Note: I don't know if this post belongs exclusively with medical devices but since it was noted during a medical devices audit, this is where I placed it.

I am reviewing two audit forms that ask "Are all production items tested at interim stages of manufacturing production?". Can somebody clairify what "interim stages" means with regards to this question?

The way I am reading it is "Are subassemblies within the unit tested at a subassembly level?" This would be as opposed to building up an entire unit and testing everything at one time.

Am I close or am I totally off base?

:thanks:

Could it be that the writer of the NC meant "interval" instead of "interim"? That is how I would interpret it. :2cents:

RCW,

I think you have it right.

In our case - sheet metal fabrication - we perform 1st piece approvals off different operations.

This would be classified as interim stages.

................... I am reviewing two audit forms that ask "Are all production items tested at interim stages of manufacturing production?". Can somebody clairify what "interim stages" means with regards to this question? ...........

Ours is an injection molding process. So I would define "Interim stages of manufacturing" as -

Incoming - Testing of Resin

In process - First sample testing, 2 hourly testing during manufacture and last sample testing

Final - Testing Product as per specifications

Out of Box Audit (OBA) - prior to shipment to Customer

I think this would be in-process controls that you are refering to.