Release Date: May 4, 2020
As a vice president of customer quality at Optel Inc. in Rochester, Joel Radford is attuned to and immersed in ISO (the International Organization for Standardization) and its requirements for quality assurance.
Eighty miles away at Tonawanda’s B&W Heat Treating Co., President Kevin Calvello doesn’t have the bandwidth to frequently check the company’s quality management system (QMS) against ISO edicts.
Two men, two different levels of ISO experience and familiarity. But they are similar in at least one way: their small businesses, no larger than a dozen employees each, periodically rely on quality management expertise from the University at Buffalo Center for Industrial Effectiveness (UB TCIE).
Building a robust system
Calvello approached the university center in 2010 with the inclination that his customers – local manufacturers needing heat treating and sandblasting – would soon request that B&W be certified to the ISO 9001:2008 Standard and therefore adhere to the international body’s guidelines.
Undertaking the process was daunting for someone without the necessary time to investigate the details, discern requirements from exclusions and prepare documentation. Research convinced Calvello to seek guidance in tightening up what was then a loose QMS for its quoting, ordering and purchasing, production, quality assurance and management processes.
“UB TCIE helped me get to the point where I was ready to go for third party certification to the ISO standard,” Calvello says, specifying that the support enabled him to customize ISO requirements to his company’s needs.
Designation awarded in 2011 opened doors, from eliminating the hassle of completing formal vendor applications and questionnaires to generating new business. B&W’s customer base expanded outside its traditional Buffalo footprint to include Rochester and beyond.
ISO standards call for companies to regularly verify ongoing compliance. ISO does not prescribe the frequency, but companies typically complete an internal audit annually. Calvello taps UB TCIE for this purpose, meeting a handful of times a year to assess and resolve any component that fails to meet a requirement, called a nonconformity.
The job also entails suggesting opportunities for improvement. For example, UB TCIE Project Engineer Akshay Sivadas encouraged Calvello to question the effectiveness of corrective actions – those that eliminate a problem and prevent its recurrence. In other words, the issue is fixed, but how do you guarantee that the solution will continue to work?
This periodic surveillance keeps the company on track for recertification, earned from a registrar every three years by passing an external audit.
“The external audit is much more detailed. About every seven years, they change the standard as well,” Calvello explains. “That’s where UB TCIE comes in. They know the standard, they know the changes in the standard, and they help me to adapt my system to stay compliant.”
Calvello is contemplating pursuing certification for the company’s newest service additions – powder coating and paint/protective coating – amid a 6,000 square-foot expansion.
The expert’s go-to
Before joining Optel, Radford amassed an extensive repository of information through years of quality management experience. Yet he still needs an outsider’s expertise from time to time.
UB TCIE is the closest dependable resource to his company’s Rochester base. Radford attended internal auditor training in 2013 and continues to return to the center for education and consulting.
Optel provides product design, manufacturing and regulatory compliance for startups in the medical device market. Part of Radford’s role involves performing internal audits for customers. To do so, he needs proof of having completed training.
“Courses I’ve taken are definitely informative,” he says, adding that interactions with fellow participants have spurred knowledge gain. “Sometimes the instructor steps back and people talk about things they’ve experienced or how they handle things.”
Optel itself is on the journey to certification. Company procedures align with the ISO 13485 standard. Radford considers the medical device distinction the best path for serving clients.
“Our customers need to show why they picked us to design their product and how we are qualified to do that,” he says. “ISO 13485 certification is not quite a requirement, but it’s moving that way for everyone in the supply chain.”
Radford writes and maintains the company’s QMS procedures. ISO regulations call for a separation between the individuals supervising a QMS and those auditing it. So, UB TCIE facilitator John Riggi was asked to inspect processes a few months ago.
Riggi discovered a handful of minor nonconformities and identified opportunities for improvement. He returned later to review Optel’s solutions for the nonconformities, officially called corrective and preventive actions (CAPA).
“Getting someone’s point of view can help a lot of things overall,” Radford says, pointing to the improvement advice. A subcontracted internal auditor like UB TCIE “can give more input than your registrar doing the certification audit.”