ML20151C558
| ML20151C558 | |
| Person / Time | |
|---|---|
| Site: | San Onofre  |
| Issue date: | 03/31/1988 |
| From: | Baskin K SOUTHERN CALIFORNIA EDISON CO. |
| To: | Martin J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION V) |
| Shared Package | |
| ML20151C319 | List: |
| References | |
| NUDOCS 8804130064 | |
| Download: ML20151C558 (4) | |
Text
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r Southem Califomia Edison Company P. O. S O M S 0 0 3344 WALNUT GROVE AVENUE ROS EM EAD, CALIFORNI A 9i770 wic Pat Ot se a e 302 os March 31, 1988 d
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U. S. Nuclear Regulatory Commission i'
_.C Office of Inspection and Enforcement
,y Region V
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1450 Haria Lane, Suite 210
'O Halnut Creek, CA 94596-5368 u,
L1 Attention: Mr. J. B. Hartin, Regional Administrator
Dear Sir:
Subject:
Docket No. 50-362 IE Inspection Report No. 50-362/88-04 Response to Notice of Violation San Onofre Nuclear Generating Station, Unit 3 i
Hr. R. A. Scarano's letter of March 3,1988 issued IE Inspection Reports 50-206/88-04, 50-361/88-04 and 50-362/88 04, and forwarded a Notice of Violation (NOV) resulting from the January 19 through 22 and February 1 through 5, 1988 inspection conducted by Mr. J. E. Russell.
In accordance with the requirements of 10 CFR 2.201, Enclosure A to this letter contains the SCE response to the alleged violation.
In addition, the referenced letter requested that SCE specifically address how its 10 CFR 50, Appendix B quality assurance program defines organizational responsibilities with respect to 10 CFR 71, Subpart H requirements.
In the Topical Quality Assurance Manual (TQAM), Chapter 8-F, responsibilities for establishing, maintaining and executing the quality assurance program with regard to radioactive material transport packages (10 CFR 71 requirements) lie with the Manager, Health Physics and the Manager, Nuclear Fuel Supply. Audit responsibility for all Health Physics / Radiation Protection programs and procedures is further defined in this Chapter for the Manager of Quality Assurancs.
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"s Mr. J. B. Hartin March 31, 1988 While organizational responsibilities with respect to 10 CFR 71 are defined in a general sense, we agree that specifics are lacking in how the 10 CFR 50, Appendix B quality assurance program is applied to transportation of radioactive materials. As addressed in Enclecure A, the specificity of the T0AM and Quality Assurance Procedures will be increased to assure that program application, organizational involvement, and major functions are more fully addressed.
Very truly yours, 1
Enclosure cc:
F. R. Huey (USNRC Senior Resident Inspector, Units 1, 2, and 3) 4 S
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., p ENCLOSURE A 4
Response to the Notice of Violation contained in Appendix A to R. A. Scarano's letter of March 3, 19B8.
Appendix A to Mr. Scarano's letter states:
"10 CFR 71.137, ' Audits' reads, in part:
'The licensee shall carry out a comprehensive system of planned and periodic audits to verify compliance with all aspects of the quality assurance program and to determine the effectiveness of the program.
The audits must be performed in accordance with written procedures or checklists by appropriately train 9d personnel not having direct responsibilities in the areas being audited.'
"Contrary to the above, since 1984, no specific procedure or checklist existed to assure that a comprehensive system of planned and periodic audits, i
to verify compliance with all applicable aspects of the Quality Assurance program and to determi*ne the effectiveness of the Quality Assurance program
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for the use of transport packages, was carried out.
i "This is a Severity Level IV violation (Supplement V)."
RESPONSE
1.
Reason for the Violation Our review of governing SCE documents confirms that application of the 10 CFR 50, Appendix B quality assurance program to handling and transportation of radioactive material has been documented only in a very general fashion. NRC approval of the SCE quality assurance program, granted in a letter from C. E. MacDonald to K. P. Baskin dated September 6, 1984, was based on the SCE Quality Assurance Program Topical Report SCE-1-A which broadly addresses the 18 criteria of 10 CFR 50, Appendix 8.
Subsequently, specific references were added to Chapter
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8F of the Topical Quality Assurance Manual (TQAM) to address extension
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of the existing program to 10 CFR 71 activities.
In accordance with management intent, the Appendix B Quality Assurance Program has been applied in full to all activities performed by SCE since that time.
However, the specific method of application of 10 CFR 71 Subpart H criteria was never fully detailed in the TQAM and the level of detail describing major organizational functions was correspondingly low.
Lack of specificity in the TQAM regarding program implementation for transportation. activities is gag contributing cause to this violation.
Quality Assurance Procedures (QAPs) exist and are being implemented for establishing audit schedules, scoping audit plans, and performing audits. Other audit program requirements are found in various parts of the Topical QA Manual (TQAM), Technical Specifications, and other documents. However, concise definition of required audit areas, audit frequency, and audit scoping is not well centralized in a single procedure or plan, I
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- Consequently, the visibility of certain requirements, particularlyThis resulted in a I
l 10 CFR 71. Subpart H has been low.
SCE judgment as to adequacy of audit coverage of 10 CFR 71, Subpart HThat QA Pr y
activities was more subjective than objective.
specificity in how 10 CFR 71, Subpart H criteria are to be audited was the second contributing cause to this violation.
The general lack of clarity of audit program procedural guidance has be A special review of identified through internal SCE audits and reviews.
Title 10 of the Federal Regulations has been undertaken to verify that all mandated audit requirements have been adequately included in corrective action to improve the specificity of the audit program.
program.
Although not related to this violation, our internal audits alsoide Action to improve these tools will be coordinated with in auditing.
corrective actions discussed below.
Corrective Steos Which Have Been Taken and the Results Achieved 2.
An indepth audit of 10 CFR 71, Subpart H requirements has been added toTh the Master Audit Schedule for 1988.
the fourth quarter of 1988.
Corrective Steos Which Hill Be Taken to Avoid Further Violations 3.
The TQAM will be reviewed and appropriate chapters will be Attention will be given specifically to assure that l
activities.
10 CFR 71.10S requirements have been addressed.
The Quality Assurance Procedures (QAPs) which address audit planning and scheduling will be reviewed and revised, where appropriate, to clearly respond to the requirements of 10 CFR 50, Appendix B Criterion XVIII and 10 CFR 71.137, as well as any other regulations which require audits of Planning tools will be reviewed the nuclear quality assurance program.and supplemented, where required, to This regarding the frequency and scope of audits to be performed procedures, as appropriate.
Date When Full Comoliance Will Be Achieved 4.
The audit T0AM and QAP revisions will be irrplemented by August 1,1988.
of 10 CFR 71, Subpart H requirements will be completed by 1
December 31, 1988.
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