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What FDA QSR and ISO 13485 Harmonization Means for Medical Device Companies
Etienne Nichols
On February 23, 2022, the FDA released its proposed rule for the new Quality Management System Regulation (QMSR). The proposed QMSR will be the result of aligning the current good manufacturing practice (cGMP) requirements of the FDA’s Quality System Regulation (QSR) with the international…
Do Your Job
Bruce Hamilton
We had been working with the Toyota Production System Support Center (TSSC) for two years to build a model line in our assembly department. As we moved from small batch production to one-by-one, the results had been astounding: Customer lead time reduced from two weeks to one day, crew size cut in…
Realistic Expectations of Artificial Intelligence
Susanne Tedrick
Although we’re still a few decades out from seeing most businesses and industries use artificial intelligence (AI) in their operations, there is certainly greater adoption than there has been in years past. It behooves business leaders to learn all they can about AI. According to a top IT training…
Global Supply Chain Management in a Post-Pandemic World
Jonathan Gilpin
The sheer scope of public-sector organizations’ requirements means many rely on the global supply chain. This involves buyers across the world procuring both goods and services from suppliers in destinations throughout the world. A global supply chain has benefits, many associated with price, but…
Is Data Quality the Same As Data Accuracy?
Rupa Mahanti
We are living in the digital age, and data have a universal presence that directly or indirectly affects our lives, even when we’re not aware of it. Hence, data quality is an important topic of discussion. Data quality isn’t only an aspect of data that determines their fitness for use, but is also…
Data Science Paves the Way for Road Safety
Danielle Underferth
As municipalities clamor for a slice of President Biden’s $1.2 trillion infrastructure spending bill, one Johns Hopkins scientist is re-examining one of the basic elements of road-building: Determining the width of road lanes. But determining the width that provides the highest level of safety,…
On-Fiber Printed Sensor for Label-Free Detection of Bacteria
Nanoscribe
According to the World Health Organization (WHO), antibiotic resistance is now one of the greatest threats to global health, food safety, and development. This immunity of bacteria is a natural evolutionary process, and that is further accelerated by the misuse of antibiotic treatments. For more…
How L&D Helps Leaders Retain Tech Employees in the Great Resignation
Christina Gialleli
The Great Resignation continues to have a major effect on the talent and skills shortage in the job market. People are still leaving their jobs at an unprecedented rate. Although the Great Resignation isn’t industry-specific, not all industries are affected the same. Although 55 percent of the U.S…
Safely Studying Dangerous Infections Just Got a Lot Easier
Aliyah Kovner
To combat a pandemic, science needs to move quickly. With safe and effective vaccines now widely available, and a handful of promising Covid-19 treatments coming soon, there’s no doubt that many aspects of biological research have been successfully accelerated during the past two years. Now,…
How Do You Know You’re Getting What You Pay For at the Grocery Store?
NIST
Whether it’s bananas, olives, potato salad, or cereal, many products are priced according to their weight. That weight is likely determined on a scale tested and certified by a specially trained state or local inspector. Weights and measures underpin approximately half of the United States gross…
E-commerce Innovations Online Businesses Can Capitalize on in 2022
Kenny Tsang
The e-commerce industry is forecast to see substantial growth in 2022. Retail e-commerce sales in 2021 totaled $4.9 trillion, and may reach $5.42 trillion this year. Exponential growth in the sector has given rise to an ecosystem of millions of third-party sellers on sites such as Amazon that make…
Manage Hybrid and Remote Teams Through Revised Performance Evaluations
Gleb Tsipursky
The pandemic forced leaders to reconcile with the need for effective hybrid and remote team management strategies, including in performance evaluations. Research has shown the benefits of moving away from large-scale quarterly or annual performance reviews. Instead, systematic, frequent, and brief…
A Security Technique to Fool Would-Be Cyber Attackers
Adam Zewe
Multiple programs running on the same computer may not be able to directly access each other’s hidden information. But because they share the same memory hardware, their secrets could be stolen by a malicious program through a “memory timing side-channel attack.” This malicious program notices…
Using Computer Vision AI to Automate Inspection
Anthony Tarantino
This article is an extract from Smart Manufacturing, the Lean Six Sigma Way, Wiley, available May 2022 The U.S. and EU economies are facing a major labor shortage in manufacturing. A pre-Covid survey projected the need for more than four million new manufacturing jobs by 2030, but with a shortfall…
Aligning Domestic Sourcing Efforts With Business Success
Gary Steinberg
Disruptions in the global supply chain have led to a new dynamic for many small and medium-sized manufacturers (SMMs)—the need to be more strategic about “second sourcing” and reshoring. The biggest increase is in what’s referred to as second sourcing, which adds redundancies such as a second…
Ninety Percent of Drugs Fail Clinical Trials
Duxin Sun
It takes 10 to 15 years and around $1 billion to develop one successful drug. Despite these significant investments in time and money, 90 percent of drug candidates in clinical trials fail. Whether because they don’t adequately treat the condition they’re meant to target or the side effects are too…
Bridging the Gap Between Strategy and Execution
Ryan E. Day
Business is changing at a faster rate than ever before, forcing companies to find ways to adapt and pivot. Keeping the entire organization aligned with current goals can be a daunting task, but surviving and thriving depends on it. One popular method to ensure enterprisewide alignment of assets is…
More Sensitive X-ray Imaging for Medicine and Industry
David Chandler
Scintillators are materials that emit light when bombarded with high-energy particles or X-rays. In medical or dental X-ray systems, they convert incoming X-ray radiation into visible light that can then be captured using film or photosensors. They’re also used for night-vision systems and for…
With a Shrinking Talent Pool, How Do Companies Do More With Less?
John D. Patterson
A record number of employees have or plan to quit. Already hobbled by the pandemic, businesses are now looking for new ways to balance investment in talent attraction, professional development, and finding tools to increase productivity. With more people reconsidering their careers, many companies…
Important Factors in Implementing an Effective HACCP
Violetta Njunina
According to the CDC, approximately one out of six Americans are diagnosed with foodborne diseases each year. Out of this, about 128,000 are hospitalized, and as many as 3,000 lose their lives. These sorry statistics show why food safety is paramount and why more effort should be put into reducing…
Use the Context in Your Data to Enable Process Improvement
Scott A. Hindle
In 2010, new to the world of statistical process control (SPC), I was intrigued by Don Wheeler’s statement that “No data have meaning apart from their context” (from his book, Understanding Variation—The Key to Managing Chaos, SPC Press, 2000, available on Amazon). For a while, I didn’t really get…
Three Predictions for Clinical Asset Management in the Year Ahead
Scott Trevino
The pandemic promises ongoing challenges for healthcare providers in 2022 as they cope with nursing shortages and cybersecurity threats amid shifts previously underway for the industry. How they manage their clinical assets, however, can present opportunities to overcome those challenges while…
The Answer to Manufacturing’s Waste Problem is Hidden in Data
V R Vijay Anand
As the world moves toward a new, post-pandemic normal, industries must leverage digital transformation at an accelerated pace. This is already happening. According to IBM, 67 percent of manufacturers have accelerated digital projects since Covid-19. Although improved operational efficiency is…
How Classifying and Fixing Dirty Data Can Help Even Those Using Spreadsheets
Tristan Mobbs
All too often the topic of fixing dirty data is neglected in the plethora of online media covering artificial intelligence (AI), data science, and analytics. This is wrong for many reasons. To highlight just one, confidence in the quality of data is the vital foundation of all analysis. This topic…
Signs of Spring
Bruce Hamilton
Every February, there are welcome reminders that spring is on the way. The first for me is a witch hazel bush in my front yard that defies subfreezing weather to produce fragrant yellow flowers. Then, a few weeks later, crocuses and winter aconites will emerge from the snow. The cycle continues…

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