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Establishing scheduled processes (Acidified food)

acidified food 21 cfr 114 qualified person scheduled process

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mjz

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Posted 22 December 2020 - 11:53 AM

Hi everyone, I work at a factory of acidified food (under regulation 21 CFR 114). We export to US. In order to comply with requirements, we are revising about that regulation. As I understand, we need a scheduled processes established by a qualified person. So here is my question, as food engineers, we are supossed to be qualified persons. Can we establish these scheduled processes ourselves? We already have experience in the production of these products, can we use our own methodology/actual process and historical data? As sustenance, we have not had any pathogen incidents over the years.Thanks in advance for your response.



olenazh

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Posted 22 December 2020 - 02:01 PM

As per their definition of "qualified person" (The scheduled process shall be established by a qualified person who has expert knowledge acquired through appropriate training and experience in the acidification and processing of acidified foods) you fall under their requirement.



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Posted 22 December 2020 - 02:46 PM

Look at requirements for process authority.


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Posted 22 December 2020 - 08:59 PM

Be very careful being the "qualified person" just because you know what you run today, does not mean you can appropriately change anything or be proven competent to put a new acidified product out the door.

 

You only have to spend the $$ once, have a proper authority run the trials, and you're bullet proof. If nothing ever changes in the process for that food--it becomes a negligible cost over time


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mjz

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Posted 27 December 2020 - 04:15 AM

Look at requirements for process authority.

 

Where?

 

Be very careful being the "qualified person" just because you know what you run today, does not mean you can appropriately change anything or be proven competent to put a new acidified product out the door.

 

You only have to spend the $$ once, have a proper authority run the trials, and you're bullet proof. If nothing ever changes in the process for that food--it becomes a negligible cost over time

 

Thing is how to sustain that cost $$ should be made if the regulation is not clear about who can be considered a process authority.



Charles.C

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Posted 27 December 2020 - 04:45 AM

SQFconsultant, on 22 Dec 2020 - 9:46 PM, said:snapback.png

Look at requirements for process authority.

Where?

 

 

Thing is how to sustain that cost $$ should be made if the regulation is not clear about who can be considered a process authority.

 

^^^^(red) - It logically depends where you are.

 

Just for example, here is, apparently, USA -

 

http://www.afdo.org/foodprocessing


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Scampi

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Posted 29 December 2020 - 01:02 PM

https://www.fda.gov/...d-canned-food-9

 

PROCESSING AUTHORITIES

[21CFR113.83 and 113.89]

A processing authority is a person who has expert knowledge of thermal processing requirements for low-acid foods packaged in hermetically sealed containers, or has expert knowledge in the acidification and processing of acidified foods. Knowledge can be obtained by education or experience or both. Expert implies experience, knowledge and achievement as well as recognition as an authority on a subject, usually by one's peers. Anyone who is establishing scheduled processes must have adequate facilities for making the appropriate determinations (21 CFR 113.83). Anyone who is evaluating processes which are less than the scheduled process must utilize procedures recognized by competent processing authorities as being adequate to detect any potential hazard to public health (21 CFR 113.89).

 

Follow the link above to get more information. There are a lot of options within the USA, not so many once you're in another country


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