Inspection Form Review And Approval - FDA Requirements

T

theGrod

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:
 

NikkiQSM

Quite Involved in Discussions
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
...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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