#LEAN Manufacturing
Browse all posts tagged with LEAN Manufacturing
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.
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.
Exposing the Hidden Factory: How COPQ Reveals Capacity Constraints
March 18, 2026 • By Mike Barlow
The Hidden Factory represents unmeasured capacity consumed by internal failure activities such as deviation investigations, production rework, and documentation errors. While these activities are tracked operationally, their economic impact is rarely quantified. Applying the Cost of Quality framework translates this consumption into financial terms, providing a basis for capacity recovery and risk-informed prioritization aligned with ICH Q9 and Q10.
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.
How to Calculate Your Facility's True COPQ (Free Calculator)
July 24, 2025 • By Mike Barlow, Paul Van Buskirk
Cost of Poor Quality (COPQ) can quietly erode margins in biopharma operations through rework, deviations, delays, and batch losses. This post breaks down the four key components of quality cost—prevention, appraisal, internal failure, and external failure—and introduces a free COPQ calculator to help you estimate the true financial impact and identify opportunities for ROI.
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.