Final Product Testing Validation
We were told by our SQF Consultant that we need to send out our final product to and ISO 17025 lab for validation. We are unsure of what all needs to be validated and how often we have to send it out. We test for acid, salt, pH, Brix (if applicable) and micro testing for Yeast/Mold and Aerobic. Does the outside lab have to test for all of these or just micro's?
Thank You
Are you currently practicing Hold and release for you micro testing of your finish product? if so i believe you have to test every batch.
Otherwise Quarterly testing should be adequate.
We were told by our SQF Consultant that we need to send out our final product to and ISO 17025 lab for validation. We are unsure of what all needs to be validated and how often we have to send it out. We test for acid, salt, pH, Brix (if applicable) and micro testing for Yeast/Mold and Aerobic. Does the outside lab have to test for all of these or just micro's?
Thank You
Hi jportz,
Simple suggestion - ask yr SQF Consultant what he is talking about.
"Validation" per se unfortunately has no meaning. Sorry.
We do hold and release for our product. We do micro testing in house but, we were told we have to send out to an outside lab for validation during our gap audit. I have asked the SQF Consultant but, he has not responded. I'm just not sure if we have to validate the acid, salt, pH, and Brix test also, and how often samples will need to be sent out for validation.
We do hold and release for our product. We do micro testing in house but, we were told we have to send out to an outside lab for validation during our gap audit. I have asked the SQF Consultant but, he has not responded. I'm just not sure if we have to validate the acid, salt, pH, and Brix test also, and how often samples will need to be sent out for validation.
Hi jportz,
I assume by "release" you are referring to "positive release". This typically (unless SQF specifies otherwise ?) requires a satisfactory, documented, review of all the safety (SQF-Lvl1?)-related testing results generated for the particular end-product XYZ under discussion.
One of the typical requirements within "positive release" is to possess data "validating" that the end-product complies with its product specification (PS) (typically a BCPA safety/quality document). From a haccp POV this would focus on safety-related parameters/limits as defined in the PS.
I speculate that this "activity" is what yr Consultant was referring to. If so, i further speculate that the items to be checked will depend on yr PS/SQF's specific requirements (if any). Possibly there is a clause in a (relevant) SQF module referring to this, (another question for yr [hopefully yet to be paid] Consultant ?
I sympathise with yr unfortunate choice of Consultant. (a cause for complaint to SQF ?)
PS - IMEX it is normal for an auditor to request seeing some external micro data to compare to in-house results on same samples. This is a very small "ring test" / validation of yr own labs capabilities.
Not required. Internal testing is perfectly suitable. However, you will need to show your validation for your internal testing methods/procedures.
Ahhh...consultants make me chuckle. I wonder, did the consultant recommend a lab to you?
It sounds like they took issue with the fact that you were performing end-item testing in-house, but that your in-house laboratory doesn't have a certification or validation that it is capable of performing the tests at the level of an ISO 17025 lab.
If this is the case, the relevant portion of the code is in module 2.
Analysis 2.5.6 Product Sampling, Inspection and Analysis
2.5.6.1
iii. All analyses are conducted to nationally recognized methods or alternative methods which are validated as equivalent to the nationally recognized methods.
iv. Where external laboratories are utilized to conduct input or product analysis, the laboratories shall be accredited to ISO 17025 or an equivalent national standard.
The combination of these two bullet points has established in-house micro lab criteria for my SQF auditors. What they've always requested is evidence of accreditation from outside labs, and a "validation" study for any parameters we tested in house. This meant that your lab did not need to be ISO, but that you did some sort of test to make sure your lab was capable of operating at that level. An example would be testing samples and sending out duplicates to an external lab quarterly or annually to ensure that your results are reasonably close to that "national standard", or a more scientific evaluation like participating in AOAC proficiency testing with the methods and equipment used in your lab.
Typically in food you're held to the methods in the FDA BAM, USDA MLG, the compendium of methods, or an AOAC or AFNOR official method. But most in-house labs are using various market methods (e.g. new rapid detection media) that are simpler and easier to interpret without an actual microbiologist. This requirement makes that okay provided you've "validated" that they're equivalent to the nationally approved methods both in their sensitivity and specificity, and using your equipment and personnel.
With the amount of testing you're performing, I would recommend AOAC proficiency testing, and use it as a performance metric for your equipment and personnel as well.
Go to basics
What do you risk assessment says or determine for the product? Can you support and explain your testing? Is your product High risk?
I hope this helps.
It will eventually, unfortunately, probably come back to resolving Post 3.
Or get some advice/interpretation from another Consultant.
My opinion is that Earth20 has provided the best response:
(1) You do not have to send to 3rd party lab.
(2) If you do send to 3rd party lab they have to be certified to ISO 17025 or equivalent.
(3) If you test internally, you need to have written proof that you are calibrating to a standard that is traceable back to a national standard.