BRI’s manufacturing facility located in Apex, NC is a leading supplier of feed additives that help poultry, swine and aqua producers optimize performance and gut health while maximizing profits in a sustainable manner. BRI maintains a well-established global distribution network across products and regions, providing global market access to our innovative products. The manufacturing facility and processes are designed for cost-efficiency and scalability, while complying with global standards and certifications including cGMP, GMP+ and FAMI-QS standards.
We took some time to sit down with Gary Cunningham, Vice President of Operations, and Travis Smith, QA/QC Manager, to discuss how BRI has been successful in continuing to pass the FAMI-QS audit and other audits with zero deficiencies for over 6 years.
What is FAMI-QS?
FAMI-QS1 is required in a lot of countries to be able to do business with governments, supply chains and consumers. Having confidence that an organization is assured and they’re doing ethical practices. What the audit is based on is a code of conduct—it is what we physically get audited by. Like most programs, like ISO 9000, or ISO 17025, it’s just an effective way of ensuring that people are standardized in their practices from organization to organization and that it’s a means of continuous improvement. A big part of these programs is “hey, what are you doing, to improve your business, improve your food safety, improve safety, improve other metrics within the organization? such as quality complaints.” It’s about standardization between organizations in the way they operate and the way they measure their performance, and also taking that data to drive improvements within the organization.
It’s a quality system for all businesses that fall under the umbrella of feed additives, materials and ingredients. People say it’s sort of the European standard, as most people in the US relate to ISO 9000.
What is BRI doing well with the FAMI-QS audit?
We’ve had two FAMI-QS audits with no majors or minors. We have already completed six consecutive audits with zero deficiencies documented.
There have been some additions to the FAMI-QS Code, which is the feed fraud defense and we’re ahead of the game on that, which didn’t become active until September 2022, and we were already prepared prior to November 2021.
A big component of the FAMI-QS is the GMP2, Good Manufacturing Practice, which is a quality management system we have at AMF. We have a certification for GMP through SGS that audits us once a year as well and where we also had zero deficiencies. We also we have a cGMP audit that the FDA conducts that ties to our certification there as well.
How frequently do we have these audits?
Annually—it’s once a year. In the month of May, we’re going to go through a FAMI-QS audit and it will either be an actual certification or surveillance audit. Surveillance audits are when they come in and do a very high-level audit to verify that we’re compliant and everything is aligning with the actual certification. The certification audit is when they issue the new document to display on the wall. This last audit was onsite with only about a 24-hour notice of them showing up.
What have we put in progress to help prepare for unannounced audits?
We have a set agenda that Travis provides us with specific processes, training programs and anything that aligns specifically with those certifications. We also have internal audits such as housekeeping and building security that we maintain on a quarterly and monthly basis. Both help to keep us in line in preparation for a surprise or scheduled audit.
Every position within this plant is trained on it every year. We have a repeat agenda, that we’re trained on every year, and it aligns with what’s required with FAMI-QS and GMP.
Are there any challenges that we’re working on to make sure that this stays consistent?
There are not enough hours in the day. In regard to some of the challenges, the standard does change from time to time to add some stuff, so making sure we’re staying on top of those changes. Some of them are pretty big. Even once you have visibility of the change, it’s understanding the change and exactly what you got to do. That can be a little bit tough. For instance, with the feed fraud and offense, which was a change that came, and we actually ended up having to get some expertise outside of BRI, to help us implement that because that was fairly new. Even when I was trying to understand and read the information on it, there wasn’t a lot of stuff, a lot of information out there on how to implement it. So, it can be a struggle as they implement new codes or practices, understanding those codes and practices and making sure that we’re well aligned for when the auditor shows up that we’re doing them correctly, that can be a challenge, because it’s basically you’re doing something without confirmation. These auditors, everybody interprets the code a little bit differently. Some auditors pay attention, give more detail or pay more attention to the details in some parts of the code than others. So, you may be really strong in one part of the code and there may be another section of the code where you’ll be covered but you may not be as confident with that information, but that auditor may kind of nail you down on that section. It can be a challenge.
Seven years ago, there were only a couple of people within the facility that knew as much as we do today. Whereas today, we’re so several layers deep in. So, we’ve got a lot more eyes and resources and people are up to a different level than they were, seven years ago. And Travis has done a lot of that too, by training more people on the regulations and the codes and, and the things that we have to repeat every year. There are just more people doing the verifications of those items.
FAMI-QS is a preeminent quality and feed safety management system for the sector of specialty feed ingredients and their mixtures. We are the worldwide leading accredited scheme for the feed industry contributing to safe food. Accreditation is an important pillar for the credibility of our scheme. It gives assurance to governments, supply chains and consumers that organizations providing FAMI-QS certification have the required competence and impartiality to do so. FAMI-QS is operating under IAF MLA. The FAMI-QS Certification System proactively responds to the emerging feed-related challenges in our sector.
The FAMI-QS Certification Scheme addresses safety, quality and address the challenging topics of integrity (fraud), defense and regulatory compliance. The system is specifically designed for international validity and the FAMI-QS Certification, since its origination in 2004, is endorsed by more than 1400 members across the globe.
Learn more: FAMI-QS Certification System
Good Manufacturing Practices (GMP) certification from SGS ensures the integrity of your food manufacturing process as well as your compliance with food safety regulations. Assurance of the safety and quality of food is an important consideration for consumers today.
Learn more: Current Good Manufacturing Practices (CGMPs) for Food and Dietary Supplements | FDA