How Digital Quality and Production Solutions Help a Manufacturer of Sleep Study Products Rest Easy

Cabinets Filled With Paper.
Uncontrolled Documents.
Poor Collaboration.

Before MasterControl, everything was paper based at Weaver and Company. Folders of procedures, forms and production records filled cabinets, taking up space and making document management unwieldy and collaboration time-consuming.

“All of our procedures and production records were printed out and written out by hand. Procedures were typed, but then they had to be printed as hard copies. And when we needed a form, we would have to go find it, make copies of it, handwrite it or scan it, and try and type over it,” according to Nicholas Lee, Weaver and Company’s Regulatory Compliance Manager.

“MasterControl will improve our accessibility of information and visibility of our finished product and how it’s handled and what it’s made of. I see record retrieval, the ease of access to information, as a big value for us.”

Not only does paper require a lot of effort to manually maintain and physical space to store, it also creates unnecessary opportunities to lose vital documents as they move through various stages of the manufacturing process.

“From the production area, they’d get moved to the mixing area, to the filling area, to the boxing area and then stacked up,” according to David Weaver, president at Weaver and Company. “The documents traveled from place to place before they were finally closed and filed.”

Relying on paper also makes manufacturers vulnerable to other common but devastating problems – including damaged or destroyed records. In the production area, where the company makes formulations that are liquid or semi-liquid, files and paperwork were left exposed to the physical environment. And when paperbased production records are completed and stored in cabinets, they risk being destroyed in the event of a disaster. For Weaver and Company, the risk of losing physical paper records during production and after was a large driving force for digitising with MasterControl.

Collaboration was also a challenge, with personnel emailing files back and forth. And because many of the company’s paper-based procedures made collaboration difficult, some procedures hadn’t been looked at in years and risked becoming outdated.

As the company has grown and created more procedures and required more collaboration, managing paper documents was no longer practical.

“With paper, it just takes time to keep everything together, which carries extra regulatory risk by having procedures with very long revision dates,” Lee says.

Quality and Production Solutions –
Implemented in Parallel.

When Weaver and Company engaged with MasterControl, they wanted documents, training and manufacturing solutions. As a company with 19 employees, two products and two master production record templates, it made sense to implement an electronic quality management system (QMS) and an electronic production record solution at the same time.

Lee, who started in production before moving into his role overseeing quality at Weaver and Company, didn’t want to spread out the process of digitising quality and production records longer than necessary. He was impressed by how easy and seamless the whole process of digitising these records was.

“It’s kind of scary and a little bit daunting to think that we’re moving our entire QMS to the electronic world. But the way that it was implemented, methodically, worked for us – it was pretty simple,” according to Lee. “I was really happy with how quickly we were able to implement MasterControl’s quality and manufacturing solutions at the same time.”

Production workers picked up the electronic production records after only a couple hours of training sessions.

“I think MasterControl designed the solution very well, in that it doesn’t really require a whole lot of direction,” Lee says. “So, user adoption is very good.”

“ With paper, it just takes time to keep everything together, which carries extra regulatory risk by having procedures with very long revision dates.”

Accessible, Visible Information.
Improved Data Integrity.
ERP Integration.

Weaver and Company bought a touchscreen computer for the mixing lab, where much of the work takes place, and got an iPad for everybody on the manufacturing floor. Employees in packaging and filling now also use iPads for mobility.

In the production area, workers are no longer filling out paper and signing documents. They’re electronically reporting all the inputs that Weaver and Company wants to document, going through the record right then and validating systems. Paper in the production booth is gone, improving access to real-time data and visibility of the entire production life cycle.

“MasterControl will improve our accessibility of information and visibility of our finished product and how it’s handled and what it’s made of,” according to Weaver. “I see record retrieval, the ease of access to information, as a big value for us. I’m very confident that MasterControl will add a lot of value, including in ways we don’t know about yet.”

The company is in the process of integrating MasterControl with its enterprise resource planning (ERP) software, NetSuite, so that materials information can be pulled directly into the electronic production record. This will eliminate data integrity issues, such as mistyping lot numbers for raw materials, and improve the ability to analyze more data.

Ultimate Result: Rapid Review and Batch Release

For Weaver and Company, the batch release process before using MasterControl took too long. The process was made more difficult if product needed to be released but nobody was there to do it.

“It would go through quality assurance (QA) testing, so we would have to walk the entire paperwork packet over to the lab. And then they’d do their testing, fill out the forms. And then it would come back to me, and then I would review it, and it would go to somebody else who would review it, do another accurate count of finished goods before they would release it in NetSuite,” Lee says.

Using MasterControl’s electronic production records, Weaver and Company can easily release product every day without having to carry paperwork to different departments. Time to release a batch has roughly been halved because no time is spent waiting for somebody to add their information.

“With NetSuite in the cloud and MasterControl also in the cloud, I can release product from anywhere in the world,” says Lee. “MasterControl is probably the greatest investment we’ve made for streamlining our processes and getting rid of paper.”