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Is validation required when consumables are changed

#1
Recently going through a regulatory audit, we were told that our validations were incomplete and not to level required as we were not re-validating the equipment when a consumable was changed (example electrode on a welding machine). As you can understand, this brought along some serious concern as these consumables are typically changed each day or two due to wear or use. Initially our machine was qualified and validated testing the extremes of the machine settings and consumables so I am having a difficult time on why you would need to put your equipment through revalidation each time a consumable was changed.

I would appreciate any feedback from the group.
 
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Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#2
I can think of two ideas

1) A risk-based assessment that these changes have no impact
2) A test where you intentionally replace the consumables and document the results to demonstrate that they have no impact.
 

JJ_FDA

Involved In Discussions
#3
Consider, depending on your risk assessment, requiring some sort of requalification test each time the consumable is replaced. Replaced a burned-out lightbulb at home? Flick the switch on and off after you replaced the bulb to make sure it works before you go on with your day. Saves you from discovering, when it's dark out, that your new lighbulb doesn't work.

Not sure why auditor is calling for revalidation of the whole thing. That seems extreme.
 
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