All Features
William A. Levinson
The current alleged quality problems with the Boeing 737 underscore the importance of zero tolerance for poor quality. No manufacturing or quality professional should ever compromise on this issue. Most importantly, the potential consequences to customers but also to the organization are simply not…
Peter Cappelli
A recent report showed that 59% of managers said they had received no training on how to be a manager before becoming one. Management professor and director of Wharton’s Center for Human Resources Peter Cappelli says that stunning statistic is compounded by the fact that most of those managers are…
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…
Kelly Nault, Ko Kuwabara, Yejin Park
Giving and receiving help are essential aspects of organizational life, whether that’s providing career advice or soliciting a colleague’s input on a tricky technical problem that you just can’t solve. Through help exchange, individuals gain access to ideas, resources, and relationships that help…
Pawel Korzynski
Amid seemingly never-ending layoffs and a laser focus on efficiency, companies expect their employees to make productive and focused use of their time on the clock. Yet, research has shown that they often spend a significant amount of time cyberloafing—using the internet for personal purposes…
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…
James Chan
Management of change (MOC) is a defined process that organizations establish and follow to ensure health, safety, and reduction of risk during periods of change. MOC systems and policies are essential for companies that undergo significant updates to their facilities, personnel, equipment, or…
Gleb Tsipursky
Generative AI, when harnessed correctly, has the potential to revolutionize the way companies operate, innovate, and compete. But the question that arises is how businesses can effectively tap into this potential. The answer lies in setting up an AI center of excellence that combines IT with…
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…
Saurabh Joshi Shripad
Risk assessment and continual process verification (CPV) are fundamental regulatory requirements for pharmaceutical companies to ensure drug safety, efficacy, and quality. While risk assessment involves analyzing, mitigating, communicating, and monitoring risks that could ultimately affect patients…
Ferdinando Fioretto
Artificial intelligence’s capacity to process and analyze vast amounts of data has revolutionized decision-making processes, making operations in healthcare, finance, criminal justice, and other sectors of society more efficient and often more effective.
However, with this transformative power…
Stephanie Ojeda
Companies today implementing automated compliance management systems are motivated by a wide variety of factors.
For many, it’s about reducing manual labor hours required to execute quality processes—and achieving greater efficiency and effectiveness in their operations. For others, the priority…
Patrick Gale
Medical equipment is a necessary yet substantial investment for any health system. Making strategic decisions about these assets can be daunting in the face of shifting patient demand, financial uncertainty, and fast-changing cybersecurity risks.
Because clinical assets account for an average 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…
Jennifer King
The cost of poor quality can be devastating to business: Failed quality control costs manufacturers anywhere between 15–20% of their total profits on average, and as much as 40% for some, the ASQ reveals. Businesses with successful quality programs, on the other hand, can benefit from increased…
William A. Levinson
What do quality and productivity have to do with World War III, which we all hope will never happen? The answer is everything. A massive loss of American manufacturing capability between 1945 and 2024 has conceded enormous advantages to aggressor nations that might be inclined to break the peace.…
Alonso Diaz, Maria DiBari
The U.S. Food and Drug Administration (FDA) emphasizes the importance of being prepared for device recalls.
FDA product recalls are on the rise in the post-pandemic era. There has been a clear upward trend from 2021 through 2023, and medical devices ranked the highest of all product types. (See…
Stephanie Ojeda
Implementing an automated compliance management solution is a mammoth undertaking with high stakes and potentially high returns for those who navigate the process successfully.
Get it right and you could save thousands of labor hours, avoid millions of dollars in compliance issues, and free up…
Stephanie Ojeda
As U.S. Supreme Court Justice Louis D. Brandeis famously wrote, “Sunlight is said to be the best of disinfectants.”
In the field of quality, internal audits are the equivalent of sunlight. Like spring cleaning, internal audits provide the opportunity to bring process issues into the open before…
Jamie Bihary
An internal audit can be an overwhelming prospect, especially if you’re new to a company or internal auditing in general.
The MedTech space is huge, and even the standards that are meant to help, like ISO 13485:2016, cover a lot of ground.
So, if you’re part of the audit team in your company, and…
James Chan
Reactive maintenance is a form of physical asset management in which maintenance is only performed on equipment or machinery when it malfunctions or fails entirely. Sometimes referred to as run-to-failure maintenance or breakdown maintenance, reactive maintenance strategies provide the most basic…
Stephanie Ojeda
Formal complaint management is a requirement in regulated industries such as medical device and pharmaceuticals under U.S. Food and Drug Administration (FDA) and other international regulations.
The FDA mandates that medical device companies, for example, designate a formal unit for managing…
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…
Jamie Fernandes-ETQ
Generative AI took the world by storm in 2023, from the classroom to the film studio, and the writer’s bench to the White House. Enterprises and creative industries worked to figure out how to leverage it in their operations, while classrooms and government entities struggled to govern its use.
In…
