How To Map Your QMS To EU MDR Requirements

[fa icon="calendar'] Fri, May 31, 2019 / by Rachel Beavins Tracy

 

Medical device manufacturers who are not up to speed with the latest European Union compliance requirements could find themselves struggling to catch up.

In May 2017, the EU adopted some of the most sweeping changes to medical device regulations in more than two decades. With the system long considered to be in need of modernization, the new rules under the EU Medical Device Regulation (EU MDR) framework have been drafted with patient safety in mind.

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Quality Management Medical Devices Life Sciences Europe Regulatory Compliance SaaS

Why ETQ Is Buckling Up And Heading To Texas

[fa icon="calendar'] Tue, May 14, 2019 / by David Bolton

With over seven decades of experience behind it, the annual ASQ World Conference on Quality and Management is one of the standout events in the quality calendar. Attracting more than 2,500 attendees, the Fort Worth-based conference is ASQ’s flagship event, mixing three days of workshops, training sessions, real-life applications and live demos, with the requisite networking opportunities and the chance to learn about the latest developments in quality management.

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Quality Management Enterprise Software SaaS ASQ Conference Quality Creates Value Product Quality

Buckle Up, The ETQ Blog Is Back

[fa icon="calendar'] Wed, May 01, 2019 / by David Bolton

Harold Wilson, the former British prime minister, famously said in 1964 that a week was a long time in politics. Just over 20 years later, iconic pop culture figure Ferris Bueller sagely remarked that life moves pretty fast, and if we don’t stop and look around once in a while, we are in danger of missing important events, remarkable moments or the nose on our face.

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Quality Management Blog Roundup Company News SaaS

ETQ: New Home, New C-Suite, Same Focus on Quality, EHS and Compliance Management

[fa icon="calendar'] Wed, Dec 05, 2018 / by Rob Gremley

Since its founding in 1992, ETQ has set the standard for delivering best-in-class quality, EHS and compliance management systems for today’s leading organizations. Over the past 25+ years, the company has developed an incredible roster of clients, a strong understanding of the industries they operate in and the expertise required to ensure they provide their customers with only the best products and services. Today, ETQ is excited to announce the next chapter in our story, and I’m thrilled to be leading the charge. 

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Quality Management quality ETQ Life Company News

4 Ways to Leverage Data for Operational Excellence

[fa icon="calendar'] Thu, Aug 16, 2018 / by Rachel Beavins Tracy

Data can be a gift and a curse when it comes to operational excellence. For some companies, ineffective practices make data a barrier to improvement, with too many data points and metrics obscuring the most strategic course of action.

 

At the same time, data is also a key enabler of operational excellence, helping businesses make sense of the vast quantities of information generated in today’s manufacturing environments. All told, a full 85% of companies aim to be data-driven, yet little more than a third of them are successful.

 

Today, we’re looking at four ways companies can better leverage data for operational excellence, looking at elements like predictive capabilities, supplier quality management and measuring effectiveness.

 

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Quality Management

How the Internet of Things Can Transform Manufacturing Safety

[fa icon="calendar'] Fri, May 25, 2018 / by Rachel Beavins Tracy

More than 1 in 3 U.S. manufacturers are using smart sensors to collect and analyze data to improve their processes. The Internet of Things (IoT), which simply means connecting non-computing devices via the Internet, is rapidly evolving and shaping how companies do business.

One of the most meaningful impacts IoT technology can have is in the realm of safety, helping reduce the 2.9 million workplace injuries and illnesses that occur every year.

With that in mind, let’s look at how companies are using IoT to address workplace safety, including areas like equipment safety, personal protective equipment (PPE) and emergency response.

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Quality Management EHS

5 Most Useful Resources for Starting Out in Quality

[fa icon="calendar'] Mon, May 21, 2018 / by Alexa Sussman

If you’re just getting started as a quality professional, it can be overwhelming. If you’re unfamiliar with the industry, it’s hard to even know where to find guidance.

To help you get started, we’ve put together some of the best quality and compliance resources we know.

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Quality Management

How Machine Learning Can Transform Quality Management

[fa icon="calendar'] Fri, May 11, 2018 / by Rachel Beavins Tracy

Services like Netflix, Google and Facebook are known for using predictive technology to learn our preferences and provide customized suggestions that get smarter over time. Now that technology is coming to the manufacturing floor, helping companies increase production capacity by as much as 20%.

More than just higher rates of production, companies can also expect to see major improvements in quality through the use of machine learning. In this post, we’re looking at how machine learning can transform quality management, from reducing defects to improving efficiency.

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Quality Management

Document Control for Food Safety: 7 Gaps to Watch Out For

[fa icon="calendar'] Fri, Mar 02, 2018 / by Rachel Beavins Tracy

Imagine the following situation: The U.S. Food and Drug Administration (FDA) is inspecting your facility, and regulators ask to see documentation for your Hazard Analysis and Critical Control Points (HACCP) plan.

You spend 20 minutes trying to pick out the most recent documents, only to get hammered by regulators because only a few are actually dated. What’s more, most references to related documents are broken. After this impressive start, how well do you think the rest of the inspection will go?

Food manufacturers must keep track of numerous documents in order to ensure compliance and mitigate risks. This post looks at 7 of the most common document control gaps that companies should address to avoid regulatory citations and food safety issues.

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Quality Management Food and Beverage

5 Questions for Your Corrective Action Plan

[fa icon="calendar'] Mon, Feb 19, 2018 / by Rachel Beavins Tracy

Danish physicist Niels Bohr once said, “Every great and deep difficulty bears in itself its own solution. It forces us to change our thinking in order to find it.”

Bohr’s work was instrumental in the discovery of the electron, an elusive subatomic particle whose location, even now, we can only describe in terms of a field of probability.

Within this context, today’s post looks at how we can change our thinking to pin down similarly elusive solutions to problems requiring corrective action. The trick is to ask detailed questions about the problem and the corrective action process, ensuring you’re not just going through the motions. 

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Quality Management

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