Is It Time to Upgrade your EHS Software?

There’s a shelf life for everything.

Even software has an expected existence. For most well-designed systems, a useful lifetime can be six to eight years. For systems that are less well designed or for applications that evolve quickly, the useful life of business software can be as short as three years.

According to a 2017 survey conducted by the National Association for Environmental Management (NAEM), most companies that are looking at replacing their environment, health & safety (EHS) software have a system in place that is less than five years old   – so, if your system is approaching five years old, it probably is or soon will be outdated.

How do you know your current software is due for a major refresh? You may need new EHS software if:

  • Your EHS software needs to integrate with your other IT systems. Many companies have other business software systems for non-EHS applications
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OSHA’s Most Common Citations – Part 3: Lockout/Tagout

Downtime may be the worst time when it comes to workplace hazards.

When a machine or other equipment operates normally, workers are protected from most of its potential hazards, assuming they operate the machinery safely and as prescribed. But when it is necessary to expose the inside of equipment for the purposes of maintenance or repair, workers may be exposed to hazards that are normally enclosed, guarded, or otherwise inaccessible. At those times, it is important to make sure that no part of the machine could unexpectedly start up, cycle, fall or release energy that could injure a worker. This is done by neutralizing all energy sources before beginning a task, and locking or tagging them out of service.

The U.S. Occupational Safety and Health Administration’s (OSHA) lockout/tagout standard, (29 CFR 1910.147) requires employers to:

  • Create energy control procedures for each piece of machinery or equipment that could pose a
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Managing QMS Validation the Modern, Efficient Way

With every trip to our local pharmacy, grocery store or corner variety shop, we pass hundreds of products that have reached the shelves only after a lengthy process designed to ensure their quality.

It’s not something the everyday consumer thinks much about. But without this crucial element of the manufacturing process, we would never be able to trust the quality of the many products whose high standards we take for granted. It’s quite easy to envision the catastrophes that would result.

Core to the process of ensuring quality is the concept of validation. This is the process whereby pharmaceutical manufacturers provide objective, documented evidence that their processes, equipment and computerized systems are checked and validated to ensure the quality of their medicines and medical devices.

Central to the validation journey is the required documentation produced with each step. To satisfy regulators, companies must record evidence to prove what work was … Read more...

Wellness Matters: More than 130 Million American Adults Suffer Chronic Health Conditions

A new frontier of employee health and safety awareness is rising. It’s the idea of wellness and a practice that’s good for people, plus there’s clear business value in the efforts made by workers to maintain and improve their good health and in the support employers provide to employees in helping them achieve that end.

An unhealthy workforce is one that’s less productive than it could be. This may be most obvious during times when there’s something “going around,” and many employees are out sick during the flu season. Productivity suffers. Workers who are sick either don’t come to work (absenteeism), or they come to work (presenteeism), but don’t get much done. Absenteeism and presenteeism are well-recognized drains on productivity, not just for individual employees but for an entire organization. A single absent employee can affect the productivity of an entire unit.

More than 130 million American adults suffer from … Read more...

What Can Go Wrong, Will Go Wrong: Quality Case Studies

How do Quality failures happen? What causes a self-driving car to kill a pedestrian? Or a well-known food brand to be contaminated with bacteria that cause a massive listeria outbreak? The sheer scale of some of these types of disasters might lead us to believe that the causes are equally large, that they ought to have been obvious to anyone or that only willful ignorance could be to blame. In reality, disaster is often the result of a cascading series of tiny, almost imperceptible Quality failures. They build slowly over time in organizational cultures not in the habit of looking for them or of being mindful of their presence and meaning when they do appear as smaller symptoms.

Quality Management isn’t simply a series of abstract ideas we follow to get a certification that allows us to bid on certain contracts from our customers. Quality Management serves a higher purpose; … Read more...

Tightening Processes is Key to Worker Safety

Variations that exist within system processes may be putting workers on a path to making poor decisions while performing their work and invariably compromising their safety. That’s an assertion made by Scott Gaddis, the Health and Safety Practice Leader for Intelex Technologies and a 25-year veteran of environmental health and safety leadership and management.

It’s important to tighten process methodologies to ensure there’s little room for interpretation by workers that forms bad safety habits. In his recently published Intelex Insight Report, entitled, Unleash a Better Safety Culture by Controlling Process Variability, Gaddis notes that, in many incidents where a worker performs an unsafe act, the decision that often led to err was likely influenced by other uncontrolled variables residing within the work system itself.

Dan Peterson, in his book, Human Error Reduction and Safety Management, writes that “Human error is involved in every accident and there are many reasons … Read more...

4 Best Practices for Life Science Manufacturers to Manage Risk

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Managing risk for life science organizations is often seen as simply a way to achieve and maintain industry compliance, and not as a means to improving operational performance.

That’s far from the perception in other industries, where effective risk management also supports continuous improvement and competitive differentiation.

Industry leaders in risk management are committed to continuous improvement programs, which drive down risks on existing products. The reality today is that the changing nature of risks requires adopting effective strategies to properly prioritize and mitigate them.

Arguably life science manufacturers should adopt a similar approach that takes advantage of best practices from across industries.

To that end, manufacturers should focus on:

Using a single unified framework for risk management

A unified framework allows the ability to compare risks, and execute continuous improvement measures. Many possible risk models exist, such as failure modes/failure effects/causes/controls/verification, or hazards/harms/controls/consequences. A unified model allows manufacturers to … Read more...