November’s FSMA Fridays session was focused on Environmental Controls relative to FSMA. Gurjit Shergill and Peyman Fatemi with The Acheson Group (TAG) provided some great insights, as well as caught us up on FSMA updates.
If you missed SafetyChain’s November FSMA Fridays session, here is a quick recap - and of course, the complete session recording is available here.
What FSMA Says About Environmental Controls
Peyman provided the following insights:
“Obviously FSMA with the current good manufacturing does lay out some high level guidance in terms of how to manage the facilities. They’re not prescriptive, so they leave it up to the facility how to specifically manage it, but that in terms of facility design... the employee GMPs, hygienic zoning, the utensil, the sanitation, all of that. There’s some specific language, and we’ve talked about that in the past. It’s always good to bring it back up, and remind that their language within FSMA says that if a ready to eat food is exposed to the facility environment after the final treatment step, or once it’s formulated and before it gets packaging and then does not see any further treatment in that packaging, then there is a requirement for the facility to implement an environmental monitoring program to verify that the controls that you do have in place are effective, the verification steps.”
How FDA is Approaching Environmental Controls
Peyman provided perspective:
“One thing in terms of FDA approach to it, they are under the pressure, the are under mandate to find out how the facilities are managing this program, not just doing the testing and showing a bunch of negatives, but if they are finding positives how are they taking corrective actions, how are they following up, what changes they’re making, and how well they’re documenting.”
“..and we're seeing more than ever FDA taking the approach of linking some previous findings from the years before, or perhaps even product and clinical isolates too potentially, and environmental isolates now so the question of resident organism..has been kind of at the forefront of some of the discussion that they've had with the facility, and they are using next gen sequencing, whole genome sequencing, and other molecular methods to make that link, and driving some of these to either recall the product, and in some cases perhaps even some criminal activities.”
“Our take is not to scare the industry, but rather make sure that if you do have an environmental monitoring program that you are diligent in following up with whenever you have a positive, find out what happened, what caused it, what are some of the root causes to this. Take corrective action, document everything, and build a story, and a certification of doing what you did, so you can explain what you’ve done.”
Have recurring events? Peyman also urges the food and beverage industry to take their environmental monitoring program one step further by having facilities consider looking at what the genetic linkage is between isolates.
“There are laboratories that offer this service, and I think it would be beneficial to determine are they coming from the same niche, same source, or are they from different sources? Are they the same organism? Different strains of the same salmonella, or listeria? That's the FDA approach, and that's the approach that I think the industry needs to take as well to get a better understanding of the environment within their facility,” commented Peyman.
Environmental Controls Is Different From Environmental Monitoring
Gurjit provided perspective:
“Environmental control is all about keeping your environment free from any potential pathogens, and you have your few basic programs in place..regarding sanitation practices, regarding GMPs, and traffic flows, and as well as training.”
Environmental monitoring, on the other hand, is an activity which can verify the effectiveness of environmental controls and sanitation.
“With environmental monitoring it's more of a verification activity to ensure that the food safety programs underpinning the program are actually effective. It allows you to get a baseline of where you are from a micro profile for your facility. It allows you to identify any potential sources of contamination, and effectively it allowed you to follow a moving target, that's the best way of explaining it, because things change all the time, so whether you're getting new equipment, you're moving equipment, you've got new processes, new ingredients, new people, “ explained Gurjit.
Again, as Gurjit mentioned, environmental monitoring is a moving target - you need to stay on top of it, be ahead of the game and know what’s in the facility. It’s imperative to look at what your results are showing, breaking down equipment and making sure your facility is aware of where the trends are going. Being prepared to answer any questions posed by your customers or through the FDA.
Continued Gurjit, “If the FDA comes knocking at your door to answer, and want answers for what did you do when you just find a positive? What corrective actions do you have, and is it under control?“
In summary, environmental controls combined with environmental monitoring ensures that facilities are taking the necessary steps, following procedures to prevent or mitigate risk from environmental hazards and applying corrective actions to control the safety of the product.
To hear the complete November FSMA Fridays session recording, visit: https://www.safetychain.com/recorded-webinars/.
For more information about how The Acheson Group (TAG) can help your company ensure you're prepared for FSMA compliance, visit: www.achesongroup.com.
Looking for ways to more effectively manage your food safety and quality programs - to ensure FSMA compliance? Visit: https://www.safetychain.com/compliance-audit-readiness/ or contact SafetyChain today.
And you won’t want to miss our last FSMA Fridays session in 2016 - What’s Ahead in 2017 – taking place December 16. To learn more and sign-up, visit: https://safetychain.com/resources/fsma-fridays/.