About Greg Enright

Greg Enright is Content Marketing Manager at Intelex Technologies. A veteran journalist, writer and editor, Greg has written extensively on technology, finance and EHSQ issues. At Intelex, he focuses primarily on Health and Safety.

Construction Abatements, Data Collection OSHA’s Chief Challenges: Report

Obtaining reliable data about workplace injuries is hindering OSHA’s efforts to determine how best to use its resources to help protect U.S. workers’ health and safety, according to a new report from the U.S. Department of Labor’s (DoL) Office of Inspector General. This challenge is particularly acute in high-risk industries like forestry, fishing, agriculture, mining and construction.

The report, titled “Top Management and Performance Challenges Facing the U.S. Department of Labor,” details challenges faced by all arms of the DoL, of which OSHA is a part.

The situation, the DoL writes, is exacerbated by underreporting of injuries by employers. Without reliable data regarding workplace injuries, OSHA “lacks the information needed to effectively focus inspection and compliance efforts on the most hazardous workplaces.”

One former OSHA official, however, believes the agency already receives more than enough data to prioritize its actions.

“Most employers over-report, not under-report. They put stuff down … Read more...

The Business Value of ISO Certification

Although companies have no requirement to do so, gaining certification to one or more standards established by the International Organization for Standardization (ISO) brings a bounty of benefits. Some are altruistic in nature, such as the satisfaction and positive public relations that come with ecological or social responsibility. Others are directly linked to a business’s overall performance, including operational competitiveness and internal process improvement. And, of course, there are those payoffs that are seen on the ledger sheets, such as increased sales and higher revenues.

So, just what is the purpose of the ISO standards? According to the nongovernmental agency itself, they are intended to “facilitate trade, spread knowledge, disseminate innovative advances in technology, and share good management and conformity assessment practices.” Upwards of 22,000 ISO standards have been published, with many being specific to certain products or industries. Some more frequently referenced ones apply more broadly, such as ISO … Read more...

HSE Prioritizes High-Risk Industry Inspections in 2019

The U.K.’s Health and Safety Executive is making inspections in high-risk industries a priority for 2019, along with the completion times of investigations and subsequent decisions, according to the body’s 2018-19 business plan.

The recently released document provides an overview of what the HSE says it has accomplished in the 2018 and a full list of where it intends to focus its energies in the coming year.

The HSE will carry out 20,000 proactive inspections and increase its use of campaigns that focus this work on “specific issues and activities found in high-risk industries.” This will include a sustained focus on health risks associated with occupational lung disease (OLD) and musculoskeletal disorders (MSDs).

As part of this targeted effort, the HSE will deliver five major inspection campaigns, each with at least 500 inspections in the following sectors: metal fabrication; agriculture; waste and recycling; food manufacturing; construction refurbishment (one that … Read more...

The New Partnership-Based Landscape of QMS Validation

Many organizations across countless industries are turning to the Cloud Computing model to validate their Quality Management Systems. With this shift comes many changes, including a new emphasis on partnerships. Let’s look at this new partnership-based landscape.

Three’s company

With more than two parties (traditionally the customer and the software provider) now involved in the validation process (the cloud provider has now added to the mix), the concept of the typical Service Level Agreement (SLA) changes in the cloud. It’s important, says Ray Glemser, CEO of IT solutions and services provider Glemser Technologies Corp., for a customer to recognize they are now in partnership with the other two players, who are performing more specialized functions for them.

“These are tied together in what we used to call an SLA,” Glemser says. “We are now organizing them into quality agreements where the quality system validation state needs to be maintained … Read more...

Making Sense of OSHA’s Recordkeeping Requirements

If you’re a health and safety professional responsible for reporting your company’s injury and illness records to OSHA, you can be forgiven for being a bit confused. After all, the rules have seemed to be changing faster than the autumn leaves.

In May 2016, OSHA added another layer of complexity when it published the final rule, titled Improve Tracking of Workplace Injuries and Illnesses. Also referred to as the Electronic Recordkeeping Rule, it required certain establishments to annually submit injury and illness data to OSHA through an online portal. This data would be posted to a public website with the intent of “shaming” employers into an increased focus on workplace safety. Despite objections, the rule’s implementation proceeded, though not without delays and modifications.

Then, a proposed rule published in July 2018 aimed to simplify the requirements and limit the scope of the rule, but its core remains intact. Significant … Read more...

How Software Provider Innovation Is Driving Change in QMS Validation

Important changes are taking place in the way many software providers develop their products, ones that have direct impacts on the validation process.

Waterfall development vs. Agile development

For many years, developers have used the “waterfall” model to create their software. This involves creating a fully developed version of the software before presenting it to customers or internal customer representatives for testing and feedback. Each step – plan, analyze, design, construct, test, deploy and maintain – is done one after the other, forming a waterfall visual.

Here, all user requirements are defined before anything is developed. A major drawback to the Waterfall model is that it is often impossible to know all user requirements at the outset of a software development project. Those that are identified often change during the months-long development cycle. Others do not become evident to users until the completed version is put before them. Developers … Read more...

Changing Roles in the QMS Cloud Validation Model

Many organizations across countless industries are turning to the Cloud Computing model to validate their Quality Management Systems. With the shift comes a change in who performs what roles in the validation process. Let’s look at this new responsibility landscape.

Who plays what roles

Who does what in the Validation model can change when we move to the Cloud. The customer remains responsible for, on the front end, validation planning and user requirements, and on the back end, user acceptance testing and validation reporting.

The software provider can assume responsibility for system requirements, detailed design, system configuration and development, unit/integration testing and system testing. The cloud provider can now look after the technical architecture and IQ.

Change control – private cloud vs. public cloud

Life sciences companies can tap into a wealth of innovative software that is being developed at a rapid rate – but it comes at a … Read more...

QMS Validation: Changes in the Cloud

Many companies in various industries are turning to the Cloud Computing model to validate their Quality Management Systems. This shift brings with it many changes to the traditional on-premises approach. Let’s look at what has changed in the cloud…and what hasn’t.

A key element in any software validation process is the Installation Qualification (IQ). This is essentially a checklist to ensure all elements needed to effectively run the software are in place. Questions to be answered include whether the software was loaded correctly and whether there is enough memory. The Cloud model’s architecture introduces new elements that companies must be aware of, as these pertain to the validation process.

Regulatory expectations for cloud providers

The traditional and the Cloud architecture share the same basic structure. It consists of:

  • A development environment, where applications are created
  • A test environment, where the recently developed software is tested exhaustively to make sure it
Read more...

Regulatory Responsibilities in the Cloud

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

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 done and when, including elements such as designs, tests and test-script executions.

A new method for achieving this is gaining significant traction. Known as the Cloud model, it sees companies handing off various parts of the validation process to third-party (or Cloud) providers who, for a fee, handle them on their own information technology infrastructure.

Companies that move to the validation of their Quality Management System (QMS) to the Cloud are still responsible for meeting the same regulatory obligations as in traditional models. … Read more...

Success Factors for Moving Into the Cloud

Customers are moving their Quality Management Systems into the cloud for many reasons:

  • It is easier to finance, with expenses spread out over a number of years. Because your company is sharing computing resources with other people, the total cost is cheaper overall. The services component will be higher than if things are kept in-house, but expenses such as hardware purchasing/upgrading and employment of increasingly expensive talent to manage the computing resources will be taken off the corporate ledger.
  • It is faster to deploy. Business benefits are realized much quicker because internal processes, such as reviews, approvals, and the accompanying meetings and endless email chains that typically bog down implementations are no longer part of the equation.
  • It offers faster access to the latest and greatest software features. No longer does the customer need to keep up with newest developments in software and implement those they want. Cloud providers
Read more...