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Posted 19 October 2021 - 05:35 PM

I have a scenario based question for possible corrective actions. 


We are food manufacturing company with cooked products that fall under both FDA and USDA regulations depending on formula. One of our CCPs for both categories is cook temperature (160 degrees minimum) with verified thermometer. All of our documnetation for this is done hand written on bright yellow paper to show importance and then turned into QA for preshipment review before release. Well, 2 shifts of this documnetation is missing for one of our recently produced FDA formulas. 

Investigation with responsible parties state that they did complete and did turn them in but now they cannot be found anywhere. This product (an entire days worth) is now on hold for determination of next steps. Operations is asking if the cook kettle's internal probes would suffice for the documentation since there is batch by batch recordings but my response is no since those thermometer are not "verified and documented daily" as stated in our HACCP plan.  These probes have been reviewed as getting well above minimum temperature but I cannot prove calibration or direct observations for the temperature. 


Is there anything I'm missing as possible way to prove risk is mitigated for release rather than the disposition of rework or disposal for this product?  



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Posted 19 October 2021 - 06:20 PM

How often are the kettle thermometers verified and calibrated,


Can you not send some finished goods to a lab to verify bacteria count? 


What does your CCP deviation procedures say to do if product isn't cooked high/long enough?


What is the cook time/temp trying to control?

Please stop referring to me as Sir/sirs


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Posted 19 October 2021 - 08:25 PM

Corrective action report: while not following our HACCP procedures, the product is still safe for ........ reasons. I usually site the source of this information.

With cooling items - the USDA and FDA differ.


Are your items hot packed or do you cool your items. If you cool your items and have those temperatures - you may be able to use your historic data to prove the items reached temperature.


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Posted 03 November 2021 - 06:44 PM

Agreed with kfrom NE.  Document why the product is safe.  The temperatures you do have, the outside lab testing to verify, etc.  Are there any other temperature recording devices?  You might want to look into circular recording charts so you have that data in the future.  


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Posted 04 November 2021 - 06:00 AM

As usual, the devil is likely to be in the (process/documentation) details.

Kind Regards,



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