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I Never Want to Be [Sic]k
Reading the news (or even your email) can be distressing to the point of despondency. It can also be fun. It’s especially fun when people say or write silly stuff, and the reporter or editor has to write [sic] after a misspelling or a stupid comment in the original transcript. Sic, usually placed…
Ramping Up Productivity With Bulk-Bag Discharge Upgrades
In food processing, bulk-bag discharge systems are used to transfer food ingredients such as flour, sugar, and spices from bulk bags to mixing and blending equipment. However, when not designed or installed properly, bulk discharge systems can become a production bottleneck. Complicating the issue…
What FDA QSR and ISO 13485 Harmonization Means for Medical Device Companies
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…
Mixing 3D Scanning With Chemical Engineering
The WAB-GROUP is where innovation and tradition come together to provide customers with world-class solutions in the areas of wet grinding technology, three-dimensional-shaking mixing technology, and flow chemistry. Present in 42 countries worldwide and anchored since 2008 in its state-of-the-art…
Twelve Strategies for Successful CAPA Management
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…
Take Out Your Customers’ Trash
‘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.…
Service Recovery in 60 Seconds or Less
Everyone makes mistakes. When you screw up and say, “I’m sorry. That’s our mistake,” it’s good customer service, but not service recovery. Most organizations never admit mistakes, and fewer than 1% practice service recovery. Keeping customers is critical to your growth. Gaining a new customer is…
Data Management and Reporting in FDA-Regulated Clinical Trials
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…
How AI Trends Can Drive Quality Management Systems
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…
How Slack Created a New Product Category
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…
New Data on Quality of ESG Audits Catches Regulators’ Attention
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…
Fundamentals of Telemedicine Equipment
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…
Customer Fog: The Real Reason Customers Leave
The cost of acquiring a new customer can be five to 10 times the cost of keeping an existing customer, depending on the industry. You already knew that. But while most organizations know why their customers opened the exit door, they devote little effort to understanding what prompted customers to…
Should You Tell Your Clients Your Business Uses AI?
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.…
Are EVs Losing on Authenticity?
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-…
Seven Deadly CX Sins Revisited
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,…
Hands-On Customer Service Training
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…
If They Only Knew How to Leverage the ADA to Fight RTO Mandates
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…
Customer Quality Management
Customer complaints are a fact of life in any industry. Even though manufacturers would prefer not to receive complaints, they do come with a silver lining. Managed effectively, they play an important role in improving your products and processes over time—that is, for companies that take a…
The Invaluable Role of Traceable Data in Aircraft
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…
Your Future Medications Could Be Personalized on a 3D Printer
Here are just a few potential advantages of 3D drug printing—a new system for manufacturing drugs and treatments onsite at pharmacies, healthcare facilities, and other remote locations: chocolate-flavored pills for children who hate taking medicine; several drugs combined into one daily pill for…
Leaders Who Empower: Why Kenny Wins Every Time
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…
QMSR and the End of DMR, DHR, and DHF
If you’re a medtech professional who’s been working with the quality system regulation (QSR) in the United States, then you’re probably familiar with the three terms the U.S. Food and Drug Administration uses for record-keeping requirements: 1) device master record (DMR), a compilation of records…
The Focused Docs and the Patient
As years roll on, I’m noticing more parts of me breaking down: Teeth, eyes, knees, cardiovascular, stomach—the list keeps getting longer, as does the list of docs I see. I’m blessed to be living in an area with the world’s finest medical care and lucky that healthcare innovation (and Medicare) have…
The Power of Change Management Tools
Look through even a few FDA warning letters and you’re likely to find violations related to change management. For instance, a recent warning letter from the U.S. Food and Drug Administration cited a pharmaceutical manager for changing drug components without justification. Another noted a lack of…

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