Validation vs/= Verification

Hello everybody

Title Validation vs/= Verification

I know that this question has been approached before on the forum but teh most I reas, more questions come into my head.


Hello everybody
I know that this question has been approached before on the forum but the most I read, the most confused I get

If you carry out microbiological analysis on the end product

a)are you verifying your HACCP system? ( it is supposed that you have validated the control measures and limits before implementing them )

b)are you making validation of control measures ? ( it is to say, making sure that the scientifid and technical information your HACCP is based on is right ?

c)are you making validation of the HACCP system ( or another food safety control system ?

It would be grateful ti get an opinion fron a FSMS auditor as well-
AND what about if you carry out calibration of equipment against national or international standards ? ( the same three questions )
Thank you
Regards
Esther

If you carry out microbiological analysis on the end product

Why are you doing the analysis ?
Because you want to increase your knowledge of the contamination of the end product.
Hence you are uncertain, aren't you ?
Why are you uncertain ?
If you know the answer, you know what you're doing (validation or verification)
If you don't know the answer ... that's your next step.

Hint: validations of controls may be performed by governmental organizations such as FDA and standardized for a particular business, verifications of HACCP plan are usually performed by each plant.

Esther,

Franco is leading you to the right direction. ....but slowly and i have a feeling he wants you to understand the difference in a practical way.

It would be grateful ti get an opinion fron a FSMS auditor as well-

And, what makes you think they will..........when FSMS Auditors generally give you "improvement suggestions" but NEVER show you "how"

I am taking a GUESS here but those people in this forum who have provided the larger chunk of professional views and comments are unlikely to be auditors but rather FSMS consultants and/or FSMS Managers in their own rights and fields.

Franco is leading you to the right direction. ....but slowly and i have a feeling he wants you to understand the difference in a practical way.

Yes Charles, you're right. I was trying to let Esther find her way to the solution.

If you carry out microbiological analysis on the end product

a)are you verifying your HACCP system? ( it is supposed that you have validated the control measures and limits before implementing them )

Hallo Esther,
microbiological spot checks show you whether the HACCP-plan works or not = verification
But befor doing that, you should validate your examinations.
An example: if a hazard might be bacillus cereus, it might not be useful to look for aerobic viable counts. Can you find the Bacilli, if they are there? An useful test should be adding the bacilli into the product and show, that your test would identify them. = Validation
But (like advices for children... ) do not do this without the help of somebody who is competent, otherwise your production line might be contaminated for longer...
Christmas greetings!
Andrea

But befor doing that, you should validate your examinations.

The key factor is the time.
Validation takes place prior to operation and its aim is to demonstrate the "food safety capability" of the process (i.e. microbiological analysis on the end product).
Verification takes place during and after the operation and its aim is to demonstrate that the intended level of control has actually been achieved (i.e. microbiological analysis on the end product).
Monitoring is done to detect any failures in the control measures (i.e. recording of pasteurization time -temperature data).
It may happen that validated processes need only monitoring and no verification at all, since it has been demonstrated that their "food safety Cp and Cpk" meet the requirements.

Esther,

Franco is leading you to the right direction. ....but slowly and i have a feeling he wants you to understand the difference in a practical way.


And, what makes you think they will..........when FSMS Auditors generally give you "improvement suggestions" but NEVER show you "how"

I am taking a GUESS here but those people in this forum who have provided the larger chunk of professional views and comments are unlikely to be auditors but rather FSMS consultants and/or FSMS Managers in their own rights and fields.

Hello ALL

This is my comment to you all, kind repliers

You all are right and I agree.

These questions came to my head after reading some articles about Verification and VAlidation.
To be honest, that difference was and is quite clear to me ( so far ) but I started wondering which one it is to auditors.

Believe, my last intention is to bother you, all members, with silly ( apparently ) questions

After reading all your answers I keep on my first idea

So thank you very much

Esther

Believe, my last intention is to bother you, all members, with silly ( apparently ) questions

Esther, I think there are no silly questions, but there are silly people who never ask questions.
Go on asking whenever you like. This is a good habit for you and for all the SDF community.

Dear All,

Hope Esther doesn't mind me borrowing her thread.
I came across this short US explanation of HACCP validation / verification from the US / FSIS (Food Safety and Inspection Service) viewpoint while browsing .
Validation_and_Verification___FSIS_Approach.ppt   49.5KB   168 downloads
It's not so high-powered as the preceding posts in this thread but seemed quite elegant and understandable to me so here it is. Hopefully it is not inconsistent with other more detailed resources already available in this forum.
(It was extracted from an immense compilation of FSIS items, many on-line, at
http://www.fsis.usda...tions/index.asp )

Rgds / Charles.C

Hello to you all,

One of the best approach to distinguish VER from VAL is the questionnaire proposed by Huss, FAO (2003):

You validate when you answer to this questions:
· are the right things done?
· will the system work when put into practice?

You verify when you ask:
· are the things done right?
· are they done as they were planned to be done?

regards, Jose

Hello to you all,

One of the best approach to distinguish VER from VAL is the questionnaire proposed by Huss, FAO (2003):

You validate when you answer to this questions:
· are the right things done?
· will the system work when put into practice?

You verify when you ask:
· are the things done right?
· are they done as they were planned to be done?

regards, Jose

That's fantastic Jose; it must be a good explanation even I can understand it.

Cheers,
Simon

[/quote]
You verify when you ask:
· are the things done right?
· are they done as they were planned to be done?[quote]

Hello Jose,

Just playing devil's advocate.

When you verify - i.e. "are the things done right and are they were planned to be done"

Question: What will happen if what they had planned to do was not right in the first place.....and if the verification planning was wrong, how could we have an effective validation.

Regards
Charles Chew

Hello to all,

A simple way of putting it would be:

A food item for example can be verified

A bomb can only be validated and not verified

Hope this helps

Dear All:

Last year, USDA checked our HACCP plan and said we need to verify what we mentioned under justification for environmental control program. We set to swab Listeria Mono environmental program every 3 months. He asked us how you can be sure every 3 months is sufficient because three months is the least minimum requirement from FSIS. He asked us to validate our justification. What we've done was we designed our analysis to swab every week for whole 3 months. We wil use the lab data as validation. And after that, verification process will be followed.

Jenny

Dear Jenny,

Thanks for interesting comments.
You didn’t specify the product but this looks like a very expensive project even if you have in-house lab facilities.
I don’t quite see why the USDA would not accept yr following their own (presumably ??) validated guideline ? Or perhaps they have some specific reason to believe there is a likelihood of significant L.mono contamination in yr environment? Perhaps this is food for the space program or babies ? (I believe most RTE foods mainly have a tolerance for L.mono. now, does this mean you are allowed to find some in routine swabbing which means quantitative estimation – even more expensive esp. if low levels?).

Maybe it’s time we invented a word (Valification? since the VA bit comes first) to combine the 2Vs and then specify the operational requirements to comply at various stages of manufacturing. One could write a book on the conversations which have taken place over the distinctions involved between VA / VE.

Rgds / Charles.C

added - sorry my lack of observation, see you are making soups etc, maybe soups fpr babies ??

Dear Charles:

Thank you for your comments. The products were RTE frozen food for school meal program. The reason why the USDA inspectors asked us to conduct validation study because we didn't have any scientific reserach to support on our justification. According to their new revised directive on List. Mono. last year, they required each establishment who produces RTE frozen food companies conduct List. Mono. environmental program at least every 3 months. The question he asked was why don't we do swab every 2 months, why we choose with the least requirement (3 months). Even on our history data record showed negative results on L. Mono when we do swab in quarterly. So we have to conduct our validation study to support our justification and as supportive data. Lately in US (esp. in 2007), USDA is very strict with RTE frozen food with chicken contained product.

Oh, this situation was happened last year when I was working at the previous company who produces RTE frozen foods.

Best regards,
Jenny

Hello to all,

A simple way of putting it would be:

A food item for example can be verified

A bomb can only be validated and not verified

Hope this helps

Sankara you must be wrong; your explanation is way to simple, even I can understand the difference between verification and validation.

Excellent.

Regards,
Simon

A food item for example can be verified

A bomb can only be validated and not verified

Trouble is there might not be enough time to verify its a bomb after it had been validated as one

Dear all:

I have conducted validation & re-validation for a few times in my company but I am not so sure whether what I did was adequate. So, I would like to know whether there is any recommended 'format' to document the validation process for improvement?

Thank you..

Dear all:

I have conducted validation & re-validation for a few times in my company but I am not so sure whether what I did was adequate. So, I would like to know whether there is any recommended 'format' to document the validation process for improvement?

Thank you..

YongYM it may be better if you attach or at least tell the forum what you did. I know there are ISO 22000 certification body auditors here who I'm sure would be more than happy to give you some constructive feedback.

Regards,
Simon

Dear YongYM,

Maybe I'm old-fashioned but I would have thought that an approved evaluation by QA or QA/Engg /Prod would be a necessary part of such a validation.

Rgds / Charles.C

Dear Charles:

For your information, the validation was actually done by the team members (QA, Packing personnel & Engineering personnel) and the form was signed by them.

Overall, can this type of format be accepted? Any other things that we still lack of?

Really appreacite you valuable advice. Thank you.

Dear YongYM,

It's probably my poor understanding of yr form but I interpreted it as implying the total validation was based on getting no customer's complaints whereas my post was only intended to ask (but poorly written -sorry) whether some basic safety validation was made at time of installation (eg not being placed under an air conditioner from which occasional water drops ocurred [has happened!]).
Maybe that was the meaning of yr last post in which case sorry again and I think yr procedure is useful. Some factories also issue a kind of running chronological addendum(s) to the previous routine yearly review of the HACCP system to allow for continuous updating in case of subsequent overlooking of such changes (auditors are quite alert at spotting obviously new equipment in my experience and requesting such evaluations!).

Rgds / Charles.C