Rachel Beavins Tracy

Rachel Beavins Tracy
Rachel Tracy is a writer for EtQ with expertise in environmental, healthcare and technology topics. She has a master’s degree from Vanderbilt University and has been writing for businesses since 2008.

Recent Posts

The Risk Management Toolbox [Infographic]

[fa icon="calendar'] Mon, Apr 30, 2018 / by Rachel Beavins Tracy

Risk Management tools help organizations make better decisions, filter events and prevent risk within the compliance system.

This infographic outlines these tools, including the risk matrix, Failure Modes and Effects Analysis (FMEA) and more.  

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Q&A: What’s the Impact of New EU Medical Device Regulations (MDR)?

[fa icon="calendar'] Fri, Apr 27, 2018 / by Rachel Beavins Tracy

The most sweeping European medical device regulations in decades are slated to go into effect in 2020, leaving many manufacturers wondering what they need to do to get up to speed. Two years may sound like a lot of time to comply, but given the number of changes coming, waiting may not be an option.

We talked to Tony Parise, Life Sciences Product Strategist for EtQ, about what the new requirements mean for medical device manufacturers.

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Life Sciences

7 Signs of a Strong Culture of Quality

[fa icon="calendar'] Fri, Apr 20, 2018 / by Rachel Beavins Tracy

Ask any expert, and you’ll get varying answers on what makes a quality culture. Definitions often center on a set of shared values, a drive to delight customers or everyone pulling together towards continuous improvement.

But according to research by Forbes and the American Society for Quality (ASQ), there’s a big disconnect between where organizations think they are and reality in terms of quality culture. In fact, while 3 in 4 executives say their organization has a culture of quality, less than half of quality professionals agree.

Today, we’re looking at 7 signs of a strong quality culture, helping you see whether you’re keeping up or at risk of being left behind.

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Getting Ready for GDPR

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

Going into effect May 25, 2018, the General Data Protection Regulation (GDPR) represents the most sweeping changes to EU data privacy laws in 20 years. However, signs are growing that companies are ready for the new requirements, including a new UK report showing fewer than half of organizations have made preparations.

Companies that sell products or services to people in the EU will need to comply with the new regulations or risk a fine of up to 4% of revenue or €20 million, whichever is greater.

In today’s post, we’re examining what companies need to do to get in compliance with the fast-approaching regulatory deadlines.

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Life Sciences General Quality

How Product Stewardship Impacts EHSQ Performance

[fa icon="calendar'] Fri, Apr 13, 2018 / by Rachel Beavins Tracy

Once upon a time, few people gave any thought to the fate of what happened to light bulbs, paint cans, computers and leftover medications after they were done with them. Use them up, throw them away and leave it to the city to figure out how to dispose of them.

Today, that paradigm has been flipped on its head, with companies engaging in product stewardship initiatives that make disposal the responsibility of the manufacturer.  

In today’s post, we’ll look at the business case for product stewardship, including how it directly impacts Environment, Health, Safety and Quality (EHSQ) performance.

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EHS

The Industry 4.0 Approach to Quality

[fa icon="calendar'] Mon, Apr 09, 2018 / by Rachel Beavins Tracy

Experts are calling Industry 4.0 the fourth Industrial Revolution (hence the 4.0). The concept represents a push towards manufacturing digitization that experts say will deliver massive improvements in efficiency, costs and profits in as little as just a few years.

But what will it take to get there, and how can it help improve quality? Today we’re lifting the lid on what Industry 4.0 means in terms of quality, focusing on benefits, challenges and the tools companies will need to make it a success.

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General Quality Industry 4.0

What Are the Changes in ISO 13485:2016?

[fa icon="calendar'] Fri, Apr 06, 2018 / by Rachel Beavins Tracy

If your organization is one of the more than 59,000 certified to ISO 13485, you should already be planning for your transition to the newest version of the standard. As of February 28, 2019, all ISO 13485:2003 certificates will expire, with the Medical Device Single Audit Program (MDSAP) requiring manufacturers to transition by January 1, 2019.

ISO 13485 is based on the popular ISO 9001 for quality management systems, although key structural differences make it a standalone standard. In this post, we’re looking at what the changes are in ISO 13485:2016, and what companies can do to streamline the transition process.

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Life Sciences

4 Hidden Costs of Poor Document Control [Infographic]

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

Poorly controlled documents are a huge source of risk in organizations today,costing millions in profits and productivity every year. This infographic highlights four hidden costs of poor document control and how automation can help. 

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General Quality

Risk-Based Regulatory Compliance for Manufacturing: A Practical 4-Step Approach

[fa icon="calendar'] Fri, Mar 23, 2018 / by Rachel Beavins Tracy

In 2015, the Code of Federal Regulations totaled nearly 180,000 pages of requirements. While not all of these will apply to any single manufacturer, regulatory compliance is still a major challenge for companies. In fact, many of them aren’t even aware of certain regulatory risks until it’s too late.

This fact is especially true when companies use manual or paper-based methods for quality or environmental management, which make it difficult to effectively track compliance activities.

With that in mind, today’s post looks at a practical, risk-based approach manufacturers can use to identify and assess compliance gaps.

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General Quality EHS Risk Management

Comparing ISO 9001 and ISO 13485

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

ISO 13485 for medical device quality management shares many similarities with ISO 9001, the leading global quality management standard with more than 1.1 million certificates worldwide.

While most standard revisions now follow ISO 9001’s new high-level structure, ISO 13485 does not, even though it was released after ISO 9001. Clearly there are structural differences, but you may be wondering—how different are they?

Today we’re looking at the similarities and differences between the two standards, and whether life sciences companies and related services need both certifications.

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General Quality