ML18179A348

Title 10 of the Code of Federal Regulations Part 50 Appendix B Criterion Xviii Interpretation

ML18179A348
Person / Time
Issue date:	08/13/2018
From:	Kerri Kavanagh NRC/NRO/DCIP/QVIB2
To:	Coren M Duke Energy Corp
Herrity T
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ML18179A342	List: ML18179A348
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Download: ML18179A348 (3)

Text

.August 13, 2018 Mark Coren NUPIC Chairman Duke Energy 526 South Church Street Mail Code: EC06L Charlotte, NC 28202

SUBJECT:

Title 10 of the Code of Federal Regulations Part 50 Appendix B Criterion XVIII Interpretation

Dear Mr. Coren,

This letter responds to your letter dated February 22, 2018, that asks for an interpretation of Title 10 of the portion of Code of Federal Regulations (10 CFR) Part 50 Appendix B Criterion XVIII Audits stating:

A comprehensive system of planned and periodic audits shall be carried out to verify compliance with all aspects of the quality assurance program and to determine the effectiveness of the program. The audits shall be performed in accordance with the written procedures or check lists by appropriately trained personnel not having direct responsibilities in the areas being audited. Audit results shall be documented and reviewed by management having responsibility in the area audited. Followup action, including reaudit of deficient areas, shall be taken where indicated.

Your letter states that the background for this question is that in the past NUPIC auditors have found situations where a supplier was conducting a single internal audit to verify compliance with all aspects of the Quality Assurance (QA) program year after year with the same contracted auditor. The suppliers internal auditor uses their own work from the previous year as evidence to determine that the supplier is compliant with Criterion XVIII. You go on to state that NUPIC auditors maintain that this situation is unacceptable because the vendors internal auditor is evaluating their own work, which is a situation that the guidance in Nuclear Regulatory Commission (NRC) Inspection Procedure (IP) 43002, Routine Inspections of Nuclear Vendors considers unacceptable. 1 1 Step c. of Section 03.18 Audits of IP 43002, Routine Inspections of Nuclear Vendors, (Jan. 27, 2017) tells inspectors to assess audit controls by doing the following: Verify that audit teams were selected using qualified auditors. Verify that selected auditors are not auditing their own work.

M. Coren Furthermore, your letter states:

Recently a supplier has challenged this, claiming that their internal auditor was not responsible for the audit program, therefore this meets the Criterion XVIII requirements.

The challenge to the findings resulted in NUPIC asking NRC for clear guidance, by posing the following question:

With regard to appropriately trained personnel not having direct responsibilities in the areas being audited, would this requirement be met if an individual responsible for evaluating the internal audit controls during an annual internal audit utilized the internal audit from the previous year performed by the same individual as objective evidence that the supplier's internal audit controls were in compliance with the supplier's QA program and 10 CFR 50 Appendix B Criterion XVIII?

You also ask that NRC explain the basis for the conclusion.

In the case presented above, it is the NRC staffs understanding that the contracted auditor performed an audit to verify compliance with all aspects of the quality assurance program and to determine the effectiveness of the program as required by Criterion XVIII. Your question concerns the next time the person performs the audit. Essentially, you ask: Can an auditor perform sequential audits pursuant to Criterion XVIII without violating the part of Criterion XVIII that states that the audits shall be performed ... by ... personnel not having direct responsibilities in the areas being audited?

If a person performed an audit of the previous audit (for which the person was directly responsible) with the twin goals of verifying compliance with the Criterion XVIII Audits aspect of the quality assurance program and determining the effectiveness of the previous Criterion XVIII audit, then the audit of the Criterion XVIII aspect of the previous audit likely would not meet the not having direct responsibilities clause of Criterion XVIII.

However, if a person simply noted the existence of the previous audit (for which the person was directly responsible), but made no assertions concerning compliance or effectiveness of the previous audit, then the practice likely would not run afoul of Criterion XVIII. Noting the existence of the previous audit is not the same as carrying out an audit of the previous audit. In this scenario, another individual would be required to do the audit to verify the effectiveness of the previous internal audit consistent with the requirements of Criterion XVIII.

I trust that this response provides the clarification you need to communicate with your suppliers.

Please contact me, Kerri Kavanagh at 301-415-3743, if further clarification is needed.

Sincerely, Kerri A. Kavanagh, Chief /RA/

Quality Assurance Vendor Inspection Branch-2 Division of Construction Inspection and Operational Programs Office of New Reactors

ML18179A342 *via e-mail NRO-002 OFFICE NRO/DCIP NRO/DCIP NRO/DCIP NRO/DCIP NAME THerrity GGalletti TJackson (JHeath for)* KKavanagh DATE 06/29/2018 06/29/2018 06/29/2018 08/13/2018 OFFICE OGC NRO/DNRL NRO/DNRL NAME MLintz JRanklin DATE 08/13/2018 07/16/2018 07/18/2018