All Features
Touradj Ebrahimi
For the last 30 years, the JPEG image format has been a staple for the internet’s billions of users. While the technologies used to display images have evolved tremendously during the past few decades, the JPEG format is still used everywhere. This is a great example of what can happen when a new…
John Hilgendorf
Whether you’re an executive with limited energy or an hourly employee trying to minimize work, the bottleneck in your productivity isn’t time or money but mental effort. And in a digital age where all data can be stored electronically, the most valuable functions of software—especially those in…
Mike Figliuolo
Reading the news (or even your email) can be distressing to the point of despondency. It can also be fun. It’s especially fun when people say or write silly stuff, and the reporter or editor has to write [sic] after a misspelling or a stupid comment in the original transcript. Sic, usually placed…
Etienne Nichols
On Jan. 31, 2024, the U.S. Food and Drug Administration (FDA) released its final rule for the new Quality Management System Regulation (QMSR).
The new QMSR is the result of aligning the current good manufacturing practice (cGMP) requirements of the FDA’s quality system regulation (QSR) with the…
Stephanie Ojeda
There’s no question about it: Should an auditor or inspector visit your facility, one thing that will certainly be under the microscope is your corrective and preventive action (CAPA) system.
CAPA management is a recurring theme in U.S. Food and Drug Administration (FDA) warning letters, a fact…
George Schuetz
In this job, I get a lot of questions. In fact, I did some figuring the other day and estimated, conservatively, that we have probably answered at least 50,000 gauging questions over the past 35 years or so.
Some of these questions have been challenging. They’ve pushed me to learn more about my…
Chris Rush
Ensuring the accuracy and security of clinical data, as well as compliance with good clinical practice (GCP), will in large part determine the success of your study and regulatory submission to the U.S. Food and Drug Administration (FDA). Data management and reporting are essential practices when…
ISO
Global awareness of climate change and sustainability has grown exponentially during the past decade, making terms like corporate responsibility, carbon footprint, and transparency the new buzzwords of our time.
The drive toward a more sustainable future has propelled environmental, social, and…
Chip Bell
The cost of acquiring a new customer can be five to 10 times the cost of keeping an existing customer, depending on the industry. You already knew that. But while most organizations know why their customers opened the exit door, they devote little effort to understanding what prompted customers to…
Patty Davidson
For the U.S. Department of Labor’s Wage and Hour Division, protecting children in the workplace is the top priority. The division is responsible for enforcing foundational labor standards, including the child labor provisions of the Fair Labor Standards Act (FLSA). The FLSA establishes minimum wage…
James Chan
Maintenance teams operate in challenging environments that can often produce workplace mishaps, near misses, and other potential hazards. That’s where maintenance incident reports come in. Not only do these reports help team members isolate and problem-solve safety concerns, leading to a safer…
Luk Van Wassenhove
In today’s business environment, where the insatiable desire to grow profits overshadows environmental and social interests, it’s easy to overlook how the actions of economic actors can shape corporate—and environmental—outcomes.
In the accounting profession, practitioners exercise skepticism…
Stephanie Ojeda
Customer complaints are a fact of life in any industry. Even though manufacturers would prefer not to receive complaints, they do come with a silver lining. Managed effectively, they play an important role in improving your products and processes over time—that is, for companies that take a…
Andreas Janz, Horacio Falcão
Failing to identify faults seems to be a prevalent issue nowadays, considering recent reports of quality control problems at Boeing and numerous recalls by car manufacturers, to name a few. Yet, excessive fault-finding occurs when the ability to pinpoint faults—a beneficial behavior—is taken too…
Creaform
When it comes to aircraft, poorly documented dents can lead to more significant problems, potentially compromising structural integrity or performance. Dents can trap moisture and lead to corrosion. The stress they generate can initiate fatigue cracks. Their effects on the structure can also affect…
James Chan
Thoughtful planning is the cornerstone of an effective preventive maintenance program. Your maintenance plan is the framework for everything from building a maintenance schedule and automating inventory management to streamlining work order management and improving interdepartmental communication…
Jones Loflin
I love gardening and growing fresh vegetables. Recently I had checked in on my Brussels sprouts seedlings and, well, they looked awful! The reason quickly became obvious to me: I had overwatered them.
I was so excited about growing Brussels sprouts this year, I didn’t want anything to happen to…
Matt Fieldman
If you look around your plant floor, I’m sure the layout, equipment, and technologies are different today from what they were 10—or even five—years ago. You’ve put time, effort, and money into improving every aspect of your operations. You’ve cut costs and made investments where they were necessary…
Etienne Nichols
If you’re a medtech professional who’s been working with the quality system regulation (QSR) in the United States, then you’re probably familiar with the three terms the U.S. Food and Drug Administration uses for record-keeping requirements: 1) device master record (DMR), a compilation of records…
David Isaacson
For any manufacturer, ensuring well-run, successful processes and protocols is the backbone of a successful and profitable operation. Yet, despite the most well-laid plans, circumstances can change and manufacturers may sidestep best practices in the race to meet demand. Still, ensuring quality,…
William A. Levinson
The International Accreditation Forum (IAF) and ISO have published a joint communiqué to require organizations to “consider” climate change in the context of risks and opportunities relevant to the management system.
Although this is pursuant to the London Declaration, which has goals for…
Stephanie Ojeda
Look through even a few FDA warning letters and you’re likely to find violations related to change management.
For instance, a recent warning letter from the U.S. Food and Drug Administration cited a pharmaceutical manager for changing drug components without justification. Another noted a lack of…
Stefano Puntoni, Bart De Langhe
Most businesses rightly see data as a source for making better decisions. But the conventional data-driven approach often falls short because of common errors made by the decision-makers. Many leaders rely excessively on existing data that might not always address the issue at hand, or they pass…
Veronica Muzquiz Edwards
Health connects each one of us to one another. No matter where we are in the world, who we are, or what we do, the state of our health is a key determinant in our quality of life. Simply put, it’s our most valuable asset.
Individual health crises can be disastrously grim, and if not addressed…
NIST
To combat global warming, companies are building direct air capture (DAC) facilities worldwide to remove carbon from the atmosphere. The National Institute of Standards and Technology (NIST) has developed a new method for testing the materials used in these plants to capture carbon. The agency…
