GxP Lifeline

Celebrating Quality Mastery (and Mishaps) on World Quality Day

On Nov. 12, World Quality Day, try asking a quality professional to describe their job. The details of their day-to-day activities might sound more like the plot of a noir film in which a hard-boiled detective desperately searches for clues. Or their description might resemble a classic tale of one man’s fight against the system, which also happens to include a perilous scavenger hunt.

These quality stories and many more like them are recounted in the entertaining — and sometimes painfully relatable — entries featured in the “Quality Shorts Film Festival.” You can celebrate this year’s World Quality Day theme, Creating Customer Value, by watching MasterControl customers’ short film submissions and seeing the creative and clever ways some experts interpret the meaning of quality. The filmmakers’ works range from farcical to adorable to cringe-inducing, yet all are united by a common motif: the fact that streamlined quality management brings value not just to your company but to the customers who benefit from your products.

The following winners of the short film contest were announced throughout the MasterControl Virtual Masters Summit held Oct. 19-23.

  • People’s Choice Award: “Quality Without MasterControl” by Deven Roberts.
  • CEO Award: “A Quality Detective” by Melissa Schleigh.
  • Best Documentary: “Kids Say the Qualityest Things” by Robin Joyner.
  • Best Comedy: “The Audit” by Karl Sharrah.
  • Best Drama: “Hi, Jeremy” by Marsha Hoffman.

More Award-Winning Examples of Quality Excellence

If you’re looking for other quality paragons that epitomize this year’s World Quality Day theme, then your search is over. During the Virtual Masters Summit, we presented Masters of Excellence Awards to our customers, and a few of them are highlighted here.

“Quality professionals are not people that get recognized a lot, so it’s great to be able to give these awards,” said MasterControl CEO Jon Beckstrand, presenter of the awards. “I didn’t anticipate feeling so much emotion, not only for the award winners and the effort that they’ve made, but for all of our customers and the incredible day-to-day things they do to get their great products to market.”

Four awards were presented to MasterControl clients for exemplifying the highest level of quality excellence and for promoting the ideal of creating customer value through quality.

Quality Champion Award: Robin Joyner, Wellington Foods Inc.

If your company’s quality assurance (QA) honcho spotlights fellow employees for their quality contributions, it’s proof that quality isn’t just his top priority — it’s his passion. That’s exactly what QA documentation and systems manager (and short film auteur) Robin Joyner does at Wellington Foods, a contract manufacturer of dietary supplements and nutritional products. He knows that quality is at the root of customer satisfaction. And he and his team put in the effort to back up their philosophy.

“Our customers expect the same quality product every time, day in and day out,” he said. “To us, quality is everyone’s job, and the key is consistency.”

Joyner has been at the center of Wellington’s successful push to eliminate paper and achieve scalability in production through the use of the MasterControl Manufacturing Excellence™ solution. His primary goal is to always ensure that “quality leads the way” and that it is reflected in every employee’s activities and roles.

“Our approach to quality is built around control, so we don’t have to build quality into a finished product. We want to build it into the process,” he said. “We want to get the right tools in the hands of the operators to allow them to do self-monitoring so they maintain control throughout the process.”

Innovation Excellence Award: Ology Bioservices

No organization is more deserving of an award for a product or service that spearheads an important change in their industry than a company on the front lines of the war against COVID-19. The combination of a proprietary vaccine delivery technology and a variety of platform expression systems has made Ology Bioservices, a leading contract development and manufacturing organization (CDMO) in the life sciences, a major player in the quest to develop a COVID-19 cure.

“We’re one of the few organizations in the United States that can perform at a level of biosafety and capacity for projects such as COVID where a large unit of measure is needed to supply the community,” said Stephanie Kuhn, Ology Bioservices senior director of QA. “The Ology Bioservices facility is state of the art, but as a CDMO, not having routine manufacturing is a challenge that we face. Every lot we produce either is a different process, a different material or a different scale.”

The open concept of the company’s manufacturing suites provides the flexibility needed to make prompt changeover between products. However, flexible manufacturing processes require equally flexible quality management practices.

“With Operation Warp Speed and all the other COVID projects we’re working with, it’s imperative that we have a quality management system that can support rapid response, moving quickly and higher risk,” Kuhn said.

A digitized quality management system (QMS) that fully integrates quality processes enables Ology to keep up with the hectic pace of vaccine development.

“Having all these solutions and components connected helps us have an overall picture when it comes to these processes,” said Aniko Perez, Ology Bioservices’ MasterControl system administrator.

The flexibility afforded by a cloud-based QMS platform has been the key to weathering the pandemic’s storms, according to Kuhn.

“We couldn’t have gotten through the pandemic, work from home and the goal of working toward a COVID-19 cure with Project Warp Speed without a seamless quality management system that’s integrated on the cloud,” Kuhn said.

Digital Transformation in Manufacturing Award: Carestream Health

Some medical device companies are inefficient because they’re dependent on paper documents. Carestream Health, a global company that produces X-ray equipment, dental film and other associated products, had a homegrown digital system for managing quality processes, but it was becoming unwieldy. The legacy system made standardization too complex and was difficult to manage efficiently because each record included options that made it possible to generate millions of permutations.

After modernizing its outdated legacy tools and advancing digital manufacturing with the Manufacturing Excellence solution, Carestream was recognized for demonstrating how a modern, paperless approach can dramatically improve production and compliance with good manufacturing practices (GMP).

“Our journey started about two years ago when we were looking for a solution to digitize device history records,” said Eli Tuber, process manager at Carestream. “We were thrilled to find not only one solution but a whole ecosystem.”

Carestream now deploys fewer, yet more modern solutions across its global manufacturing environment.

“We’ve already migrated our complaint handling system and now we’re looking at moving all our QMS solutions into one system,” Tuber said.

Having a single digital platform has enabled the company to maintain a centralized source of current data and is helping staff mitigate duplicated efforts.

“Digitizing our data not only allows us to collect it efficiently, but it also allows us to create reporting, data analysis, trending and things of that nature,” Tuber said. “Links between the different modules allow us to eliminate a lot of redundancy and having to repeat information in multiple places. Having everything in one place will save and reduce a lot of time and effort in the company.”

Validation Transformation Award: Chronos Imaging

Anyone in quality management knows that validation is the most painful part of working with computerized systems. Chronos Imaging used MasterControl’s patented, industry-first Validation Excellence Tool (VxT) to reduce the time required to validate its digital QMS by 92%.

“We went from a validation plan potentially taking months to do, to it taking us less than eight hours of time to do over the course of a few days,” said Deana Vanderheyden, Chronos Imaging quality system program manager. “And the validation was able to be signed off by multiple regulatory affairs engineers.”

Chronos Imaging is a medical device contractor that manufactures and globally distributes computed tomography (CT) tubes, so their team knew that minimizing validation burdens would be critical to producing and distributing high-quality products efficiently.

“When we decided to select a (QMS) tool, our regulatory affairs team was concerned about the amount of validation that would have to be done,” Vanderheyden said. “When we were able to tell our team we could purchase a standard tool where the validation has all been done by MasterControl, and any changes they do to the software will also be validated, that was very appealing.”

The efficiency of its QMS has carried over into the company’s performance during audits.

“We’ve had no findings in three audits,” Vanderheyden said. “This company has never done that, and to be able to repeat that three times is pretty darn amazing.”

With quality efficiency as a guiding force, Chronos Imaging is ready for any obstacles it may face.

“We’ll always have challenges — we’re not perfect — but we know we need to drive toward living and breathing quality in absolutely everything we do,” Vanderheyden said. “It’s just walk, talk and live it every single day. That’s what is going to help us be more sustainable and more profitable.”


James Jardine is the editor of the GxP Lifeline blog and the marketing content team manager at MasterControl, Inc., a leading provider of cloud-based quality, manufacturing, and compliance software solutions. He has covered life sciences, technology and regulatory matters for MasterControl and various industry publications since 2007. He has a bachelor’s degree in communications with an emphasis in journalism from the University of Utah. Prior to joining MasterControl, James held several senior communications, operations, and development positions. Working for more than a decade in the non-profit sector, he served as the Utah/Idaho director of communications for the American Cancer Society and as the Utah Food Bank’s grants and contracts manager.

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