All Features
Saurabh Joshi Shripad
Before the ICH Harmonized Tripartite Guideline Q9—“Quality risk management”—was introduced in 2005, the pharmaceutical industry was evolving but lacked a structured, scientific, and systematic approach. Various stakeholders, including the industry, regulators, and patient rights groups, recognized…
George Schuetz
Electronic temperature compensation in gaging has become a valuable tool in improving the accuracy and gage repeatability and reproducibility (GR&R) of gages in harsh manufacturing environments.
The need for temperature compensation comes into play when the expected errors from temperature…
ISO
In a world where change is the only constant, organizations can no longer afford to be complacent. Keeping up with the pace of technological change is tough, and all business leaders must learn to adapt. It’s no longer enough to react to disruption. To get ahead of the competition, organizations…
James Chan
The U.S. Food and Drug Administration (FDA) is the country’s chief agency for regulating the manufacture, marketing, and distribution of critical consumer goods including food, cosmetics, medical devices, biological products, and pharmaceuticals. The FDA provides direct oversight of the businesses…
William A. Levinson
Most quality practitioners are familiar with the Taguchi loss function, which contends that the cost of any deviation from the nominal follows a quadratic model. This is in contrast to the traditional goalpost model, where anything inside the specification limits is good, and anything outside them…
Etienne Nichols
Design controls are a set of quality practices and procedures used to ensure that a finished device meets its user needs, intended use, and specified requirements.
The requirement for medical device companies to use design controls is established in 21 CFR Part 820, as well as ISO 13485:2016.
The…
Jennifer King
Many people don’t realize just how long AI has been around in the healthcare industry—and are surprised to find out that it’s something that’s been relied on for 50 years already.
MYCIN, a computer-based model with machine learning capabilities, was developed by a team of researchers at Stanford…
Donald J. Wheeler
The objective of all improvement projects should be to improve the overall process. Everything else should be secondary to this objective. If you improve the efficiency of a support process, or even a portion of the core process, but at the same time lower the efficiency of the overall process,…
Robyn Coward, Brian Brooks
This year, the Medical Device Innovation Consortium held an Excellence in Quality Summit where it was promised that participants would receive a “unique opportunity to learn adoptable cutting-edge practices to maximize the impact of investing in quality across [their] total product life cycle.”…
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…
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…
