7 replies to this topic

[matthewcc]

Hello all, I have a question about a critical control point (CCP)/preventive control that was missed during a packaging run.

 

To be clear, this was a metal detection CCP, and two of the three test pieces were rejected properly. The third was not. In lieu of repairing the metal detector, confirming all three test pieces were rejected, and re-running all product through the metal detector, we inspected screws and bolts on the packaging line to see whether any were missing. Seeing none missing, we released the product.

 

1. Is it acceptable to handle a missed CCP like this? That is, is it acceptable that, in place of repairing the metal detector, confirming all three test pieces were rejected, and re-running all product through the metal detector, we had a different way of determining that no metal pieces were in the product?

 

2. If it is acceptable, then don't we need some comprehensive list of all screws we need to check for, and verify that's done, instead of simply saying we examined the machines and saw no screws missing. In other words, how detailed do we need to get?

 

I'm wondering how alarmed I should be that this CCP was missed and we released product anyway with this documented check.

 

We are regulated in the United States under 21 CFR Part 111 and 117 and we have SQF and NSF GMP certifications. 

 

Thank you,

Matthew

[SQFconsultant]

is that the procedure that your written documentation on metal detecting calls for?

 

But, then, what happens every time you run a check on the test piece and it fails to trip - do you have to do all this stuff instead of what the standards call for?

 

As an Auditor if i saw this as the correction, I' compare what was done vs. what the written documentation says is to be done and act accordingly - something tells me this would not be an acceptable thng considering that metal may possibly be introduced - then making sure all the bolts and screws are in place would not matter.

[matthewcc]

No, this is not what our procedure and written documentation on metal detecting call for.

[kconf]

I am lost. Where does checking nuts and screws come from?

[kconf]

And what was the third piece for? SS, Fe, NFe? 

[matthewcc]

Checking the screws and bolts on the packaging line was to verify that none were missing in lieu of meeting the CCP requirements; it was to verify that there were no metal pieces in the product. It was an attempt to perform the same function as the metal detector to verify that there was no foreign object metal in the product bottles.

 

I am lost. Where does checking nuts and screws come from?

[matthewcc]

The blue ferrous card 1.0 mm Fe passed through undetected.

 

And what was the third piece for? SS, Fe, NFe? 

[kconf]

IDK man. You are in trouble zone.