Are records compulsory for evidence of validation?

Is record compulsory for validation?

As in do you have to have some record of your validation exercise? I would say it's not a legal requirement in the UK, however, if you don't have a record, how can you prove you've done it? Turn the question round; if you are going through a validation exercise why not record it?

Records are very, very important, they tell you what, when, who, where, how etc. If you go to the trouble of doing anything, record it or in the eyes of an auditor or other person checking your system 'you didn't do it'.

How can we get validation to recorded?

Records are very, very important, they tell you what, when, who, where, how etc. If you go to the trouble of doing anything, record it or in the eyes of an auditor or other person checking your system 'you didn't do it'.

I don't really understand the question Ahmet. You would just record what you have done as your validation exercise or what you have referenced. Strictly speaking most auditors will only ask for the CCPs to be validated, however, you should really validate your whole HACCP plan to check that there is some basis for the validity of it. In my head, I interpret Validation as meaning "Can it work?" so your validation document is a record of how you have come to the decision (which you presumably have) that the HACCP plan, if applied correctly, can work to control food safety.

How can we get validation to recorded?

Hi Ahmet

Here is an example of a validation record

Hopefully it will give you an idea of what is required

Regards,

Tony

thank you Tony

How do I plan for validation?

Hi Ahmet

Here is an example of a validation record

Hopefully it will give you an idea of what is required

Regards,

Tony

Dear ahmet,

What are you (specifically) trying to validate ?

Rgds / Charles.C

Here is an example of a validation record

Hi Tony,

I would say that the document 'HACCP project 1 ATP swabbing 21/09/09' is your validation report. The record you send seems to me more as a checklist with ways to validate. I am also missing 'validation based on scientifically literature' in this list.

Is record compulsory for validation?

Dear ahmet,

Well, your question now is going beyond the requirement for record. It seems that there is no paragraph in ISO 22000 that states you have to document your validation, but the definition of validation is obteining evidence that demonstrate your control measures (OPRP´s and CCP) are efective, that translates to documents, so you just need to gather some things like a plan (the methodology to validate), the data of your experiments, the report of the results.

Regards,

FSSM

CCP and oPRP

Rgds
Ahmet

Dear ahmet,

What are you (specifically) trying to validate ?

Rgds / Charles.C

Dear ahmet,

How do I plan for validation?

if you mean - "How do I validate a control measure used at a CCP ?" some possible routes are listed in Tony's atachment, eg one of the most popular methods is to look for a published example of a similar nature to yr own in the literature. This is usually acceptable as a validating reference for the principle used although you will hv to carry out yr own trials to obtain the associated data as relevant to yr specific case/system.
For example a common microbial CCP control measure is elimination of vegetative bacteria by heat, you can often find the published time/temperature data required to produce a satisfactory killing efect, eg 70degC/2mins gives 6D (6logbase 10 reductions)for L.monocytogenes. So if you can demonstrate that yr system achieves the same/better or equivalent temp/time this is a possible validation (this assumes that yr product/process is matchable to the referenced literature example).

Rgds / Charles.C

PS - Sorry if you knew all that already

Yep, I agree with Charles' approach. What I tend to do is pull together an overarching document which then references the trials and other reference information and concludes on whether each point is validated. So, for a CCP on cooking, I've done in the past as Charles has suggested, used a cooking temperature which gives a sufficient reduction in vegetative bacteria so it is likely to kill Listeria spp. for example. I've then had cooking trial data which is datalogged to prove over the oven that the temperature can be achieved and then cross referenced this with a take off temperature. The product is then tested microbiologically to ensure it complies with customer specs (which are also a good validation reference).

Remember though as I said before, the whole of your HACCP plan should ideally be validated. For example, how do you know your personal hygiene controls are likely to be effective? Why have you chosen the handwashing procedure you have? I'd start with CCPs but it really is worth considering the whole thing so ideally I'd move onto PRPs next to ensure there is some valid basis for your choice of them.

Hi Tony,

I would say that the document 'HACCP project 1 ATP swabbing 21/09/09' is your validation report. The record you send seems to me more as a checklist with ways to validate. I am also missing 'validation based on scientifically literature' in this list.

Hi Madam A

Yes the record/checklist would need to be supported by validation data/report. In this case ATP Swabbing Project Data & Report. Scientific Literature is covered by Third Party Scientific Validation.

Kind regards,

Tony

CCP and oPRP's

Kind regards,

Ahmet