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The Sky isn’t Going to Fall on September 17 if You’re Not Ready for FSMA

Posted on April 24, 2018 by Brian Sharp
Final recap of July's Special Extended FSMA Fridays Session on What Being FSMA Compliant Really Means

The clock is ticking quickly towards the first major compliant date for FSMA.  And not surprising we’ve received many questions in the past few FSMA Friday sessions about what will happen after September 17th if your company is not prepared. Dr. Acheson provided a calming perspective on this question during our July FSMA Fridays session, rounding off a great session discussion about what being FSMA compliant really means:

If you don't think you're going to be ready by September 17th .. I don't think it's the end of the world, the sky isn't going to fall on you.. “   Continued Acheson, “My view is, obviously, continue to be ready. Be prepared to have a discussion with an FDA inspector about how far you've got and and where you're chasing gaps.”  

Some specific examples Acheson provided around this included:

  • Guiding the conversation: “ .. be ready so when an inspector comes in and talks to you or asks you for specific FSMA requirements that the person in the facility who's dealing with the inspector understands the philosophy of FSMA, understands the things we've been talking about, understands that you're moving to risk-based preventive controls. Be able to show an inspector how you laid out your risk thinking. Even if it's not complete. That's, to me, I'm not saying that's okay, but that's reality.”
  • Showing progress with preventive controls:  “ .. don't have it fully validated yet, have a game plan to be able to explain how far you've got, what your trajectory is to get where you need to go for compliance…” [identify the specifics what’s been achieved and what's in the works]
  • Addressing where you are at with PCQI [Preventive Controls Qualified Individual]: “ ..  PCQI isn't exactly where you want them yet, I won't say that's okay, because it's not, you're out of compliance, but at least be ready to say, "Well, yeah, Joe is off the PCQI training December 1st. It's the earliest we could get him in, but he's got all this experience. We feel pretty good, but we're going to get him trained."

But wait, not all FDA guidance documents are out - FSMA compliant dates just might be pushed out right?  

This was top of mind for many that joined us, as evident by the questions we received around this notion of compliant dates slipping. When asked that question, Acheson was quick to diminish this line of thinking:

“..  I would say categorical no. I think if we're relying on compliant dates to be pushed out, I don't rely on that at all. If they are, then that's a bonus for all of us, but no. I doubt that.  The reason I doubt that is.. the current administration has pushed very hard, Mike Taylor has done a heck of a job at getting these rules out the door. So the rules are out there. We've got them there. We've got dates. If they start to slide and then it opens the door to keep from sliding, and being realistic, and somebody works in Washington for a bunch of years, is they could slide for a long time. I don't think that's going to happen..that's a case of political landscape.”

So will the sky fall on September 17th for those companies that fall into the first compliant date category? We think it's safe to say no.  Will companies be pressed upon to show they’re fairly prepared when the FDA inspector shows up post this date?  Possibly.  But as Dr. Acheson shared -- showing that you’re well into the journey of understanding and adapting your programs to meet FSMA requirements relevant to your organization is going to be key.

And for those that aren’t prepared to have that dialog? Acheson commented, “I think that's my advice, is be ready to talk the talk. If when the inspector shows up and says, 'Show me your food safety plan,' and you say, 'Show you my what?', you're in trouble. I think that's, I'm stating the obvious, I don't think anybody who's taken the trouble to dial in for this conversation [FSMA Fridays] will be in that position .. “

Wow! Our July FSMA Fridays turned out to be quite an interactive session, as we tackled what turned out to be a philosophical but important discussion on what being FSMA compliant really means.  If you missed it - not to worry, we have the recording accessible here.  And session recaps 1 and 2:

THANK YOU to all our series participants for sharing their viewpoints during not only our July session, but the many FSMA Fridays sessions that we’ve hosted these past few years. That’s what has made this series truly relevant and educational for all those involved.

And yes, the conversation will continue in our August session and beyond - including peers sharing their experiences with FDA inspectors post September.  Stay tuned - and be sure to join us as the dialog continues in the coming months - www.FSMAFridays.com