ML19318C190
| ML19318C190 | |
| Person / Time | |
|---|---|
| Issue date: | 03/26/1980 |
| From: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | |
| Shared Package | |
| ML19318C172 | List: |
| References | |
| REF-QA-99900384 99900384-80-1, NUDOCS 8007010167 | |
| Download: ML19318C190 (4) | |
Text
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O Gulf & Western Manufacturing Company Eagle Signal Division 99900384/80-01 NOTICE OF DEVIATION Based on the results of an NRC inspection conducted on March 3-7, 1980, it appears that certain of your activities were not conducted in accordance with NRC requirements as indicated below:
Criterion V of Appendix B to 10 CFR 50 states:
" Activities affecting quality shall be prescribed by documented instructions, procedures, or drawings, of a type appropriate to the circumstances and shall be accomplished in accordance with these instructions, procedures, or drawings.
Instructions, procedures, or drawings shall include appropriate quantitative or qualitative acceptance criteria for determining that important activities have been satisfactorily accomplished." Deviations from these requirements are as follows:
A.
Section 9.3.4.1, dated May 18, and August 2, 1978, of the Quality Systems Manual, contains the following requirements:
1.
Paragraph 1.d. states, "All Inspection (Receiving] will be done on an attribute basis using the sample tables found in Spec.
9.3.6.5 of the Inspection Manual, and/or by other plans approved by the Quality Assurance Engineer."
2.
Paragraph 1.e., states in part, "Upon completion of the process-ing of the material in Receiving Inspection, the inspector will date, initial and stamp the packing ticket."
Contrary to the above:
1.
Receiving inspection had not been done using the sample tables found in Specification No. 9.3.6.5 of the Inspection Manual and/
or by other plans approved by the Quality Assurance Engineer.
The NRC inspector was informed that the Inspection Manual had not been written; secondly, the NRC inspector observed that the sample plans in use had not been approved by the Quality Assurance Engineer.
2.
The inspector had not dated and initialed the inspection stamp on the following completed packing tickets:
Eagle Signal Sequence Nos. 007784, dated February 26, 1980; 007193, dated February 11, 1980; 007542, dated February 8, 1980; 007698, dated February 21, 1980; and 007872, dated February 26, 1980.
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B.
Section 9.3.7.3, dated June 22, 1978, of the Quality Systems Manual, contains the following requirements:
1.
Item 6. under CALIBRATION PROCEDURES, states in part, " Calibration Certification Labels: Measuring and testing equipment and measure-ment standards shall be labeled to indicate the date of last calibration, by whom it was calibrated (Inspection Stamp), and when the next calibration is due."
2.
Item 9. under CALIBRATION PROCEDURES, states in part, " Equipment Records: The Instrument Calibration Technician shall be regularly responsible for the completeness and accuracy of the calibration and control records. Each calibration result is to be recorded as it is accomplished."
3.
Annex III, regarding the Instrument Identification Record Card (EWB374), states in part, " CAL 1BRATION PROCEDURE: Enter the title or identifying number for the calibration procedure covering the list instrument.
Each instrument shall have a j
procedure governing its service and calibration, either pro-i vided through the manufacturer's manuals, or written into an Eagle Signal procedure."
4.
Annex III, regarding the Calibration Record Card (EWB805), states in part, " INSTRUMENT INDICATION BLOCKS:
The measurement observed on the inspected instrument resulting from testing at the standard calibration point shall be written in the block, corresponding to the column of a given calibration interval.
Example:
Calibration Standard reads 300 VAC and inspected instrument j
reads 296 VAC, write 296 VAC in the block."
l Contrary to the above:
1.
Digital Multimeter, Serial No. GT-1007 had not been labeled to indicate the date of last calibration, by whom it was calibrated, and when the next calibration was due. This item was located in a file cabinet in the production area.
2.
Each calibration result had not been recorded as accomplished as evidenced by the following calibration Record Cards (EWB805) which had not been updated to agree with the calibration label on the instruments: DC Ammeter, Serial No. T-1001 indicated that calibration was due on December 17, 1979 while the cali-bration label on the instrument indicated that calibration was due on March 14, 1980; DC Voltmeter, Serial No. T-3001 indicated
Gulf & Western Manufacturing Company 3
that calibration was due on December 17, 1979 while the j
calibration label on the instrustent indicated that calibration was due on March 14, 1980.
3.
Each instrument did not have a procedure governing its service and calibration as evidenced by the following EWB 374s which reflected no information in the Calibration Procedure block:
DC Ammeter, Serial No. T-1001; DC Voltmeter, Serial No. T-3001; and AC Variac, Serial No. T-2015.
4.
The observed measurement of the inspected instrument had not been written in the Instrument Indication block for DC Ammeter, Serial No. T-1001. Entries dated September 14, 1978 through September 17, 1979 indicated "OK" rather than actual measurements.
C.
Section 9.3.6.1, dated May 19, 1978, of the Quality Systems Manual, contains the following requirements:
1.
"At the time that the new or redeveloped product design engineering release is made, it will be the responsibility for the responsible Quality Assurance Engineer to supply the following directly to the Inspection Department.
2.
Inspection Check List "The Inspection Checklist shall consist of the following items commencing with piece part inspection to board or sub-assembly inspection to final product inspection. The Checklist shall contain all appropriate visual, mechanical and electrical inspection instructions.
d.
Electrical tests required and a description of procedure and setup of test equipment."
Contrary to the above:
1.
An Inspection Checklist had not been supplied to the Inspection Department for the Contact Stack, Part No. HP 50-117, even though engineering release had occurred and the sub-assembly was in production.
2.
_The HPS Inspection Checklist, for Timer, Part No. HP 57A6, did not contain required electrical tests and a description of procedure and setup of test equipment. The timers were being subjected to functional and high potential tests without bene-fit of documented instructions or procedures.
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Gulf & Western Manufacturing Company 4
In addition to the above, the following deviations on Quality Assurance Program content were identified:
D.
Criterion II of Appendix B to 10 CFR 50, states in part, "The applicant shall establish at the earliest practicable time, consistent with the schedule for accomplishing the activities, a quality assurance program which complies with the requirements of this appendix.
This program shall be documented by written policies, procedures, or instructions and shall be carried out.
. in accordance with those policies, procedures, or instructions."
Harlo Corporation, Control Panel Division Purchase Order No. 27487S, dated November 10, 1978 identified 10 CFR 50 as the governing Quality Assurance star.Jard.
General Electric Company, Nuclear Energy Division Purchase Order No.
282-TG108, Revision 99, dated January 2, 1980 identified Quality Plan No. 30.123, Revision @? as a requirement.
Revision 2 of the Quality Plan was not available but Revisions 1 and 3 were available.
The criteria of the. Quality Plan correlates with Appendix B to 10 CFR 50.
Contrary to the above, Eagle Signal's Quality Assurance Program did not address Test Control; Corrective Action; Quality Assurance Records; or Audits.
E.
Criterion XII of Appendix B to 10 CFR 50 states, " Measures shall be established to assure that tools, gages, instruments, and other j
l measuring and testing devices used in activities affecting quality are properly controlled, calibrated, and adjusted at specified periods to maintain accuracy within necessary limits."
Contrary to the above, measures had not been established to control, calibrate, and adjust gram gauges, feeler gauges, torque wrenches and torque screw drivers. These items were being used to measure and/or adjust and inspect design criteria by personnel in the Production and Inspection Departments.
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