In-House Gluten Testing – Do COA Results Require Validation?

Hello, 

 

Due to recent issue we have had with gluten, I want to start testing some of our materials. We have glutentox pro tests and have used them for internal investigations. 

 

My question is, if I want to test a material using glutentox pro and report these results on our COA, or to use for incoming material approval, do I need to do a validation or something for this testing?

 

Currently we do no in house testing, the results reported on our COAs are results from a 3rd party lab or supplier's lab. 

 

Thanks!

Since it is a kit, the method and materials are validated by the manufacturer (presuming they sell it under some certification or claim it meets some standard).  What you would need to round things out is competency testing for whoever is performing the testing at your facility.

Glutentox Pro is an AOAC licensed test kit, which you can reference in in your COA to state the method:  AOAC-Glutentox Pro (Internal).   For any incoming material just keep a log and associate this with 2.4.5 NC Product if anything is out of spec.  

 

As GM stated make sure you have some proficiency testing on those who are performing the tests to meet 2.4.4.2.  

 

2.4.4.2 Product analyses shall be conducted to nationally recognized methods or company requirements, or alternative methods that are validated as equivalent to the nationally recognized methods.

Where internal laboratories are used to conduct input, environmental, or product analyses, sampling and testing methods shall be in accordance with the applicable requirements of ISO/IEC 17025, including annual proficiency testing for staff conducting analyses.

External laboratories shall be accredited to ISO/IEC 17025, or an equivalent international standard, and included on the site’s contract service specifications list (refer to 2.3.2.11). 

Follow up question... if we use gluten testing in-house to put on a COA, do we need to participate in a proficiency test with an outside lab annually? 2 of our customers require it for gluten certified products. or is an in-house competency test sufficient?

Follow up question... if we use gluten testing in-house to put on a COA, do we need to participate in a proficiency test with an outside lab annually? 2 of our customers require it for gluten certified products. or is an in-house competency test sufficient?

I know the GFCO (Gluten Free Certification Organization) requires 3rd party proficiency testing, more that they send blind sample for you to test inhouse and report back results.  Its not a bad idea to perform this externally, however can be done internally with a with the proper methods, especially since the results are being put on a COA.  

Follow up question... if we use gluten testing in-house to put on a COA, do we need to participate in a proficiency test with an outside lab annually? 2 of our customers require it for gluten certified products. or is an in-house competency test sufficient?

 

It is probably more practical to use a third party competency process.  If you want to do it internally you then need to validate or certify your own testing process, which for most manufacturers is not cost effective.