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What do auditors accept as validation evidence?

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Esther

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Posted 18 October 2009 - 11:09 PM

Hello everybody

I would like to make this question to an BRC/IFS or ISO 22000 auditor or to someone who has gone throught an BRC/IFS/ISO 22000 audit.

I would like to know your opinion regarding to what do you expect to see when you ask for the validation process for a canned heat treatment for fish or vegetables for example?

And, what do you expect to see when you ask for the validation process for a pasterized heat treatment for meat products for example? Or, do you really need to ask for that in this last case?

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Esther



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Posted 19 October 2009 - 01:19 AM

Hello everybody

I would like to make this question to an BRC/IFS or ISO 22000 auditor or to someone who has gone throught an BRC/IFS/ISO 22000 audit.

I would like to know your opinion regarding to what do you expect to see when you ask for the validation process for a canned heat treatment for fish or vegetables for example?

And, what do you expect to see when you ask for the validation process for a pasterized heat treatment for meat products for example? Or, do you really need to ask for that in this last case?

Regards
Esther


First i want to define the validation, based on food codex definition validation is Obtaining evidence that the elements of the HACCP plan are effective..
so...
my opinion is the same for both question: "I want to know scientific background for your control measure, is that effective to control your hazard ? ".


rgds

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Tony-C

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Posted 19 October 2009 - 01:49 AM

Hello everybody

And, what do you expect to see when you ask for the validation process for a pasterized heat treatment for meat products for example? Or, do you really need to ask for that in this last case?

Regards
Esther


Hi Ester,

Validation evidence usually comes from:

Regulatory limits
Industry Code of Practice Guidelines
Scientific journals
Documented challenge studies
In-house data

I would expect you to have at least one of these types of documents as evidence that your process is safe.

Regards,

Tony :smile:


Esther

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Posted 22 October 2009 - 08:55 PM

Thank you very much As Nur and Tony-C

For the second part of my question, regarding pasterization on meat products which are going to be kept under refrigerated conditions, I will focus on get rid of Listeria monocytogenes. There are quite a lot of recognized documents studies and regulatory limits regarding listeria monocytogenes. For me it should be a general knowlegde for all auditors who made audits on meat industry. I would be really surprised if the auditor ask me for the validation process.

For the first part, what do you do when there are no documented studies, or scientific journals because your product is unusual, for example, vacuum cooked chestnuts to be kept to room temperature and 2 years of sheft life. This company has the experience for years, and now it is making incubations for each heat treatment batch and analysis for anaerobic spores and botulinum toxin on final product in a random basis. Should it be enough?

Regards
Esther



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Posted 23 October 2009 - 03:28 AM

Thank you very much As Nur and Tony-C

For the first part, what do you do when there are no documented studies, or scientific journals because your product is unusual, for example, vacuum cooked chestnuts to be kept to room temperature and 2 years of sheft life. This company has the experience for years, and now it is making incubations for each heat treatment batch and analysis for anaerobic spores and botulinum toxin on final product in a random basis. Should it be enough?

Regards
Esther



IMEX.. i did some test (rapid test) to make sure the shelf life of product is 2 years and do some challenge test to see what the efffect to product.. e.c i kept my product in extreem temperature (55, 60 and 70 oC) to see the change of product


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Posted 23 October 2009 - 06:21 AM

Dear Esther,

For the first part, what do you do when there are no documented studies, or scientific journals because your product is unusual, for example, vacuum cooked chestnuts to be kept to room temperature and 2 years of sheft life. This company has the experience for years, and now it is making incubations for each heat treatment batch and analysis for anaerobic spores and botulinum toxin on final product in a random basis. Should it be enough?


It seems to me that the logical question to address to the auditee is "where is yr validation that this procedure is sufficient". IMEX, no routine methodology has zero references although it may not necessarily be in a directly comparable form. Or are you hoping to find an expert on vacuum cooked chestnuts on this forum ? :smile:

As far as canned goods are concerned, I don't know about Europe but the USA have, for a very long time, had a highly systemised approach for many canned products such that the (minimum) appropriate (different can size etc) sterilisation conditions are officially published for general reference and use by people like the FDA.

Rgds / Charles.C

Kind Regards,

 

Charles.C




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