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…
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…
Chip Bell
‘T ake out the papers and the trash.” That was the opening line of the song “Yakety Yak” by The Coasters. It spent weeks as the No. 1 hit in 1958. Teenagers everywhere wore out their shoes dancing to the hot song. The lyrics hold a strong message about delivering a superior customer experience.…
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…
Mike Figliuolo
We take ourselves too seriously, and in doing so we become boring and no fun. Sometimes it’s OK to let loose, act silly, and have a good time. It’s energizing.
So often we while away the days being the consummate professional. We read professional journals. We write professional messages. We hold…
Jennifer King
At a time when virtual meetings, video conferences, and online work calls are the norm, there’s good news for those who see a unique value in in-person networking. A survey conducted by Harvard Business Review has found that 95% of professionals believe face-to-face meetings are crucial to…
Mike King
Historically, the sensitive nature of personal and company proprietary information held in life sciences quality management systems (QMS) has been a factor for quality management teams’ reluctance to adopt AI. Add to that the complex global regulatory environment and the penalties of noncompliance…
Josh Leath
As the transition to a more sustainable future continues, more Americans are discovering the advantages of electric vehicles (EVs). From limited maintenance to incredible torque, acceleration, the ability to fuel from home, and attractive rebates, EVs are no longer just a “green” vehicle option but…
Yushiro Kato
These days, incessant pings and buzzes from your workspace’s preferred team management software may seem like a fact of life. But not too long ago, the idea of having software beyond emailing to manage teams was beyond imagination. Then one of the market’s leaders stumbled into creating the perfect…
Jones Loflin
In a previous article, I discussed the concept of “stress bragging”—that tendency to boast about our stress levels as a way to highlight our productivity and importance. I touched on ways to curb this habit in ourselves. But what about when others do it? Here are some effective strategies for…
Alexander Gelfand
All publicly traded companies in the United States are legally required to have their financial statements vetted by independent auditors. And plenty of other firms hire external auditors to enhance their credibility in the eyes of investors and other stakeholders. But what about the ESG reports…
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…
John Tschohl
Why do people leave their jobs? Even if they’re well paid and have good benefits, many will wave goodbye as they walk out the door, never to return.
They don’t leave because they want more money or better benefits. They don’t leave because they don’t like their jobs or their co-workers. They leave…
Natalie King
The use of artificial intelligence (AI) is now so widespread that it’s rare to come across a company that isn’t using it in some capacity. While many clients look on the technology favorably, in a recent survey 14% of people still reported that they were unlikely to trust a company that uses AI.…
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-…
Annette Franz
Years ago—actually nine years ago, in February 2015—I wrote about “The 7 Deadly Sins of Customer Experience.”
I shared that article on LinkedIn recently and recognized that the sins may need some updating. I don’t disagree with the sins I originally wrote about, but I’m OK with consolidating,…
Mike Figliuolo
It’s all well and good to pontificate about “the customer comes first” or “deliver outstanding service,” but often it’s hard for your team members to wrap their heads around what that really means. You can say these things until your jaw muscles are sore, and post all the customer service rules you…
Gleb Tsipursky
Many employees are unaware that they can leverage the Americans with Disabilities Act (ADA) to request work-from-home (WFH) accommodations based on mental health conditions. This knowledge gap has the potential to reshape the “return to office” (RTO) landscape, creating both opportunities and…
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…
Jones Loflin
I was driving along listening to the audio book Trust, by Henry Cloud (Faith Words, 2023). When the person reading the book made the comment, “Trustworthy leaders make their teams care less,” I almost had to pull over. Hearing that made me question exactly what they were talking about.
However,…
Mike Figliuolo
Congratulations! You’ve arrived. You’ve earned that nice cushy office where you can shut the door and no one can hear you listening to the greatest American Idol video ever on YouTube (or looking for a video card to send to your mom on Mother’s Day).
Yep, the office is fantastic. But if you want…
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…
Kate Zabriskie
‘I don’t like confrontation, but I’m tired of his abuse. He signed me up for another committee without asking.”
“I know I need to say something about her taking credit for my work, but how to start?”
“Another joy of adulting, I’ve got to have one of those thorny conversations. Not fun.”
Difficult…
Harish Jose
I have always been interested in the idea of autonomy in a social setting. In this article, I’m looking at autonomy in a social setting—such as an organization—from a cybernetics viewpoint. I’ll lean on the ideas of Heinz von Foerster and Stafford Beer.
Von Foerster came up with the notion of…
Mike Figliuolo
Are you giving your lowest-level employees the power to make crucial customer-relations decisions without supervision? If not, you’re making a huge mistake.
Within a four-hour period on Friday I witnessed both excellent leadership and an abject failure of it. These experiences occurred with the…
