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How Teaming Supercharges Collaboration
Stanislav Shekshnia, Sergey Vorobiev
In the complex, uncertain, and fast-changing world we live in, success and even survival require intensive collaboration among individuals, organizations, and countries. The outcomes of such collaboration can be breathtaking: Consider the growth of Netflix and Amazon, the rebirth of Microsoft and…
Twelve Ways to Assess Manufacturing Control and Analytics Software
John Hilgendorf
Whether you’re an executive with limited energy or an hourly employee trying to minimize work, the bottleneck in your productivity isn’t time or money but mental effort. And in a digital age where all data can be stored electronically, the most valuable functions of software—especially those in…
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…
The Comfort Continuum
Daniel Marzullo
The “comfort zone” is that cozy space where everything feels familiar and stress-free. It’s where we stick to what we know, using the same old strategies that keep things steady but can also lead to feeling stuck. In this zone, there’s not much motivation to push for new achievements, so progress…
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…
A Very Round Object Helps Build a Better Mass Measurement
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…
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…
How Can Companies Rethink the Idea of Productivity?
Henrik Bresman
Traditional productivity metrics are used by many companies to assess the value that employees bring to the organization. These tangible, quantifiable, results-based measurements include work quality and output, efficiency, and the number of projects completed on time and on budget. Some managers…
Measurement Rules of Thumb, Part 1
George Schuetz
In this job, I get a lot of questions. In fact, I did some figuring the other day and estimated, conservatively, that we have probably answered at least 50,000 gauging questions over the past 35 years or so. Some of these questions have been challenging. They’ve pushed me to learn more about my…
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…
You’ve Been Pwned!
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…
The Future Looks Bright for In-Person Networking
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…
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…
Remaining Relevant During the EV Manufacturing Shift
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…
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…
Navigating Stress Bragging, Part 2
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…
Building a Sustainable Path to ESG Reporting
ISO
Global awareness of climate change and sustainability has grown exponentially during the past decade, making terms like corporate responsibility, carbon footprint, and transparency the new buzzwords of our time. The drive toward a more sustainable future has propelled environmental, social, and…
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…
Child Labor Law Compliance in Manufacturing
Patty Davidson
For the U.S. Department of Labor’s Wage and Hour Division, protecting children in the workplace is the top priority. The division is responsible for enforcing foundational labor standards, including the child labor provisions of the Fair Labor Standards Act (FLSA). The FLSA establishes minimum wage…

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