10 CFR Part 21 - Reporting of Defects and Noncompliance

T

TamTom

#1
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
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#3
One more quick "Bump". My thanks in advance to anyone who can help with this one.
 
H

Hemi999

#4
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.
 
Last edited by a moderator:

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#5
Anything you can post here to share, such as file attachments, will be appreciated. I do appreciate your reply above either way. Thanks!
 
B

Brad623

#6
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.
 
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