Picture this: It's Halloween night. You've spent weeks planning—ordered the decorations, stocked up on candy, picked up your costume. But when the doorbell rings at 6:05 PM, you realize you forgot to carve the pumpkins, the fog machine is still in the box, and somehow you're already running low on candy. The event you planned for is here, but you're not quite ready for what happens next.
If you've ever led a capital project to PPQ (Process Performance Qualification), you know this feeling. Months of planning culminate in those final validation runs. The pressure is intense. The timeline is non-negotiable. And just like Halloween night, you discover the blind spots only when it's too late to turn back.
But here's the twist that makes this truly scary: PPQ isn't the end of the story. It's just October 31st. November 1st is when your facility needs to wake up and operate efficiently, day after day, for years to come. And if you've sprinted to the finish line without designing for that reality? That's when things get genuinely frightening.
The Case of the Climbing Filter. A state-of-the-art facility, designed with beautiful 3D models and cutting-edge automation. Everything looked perfect—on screen. Then operators showed up for their first shift and discovered that accessing the sterile filter for routine maintenance required climbing scaffolding. Every. Single. Time. The equipment worked flawlessly. The ergonomics? Terrifying.
The Tale of the Too-Small Tank. Imagine spending millions on a CIP (clean-in-place) system, passing all your validation runs, and then realizing the rinse tank is undersized for your actual cycle requirements. The solution? Double batching. The result? Theoretical capacity cut in half. Like handing out king-size candy bars only to run out by 7 PM.
The Curse of the Cybersecurity Blindspot. A digital-first facility with impressive automation and data collection. But the OT (operational technology) environment was treated like traditional IT. With cyberattacks on industrial systems doubling and tripling annually—and CGMP now mandating OT cyber plans—this isn't just a technical gap. It's a vulnerability hiding in plain sight.
These aren't failures of effort or expertise. They're the predictable consequences of prioritizing speed over sustainability. When your decision-making is driven by "just get it done," you create technical debt that haunts your operations for years.
The Setup: Stakeholder Silos. By the time QA and operations teams get involved, major decisions are locked in. Equipment is ordered. Layouts are finalized. Construction is underway. These teams inherit designs they didn't influence, which means they inherit problems they can see coming but can't prevent.
The Pressure: Deadline Dominance. Those final three to six months before PPQ are brutal. Water runs, mixing studies, engineering runs—all the critical validation steps get compressed into timelines that were aggressive before the inevitable delays hit. Every conversation defaults to: "Will this delay PPQ?" The question that should be asked—"Will this create operational problems later?"—gets drowned out by urgency.
The Collision: Digital Dreams vs. Construction Reality. The reshoring trend and Industry 4.0 excitement have created a wave of "digital-first" facility ambitions. But when construction schedules dominate, technology becomes an afterthought. Systems get bolted on rather than built in. The result? Underutilized tools, fragmented data, and frustrated teams.
The scariest part? We don't talk about these failures enough. There's a cultural tendency to celebrate the PPQ success and move on, leaving the operational team to quietly manage the consequences. But as one of our industry peers recently recognized, "We don't talk about our failures enough"—and that silence perpetuates the cycle.
If you've ever led a capital project to PPQ (Process Performance Qualification), you know this feeling. Months of planning culminate in those final validation runs. The pressure is intense. The timeline is non-negotiable. And just like Halloween night, you discover the blind spots only when it's too late to turn back.
But here's the twist that makes this truly scary: PPQ isn't the end of the story. It's just October 31st. November 1st is when your facility needs to wake up and operate efficiently, day after day, for years to come. And if you've sprinted to the finish line without designing for that reality? That's when things get genuinely frightening.
Tales from the Haunted House
Let's walk through some real scenarios that emerged after the PPQ celebration ended and operations began:The Case of the Climbing Filter. A state-of-the-art facility, designed with beautiful 3D models and cutting-edge automation. Everything looked perfect—on screen. Then operators showed up for their first shift and discovered that accessing the sterile filter for routine maintenance required climbing scaffolding. Every. Single. Time. The equipment worked flawlessly. The ergonomics? Terrifying.
The Tale of the Too-Small Tank. Imagine spending millions on a CIP (clean-in-place) system, passing all your validation runs, and then realizing the rinse tank is undersized for your actual cycle requirements. The solution? Double batching. The result? Theoretical capacity cut in half. Like handing out king-size candy bars only to run out by 7 PM.
The Curse of the Cybersecurity Blindspot. A digital-first facility with impressive automation and data collection. But the OT (operational technology) environment was treated like traditional IT. With cyberattacks on industrial systems doubling and tripling annually—and CGMP now mandating OT cyber plans—this isn't just a technical gap. It's a vulnerability hiding in plain sight.
These aren't failures of effort or expertise. They're the predictable consequences of prioritizing speed over sustainability. When your decision-making is driven by "just get it done," you create technical debt that haunts your operations for years.
Why Do Smart Teams Keep Making These Mistakes?
Everyone involved in these projects is intelligent, capable, and working incredibly hard. So why do the same issues keep appearing? Because the system is designed to produce exactly these outcomes.The Setup: Stakeholder Silos. By the time QA and operations teams get involved, major decisions are locked in. Equipment is ordered. Layouts are finalized. Construction is underway. These teams inherit designs they didn't influence, which means they inherit problems they can see coming but can't prevent.
The Pressure: Deadline Dominance. Those final three to six months before PPQ are brutal. Water runs, mixing studies, engineering runs—all the critical validation steps get compressed into timelines that were aggressive before the inevitable delays hit. Every conversation defaults to: "Will this delay PPQ?" The question that should be asked—"Will this create operational problems later?"—gets drowned out by urgency.
The Collision: Digital Dreams vs. Construction Reality. The reshoring trend and Industry 4.0 excitement have created a wave of "digital-first" facility ambitions. But when construction schedules dominate, technology becomes an afterthought. Systems get bolted on rather than built in. The result? Underutilized tools, fragmented data, and frustrated teams.
The scariest part? We don't talk about these failures enough. There's a cultural tendency to celebrate the PPQ success and move on, leaving the operational team to quietly manage the consequences. But as one of our industry peers recently recognized, "We don't talk about our failures enough"—and that silence perpetuates the cycle.
So What Can We Do About It?
The good news? These haunted houses are avoidable. They're the result of systems and incentives that prioritize the wrong things at the wrong times. The organizations that succeed aren't necessarily the fastest to PPQ—they're the ones who recognize that operational excellence is a marathon, not a sprint.
In our next post, we'll explore the "November 1st Mindset"—practical strategies for designing facilities that perform not just at PPQ, but for years to come. We'll share how to break down silos, build fusion teams, and balance speed with sustainability. Because nobody likes a haunted house they didn't sign up for.
