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Five Biggest Quality Management Mistakes in the Medical Device Industry
Sara Adams
At Greenlight Guru, we collectively have hundreds of years of experience in medical device quality management. We’ve all seen some great successes during our time in the industry—high-quality medical devices that improved the quality of life for countless people around the world. But we’ve also…
Apprenticeships and Workforce Development Programs Are Having a Moment
Torsten Schimanski
The manufacturing skills gap has been a topic of discussion for several years. According to a 2021 Deloitte study, it is estimated that by 2030, there will be 2.1 million manufacturing jobs that will need to be filled. Finding employees who are trained, skilled workers is becoming more critical in…
How to Use ISO 9004 to Improve Your Manufacturing Operation
Eliot Dratch
The International Organization for Standardization (ISO) is an independent, nongovernmental, international organization that develops standards to ensure the quality, safety, and efficiency of products, services, and systems. As technology continues to rapidly develop, new standards are drafted and…
Improving Manufacturing With a Single Source of Truth
Lauren Dunford
Manufacturing is stepping up investment as the U.S. economy recovers from the challenges of 2020. Nearly 40 percent of manufacturers have increased CapEx spending, with less than 7 percent planning to spend less, the National Association of Manufacturers reports. With that investment, factories…
How to Manage Project-Based Manufacturing
Matt Mong
During a recent interview with Dirk Dusharme, host of Quality Digest’s QDL, we discussed project-based manufacturing, the umbrella term that covers the types of manufacturing done on a project-driven schedule. Some refer to this as “engineer to order” (ETO), a niche in engineering-focused…
Ergonomic Microscopes From Olympus Improve Productivity
Taran March @ Quality Digest
You may work in a state-of-the-art lab, but do your ergonomic practices still linger in the 19th century? If you spend more than five hours a day at a microscope, leave work with blurred vision and a persistent downward tilt to your neck, then the answer is, sadly, yes. In that case it’s time you…
Confocal Microscopy for 3D Surface Finish Measurement and Analysis
Ryan E. Day
Manufacturing is a very competitive business where high-quality products are expected. And some clients require extremely tight surface measurement tolerances, so being competitive means investing in tools that can satisfy customer requirements. The confocal advantage Submicron 3D observation and…
Inspection and Compliance in One Reliable Package
Taran March @ Quality Digest
In regulated industries, every step of the production process must be verified to some sort of guidance or standard. What this comes down to, practically speaking, is an enormous amount of time and effort spent on actions outside the sphere of production. Every day of production seems to create a…
What Is Destructive Testing?
Bryan Christiansen
A lot of thought goes into building reliable assets. Extensive testing is a part of the process that has to be done to estimate the durability of machines, materials, and components. The testing can be done destructively or nondestructively. In this article, we take a deep dive into the various…
Berkeley Lab Optical Innovation Could Calm the Jitters of High-Power Lasers
Joe Chew, Jeroen van Tilborg
The Berkeley Lab Laser Accelerator (BELLA) Center at the Department of Energy’s Lawrence Berkeley National Laboratory (Berkeley Lab) has developed and tested an innovative optical system to precisely measure and control the position and pointing angle of high-power laser beams with unprecedented…
Taking on Transformation: A Hands-on Start to Gain Digital Momentum
Jason Chester
The most popular phrase in manufacturing today is “digital transformation.” Every company now understands the immense value digital transformation can provide. It’s essential for overhauling efficiency, agility, and ultimately, the bottom line. Digital transformation represents the very essence of…
How a New Standard Is Helping Small Firms Think Big
Ann Brady
Better buying power, greater efficiencies, and more innovative ideas are not just for big businesses. The publication of ISO 44003 is helping smaller players flex their collective muscle by making the most of strategic partnerships. How many of us cooped up at home during the lockdowns and travel…
Advances in Machine Vision Enable Automation of Quality Inspections
Jeffrey Heimgartner
During the Association for Advancing Automation (A3) Vision Week in June 2020, experts from Amazon Web Services and Elementary Robotics weighed in on the traditional challenges organizations face when using machine vision. They discussed how to incorporate the latest advances—including the cloud—to…
Five Postmarket Surveillance-System Musts for EU Medical-Device Manufacturers
Sara Adams
Designing, developing, and getting your medical device approved and onto the market is a huge accomplishment—but it isn’t the end of your responsibilities. For the European Union (EU) market, the European Commission (EC) requires manufacturers to perform ongoing postmarket surveillance (PMS)…
Shaping Shipping
Rick Gould
Ever since people could tie logs together to form rafts and use them to transport goods by water, seaborne trade has flourished and grown. Historians believe that the first international trade routes were developed 5,000 years ago between the Arabian Peninsula and Pakistan, while by the 18th…
Risk Management for Medical Devices
Wade Schroeder
As more medical devices using network-connection technology are developed, cybersecurity will continue to grow in importance and focus among regulators and manufacturers. Many connected devices store or transmit patient data for which there is an expectation of both privacy and accuracy. Any sort…
Through Integration and Redesign, Health System Cares for ‘Loved Ones’
Dawn Bailey
‘What would be important to you in the care of your daughter?” John Chessare, president and CEO of Baldrige Award-recipient GBMC HealthCare (GBMC), asked a virtual Quest for Excellence conference audience. “The No. 1 answer is always that people want the best possible health outcome for their…
A Blueprint for Sustainable Innovation
Ann Brady
Innovation is the fuel that drives a successful business. Organizations that give their managers and employees the tools to respond to and make the most of opportunities, both internal and external, are well placed to grow profits, improve the health and well-being of their employees, and thereby,…
Google Cloud’s Visual Inspection AI Reinvents Manufacturing Quality Control
Edis Osmanbasic
In June 2021, Google enriched its Google Cloud Platform with Visual Inspection AI, an artificial intelligence (AI)-driven, purpose-built solution designed to quickly and accurately detect defects and errors in a variety of production pipelines. It is a continuation of Google’s previous efforts to…
Matching Healthcare Offices With Short-Term Workers
Zach Winn
This story was originally published by MIT News. For small healthcare groups like dentist’s offices, one sick staff member can mean a day’s worth of cancelled appointments. Such offices can either continue short-staffed, which could negatively affect patient care, or reschedule appointments,…
What Is Nondestructive Testing?
Bryan Christiansen
Testing is an integral part of equipment maintenance. It must be carried out to evaluate the materials, components, design, or structure of mechanical components. Based on the state of the tested component after the testing is done, the procedures used can be classified under destructive testing or…
Five Ways Leaders and Analysts Can Try Thinking Differently to Be Data-Led
Harry Powell
In previous posts I’ve shared resources to help you educate your leaders in data literacy, but beyond knowledge, this also requires thinking differently. We need to get thinking about our thinking. Helping leaders get their heads around thinking styles can be a challenge. Many of us spend most of…
It’s Time for a Government Reset, and the Ideas Are Flourishing
M. Mitchell Waldrop, Knowable Magazine
This story was originally published by Knowable Magazine. If the cascading upheavals of the past year have done nothing else, they’ve spurred widespread calls for reform and renewal in just about every institution we have. A mishandled public-health response to the Covid-19 pandemic, an economic…
What Are the Benefits of a Low-NOx Boiler?
Emily Newton
Nitrogen oxides (NOx) are harmful chemical compounds produced as a byproduct of normal boiler function. The EPA regulates them due to the damage they can cause to humans and the environment. Low-NOx boilers, outfitted with special components that reduce nitrogen oxides, are essential for…
Inner-City Hospital Inspires a Healthy Community With Rhythm
Dawn Bailey
The spirit of service—for a small clinic started in 1913 to provide free care to Los Angeles (LA)—lives today in the servant-leader aspirations of 2019 Baldrige Award recipient Adventist Health White Memorial (AHWM), a 353-bed, safety-net hospital. The community of two million people that AHWM…

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