8 replies to this topic

[TruptiG]

Hello,

 

My facility just purchased Xray machine for RTE Not shelf stable deli meat. I need help writing the program and updating the HACCP plan. Only one line will be using X ray detector. Other lines will continue using regular metal detector. 

 

Thank you,

[kingstudruler1]

You have one HACCP plan that covers both lines and the metal detector is a CCP?

 

If you are changing your Hazard Analysis to indicate the x-ray is needed to reduce a FM risk other than metal,   both lines need to have an X-Ray

 

If you purchased the added protection of an X-Ray but there is no added risk of FM other than metal, label the step "metal detection (metal detector or X-Ray)"

 

If one line has a risk of FM other than metal (the one with the x-ray) and the other one doesnt, separate into 2 haccp plans.  

 

Does that work for you?

[jfrey123]

Me thinks kingstudruler hit with the nail on the head.  I'm going to bet one non-existent fake dollar that OP's plant is adding x-ray to satisfy a customer requirement, maybe someone that rhymes with Rostro.  If your PRP's and PC's are controlling FM but metal was the only hazard identified as needing a CCP, and that hasn't changed in your process or HA, then technically that x-ray is only there to detect metal.  The CCP does not dictate what hazards we scan for.  In my agreement with king, you'll want to ensure the x-ray can meet the same critical limits for metal FM as your metal detectors do, and they can then be listed in the same metal detection step in the HACCP flow chart and HA.

 

Now, what'll be interesting to monitor is whether the x-ray starts to hit on things you weren't expecting to find.  Could be that with its non-metal superpowers, you start finding rejections bearing non-metal FM's.  In which case, you'd have to wholly revisit your HA to discover where the non-metal FM is not being controlled and then update that that FM is being controlled at your x-ray CCP.  Which then means MD alone won't be enough for identical lines/processes.

Edited by jfrey123, 04 June 2025 - 08:00 PM.

[Tony-C]

Hi TruptiG,

 

I agree with kingstudruler1 & jfrey123, if you have put in that X-Ray Machine to comply with Costco requirements then it is only a minor change to the HACCP plan: metal detector or X-Ray to remove a metal hazard and I would note that the X-Ray is to comply with the Costco requirement.

 

The SQF Food Safety Code requires compliance with customer and regulatory requirements to supply safe food.

 

Costco: All manufacturing operations must have a properly installed and calibrated X-ray detection device for finished product, except …

 

If the X-Ray Machine is to control a different additional foreign body hazard then that means a separate but similar HACCP plan.

 

Kind regards,

 

Tony

[GMO]

To my mind, the hazard you're controlling for is metal.  It's still metal unless your retailer has demanded otherwise.  Other foreign matter contaminants are often badly detected in x-rays (whatever the glossy brochures say), the only exception I can think of is small stones in root vegetables but not a problem with your product.

 

I would write the HACCP plan with the hazard you're controlling for is metal, explain elsewhere how glass, hard plastic, bone etc are controlled for.  The full hazard would be something like "persistence of metal contamination due to ineffective metal detection or x-ray".  Then your control measure is effective metal detection or effective x-ray detection of metal.

 

In your validation, I'd validate both methods and prove that both are effective.  Just remember to make sure that you buy test pieces appropriate to x-ray and train staff etc.  Some of the controls are different (e.g. put the test card normally on top of pack, not centre of the aperture).  You might have different test piece sizes so you'll need to justify both are acceptable.  I normally use the FDA document on hard and sharp foods as a basis for that.  That's it really.  While some sites will use plastic and ceramic test pieces (the latter as a substitute for bone), the plastic used is often not the same density as plastic in food facilities which is often not detectable and cooked bones are often very hard to detect (especially small pieces).  So they might do that and show it to the auditor but actually if you get them to slice off a piece of the plastic they're using or have a piece of bone returned from a consumer, both do not always detect.  

 

An aside:  I'm going to "big up" metal detectors still.  I think the move to x-rays is understandable where you want that sensitivity improvement which is great for wet or multi component foods.  BUT what metal detectors can do is detect multiple contaminants.  I remember once having an issue where there was metal on metal contact on a line and we were getting small pieces of swarf in product.  They were way below the limit of detection for x-ray but metal detection picked it up because the overall pack had a significantly changed signal in the magnetic field.

[G M]

I don't think I've seen anyone else mention it, but you'll want to add radiation over-exposure to your risk assessment.  More than likely you have a 'low' energy device with some automatic shutoff conditions programmed in, but it will need to be assessed every year, or whatever the manufacturer recommendation is, as part of your annual re-evaluation.

[GMO]

I don't think I've seen anyone else mention it, but you'll want to add radiation over-exposure to your risk assessment.  More than likely you have a 'low' energy device with some automatic shutoff conditions programmed in, but it will need to be assessed every year, or whatever the manufacturer recommendation is, as part of your annual re-evaluation.

 

Radiation exposure to food is not a food safety risk from an x-ray.  The radiation exposure risk is a health and safety risk.  When the "radiological hazards" section of GFSI / FSMA came in, that's considering risks near historical dumping, weapons, accidents etc.  Not industrial x-rays.  Not needed for a HACCP plan.

[G M]

Radiation exposure to food is not a food safety risk from an x-ray.  The radiation exposure risk is a health and safety risk.  When the "radiological hazards" section of GFSI / FSMA came in, that's considering risks near historical dumping, weapons, accidents etc.  Not industrial x-rays.  Not needed for a HACCP plan.

 

It shouldn't be if the device is operating correctly, but that doesn't mean the risk hasn't been introduced.  There are limits to what is acceptable, and you can document that your device is below the designated energy level.  

 

The xray energy limits for food inspection existed decades before FSMA did (Mar. 15, 1977). 21 CFR, Subpart B, Part 179.21

 

§ 179.21 Sources of radiation used for inspection of food, for inspection of packaged food, and for controlling food processing.

 

Sources of radiation for the purposes of inspection of foods, for inspection of packaged food, and for controlling food processing may be safely used under the following conditions:

 

(a) The radiation source is one of the following:

 

(1) X-ray tubes producing X-radiation from operation of the tube source at a voltage of 500 kilovolt peak or lower.

 

(2) Sealed units producing radiations at energy levels of not more than 2.2 million electron volts from one of the following isotopes: Americium-241, cesium-137, cobalt-60, iodine-125, krypton-85, radium-226, and strontium-90.

 

(3) Sealed units producing neutron radiation from the isotope Californium-252 (CAS Reg. No. 13981-17-4) to measure moisture in food.

 

(4) Machine sources producing X-radiation at energies no greater than 10 million electron volts (MeV).

 

(5) Monoenergetic neutron sources producing neutrons at energies not less than 1 MeV but no greater than 14 MeV.

 

 

 

[GMO]

You'd have more risk from Radon sources in the UK.  Genuinely.  

 

Guide to X-ray inspection in the food industry |Loma Systems

 

Summary above.  They're at 1 millionth of the current limit.

 

I have never included it as a hazard and one auditor told me a story of a site who had, she was laughing at their misunderstanding of what radiological hazards are.  Sorry.