4 replies to this topic

[QAKat]

Hello, 

 

I have a customer asking for our foreign object mitigation validation but I have no clue what that is or how to do it. 

Can someone help in translating it into layman's terms?

 

Thank you!

[Tony-C]

I QAKat,

 

What foreign body risks have you identified? what control measures have you implemented to prevent/minimise the risk of product contamination? and for any significant hazards what evidence do you have that that your control measure/control limits are appropriate?

 

Validation can come from legislation, scientific studies, industry codes of practice etc. Examples that come to mind include:

 

Food and Drug Administration - CPG Sec. 555.425 Foods, Adulteration Involving hard or Sharp Foreign Objects

 

Food Defect Levels Handbook

 

Kind regards,

 

Tony

 

 

[CaliforniaFS]

Hi, it means they want your SOP for foreign object control and how has it been proven to be effective.

Depending on your commodity it could be as simple as visual inspections to a metal detector. Your validation for visual inspections would be your quality inspections finding no foreign objects and not having customer/consumer complaints... validation for metal detector would be records and not having customer/consumer complaints. Some commodities can be visual while others such as baked goods, or powders need metal detectors or even x-rays.

[Tony-C]

Hi, it means they want your SOP for foreign object control and how has it been proven to be effective.

Depending on your commodity it could be as simple as visual inspections to a metal detector. Your validation for visual inspections would be your quality inspections finding no foreign objects and not having customer/consumer complaints... validation for metal detector would be records and not having customer/consumer complaints. Some commodities can be visual while others such as baked goods, or powders need metal detectors or even x-rays.

 

Hi CaliforniaFS,

 

That may be what they want but what you are referring to is verification

 

To explain taking your example, metal detection testing requires running test pieces of a nominated size and material through the metal detector and ensuring that they are rejected (or identified) if there is no rejection mechanism. For metal detector validation I would want, a recommended method and test piece sizes from the manufacturer, validation evidence that the test piece size and method will remove the target hazards and validation trials that show that products with test pieces inside are identified/rejected when placed in the least sensitive part of the detector. At the same time as validation trials you can establish your verification methods with ensuring you get the same result using the test pieces outside of the product.

 

Further verification can be achieved by analysis of rejected samples and customer complaints.

 

Kind regards,

 

Tony

[CaliforniaFS]

Hi CaliforniaFS,
 
That may be what they want but what you are referring to is verification
 
To explain taking your example, metal detection testing requires running test pieces of a nominated size and material through the metal detector and ensuring that they are rejected (or identified) if there is no rejection mechanism. For metal detector validation I would want, a recommended method and test piece sizes from the manufacturer, validation evidence that the test piece size and method will remove the target hazards and validation trials that show that products with test pieces inside are identified/rejected when placed in the least sensitive part of the detector. At the same time as validation trials you can establish your verification methods with ensuring you get the same result using the test pieces outside of the product.
 
Further verification can be achieved by analysis of rejected samples and customer complaints.
 
Kind regards,
 
Tony

Yes you’re right. The records would have that validation. With a metal detector you validate before running by using those sticks with metal samples on them… I forget what their called but I remember it being required before production. Also calibration records were needed. All of which is noted on the SOP. Not all products require metal detection, interested in knowing what the poster needs validation on.