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Avoid the ‘Blockbuster Effect’ in Life Sciences With Preventive Quality
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.”…
Authentic Leadership: His Name Is Angel
Mike Figliuolo
I hate the use of the word just in front of anyone’s title, as in, “He’s just an analyst,” or, “She’s just a cafeteria worker,” or, “I’m just an administrative assistant.” No one is just anything. The word is demeaning and pejorative. We’re all people—we happen to have different responsibilities.…
Are Your Employees Empowered?
John Tschohl
Are your employees empowered to make decisions on the spot in favor of the customer? Your single goal should be to have overly happy customers. Too many things go wrong each day. You want your employees to understand they are in customer service, and their No. 1 responsibility is to take care of…
I Never Want to Be [Sic]k
Mike Figliuolo
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
Del Williams
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
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…
Mixing 3D Scanning With Chemical Engineering
Creaform
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
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…
Take Out Your Customers’ Trash
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.…
Service Recovery in 60 Seconds or Less
John Tschohl
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
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…
How AI Trends Can Drive Quality Management Systems
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…
How Slack Created a New Product Category
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…
New Data on Quality of ESG Audits Catches Regulators’ Attention
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…
Fundamentals of Telemedicine Equipment
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…
Customer Fog: The Real Reason Customers Leave
Chip Bell
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?
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.…
Are EVs Losing on Authenticity?
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-…
Seven Deadly CX Sins Revisited
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,…
Hands-On Customer Service Training
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…
If They Only Knew How to Leverage the ADA to Fight RTO Mandates
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…
Customer Quality Management
Stephanie Ojeda
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
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…
Your Future Medications Could Be Personalized on a 3D Printer
Lawrence Goodman
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
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…

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