ISO 13485 8.3 - Non-Conforming Materials - on-line rework or part of process?

Tagin

Trusted Information Resource
The NC Process requires that repeated occurrence of minor issues over multiple batches are investigated under CAPA.

And yet, this situation sounds like these defects are an ongoing problem, that CAPAs heretofore have not resolved? Is there any way to modify the NC process to specify that as long as certain types of defects (i.e., reworkable defects) occur at a rate is under X% then only rework is required?
 

ThatSinc

Quite Involved in Discussions
And yet, this situation sounds like these defects are an ongoing problem, that CAPAs heretofore have not resolved? Is there any way to modify the NC process to specify that as long as certain types of defects (i.e., reworkable defects) occur at a rate is under X% then only rework is required?

This requirement has only just been implemented ;)
 
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