All Features
John Tschohl
Why do customers patronize one company over another? Many of you might say that the quality and price of the products or services are key factors. But while those things might play into a purchasing decision, they aren’t the most important consideration.
So, what is? Customer service. How you and…
Hexagon Manufacturing Intelligence
Did you know that shutdowns, turnarounds, and outages (STOs) can consume up to 50% of a plant’s annual maintenance budget? That’s according to a report by the Boston Consulting Group.
STOs are among the most complex and high-stakes events in industrial operations. They’re costly, especially when…
Bryan Christiansen
Facility teams are constantly balancing urgent repairs, preventive tasks, asset tracking, and compliance, all while ensuring smooth day-to-day operations. But when processes are manual, fragmented, or unclear, even simple tasks can spiral into delays, miscommunication, and wasted time.
The…
Harish Jose
Readers of my blog might be aware that I appreciate the nuances of cybernetic constructivism. Cybernetic constructivism rejects the idea that we have access to an objective reality. It doesn’t deny that there’s an external reality independent of an observer. However, we don’t have direct access to…
Cornelia C. Walther
When artificial intelligence burst into mainstream business consciousness, the narrative was compelling: Intelligent machines would handle routine tasks, freeing humans for higher-level creative and strategic work. McKinsey research sized the long-term AI opportunity at $4.4 trillion in added…
Etienne Nichols
The corrective and preventive action (CAPA) process is one of the most important elements within a medtech company’s quality management system (QMS). The goal of the CAPA system is to identify, address, and prevent systemic issues that could compromise product safety, regulatory compliance, and the…
Stephanie Ojeda
Many companies are still clinging to paper-based and unconnected electronic processes, despite the clear disadvantages. Without modern tools like QMS software, these organizations risk compromising product quality, falling behind in compliance, and ultimately losing competitive ground.
In contrast…
Sanath Hegde
For quality heads, compliance officers, auditors, and engineering leaders, audits have been a time-consuming, resource-intensive process, yet necessary to build resilient operations, prevent costly failures, and maintain competitive advantage.
The question isn’t whether to audit, but how to…
Harish Jose
In this article I’m exploring the need for ethics in systems thinking using the ideas of Heinz von Foerster and Russell Ackoff. The two come from different traditions within systems thinking. Von Foerster comes from physics and second-order cybernetics, and Ackoff from operations research and…
Gleb Tsipursky
As companies and government agencies push forward with return-to-office (RTO) mandates, they risk exacerbating a workplace problem that many have failed to address adequately: gender discrimination.
New research from the University of Toronto’s Rotman School of Management highlights how in-person…
Prasant Prusty, Arundhathy Shabu
A global food safety and quality certification, BRCGS (British Retail Consortium Global Standards) initially focused on food safety but now comprises various sectors such as packaging, consumer products, and retail. It aims to ensure that businesses maintain high standards of safety and quality…
Etienne Nichols
As part of its effort to address the changing landscape around artificial intelligence (AI) in medical devices, the U.S. Food and Drug Administration (FDA) has recently released two new guidance documents on artificial intelligence-enabled device software functions (AI-DSF): • “AI-enabled device…
Cornelia C. Walther
On April 8, 2025, a driverless Zoox robotaxi misjudged an approaching vehicle, braked too late, and sideswiped it at 43 mph on the Las Vegas Strip.
One month later, the Amazon subsidiary issued a software recall on 270 autonomous vehicles and suspended operations while regulators investigated the…
Heidi Drafall
Anyone who has cracked their smartphone screen or had a rapid oil change knows that sometimes the OEM isn’t the most affordable or convenient service option. Consumer flexibility, paired with lower-cost, high-quality options, is logical, whether it’s in the consumer market or in healthcare.
The…
Jones Loflin
This past weekend I engaged in one of my favorite activities as a beekeeper. I got to catch a swarm of bees.
If you haven’t seen it before, it’s wild. About half of the bees leave with a queen and set up somewhere temporarily while they’re looking for their new permanent home. In the case of this…
William A. Levinson
According to the U.S. News & World Report article “FDA Warns Sanofi of Manufacturing Irregularities at Key Facility” (Jan. 23, 2025), the pharmaceutical company Sanofi received a U.S. Food and Drug Administration warning letter “stating that FDA inspectors found irregularities with the facility…
Bryan Christiansen
The cornerstone of efficient industrial and facility management, maintenance, repair, and operations (MRO) cover all activities related to equipment maintenance, procurement, upkeep, and inventory management. This includes spare parts, consumables, lubricants, cleaning supplies, safety equipment,…
Harish Jose
I am a longtime admirer of George Spencer-Brown’s “Laws of Form.” In this article, I explore how his notion of reentry helps illuminate the paradoxes and blind spots in modern ideologies, especially the rise of xenophobia and extreme nationalism. These rigid ideologies depend on distinctions…
Matt McFarlane
One of the key findings in Greenlight Guru’s 2025 Medical Device Industry Report was that economic uncertainty is playing a large role in the decisions medical device companies make this year.
The report surveyed more than 500 medical device professionals across quality, regulatory, product…
Stephanie Ojeda
Every day, quality leaders face a variety of production and process issues. Although some problems are easy to fix, others require deeper investigation, such as using a 5 Whys analysis or fishbone diagram. But then there are the stubborn, recurring issues that can lead to quality issues, increased…
ISO
Occupational health and safety (OHS) is often brushed aside as a checkbox exercise—something assigned to compliance officers or forgotten in day-to-day operations. But this mindset comes at a cost. Every year, millions of people suffer injuries, illnesses, or worse, simply because their workplace…
Stephen Graham, Quality Digest
Uploading something “to the cloud” has become common enough that most people are acutely aware of the storage advantages of cloud services—whether in their personal or professional lives—as well as how they might benefit administrators in any business. What might surprise people is the additional…
Colin Strachan
Most industrial leaders strive to be more proactive and data-driven. But getting there can feel overwhelming, especially if your teams spend much of the day firefighting.
Maintenance maturity depends on the quality of your data, how effectively you use them, and the processes and culture that…
Prerna Sudera
Ensuring that automotive components meet the highest quality standards is critical to vehicle safety and performance. Metals and protective coatings used in automotive manufacturing must withstand extreme conditions such as mechanical stresses, corrosion, and wear during a vehicle’s lifespan. Here…
CIH Equipment
Industrial hygiene equipment plays a critical role in ensuring workplace safety by monitoring airborne contaminants, noise levels, and other hazardous conditions. However, accurate readings depend on regular industrial hygiene equipment calibration to maintain precision and compliance with…
