Management

From Transition to Compliance: Navigating QMSR Implementation and Inspection Readiness

Sun, 26 Jul 2026 00:00:00 -0400

With February 2026 now behind us, the FDA’s Quality Management System Regulation (QMSR) is here. For medical device manufacturers, the question has shifted from “are we ready?” to “can we demonstrate it?”

Earning the Credential, Developing the Practitioner

Sat, 25 Jul 2026 00:00:00 -0400

Certification preparation shifts that vantage point. It demands conceptualization and integration across the full system, including domains you’ve never been required to use professionally.

The Investigation Gap: Why Quality Systems Miss Systemic Risk Before Failure Occurs

Fri, 24 Jul 2026 00:00:00 -0400

The next evolution of quality management will depend less on collecting additional information and more on connecting information that already exists.

Artificial Intelligence: Where to Begin

Mon, 20 Jul 2026 00:00:00 -0400

Jon Reneberg is the lead digital manufacturing specialist at Purdue Manufacturing Extension Partnership, or MEP.

Building Quality Systems for Semiconductor Yield Ramp and High-Volume Production

Sun, 19 Jul 2026 00:00:00 -0400

In this interview, Karnik discusses the technical and organizational challenges of semiconductor NPI, how yield ramp exposes hidden manufacturing risks, and what it takes to move emerging technologies into high-volume manufacturing with confidence.

When Smart Manufacturing Meets Human Intuition

Sat, 18 Jul 2026 00:00:00 -0400

After decades beside injection molding machines, I have learned an important truth: Data can provide facts, but only human intuition can reveal the truth behind them.

From Document Control to Process Evidence: Why AM Quality Needs A New “System”

Thu, 16 Jul 2026 00:00:00 -0400

In production AM, the question that matters is not only “Do you have a procedure?” It’s also “Can you prove what actually happened to this part, quickly, consistently, and at scale?”

Reengineering Quality for the AI Era

Sun, 12 Jul 2026 00:00:00 -0400

Quality leaders now face a new challenge: how to reengineer quality systems for an increasingly intelligent and connected world.

Supplier Award Pitfalls

smith_jim_l@cat.com (Jimmy L. Smith) — Sat, 11 Jul 2026 00:00:00 -0400

Many suppliers are primarily motivated by purchase orders. While they may enjoy being “wined and dined,” what suppliers really prefer from their customers as reward for superior performance is additional business.

How Precision Manufacturing and Verisurf Helped Power the Success of Artemis II

Fri, 10 Jul 2026 00:00:00 -0400

The collaboration between Amro Fabrication and Verisurf Software demonstrates how precision manufacturing and digital inspection can enable missions once thought impossible.

Beyond Membership: Discovering the Unexpected Rewards of Being Involved in ASQ

Tue, 07 Jul 2026 00:00:00 -0400

When I first joined ASQ, I simply wanted a way to stay connected to the quality profession outside my day-to-day work, but it ended up shaping my career—and even my personal growth.

PODCAST | Hey, What Does This Button Do?

Mon, 06 Jul 2026 00:00:00 -0400

In her role as an instructor, Dr. Cook discusses education and the changes she has witnessed.

They Just Told Me I’m Going to Be the New Internal Auditor – YIKES! (Part 1)

Mon, 06 Jul 2026 00:00:00 -0400

Why do we perform internal audits in the first place, beyond the fact that ISO 9001:2015 requires them?

Quality Management Systems 101: What Manufacturers Need to Know

Mon, 06 Jul 2026 00:00:00 -0400

A Quality Management System (QMS) in manufacturing is a foundational framework of policies, processes, and procedures that ensures products consistently meet strict customer and regulatory requirements.

Building Better Inspectors Through Hands-On NDT Practice

Sat, 04 Jul 2026 00:00:00 -0400

Across the industry, one of the biggest challenges in technician development is the gap between classroom knowledge and real-world readiness.

The Demand for Integrating Cybersecurity into Aerospace Quality

inquiry.msamericas@bsigroup.com (David Harvey) — Fri, 03 Jul 2026 00:00:00 -0400

Quality and cybersecurity departments have operated as largely independent disciplines. That separation is no longer sustainable.

Why Inspection Bodies Should Think Differently About Digital Evidence Under ISO/IEC 17020:2026

Thu, 02 Jul 2026 00:00:00 -0400

The 2012 edition acknowledged electronic records. The 2026 edition regulates them.

ISO14001: 2026 is Published

jvdbd@hotmail.com (John Vandenbemden) — Wed, 01 Jul 2026 00:00:00 -0400

ISO14001: 2026 doesn’t require more documented information, but instead expects organizations to better manage their EMS with proof of real performance and effective management.

Flopping

selandd@bnpmedia.com (Darryl Seland) — Tue, 30 Jun 2026 00:00:00 -0400

The approach to both basketball and quality manufacturing deals with system predictability, elimination of waste, process control and enforcement, and continuous improvement.

ISO 9001: The Most Recognized Standard—and the Least Truly Used

Sun, 28 Jun 2026 00:00:00 -0400

One of the most common misunderstandings is the belief that quality is something checked at the end. But in real operations, quality starts much earlier.

Not Such a Cruel Summer: An Economic Outlook

Fri, 26 Jun 2026 12:00:00 -0400

Christopher Chidzik is the principal economist at AMT, the Association for Manufacturing Technology.

What ISO 9001:2015 Really Means to an Organization

Fri, 26 Jun 2026 00:00:00 -0400

The purpose of this system is simple: to ensure that processes are defined, measurable, and capable of being analyzed.

A First Look at the AIAGVDA SPC Manual

jvdbd@hotmail.com (John Vandenbemden) — Thu, 25 Jun 2026 00:00:00 -0400

I did not know what to expect based on past experiences with the manual but this was surprisingly well developed.

Where Is ISO9001:2026 Taking Us?

jvdbd@hotmail.com (John Vandenbemden) — Wed, 24 Jun 2026 00:00:00 -0400

Although supply chain concerns are sometimes reviewed, their direct impacts on organizations are often overlooked.

ASQ Quality in Education Think Tank

dlbrecken@sbcglobal.net (Don Brecken) — Tue, 23 Jun 2026 00:00:00 -0400

By emphasizing continuous improvement in education, ASQ prepares students for future career challenges and cultivates a culture of accountability and innovation within educational systems.

AI in the Quality Department: A Practical Path Forward for Small Manufacturers

jonreneberg@purdue.edu (Jon Reneberg) — Tue, 23 Jun 2026 00:00:00 -0400

Think of AI as the world’s most capable intern: fast, patient, and perfectly happy running the same analysis a hundred times without complaining. Your job is to direct it.

Why Your Escalation Queue Is Getting Longer and What It Actually Means

Mon, 22 Jun 2026 00:00:00 -0400

The Meeting Room Is a Quality System. Are You Managing It Like One?

Mon, 22 Jun 2026 00:00:00 -0400

Most organizations treat meetings as calendar events. Looking at it that way would be a fatal system thinking error.

Why AI in Manufacturing Fails Without Quality Data

Sun, 21 Jun 2026 00:00:00 -0400

In manufacturing, where data is fragmented across machines, operators, and disconnected legacy systems, the risk of poor data readiness is amplified.

Hey, How Would You Like to be a Quality Inspector?

Tue, 16 Jun 2026 00:00:00 -0400

Andrew Davison is an experienced quality executive with more than 20 years working in the medical device industry.