All Features
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…
Megan King
In 2018, the world agreed to redefine the kilogram. Instead of being pegged to the mass of a physical object in a vault in France, the kilogram is now defined by a few fundamental constants in nature.
This means researchers no longer have to worry about a physical object that can decay or change…
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
When a patient comes into a clinic or hospital, healthcare practitioners have all the tools at their disposal to conduct thorough examinations. However, when they see a patient online, they may lack the necessary equipment to conduct the visit properly. One reason for this is that virtual care…
Andrey Solin
Disclaimer: This isn’t meant to be a car review. This is an article on brand authenticity.
Back in 2021, when Ford was promoting the Mustang Mach-E GT, its high-performance electric vehicle, the company found a way to appeal to potential buyers who somehow missed the sensory appeal of gasoline-…
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…
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…
James Chan
Preventive maintenance (PM) is a proactive maintenance strategy built on calendar-based maintenance tasks, regular inspection, and preemptive repair of physical assets. Physical assets may refer to equipment, production machinery, and operational facilities. Preventive maintenance tasks are…
Pierre-Nicolas Disser, Megan Wallin-Kerth
QIMA, previously called AsiaInspection, is known for not only making inspection and certifications easier, but also increasing accessibility via a convenient digital platform and strong focus on compliance. Both SMEs and e-commerce businesses have benefited from this increase in affordability and…
ISO
From small family-run companies to tech giants, the business world is changing at an unrelenting pace. Amid a constantly evolving economic landscape and sometimes dizzying technological advances, one thing remains constant: the need to maintain the highest level of quality that endures over time.…
Michael Sharp
American manufacturing is associated with high-quality standards that are meant to ensure both the reliability and longevity of the products produced. Manufacturers across all industries are looking for technological solutions and enhancements to continue to meet these high-bar standards and to…
Elizabeth Norwood
In manufacturing, selecting the right cleaning fluids is a critical determinant of product quality, reliability, and environmental impact. As industries increasingly prioritize sustainability, the transition to environmentally friendly cleaning fluids is imperative. This article delves into…
Donald J. Wheeler
One hundred years ago this month, Walter Shewhart wrote a memo that contained the first process behavior chart. In recognition of this centennial, this column reviews four different applications of the techniques that grew out of that memo.
The first principle for interpreting data is that no data…
Etienne Nichols
In the United States, the Food and Drug Administration (FDA) is the federal agency tasked with regulating the medical device market and ensuring the safety and effectiveness of all devices for patients.
The FDA classifies medical devices by risk into three categories: Class I, Class II, and Class…
Stephanie Ojeda
An analysis of U.S. Food and Drug Administration (FDA) warning letters by the Food and Drug Law Institute reveals a perhaps not-so-surprising link between training gaps and FDA violations.
It’s one of several factors motivating companies to switch to automated training management software. The…
Morehouse Instrument Co.
In the healthcare sector, precision isn’t just a requirement. It’s a necessity where the margins for error are perilously thin, and the consequences of inaccuracy can be grave. At the heart of this precision lies the unassuming yet critical load cell, a device whose reliability is foundational to…
Dawn Bailey
The Center for Organ Recovery & Education (CORE), a 2019 Baldrige Award recipient, is a nonprofit organ procurement organization (OPO) in Pittsburgh with a federally designated service area encompassing a population of 5.5 million in western Pennsylvania, West Virginia, and one county in New…
ISO
Trust makes the world go ’round. Without it, democracies crumble and relationships suffer. The same goes for organizations and businesses: Without the trust of their customer base, they simply can’t succeed.
Trust, however, is never a given. Like respect, it must be won. In an ever-evolving…
Douglas C. Fair, Scott A. Hindle
In less than two months we will celebrate the 100th anniversary of the invention of the control chart, a tool most often associated with statistical process control (SPC). Considering SPC from our modern perspective made us ask, “Is SPC still relevant?”
It’s a question asked within the purview of…
Denise Robitaille
The buzz has begun. ISO 9001 is being revised. There hasn’t been a revision in about 10 years, so it’s due—if not overdue. Still, there are individuals who don’t understand the justification or the purpose of the revision. After all, it’s a perfectly good standard. So, what’s up?
It’s worth…
William A. Levinson
In his Quality Digest article published in February 2023, Michael Mills1 reported that the next version of ISO 9001 will add to clause 4.1, “Understanding the organization and its context” the words, “the organization shall determine whether climate change is a relevant issue.”
Although nothing in…
Grant Ramaley
When it comes to protecting anyone or anything from harm caused by something manufactured, grown on a farm, or rolling down a highway or a runway, quality is of utmost importance. Our trust forms the backbone of what we expect from our food, cars, planes, medical devices, and protection of the…
Denise Robitaille
ISO 9001 has begun its revision process. In the next few months, all eyes will be riveted on that arena as everyone seeks to anticipate the changes and what they’ll augur for their own quality management systems. The attention is not undeserved.
Equally important but with considerably less…
Matthew Barsalou
The FMEA (failure modes and effects analysis) turned 75 years old in 2024. However, a look at the literature may paint a different picture. Both the origin year of FMEAs and the name of the organization that developed FMEAs seem to vary among authors. Much of the literature on FMEAs is inconsistent…
