Health & Safety is a Team Effort: Industry 4.0 and IIoT

 
The Industrial Internet of Things (IIoT) and Industry 4.0 are forcing companies to rethink their approach to health and safety. Digital transformation uses innovative IoT endpoints and their data to improve the company’s core business, but they make health and safety more complex than ever. When properly deployed and integrated, sensors, endpoints and devices improve the individual safety of workers and identify additional areas for process improvement. 

More connected workers, more devices, more data — this massive influx of information and capability requires an end-to-end solution that addresses new and evolving EHS challenges. A solution that can capture the data produced from edge devices, analyze it and organize it in meaningful ways to improve health and safety programs and processes. Intelex Technologies and Honeywell are working together to create an integrated EHS solution that solves the challenges posed by Industry 4.0 and IIoT.  

The Number of Connected “Things”  

The global IIoT market will grow to $310 billion USD by 2023, and some of that growth will be from the increase in the number of “Connected Workers.” This means that the average industrial worker is going to be wearing and carrying multiple devices to help them do their job. Deployment, management and training … Read more...

Six Tips for Managing your Regulatory Content

Over the last century, globalization has driven a 4000% increase in international trade and prompted a rapid rise in the number of multinational (MNC) and transnational (TNC) corporations operating around the world. But companies operating in multiple countries must comply with rapidly changing local environment, health and safety (EHS) regulations such as OSHA in the U.S., the “Framework Directive” in the EU and JICOSH in Japan. In 2018, Enhesa covered 4,222 EHS regulatory developments from over 40 countries and 275 jurisdictions globally, an increase of 20% from 2017.

The short- and long-term costs (shut-downs, fines, litigation and tarnished brand) of non-compliance can be staggering. A recent Enhesa benchmarking survey of corporate EHS Executives found that:

  • 74 percent had incurred an enforcement action in the last five years
  • Two-thirds of the respondents had been issued regulatory fines up to $100k due to recent non-compliance. An additional 10 percent experienced fines in
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What is the Voice of the Customer?

Businesses are constantly speaking to their customer base using a strategic blend of marketing channels and public relations to optimize engagement. It’s an easy way to control their message, create customer loyalty, drive customer retention and leverage a consistent brand image. But how much listening do they do?

Listening to the customer is incredibly important and failing to engage with actionable, data driven intelligence can result in customer dissatisfaction and a deterioration of the customer relationship. This skill is especially important in the early stages of product and service development. Ensuring satisfaction from the beginning of the customer journey can help reduce the likelihood of waste and rework later.

The Voice of the Customer (VoC) is a process to help organizations drive continuous improvement and innovation through insight gained from customer feedback data. This can be a massive undertaking, so without a clearly defined methodology for understanding the customer experience … Read more...

Quality Management Requires a Cross-Industry Approach

The fundamental guiding principle of Quality Management lands squarely upon the business need for continuous process analysis and improvement. Doing it successfully results in increased customer satisfaction, employee engagement and organizational efficiency. Every organization, regardless of industry or size, should have Quality Management as a core pillar upon which objectives and strategy are based.

Yet there is no single way to apply Quality Management that makes it effective for all. While you can certify to a standard like ISO 9001:2015, those standards don’t tell you how to uniquely apply quality to your businesses or provide a simple path to achieve a Culture of Quality. Every industry, from food production to automotive manufacturing, has a myriad of different priorities, obligations, and requirements that shape the way they engage with and apply the principles of Quality Management.

Read Intelex’s new Insight Report, “A Cross-Industry Look at Quality Management,” to learn the … Read more...

Manufacturer Exits Paper Trail – Moves to a Software Path for Better EHS Management

It was really a matter of getting with the times.

PACE Industries, a U.S.-based die-casting company, was not unlike many organizations struggling to manage environmental, health and safety (EHS) processes. They were looking to get out of the old world of paper and Excel spreadsheets and into the modern age of intelligent digital reporting.

A company with a history dating to the 1970s, PACE was buried under a spreadsheet mountain of incident reporting from 12 divisions and 21 locations throughout the U.S., plus two plants in Mexico. It’s a busy place. You name it, and PACE probably manufactures it, taking aluminum, magnesium and zinc, melting it down, putting it in high-pressure molds, and literally turning it into thousands of parts. Everything from components for the automotive and lighting industries, to barbecue grills, and even guidance chips for missile systems. Suffice to say, paper-based processes simply weren’t cutting it.

“We wanted … Read more...

BRC Version 8 targets global food safety and quality assurance

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Today’s food literally comes from everywhere in the world. The sourcing of it is now an international affair and assurance of food safety and quality is perhaps more important than ever.

Among those looking to bring uniformity to … Read more...

3 Ways MDSAP Improves Audit Effectiveness


What is the MDSAP program?
In Singapore in 2012, the International Medical Device Regulators Forum (IMDRF) began development of a Medical Device Single Audit Program (MDSAP). MDSAP allows approved auditing organizations to conduct a single regulatory audit of a medical device manufacturer. This single audit expands the scope of the audit to previously unaudited areas of large organizations, standardizes a consistent auditing model, and replaces as many as five separate . It also satisfies the regulatory requirements of the authorities participating in the program – even ISO 13485:2016. MDSAP focuses on defined and linked processes and is based on requirements for risk management. The goals of MDSAP are:

  1. to improve audit effectiveness and the influence the audit can have on outcomes that improve patient safety, and
  2. to reduce the resource demands on both regulatory bodies and auditees in organizations having to comply with a variety of global standards and .
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ISO 45001 May Be Particularly Beneficial to Manufacturing

ISO 45001 will heap a whole lot more responsibility on to the already full plates of top managers. The standard puts business management on the hook to create, orchestrate, maintain, monitor, develop and actively promote a system that takes occupational health and safety (OH&S) policies and embeds these into the culture and operation of a business’s everyday activities. The corollary to this is that leaders will need to find a way to ensure sufficient financial, personnel and time resources are devoted to the successful implementation of a management system for OH&S.

At the heart of the ISO 45001 standard is a need for worker involvement through participation in decision making, evaluation procedures, implementation and feedback mechanisms.

The new standard will amplify a need for an effective safety solution, including tools that will allow manufacturers to connect with different stakeholders throughout their organizations, to foster trust and collaboration at each level.… Read more...

How a Safety Management System Can Save You Money

A software-based system for managing safety in manufacturing organizations may hold the key to unlocking efficiency, improving processes and creating safer workplaces that, at the end of the day, puts money back in the pockets of these businesses.

Experts say that Safety Management System (SMS) support the ability of manufacturing companies to help change leadership thinking and cultures in reducing the number of workplace injuries through increased awareness of, and involvement in, safety programs, and ultimately elevating the important of and commitment to safety across entire organizations.

In the U.S. a total of US$170 billion is spent by business each year on occupational injury- and illness-related costs that eat away at net earnings. The National Safety Council reports that a dollar invested in an SMS – and the subsequent potential improvements that can be achieved in overall safety management – returns anywhere from between $2 and $6. These savings come … Read more...

Four Reasons Why Life Sciences Organizations Are Moving Their QMS to the Cloud

Life sciences organizations, including pharmaceuticals, and medical device manufacturers, constantly look for ways to reduce risk, increase patient safety, and achieve operational excellence. To be successful in these three areas, pharmaceutical and medical device manufacturing companies need to have robust management systems in place. This is even more critical than in other industries where the breadth of regulatory requirements is not as vast.

Transforming their QMS to the cloud can help them achieve these strategic objectives. Along this digital transformation journey, software validation can be a challenge with varying degrees of intricacy across organizations. Causes can range from lack of experience and expertise to the complexity of internal and external stakeholders involved. Ultimately, no one wants to receive a 483 from the FDA due to noncompliance with 21 CFR 11, which will put an organization in a bind and ultimately impact patient safety.

As pharmaceuticals and medical device manufacturers look … Read more...