ML20056F218
| ML20056F218 | |
| Person / Time | |
|---|---|
| Issue date: | 07/16/1993 |
| From: | Office of Nuclear Reactor Regulation |
| To: | |
| Shared Package | |
| ML20056F216 | List: |
| References | |
| REF-QA-99901265 99901265-93-01, 99901265-93-1, NUDOCS 9308260200 | |
| Download: ML20056F218 (2) | |
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NOTICE OF VIOLATION Continuum Dynamics, Inc.
Docket No.: 99901265/93-01 l
Princeton, New Jersey During an NRC inspection conducted on May 4-5, 1993, a violation of NRC requirements was identified.
In accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions," 10 CFR Part 2, Appendix C (1992), the violation is listed below:
Section 21.21, " Notification of failure to comply or existence of a defect and its evaluation," of 10 CFR Part 21, " Reporting of Defects and Noncompliance,"
of Title 10 of the Code of Federal Reaulations requires, in part, that each individual, corporation, or entity subject to the regulations in this part adopt appropriate procedures to ensure the evaluation and proper reporting of deviations and failures to comply (s21.21(a)) and that if a deviation or failure to comply is discovered by a supplier of basic components or services associated with basic components, and the supplier determines it does not have the capability to perform the evaluation to determine if a defect exists, the supplier must inform the purchasers or affected licensees within five working days of this determination so that the purchasers or affected licensees may evaluate the deviation or failure to comply (621.21(b)).
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Contrary to the above, Continuum Dynamics, Inc. (CDI) Quality Assurance Manual, Revision 10, dated December 1992, for implementing 10 CFR Part 21, was inadequate because:
(1) It had not been updated to address substantive changes in evaluation and reporting requirements of 10 CFR Part 21 that became effective on October 29,
- 1991, (2) It was written in a way which could effectively preclude reporting of l
deviations by employees because it contained provisions to report substantial safety hazards instead of requiring to report deviations for evaluation to determine if they were substantial safety hazards, and (3) It did not contain provisions to ensure that all affected licensees or purchasers are informed of deviations which CDI is unable to evaluate.
This is a Severity Level IV violation (10 CFR Part 2, Appendix C, Supplement VII).
(93-01-01)
Pursuant to the provisions of 10 CFR 2.201, CDI is hereby required to submit a written statement or explanation to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, D.C. 20555 with a copy to the Chief, Vendor Inspection Branch, Division of Reactor Inspection and Licensee
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