7 replies to this topic

[clarencestj]

Hi, i need some help with the validation. Last week i was asked by the auditor to show the validation, when i give the microb result, she says that was a verification. So got little confuse with this, what should i do? i cannot find related document in the forum, only some explanation of validation.

[Scotty]

Attached report snapshot may help.

Regards

Attached Files

•  Validation Verification report snapshot.pdf   6.79KB   225 downloads

[George @ Safefood 360°]

Hi Clarencestj

More information would be required to answer this fully but nonetheless it is a question that comes up often and the levels of confusion persists (including auditors). In short micro results can act as both verification and validation depending on the context. For example:

Verification - micro results that show a finished product has met the microbial specification or criteria. e.g. results show Coliforms to be less than 10 per ml. The specification has been met, the product can be released and verification has been completed. All this is done because there is an undelying opinion/belief/assumption/fact that less than 10 per ml represents a SAFE food product... but how do we know this? Well we know it through Validation.

Validation - this may be scientific or some other valid data which proves that less than 10 per ml is in fact safe. This can also include micro results arising from challange testing of a lethal control step such as cooking.

So in short - VERIFICATION is checking that what we say we are doing we are in fact doing. VALIDATION is proving that what we are doing is in fact capable of producing a safe food product...or

VERIFCATION = checking the product is less than 10 per ml.

VALIDATION = proving that less than 10 per ml is safe.

Finally thanks Scotty for the Report. I might suggest that you recheck it in the context of the above explanation. It should help you to refine it slightly.


George

[Charles.C]

Hi, i need some help with the validation. Last week i was asked by the auditor to show the validation, when i give the microb result, she says that was a verification. So got little confuse with this, what should i do? i cannot find related document in the forum, only some explanation of validation.

Dear clarencestj,

The most beneficial way for you to get an opinion on yr specific situation would perhaps be to inform us what the text of yr case/NC actually was. It may also relate to the specific food standard which you omitted.

If you hv looked at some of the many discussions here on Va/Ve you will hv realised that there are different interpretations of these terms in some food standards, eg BRC / SQF. And also geographically in some layouts, eg, occasionally, USA / Europe.

BRC usually seems to follow Codex viewpoints. There is a nice, much posted Codex document on validation here which you hv probably seen already.

One fundamental difference (at least IMEX of BRC) which I personally found helpful relates to chronology. Ideally, validation (finding evidential justification for intended procedure) is carried out prior to routine implementation of the process in question. Verification is typically related to operational results derived subsequent to the routine implementation. If the actual validation situation is not totally matchable to such a timing scenario, it is not uncommon to postulate / generate an independent / “parallel” validation exercise. One or two examples of this approach / format can be found on the forum. I can do some searching for links if you are interested.

Rgds / Charles.C

PS - Ve also overlaps into some aspects which cross-relate to operational results, eg calibration etc but this part is usually less argumentative IMEX.

[clarencestj]

Attached report snapshot may help.

Regards

Dear Scotty

thank for the attachment

[clarencestj]

Hi Clarencestj

More information would be required to answer this fully but nonetheless it is a question that comes up often and the levels of confusion persists (including auditors). In short micro results can act as both verification and validation depending on the context. For example:

Verification - micro results that show a finished product has met the microbial specification or criteria. e.g. results show Coliforms to be less than 10 per ml. The specification has been met, the product can be released and verification has been completed. All this is done because there is an undelying opinion/belief/assumption/fact that less than 10 per ml represents a SAFE food product... but how do we know this? Well we know it through Validation.

Validation - this may be scientific or some other valid data which proves that less than 10 per ml is in fact safe. This can also include micro results arising from challange testing of a lethal control step such as cooking.

So in short - VERIFICATION is checking that what we say we are doing we are in fact doing. VALIDATION is proving that what we are doing is in fact capable of producing a safe food product...or

VERIFCATION = checking the product is less than 10 per ml.

VALIDATION = proving that less than 10 per ml is safe.

Finally thanks Scotty for the Report. I might suggest that you recheck it in the context of the above explanation. It should help you to refine it slightly.


George

Dear George

Thank for your responce. Accually i m working in a bakery, there are 2 CCP in my HACCP Plan
1. Storage (Freezer) = below -18oC
2. Product Temperature = Above 90oC

So how should i validate those CCP?

[clarencestj]

Dear clarencestj,

The most beneficial way for you to get an opinion on yr specific situation would perhaps be to inform us what the text of yr case/NC actually was. It may also relate to the specific food standard which you omitted.

If you hv looked at some of the many discussions here on Va/Ve you will hv realised that there are different interpretations of these terms in some food standards, eg BRC / SQF. And also geographically in some layouts, eg, occasionally, USA / Europe.

BRC usually seems to follow Codex viewpoints. There is a nice, much posted Codex document on validation here which you hv probably seen already.

One fundamental difference (at least IMEX of BRC) which I personally found helpful relates to chronology. Ideally, validation (finding evidential justification for intended procedure) is carried out prior to routine implementation of the process in question. Verification is typically related to operational results derived subsequent to the routine implementation. If the actual validation situation is not totally matchable to such a timing scenario, it is not uncommon to postulate / generate an independent / “parallel” validation exercise. One or two examples of this approach / format can be found on the forum. I can do some searching for links if you are interested.

Rgds / Charles.C

PS - Ve also overlaps into some aspects which cross-relate to operational results, eg calibration etc but this part is usually less argumentative IMEX.

Dear Charles

the NC raise was "There are no any validation document to support the HACCP Plan", but i dont have any idea about the validation document, it's a record or report?

[Charles.C]

Dear Charles

the NC raise was "There are no any validation document to support the HACCP Plan", but i dont have any idea about the validation document, it's a record or report?

Thank for your responce. Accually i m working in a bakery, there are 2 CCP in my HACCP Plan
1. Storage (Freezer) = below -18oC
2. Product Temperature = Above 90oC

So how should i validate those CCP?

Dear clarencestij,

I am guessing the above 2 extracts are cross-related.

Assuming a traditional standard is involved, the basic "mechanism" of the HACCP plan such as the hazard analysis, selection of CCPs, etc is essentially validated via quoting a reference procedure, eg like Codex if that was the basis of the one you used, or as appropriate for yr case. Obviously the auditor will then evaluate yr conclusions on this basis.

Typically, some additional validation required is directed towards the specific values you select for critical limits, eg why 90degC, why <(-)18degC ?

There are several discussions regarding haccp for baking here. Try searching for baking or bakery.
Not a baker myself but i suspect many people here do not consider storage temp. as a CCP, although some do. Depends on yr hazard analysis etc of course.
And again, the choice of the baking temp. as a CCP seems to be about 50/50 here. Again depending on yr hazard analysis et seq.

Validation of (-)18degC can be found on this forum (with refs.) in several places, some searching required.

Validation of 90degC might be referred to one specific point in the table of L.mono. (T.vs.t) values from which the typical 70degC/2min rule is taken. I daresay you are probably familiar with this official heating / cooking guideline.? Once the core product temp. reaches approx. 75degC the minimum holding time for "elimination" of vegetative pathogens is ca. seconds-instantaneous. Presumably 90degC will be even more wide spectrum, the bakers here will know better than me.

Rgds / Charles.C