10 replies to this topic

[ana]

Hello all,

We are co-operative dairy sector going to face 22000 certification audit next month.
One pre-audit issue required - " The rationale for the chosen critical limits to be documented " as per clause 7.6.3

It is different from the validation of control measures ? How to address it ?

can anybody help?

[Simon]

Can anyone help Ana out with this one?

[Erasmo]

Hello all,

We are co-operative dairy sector going to face 22000 certification audit next month.
One pre-audit issue required - " The rationale for the chosen critical limits to be documented " as per clause 7.6.3

It is different from the validation of control measures ? How to address it ?

can anybody help?

Hi,
It is the same requirement (8.2), but you have to show the validation protocol for each CCP.
I hope this help.

Please make sure that the auditor assess all validation activities during the stage 1 audit. it is important that all questions and differences in validation activities be reviewed in the ST1 audit.

According to ISO-22003. (9.2.3.1.2) the validation has to ve assessedin the ST1 audit.

Saludos.

[GMO]

I include this in with my validation because in my mind validation is not only proving your CCP can work but proving the critical limits proposed are sensible; so, for example, on the slightly thorny question of test card / stick size, I use the FDA document as the basis of my rationale.

[Charles.C]

Dear ana,

One pre-audit issue required - " The rationale for the chosen critical limits to be documented " as per clause 7.6.3

It is different from the validation of control measures ? How to address it ?

In the absence of an ISO definition, wiki gives for "rationale" -

1. Fundamental reasons; the basis.
2. An exposition of principles or reasons.

IMO, one can (here) equate this to "validation" if one wishes (similar to Erasmo, I think ). So the answer to yr question is that you hv to explain why the values you hv selected for yr critical limits are "valid", eg already published and proven, legislatory, proven by you (with data available), etc

"control measure" as such is a general term unless you specify for what, eg ccp whatever.

Validating the critical limits would normally (in traditional HACCP) simply be part of the triangular routine for validating a ccp together with its associated control measure. ISO 22000 successfully blurs the whole topic although it does at least discuss the way to validate (8.2).

Rgds / Charles.C

[Erasmo]

Dear ana,



In the absence of an ISO definition, wiki gives for "rationale" -

1. Fundamental reasons; the basis.
2. An exposition of principles or reasons.

IMO, one can (here) equate this to "validation" if one wishes (similar to Erasmo, I think ). So the answer to yr question is that you hv to explain why the values you hv selected for yr critical limits are "valid", eg already published and proven, legislatory, proven by you (with data available), etc

"control measure" as such is a general term unless you specify for what, eg ccp whatever.

Validating the critical limits would normally (in traditional HACCP) simply be part of the triangular routine for validating a ccp together with its associated control measure. ISO 22000 successfully blurs the whole topic although it does at least discuss the way to validate (8.2).

Rgds / Charles.C

Charles,
There is a definition (guidance):
Rationale: exposition of principles or reasons.

I'm attaching the document.

Guidance on the Terminology used in ISO 9001and ISO 9004

Attached Files

•  Terminology.doc   212KB   127 downloads

[Charles.C]

dear Erasmo,

thks for the info. I guess that's where wiki got it from.

Rgds / Charles.C

[ana]

It has cleared my mind now.

Thank you charles ,Thanks everybody.

Ana

[Charles Chew]

It is the same requirement (8.2), but you have to show the validation protocol for each CCP. I hope this help.

It would appear that under the "process approach", the prospective validation approach is implied here however IMO this is viable under certain circumstances. Personally, I would prefer the retrospective approach or the concurrent method where data implementation is available.

But on the same note, validation under ISO9K is different from ISO22K as the acceptable tolerance level pertaining to food risks cannot be compared on the same platform.

Validating the critical limits would normally (in traditional HACCP) simply be part of the triangular routine for validating a ccp together with its associated control measure. ISO 22000 successfully blurs the whole topic although it does at least discuss the way to validate (8.2).

Charles, if you are a user of ISO22000 I would believe your opinion would be different.

Regards
Charles Chew

[Charles.C]

Dear Charles Chew,

Nice to hear from you.

Charles, if you are a user of ISO22000 I would believe your opinion would be different.

Well, based on the progressive intelligibility of BRC, I suspect my opinion might be similar but it's true that my flexibility to demonstrate it would almost certainly decrease. Maybe the next version of I22000 will change my mind, especially if they delete Oprps.

It is the same requirement (8.2), but you have to show the validation protocol for each CCP. I hope this help.

It would appear that under the "process approach", the prospective validation approach is implied here however IMO this is viable under certain circumstances. Personally, I would prefer the retrospective approach or the concurrent method where data implementation is available.

Possibly because I'm not a user, I do confess that I didn't understand the significance of the above paragraphs.

Rgds / Charles.C

[Buddy]

I include this in with my validation because in my mind validation is not only proving your CCP can work but proving the critical limits proposed are sensible; so, for example, on the slightly thorny question of test card / stick size, I use the FDA document as the basis of my rationale.

GMO,

You mention 'the FDA document', how can this be accessed?

Thanks!