Alexa Sussman

Alexa Sussman

Recent Posts

How Does Quality 4.0 Fit into My Quality Plan

[fa icon="calendar'] Thu, Aug 30, 2018 / by Alexa Sussman

A major misconception about Quality 4.0 is that it is meant to completely replace your current quality management practices.

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quality management software

Understanding Gartner's 5 Dimensions of Manufacturing Maturity

[fa icon="calendar'] Thu, Jul 26, 2018 / by Alexa Sussman

Gartner recently released a report as guidance for organizations to build more efficient manufacturing process while keeping up with initiatives like Industry 4.0.

The five-stage maturity model for manufacturing excellence will help manufacturers assess current capabilities, make a plan for change and support the development of future manufacturing operations with the supply chain.

Previously, we discussed a basic overview of the five maturity stages that Gartner outlined. Now, we’ll be looking at the dimensions used to define those stages.

The five dimensions of maturity are a good to mature and transform manufacturing processes, with the end goal of developing smart manufacturing as per Industry 4.0.

Here’s a little bit more about each one:

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Industry 4.0

3 Steps to Achieving Manufacturing Operational Excellence

[fa icon="calendar'] Thu, Jul 05, 2018 / by Alexa Sussman

Gartner’s five stage manufacturing maturity model helps organizations improve their manufacturing processes and supply chain management.

This is especially important as organizations need a holistic strategy to build their existing capabilities to adjust to new initiatives such as Industry 4.0 and factory of the future.

Adopting Gartner’s five stage manufacturing maturity model helps organizations advance in three main ways: identifying current maturity levels an identify which dimensions are lagging, making a plan that leverages current practices to prioritize necessary changes and engaging stakeholders while road-mapping programs to incrementally mature operations.

Here’s more on each.

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Life Sciences

3 Ways Blockchain is Transforming Manufacturing

[fa icon="calendar'] Mon, Jun 04, 2018 / by Alexa Sussman

Traditional business methods are enough to handle basic manufacturing processes but can’t keep up with the pace at which markets and technology are advancing.

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General Quality

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

6 Environmental Health and Safety (EHS) Training Trends  to Start Incorporating Now

[fa icon="calendar'] Mon, May 14, 2018 / by Alexa Sussman

Training your employees should be more than just having them memorize processes and testing them on safety procedures. The latest developments in EHS training software for employees revolve around engagement and utilizing today’s latest technology. Tools like mobile devices and virtual reality have completely changed how managers can create effective and engaging safety training programs.

Here are some of the upcoming trends for EHS Management Software that leaders should be paying attention to in order to ensure environmental health and safety training success:

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EHS

The FDA Issued Its First Mandatory Recall—What Does This Mean for Food & Beverage Organizations?

[fa icon="calendar'] Sat, May 12, 2018 / by Alexa Sussman

On April 3, 2018, the United States Food and Drug Administration (FDA) issued its first ever mandatory recall to Triangle Pharmanaturals for kratom that was contaminated with salmonella.

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Food and Beverage

EHS 4.0: What You Need to Know About the Digital Transformation

[fa icon="calendar'] Mon, Apr 23, 2018 / by Alexa Sussman

 

Environmental, health and safety (EHS) management has always had three main goals: to keep people safe, minimize negative impact on the environment and keep operations running productively and without incident. This means adhering strictly to compliance regulations and looking for new ways to increase profitability while decreasing incident rates.

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What the FDA is Doing About Illicit Opioid Sales

[fa icon="calendar'] Tue, Apr 17, 2018 / by Alexa Sussman

What’s Going On?

FDA chief Scott Gottlieb addressed social media leaders in a speech on April 4, 2018, drawing attention to how their platforms have facilitated the opioid crisis by creating a channel for illicit opioid sales.

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3 Things You Need to Know About the MDSAP

[fa icon="calendar'] Mon, Mar 26, 2018 / by Alexa Sussman

Audits are an essential part of the Life Sciences as they ensure manufacturers are producing safe products and operating within compliance.

Previously, audits meant surprise business interruptions for manufacturers and a lot of travel and administrative work for auditors. With many Life Science manufacturers operating internationally, they were being audited separately to satisfy the requirements of each country in which they operated. At the end of the day, there was a lot of repeat work on both ends.

So regulatory agencies and legislators have come together to develop single audit programs that create comprehensive audits that satisfy the requirements of multiple countries. This creates a globally harmonized and efficient international audit management system.

One of the major programs is the Medical Device Single Audit Program (MDSAP). As the deadlines for these changes approaches quickly, here are 3 things that medical device manufacturers should know about the MDSAP.

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Life Sciences General Quality