At SFI Health, product quality isn’t just about meeting standards. It’s about surpassing those standards and still seeking improvement.
It’s the reason that Ambir Hukkanen gets out of bed in the morning. “It is one thing to talk about quality, and another thing to live it,” she says. 

Ambir has worked in Quality Assurance and Regulatory Affairs for her entire career. As SFI Health’s Head of Quality Americas, her passion remains unwavering. “It’s really important to me to believe in the products, services and systems. SFI Health has great products, and people who care,” she says. “It’s that focus on quality and regulatory compliance that ensures our customers receive safe, effective, and reliable products, which builds customer satisfaction and drives business performance.”

The natural health industry is already heavily regulated, but SFI Health’s customer-centric approach takes this one step further. The company’s journey to exceeding FDA compliance requires quality to be embedded in every part of the process. 

“When most people hear the word quality, they automatically assume that it is the quality of the product itself,” Ambir says. “However, finished goods quality is actually the output of what our quality team does. Our science and product development teams tell us what our finished product needs to achieve. Quality is about how we can make sure we are achieving the desired output consistently. It’s our manufacturing process, our people, our training. It’s about using our resources in a way our customers care about.”

The company currently upholds strict independent third-party certification through US Pharmacopeia (USP) for Good Manufacturing Practices, as well as a certified Food Safety System Certification through SGS, which Ambir says goes beyond that required by the International Organization for Standardization Food Safety Management (ISO 22000).

“We want to exceed that and invest in testing that builds confidence and creates differentiation from the choices consumers have. Right now, our focus is on raw material receiving, ensuring that nothing goes into our manufacturing process that doesn’t meet our requirements. We are also piloting programs that include AQL testing on the production floor that are above industry norms.”

All suppliers undergo a qualification process, including risk-based auditing systems, so that materials can be closely monitored. Raw materials are also tested to ensure they meet label and safety requirements before they are used, and any materials that do not meet SFI Health’s requirements are rejected. Quality Assurance signs off on each phase of the manufacturing process before a product can be moved on. AQLs are maintained throughout with regular testing and visual checks for variations that may not be within specification. Equipment is meticulously maintained, and ongoing training ensures a high level of effectiveness. All cleaning procedures are validated and strict allergen controls prevent cross contaminations. 

This stringent adherence to quality control is all part of ensuring that every product meets the highest standards. Although reactive monitoring is also enforced, Ambir says that testing a finished product is less effective than proactive monitoring. “Label claims are a large part of testing to ensure potency and purity – a consumer wants to know that the product they are taking matches the values on the label. But testing a finished product is reactive, because the product is already made. At SFI, we look to implement more robust processes, controls and upstream testing that delivers a confident finished good to a consumer.”

Rigorous as the process is, Ambir firmly believes in a “continuous improvement approach”. “While I stand by our processes today, I like to say I reserve the right to be smarter tomorrow! We are continually evolving our quality expectations based on industry best practices, technology advances, customer expectations or new knowledge.”    

As a veteran of the regulated industries, Ambir is confident that SFI Health will continue its trajectory towards even greater prominence and excellence. “This is a really exciting time for SFI Health here in the US. We have the right talent, we have a team that is excited, and we are making some large time investments in data analysis. We are shifting our focus away from relying on test results of a finished product and instead having testing throughout all phases of the value chain, as well as tracking our mistakes, tracking the voice of the customer, working to create strong supplier relationships and preventing mistakes before they occur. The world moves fast, and we need to be able to anticipate our consumer needs and respond accordingly.  I believe we are headed there, and I am excited to be a part of this phase of SFI’s chapter.”