ML20046D386
| ML20046D386 | |
| Person / Time | |
|---|---|
| Issue date: | 06/28/1993 |
| From: | NRC |
| To: | |
| Shared Package | |
| ML20046D385 | List: |
| References | |
| REF-QA-99901264 99901264-93-01, 99901264-93-1, NUDOCS 9308190080 | |
| Download: ML20046D386 (2) | |
Text
_ _ _ _ _ _ _ _ _ _ -
Pd w
NOTICE OF VIOLATION Fluid Components, Incorporated Docket No.: 99901264/93-01 San Marcos, California During an NRC inspection conducted on April 13 through 15, 1993, violations of NRC requirements were identified.
In accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions," 10 CFR Part 2, Appendix C (1992), the violations are listed below:
A.
10 CFR 21.21, " Notification of Failures to Comply or Exis-tence of a Defect and Its Evaluation," requires, in part, that each corporation subject to the regulations adopt appropriate procedures to ensure the evaluation and proper reporting of deviations and failures to comply, and to submit an interin report to the Commission if the evaluation of the deviation or failure to comply cannot be completed within 60 days.
Section 21.21 further requires 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 I
determination so that the purchasers or affected licensees may evaluate the deviation or failure to comply.
Contrary to the above, Fluid Components, Incorporated (FCI) was informed in two discrepancy reports of significant errors in transfer standards used to calibrate delivered l
basic components--i.e., flow switches--and failed to l
evaluate the impact of the errors on the accuracy of the basic components.
Specifically, Discrepancy Reports No.
02726 dated October 4, 1992, and No. 02914 dated February 15, 1993, reported that two transfer standard turbine flowmeters differed by as much as 7 to 16% of reading from the sonic nozzle traveling standards six months after their previous calibrations.
These errors could potentially cause the basic components to deviate from their technical procurement specifications for accuracy.
Thus, FCI failed to evaluate a possible deviation to determine if it could create a substantial safety hazard within the 60 days prescribed by 10 CFR Part 21, nor was an interim report made to the Commission as required when the evaluation was not completed within the allotted time, nor were all affected licensees or purchasers informed of the deviation.
Although your subsequent evaluation of the second instance determined that the specific error reported did not apply to purchase orders for basic components, that information was not developed within the reporting period specified by 10 CFR 21.21.
7 9308190080 930628 PDR GA999 EMVFLUID 99901264 PDR g
O
-This is a Severity Level IV violation (Supplement VII).
(99901264/93-01-01)
B.
10 CFR 21.21, " Notification of Failure to Comply or Existence of a Defect and Its Evaluation," requires, in part, that each corporation subject to the regulations adopt appropriate procedures for either evaluating deviations and failures to comply, or informing the licensee or purchaser of the deviation or failure to comply.
In addition, 10 CFR 21.6, " Posting Requirements," requires posting a current copy of 10 CFR Part 21.
Contrary to the above requirements, at the time of the inspection FCI had not revised Quality Assurance Procedure 704011, "10CFR21 Reporting of Defects and Nonconformances,"
Revision B, October 31, 1988, to address the substantive revisions to 10 CFR Part 21 that became effective on October 29, 1991, and November 24, 1992.
In addition, the procedure could preclude reporting of deviations by employees, it unduly restricted the scope of failures to comply that should be reported, and it lacked provisions to ensure notification to affected licensees or purchasers of deviations or failures to comply when FCI was unable to determine if a defect existed.
Further, FCI had posted the issue of 10 CFR Part 21 effective October 29, 1991, rather than a current copy.
This is a Severity Level V violation (Supplement VII).
(99901264/93-01-02)
Pursuant to the provisions of 10 CFR 2.201, Fluid Components, Incorporated, 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 Performance, Office of Nuclear Reactor Regulation, within 30 days of the date of the letter transmitting this Notice of Violation.
This reply should be clearly marked as a " Reply to a Notice of Violation" and should include for each violation:
(1) the reason for the violation, or, if contested, the basis for disputing the violation, (2) the corrective steps that have been taken and the results achieved, (3) the corrective steps that will be taken to avoid further violations, and (4) the date when full compliance will be achieved.
Where good cause is shown, consideration will be given to extending the response time.
Dated at Rockville,-Maryland thi s.2_ $ 4 day of p+a 1993.