Validations In Haccp

Hi Simon,

Hope you had a great holiday! Thought I would start a new topic

Verifications and Validations are two frequently used terminologies in HACCP but often misinterpreted but under this topic, we are concerned with validations only.

HACCP is essentially science base and where possible, issues concerning "chemical and microbial hazards" be confirmed or validated as "compliance benchmark" by external independent laboratories with appropriate test facilities. Laboratories should also use ISO 17025 certified test methods to validate as well. (Physical hazards are generally not included)

For example, we have a manufacturer that claims their salsa sauces packed in glass bottles has a SHELF LIFE of say two (2) years from date of manufacture. There were never any test records to proof that it is indeed good for the claimed period nor were there any historical records of customer complaints or recall.

The food auditor came by for their initial audit and did not approve certification until close-out of MAJOR CARs including other CLs are done. Is this decision necessary despite having no historical records of recalls or complaints implying that the products are good for consumption up to expiry date?

In such cases, should validations be waived and the products assumed to be good for the period claimed and certification rightfully given? Any comments from out there!

A Poll is in order.

Cheers

Charles Chew

Hope you had a great holiday! Thought I would start a new topic 

I certainly did Charles thank you. It's good to be back though. :D

I'm not an expert, but could accelerated shelf-life trials be a possible option?

Regards,
Simon

HACCP as a science base system, accelerated shelf life studies will certainly be an excellent validation exercise. But what if I have isolated stocks of salsa left in my stores that are more than two years old.

In this case, will a "successful" micro test for a specific range of test parameters be sufficient to proof beyond reasonable doubt that the product is good for the shelf life as claimed. I believe so. What are the Saferpakers' view on this?

Interestingly, how do we know that the micro test is a success if we do not benchmark the results with industrial standards or other recognised literatures.

For fear of contaminations, perhaps, we should also look at how samples be prepared and taken through the chain of custody prior to the actual test being done. What content should the test report contain to support validation?

Validation is such an important issue in meeting audit requirements AND there is so much involved.

Charles Chew

I guess there is nothing scientific about calibrating the thermometer or the weighing scale (say for measuring preservatives) in making sure that their readings are accurate.

Certain validations do not require scientific evidence but technical confirmation is sufficient. Really, what is validation which must indeed go in hand with verification.

Surely, we would need to validate the identified CCPs are correct during our hazard analysis. Don't we need to validate the Critical Limit Values in maintaining system integrity and of course, validating the Control Measures to ensure system conformity................thats a hell of a lot validations.

In reality, validation and verification activities are hands in gloves. Simply put,

Validation - activities to confirm what we do is correct.
Verification - activities to make sure what we want to do is done.

Validation is the core of any HACCP Plan and it helps to maintain integrity of the system. But, Verification allows us to have a measurable food safety plan.



Charles Chew

Hi Simon,

Hope you had a great holiday! Thought I would start a new topic

Verifications and Validations are two frequently used terminologies in HACCP but often misinterpreted but under this topic, we are concerned with validations only.

HACCP is essentially science base and where possible, issues concerning "chemical and microbial hazards" be confirmed or validated as "compliance benchmark" by external independent laboratories with appropriate test facilities. Laboratories should also use ISO 17025 certified test methods to validate as well. (Physical hazards are generally not included)

For example, we have a manufacturer that claims their salsa sauces packed in glass bottles has a SHELF LIFE of say two (2) years from date of manufacture. There were never any test records to proof that it is indeed good for the claimed period nor were there any historical records of customer complaints or recall.

The food auditor came by for their initial audit and did not approve certification until close-out of MAJOR CARs including other CLs are done. Is this decision necessary despite having no historical records of recalls or complaints implying that the products are good for consumption up to expiry date?

In such cases, should validations be waived and the products assumed to be good for the period claimed and certification rightfully given? Any comments from out there!

A Poll is in order.

Cheers

Charles Chew

Hi Charles,
In my view validation is must.
Shelf life is required to be detrmined.
Having said that an organization implementing HACCP does not require to generate their own data every time. Ig they are producing some standard kind pf product and a well accepted data from reliable source is available; that can be accepted for deciding the critical limits for some of the CCPs e.g. cooking temperatures in a typical atering operation.
Shelf life can be a factors of number of inputs e.g. raw material, production method, type and kind of packaging, the condition expected under which the product wouold be transported, and kept on the shelves. Hence shelf life study (raed validation of shelf life) is must.

Please do comment on this.

Thanks

In terms of my validation of metal test pieces size..I have a copy of FDA 555.425 in my HACCP manual.

...sorry I forgot to mention that MD is my only CCP

Hi Charles,
In my view validation is must.
Shelf life is required to be detrmined.
Having said that an organization implementing HACCP does not require to generate their own data every time. Ig they are producing some standard kind pf product and a well accepted data from reliable source is available; that can be accepted for deciding the critical limits for some of the CCPs e.g. cooking temperatures in a typical atering operation.
Shelf life can be a factors of number of inputs e.g. raw material, production method, type and kind of packaging, the condition expected under which the product wouold be transported, and kept on the shelves. Hence shelf life study (raed validation of shelf life) is must.

Please do comment on this.

Thanks

Hi Gourav

So are you saying for a product with a 2 year shelf life that you should wait 2 years to validate the shelf life before you launch the product?

Regards,

Tony

I would argue that anything with a shelf life of 2 years does not have a shelf life which is related to food safety but one which is related to quality and so you're not validating it under HACCP unless you also include quality in your HACCP plan. (Sorry to be a pedant!)

However, I would suggest in these circumstances that if possible you design an accelerated shelf life protocol which would mimic the shelf life over a shorter period, or you do some work to prove that a short time period; e.g. 2-3 months would pick up spoilage issues which would be picked up over the whole shelf life and no significant deterioration occurs later which is not picked up at this early stage.

I would like to expand this discussion to validation of pre-requisite and operational pre-requisite. I am struggling on how this can be done in a HACCP plan for food safety. I understand completely the validation of CCP's and critical limits. How would you validate your personnel practices (GMP's; Employees' Uniforms)? Does anyone have any ideas or dealt with validating those items?

Thanks

Dear holewinj,

IMO, your query involves a potential mixture of specific and / or semantic aspects.

If your example is specifically referring to ISO 22000, prerequisite functions are required to be verifiable but not validatable within the 22000 interpretation of those terms. The stated verification procedure is for example as per section 7.8 and would presumably include the usual product parameters / hygiene related data.
Operational prerequisites are technically required to be in compliance with the conveniently vague 22000 definition and are, equally conveniently, not required to have specific critical limits. These characteristics obviously facilitate agreement with the stipulated (section 8.2) validatable property and verification as mentioned above.

Despite the above, in previous discussions here on this (validation) topic, various people here including myself opined that it seems rather nonsensical to implement any (prerequisite) control measure without preliminary analysis of its likelihood of being effective (ie reaching or approximating a validation). I suppose in yr specific example, it can be argued that the existence of such hygiene procedures within published GMP manuals is a self- fulfilling (conceptual) validation subsequently backed up by a verification. And similarly for other hygiene related “Good Manufacturing Practices” . The situation becomes rather more complex if a “hygiene type” procedure is classified as an OPRP (hence the historical non-requirement of critical limits) but in most cases I guess this event can anyway be avoided by appropriate manipulation of the risk analysis or increasingly through the ever - expanding PAS 220.

If you are not referring to ISO 22000, the aspect of validation of prerequisites tends IMEX to not specifically have such emphasis in comparison to the examination of CCPs. Thanks so much, ISO 22000.

Regards / Charles.C

Any further comments on this?

In our Level 4 course the tutor did encourage us to validate and verify all of our HACCP; including prerequisites and it's a sensible approach IMO.

One which is a prime prerequisite to validate would be cleaning procedures. You could validate these by pre and post cleaning swabbing (extensive, more so than "verification" swabbing) under trial conditions.

"GMP" is harder as it covers so many concepts but if you mean housekeeping, then I would validate this with reference to literature on tidy well organised work places being more hygienic and leading to better working practices rather than some kind of trial, your verification could then be auditing.

For workwear you could validate your choice by looking at the likelihood of foreign body and micro contamination in your choice and (if used) the controls in place at your laundry. Your verification could then be occasional swabbing and inspection?

Hi Charles -

Thanks for the information. I am only familiar with SQF 2000 - Level II. I am confused by what SQF states is validation in their guidance verses CODEX validation.

The CCP's in our HACCP plan are scientifically validated because they are the "Kill" step. According to SQF, this is how CCP's should be validated but than on the other hand SQF states Validation for pre-requisite programs as personnel practices (GMP's - Hand-washing, Proper Clothing, Hygiene....) can be validated by observing employees doing these practices (Section 4.5.2 SQF Guidance). Now validating personnel practices using that method is verification not validation. This is confusing me. This is what I am specifically talking about.

I want to use validation under a standard format. Should I not have some type of scientific study done or reference a sceintific study that states our hand-washing, proper clothing, hygience is found to eliminate or reduce the risk of hazard to acceptable limit for food manufacturing.

Best Regards - holewinj

Dear holewinj,

IMO, your query involves a potential mixture of specific and / or semantic aspects.

If your example is specifically referring to ISO 22000, prerequisite functions are required to be verifiable but not validatable within the 22000 interpretation of those terms. The stated verification procedure is for example as per section 7.8 and would presumably include the usual product parameters / hygiene related data.
Operational prerequisites are technically required to be in compliance with the conveniently vague 22000 definition and are, equally conveniently, not required to have specific critical limits. These characteristics obviously facilitate agreement with the stipulated (section 8.2) validatable property and verification as mentioned above.

Despite the above, in previous discussions here on this (validation) topic, various people here including myself opined that it seems rather nonsensical to implement any (prerequisite) control measure without preliminary analysis of its likelihood of being effective (ie reaching or approximating a validation). I suppose in yr specific example, it can be argued that the existence of such hygiene procedures within published GMP manuals is a self- fulfilling (conceptual) validation subsequently backed up by a verification. And similarly for other hygiene related “Good Manufacturing Practices” . The situation becomes rather more complex if a “hygiene type” procedure is classified as an OPRP (hence the historical non-requirement of critical limits) but in most cases I guess this event can anyway be avoided by appropriate manipulation of the risk analysis or increasingly through the ever - expanding PAS 220.

If you are not referring to ISO 22000, the aspect of validation of prerequisites tends IMEX to not specifically have such emphasis in comparison to the examination of CCPs. Thanks so much, ISO 22000.

Regards / Charles.C

Ok, this is what I was looking for too. This was the next question to ask. How do I go about doing this for pre-requisite programs. So this was in training for level 4? Interesting....Where is this training held? Is there anything in the US? You just opened me up for so much more ideas. Thanks so much!

In our Level 4 course the tutor did encourage us to validate and verify all of our HACCP; including prerequisites and it's a sensible approach IMO.

One which is a prime prerequisite to validate would be cleaning procedures. You could validate these by pre and post cleaning swabbing (extensive, more so than "verification" swabbing) under trial conditions.

"GMP" is harder as it covers so many concepts but if you mean housekeeping, then I would validate this with reference to literature on tidy well organised work places being more hygienic and leading to better working practices rather than some kind of trial, your verification could then be auditing.

For workwear you could validate your choice by looking at the likelihood of foreign body and micro contamination in your choice and (if used) the controls in place at your laundry. Your verification could then be occasional swabbing and inspection?

Dear holewinj28,

Hmm. Interesting comments.

I had a look at the section you refer. I have no direct experience of SQF2000 but offhand i rather agree with your opinion.I don't recall seeing any other major publication having a detailed interpretation of validation of a hygiene pre-requisite as per the SQF guidance text. It appears that they have decided to use a (IMO) verification-type scenario and call it validation. Strange. The concept could make sense if the observations were with respect to some kind of a pilot project conceived so as to generate preliminary support for a control measure about to be introduced into the routine process but this does not appear to be the case here. Or perhaps their (twisted?) concept is that since the prerequisite function is ideally established prior to the implementation of the main production, the features described can be considered as a validation process. (personally I prefer my previously posted solution )

Whatever, I think SQF are on their own on this one but I daresay any experts on SQF here (???) should know the (perhaps obvious ? ) answer.

Out of curiosity, I very briefly looked at the guidance text regarding selection of critical points and it seemed rather inadequately presented to me. The generous idea of supplying this huge body of support material is excellent but it represents a not inconsiderable task to make it all hold together IMHO.

Rgds / Charles.C

PS slightly off-topic but it is a fact that the integration of Va, Ve has always generated a variety of interpretations, for example can compare the views shown at the higher and lower parts of this page link -

http://www.fao.org/d...3e/y4743e0i.htm