2 replies to this topic

[raindonald]

We’re planning to add an X-ray inspection machine (Filter FT-75) to our bottling line and I wanted to check in with others who may have gone through a similar process.

Specifically:

• Does adding an X-ray unit require any additional SOPs or updates to the HACCP manual?
• Are there specific requirements or certifications we need to be aware of under SQF?
• Any documentation or validation procedures we should plan for?

We’re already SQF-certified, and food safety is obviously our top priority—just want to make sure we’re covering all the bases before we finalize installation.

Appreciate any insights or experiences you can share!

[nwilson]

• Does adding an X-ray unit require any additional SOPs or updates to the HACCP manual?  Yes, you will need SOP's as part of general operation and any non-conformances found, your HACCP/Food Safety Plan will need to be updated with the foreign detection device as this is becoming a part of the process flow.  You are also installing/implementing this equipment to reduce foreign material correct? Which would probably fall into CCP/Preventive Control territory depending on the risk assessment and decision matrix. 
• Are there specific requirements or certifications we need to be aware of under SQF?  Requirements are to comply with Separation of Functions in the applicable module to your process as well as 2.4 under food safety plans.  There should be a formal review and sign off on all updated documentation.  
• Any documentation or validation procedures we should plan for? Did you perform a study to assure that your products are suitable for an X-Ray device?  This can be the appropriation study conducted with the manufacturer of the x-ray.  You should have relevant test pieces to conduct verification while the equipment is in use.  What frequency are you going to be verifying the effectiveness of the x-ray machine?  Checklists, CAPA, etc.? 

Edited by nwilson, 21 March 2025 - 08:09 PM.

[G M]

• Does adding an X-ray unit require any additional SOPs or updates to the HACCP manual?

 

On this point you are likely going to need to consider rewording part of your verification.  Specifically, most old schemes for metal detectors rely on three seed types ferrous steel, stainless steel, and "non-ferrous" -- and in the context of an x-ray that last one is problematic because it can mean practically anything.  Its honestly not great for metal detection either. 

 

While aluminum and brass have similar signatures to a metal detector and can be lumped together as "non-ferrous", they are wildly different to an xray.  Copper is three times as dense as aluminum.

 

Our programs specifically call the third challenge out as a 'copper alloy', because brass or bronze bushings and fittings are a reasonable concern.

 

If you have significant sources of aluminum in your process or supply chain that will need to be addressed, its density is much lower than steel.