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

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

Avoid FDA Warning Letters with These 4 Document Control Best Practices

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

Incomplete records stuffed in the trash, with the signatures still showing. Blank forms issued complete with signatures. Employees shredding documents without bothering to record why and what they were destroying, even as inspectors were onsite.

These practices may sound outrageous, but the document control horror stories are all right there in the U.S. Food and Drug Administration (FDA) warning letters. Even organizations that wouldn’t dream of engaging in such obvious violations could be subject to 483 notices and warning letters if they don’t get document control right.

With that in mind, let’s take a look at 4 document control best practices to help companies avoid FDA warning letters.

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Life Sciences

How Different Industries Use Bowtie Risk Assessment

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

When it comes to making decisions informed by risk, each industry has its preferred risk assessment tools. A risk matrix is a common one, as is Failure Modes and Effects Analysis (FMEA).

One tool that doesn’t get as much attention is the bowtie risk assessment. The bowtie model is useful for visualizing complex risk scenarios where you don’t have historical data to create a risk matrix.

Let’s look at how different industries like aviation, energy, life sciences and manufacturing are using this risk model.

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Quality Management EHS

Employee Training Tips for a GMP Compliant Workforce

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

Is your employee training program proactive, looking forward and evolving to incorporate lessons learned? Or is it reactive, only changing after problems occur?

A proactive approach to employee training is the foundation to Good Manufacturing Practice (GMP) compliance. By creating a comprehensive, standardized program and keeping an eye out for common mistakes, companies can foster a proactive quality culture that prevents problems at their source.

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Best Practices in Automated Industrial Hygiene Management

[fa icon="calendar'] Mon, Jan 22, 2018 / by Rachel Beavins Tracy

Best Practices in Automated Industrial Hygiene ManagementHumans have been concerned with industrial hygiene since ancient times, when in the 4th Century B.C., Greek physician Hippocrates (of the famed Hippocratic Oath) described the case of a miner with lead poisoning.

Today the U.S. Occupational Safety and Health Administration (OSHA) requires employers to comply with a range of laws and requirements dealing with industrial hygiene. In fact, a full 40% of the OSHA inspection workforce is made up of industrial hygienists responsible for enforcing rules at more than 6 million workplaces.   

So what do companies need to track, and how can they better protect workers? Let’s look at the basics of industrial hygiene, including hazards, controls and risk assessment strategies.

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EHS

7 Strategies for More Engaging Employee Training

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

7 Strategies for More Engaging Employee TrainingA large study of over 4,000 workers showed that nearly 3 in 4 employees don’t think they’re achieving their full potential. Add the fact that one-third say boring training content hinders learning, and it’s clear organizations have a long way to go in terms of effective training.

Lackluster training isn’t just an annoyance. It also carries a multi-million-dollar price tag for organizations in terms of poor performance and employee turnover. To help companies avoid these problems, we’re looking at 7 strategies to make your employee training programs better. 

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Quality Management

3 Elements of Effective Corrective Actions

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

Many quality or Environmental, Health and Safety (EHS) management professionals rely on Corrective Action software everyday to manage events such as nonconforming materials, customer complaints and safety incidents.

And yet, time and again, we see companies falling behind on their corrective action goals. Corrective actions don’t work. They have weak fixes, where people automatically assign human error as a root cause without examining the systemic factors behind the error. And when an incident occurs, it’s not uncommon for someone to comment that they knew it was bound to happen—a sure sign of ineffective corrective actions.

What can companies do from a technology perspective?

To ensure your corrective action process is working, you need corrective actions that are findable, trackable and designed to prevent systemic issues.

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Quality Management

Understanding the Basics of ISO 13485 for Medical Device Quality Management Systems (QMS)

[fa icon="calendar'] Mon, Jan 08, 2018 / by Rachel Beavins Tracy

ISO 13485 for Medical Device Quality Management Systems is growing in popularity, with the number of certified facilities jumping 13% from 2015 to 2016.

But how is ISO 13485 different from ISO 9001 for Quality Management, and who should certify?

In this post, we’ll take a look at the basics of ISO 13485 to help you decide whether it’s worth pursuing this certification.

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Life Sciences

How EHS Software Can Keep You Audit Ready

[fa icon="calendar'] Fri, Dec 29, 2017 / by Rachel Beavins Tracy

Think for a moment about the last time a safety auditor came to your facility. Were you nervous? Did you feel ready? Were you reasonably certain you would pass? Were you caught off-guard by the results and findings?

Whether we’re talking about internal, third-party certification or regulatory audits, success often comes down to effective preparation. In this post, we’ll look at how EHS software can help you prepare, focusing on the tools that are most important for audit readiness.

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EHS

5 Operational Excellence Myths and Facts

[fa icon="calendar'] Thu, Dec 28, 2017 / by Rachel Beavins Tracy

When you hear the term operational excellence, what’s the first thing that comes to mind? Is it:

  1. Just another worthless top-down initiative forced on overworked employees.
  2. The answer to all the problems plaguing your company.
  3. Something corporate goons invented to make themselves look good and justify their bloated salaries.

The correct answer: none of the above. Like many things in life, success with operational excellence is all in how you approach it.

In today’s post, we’ll bust common myths and misconceptions around operational excellence, so you can identify an effective strategy that’s grounded in reality.

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Quality Management

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