'Metal detection equipment shall be in place unless risk assessment demonstrates that this does not improve the protection of final products from metal contamination. Where metal detectors are not used justification shall be documented. The absence of metal detection would only normally be based on the use of an alternative, more effective method of protection (e.g. use of X-ray, fine sieves or filtration of products).'
So how do I go about risk assessing my way out of this one?
This is what I have so far -
The mix goes through a very fine sieve, and there are not many process steps after sieving. We have added the sieve as close to filling as we possibly can.
We do add some more raw materials after the sieving, some in solid form and some in liquid.
All of our suppliers have some sort of foreign object detection as declared in their RMQ. So we would hope they are metal free!
There are basically 3 possibilities of contamination
-raw materials (they guarantee to be free from foreign matter)
-Our own process machinery (always a chance a pump can grind or whatever)
-From the sorroundings (not very likely,but sometimes it does happen in industry, loose screws or whatever).
We have never had the metal detectors on the other lines pick up metal, and they share a lot of the same raw materials and sometimes some of the same prcoess equipment (it can be moved fom line to line).
We have also never had a customer complaint about metal.
I am actually not that concerned about metal contamination, it's not a process that is likely to pose a risk.
So many experts in the field here - would an auditor be satisfied with my arguements or is there more I should consider?
In my experiece, if we did start to have metal contamination, it is most likely to be small shard from a pump grinding on itself, which would not be picked up by the metal detector until suddenly bigger pieces started to come off. Hopefully this will never happen, thats why we have preventative maintenance right!