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Practical FSMA Compliance Tips

Denis Storey
June 1, 2021

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While the Food Safety Modernization Act (FSMA) rules have all been finalized for a while now, there’s still a lot of confusion regarding implementation and what companies should do from a food safety standpoint.

To clarify, we sat down with a panel of TraceGains customers to discuss not only how their companies have managed to meet FSMA requirements, but also their real-life, practical approaches. Often, we read articles or listen to webinars discussing the rules in general and how to comply with FSMA, but sometimes what we need is a real account as to how other companies do it.

Our panel consisted of food safety and quality executives from leading food companies around the nation: Pari Sangern from Topco Associates, Mark Guy from John B. Sanfilippo & Son Inc., Brian Perry from Bay Valley Foods, a TreeHouse Foods company, Teresa Martinez from Nation’s Pizza, Evan Rosen from PacMoore, and Dan Herzog from Gonella.

We broke it down into sections for common themes since each company is different in how they need to comply with FSMA.

FSMA Education and Training

Many folks have taken the Preventive Controls Qualified Individual (PCQI) training, and if you haven’t, here’s a great post as to why you should. To start our panel discussion, we asked Teresa Martinez of Nation’s Pizza to talk to us a little bit about how they’ve approached FSMA training for the different members of the company and the different levels.

Teresa Martinez (Nation’s Pizza): “Myself, along with my quality assurance manager at the plant and our HACCP coordinator, are all PCQIs. However, we did not take our training together; we chose to take it independently. I went to a training last January, and the next person went in March, and so on. Additionally, all of us did our training from different training organizations – all supported by FSPCA – but from various training organizations to get different perspectives and see different examples.

When we met as our core team, we each had something different to bring to the table. We didn’t have the same examples, which helped us a lot. When we had questions, we would all dig out our different examples while trying to sort through it.

So, from a leadership perspective, we each had different training. Then, as we’ve pushed training through the rest of the organization, we followed our same training model.”

Additionally, outside of PCQI training, other companies have mentioned it’s essential to make sure the folks on the front lines have the appropriate training since those are the individuals handling the food and are the ones the FDA will be most concerned about. So, shifting that PCQI training and focusing on developing staff training to harmonize with that is very important.

TraceGains: Dan Herzog (Gonella), I know your company has hired a consultant to do a mock FDA inspection. Could you tell the audience a little bit about that experience and the lessons you learned?

Dan Herzog (Gonella): We thought it would be a great idea if we went ahead and had a mock FDA inspection, and it was an exciting experience. With FSMA, FDA has told us they’re coming; it’s no secret. And I think we’re going to be getting into a paradigm shift as we move on and continue.

But we thought it was a good idea to surprise one of our plants with a mock FDA inspection, so one of our facilities had a big knock on the door one morning. There were only three VPs who knew about it: me and two others.

Just like with the mock recalls we all do, we’re always expecting to learn something, and we found that our programs did align quite nicely. Whether it was because of our BRC inspections or AIV inspections, our schedules aligned well with FSMA requirements.

There was some element of surprise. Our staff knew it was a fake FDA inspection, but they still went through the whole process anyway, and we ended up understanding that some of our records were not where they needed to be. We also discovered that we need to push down that training piece (several of our top-level VPs and our quality managers have gone through PCQI training) further into our facility.

Regarding the FDA and transparency, we feel we need to build those relationships with the FDA. We’ve contacted our FDA offices, we’ve learned their names, we know they’re coming, and I’d much rather know who we’ll be dealing with the event of a recall than have that significant element of surprise.

TraceGains: Do you think that the GFSI scheme you’re certified to has helped or hindered your ability to get FSMA ready?

Mark Guy (John B. Sanfilippo): All of our facilities are SQF certified, and from my standpoint, it has been a benefit. We started SQF in 2009, and the first thing we changed was the structure around our documentation – our document control and record control. It began with documentation. Because when we went through the exercise of asking what the policies and procedures were, we’d have six different versions of the same thing. Just having the structure around document control is necessary for your verifications, validations, and internal audits. As the saying goes, “Say what you do, do what you say, prove it, and improve it.”

So, for us, having the documentation and the structure in place, and an outline of how you verify and validate helps us determine if what we’re doing is effective. So, from that standpoint, SQF has helped get us ready for FSMA.

When it comes down to the food safety plans for FSMA, we had to do a little more digging into our suppliers. This investigation led us to TraceGains. It’s one thing to have the documentation, but you need to understand it and apply it within your facility.

Adaptation for FSMA

TraceGains: With the explosion of documentation requests and the new responsibilities that FSMA has brought, have you had to add headcount to meet FSMA compliance?

Brian Perry (Bay Valley Foods, a TreeHouse Foods company): In general, we’ve added additional resources and created departments to validate our foreign supplier verification programs. I think that’s one of the critical elements that, as we looked at our programs and took a hard look in the mirror, we realized we’d been primarily focused on our audits domestically. We’ve focused on the documents and what we’re getting with that.

It came to light that we had an opportunity to understand the culture of the suppliers we work with, and that’s tough to do from just a document; it’s tough to know what you’re going to get. And while all of these documents are important – and understanding them is essential – having those auditors in the field and sitting across the table from the leadership team, and understanding if they get it has been one of the most important things we’ve had to address.

TraceGains: What tools are you using to meet FSMA compliance?

Evan Rosen (PacMoore Products): One of the critical tools for us is TraceGains. There were quite a few wake-up calls within our company when we started to automate supplier compliance. And specifically, this meant comparing COAs, the specifications, the timing of it all, knowing what information is bubbling up, and understanding what we’re going to be doing with that information.

As we got our information into TraceGains, it was interesting to see what kinds of discrepancies there were. And with the volume of data coming in, it was unbelievable how much time we spent doing this, and how much could be streamlined with automating the process.

We looked at the patterns we were seeing, and it helped us to become nimble. For example, stopping shipments at loading rather than dealing with it at the door in a reactive mode. It’s just invaluable and has been an educational tool and something that’s helped us to start streamlining going forward.

We share this information with our customers, and they’re looking inward at how to change systems. With FSMA, this just provided such focus in one key area that many sites don’t even realize could potentially have a big problem.

TraceGains: Along those lines, would you say there is a shift in culture within the organization as to how we need to approach FSMA?

Evan Rosen (PacMoore Products): There was in ours, and I think it would be in any company that gets more than just the quality manager involved. What we did internally was to get all the various departments involved. We started removing the word “quality” because when you use those terminologies, it becomes a hot potato, and everyone is tossing it to someone else. So, when we change the way we identify it, we can get ownership across all the departments and get the buy-in we’re looking for.

What’s on the Radar?

TraceGains: As you become FSMA ready, what are some of the deal killers you’ve identified when it comes to suppliers and supplier management?

Brian Perry (Bay Valley Foods): As we look at the scalability of readiness in our vendor partners, or even as we look at ourselves regarding being ready for FSMA, it comes down to three pieces. The first piece is — and you’ve heard it as a common theme throughout the conference — transparency. And not only can you trace product down to the location, but you can get a sense of whether your supplier, vendor, or partner will share the information with you to understand how their food safety system is designed and implemented. “One back” is not enough anymore. It’s really about understanding your supplier’s food safety systems and their supplier’s systems.

The second piece is around recordkeeping. One of the critical elements of FSMA is the documentation necessary for both the regulators and your customers. If those records are not complete or inaccurate, they don’t reflect how you executed your food safety system. Documents can be very damning or can be used to help you out. So, if you think about the products that were produced months ago, the only items you’re going to have to demonstrate your quality system works appropriately are your records.

And then lastly, I go back to the food safety culture, which is probably the most critical piece of how FSMA readiness is demonstrated. We look at the C-suite down to the leaders who are heading the different functions within the company. We then look at how that culture translates down to the production floor, and what it means to individuals in the daily work.

Pari Sangern (Topco Associates): Gone are the days when you can stand behind proprietary information. You need to be able to prove you’re compliant. And how do you prove it? Providing documentation and a food safety plan that is comprehensive covers all of your bases, shows you’re doing good recordkeeping, and you’re compliant. And with culture, if you don’t believe you don’t have to rush to get this done or be compliant, or if your top-down or bottom-up isn’t agreeing with you, then you’re going to have a problem overall. So, you want to get everybody on board, not only internally, but also your suppliers.

The central theme of FSMA is proactive, preventative compliance. And while there are different approaches to achieving compliance, as illustrated by these companies above, the result is that a safer food supply chain, which we can all agree, is a good thing. 

Find out how TraceGains can help you manage your suppliers easily while keeping you compliant with FSMA.