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FSMA October 2017 Session – What’s Been Trending

Posted on July 13, 2020 by Brian Sharp

Thank you to those who joined us for our October FSMA Fridays session. We were joined by Rolando Gonzalez, Senior Director of Technical and Scientific Affairs and Eric Edmunds, Food Safety Director with The Acheson Group (TAG). Both Rolando and Eric shared great insights on the latest FSMA updates and current trends. Note: This is Part 2 of a two part recap from the session. Click here for Part 1.

Unfortunately, Rolando’s audio was intermittent. Here’s the additional information he shared on this informative session!

FSMA Fridays – What’s Trending

The voices of many companies that we have visited after FDA started enforcing compliance with FSMA requirements tell us that there are three things that are happening frequently:

Training – FDA is walking into facilities and asking to see training records right off the bat!

This is somewhat different than the original expectation which was that FDA was going to seek those if they had questions about the adequacy of the food safety plan or other red flags in the facility or documentation.

 

Rolando Gonzalez Rolando Gonzalez

 

TAG recommends having those readily available, including the PCQI certificate and/or other documentation related to the training and qualifications of that person(s), particularly if you are relying solely on training, education and

experience to fulfill the PCQI training requirements! Now, let’s not forget the training of the qualified individuals (all other employees engaged in cGMPs and PC, overall handling food), for which FDA requires training on food hygiene and food safety (including employee health and personal hygiene) and training specific to the functions of their jobs – we know that many companies have HR keep track of that – make sure they are ready to be shown to the FDA if requested).

FDA documenting their observations – photos taking by FDA during inspections.

The FDA Investigations Operations Manual directs inspectors to bring in their camera or other photographic equipment and take photos as needed without requesting authorization from management, and they are doing exactly that! Companies pretty much have two options and TAG recommends the following in each case:

  • Allow the inspector to photograph
    • Pick your battles! Is this one you really want or need to fight?
    • Consider escorting the auditor and taking your own photos, maybe with an expanded context that may assist with future dealings with the agency.
  • Enforce a no-photo policy
    • Communicate the policy to the inspector right at the beginning of the meeting, including the relevant reasons (e.g., protection of business sensitive details), and make sure that it has been posted for view and applied consistently to all external visiting and remote parties (e.g., careful about facility photos posted on company website).
    • The FDA will probably emphasize their right to take photos based on previous court’s decisions. Some legal experts have determined that these do not or may not provide sufficient legal basis for the agency to do so, so engage your legal counsel as the agency may seek further actions (e.g., getting an inspection warrant!).
FDA is focusing on Environmental Monitoring Programs (EMPs)

The agency is placing a lot of focus on the details of EMPs, on specifics such as selection of vector swabbing sites and other technical aspects of the program. TAG recommends:

 

Eric Edmunds Eric Edmunds

 

  • First, remember that under FSMA environmental monitoring is required when a RTE food is exposed to an environment where an environmental pathogen has been identified as a hazard requiring a preventive control and the food does not receive treatment to control that hazard before packaging or otherwise contains a control measure lethal to the pathogen.
  • Ensure that your program is aligned with the “seek and destroy” approach (in other words, the intent is to find the pathogen if present!)
  • Use the data gathered via your EMP to determine if you have a problem, instead of the FDA finding out for you!
  • Seek additional resources (publications, experts) if you need help ensuring the adequacy of the EMP for your specific operation.

Interested in learning more about The Acheson Group? Click here to learn about what TAG can do for you.

Ready to learn more about how SafetyChain solutions are helping food companies achieve 24/7 audit readiness and improve operational performance? Click here to request a demo!

Topics: Compliance