ML23261C372
| ML23261C372 | |
| Person / Time | |
|---|---|
| Issue date: | 09/20/2023 |
| From: | Fitzgerald M, Greg Galletti, Kerri Kavanagh NRC/NRR/DRO/IQVB |
| To: | |
| References | |
| Download: ML23261C372 (6) | |
Text
NUPIC Vendor Inspection Issues Discussion September 19-20, 2023 Detroit, MI Kerri Kavanagh, Greg Galletti, & Michael Fitzgerald Quality Assurance & Vendor Inspection Branch Office of Nuclear Reactor Regulation
Discussion Topics 2
Recent Issues observed by NRC Staff:
Potential Missed Opportunities Internal Audits Commercial Grade Dedication
Potential Missed Opportunities 3
Both Mistras Services & ANSYS:
Section 21.21(a)(1)
Evaluation of Deviations and Failures to Comply Mistras Services:
Section 21.21(a)(2)
Submission of Evaluation within 60 days from Discovery Inspection Report (ML23151A458)
Inspection Report, Revision 1 pending ANSYS:
Section 21.21(b)
Failed to inform the purchasers or affected licensees, based on not having capability to perform defect evaluations.
Technical and regulatory (Part 21 & App. B) requirements in the purchase orders did not align with the procedures and processes at both vendors.
ANSYS stated repeatedly that they do not provide a basic component.
Inspection Report (ML23237B258)
Internal Audits 4
Some vendors are not performing.
More complex case of meeting of Criterion XVIII:
Rehiring same firm over multiple years.
Does not examine internal auditing controls and programs.
Questions:
Is Criterion XVIII tacitly approved by acceptance of external auditors report?
Who is performing the evaluation of the audit report?
What is the documented objective evidence that it is appropriate?
What is the basis for using a CoC to meet a Method 3 Evaluation?
Licensees will accept a CoC without performing a survey.
Why is it acceptable to rely on a CoC without a survey to establish the validity of the CoC process?
Maintaining survey audit reports Surveys represent objective quality evidence of completion of the dedication.
Has the component been dedicated if survey has not been maintained?
Survey is performed showing programmatic controls.
When procurement documents are drafted, the utility failed to invoke the controls documented in the survey (by specific procedures or program documents).
One example was of a supplier using a later revision than was evaluated with the survey.
The time scale involved leads to a very large extent of conditions.
6 Michael Fitzgerald Reactor Operations Engineer (301) 415-0420 Michael.Fitzgerald@nrc.gov Greg Galletti Senior Reactor Operations Engineer (301) 415-1813 Greg.Galletti@nrc.gov