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

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

Using Technology to Support Behavior Based Safety Programs 

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

Look at leading organizations with low incidence rates, and you’ll notice one thing many of them have in common: behavior based safety (BBS) programs.

BBS is a best practices strategy for improving safety performance, but without the right tools in place, companies face a high risk of failure. That’s because BBS is all about changing human habits, which are often ingrained over years of habit. You can’t manage what you don’t measure, which is why soft programs that live outside the EHS Management System often fail.

In this post, we’ll look at what BBS is and how technology can help support your BBS program, including tips on how to construct powerful BBS checklists.

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EHS

Reducing Overdue Corrective Actions: A Practical Guide

[fa icon="calendar'] Mon, Mar 12, 2018 / by Rachel Beavins Tracy

Imagine a situation where your plant has a huge backlog of corrective actions 30, 60, even 90 days overdue. Defects and complaints are high, quality costs are rising and nobody seems motivated to fix the problem.

You got a nonconformance from your ISO registrar because of it, and you’ve got another audit next week where you’ll surely get hammered again. One of your most valued team members is so frustrated with the inaction and lack of accountability, he’s looking for a new job. Sound extreme?

It’s more common than you think.

Today we’re tackling the issue of overdue corrective actions, providing a practical guide for turning the ship around so you can stop this destructive cycle.

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