Validation of Pre-Requisites
We have recently completed our SQF audit. I am looking for suggestions for a validation on two of our Pre-Requisites. We are an allergen free facility and I need to validate that. Also, I need to validate our water quality. Any help is greatly appreciated.
A few questions come to mind immediately - first, did your Allergen Policy clearly state that your facility does not utilize any allergen-containing ingredients or products? And did it state that this is controlled by your Receiving Policy, which would then have a provision in it that required the person responsible for receiving of ingredients, product, etc. to verify and document that a check was done of labels, COA, etc. to ensure nothing with allergens was received?
As far as your water goes, is it municipal water? If so, did you obtain any documentation showing testing results from your municipality?
It's hard to know what you will need to validate without knowing what steps have already been taken, and what the auditor therefore considered to be inadequate.
Brian
We have recently completed our SQF audit. I am looking for suggestions for a validation on two of our Pre-Requisites. We are an allergen free facility and I need to validate that. Also, I need to validate our water quality. Any help is greatly appreciated.
Yr specific product / process / NCR is unstated but afaik and based on previous threads in this forum / SQF website -
SQF Prerequisites are not required to be validated.
Is the Allergen Management Program a defined exception ?
Auditor challenge ?
Yr specific product / process / NCR is unstated but afaik and based on previous threads in this forum / SQF website -
SQF Prerequisites are not required to be validated.
Is the Allergen Management Program a defined exception ?
Auditor challenge ?
To answer my own question -
Yes, albeit implicitly,
2.8.2.1. viii
Based on risk assessment, procedures for validation and verification of the effectiveness of the cleaning and sanitation of areas and equipment in which allergens are used shall be effectively implemented.
It would seem that as a corollary – SQF no longer regards the Allergen Management Program as a PRP (post sqf2000)
PS - i believe there is at least one older thread here on the requirements to "validate" that a site is "allergen free". Presumably a question of documented elimination regarding raw materials, chemicals, services, amenities, etc. I recall vending machines was a favorite audit.
For allergens, we require an allergen statement by the supplier along with the agreed-upon specification. Checking all ingredients at receiving as noted by Brian above is a very good measure. If you're going to claim allergen-free facility, make sure to consider food allergens that may be brought in by employees for personal consumption or allergens present in vending machines - what control(s) do you have in place to prevent cross contamination (e.g., cleaning procedures for break areas, training, policies: gmp, uniform, outside food, vending, etc)?
For municipal source water, in addition to municipal source analysis (our local source post this on their website that I download and review) I would take samples at the point of use in your facility and send them to an independant lab for analysis - or I suppose you could do it in-house if you have the ability. The thought is that while the municipal source tested potable, there may be contamination somewhere between the municipal source and your point of use. Testing at point of use puts all at ease. As for what attributes to test, find standards for potability and test to those standards along with any customer requirements you have.
Yr specific product / process / NCR is unstated but afaik and based on previous threads in this forum / SQF website -
SQF Prerequisites are not required to be validated.
Is the Allergen Management Program a defined exception ?
Auditor challenge ?
I'm sorry... I'm not sure I understand your post... Are you saying that SQF does not require validation of PPs?
2.5.2 clearly states:
- The methods, responsibility and criteria for ensuring the effectiveness of pre-requisite programs, and validating critical food safety limits to ensure they achieve their intended purpose shall be documented and implemented. The methods applied shall ensure that:
i. Pre-requisite programs are confirmed to ensure they achieve the required result
I assume that this means SQF requires validation. Am I incorrect in thinking that validation is required, and the PPs must be ensured to be achieving the required result? Is that not validation?
Thanks.
I assume that this means SQF requires validation. Am I incorrect in thinking that validation is required,
Thanks.
Hi amppyyr,
Yes, to the best of my understanding, you are incorrect.
Maybe have a look at the FAQ on the SQF website. Not 100% guaranteed to be currrent but it's the nearest i can offer.
There are various threads on this topic if you search back a little.
Anyone with contrary knowledge only too welcome to post.
Of course the issue of SQF's approach to "Validation" is itself already legendary.
Definitions of validation and verification differ slightly from standard to standard. The GFSI Guidance
Document version 6.2 defines validation as “an activity to obtain evidence that a requirement is controlled
effectively” and verification as “a confirmation through the review of effective evidence that requirements have
been fulfilled.” SQF uses the Codex definition. In other words, validation applies to scientific authentication
that the critical limits set for each CCP and CQP will achieve the intended results (refer 2.5.2). Verification
applies to the entire SQF System and includes methods such as sampling, internal audit and re-validation to
demonstrate that the SQF System is working and is effective.
If only .... :smile:
Hello,
validation that a plant is "allergen-free" - can this really be done? I wonder about the high numbers of "free from ..." statements on US products.
Ok, I am able to organize that procedures and specs signed are in place. Supplier have to guarantee that...what? -> same as I can do.
Proven evidence by analytics - impossible. Is under that circumstances validation possible where no limits exists? No, but we can have pre-requisites to reduce probability of occurrence of unintended contamination. You never will be able to demonstrate the ZERO=free from-level.
To demonstrate that products are "free from..." are really free from is scientifically impossible, even if you are taking many samples to increase confidence in statistics.
My position is clearly to state free from only in that cases where free from is defined e.g. gluten-free, perhaps in some countries lactose-free, alcohol-free i.e. where an accepted level + analytical method exists. Is this available for all "tree nuts" as defined by.... there are worldwide several legal definitions what tree nuts are. You have to take care about this too if you are exporting. Do you are able to get statements about pine contamination in supplied ingredients in Europe? Most companies stick to the "allergen profile" defined by local law.
In the case of allergens there is an individual dose-response curve - no accepted level. What free from ....allergens mean? Somethings else than 100% protection?
The Vital 2.0 concept (the basis was proposed by the Allergen Threshhold Group in the US) wants to protect most, not all consumers by using "may contain..." Information which is based on a certain level of an allergenic protein.
To finalize: In my opinion a validation of free from=ZERO-level is not possible on a scientific basis.
Rgds
moskito
Agree with RMAV's post on water validation. Would add that if your water is treated (carbon filtered, softener, RO, DI, UV etc) be sure to send sample of treated water to an independent lab for analysis. Legislation and customer requirements can ell you what the criteria will be for water purity. Also take a close look at water safety in terms of storage, re-circulation, and process flow to be sure the water remains safe from contamination issues. In addition to independent lab analysis we use an outside service to provide monthly PM's and testing on our RO system and water storage, re-circulation and UV treatment. Good luck!