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FDA Food Defense Plan Builder 2.0 Corrective Action and Verification Procedures


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pkruse

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Posted 16 June 2021 - 03:38 PM

Hello! I am working on using the the FDA Plan Builder and I'm to the point of the corrective action procedures and verification procedures. I'm stuck here because I'm not really sure what to put based on what I have already. I might just be overthinking it but I was hoping someone could send me or post this section of their food defense plan if they've used the FDA Plan Builder. Thank you! Paige  



TimG

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Posted 16 June 2021 - 04:38 PM

Good morning,

First of all, no one should ever post their FDP info, even the FDA will tell you that. So this example below is completely made up.

I guess it depends on what's sticking ya.

Did your vulnerability assessment give you some actionable process steps?

If so, you have mitigation strats and then monitoring procedures in place already?

If yes yes and yes, than you need to come up with some ideas about what you will do when during that monitoring procedure you find you don't meet your expected finding.

Example:

  • Process: Bulk liquid receiving.
  • Vuln assess: Actionable process step=yes
  • Mitig strat: Mag locked gate over receiving points with limited access (you should list out more here but this is just an example)
  • Monit Proced: X inspects mag lock gate to ensure it is locked and valve is inaccessible
  • Corrective Action procedure: Immediately lock gate if possible. If mechanical failure is cause of issue, open Maintenance ticket to repair at action level "CRITICAL-FOOD SAFETY" (that's just how we have ours set up to assign priority so it's an example). Open a Corrective Action ticket to track for repeat occurrences (or however you track repeats)
  • Verification Procedures: Review records listed monthly to determine if procedure was followed correctly.
    • 1) XXX document-daily operator inspection (the doc doing the actual inspection)
    • 2) XXX maintenance ticket
    • 3) xxx CAPA ticket
    • 4) xxx monthly verification document

 

 

That's just off the top of my head, but might grease the wheel



pkruse

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Posted 16 June 2021 - 04:42 PM

Thanks Tim! That is helpful! I think I'm just over thinking it.. We are a bakery so there are a lot of times where all of the examples don't make any sense for our facility so then I feel stuck trying to come up with ideas on how to apply these regulations or rules to our facility. 

 

I also found the FSIS self assessment tool that I might use to help see where we are at and go from there with applying new mitigation techniques or corrective action procedures.

 

Paige 



TimG

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Posted 16 June 2021 - 04:54 PM

Yeah, the examples are very vanilla. We make chemicals that meet FCC standards, all of which undergo further processing by our customers (our FDA listing is ingredient/processing aids of GRAS chemicals). So for me it's kind of hard to wrap my head around certain things when it comes to 'wide scale public harm' because the amount of contaminant which would need to be added to our 50,000lb batch would be so dilute that someone would have to be dumping barrels in. Not to mention the actual chemicals we produce have to be further diluted by our customers (depends on govt reg but around 5,000 ppm max is typical).

Heck, our 'ingredients' are actually hazardous and are not food grade.



angelamartinez28

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Posted 17 June 2021 - 04:58 PM

Hello,

 

Do you know if animal feed - pet food  facilities are required to do a vulnerability assessment

 

Good morning,

First of all, no one should ever post their FDP info, even the FDA will tell you that. So this example below is completely made up.

I guess it depends on what's sticking ya.

Did your vulnerability assessment give you some actionable process steps?

If so, you have mitigation strats and then monitoring procedures in place already?

If yes yes and yes, than you need to come up with some ideas about what you will do when during that monitoring procedure you find you don't meet your expected finding.

Example:

  • Process: Bulk liquid receiving.
  • Vuln assess: Actionable process step=yes
  • Mitig strat: Mag locked gate over receiving points with limited access (you should list out more here but this is just an example)
  • Monit Proced: X inspects mag lock gate to ensure it is locked and valve is inaccessible
  • Corrective Action procedure: Immediately lock gate if possible. If mechanical failure is cause of issue, open Maintenance ticket to repair at action level "CRITICAL-FOOD SAFETY" (that's just how we have ours set up to assign priority so it's an example). Open a Corrective Action ticket to track for repeat occurrences (or however you track repeats)
  • Verification Procedures: Review records listed monthly to determine if procedure was followed correctly.
    • 1) XXX document-daily operator inspection (the doc doing the actual inspection)
    • 2) XXX maintenance ticket
    • 3) xxx CAPA ticket
    • 4) xxx monthly verification document

 

 

That's just off the top of my head, but might grease the wheel

 



TimG

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Posted 17 June 2021 - 05:48 PM

Hello Angel,

Check out https://www.fda.gov/...al-adulteration

 

And scroll down to exemptions.

Among the exemptions you will find:

  • Manufacturing, processing, packing, or holding of food for animals

I do imagine that eventually the law will expand to cover it, but at this time animal food is exempt. 



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