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.Read More
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.
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.
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.
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.
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.Read More
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.Read More
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.
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.Read More
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.Read More