All Features
Meg Sinclair
At Qualio, our mission is to help life science companies embed robust digitized quality to get their critical products to market at rapid speed and keep them there. And because the Qualio+ team combines over a century of collective quality and regulatory experience from within the life science…
Pierre-Nicolas Disser
With concerns for an economic downturn constantly looming, the global manufacturing industry finds itself navigating through a sensitive time. Once bustling factories, go-to for the world’s largest brands, are experiencing an unexpected lull attributed to multiple factors, including inflation and…
Jennifer King
In the hustling world of manufacturing, where machines hum and productivity is king, there’s a human element that’s sometimes overlooked: the well-being of the workers themselves. That’s where employee wellness programs come in, adding a jolt of energy and care into the mix. These programs aren’t…
Michael Mills
Superficially, ISO 9001 and climate change sound different: ISO 9001 is about how to do things well so your organization satisfies its customers; climate change is about physical and chemical interactions in the atmosphere, and the consequences for our lives in the future.
But ISO is adding…
Del Williams
An experienced conveyor supplier can advise food processors on the ideal options for resolving common challenges associated with conveying powdered food products, such as caking, packing, and hazardous dust emissions.
Almost every industry has a powdered version of products or ingredients that…
Alonso Diaz, Maria DiBari
Inspections by the U.S. Food and Drug Administration (FDA) are on the rise after the nation has recovered from the Covid-19 pandemic. Domestic inspections showed a drop in 2020 due to state health guidelines around quarantine.
The rise has more than doubled within three years of post-pandemic…
Anjana Susarla, Casey Fiesler, Kentaro Toyama
The year 2023 was one of AI hype. Regardless of whether the narrative was that AI was going to save the world or destroy it, it often felt as if visions of what AI might be someday overwhelmed the current reality. And though anticipating future harms is a critical component of overcoming ethical…
Alonso Diaz, Maria DiBari
Quality consistently ranks among organizations’ foremost competitive priorities; it’s a prerequisite for success in the global marketplace. Firms that want a competitive edge do it by delivering products that meet customer needs and function as intended.
Despite the long-standing emphasis on the…
ComplianceQuest
Today’s quality leaders in the life sciences industry have nearly impossible charters. Long-term trends and sudden black swan events in combination can hinder an organization’s ability to exert control over product quality. Globalization, labor shortages and strikes, outsourcing, just-in-time…
Matthew Zajechowski
Stress is an inevitable part of life, shaping and influencing our every decision, emotion, and action, including the way we communicate. It may induce the silent treatment or cause an emotional outburst, both of which can cause future regret.
Preply, a language learning service, surveyed Americans…
The MEP National Network
The personalized nature of coaching makes it a powerful force for manufacturers. You can employ coaching to improve leadership, enhance performance and teamwork, or address personal and organizational development.
With as many as five generations in the workplace at the same time, and constant…
Mark Hembree
Without raising false alarms, it’s fair to say that password insecurity is a problem that lives near you and is worthy of your attention.
In its article, “139 password statistics to help you stay safe in 2023,” digital security firm Norton cites a report by password manager LastPass that more than…
Kari Miller
Traditionally, quality management in the pharmaceutical industry has strayed away from artificial intelligence (AI) for fear of setting it loose with such sensitive information. They have been cautious of implementing an additional element of intelligence into their process. But will organizations…
Gleb Tsipursky
Are employers walking into a legal storm by enforcing rigid return-to-office (RTO) mandates? The post-pandemic era presents a unique challenge as employers grapple with shifting workforce dynamics. The insistence on a full return to the office without considering individual circumstances could lead…
Stephanie Ojeda
There’s an old saying in regulated industries: If it isn’t documented, it didn’t happen.
In the past, maintaining fully compliant documentation meant handling a mountain of paper, which created extra work—and hidden risks—from a quality perspective.
Today, document management has become the…
Brad Jobe
Artificial intelligence (AI) has the potential to reshape the healthcare industry. There is a massive amount of healthcare data available for AI to process. Nearly one-third of the world’s data volume is generated by the healthcare industry, and the volume of big data is projected to increase…
Erin Vogen
One large concern when maintaining a business’ facilities and assets is cost. Managing the costs of repairs, new parts, and personnel can present a challenge.
Although maintenance can be costly, it’s important to see it as an investment that prolongs equipment life span, enhances productivity, and…
Master Gage and Tool Co.
Calibration is essential in almost every facet of industrial processes. The calibration process verifies test instrument accuracy by comparison with recognized standards, and measurement validity hinges on one crucial concept: traceability.
Traceability adherence ensures a continuous link between…
Jón Bergsteinsson
Clinical investigations play an important role in your journey of bringing a medical device to market. While the relevant standards are often perceived as difficult and complex, having a good grasp of them makes the process less confusing.
Understanding ISO 14155:2020 is essential. It’s a guide to…
Megan Wallin-Kerth
We all make mistakes. Despite a vigorous editing process, there may even be one in this article! Although everyone makes mistakes, not everyone owns up to them, and thus they miss an opportunity to grow, learn, and—if they appreciate and apply what they’ve learned—consistently improve the quality…
Shaneé Dawkins
A scene from the movie Ocean’s 8 provides a surprisingly useful lesson on cybersecurity. The character played by Rihanna needs to hack into a security person’s computer. She looks up his social media to find he loves corgis. The Rihanna character sends him a phishing email featuring corgis, and he…
Gleb Tsipursky
In an era when flexibility and autonomy are requirements, financial services leaders are ready to break the chains of traditional office norms. The results of a recent Deloitte and Workplace Intelligence survey make it clear: The future of the financial services sector is hanging in the balance,…
Scott A. Hindle, Douglas C. Fair
We are one year away from the 100th anniversary of the creation of the control chart: Walter Shewhart created the control chart in 1924 as an aid to Western Electric’s manufacturing operations. Since it’s almost prehistoric, is it now time to leave the control chart technique—that started out using…
Rob Moorey
Growing medical equipment inventories and increasing technical complexity are demanding more than ever from the clinical engineering teams responsible for maintaining clinical assets. Simultaneously, a shrinking talent pool of biomedical equipment technicians (BMETs) could lead to large staffing…
Stephanie Ojeda
In December 2023, the U.S. Food and Drug Administration (FDA) expects to issue its long-awaited overhaul of its Quality System Regulation (QSR). The biggest change is that the new Quality Management System Regulation (QMSR) will harmonize with ISO 13485 for medical device quality management. With…
