In 2015, the Code of Federal Regulations totaled nearly 180,000 pages of requirements. While not all of these will apply to any single manufacturer, regulatory compliance is still a major challenge for companies. In fact, many of them aren’t even aware of certain regulatory risks until it’s too late.

This fact is especially true when companies use manual or paper-based methods for quality or environmental management, which make it difficult to effectively track compliance activities.

With that in mind, today’s post looks at a practical, risk-based approach manufacturers can use to identify and assess compliance gaps.

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To achieve operational excellence, you need a comprehensive, forward-thinking approach to managing safety and quality risks.

This infographic identifies 4 of the most common risk management gaps and shows you how solutions like quality management software can help mitigate these risks.

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Life sciences companies face risks that threaten product quality, patient safety and profitability--this infographic reviews these risks and provides tips for mitigating them. Read More

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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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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The ISO 9001:2015 standard places a great deal of emphasis on using risk to drive processes and make decisions. The old mindset of using corrective actions to deal with adverse events has been replaced with the risk-driven approach, aiming to prevent it from happening rather than recovering from it once it happens. For those that are new to risk management, however, this can be a challenging shift.

Not only do business leaders need to understand the latest standards, they need to understand the role of risk and the tools available to them to help manage risk.

This post will consider 5 risk tools that you can use to leverage risk management within your organization.

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Risk has always had an implicit role in ISO standards, but newer versions are giving risk a more prominent place in quality and environmental management standards. Updated standards like ISO 9001:2015 and 14001:2015 require companies to apply risk-based thinking to a variety of processes across planning, operations and performance evaluation.

But what exactly does ISO mean by risk-based thinking? A deeper look reveals that while it’s not the same as risk management, automated risk management tools can help you incorporate risk-based thinking into your processes.

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You can do all the audits you want and assign corrective actions until the cows come home, but unless your aviation Safety Management System (SMS) incorporates the essential element of risk, you’re missing the point.

Reducing risk to individuals, and really the organization as a whole, is the entire purpose of an SMS. And yet, most companies still tend to look at risk management from a siloed perspective, with only 20 percent integrating risk management data with other business systems.

This post looks at essential places to integrate risk into your SMS, helping you shift from reactive approaches focused on past incidents to proactive strategies that help prevent them.

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More than 4 in 5 companies believe risk management is a key capability for managing complexity and adapting to changes in the market. Yet time and again, we see poor risk management making big headlines, from defective devices to counterfeit drugs to reputational damage due to poor communication strategies.

So what can companies do to prevent these problems and protect the long-term value of the company?

Let’s look at 6 common risk management gaps that life sciences companies should focus on.

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U.S. Department of Labor statistics show that the aviation industry has an incidence rate more than double that of private industry. Making progress towards reducing worker injuries requires strategies that go beyond the surface of incident reporting, leveraging all the data available to prevent future occurrences.

One way companies can do this is by incorporating risk management into their incident reporting processes. Risk adds a new dimension to the data, giving you more information that helps you better analyze, prioritize and solve problems.

Let’s look at a few key areas where aviation companies can make incident reporting a risk-based process.

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