ML19269E529
| ML19269E529 | |
| Person / Time | |
|---|---|
| Issue date: | 03/19/1979 |
| From: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | |
| Shared Package | |
| ML19269E516 | List: |
| References | |
| REF-QA-99900334 99900334-79-1, NUDOCS 7906290229 | |
| Download: ML19269E529 (4) | |
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1-De Laval Turbine Incorporated Engine and Compressor Division Docket No. 99900334/79-01
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b NOTICE OF DEVIATION Based on the results of an NRC inspection conducted on March 5-9, 1979, it appeared that certain of your activities were not conducted in full accordance with NRC requirements as indicated below:
A.
Criterion II of Appendix B to 10 CFR 50, states in part, "The applicant shall identify the structures, systems, and components to be covered by the quality assurance program and the major organizations partici-pating in the program, together with the designaced functions of these organizations."
t Paragraph 2.7.2 of the Quality Assurance Manual, Revision 11, dated J
July 6,1978 states, "Each De Laval department identified as having responsibilities in this manual establishes and maintains its own procedures and procedures manuals."
Organization charts in the manual are identified as:
" Engineering Department...," " Manufacturing Department...," " Material Control Department...," and " Quality Control Department." Also, each of the foregoing departments is identified in the manual as having responsibilities.
Contrary to the above, procedures and procedures manuals had not been established for the Manufacturing and Material Control Departments.
B.
Criterion XII of Appendix B to 10 CFR 50 states, " Measures shall be y
established to assure that tools, gages, instruments, and other measuring devices used in activities affacting qt:ality are properly controlled, calibrated, and adjusted at specified pe.-iods to maintain accuracy within necessary limits."
4 a
Paragraphs 4.11.7, 4.16.4 and 4.53.3 of the Quality Control Manual No. IP-100, Revision 3, dated January 30, 1978 state, " Record Data",
for Outside Micrometers, Thread Micrometers and Pressure Gages,
.y respectively. This referred te recording actual readings of measuring and test equipment undergoing periodic recalibration.
Contrary to the above, data (actual readings) had not been recorded for:
1.
Outside Micrometers, Serial Numbers (S/N) DTE-001-B and DTE-014-B, last recalibrated in January,1979 and February,1979, respectively.
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Pitch Micrometer, S/N DTE-002J and Thread Micrometer, S/N DTE-002-AC, both were last recalibrated in January,1979.
3.
Pressure Gage, S/N DEC-007-AAM, last recalibrated in July,1978.
C.
Criterion VII of Appendix B to 10 CFR 50, states in part, " Measures shall be established to assure that purchased material, equipment, and serv %es... confonn to the procurement documents.
These measures shall include provisions, as appropriate, for source evalua-tion and selection, objective evidence of quality furnished by the contractor or subcontractor, inspection at the contractor or subcon-tractor source, and examination of products upon delivery. The effectiveness of the control of quality by contractors and subcon-tractors shall be assessed... at intervals consistent with the importance, complexity, and quantity of the product or services."
1.
Paragraph 9.1.2 of the Quality Control Manual No. IP-700, Revision 1, dated January 30, 1978, states in part, "The Quality Engineer assigned the responsibility wC1 update the Qualified Supplers List every 3 months" 2.
Paragraph 6.1.1 of the Qualified Suppliers List Procedures, dated February 3, 1976 states, "The QSL Qualified Suppliers List will be issued at the beginning of each month."
3.
Paragraph 5.2.4 of the Quality Control Manual No. QC1, Revision 2, dated January 30, 1978 states, "A monthly summary of the quality rating of vendors is forwarded to Quality Control and Purchasing and is added to the matrix of data used to establish the vendor qualf,ty rating."
Contrary to the above:
1.
The Qualified Suppliers List (QSL) had not been updated every three (3) months nor monthly.
The most current QSL exhibited a date of August 24, 1978.
2.
A monthly summary of the quality rating of vendors had not been forwarded to Quality Control and Purchasing.
D.
Criterion XVI of Appendix B to 10 CFR 50, states in part, " Measures shall be established to assure that conditions adverse to quality...
are promptly identified and corrected.
The identification of the significant condition adverse to quality, the cause of the condition, and the corrective action taken shall be documented and reported to appropriate levels of management."
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. Paragraph 6.4.5 of the Quality Control Manual No. QC1, Revision 2, dated January 30, 1978 states, "When the Corrective Action Request has been completed; then all problem areas identified, corrective actions required, and problem resolutions shall be repoited by the Manager of Quality Control to the Division General Manger on a quarterly basis."
Contrary to the above, ccmpleted Corrective Action Request activity had not been reported to the Division General Manager on a quarterly basis; i.e., there was no indication this had ever been accomplished.
E.
Criterion XVII of Appendix B to 10 CFR 50, states in part, " Consistent with applicable regulatory requirements, the applicant shall establish requirements concerning record retention, such as duration, location, and assigned responsibility."
Paragraph 16.7.1 of the Quality Assurance Manual, Revision 11, dated July 6,1978 states, " Records will be securely stored at De Laval and shall be protected against fire, damage or loss."
Contrary to the above, records in the Document Control Center had not been protected against fire inasmuch as they occupy 10/5 drawer and 1/4 drawer file cabinets. The latter (1/4 drawer files) is the 0
only one fire-rated (350 F for one hour).
F.
Criterion XVIII of Appendix B to 10 CFR 50, states in part, "A comprehensive system of planned and periodic audits shall be carried out to verif compliance with all aspects of the quality assurance program and to determine the effectiveness of the program."
Paragraph 17.1.1 of the Quality Assurance Manual, Revision 11, dated July 6,1978, states in part, " Audits of the Divisions quality assurance programs, processess and procedures shall be perfomed semi-annually by Quality Control Engineering to determine their effectiveness."
Contrary to the above, audits had not been performed semi-annually for the Foundry, Manufacturing, and Support activities.
Records indicated audits had been performed as follows: Foundry, March 14, 1977; Manufacturing, June 24, 1977 and May 31, 1978; and Support, August 15, 1977.
G.
Criterion III of Appendix B to 10 CFR 50, states in part, " Design changes, including field changes, shall be subject to design control measures commensurate with those applied to the original design and be approved by the organization that perfomed the original c'.esign unless the applicant designates another responsible organization."
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. 1.
Paragraphs II.3. and.4. of Division Standard Practice (DSP)
No. 4.101, dated September 15, 1969, require that Industi ial Engineering review all design changes or new designs, approve or disapprove and sign the Engineering Change Notice before drawings are released to the shop.
2.
DSP No. 4.201, dated April 15, 1970:
(a)
Paragraph A.4. requires that an Engineering Change Log be maintained, instructions for completion are in the DSP and on the fann.
(b)
Paragraph A.5. requires that all accepted requests be classified major or minor.
(c) Paragraph B.1. requires the originator of a change to obtain Request for Drawing and Parts List Change, Form No.
E-219A and complete Section 1.
Contrary to the above:
1.
Industrial Engineering had not reviewed, approved or disapproved and signed Engineering Change Notice, Control No. 8-92 before the drasing had been released to the shop.
2.
(a) The Engineering Change Log had not been maintained as evidenced by lack of required entries in the " Change Class" and "R Code" columns and changing the " Action Taken" heading to "Cust Job."
(b)
Accepted requests, Control Nos.-8-42 and 8-217 had not been classified as major or minor, (c)
The originator had not initiated Request for Drawing and Parts List Change, Form No. E-219A, for changes identified on memoranda as Control Nos. 8-19 and 8-60.
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