While the Food Safety Modernization Act (FSMA) rules have all been finalized for quite a few months now, there are still significant amounts of confusion and questions regarding implementation and what companies actually need to do from a food safety standpoint.
To help clarify, we recently sat down with a panel of TraceGains customers at the Food Safety Consortium to discuss not only how their companies have managed to meet FSMA requirements, but also their real-life, practical approaches in doing so. Often times we read articles or listen to webinars discussing the rules in general and how to comply with FSMA, but sometimes what we really need is a real account as to how it’s actually done by other companies.
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 LLC, 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
A lot of 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. So, to start off 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 for 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, the next person went in March, and so on and so forth. Additionally, all of us did our training from different training organizations – all supported by FSPCA – but from different training organizations to get different perspectives and to 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 important to make sure the folks on the front lines have the appropriate training as well, 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 that 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 actually a very interesting experience. With FSMA, FDA has told us they're coming; it's no secret. And I think that 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 that knew about it: myself and two others.
Just like with the mock recalls that we all do, we're always expecting to learn something, and we actually found that our programs really did align quite nicely. Whether it be because of our BRC inspections or AIV inspections, our programs aligned nicely 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 anyways 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 in the event of a recall than have that big 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 definitely 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 started with documentation because when we went to go through the exercise of asking what the policies and procedures were, we would have six different versions of the same thing. Just having the structure around document control is necessary for your verifications, validations, and internal audits. Like the saying goes, “Say what 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 to also determine if what we’re doing is effective. So, from that standpoint, SQF has definitely 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 is where we ended up partnering with TraceGains as well. It's one thing to have the documentation, but you really need to understand it and know how to apply it within your facility.
Adaptation for FSMA
TraceGains: With the explosion of documentation requests and the new responsibilities that FSMA has brought, have any of you had to add headcount to be able to meet FSMA compliance?
Brian Perry (Bay Valley Foods LLC, a TreeHouse Foods company): In general, we have added additional resources and created departments to look at the validation of our foreign supplier verification programs. I think that's one of the key 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 and we've been focused, very much so, on the documents and what we were getting with that.
It came to light that we had an opportunity to really understand the culture of our suppliers we work with, and that's tough to do from just a document; it's tough to understand what you're going to get. And while all of these documents are extremely important, and being able to understand what these documents actually tell you is important, having those auditors that are actually in the field and sitting across the table from the leadership team, and understanding if they get it or not has been one of the most important things that we've had to add additional resources for.
TraceGains: What tools are you using to meet FSMA compliance?
Evan Rosen (PacMoore Products): One of the key tools for us is actually TraceGains. There were quite a few wake up calls within our company when we started to automate supplier compliance. And specifically, this meant the comparing of 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 information coming in, it was just unbelievable how much time was spent doing this in the past, and how much of it could be streamlined with automating the process.
We looked at the patterns we were seeing, and it really helped us to become nimble. For example, stopping shipments at the point of it being loaded rather than dealing with it at the door in a reactive mode. It’s just invaluable and has really been an educational tool, and something that’s helped us to start streamlining going forward.
We share this information with a lot of our customers, and they're now looking inward and doing a hard look on how to change systems going forward. With FSMA, this just provided such focus in one key area that a lot of sites don't even realize could potentially have a big problem.
TraceGains: Along those lines, would you say there is a true 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 in it. We started removing the word “quality” because when you use those terminologies, a lot of times it becomes a hot potato and everyone is tossing it to everyone else. So, when we change the way we identify it, we can get ownership across all the departments with it and really get the buy-in that we're looking for.
What’s on the Radar?
TraceGains: As you become FSMA ready, what are some of the deal-killers that you've identified when it comes to suppliers and supplier management?
Brian Perry (Bay Valley Foods LLC, a TreeHouse Foods company): As we look at the scalability of readiness in our vendor partners, or even as we look at ourselves in regards to being ready for FSMA, it really 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 being able to trace product and understand where your product is coming from down to the location, but it's really about getting a sense of whether your supplier, vendor, or partner is willing to share the information with you to let you understand how their food safety system is designed and how it's 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 key elements to FSMA is the documentation necessary for both the regulators and for your customers. If those records are not complete or if they're inaccurate, then they really don't reflect how you executed your food safety system. Records can be very damning, or can be used to help you out as well. So, if you think about the products that were produced months and months ago, the only items you're going to have to be able to demonstrate that your quality system worked appropriately are your records.
And then lastly, I go back to the food safety culture, which is probably the most important piece of how FSMA readiness is demonstrated. We look at the C-suite all the way down to the leaders that 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 that they do.
Pari Sangern (Topco Associates): No longer are the days when you can stand behind proprietary information. You need to be able to prove that you are compliant. And how do you prove it? By providing documentation and a food safety plan that is comprehensive, covers all of your bases, shows that you are doing good recordkeeping, and that you are being compliant. And with culture, if you don't believe that 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 with your current suppliers.
The main theme to FSMA is proactive, preventative compliance. And while there are different approaches to achieving compliance, as illustrated by these companies above, the end result is a safer food supply chain overall, which we can all agree is a good thing.
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