4 Things Life Sciences Companies Should Know About FDA Warning Letters

[fa icon="calendar'] Fri, Aug 17, 2018 / by Rachel Beavins Tracy

The number of warning letters handed out by the U.S. Food and Drug Administration (FDA) has been on a steady rise over the past several years. In fact, the agency handed out more than 100 warning letters in 2016 alone, often after missed opportunities to correct mistakes pointed out in Form 483 observation reports.

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Life Sciences

4 Ways to Leverage Data for Operational Excellence

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

Data can be a gift and a curse when it comes to operational excellence. For some companies, ineffective practices make data a barrier to improvement, with too many data points and metrics obscuring the most strategic course of action.

 

At the same time, data is also a key enabler of operational excellence, helping businesses make sense of the vast quantities of information generated in today’s manufacturing environments. All told, a full 85% of companies aim to be data-driven, yet little more than a third of them are successful.

 

Today, we’re looking at four ways companies can better leverage data for operational excellence, looking at elements like predictive capabilities, supplier quality management and measuring effectiveness.

 

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Quality Management

Tracking Waste: How to Avoid Common RCRA Pitfalls

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

The Resource Conservation and Recovery Act (RCRA) is the main U.S. law governing hazardous and non-hazardous solid waste management. The U.S. Environmental Protection Agency (EPA) is responsible for enforcing the law, handing out $200 billion in criminal fines in 2016 over RCRA and other violations.

 

The problem for manufacturers is that, despite many companies’ hopes of a more relaxed regulatory environment, the potential EPA penalties are more costly than ever. In this post, we’re looking at some of the most common RCRA pitfalls, including how to avoid errors in waste determinations, labeling and storage.

 

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EHS

6 Ways You Could Be Using Your EHS Software More Effectively

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

Nearly 3 in 4 Environmental, Health and Safety (EHS) professionals say their department is understaffed. Whether due to underfunding of EHS priorities or the current skills shortage, it’s a problem that many safety professionals must grapple with.

 

At the same time, adoption of EHS Software is growing, presenting new opportunities for improving efficiency of EHS processes.

 

With these facts in mind, let’s take a look at 7 ways you could be using your EHS Software more effectively to get better results.

 

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EHS Management

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

9 Free OSHA Resources to Help Companies Improve Safety

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

Where do you start if you need to create a comprehensive employee safety program from scratch? What can you do if your company is struggling with high rates of injuries and illnesses?

 

These and other questions can be difficult to answer, particularly for companies in high-risk industries or without much in-house Environmental, Health and Safety (EHS) expertise.

 

What many organizations don’t realize is that the U.S. Occupational Safety and Health Administration (OHSA) offers a broad array of completely free resources to help improve safety. Today we’re looking at nine of them, from basic best practices to personalized guidance to resources designed specifically for small businesses.

 

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EHS Management

ISO 13485 Countdown: 5 Critical Tasks to Focus on Now

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

The clock is ticking: in less than a year—February 28, 2019—previous ISO 13485:2003 certificates will no longer be valid. And if you plan to participate in the Medical Device Single Audit Program (MDSAP), that deadline is even earlier, as you’ll need to make the switch by the first of the year.

If you feel like you’re behind schedule, taking concrete action can help eliminate some of the stress. Let’s look at 5 practical steps you can focus on right now to make sure you’re ready ahead of the deadline.

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Life Sciences

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

150,000 Tons of Food is Wasted in the US: How Automation Can Help

[fa icon="calendar'] Fri, Jun 29, 2018 / by Emily Ysaguirre

Americans waste 150,000 tons of food each day, which is the equivalent to a pound per person, says the Guardian. According to the article, research shows that people with healthy diets that are rich in fruit and vegetables are in fact the most wasteful. The article states that, fruit and vegetables require less land to grow than other foods but in turn, require a large amount of water and pesticides. 

It explains, “This waste has an environmental toll, with the volume of discarded food equivalent to the yearly use of 30m acres of land, 780m pounds of pesticide and 4.2tn gallons of irrigated water. Rotting food also clogs up landfills and releases methane, a powerful greenhouse gas.”

Lisa Jahns, a nutritionist at USDA and co-author of the study, said, “we need a simultaneous effort to increase food quality as well as reduce food waste. We need to put both of those things out.” Further stating that food waste occurs from farm to plate in the US. A report by the Center for Biological Diversity states, only four out of the 10 largest grocery chains in the US have specific food waste reduction commitments and a further 10 don’t prevent the waste of food considered too cosmetically imperfect to sell.

Jahns also says that consumers in busy households do not prioritize the time and energy it takes to prepare food.

What can we do? I’m glad you asked!

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General Quality Food and Beverage

Industrial Hygiene Trends [Infographic]

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

Industrial Hygiene (IH) software helps perform qualitative assessments utilizing Similar Exposure Group (SEG) methodologies for the categorization of hazard types, job roles, processes, locations, demographics and more. 

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EHS