#LEAN Manufacturing
Browse all posts tagged with LEAN Manufacturing
Most Teams Skip the Most Important Question
May 20, 2026 • By Paul Van Buskirk
Most organizations do not struggle to identify problems. They struggle to interpret them. In pharmaceutical manufacturing, teams are surrounded by dashboards, metrics, deviations, CAPAs, and operational data—yet the same execution issues continue to persist. This Field Guide explores the difference between “The What,” “The So What,” and “The Now What,” and why operational recovery depends on more than visibility alone. Because identifying the problem is only the beginning. Translating it into disciplined execution is where leadership actually begins.
Quality System Governance Archetypes: The Faucet, the Sink, and the Drain
May 12, 2026 • By Mike Barlow, Paul Van Buskirk
Many GMP governance meetings are overloaded with metrics but starved for operational clarity. Today's GMPKit Field Guide article introduces a simple stock-to-flow model—the faucet, sink, and drain—to help pharmaceutical operations and quality leaders identify hidden backlog formation, predict system saturation earlier, and transform Quality System KPI review from administrative reporting into operational control.
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.
What Is Cell Therapy Manufacturing?
August 30, 2024 • By Mike Barlow
Cell therapy manufacturing involves several complex steps that require specialized training, equipment and strict quality assurance and control measures to ensure the safety, efficacy, and consistency of the final product.
How Does CAR-T Cell Therapy Work?
August 16, 2024 • By Mike Barlow, Paul Van Buskirk
In the world of medical advancements, few breakthroughs have captured as much attention and hope as CAR-T cell therapy. This innovative approach to cancer treatment holds the promise of revolutionizing the way we combat certain types of cancer. But how does CAR-T cell therapy work, and what makes it so remarkable? In this article, we'll delve into the intricacies of CAR-T cell therapy and explore how it harnesses the body's immune system to target and destroy cancer cells.
Cell Therapy vs. Gene Therapy: What’s the Difference?
July 12, 2024 • By Mike Barlow
In modern medicine, two powerful technologies—Cell Therapy and Gene Therapy—are reshaping how we treat serious diseases. Both aim to repair or replace what’s malfunctioning inside the body, but they take fundamentally different approaches.
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.
Biologics Manufacturing Processing Steps - Upstream and Downstream Operations
August 21, 2023 • By Mike Barlow, Paul Van Buskirk
Typical biologics manufacturing involves culturing cells in bioreactors (upstream processing) to produce the target protein, followed by harvesting to separate cells from the product-containing broth. The product is then purified through downstream processing methods like filtration and chromatography. Finally, it's formulated with stabilizers, filled into sterile containers, and undergoes quality testing before release.
What are Biologics?
May 18, 2023 • By Mike Barlow
In biotechnology, biologics are therapeutic products made from living cells or organisms. Unlike chemically synthesized drugs, biologics are usually large, complex molecules such as proteins, cells, or genetic material.