#Root Cause Analysis
Browse all posts tagged with Root Cause Analysis
Can You Write the Ship?
April 21, 2026 • By Paul Van Buskirk
AI can generate answers that look right—but what happens when teams lose the ability to build them on their own? In GxP environments, this isn’t just a technology risk—it’s a capability risk that shows up in execution, decision-making, and ultimately, Cost of Poor Quality.
The True Cost of a Failed Pharmaceutical Batch
April 15, 2026 • By Mike Barlow, Paul Van Buskirk
Most companies underestimate the true cost of a lost batch by 5–10×. Beyond the write-off, hidden work, capacity loss, and system disruption drive a much larger Cost of Poor Quality (COPQ) than is typically measured.
Digital Doesn’t Fix Broken Execution
April 8, 2026 • By Paul Van Buskirk
Pharmaceutical companies continue to invest heavily in digital transformation, yet operational outcomes remain unchanged. This article explains why visibility alone doesn’t improve execution—and how governance and discipline must come first.
Artificial Intelligence in GxP Environments
April 6, 2026 • By Paul Van Buskirk
Artificial Intelligence (AI) in GxP environments is not a decision-making system—it is structured decision support aligned with GAMP 5. Most organizations get this wrong, positioning AI in ways that introduce unnecessary compliance risk. This whitepaper defines the correct framework—how to apply AI with discipline, maintain human ownership of decisions, and align with regulatory expectations without increasing validation burden.
Don’t Start Conversations as a Bulldozer — Start Them as a Domino
March 25, 2026 • By Paul Van Buskirk
Most operational conversations in pharmaceutical manufacturing begin like bulldozers—forceful, reactive, and loud. Effective leaders start them like dominos: small, precise actions that trigger system-wide improvement.
Dashboards Don’t Stop Debris
February 26, 2026 • By Paul Van Buskirk
Dashboards were never meant to be decorative. The original dashboard existed to stop debris before it reached the passenger. Modern business dashboards do the opposite — they measure the mess after it hits. In pharmaceutical manufacturing, that mess shows up as lost batches, deviation backlog, delayed disposition, and rework — the true drivers of Cost of Poor Quality. Visibility alone does not prevent failure. Structural correction does.
BatchTrak - Is it an Obeya Room?
July 12, 2025 • By Paul Van Buskirk
What is an Obeya Room? An Obeya room (from the Japanese word "Obeya" 大部屋, meaning "big room") is a centralized, physical or digital space used for collaborative project management and visual coordination, especially in Lean and Agile environments.
How To Write the Perfect Problem Statement
May 29, 2024 • By Mike Barlow
If you work in Biopharmaceutical Manufacturing or Quality, one of the best things you can do to drive reliability in GMP Manufacturing is learn how to craft a strong problem statement. In this video, we will show you how to do that. Creating a strong problem statement is pivotal in problem-solving. A well-defined problem statement sets the stage for effective GMP deviation investigation and problem solving.
What is a GMP Deviation Investigation?
August 26, 2023 • By Mike Barlow
In GMP pharmaceutical production, including biologics and cell therapy manufacturing, a GMP Deviation Investigation is the structured process used to identify, document, analyze, and resolve any unexpected events or conditions that do not comply with approved procedures, specifications, or regulatory requirements.