It’s been six long years since the Food Safety Modernization Act (FSMA) was signed into law, years of waiting to see what FDA will require; of discussing and commenting on the proposed rules; then figuring out how to apply all the provisions of the final rule to your operations. The industry was in a state of “Build,” especially regarding a food safety plan (FSP) to be in compliance with the preventive control rules. Large companies had to be in compliance by September last year and small companies (less than 500 people) will have to be in compliance in September this year – only two months away. So as you have been building, you now have everything in compliance, or soon will. You assigned Preventive Controls Qualified Individuals (PCQIs), you’ve written a Food Safety Plan, you’ve set up environmental monitoring and controls, you’re documenting everything. Now that it’s all in place, you deserve a little time to relax, right? Heck, even FDA has been reciting the mantra of “Educate before and while we regulate.” So even if you’re one of the first of the FSMA inspections, they’ll be taking a light hand, helping you understand anything you may have been a little off on, and letting you ride a little if needed. So, you’re done. Finally! … Right? Well … first I will congratulate you on the build, on getting it all in place and getting your operations in compliance. But, unfortunately, I have to add that no, you are not done. In fact, you will never be “done.” In reality, you are only just beginning on the FSMA journey. Getting everything in place for FSMA enactment and compliance has been a primary focus for the entire food industry – both public and private – for the last several years. So much so that FDA is giving a few passes now – educating while it regulates on the details of the Food Safety Plan, on the format of your documentation, on some of the minutia of the rules on which they, themselves, are still in a learning curve. But soon enough, “Educate before and while we regulate” will be simply: Regulate. And you will not only be inspected on having a Food Safety Plan and environmental controls in place, you will be inspected and held accountable for their full implementation and maintenance. My point is that you are now moving from a “Build” to a “Maintenance” mode. This is where FSMA really counts. Your food safety plan talks about what you will do, but the records you keep – that FDA will be focusing on – speak to how you are actually controlling those risks on a day-to-day basis. So some points to keep in mind as you move into maintenance mode: Do you know everything that your PCQI and food safety team wrote into your food safety plan, and are they executing on it? Are you implementing the environmental controls, monitoring the environment, and documenting it all? Do your plant management teams understand all your compliance deliverables – and implementing them? Have your workers been educated and trained on the action items which are applicable to them and did you document that all? And, most importantly, do you have a protocol in place to maintain it all? If you are doing things right, you are likely to find that maintenance is actually more difficult than it was to bring your facility into compliance – despite all the work that required. Think of it this way: Your doctor tells you that the results of your latest physical are showing that you need to add an exercise regimen into your day. To get it started, you decide to work with a personal trainer. The trainer (like your PCQI) sets up a plan and walks you through it for a few reps. Then he gives you the schedule you need to follow, shakes your hand, and you’re on your own. The first week wasn’t too bad … though you did skip Thursday when you had an evening function … and it was awfully hard to get up Saturday morning to hit it before all the other duties of the day. Then the second week came around and you’re a bit sore from all the reps and you’re already getting bored with doing the same thing over. Then the stairclimber broke; you knew you should do double time on the treadmill to make up for it, but, well, dinner is waiting, you know. While you may have gotten a bit of a chuckle over that example – or seen yourself in it a bit too clearly – we all know that we should exercise for health reasons, but it can be a challenge to maintain a strong regime on a regular basis. In the same way, once you’ve brought your facility into FSMA compliance, it is just as critical – and challenging – to maintain it at a high level for the long-term for the health of your consumers and your brand. And, yes, to pass FDA inspections. So, while you need to ask yourself the previously listed questions now, you need to continue to ask yourself and your entire operation the questions on a regular basis, long-term; continually review and update your FSP and environmental monitoring program; and delve further into the rules and your operations to ask what else you can be doing, not just to comply, but to go beyond the regulation and maintain a preventive control culture. Keep in mind that as we move forward, FDA will be much more focused on the monitoring and corrective action aspects of your FSP. So you may have to make sure your company leadership is well aware that, although the FSMA build is done, you will still need resources and focus to keep the plans where they need to be for regulatory compliance. About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com
