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Microbiological Testing of product in case CCP deviation happens

Started by , Jul 15 2021 08:36 PM
8 Replies

Hi all, sometimes my non-RTE product (vacuum packed 6 Lbs tofu, product of USA) does not meet 6 hours cooling time. I have to take samples for microbiological testing since it is a CCP deviation. Currently I am using AQL 6.5 inspection level 1 to determine how many samples to be taken. Most of cases, 6 samples are taken. My questions are 1- Is AQL 6.5 inspection level 1 (link below) sufficient for this deviation? https://inspection.c...09209602?chap=2

2- Is it acceptable if I convert 6 samples into to 2 or 3 composite samples or get my contract lab do it for me before testing? 3- Currently I input data (time and temperature) on a free internet-based modeling program to predict pathogenic growth. Sometimes it predicts that a couples of pathogen likely grow (such as L.mono, Salmonella spp, B. cereus) at the same time

 Is there any (other) way to correctly identify one target testing pathogen to reduce testing cost. Look forwards to getting your replies.  Thank you. O.C 

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The free internet-based modeling program to predict pathogenic growth is https://www.combase.cc/index.php/en/

I also need to input pH, salt content in addition to time and internal temperature of the product

 

O.C

Hi All,

 

Sometimes my non-RTE product (vacuum packed 6 Lbs tofu, product of USA) does not meet 6 hours cooling time. I have to take samples for microbiological testing since it is a CCP deviation. Currently I am using AQL 6.5 inspection level 1 to determine how many samples to be taken. Most of cases, 6 samples are taken. My questions are

 

1- Is AQL 6.5 inspection level 1 (link below) sufficient for this deviation?

 

https://inspection.c...09209602?chap=2

 

2- Is it acceptable if I convert 6 samples into to 2 or 3 composite samples or get my contract lab do it for me before testing ?

 

3- Currently I input data (time and temperature) on a free internet-based modeling program to predict pathogenic growth. Sometimes it predicts that a couples of pathogen likely grow (such as L.mono, Salmonella spp, B. cereus) at the same time

 Is there any (other) way to correctly identify one target testing pathogen to reduce testing cost.

 

Look forwards to getting your replies. 

 

Thank you

 

O.C 

 

Hi OC,

 

Is this a chilled or frozen stored product ?

 

I deduce yr OP is referring to a (somewhere) FDA-driven CCP.

 

Not sure where the 6hr cooling time restriction mentioned derives from ?

 

I anticipate the micro.testing you refer is oriented to pathogen and/or toxin testing. For ? specifically ?

 

I would anticipate that any FDA CCP is (somewhere) associated with a specific sampling program, eg via BAM.

 

AQL tables are (logically) not appropriate for a zero-tolerant defect.

 

(The AQL tables do not mention critical defects in their tables. A critical defect is one that could cause injury to a customer or even death).

Hi Charles,

 

Please find my relies below

 

Is this a chilled or frozen stored product ?

 

Chilled storage

 

I deduce yr OP is referring to a (somewhere) FDA-driven CCP

 

Not sure where the 6hr cooling time restriction mentioned derives from ?

 

 According to FDA food code, food shall be cooled down from 135oF to 40oF within 6 hours total after cooking. In my food safety plan, this cooling step is a CCP

 

I anticipate the micro.testing you refer is oriented to pathogen and/or toxin testing. For ? specifically ?

 

Only pathogens that likely grow, no toxin testing 

 

I would anticipate that any FDA CCP is (somewhere) associated with a specific sampling program, eg via BAM.

 

AQL tables are (logically) not appropriate for a zero-tolerant defect.

 

(The AQL tables do not mention critical defects in their tables. A critical defect is one that could cause injury to a customer or even death). 

 

I set zero tolerance criteria for pathogens meaning all of 6 samples shall be negative with any pathogens. 

 

Thanks

 

O.C 

Why would you need to cool for 6 hours if you meet a minimum product cooling temperature? I imagine that if you reach you target temperature before 6 hours it should be fine to move product around, provided that you do not temperature abuse it afterwards.

In the first post, I mean the total cooling time sometimes is longer than 6 hours. That is why I have to take samples for micro testing. 

 

 

Thanks

 

O.C

Hi All,

 

Sometimes my non-RTE product (vacuum packed 6 Lbs tofu, product of USA) does not meet 6 hours cooling time. I have to take samples for microbiological testing since it is a CCP deviation. Currently I am using AQL 6.5 inspection level 1 to determine how many samples to be taken. Most of cases, 6 samples are taken. My questions are

 

1- Is AQL 6.5 inspection level 1 (link below) sufficient for this deviation?

 

https://inspection.c...09209602?chap=2

 

2- Is it acceptable if I convert 6 samples into to 2 or 3 composite samples or get my contract lab do it for me before testing ?

 

3- Currently I input data (time and temperature) on a free internet-based modeling program to predict pathogenic growth. Sometimes it predicts that a couples of pathogen likely grow (such as L.mono, Salmonella spp, B. cereus) at the same time

 Is there any (other) way to correctly identify one target testing pathogen to reduce testing cost.

 

Look forwards to getting your replies. 

 

Thank you

 

O.C 

 

Hi OC,

 

(1) No, due comments as per Post 3. Just for illustration, FDA Lot Sampling is detailed here - 

 

https://www.fda.gov/...mple-homogenate

 

(2) Maybe. For illustration of practical aspects/limitations see the link in (1) above

 

(3} Need to know the specific, basic, process in order to predict hazards, The possiblities may include Salmonella, C.botulinum, L.mono. et al

 

JFI here is an example which is not NRTE/chilled/VP -

 

haccp plan, fried_tofu.pdf   282.99KB   16 downloads

 

and one more -

 

hazards associated with tofu production.pdf   1.6MB   19 downloads

1 Thank
This draft guidance is specific to seafood, but it should give you an idea of FDA’s thinking regarding bacterial testing in order to clear product.
https://www.fda.gov/...cts-segregation

Why would you need to cool for 6 hours if you meet a minimum product cooling temperature? I imagine that if you reach you target temperature before 6 hours it should be fine to move product around, provided that you do not temperature abuse it afterwards.

 

I believe the OP means time/temp requirement for cooling to be a deviation of 135-70 within 2 hours, and to 40 within 4 hours. Of course a deviation in first part of matrix would be more conducive to pathogen log phase.


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