NRC-98-0001, Requests NRC Review & Approval of Change to QA Program as Contained in Section 17.2 of Plant Ufsar.Proposed Change Deletes Fitness for Duty Lab from List of Nuclear Generation Areas That Will Be Audited on Periodic Basis
| ML20198P538 | |
| Person / Time | |
|---|---|
| Site: | Fermi  |
| Issue date: | 01/14/1998 |
| From: | Borer P DETROIT EDISON CO. |
| To: | NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM) |
| References | |
| CON-NRC-98-0001, CON-NRC-98-1 NUDOCS 9801220148 | |
| Download: ML20198P538 (5) | |
Text
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January 14,1998 NRC-98-0001 U. S. Nuclear Reguhtory Commission Attn.: Document Control Desk Washington, D.C. 20555
References:
- 1) Fermi 2 NRC Docket No. 50-341 NRC License No. NPF-43
- 2) Detroit Edison Letter to NRC," Proposed Quality Assurance Program Change for Audit Program" NRC-96-0043, dated May 10,1996
- 3) NRC Letter to Detroit Edison, dated June 7,1996
Subject:
Pmnosed Ouality Assurance Procram Chance for Audit Procram In accordance with 10 CFR 50.54(a), Detroit Edison requests NRC review and approval of a change to the Fermi 2 Quality Assurance Program as contained in Section 17.2 of the Fermi 2 Updated final Safety Analysis Report (UFSAR). This change is to revise Section 17.2.18.5, " Scope and Schedule of Audits" of the UFSAR by deleting ' Fitness for Duty Laboratory' from the list of Nuclear Generation areas that will be audited on a periodic basis.
In Reference 2 Detroit Edison requested approval to remove the requiremer.t to perform an annual audit of the fitness for duty laboratory, which was subsequently granted by the NRC in Reference 3. However, in Reference 2, Detroit Edison committed to conducting this audit "as specified in the Quality Assurance Program, i.e., at least once per 24 months or as necessary based on program performance or changes in the program." The regulation [10 CFR 26.80 (c)) containing requirements related to audits of the fitness-for-duty program makes reference to Appendix A for NRC guidelines requiring licensee audits of Department cf Health and Human Services (HHS)-certified laboratories. However,10 CFR 26 Appendix A, Section 2.7 (m) discusses only inspections and evaluations prior to the award of a contract, and does not require periodic QA audits of HHS-certified fitness for duty il laboratories.
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USNRC NRC-98-0001 Page 2 Additionally, the provision for conducting periodic audits of fitt.ess for duty program contractors and vendors as described in 10 CFR 26.80 (a) does not apply to the fitness for duty laboratories, as they are not within the protected area of the plant.
Therefore, Detroit Edison requests Orproval to delete ' Fitness for Duty Laboratory' from the list of Nuclear Generation areas that will be audited at least once per 24 months as described in the Fermi 2 Quality Assurance Program Description, UFSAR Section 17.2.18.5. Ilowever, Detroit Edison will continue to conduct audits and evaluations of these laboratories before awarding the contract, and reserves the right to audit the contracted laboratories at any time by Detroit Edison and the NRC.
Detroit Edison's compliance with the requirements of 10 CFR 50, Appendix B is not adversely affected by this proposed change in the Fermi 2 Quality Assurance program. The marked up pages of Section 17.2.18.5 of the Fermi 2 UFSAR are attached. Prompt review and approval of this request will be appreciated.
If you have any questions, please contact Mr. Norman K. Peterson, Director, Nuclear Licensing at (313) 586-4258.
Sincerely,
)
e Paul J. Borer Vice Presiden Nuclear Generation Enclosure cc: A. B. Beach B. L. Burgess G. A. Ilarris A. J. Kugler
Enclosure to NRC-98-0001 Page1 FERMl 2 UFSAR 17.2.18.5 Scone and Schedule of
- dit s The scope and schedule of audits to be performed will be established by Nuclear QA in coordination with the responsible organizations in accordance with the requiremente of the Nuclear QA progra.n.
Audit schedules will indicate the activity to be audited and the minimum frequency, and will assign the primary responsibility for the performance of the addit.
The audit schedule will be reviewed and revised periodically by Nuclear QA in coordination with the responsible organizations to make certain that coverage and schcaule reflect current activities.
A prominent factor in developing and revising audit schedules will be performance in the subject area.
The audit schedule will be revised so that weak or declining areas get increased audit or surveillance coverage and strong areas receive less coverage.
A maximum interval is set to ensure that all areas receive periodic audit coverage.
The following internal Nuclear Generation areas will be audited at least once per 24 months, except where a specific frequency is listed or a frequency is specified by regulation.
a.
The conformance of unit operation to prov.4sions contained within the Technical Specifications and applicable license conditions.
b.
The performance, training and qualifications of the entire unit staff.
c.
The results of actions taken to correct deficiencies occurring in unit equipment, structures, systems, or method of operation that affect nuclear safety at least once per 12 months.
d.
The performance of activities required by the Operational Quality Assurance Program to meet the crite -i a of Appendix B, 10CFR Part 50.
e.
The fire protection programmatic controls including the implementing procedures by qualified licensee QA personnel.
f.
The fire protection equipment and program implementation, utilizing either a qualified
Enclosure to NRC-98 0001 Page 2 offsite licensee fire protection engineer (s) or an outside independent fire protection consultant.
An outside independent fire protection consultant shall be utilized at least every third year.
g.
Any other area of unit operation considered 4
appropriate by the Nuclear Safety Review Group or the Senior Vice President-Nuclear Generation.
h.
The radiological environmental monitoring program and the recults thereof, i.
The OFFSITE DOSE CALCULATION MANUAL and implementing procedures, j.
The PROCESS CONTROL PROGRAM and implementing procedures for processing and packaging of radioactive wLates, k.
The performance of activities required by the Quality Assurance Program to meet the provisions of Regulatory Guide 1.21, Revision 1, June 1974 and Regulatory Guide 4.1, Revision 1, April 1975.
(Radioactive Effluents and Environmental Monitoring) 1.
The Safeguards Contingency Plan and Security Program (as specified by regulation).
m.
Access Authorization (as specified by regulation).
n.
Fitness for Duty (as specified by regulation),
o.
Emergency Preparedness (as specified by regulation).
p.
Radiological Protection (as specified by regulation).
q; _Pitnccc for Outy Labcratory.
l q e.
Station Blackout.
r e.
Nonradiological Environmental Protection Program.
Enclosure to
_ NRC-98-0001 Page 3 t
Audits are initiated as early as practicable in the life of the activity, consistent with the schedule for accomplishing the activity, to ensure the timely implementation of QA requirements.
Audit scope and schedules are established based on the status and importance of the activities performed to ensure the adequacy of, and conformance with, the Nuclear QA
. program.
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