Ask Brea Viratos, CEO for Columbia Nutritional, just how important quality is in the nutraceuticals industry, and she’ll tell you in no uncertain terms.
“To put it simply, it’s critical,” she says. “Quality and regulatory compliance, in the most basic sense, is an absolutely mandatory requirement for you to not only operate legally, but to also ensure the safety of the product – and the satisfaction of your customers.”
Indeed, quality – and a commitment to it – is imperative in the nutritional supplement world, especially when it comes to the manufacturing side of the story. And that’s why Columbia Nutritional, a manufacturer of dietary supplements based in Vancouver, Washington, for more than 20 years, has continually expanded its focus on quality in everything it does.
“We have an organizational objective to deliver high-quality products on time, and every department in the company has set SMART goals that roll up to that organizational objective,” says Brea Viratos, CEO of Columbia Nutritional, referencing the acronym Specific, Measurable, Achievable, Realistic and Timely. “I don’t know that you’re going to find a contract manufacturer that has an organizational objective like that, with each department actively striving toward it. It’s very unique in manufacturing, let alone in the nutraceuticals industry.”
New light on quality
While quality has always been important in the world of dietary supplements, it’s become even more so in recent times. Part of that stems from the simple fact that consumers who rely on supplements need them to be both high quality and safe.
“These products are typically going to individuals who are either looking to be healthier or who need support with health ailments,” Viratos says. “It’s important they are getting the products they think they’re getting and that those products are safe. So, it’s also about transparency and trust.”
On top of consumer safety, regulatory compliance has also come to play a much larger role in quality assurance. Viratos says consumer litigation has changed the way the Food and Drug Administration approaches compliance. Unlike 10 or 12 years ago, these days, warning letters from the agency leave not only a public – and permanent – mark on a brand, but they can implicate specific people at a company. Warning letters can also quickly escalate to more severe penalizations like fines and even imprisonment.
“So, there’s a personal investment beyond doing the right thing,” Viratos says. “There’s also protection of yourself to be sure that you are following the rules and producing a compliant, quality product.”
Columbia’s continuous improvements
In just the past few years, Columbia Nutritional has sharpened its focus on quality and made strides to continuously improve. Viratos says for starters, there’s been a shift in the quality team aimed at making sure everyone has a true understanding of the regulations and procedures in place. All members of the team have a copy of the Code of Federal Regulations, known as CFR 111, on their desks to ensure that understanding.
Each department also has specific goals that align with the larger organizational objective of delivering high-quality products on time. Those goals, along with key performance indicators, are tracked regularly; trend analysis then allows Columbia Nutritional to identify any issues well before they might become problematic.
The company has also invested in new personnel – an experienced director of manufacturing, for one – and equipment that’s upped its output quality. For example, they recently purchased equipment for in-house microbiological testing. And when Columbia Nutritional does need to outsource quality control analysis to external labs, it has a rigorous review process.
“We are not only evaluating ourselves,” Viratos says, “but we are making sure, if we are leaving some of the technical work to an outside party, that we are heavily involved with ensuring they’re held to the same standards we have in-house.”
With its improved quality systems and focus on continuous improvement, Columbia Nutritional has also seen its certification collection proliferate. It earned NSF certification in 2020, and it’s also obtained Natural Productions Association/Underwriters Laboratory certification for Good Manufacturing Practices (GMP). Those join a long list of other certifications and registrations that include USDA Organic, Health Canada and NSF’s GMP for Sport.
Above – and beyond
But Columbia Nutritional isn’t done with its efforts to continuously improve quality. Far from it, in fact.
“Our focus isn’t just on the bare minimums required,” Viratos says. “It’s staying on the leading edge, at the top of the industry, and going above and beyond what’s required.”
With that in mind, Columbia Nutritional has launched a new and sophisticated Food Safety program that far exceeds current regulatory requirements. It is a program that involves personnel from every department of the company.
“We’re seeing a trend where regulations for manufacturing supplements are aligning more and more to regulations on manufacturing food products. We are staying well ahead of that trend with our new Food Safety program,” Viratos says.
Columbia Nutritional also plans to continue building on a major overhaul of its sanitation program from two years ago, and it’s aiming to get out ahead of revisions that are expected to come to the federal Dietary Supplement Health and Education Act, which sets standards for dietary supplements. That will ensure the company is not only compliant in advance, but far exceeding any new regulations that arise.
And it’s all being done with the goal of continuously improving quality.
“We will always be looking for trends and opportunities for improvement. That’s what’s driving our goals,” Viratos says. “We have quite a few projects in the works, and a three-year road map for our quality team alone, so we will continue to hold ourselves accountable to get even better every step of the way.”
To find out more about Columbia Nutritional’s manufacturing process and quality assurance programs, contact us.
