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Inspection Form Review And Approval - FDA Requirements

T

theGrod

#1
I would like to know where it is required that inspection forms need to be reviewed and approved by QA before release. I see in 21CFR820.80 where Final Release paperwork needs to be reviewed and approved by QA and/or designated second party. However, I don't see either in 820.80 or in ISO-13485 where incoming and in process inspection sheets need to be reviewed and approved by QA. :bonk:
 
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NikkiQSM

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#2
ISO 13485 - 8.2.4.1 - Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate the person(s) authorizing release of product.
 

Mark Meer

Trusted Information Resource
#3
...Final Release paperwork needs to be reviewed and approved by QA and/or designated second party. However, I don't see either in 820.80 or in ISO-13485 where incoming and in process inspection sheets need to be reviewed and approved by QA.
That might be because "reviewed & approved", and "authorized" are casually used interchangeably whereas, in practice, "review" (e.g. of documentation) is usually a step in the authorization process.

Note that there is no specification of "QA and/or designated second party" for authorization activities. Although this might make the most sense, strictly by the 820 regulations and ISO13485, authorization could be by any "designated individual(s)" (read: appropriately trained/qualified).

So, my suggestion is:

- Authorization to transfer received product to inventory is by the person(s) responsible for receiving. (...and these records may be subject to later review in quality audits).

- Person(s) conducting in-process acceptance activities sign-and-date documentation of their activities. (...and these records are subject to later review during final acceptance).

- A designated person (e.g. QA), authorizes final product release, which includes the activity of reviewing any associated in-process acceptance records (this is part of covering the 21 CFR 820.80(d)(2) requirement that "the associated data and documentation is reviewed").
 
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