Bob Bauer, AFI
I’ve spent approximately 50 days out of the office over the past 14 months conducting sessions of the course designed to help importers comply with the Foreign Supplier Verification Program regulation. (That was after a similar though smaller number of days helping to design the course, which has curriculum recognized by FDA.) It’s given me a great perspective on where the industry is in terms of understanding and being able to comply with the rules.
That’s why I wasn’t surprised to hear an FDA official mention the common FSVP inspection issues that are outlined in the article that begins on Page 16. The combination of blank stares and questions when those areas are covered are greater than in other portions of the course. Let’s look as some of these issues.
Failure to have an FSVP program: those companies haven’t been paying attention and are playing with fire, both on regulatory and commercial fronts. If you’re in that position, reach out to me immediately.
The requirement for a hazard analysis to be on file shouldn’t really be a surprise but many importers don’t have them. The Food Safety Modernization Act is a paradigm shift to a focus on prevention. The first step in being able to prevent an issue is to analyze the known or reasonably foreseeable hazards. How can you prevent what you haven’t identified? Once you have identified the potential hazards, you can take the next step of putting measures in place to prevent or mitigate those hazards.
All production facilities must have a hazard analysis for each product produced/ handled in that facility. All U.S. importers identified as the FSVP importer must conduct their own hazard analysis or rely on the hazard analysis of their supplier or a qualified third party. They can even have two – their own and one written by the supplier or a third party. The rule, however, clearly states the importer must have a hazard analysis on file. As with any document provided by another entity, if you rely on a hazard analysis provided by someone else, it must be reviewed by someone on the FSVP importer’s staff and must be kept on file. It’s not enough just to have the document on file. The regulation requires the FSVP importer to review/approve the document.
The two on the list that don’t surprise me at all are the failure to have a written policy of using only approved foreign suppliers and the failure to document approval of foreign suppliers. I usually poll the attendees in my FSVP sessions to get an idea of how many people have these measures in place and the percentage is typically pretty low. FSVP importers must create a document that outlines the process to approve foreign suppliers, have a document approving the foreign supplier and a written policy of using only approved foreign suppliers. These sorts of activities typically were done informally. That won’t suffice any longer.
Please don’t think the information above is all you need to know in order to comply with the FSVP regulation; it’s just a 30,000-foot view of a few components. Don’t make the mistake of thinking you’ll be able to bluff your way through an FDA inspection. Take the time to learn what’s required and put those measures in place.
In his report in this publication, AFI Chairman Steve O’Mara mentioned AFI’s approach to help the entire U.S. food import industry. The FSVP courses have been a great vehicle for that. Since AFI members were early adapters, most of the people in the sessions these days are not from member companies. So we’re continuing to offer the courses now as a way to help educate the entire sector.
I also noticed a lot of industry veterans were skeptical of the value of taking the course. But I’m finding they get as much out of it as those much newer to the industry and many have said just that.
It’s important to remember that every incident with imported foods impacts the entire food import sector in one way, shape or form. We all need to reach out to those who haven’t been paying attention and get them to understand food safety is not optional. You don’t know what you don’t know and in this case, it can put people in danger and put companies out of business.