#Root Cause Analysis
Browse all posts tagged with Root Cause Analysis
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.
What is Tangential Flow Filtration?
July 27, 2023 • By Mike Barlow
Tangential Flow Filtration (TFF), also known as Crossflow Filtration, is a widely used separation technique in biologics manufacturing for processes such as concentration, diafiltration, and buffer exchange of biomolecules like proteins, antibodies, and vaccines.