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Successful Knowledge Capture in Advanced Manufacturing & Medical Devices

For the past 15 years, Novatek’s technical writing, documentation, and training team have worked with Ortho Clinical Diagnostics (OCD) to ensure compliance, quality, and usability in their medical device products. In this interview, Rick Wetzel, Operations Training Manager for OCD, shares his insights on industry trends and their impact on training a highly skilled workforce.

ortho-clinical-diagnostics-logo.jpgRick, as you plan for 2016, what trends do you anticipate, and how will they impact your training strategy?

There are 2 major trends that will impact our work in the coming years:

First, changing demographics in the workforce. This is the only time in history we’ve seen four generations working together. We have a large population who may choose to retire in the next five years. They hold a lot of technical and proprietary information, which could be lost if we do not proactively transfer knowledge to others.

What’s your game plan for knowledge transfer?

In the last two years, we’ve worked to create the tools to identify a baseline for key skillsets, to identify whether they’d be needed in the future, and a plan to build those skills in our upcoming workforce. We’re working hand in hand with the maintenance organization to create an in-house apprenticeship program, incorporating existing courses at Monroe Community College. This reduces costs both to launch the program and run the three-year apprenticeship. We use outside resources wherever we’re able—we don’t always have the resources to ‘invent it all here.’

And the second trend?

Increased scrutiny from the regulatory and notifying bodies, like the FDA, BSi and other global bodies. As a manufacturer of medical devices, OCD must comply with the global quality standards, including manufacturing, to ensure our products are safe and fit for their intended use. It’s about understanding and applying the current Good Manufacturing Practices to everything we do. As a result of this increased scrutiny, we must continually demonstrate that we are not only in compliance with the standards, but we must ensure everyone who provides training is qualified to do so and those who receive training, truly understand how their role impacts the quality of our products and meets the government standards.

To meet the standards we document everything! The organization has thousands of processes and procedures that enable us to demonstrate our compliance. We are in the process of implementing a new learning management system to allow us to even do a better job of tracking our training requirements, training records and individual qualifications.

Sales training and customer training are handled in separate departments, but all are overseen by our global training governance council to ensure that everyone has training plans, and has successfully completed all required training.

We will soon launch standardized global on-boarding to further improve compliance and quality from day one.

My team works closely with both HR and the local leadership teams to ensure that our people in all areas of the business are offered leadership development opportunities. We also evaluate and partner with existing community and industry resources to offer employees the best available resources.

Is training seen as a priority in today’s business environment?

Yes. Today, more leaders at all levels recognize the value of training. Training is more than just a necessity to meet compliance standards. Effective training establishes the foundation for quality. It enables employee engagement, innovation, and increased productivity – all of which drive business results. Customer and sales training are a natural focus, but we are doing a lot of forward-looking things in operations training as well.

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Topics: trends, knowledge transfer

 EU MDR