When the Margin Is Unknown, Control Becomes Reaction Not everything can be turned into a process. This is especially true in early product development, where learning, discovery, and iteration dominate. However, when ambiguity persists beyond its appropriate stage—especially around dimensions, tolerances, and margins—organizations unintentionally transfer risk downstream. The image illustrates a simple truth: when the […]

When Testing Competes with the Calendar Not everything can be turned into a process—especially early in product development, where learning is still underway. However, one decision consistently creates downstream damage: allowing testing to compete directly against launch dates. The image captures a familiar and dangerous scenario—standing still on the tracks while “time to ship” accelerates […]

Problems Are Symptoms of Unmanaged Risk  by Jon M Quigley This post is in response to an article on LinkedIn from Habib ur Rehman on blaming operator mistake as the root cause, and operator training as corrective action. This article is very timely, as I have been involved in consulting work where this situation was […]

The PFMEA–Control Plan Connection in Manufacturing A robust PFMEA connected to a control plan strategy is essential when launching a new manufacturing line or improving an existing one. The Process Failure Mode and Effects Analysis (PFMEA) identifies where and how a process might fail, while the control plan documents how those risks will be monitored, […]

Manufacturing Repeatability and the Importance of Repeatable Processes Manufacturing organizations striving for predictable, high-quality output often discover that manufacturing repeatability is not achieved by accident—it is engineered through disciplined, repeatable processes. In competitive markets, manufacturers cannot rely on tribal knowledge or inconsistent practices; they must establish process stability that consistently converts raw materials into reliable […]

Factory Acceptance Test (FAT) and Site Acceptance Testing (SAT) Overview In product development, acceptance testing is a cornerstone of predictable, high-quality system deployment.  As one of the authors of Configuration Management Theory and Practice, Testing of Complex and Embedded Systems, and multiple industry articles, I often emphasize that product and system verification must validate performance across both controlled […]

Openness Builds Stronger Cultures In the past few weeks, I’ve been reflecting on a pattern that appears across high-performing, logic-driven organizations: brilliant teams slowly losing momentum because the fight to be proper overshadows the desire to understand. Then I saw this LinkedIn article, which is the genesis of this article. I have worked on teams […]

Understanding Lean Process Limits Lean principles have transformed how we design and manufacture products. By emphasizing waste reduction, continuous improvement, and customer value, lean thinking drives productivity and focus. Yet, even discipline can turn dangerous when taken to extremes—revealing what we might call the limits of lean processes.  Everything has limits, and exceeding those limits […]

What is 2D Barcode Traceability? 2D barcode (also known as QR Code or Data Matrix) traceability drives modern manufacturing efficiency by linking every product to its digital records, including build instructions and test data. Unlike traditional labels, 2D barcodes such as Data Matrix or QR codes can encode a unique job ID, serial number, or […]

Work Instruction Updates: Capturing Continuous Improvement and Tribal Knowledge By Jon M Quigley Why Work Instruction Updates Matter Work instruction updates are more than administrative chores; they are potent tools for continuous improvement and the preservation of tribal knowledge. As organizations adapt to changing customer needs, technological shifts, and workforce turnover, the need to capture, […]