Alexa Sussman

Alexa Sussman

Recent Posts

Should Life Science Companies Comply with ISO 9001 or ISO 13485…or Both?

[fa icon="calendar'] Tue, Sep 05, 2017 / by Alexa Sussman

Many Life Science organizations are asking that question as new ISO deadlines approach.

Medical device manufacturing companies need to comply with a regulatory standard to maintain compliance and be sure that products are safe and effective. But there are multiple options that complicate the process of deciding which standard to comply with. Some make the decision to comply with more than one for the sake of covering all bases.

Here’s a breakdown of what Life Science organizations should consider about the two most common standards for medical device companies: ISO 9001:2015 and ISO 13485: 2016.

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ISO 9000 Life Sciences iso 13485

10 Ways to Automate Your Business with Quality Management Software

[fa icon="calendar'] Fri, Sep 01, 2017 / by Alexa Sussman

These days, it’s not enough to just survive in the business world—you need to thrive. There’s so much competition across all sectors that it’s no longer enough to just be enough. To really succeed, you need to excel standard business practices to achieve something greater. We call that “operational excellence.”

The challenge facing businesses is figuring out how to achieve operational excellence when so much of your time is devoted to handling everyday operations. But there’s a simple solution.

Automating basic tasks with quality management software frees up time and resources, putting everyday tasks in the hands of automation and putting operational excellence within reach. So, what steps can you take to quickly take your business to the next level? We have some ideas.

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Quality Management

How Risk Management Helps When Disaster Strikes

[fa icon="calendar'] Tue, Aug 29, 2017 / by Alexa Sussman

Hurricane Harvey has been wreaking havoc on Texas and the surrounding area for days now. By now I’m sure your social media feeds are filled with pictures of the effects, as well as links to resources and how you can help.

For some of you who have experienced a natural disaster, you can imagine all too well what these people are going through. But for those who haven’t, it may be hard to imagine. Some might even find themselves asking: couldn’t they have prepared better for this?

Unfortunately, the answer is no. No matter how much you prepare, sometimes events—like hurricanes—happen that are completely outside of your control and carry consequences beyond the scope of your organization.

In those cases, focus must immediately shift to disaster response efforts. It’s here that a little extra planning and thinking ahead can help you recover faster.

Here’s how.

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Risk Management

14 CFR Part 5: What You Need to Know for Aviation Safety Management Systems

[fa icon="calendar'] Tue, Aug 22, 2017 / by Alexa Sussman

The deadline for 14 CFR Part 5 is quickly approaching—aviation organizations have until 2018 to have a Safety Management System (SMS) in place. While aircraft accidents worldwide have decreased, the number of accidents stemming from the operating environment has generally unchanged. The U.S. Federal Aviation Administration (FAA) issued this final rule in an effort to reduce incidents by shifting focus from reactive strategies to proactive risk management.

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3 Questions About Behavior-Based Safety, Answered

[fa icon="calendar'] Tue, Aug 15, 2017 / by Alexa Sussman

Behavior-based safety (BBS) programs are one of the guiding principles of an integrated management system. They bring together people, processes and technology to promote a total safety culture.

Here are 3 commonly asked questions about BBS programs—answered.

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EHS behavior-based safety

Weathering the Storm: The Importance of a Weather-Related Risk Management Plan for Your Supply Chain

[fa icon="calendar'] Tue, Aug 01, 2017 / by Alexa Sussman

We wear boots to walk on icy sidewalks and bring umbrellas when it rains—we plan ahead and prepare for bad weather events in our daily lives. But in our businesses, we tend to overlook nature and weather-related issues in favor of operational ones.

So why don’t we batten down the hatches (so to speak) when it comes to weather-related risks and our businesses? After all, weather events can affect your business just as much—if not more—than operational risks.

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EHS Risk Management

­­­­­­Wearable Devices for EHS & Job Safety: 4 Key Insights

[fa icon="calendar'] Tue, May 23, 2017 / by Alexa Sussman

In 2015 alone, there were 7.2 million work days lost from occupational injuries and illnesses and 4,821 workers killed on the job, costing all sectors a total of about $170 billion.

As technological advancements have brought us wearable devices—like smart watches, fitness trackers and augmented reality glasses—EHS professionals are introducing them into EHS and job safety to reduce those numbers.

Here are 4 insights into this development:

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Join EtQ at the NAEM EHS & Sustainability Software Conference

[fa icon="calendar'] Tue, Mar 07, 2017 / by Alexa Sussman

Where in the world is EtQ?!

In Houston, Texas, at the National Association for Environmental Management’s (NAEM) EHS & Sustainability Software and Data Management conference.

This conference offers potential buyers information on software selection, implementing and integrating new systems and how to optimize current software.

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FDA Recommendations for Cybersecurity in Life Sciences

[fa icon="calendar'] Tue, Feb 07, 2017 / by Alexa Sussman

“Cybersecurity threats are real, ever-present, and continuously changing.”

That’s how Suzanne B. Schwartz of the FDA describes production and postmarket for medical devices. And it’s true, cybersecurity threats pose ever-present challenges to the Life Sciences industry, putting people’s health, safety and security at risk.

With that in mind, the FDA released official guidance for postmarket cybersecurity management.

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Life Sciences

What Do CSR Trends Mean for EHS Management?

[fa icon="calendar'] Thu, Jan 26, 2017 / by Alexa Sussman

Forbes recently released an article called 6 CSR Trends to Watch in 2017. As Corporate Social Responsibility (CSR) becomes a stronger fundamental business priority, we were thinking about the ways that these 6 shifts may impact EHS management.

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