ML20046D384
| ML20046D384 | |
| Person / Time | |
|---|---|
| Issue date: | 06/28/1993 |
| From: | Norrholm L Office of Nuclear Reactor Regulation |
| To: | Mcqueen M FLUID COMPONENTS, INC. |
| Shared Package | |
| ML20046D385 | List: |
| References | |
| REF-QA-99901264 NUDOCS 9308190076 | |
| Download: ML20046D384 (4) | |
Text
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UNITED STATES
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Docket No. 99901264 Mr. Malcolm M.
McQueen, President Fluid Components, Incorporated i
1755 La Costa Meadows Drive San Marcos, California 92069
Dear Mr. McQueen:
SUBJECT:
NOTICE OF VIOLATION AND NOTICE OF NONCONFORMANCE (NRC INSPECTION REPORT 99901264/93-01)
This letter addresses the inspection of Fluid Components, Incor-porated (FCI) at San Marcos, California, conducted by Messrs.
R.C. Wilson and S.D. Alexander of this office on April 13-15, 1993, and the discussion of their findings with you and members of your staff on April 15, 1993.
The purpose of the inspection was to review FCI activities conducted under your 10 CFR Part 50, l
Appendix B, quality assurance program and 10 CFR Part 21 reporting program, with emphasis on flowmeter calibration.
Areas examined during tne Nuclear Regulatory Commission (NRC) inspection and our findings are discussed in the enclosed report.
This inspection consisted of an examination of procedures and records, interviews with personnel, and observations by the inspectors.
The inspectors found that the implementation of your quality assurance program failed to meet certain NRC requirements.
Specifically, FCI did not actually determine or document the accuracy of safety-related air flowmeters that were certified to an accuracy of 3% of full scale, and did not appear to have identified or quantified all of the applicable error sources.
In addition, procedures were lacking for significant calibration activities, the procedure that did cover production unit cali-bration was not properly controlled and was not always followed in practice, and vendors providing calibration services were not audited to verify their technical and quality programs.
The specific findings and references to the pertinent requirements are identified in the enclosures to this letter.
The inspectors also identified that certain of your activities appeared to be in violation of NRC requirements, as specified in the enclosed Notice of Violation (Enclosure 1).
Specifically, FCI failed to initiate timely evaluations of two potential deviations identified by discrepancy reports dated October 4, g
1992, and February 15, 1993, which reported errors of as much as f' h.
g 7 to 16% of reading in transfer standards used to calibrate flow jh ermnem m OPQT 1
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switches supplied for safety-related service with certified accuracy of 3% of full scale.
Even though your subsequent evaluation reportedly showed that these concerns did not necessarily violate the certified accuracy specification of delivered flow switches, that information was not developed within the reporting period specified by 10 CFR 21.21.
Further, your procedure for implementing 10 CFR Part 21 that was in effect at the close of the inspection on April 15, 1993, did not reflect revisions which had instituted substantial changes in evaluation and reporting requirements; it could preclude reporting of deviations by employees; it restricted the scope of l
failures to comply that would be reportei; and it did not ensure that all affected licensees or purchasers are informed of deviations that FCI determines it cannot evaluate.
In addition, the issue of 10 CFR Part 21 effective October 29, 1991 was posted rather than a current copy.
Flowmeters and flow switches supplied by FCI are used in numerous commercial nuclear power plants licensed by the NRC.
Failures of
- hese instruments could significantly impact plant safety.
We expect that you will develop a plan to identify and correct deficiencies in your calibration program, including underlying causes. I trust that as you carry out that plan, you will bear in mind your responsibilities under 10 CFR Part 21 to report any safety-related deviations that you discover thet could affect previously-shipped instruments, as well as current production.
t After you have completed your upgraded program to meet the quality assurance requirements of Appendix B to 10 CFR Part 50, we will perform a followup inspection of your facility that will also cover the aspects of your safety-related quality assurance program that were not included in the present inspection.
j You are required to respond to this letter and should follow the instructions specified in the enclosed Notice of Violation when preparing your response.
In your response, you should document l
the specific actions taken and any additional actions you plan to
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prevent recurrence.
After reviewing your response to this i
Notice, including your proposed corrective actions and the results of future inspections, the NRC will determine whether i
further NRC enforcement action is necessary to ensure compliance with NRC regulatory requirements.
Further, please provide us within 30 days from the date of this letter a written statement in accordance with the instructions specified in the enclosed Notice of Nonconformance.
In accordance with 10 CFR Part 2.790 of the NRC's " Rules of Practice," a copy of this letter and its enclosures will be placed in the NRC's Public Document Room.
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v Mr.
M. M. McQueen The responses directed by this letter and the enclosed notices are not subject to the clearance procedures of the Office of Management and Budget as required by the Paperwork Reduction Act of 1980, Public Law No.96-511.
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Leif J.
Norrholm, Chief Vendor Inspection Branch Division of Reactor Inspection and Licensee Performance Office of Nuclear Reactor Regulation
Enclosures:
1.
,2.
Notice of Nonconformance 3.
Inspection Report 99901264/93-01
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,Mr. M. M. McQueen
-J-The responses directed by this letter and the enclosed notices are not subject to the clearance procedures of the Office of Management and Budget as required by the Paperwork Reduction Act of 1980, Public Law No.96-511.
Sincerely, OriginalSigned tif l
Leif J. Norrholm, Chief l
Vendor Inspection Branch Division of~ Reactor Inspection and Licensee Performance Office of Nuclear Reactor Regulation
Enclosures:
1.
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2.
Notice of Nonconformance 3.
Inspection Report 99901264/93-01 HISTRIBUTION:
Central Files / Docket File No. 99901264/ RIDS IE:09 V1B R/F j
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(Ye kio Yes/No Yes/No Yes/No 'N COPY No 2-OFFICE D/DRIL Cdkoh5f k NAME DATE 6/fj'93 j
COPY Yes/No l
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