X Ray Scan replaced by a Metal Detector is a NC?

Our X Ray Scan is stablished as a CCP, it went off for one day because of bad functioning and a metal detector was installed instead. Should this be reported as a Non Conformance? I think it should, since ceramic and glass materials cannot be detected with the metal detector. And finished product should be passed trough the scanner once it gets reinstalled.

Hi ajrfrank,


Since X-ray scanner is a CCP, you will need to raise a corrective action with process and the product both.


MM1

Hi.
It depends on what you state as your control measure and critical limits.
If your control measure states "X-Ray" then yes you have a non-conformance. However, if it states "metal detector" then the X-Ray is just that - a metal detector - and do not believe this is a non-conformance. If you mention ceramics or glass in the critical limits or the metal detector cannot detect to the critical limit then again you have a non-conformance.

It depends what the hazard you are controlling is. If the hazard is "persistence of metal in the food due to failure of the x-ray to function correctly" (or similar) and the metal detector is equally effective at detecting metal, then it's fine. However, if the sensitivity of the x-ray is greater or it's being used to detect other contaminants, then you could have an issue come audit.

More importantly though, you need to think through the real risks to the product.

The questions I would ask are:

• Is the x-ray genuinely capable (and challenge tested) against other contaminants, e.g. glass?
• What is the sensitivity of the x-ray machine? How does this compare with the metal detector?
• If the sensitivity of the metal detector is lower, is this likely to cause a hazard to the consumer.

It's also worth remembering that metal detectors are actually better at detecting certain kinds of contaminants, small pieces, thin metal, metal detectable plastics etc.