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#1 clcapanni

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Posted 20 January 2021 - 03:51 PM

Hello! We are approaching our initial certification audit for BRCGS and I am a little stumped on metal detector validation...

 

In July we had a gap analysis done of our BRCGS system at the time and our auditor gave us a NC for "4.10.1.2 Minor: Metal Detector Validation is not available for review". To give you some background:

 

- We produce extruded cereal crisps that are purchased by our customers for further processing into nutrition bars, cereals, granolas, etc.,

- We have 1 production line with a vertical fall metal detector. Compressed air forces out any detected metal into a separate bin. Finished product gets packaged into various lined corrugated boxes or totes

- We verify hourly with Fe, Non-Fe, SS at 1.0, 1.2, and 1.5. If detector fails, we pass 2.0 of all and notify maintenance of the issue. If 2.0 were to fail all product goes on hold to last check and production stops until corrected. 

 

I pointed out that it had been inspected and certified by the manufacturer just prior to my start with the company but she stated this was not the same as validation. We had the metal detector inspected and checked by the manufacturer again after the gap analysis for annual certification. When they were out we asked how to validate and the tech was puzzled by our request.

 

We had a consultant out recently to review where we were at with our system and to help troubleshoot some of the hurdles we were stumbling across, the above scenario included. He could not provide much guidance other than an FDA guideline for fisheries. 

 

I have searched through these forums countless times trying to determine if what we do is sufficient or if there is more we should be doing but have not had much luck. Our product is about the size of a rice crispy or slightly larger so creating samples with metal in them to test is not an option.

 

Thank you in advance for your help!



#2 Charles.C

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Posted 21 January 2021 - 12:13 AM

Hello! We are approaching our initial certification audit for BRCGS and I am a little stumped on metal detector validation...

 

In July we had a gap analysis done of our BRCGS system at the time and our auditor gave us a NC for "4.10.1.2 Minor: Metal Detector Validation is not available for review". To give you some background:

 

- We produce extruded cereal crisps that are purchased by our customers for further processing into nutrition bars, cereals, granolas, etc.,

- We have 1 production line with a vertical fall metal detector. Compressed air forces out any detected metal into a separate bin. Finished product gets packaged into various lined corrugated boxes or totes

- We verify hourly with Fe, Non-Fe, SS at 1.0, 1.2, and 1.5. If detector fails, we pass 2.0 of all and notify maintenance of the issue. If 2.0 were to fail all product goes on hold to last check and production stops until corrected. 

 

I pointed out that it had been inspected and certified by the manufacturer just prior to my start with the company but she stated this was not the same as validation. We had the metal detector inspected and checked by the manufacturer again after the gap analysis for annual certification. When they were out we asked how to validate and the tech was puzzled by our request.

 

We had a consultant out recently to review where we were at with our system and to help troubleshoot some of the hurdles we were stumbling across, the above scenario included. He could not provide much guidance other than an FDA guideline for fisheries. 

 

I have searched through these forums countless times trying to determine if what we do is sufficient or if there is more we should be doing but have not had much luck. Our product is about the size of a rice crispy or slightly larger so creating samples with metal in them to test is not an option.

 

Thank you in advance for your help!

 

Hi cicapanni,

 

The diffficulty is usually related to misunderstandings of terms like "validation" and "sensitivity".

 

"Validation" of a MD may cover several elements (see 3rd attachment below) but typically includes validation of the haccp critical limit which requires a procedure whereby yr choice of test strip sizes (= sensitivity)  is justified/validated. So the result is effectively a validation of sensitivity. I anticipate that this aspect is what yr auditor was looking for.

 

The (MD) relevant clause is probably more accurately detailed in 4.10.3.3

 

For one explanation (there are many other threads) see -

 

https://www.ifsqn.co...ng/#entry104767

( the validation procedures involved are basically an evaluation of LOD for the detector)

 

Some comments for  vertical fall MDs  exist elsewhere on this forum. I have attached (first) 2 hopefully useful documents (see Pgs 71, 6 respectively) -

 

Attached File  Metal Detection Guide.pdf   3.17MB   10 downloads

Attached File  guide_how_to_test_your_metal_detector.pdf   815.46KB   14 downloads

Attached File  Mettler - Validation of Metal Detector.pdf   1.39MB   20 downloads

 

This link for horizontal detectors is also quite useful "terminologically" -

 

https://techni-k.co....ion-validation/

 

PS - the manufacturer's preliminary certification is often described as "calibration," just to further confuse the issue.


Kind Regards,

 

Charles.C





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