4 replies to this topic

[BigEats]

I am conducting a past paper on HACCP, and a question is asking -

Explain why the HACCP plan, particulary at critical control points, needs to be validated before implementation.

I still get very confused between validated and verification any help much appreciated.

[GMO]

This is Dr GMO's (patent pending) method to explain and remember Validation vs. Monitoring vs. Verificiation.

Validation = can it work?
Monitoring = is it working?
Verification = independent evidence that it's working

Validation is before you start (ideally, you may have to do something retrospective if you have an existing system but that's not ideal.)
Monitoring is real time
Verification is often after the fact and infrequent.

So, validation is often theoretical. Think about it this way with the example of cooking a chicken. You know that if you don't cook it, you're likely to get Salmonella or Campylobacter right? So you cook it.

But how do you know that cooking kills these bacteria? What critical limit should you chose? It's not practical in a kitchen to do microbiological testing so how do you approach it? Well, if you're a geek or maybe a caterer you might look up in a microbiology book or refer to a business run scheme like Safer Food, Better Business. From either of these sources you're likely to be able to find that cooking kills these pathogens and the temperatures at which these vegetative bacteria will be killed. Therefore, you have now found some Validation information before you even unwrap the chicken.

So validation is all about designing your process to ensure the HACCP plan and CCPs are effective.

Validation though does not need to be theoretical. Here's another example. If you were designing a retort cooking process for a meal, you would refer to sources of informaiton on microbiology as before but because the retort has a cooling cycle and probing the packs is destructive, you decide to do some experimental monitoring of the retort programme to design the programme to ensure 90oC is achieved for minimum 10 mins for example. The product used for the trials wouldn't be sent out to customers because until you've designed your retort programme, you're not sure the product is safe.

Once you've set up everything you're going to do, you then do some monitoring. For your chicken, you could monitor by using a kitchen temperature probe. For the retort it might be monitoring of the programme itself (if you've validated that a certain programme temperature achieves an acceptable internal temperature).

Then verification, for this you can look at microbiological results (for your retort), customer complaints (did your wife complain the chicken made her sick?!) etc etc.

[George @ Safefood 360°]

Hi Big Eats This topic comes up every so often and there is much confusion about the meaning and use of these terms when applied to food safety management. So no worries, you are not alone. GMO has provided you with a very comprehensive explanation of the terms and some good practical examples.

At risk of patent infringement I would add that the terms themselves are often used interchangeably to describe the same function or activity. Global Standards and codes of practice use them with an assumption the user already has a clear understanding of their meaning – which is not always the case. I have also experienced third party auditors who displayed a poor understanding of the two terms but to be honest this is rare these days.

I have said before on the forum that I am a veteran of the mental twists and turns required to pin-down exactly what Verification and Validation mean when applied to quality and food safety. To gain a clear insight it is helpful to apply them to a real food safety scenario…

Let’s take, for example, the following:

· A food company producing a cooked meat product.
· Their Hazard Analysis has identified Salmonella spp. as a hazard.
· The company cooks the meat to a minimum temperature of 70^oC for a minimum 2 minutes.
· This is a CCP and is applied to reduce the risk to an acceptable level. ·

The company now sets up a monitoring plan to check the core temperature of the meat every 10 minutes during the cooking process using a temperature probe. It is the Cooker Operator’s responsibility to check and record the temperature / time is to specification.

Now applied to the above we may define Verification and Validation as follows:

VERIFICATION: This is the action of checking that what we say we are doing - we are in fact doing! i.e. the operator is checking the temperature / time every 10 minutes according to the HACCP plan to ensure the temperatures and times are being achieved; and recording the result. We are simply ‘verifying’ that the requirements of the plan are being met.

VALIDATION: This is confirming (or proving) that what weare doing is in fact capable of reducing the hazard to an acceptable level. Inother words ‘Is cooking the meat to 70^oC for 2 minutes sufficient to kill Salmonella?’

So we are answering two separate questions: 1) Are wedoing what we say? (Verification) and 2) Is what we’re doing adequate? (Validation).

Verification activities include sign-off of records by a Supervisor/Manager, internal auditing, calibration etc.

Validation activities include challenge testing,shelf-life testing, reference to reputable standards, micro-modeling, calculating Z-values, research papers,legislation, codes of practice etc. and as GMO states should be conducted before any product is released to the market for sale and consumption.

The above, from my experience, is a good example and is generally accepted by auditors – I hope it provides some clarification.

[Charles.C]

Dear George,

Nice examples.

Is cooking the meat to 70oC for 2 minutes sufficient to kill Salmonella?’

L.mono.. perhaps ?, in UK anyway. Should certainly pulverize Salmonella too.

Also seemed to me that previous 2 posts well fit the Codex model. Other "Standards" maybe less so (as intimated in George's second paragraph above).For example SQF, maybe.

Rgds / Charles.C

[foodsafetyboy]

I am conducting a past paper on HACCP, and a question is asking -

Explain why the HACCP plan, particulary at critical control points, needs to be validated before implementation.

I still get very confused between validated and verification any help much appreciated.

Hello,

I think the answer to that question is very obvious. Validation is done to ensure that elements of the HACCP system particularly the CCPs really is going to work.
Validation is more like gathering evidences that elements of the HACCP system are effective.
Regards,
food safety boy