Dirk Dusharme @ Quality Digest’s picture

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. 

Megan Wallin-Kerth’s picture

By: Megan Wallin-Kerth

Founded in 2012, GoFormz is a uniquely flexible documentation platform for professionals in all industries—and a long-awaited solution for those chasing lean efficiency without sacrificing quality.

What does that mean? Well, unlike using a fillable PDF or Adobe document, GoFormz is an online software platform that allows workers to use current industry-specific—or even company-specific—documents, incorporating automation and other time-saving elements for an easy way to digitally document, file, and share information.

Rather than thumbing through literal papers to find that repair request or inspection report, for instance, a construction site worker can simply pull out their phone, locate the document on GoFormz, and fill it out onsite—all in real time.  


Rob Brewster, GoFormz CEO. Credit: GoFormz

Stephanie Ojeda’s picture

By: Stephanie Ojeda

Corrective and preventive action (CAPA) is a core function in any quality management system (QMS), and a critical piece in the plan-do-check-act process approach. Like any quality process, tracking CAPA key performance indicators (KPIs) is crucial to continuous improvement.

It’s also a focus of regulators and auditors, and is consistently highlighted in the more than 500 warning letters issued to date in 2022 by the U.S. Food and Drug Administration (FDA).

Many companies take a reactive approach to corrective actions. Unfortunately, reacting to issues that get the most attention isn’t an efficient way to manage quality issues. Rather, tracking CAPA KPIs is a proactive strategy that helps prioritize issues and improve root cause analysis as part of best practices driving quality improvement.

Let’s look at eight CAPA KPIs that can help manufacturers achieve these goals, plus best practices for setting targets.

Rob Press’s picture

By: Rob Press

Without the perfect balance of efficient workers, adequate resources, and satisfied customers, manufacturing businesses risk sending their operations into a tailspin.

Workforce optimization (WFO) streamlines manufacturing workflow by cutting costs and increasing productivity—allowing you to equilibrate critical manufacturing tasks such as product planning, resource allocation, staff scheduling, and product shipping.

Here, we’ll show you four tips that will help you easily optimize your workforce.

1. Implement better communication systems

It’s time to think outside of the suggestion box—a good bottom-up communication system allows the plant management and the factory floor to better coordinate. This prevents work-related misunderstandings that can lead to poor product quality, delays in the production process, and workers feeling like they aren’t appreciated.

In any manufacturing plant, the factory floor workers have the information on why production is slacking, what machines are acting up, and why there are a lot of late deliveries—and they might have ideas to solve these issues.

Rashan Dixon’s picture

By: Rashan Dixon

The ability of flawed and inherently limited humans to lead others like them toward a common goal takes a special skill set.  Even if a leader has the talents required to lead a business, that doesn’t mean they’ll immediately see positive results. Good leaders know that they need to find ways to step out of their egos and truly see themselves from a rational, unbiased perspective.

If you’re a leader who is struggling to remove the blinders, here are some ways to help you accurately measure your leadership effectiveness―as well as a few tips to address any shortcomings you might discover along the way.

Bryan Christiansen’s picture

By: Bryan Christiansen

Every day, manufacturers rely on a large number of tools, machinery, and infrastructure to produce their goods. And while all of those assets help you generate profit, they are a significant expenditure—both in terms of the purchase cost and ongoing maintenance costs.

When deciding which maintenance actions work best for your business, it’s crucial to consider asset life-cycle costs. This is where level of repair analysis (LORA) comes into play.

Join us as we discuss what LORA actually stands for, how to put it into action, and how a modern CMMS supports such an analysis.

What is LORA?

A level of repair analysis is a method of analyzing systems or machinery to minimize the money and time you spend on maintenance. The outcome of a LORA gives you tactics to return the machinery to a serviceable state while reducing its overall life-cycle costs.

The analysis uses two considerations to determine an asset’s best course of maintenance action, along with other factors like in-house skills, specialist tooling, support equipment, and available facilities:
• Should an item be replaced or repaired?
• What is the ideal location for the repair/maintenance work to happen?

Doug Folsom’s picture

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.

Lee Seok Hwai’s picture

By: Lee Seok Hwai

Think innovation, and what comes to mind? For many, it invariably evokes big names like Apple and Tesla, their epoch-defining products ranging from the smartphone to electric vehicles, and genius leaders like Elon Musk and Steve Jobs. But is innovation only for the select few?

Not at all, according to Ben M. Bensaou, INSEAD professor of technology management, and Asian business and comparative management. During a recent Thinkers50 webinar, Bensaou stressed that innovation isn’t just about radical creativity or breakthrough products. It can be a systematic habit applied to a company’s internal processes and functions. It has the potential to bring joy to both customers and noncustomers, i.e., suppliers, retailers, regulators, and other players in a company’s business ecosystem.

In short, said Bensaou, anyone can innovate, and they can innovate in everything.

Harry Hertz’s picture

By: Harry Hertz

The saying is nothing new: The customer is always right. Customers come first. We’ve heard these adages for a long time. And we’ve questioned them for almost as long. Those of you who know me know that I’ve certainly been doing that for a long time!

Two recent experiences brought this topic back to top of mind. Furthermore, my wife thought it was time for a break from my more academic blog posts. 

Story No. 1

I recently made a routine trip to our local supermarket. As I prepared to check out, I started unloading my purchases on the cashier’s checkout conveyor belt. While I was unloading, another customer (customer No. 2) came behind me and dumped a bunch of items on the belt, saying she hoped I didn’t mind; she didn’t have a cart, and the items were bulky. I said, “Sure. Put them on the belt,” and I continued unloading my items. As the conveyor belt moved forward, I assumed the other customer would hold her purchases back so I could continue unloading. However, I found that I had to keep moving the items back myself. When I turned around to politely ask that she hold her items back, I discovered that nobody was there. When I was finished unloading, there was no stop bar to put at the end of my merchandise, so I told the cashier that my purchases ended with the bag of peppers.

Multiple Authors
By: Hanen Khemakhem, Mahbub Zaman, Nadia Smaili, Richard Fontaine

Whistleblowing is a cornerstone of corporate governance. It allows employees to anonymously disclose questionable financial matters about their companies to help prevent fraud, which is a pressing issue in Canada. It’s also incredibly effective, with 42 percent of occupational fraud being reported through tips.

But whistleblowing isn’t just an essential organizational tool; it’s also codified into law. In Canada, whistleblowing procedures are outlined in a national regulation called National Instrument 52-110. This regulation has been in place since 2004 and applies to all companies listed on stock exchanges throughout Canada.

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