In Reply to Parent Post by Ronen E
in the medical industry products made for final validation are typically usable / sellable provided that the (documented) settings used in their making are within the eventually approved ones. Such products are usually quarantined until final approval and then released for use / sale. Products made prior to the final validation (usually smaller quantities) are typically scrapped / recycled / archived (depending on the particulars)
It seems that some of this not only varies (a lot) by market segment or industry segment...but that it also varies quite a bit by outlook.
Does "Effective date" mean:
- Date the procedure went into use
- Date the procedure went into approved, documented use.
- Date prior to which the procedure should not be used
- Date you came up with the procedure that ended up later being validated
- Date the document went into play
In DoD, it seems that Document comes first, then you can do it. I'm not in DoD.
In an ongoing manufacturing line like mine, the process goes into play (with customers informed it is in development), gets validated (often via customer feedback), then gets documented, approved and distributed.
If it is a tweak to an existing process, it is under mutual waiver of the existing process.
When I write a document for a process, it has an effective date as of when we started using
the version that later got validated and documented.
I have no issue at all with a final approval in March for a document effective as of January...provided that there was a temporary work order/waiver/process development/new process design in place from January through distribution.
.....And provided that anyone who got the product was aware that it was made by a developmental process.
Fly in DoD...apparently not.
Fly in medical...apparently not.
And this is a medical thread.....so I'll stop.