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By: Quality Digest

(Master Control: Salt Lake City) -- MasterControl, a leading provider of quality and manufacturing software solutions for the life sciences, today announced its first ever funding, a $150 million Series A round led by Sixth Street Growth. MasterControl has grown profitably for nearly 30 years, and with this funding is valued at $1.3 billion. The proceeds will be used to accelerate the development of SaaS solutions serving the company’s global life sciences customers, which include Pfizer, Cochlear, Thermo Fisher Scientific and more than 1,100 others worldwide.

“For nearly three decades, we’ve been laser-focused on our mission to make life-changing products available to more people sooner,” says Jon Beckstrand, CEO of MasterControl. “This commitment has led us to attack inefficiencies in quality and manufacturing that were extending product research and delivery cycles. We see an urgent need to help our customers deliver their breakthrough technologies to the market faster and at a lower cost. Our goal is to add a strategic partner with resources and expertise to help us meet the significant need for our solutions. We’re fortunate to have the experienced investment team at Sixth Street Growth to help make that a reality.”

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By: Quality Digest

(ETQ: Burlington, MA) -- ETQ, part of Hexagon, has announced the availability of an enhanced failure mode and effects analysis (FMEA) solution for use with its industry-leading Reliance NXG quality management system (QMS). ETQ developed the solution in partnership with Sandalwood, an engineering and ergonomics services firm with deep automotive expertise.

The AIAG-VDA FMEA software application helps automotive, aerospace, and other discrete manufacturer suppliers perform thorough risk analysis to predict and prevent failures in product design and production processes. The built-in framework ensures compliance with the harmonized international FMEA guide produced by the Automotive Industry Action Group (AIAG) and the German Association of the Automotive Industry (VDA). Adherence to the combined handbook is becoming a core requirement for suppliers doing business with many of the world’s largest OEMs.

The AIAG-VDA FMEA application is available immediately as an optional enhancement to Reliance NXG, ETQ’s cloud-native enterprise QMS platform. As with all Reliance applications, the enhanced FMEA is flexible and configurable to meet specific customer requirements, and integrates with related quality processes like corrective and preventive actions and nonconformance reporting.

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By: Andrey Solin

The other day I watched House of Gucci—a biographical movie directed by Ridley Scott about the Tuscan dynasty representing the famous luxury fashion house. The story is based on a nonfiction book written by Sara Gay Forden, The House of Gucci: A Sensational Story of Murder, Madness, Glamour, and Greed (Custom House, 2021).

Apart from all the drama and all the glamour, what I was looking for was how the Gucci family approached quality. As a quality manager and researcher, I had previously addressed the subject of perceived quality and how some manufacturers, especially the manufacturers of luxury goods, had worked to purposefully create the impression of high quality.1 Often, their reputations for craftsmanship would later be abused by unscrupulous dealers who flooded the markets with knockoffs. It’s in this respect that I found one deviation of the movie from the book quite unsettling.

‘Quality is remembered long after price is forgotten.’
—Aldo Gucci

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By: Dirk Dusharme @ Quality Digest

Updated 12/12/22

At a meeting of EU health ministers in Brussels on Dec. 9, 2022, the Employment, Social Policy, Health and Consumer Affairs (EPSCO) Council announced it will be proposing an extension to the transition date for Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). On the table will be the possibility to extend the deadline to 2027 for higher-risk devices and 2028 for lower-risk devices. 

The European Commission had come under increasing pressure to extend the deadline after EU member states, notified bodies, and medical device companies told the commission that it would be impossible for all medical devices currently approved under the old medical device regulations to transition to the newer regulations by the May 2024 deadline. This was something the Commission’s own studies were bearing out.

This is good news for the medical device community and the EU healthcare system. 

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By: Gleb Tsipursky

After firing half its workforce, Twitter is already asking many to come back. Indeed, research from McKinsey finds that even as recession fears grow, 40 percent of workers plan to quit their jobs. And a survey from Greenhouse, a New York-based hiring software provider, finds that 57 percent of 1,500 employees plan to still be actively looking for a new job even if a recession hits. That’s not surprising—and it aligns with the early November 2022 jobs report, which finds that U.S. employers added 261,000 jobs in October, higher than the 200,000 predicted by economists.

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By: Doug Folsom

Unpatched vulnerabilities remain a target of cyberattacks, and an ever-present risk for healthcare organizations. Medical devices pose an additional burden because patches are frequently unavailable for medical devices. So, dealing with the potential threat isn’t usually straightforward. The stakes are also high in healthcare, because cybersecurity risks can expose or hinder access to electronic protected health information (ePHI) or even harm patients if the equipment malfunctions or is inaccessible.

Medical device cybersecurity hinges on knowing the vulnerabilities of each device and whether patches are available, as well as how critical each piece of equipment is to the overall function—and determining any risk to patient safety, among other factors. Continuous assessment and real-time risk measurement help prioritize surveillance efforts, raise red flags, and mitigate risk efficiently.

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By: Quality Digest

(Evident: Waltham, MA) -- Wind turbine gearbox inspections take place in cramped quarters, so inspection tools must be both compact and effective. Designed specifically for these challenges, the IPLEX G Lite-W videoscope from Evident combines portability with powerful imaging features packed into a small, ergonomic form factor. This enables users to visually inspect inside a wind turbine gearbox without disassembling it to spot issues before they turn into lengthy shutdowns.

Finish inspections faster

Wind turbine gearboxes contain lubricating oil that can adhere to the videoscope’s lens and cause blurry images. The IPLEX G Lite-W videoscope’s sealed tip keeps oil out, while channels on the oil-clearing tip adaptor use capillary action to draw oil away from the lens and help keep images clear.

To reduce the chance of damage during an inspection, the IPLEX G Lite-W videoscope is designed to meet IP65 standards and built to pass U.S. Department of Defense testing (MIL-STD). The insertion tube’s durable articulation mechanism helps protect the scope from damage when used in tight spaces.

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By: Quality Digest

(Omnex: Ann Arbor, MI) -- Omnex has announced it’s latest webinar, “Assessing your Cybersecurity Maturity Level: A Government and Industry Priority.”

Date and time: Dec. 13, 2022, at 11 a.m.
Speakers: Marc Atayi, Martin Hettwer

Register here.

While security ratings are a great way to demonstrate that you’re paying attention to the cyber-health of your organization, you also need to show that you’re adhering to industry and regulatory best practices for cybersecurity, and making informed decisions for the long term. A cybersecurity framework can help.

A cybersecurity framework provides a common language and set of standards for security leaders across industries, sectors, and countries to understand their security postures and those of their vendors. With a framework in place, it becomes much easier to define the processes and procedures that your organization must take to assess, monitor, and mitigate cybersecurity risk.

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By: Quality Digest

(ETQ: Burlington, MA) -- ETQ, part of Hexagon, has launched a new release of its award-winning, cloud-native QMS, Reliance NXG, providing an updated version of its popular training management application to enable better visibility and tracking of training activity. The Training Management enhancements, along with an improved user experience in Reliance NXG, make it easier for enterprise users to optimize quality and safety management.

“Quality now touches all phases and roles within the product life cycle—from connected workers and shop-floor engineering managers to new product designers and others—which means an effective QMS and training system must provide a more intuitive user experience,” says Jamie Fernandes, ETQ vice president of product management. “The newest version of Reliance NXG and Training Management were designed in response to customer requests for greater usability, visibility, and training management adaptability.”

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By: Gleb Tsipursky

Why do companies bury their heads in the sand instead of facing dangerous facts, whether about quality problems or other issues? It happens more often than you might think—most recently with Adidas. It usually boils down to companies falling for three cognitive biases.

“Adidas does not tolerate antisemitism and any other sort of hate speech... the company has taken the decision to terminate the partnership with Ye immediately,” the company stated in its Oct. 25, 2022, news release. That statement conveys a principled and admirable stance against the antisemitism shown by the rapper formerly known as Kanye West after his antisemitic tweet on Oct. 10 that he would go “death con 3 on JEWISH PEOPLE.”