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

Using the Industrial Internet of Things (IIot) to Improve Quality

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

Disruptive technologies like ride-sharing, 3D printing and self-driving vehicles are driving rapid transformation across many industries. The Industrial Internet of Things (IIoT) is no exception, with manufacturing ripe for disruption due to the prevalence of manual processes.

Given that human error is responsible for 85% of quality problems, it’s no surprise that roughly 1 in 4 companies who plan to implement IIoT are doing it to improve quality.

So how can companies expect to improve quality through the interconnectedness of devices? This posts looks at several key drivers of the transformation.

 

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quality system

What Does EU’s New MDR Mean for Small to Medium-Sized Companies?

[fa icon="calendar'] Mon, Jun 18, 2018 / by Rachel Beavins Tracy

As of 2020, medical device companies that market products in Europe will be subject to a much larger set of requirements that mirror rigorous U.S. Food and Drug Administration (FDA) regulations.

And while large companies have extensive resources to pour into complying with the new EU Medical Device Regulation (MDR), it’s not necessarily true for smaller companies. In fact, some experts predict that the new requirements could wipe out some organizations altogether.

In today’s post, we’re looking at what small to medium-sized medical device companies need to know about the new EU MDR. We’ll examine some of the most important changes, timing considerations and practical steps to take now to successfully manage the transition.

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Life Sciences

The Industrial Internet of Things (IIoT) for EHS: Risks and Rewards

[fa icon="calendar'] Fri, Jun 15, 2018 / by Rachel Beavins Tracy

TechTarget defines an Internet of Things device as “any nonstandard computing device that connects wirelessly to a network and has the ability to transmit data.”

The Industrial Internet of things (IIoT) has the potential to revolutionize manufacturing, not least of all when it comes to health and safety. What’s equally clear is that implementing IIoT is a huge undertaking, and not without its risks.

In today’s post, we’ll look at what environmental, health and safety (EHS) professionals can expect with the evolution towards IIoT, both in terms of risks and benefits.

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EHS

Documentation Requirements in ISO 13485 - Start with a Quality Management System (QMS)

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

When it comes to ISO certifications, one thing companies can count on is a mountain of documentation.

It’s especially true for certifying to ISO 13485 for medical device quality management, as medical device manufacturers must provide extensive documentation as evidence of the safety of their products—and the effectiveness of their quality processes.

In today’s post, we’re examining ISO 13485:2016 documentation requirements to help manufacturers get organized as they transition to the latest standard version.

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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

Using the Quality Management System (QMS) to Support the 8 Principles of Total Quality Management (TQM)

[fa icon="calendar'] Fri, Jun 01, 2018 / by Rachel Beavins Tracy

Total Quality Management (TQM) emerged in the 1980s in response to economic losses experienced due to Japanese manufacturers producing higher quality goods at lower cost. TQM was a natural outgrowth of the Toyota Production System, eventually giving rise to approaches like Lean Manufacturing and Six Sigma.

Companies that adopt TQM and related process excellence methodologies need a specific set of Quality Management System (QMS) tools. With that in mind, today we’re looking at how the QMS supports what the American Society for Quality (ASQ) calls the 8 principles of TQM.

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General Quality