10 CFR Part 21 - Reporting of Defects and Noncompliance

[TamTom]

Hello,

to all of you, who must fulfill NQA-1 or other nuclear standards.

How did you fulfill the part 21.21, that I must consider on all complaints failures etc. I have on any part (nuclear or not), if a risk for a nuclear part is existing.

I want to prepare a checklist, that shal be used for complaints as well for nonconform mesuring devices.

Did anyone have something similar?

Regards,

Tamara

[Stijloor]

A Quick Bump!

Can someone help Tamara?

Thank you very much!!

Stijloor.

[Marc]

One more quick "Bump". My thanks in advance to anyone who can help with this one.

[Hemi999]

Not sure just what you are asking but I will take a stab at it.
On the NCR form add a check box for 10CFR21 review, it should state applicable or not applicable. Contact me and i will also get you a procedure and forms to use as an example.

Admin note: Jim can be contacted through information in his User Profile: Hemi999.

[Marc]

Anything you can post here to share, such as file attachments, will be appreciated. I do appreciate your reply above either way. Thanks!

[Brad623]

Here is what an auditor (like me) would expect to see:

On your Nonconformance Report form, in an area where the QA Manager or equivalent will be reviewing the NCR, there should be a question stating "10CFR21 evaluation required?" with a Yes and No check box.

There should be something similar on your Corrective Action form if it is a separate form.

There should then be a separate form for a 10CFR21 evaluation which includes questions regarding whether the issue affects items that have left your location and whether they could affect safety of a nuclear power plant.

[crager34]

I know it's late, but here is the form I use which should meet 10 CFR50 Appendix B, NQA-1, and ISO 9001-2008