:argue: Does anyone know if there is any regulatory (CFR or ISO) requirement who Receiving Inspection reports to?

I don't think there is however unless it reports into the Quality Organization there is definitely a potential for a conflict of interest if it reports into the operations group.

:argue: Does anyone know if there is any regulatory (CFR or ISO) requirement who Receiving Inspection reports to?

I don't think there is however unless it reports into the Quality Organization there is definitely a potential for a conflict of interest if it reports into the operations group.

The Receiving Inspection section should report to QUALITY Department and is very true to what you said on potential for conflict of interest.

This is mentioned clearly in section 211.22 of 21 CFR Part 211, by FDA. Refer to the weblink, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=211.22

You can also refer to this weblink point no. 5, http://www.fda.gov/foi/warning_letters/g5436d.pdf which is a warning letter for not fulfilling the requirements of section 211.22.

Hope this clarifies.

The requirements of ISO 9001:2000 and FDA requirements are not the same. In general, FDA requirements will be more prescriptive.

There is no requirement within ISO 9001:2000 for the reporting structure or independence of inspection. The only requirement for independence is in the internal audit.

The need for independence will depend on the maturity level of the organization. I worked in one ISO registered facility where there were zero quality inspectors. All inspection was performed by the operator as part of their job. This facility had the best quality of any that I have worked at. Other facilities that were less mature absolutely required an independent inspection function.

The more mature the facility, the more responsibility should be moved to the operator and away from the inspection function.

The requirements of ISO 9001:2000 and FDA requirements are not the same. In general, FDA requirements will be more prescriptive.

There is no requirement within ISO 9001:2000 for the reporting structure or independence of inspection. The only requirement for independence is in the internal audit.

Yes, Miner. I am aware of this.

[/QUOTE] Does anyone know if there is any regulatory (CFR or ISO) requirement who Receiving Inspection reports to? [/QUOTE]

Gave the FDA reference as the originator of the thread, gwaikle, wanted to know if there are CFR or ISO requirements for incoming inspection.

The Receiving Inspection section should report to QUALITY Department and is very true to what you said on potential for conflict of interest.

This is mentioned clearly in section 211.22 of 21 CFR Part 211, by FDA. Refer to the weblink, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=211.22

You can also refer to this weblink point no. 5, http://www.fda.gov/foi/warning_letters/g5436d.pdf which is a warning letter for not fulfilling the requirements of section 211.22.

Hope this clarifies.There is nothing in the references you cited that addresses to whom that the Quality Control Unit reports to. I've never seen a documented requirement for that.

There is nothing in the references you cited that addresses to whom that the Quality Control Unit reports to. I've never seen a documented requirement for that.

I think the question was whether it's required for receiving inspection to report to the QCU.

I did a quick search at the electronic CFR site ( http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title14/14tab_02.tpl ) and received six hits on "receiving Inspection" non of which touched on who they would report to. I know that there is nothing in 14 CFR 145 about who they report to.

I did a quick search at the electronic CFR site ( http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title14/14tab_02.tpl ) and received six hits on "receiving Inspection" non of which touched on who they would report to. I know that there is nothing in 14 CFR 145 about who they report to.

I'm far from being an expert in this area, but it seems to me that the regulations require the existence of a 'Quality Control Unit,' and specify the responsibility and authority that the unit must have, but they don't say that other "units" within the business can't have similar responsibility and authority. In other words, if the QCU has the authority to inspect and reject stuff, that doesn't mean (the way I read it) that no one else can inspect and reject stuff.

Firstly ISO 9001 is not a regulatory requirement.

Secondly, suggest you search the Medical Device Quality Systems Manual (http://www.fda.gov/cdrh/qsr/contnt.html)

When I searched the FDA QSR (http://www.fda.gov/cdrh/fr1007ap.pdf), I found out the following:


Subpart H—Acceptance Activities
§ 820.80 Receiving, in-process, and finished device acceptance.
(a) General. Each manufacturer shall establish and maintain procedures for
acceptance activities. Acceptance activities include inspections, tests, or
other verification activities.
(b) Receiving acceptance activities. Each manufacturer shall establish and
maintain procedures for acceptance of incoming product. Incoming product shall be inspected, tested, or otherwise verified as conforming to specified requirements. Acceptance or rejection shall be documented.....

(e) Acceptance records. Each manufacturer shall documentacceptance activities required by this part. These records shall include: (1) The acceptance activities performed; (2) the dates acceptance activities are performed; (3) the results; (4) the signature of the individual(s) conducting the acceptance activities; and (5) where appropriate the equipment used. These records shall be part of the DHR.
So, as far as I can tell, the FDA does not impose any requirements about the organizational structure and lines of reporting for the incoming inspection function. That said, we all should remember that many FDA inspectors are "old school" and might get concerned with the scenario where an incoming inspection department reports outside of the QA function.

Thank you all for your interest in answering this question. My firm belief is that eventhough there is not a direct command in either the CFR 820 (or any other section for that matter) or ISO13485:2003 there is a danger of an observation from one of the agencies, either the FDA or a Notified body that your receiving inspection operation is being influenced to push items through because production needs them. At least if RI is under QA/QC you can avoid that perception of bias.
As I indicated in my very first post I was pretty sure there is not any direct requirement forcing the RI to be under QA/QC, but it "probably" should be.
The warning letter alluded to above was for a company that falls under the drug GMP's. We fall under the device GMP's. since we make Class II and Class III medical devices for cardio vascular desease. :thanx:

...that your receiving inspection operation is being influenced to push items through because production needs them. At least if RI is under QA/QC you can avoid that perception of bias.
Actually, the FDA acknowledges the fact that production might get a hold AND use incoming products that have not been fully verified at receiving inspection:


FDA has permitted manufacturers to use incoming items that had not yet been proven acceptable for use, provided that the manufacturer maintained control of the unapproved items and could retrieve the product that contained the unapproved items before distribution. Therefore, the requirement that product ‘‘shall not be used or processed until * * * verified’’ has been deleted from § 820.80(b), now entitled ‘‘Receiving acceptance activities.’’ However, FDA emphasizes that while the product can be used in production prior to verification, it cannot be distributed prior to verification. FDA does not permit the distribution of unapproved product through an urgent use provision, because all finished devices must comply with § 820.80(d), ‘‘Final acceptance activities,’’ before they are released for distribution.