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FDA FDPB vr.2: clarification on corrective action procedures


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#1 sangle

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Posted 02 March 2020 - 10:15 PM

I am looking for some clarification.  There is a section if the food defense plan builder that asks for corrective action procedures.  Is this in the event the mitigation strategy is proves not to be sufficient?

 

Thank you

Shanna



#2 kettlecorn

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Posted 02 March 2020 - 10:42 PM

I haven't looked at the FDA food defense plan builder in a while, but yes, since mitigation strategies are just that, defense strategies, and are roughly comparable to preventive controls, there may be ways they could fail or be insufficiently effective in practice, in which case you would need corrective action procedures to ensure the plan is actually mitigating the risk. 



#3 kettlecorn

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Posted 02 March 2020 - 11:01 PM

sangle,

 

This might help clarify, from our friends at the Penn State Food Safety Blog:

 

In general, the guidance allows a more basic and flexible approach than Preventive Controls regarding corrective action and verification activities. For example, if a mitigation strategy is having a tank hatch locked with a monitoring activity stated as checking the lock. The corrective action if a tank is not locked would be to lock it and retrain the employee.  Verification is simply checking records to make sure the lock check was taking place, and the corrective action of retraining the employee took place.  And of course, conducting analysis of the plan every 3 years (unless there is a process change or other special conditions).

 

https://pennstatefoo...ntal-draft.html



#4 sangle

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Posted 03 March 2020 - 12:51 AM

Thanks bunches, kettlecorn.  Information will go a long way.  We had our FSSC and ISO 9001 audit last week.  Went from 4 minors last year to 19 this year.  New auditor, new areas of focus.  Good thing this is a growing process!!

Have a good night.

 

Shanna






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