to gather critical information before determining recall scope.
Step 2: Define non-negotiable compliance boundaries
Before considering any options, state the regulatory, safety, and quality constraints that cannot be breached. Align with Quality and Regulatory on the compliance baseline, document it, and communicate it before operational discussions begin.
Vaccine case: The site head opened with three non-negotiables: patient safety takes precedence; decisions must be fully defensible to regulators with complete documentation; no GMP shortcuts to accelerate the remediation. Commercial teams argued for completing the investigation before recalling product. Within the defined boundaries, that position was not acceptable. Visible coloured injectable product requires action, not deferral.
Step 3: Apply decision rights and escalate early
Confirm who holds decision authority and escalate immediately if the decision exceeds site mandate. For matters involving regulatory reporting, recalls, or material financial exposure, assume escalation is required.
Vaccine case: The site head recognised that withdrawing eight batches exceeded site authority. Within the first hour, the issue was escalated to the COO with a structured brief: situation summary, compliance boundaries, information being gathered, and a recommendation for precautionary market withdrawal while the investigation continued. The COO retained ownership of the recall decision; the site head owned investigation and corrective actions. Roles were clear. Time was not lost.
Step 4: Test the decision against strategic intent
Before final confirmation, ask a single question: “What does this decision signal about our priorities?” Assess six- and twelve-month implications. If operational convenience conflicts with strategic intent, escalate rather than dilute the position.
Vaccine case: Commercial teams proposed a selective recall, limited to affected batches in order to reduce disruption. The site head tested this against the company’s stated objective of non compromising on patient safety. A selective recall may have been legally defensible, but it weakened that position. The recommendation was a full recall of all eight batches, voluntary regulatory notification, and transparent customer communication. The revenue impact was material. The patient safety and strategic consistency were non-negotiable.
Step 5: Insert a verification checkpoint
Before execution, expose the decision and rationale to a qualified peer who was not involved in the initial discussions. Ask one question: “What have we missed?” Allocate 5–10 minutes.
Vaccine case: Prior to final execution, the COO asked the Chief Medical Officer to review the plan. The review identified a gap: communications covered regulators and customers but omitted public-health authorities reliant on vaccine supply forecasts. A short call corrected this. Proactive outreach to health departments reframed the recall from a disruption into a controlled, transparent response.

The discipline that defines leadership
The vaccine contamination case resolved over 72 intensive hours. The recall was executed. The root cause; a cleaning validation gap introduced during a recent equipment modification was identified and corrected. New batches were manufactured under enhanced oversight. And critically, not a single adverse event was ever reported from the affected batches.
The real outcome wasn't just managing the crisis. It was how the crisis was managed. When regulators audited the decision process months later, they found complete documentation, clear rationale, and decisions that consistently prioritised patient safety over commercial pressure. During the team after-action review, reflecting on what has happened and how they can improve dealing with such situation, they highlighted leadership that didn't abandon process under pressure but relied on it precisely when it mattered most.
Rational decision-making under pressure isn't about eliminating the pressure—that's neither possible nor desirable in a dynamic manufacturing environment. It's about having a disciplined process that functions precisely when instinct wants to take over. IT is not unusual that leaders under high pressure at site level but also from Tier 4 and 5 level would say to me that they are dealing with a few challenges and the only way is to go "through the wall"…whatever this means it does not sound like a good strategy. The leaders who excel in manufacturing aren't those with the fastest reflexes or the loudest voices in the crisis room. They're the ones who've built and practiced a decision framework that works under pressure because it's designed specifically for pressure.
These five steps don't add significant time to your decision process. In the vaccine case, the entire decision framework from first report to recall authorisation took less than four hours—but those four hours of structured thinking prevented months of potential regulatory consequences, customer trust erosion, and strategic misalignment. What this framework adds is structure, and structure under pressure is what separates decisions you'll stand behind from decisions you'll spend months explaining.
More importantly, when your team sees you following a consistent, rational process even in crisis moments, you model the behavior that shapes your entire operational culture. You demonstrate that compliance isn't negotiable, that strategic alignment isn't optional, and that good process isn't something you abandon when things get difficult; it's precisely what you rely on.
The mark of manufacturing leadership isn't perfection in every decision. It's the ability to make defensible decisions under imperfect conditions, decisions that satisfy the immediate operational need while protecting the long-term interests of quality, compliance, and strategic direction. That capability isn't innate; it's built through disciplined practice of frameworks exactly like this one.
When the next crisis comes, you won't need to invent your decision process in the moment. You'll execute the one you've already built.
Newsletter #15
Keeping decisions rational under pressure: A framework for manufacturing leaders
Feb 6, 2026
10 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.
Fast decisions…slow consequences
It's monday morning 7am, a critical filling line is down. At 9am, Quality has flagged a potential non-conformance on a shipment already loaded for delivery…11am, Procurement is warning of a supplier failure that could halt production within 48 hours.
Your phone keeps vibrating, each message demanding a decision, now…
Never mind, you have to rush to a customer meeting right now.
For COOs and site heads, this isn’t a hypothetical scenario. It’s a familiar rhythm for many General managers
Manufacturing is where operational intensity collides with regulatory scrutiny. Decisions are made in minutes, yet judged over months, sometimes years, through audits, investigations, and post-incident reviews. What feels like a technical choice in the moment can quickly become a quality event, a supply disruption, or an executive escalation with enterprise-level consequences.
The real challenge isn’t simply deciding under pressure.
It’s deciding in a way that remains defensible once the pressure has passed.
In the heat of the moment, speed is rewarded. But when the crisis fades, the question inevitably shifts from “Did we act fast enough?” to “Can we explain why we acted this way?”; to regulators, to senior leadership, and to ourselves.
Site heads sit at this uncomfortable intersection: accountable for immediate operational continuity, yet equally responsible for compliance, data integrity, and strategic alignment. Acting too slowly risks production and credibility. Acting too quickly, without the right signals, context, or governance creates exposure that may only surface weeks later.

Five steps to decide well under pressure
Step 1: Pause and categorise the type of decision
Take the time required to first categorise the situation. Is this an immediate safety issue requiring action now, or an urgent issue requiring action within hours?
Be explicit about what is known, what is unknown, and what must be established before a decision is taken.
Vaccine case: The site head convened a 45-minute rapid assessment with Quality, Medical Affairs, and Regulatory. The key question was not “what do we do?” but “what category of risk are we managing?” Discolouration was confirmed, with no reported adverse events. This was a serious quality deviation requiring urgent action. A four-hour window was set to gather critical information before determining recall scope.
Step 2: Define non-negotiable compliance boundaries
Before considering any options, state the regulatory, safety, and quality constraints that cannot be breached. Align with Quality and Regulatory on the compliance baseline, document it, and communicate it before operational discussions begin.
Vaccine case: The site head opened with three non-negotiables: patient safety takes precedence; decisions must be fully defensible to regulators with complete documentation; no GMP shortcuts to accelerate the remediation. Commercial teams argued for completing the investigation before recalling product. Within the defined boundaries, that position was not acceptable. Visible coloured injectable product requires action, not deferral.
Step 3: Apply decision rights and escalate early
Confirm who holds decision authority and escalate immediately if the decision exceeds site mandate. For matters involving regulatory reporting, recalls, or material financial exposure, assume escalation is required.
Vaccine case: The site head recognised that withdrawing eight batches exceeded site authority. Within the first hour, the issue was escalated to the COO with a structured brief: situation summary, compliance boundaries, information being gathered, and a recommendation for precautionary market withdrawal while the investigation continued. The COO retained ownership of the recall decision; the site head owned investigation and corrective actions. Roles were clear. Time was not lost.
Step 4: Test the decision against strategic intent
Before final confirmation, ask a single question: “What does this decision signal about our priorities?” Assess six- and twelve-month implications. If operational convenience conflicts with strategic intent, escalate rather than dilute the position.
Vaccine case: Commercial teams proposed a selective recall, limited to affected batches in order to reduce disruption. The site head tested this against the company’s stated objective of non compromising on patient safety. A selective recall may have been legally defensible, but it weakened that position. The recommendation was a full recall of all eight batches, voluntary regulatory notification, and transparent customer communication. The revenue impact was material. The patient safety and strategic consistency were non-negotiable.
Step 5: Insert a verification checkpoint
Before execution, expose the decision and rationale to a qualified peer who was not involved in the initial discussions. Ask one question: “What have we missed?” Allocate 5–10 minutes.
Vaccine case: Prior to final execution, the COO asked the Chief Medical Officer to review the plan. The review identified a gap: communications covered regulators and customers but omitted public-health authorities reliant on vaccine supply forecasts. A short call corrected this. Proactive outreach to health departments reframed the recall from a disruption into a controlled, transparent response.

The discipline that defines leadership
The vaccine contamination case resolved over 72 intensive hours. The recall was executed. The root cause; a cleaning validation gap introduced during a recent equipment modification was identified and corrected. New batches were manufactured under enhanced oversight. And critically, not a single adverse event was ever reported from the affected batches.
The real outcome wasn't just managing the crisis. It was how the crisis was managed. When regulators audited the decision process months later, they found complete documentation, clear rationale, and decisions that consistently prioritised patient safety over commercial pressure. During the team after-action review, reflecting on what has happened and how they can improve dealing with such situation, they highlighted leadership that didn't abandon process under pressure but relied on it precisely when it mattered most.
Rational decision-making under pressure isn't about eliminating the pressure—that's neither possible nor desirable in a dynamic manufacturing environment. It's about having a disciplined process that functions precisely when instinct wants to take over. IT is not unusual that leaders under high pressure at site level but also from Tier 4 and 5 level would say to me that they are dealing with a few challenges and the only way is to go "through the wall"…whatever this means it does not sound like a good strategy. The leaders who excel in manufacturing aren't those with the fastest reflexes or the loudest voices in the crisis room. They're the ones who've built and practiced a decision framework that works under pressure because it's designed specifically for pressure.
These five steps don't add significant time to your decision process. In the vaccine case, the entire decision framework from first report to recall authorisation took less than four hours—but those four hours of structured thinking prevented months of potential regulatory consequences, customer trust erosion, and strategic misalignment. What this framework adds is structure, and structure under pressure is what separates decisions you'll stand behind from decisions you'll spend months explaining.
More importantly, when your team sees you following a consistent, rational process even in crisis moments, you model the behavior that shapes your entire operational culture. You demonstrate that compliance isn't negotiable, that strategic alignment isn't optional, and that good process isn't something you abandon when things get difficult; it's precisely what you rely on.
The mark of manufacturing leadership isn't perfection in every decision. It's the ability to make defensible decisions under imperfect conditions, decisions that satisfy the immediate operational need while protecting the long-term interests of quality, compliance, and strategic direction. That capability isn't innate; it's built through disciplined practice of frameworks exactly like this one.
When the next crisis comes, you won't need to invent your decision process in the moment. You'll execute the one you've already built.