ML20056C902
| ML20056C902 | |
| Person / Time | |
|---|---|
| Issue date: | 06/10/1993 |
| From: | Rossi C Office of Nuclear Reactor Regulation |
| To: | Bilanin A CONTINUUM DYNAMICS, INC. |
| References | |
| REF-QA-99901265 NUDOCS 9307260115 | |
| Download: ML20056C902 (4) | |
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JUN.10 1993 Docket No. 99901265 Dr. Alan J. Bilanin, President Continuum Dynamics, Inc.
P.O. Box 3073 Princeton, New Jersey 08543
Dear Dr. Bilanin:
SUBJECT:
FINDINGS IDENTIFIED DURING THE VEND 0R BRANCH INSPECTION AT CONTINUU DYNAMICS, INC. (INSPECTION REPORT NO. 99901265/93-01)
On May 4-5, 1993, the Nuclear Regulatory Commission (NRC) reviewed whether tests conducted by Continuum Dynamics, Inc. (CDI) were performed in accordance with your quality assurance (QA) program and applicable purchase order (P0) requirements, including 10 CFR Part 21 and Appendix B to 10 CFR Part 50.
The inspection consisted of an examination of procedures and records, interviews with personnel, and observations by the inspectors.
In addition, we hwe reviewed your letter of May 10, 1993, which provided additional information relating to the inspection.
The details of the inspection findings were discussed with you and your staff during the inspection and at the exit meeting on May 5, 1993.
The results of the inspection will assist the NRC in its determination of whether tests performed by CDI, in support of the Boiling Water Reactors Owner's Group (BWROG) Reactor Water Level Monitoring (RWLM) Long Term Program, have an adequate QA basis.
This letter provides a summary of the most significant inspection findings in advance of the inspection report so that you may take appropriate and timely corrective action.
The inspectors did not identify problems with the actual conduct of the tests or the gathering of test data. However, as discussed below, the inspection did identify problems associated with your QA program, particularly with regard to calibration services supplied by several vendors.
The technical adequacy of the tests and their relationship to nuclear safety are being evaluated by the staff and will be addressed separately.
The team concluded that the overall QA program in-place at CDI appears adequate to perform testing under the scope of work outlined in your contract with the Electric Power Research Institute (EPR!).
However, the inspection team identified the following findings with respect to the impleraentation of your QA program:
i 0 1.
CDI QA Manual (Revision 10, dated December 1992) does not contain provisions for dedicating items purchased by CD1 as commercial grade and used as part of a safety-related activity, subject to the requirements of 10 CFR Part 50, Appendix B.
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Inadequate measures were established for the selection and review for suitability of application of materials, parts, and equipment that are essential to the safety-related functions of systems and components.
Specifically:
CDI purchased commercial grade instrument calibration services from Omega Engineering, Inc. and Test Equipment Service, Inc. without performing any assessments or surveys to verify that the suppliers' quality programs and controls in-place were effectively being implemented for the types of instrument calibration services purchased. Such instruments were used in tests conducted by CDI in support of the BWROG RWLM Long Term Program.
In several commercial grade P0s-to American Electronic Laboratories (AEL) for instrument calibration services, CDI did not reference AEL's commercial.or quality controls (approved by CDI on February 10,1993) as a part of the P0 requirements.
CDI's survey of AEL's commercial quality program and controls (performed by CDI on February 9, 1993) did not adequately address AEL's basis for. notifying CDI of conditions "significantly.out of tolerance" during the calibration process. Such basis may.be critical since AEL's reporting threshold may not be consistent with that of CDI, thereby precluding reporting of such conditions to CDI.
The failure of.AEL to report such conditions to CDI could have an adverse effect on tests performed by CDI. Add'itionally, CDI's survey did not document the training of AEL personnel involved in-the calibration process.
3.
CDI's procedure for implementing the requirements of 10 CFR Part 21 appeared to be inadequate in that it:
j Did not address the evaluation and reporting timeliness requirements
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which first appeared in the July 1991 revision of 10 CFR Part 21.
Placed the burden of determining if a significant safety hazard exists on employees who may'not be able to make that determination.
Did not address informing customers of deviations which CDI is
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unable to evaluate.
Prior to issuance of the final test report to EPRI, CDI is requested to evaluate the impact the above findings may have on the test data obtained.
The NRC continued the inspection efforts related to CDI's performance of the RWLM testing during a visit to EPRI's Nondestructive Examination facility.on June 4, 1993. A complete description of all findings from the NRC inspection at CDI and EPRI will be included in NRC-Inspection Report No. 99901265/93-01.
No response is required to this letter.-
- Dr. Al an J. Bilanin O (3 e
OUN 1 0 1993
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Dr. Alan J. Bilanin In accordance with 10 CFR 2.790 of the NRC's " Rules of Practice," a copy of this letter will 'be placed in the NRC Public Document Room.
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O ag.gav Charles E. Rossi, Director V Division of Reactor Inspection and Licensee Performance Office of Nuclear Reactor Regulation cc:
Mr. Paul Blanch 135 Hyde Road West Hartford, CT 06117 Mr. Earnest Hadley 414 Main Street P.O. Box 3121 Wareham, MA 02571 W