Ditching File Cabinets and Spreadsheets for Digital Excellence

BUSINESS CHALLENGES

When it comes to next-generation X-ray technology, Precision is working on some fascinating projects. With design and manufacturing done in-house, the company has built an innovative product line of irradiators and accessories in pre-clinical research, cannabis decontamination, virus inactivation, sterile insect technique, X-ray sterilization, and more.

Over the last few years, Precision has faced several challenges in the push for ISO compliance, and the constraints of paper-based processes. Ed Engstrom, Quality Assurance Supervisor, said, “As we grew and tried to manage multiple product lines, keeping track of design documents buried in dusty file cabinets, maintaining current SOPs, and managing training records became an insurmountable task.”

As we grew and tried to manage multiple product lines, keeping track of design documents buried in dusty file cabinets, maintaining current SOPs, and managing training records became an insurmountable task.”

—Ed Engstrom, Quality Assurance Supervisor, Precision X-Ray

THE SOLUTION

Precision knew they needed a solution that included a centralized location for product documentation, a place to manage and track quality documents, flexibility to scale with the company, capability to support ISO compliance requirements, the ability to automate change control processes, and to move away from paper-based processes.

With the prospects of purchasing a new solution, staying within the IT budget was also a concern. After evaluating multiple quality management systems (QMS) and product lifecycle management (PLM) solutions, Precision selected Arena’s product-centric QMS. Arena not only checked off most of their must haves, but also met the budget requirements. Ed explained, “One of the main reasons we went with Arena was because employees liked the fact that Arena gave them secure remote access.”

Arena has helped Precision pass the first stage of their ISO 9001 certification journey. This ISO green light has given the company the confidence and momentum to move forward in strengthening other compliance certifications such as a dedicated RoHS and REACH program. Processes that used to live in silos, such as the approved supplier list (ASL) and supplier corrective action requests (SCARs), are now seamlessly connected which provides traceability and company-wide access in Arena.

Ed clearly sees the value Arena provides Precision when it comes to managing its training program. “In the past, we would have had to reference a spreadsheet to find the training matrix for each department when a new employee joined the team, someone changed departments, or an auditor inquired about our records; it was only as accurate as the person maintaining it,” stated Engstrom. “Now, adding, subtracting, and tracking individual employee training is organized and automated inside Arena. All relevant training is entered into ‘buckets’ by job function and employees are slotted into them as needed. Retraining on new revisions is now pushed automatically by change control; the need for a standalone matrix has been completely obsoleted.”