ML21349B323
| ML21349B323 | |
| Person / Time | |
|---|---|
| Site: | 99900905 |
| Issue date: | 12/15/2021 |
| From: | Kerri Kavanagh NRC/NRR/DRO |
| To: | Jefferson F NTS Huntsville |
| Diaz-Castillo Y | |
| References | |
| IR 2021201 | |
| Download: ML21349B323 (3) | |
Text
December 15, 2021 Mr. Fred Jefferson Nuclear Quality Manager NTS Huntsville 7800 Highway 20 West Huntsville, AL 35806
SUBJECT:
NUCLEAR REGULATORY COMMISSION VENDOR INSPECTION REPORT OF NTS HUNTSVILLE, NO. 99900905/2021-201 AND NOTICE OF NONCONFORMANCE
Dear Mr. Jefferson:
Thank you for your December 6, 2021, letter in response to the Notice of Nonconformance (NON) that was discussed in the subject U.S. Nuclear Regulatory Commission (NRC) inspection report (IR).
We have reviewed your letter and found that it is not fully responsive to NON 99900905/2021-201-01. Specifically:
1.
Your response to NON 99900905/2021-201-01 failed to address several areas of concern to the NRC staff. Please clarify your response as follows:
a.
The response does not address if NTS Huntsville performed an extent of condition.
Clarify if NTS Huntsville performed an extent of condition and provide the results of this evaluation to determine if other suppliers in the Approved Suppliers List were also reviewed and approved using a remote technique (e.g., audit or commercial-grade survey).
b.
The response states, in part, that NTS performed a review of the purchase orders issued to the vendor since the May 2021 survey was conducted. All purchase orders issued to the vendor required the vendor to perform calibration services to their ISO/IEC 17025:2017 accreditation. The use of the ISO/IEC 17025:2017 accreditation in lieu of performing a commercial-grade survey is subject to the implementation of certain requirements as documented in the NRCs Final Safety Evaluation for Technical Report NEI 14-05A, "Guidelines for the Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services," Revision 1, dated November 23, 2020 (Agencywide Documents Access and Management System Accession No. ML20322A019). Clarify if the purchase orders issued to the vendor since May 2021 adequately implement the applicable requirements for the use of the ISO 17025:2017 accreditation process.
In accordance with Title 10 of the Code of Federal Regulations (10 CFR) 2.390, Public Inspections, Exemptions, Requests for Withholding, the NRC will make available electronically for public inspection a copy of this letter, its enclosure, and your response through the NRCs Public Document Room or from the NRCs Agencywide Documents Access and Management System, which is accessible at http://www.nrc.gov/reading-rm/adams.html. To the extent
F. Jefferson 2
possible, your response (and if applicable), should not include any personal privacy, proprietary, or Safeguards Information (SGI) so that it can be made available to the public without redaction.
If personal privacy or proprietary information is necessary to provide an acceptable response, please provide a bracketed copy of your response that identifies the information that should be protected and a redacted copy of your response that deletes such information. If you request that such material be withheld from public disclosure, you must specifically identify the portions of your response that you seek to have withheld and provide in detail the bases for your claim (e.g., explain why the disclosure of information would create an unwarranted invasion of personal privacy or provide the information required by 10 CFR 2.390(b) to support a request for withholding confidential commercial or financial information). If SGI is necessary to provide an acceptable response, please provide the level of protection described in 10 CFR 73.21, Protection of Safeguards Information: Performance Requirements.
Please contact Mr. Yamir Diaz-Castillo at 301-415-2228, or via electronic mail at Yamir.Diaz-Castillo@nrc.gov, if you have any questions or need assistance regarding this matter.
Sincerely, Kerri A. Kavanagh, Chief Quality Assurance and Vendor Inspection Branch Division of Reactor Oversight Office of Nuclear Reactor Regulation Docket No.: 99900905 Signed by Kavanagh, K on 12/15/21
ML21349B323 NRR-106 OFFICE NRR/DRO/IQVB NRR/DRO/IQVB NAME YDiaz-Castillo KKavanagh DATE 12/15/2021 12/15/2021