ISO 22000 Validations and Verification

One of the major requirements that you would need to capture in your ISO 22K FSMS (refer to clause 8 of the FDIS Standard) is the ability to demonstrate valid and effective procedures / activities on a regular review basis on Validations and Verifications.

Attached is the proposed draft guidelines discussed by Codex Committee on Food Hygiene in March 2005.

Do note the countries involved in the preparation of this document. I am very impressed with Thailand.

Charles Chew

From the guidelines provided by Codex and the direction by FDISO 22000, validations covers not just scientific support of critical limit but beyond confirmation that the SOP programmes are continually updated and reflects current production / operation processes; conformance to wrtitten plan and procedures; validity of monitoring and verification programs; validity of internal / system audit report vis-a-vis FSMS etc etc.

There is a huge area that needed to be captured under the ISO 22K and to be honest, it is really quite prescriptive and its frightening to think that it is considered a generic program for organizaitons of whatever sizes and types.

I do not feel too sure about this "flexibility". Worried! - Under Guide 62, it gets even more worrisome when you have an auditor who does not have sufficient food process background.

Well, whats new!

Charles Chew

Do you have a verification procedure for product compliance to "legality, regulatory, allergen management and processing aids etc PRIOR to developing or exporting a specific product type to a foreign country.

You may say, its part of a product development or export program where internal / external communications and the verification procedure on compliant are a requirement under ISO 22K

Indeed, part of BRC's requirement as well.

Charles Chew

Attached is the proposed draft guidelines discussed by Codex Committee on Food Hygiene in March 2005.

Comments on the draft from EU EU position

and a document from ILSI ILSI validation and verification

Regards. Franco

IF you are implementing your ISO 22000 for the UKAS Pilot Certification Scheme - its almost another 2 months plus before end of Jan. 2006.

Have you completed your "Pre-Implementation Verification and Validation Exercise" on your system and programs. Consequently, "post-implementation verification and validation" will provide the confirmation of your overall system effectveness, currency and validity. I think UKAS is going to be hawking on this area.

We are on the last leg of the programme with documentation audit in early Dec. and external audit on the 1st week on Jan, 2006.

IMO - After going the mile on ISO 22000, the new FSMS benchmark is really way ahead of current major private standards eg BRC

BTW, base on the depth, I am not too sure how the smaller firms will be able to implement this system. IMO w/o technical strength, it would be really tough to do so despite what ISO feels that this is a system meant for organizations of differing sizes and complexity.

Regards
Charles Chew

Clause 8 of the ISO 22000 is dedicted to "Validation, Verification and Improvement of the FSMS" and if this MAJOR requirement is NOT performed before and after system implementation - you have missed the CORE ISSUE of ISO 22K (as in any other food safety systems) and of course a major non-conformity is imminent.

Dear All,

This thread already contains some excellent prescriptive resources on validation particularly directed towards HACCP.
I came across the reference below which is a bit broader based and seemed to have some interesting thoughts / examples (though the penultimate chunk is a bit laborious). Anyway, it's free to be criticised and I'm sure CharlesChew won't mind me borrowing his topic.

http://www.foodsafet...0602/feat02.htm

Rgds / Charles.C

Post-Modem Situation -

What should I do when a control measure cannot be validated but according to our risk assessment, this control measure remains effective in combination with other measures to reducing the identified hazard risk.

Meanwhile, I cannot place it in the HACCP Plan or classify it as an OPRP.

May I invite those who have claimed to have taken Companies to ISO 22000 Certification to indulge in this debate.

(Perhaps Simon can send invitation out to members who have laid earlier claims echoing Joy Frank's statement in another thread)

Post-Modem Situation -

What should I do when a control measure cannot be validated but according to our risk assessment, this control measure remains effective in combination with other measures to reducing the identified hazard risk.

Meanwhile, I cannot place it in the HACCP Plan or classify it as an OPRP.

May I invite those who have claimed to have taken Companies to ISO 22000 Certification to indulge in this debate.

(Perhaps Simon can send invitation out to members who have laid earlier claims echoing Joy Frank's statement in another thread)

Most of the members who are interested in ISO 22000 are subscribed to the ISO 22000 forum and will receive automatic updates of new topics and posts.

Simon

Dear All

It appears that your food risk assessment methodology is in trouble. You should consult your nearest food safety expert for advice, not an engineering converted food expert.

You may have to modify your work process(s) if control measures cannot be confirmed. Alternatively, the food safety system(s) needs to be re-designed and the chosen control measures be re-validated.

I was told repeatedly that many food safety consultants including engineering converted experts are having trouble with Clause 8 of the Standard. I am not sure whether or not this is the case in your part of the world.

I hope this may help.

Regards/Wayne