ML19273B539
| ML19273B539 | |
| Person / Time | |
|---|---|
| Issue date: | 06/21/1978 |
| From: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | |
| Shared Package | |
| ML19273B533 | List: |
| References | |
| REF-QA-99900318 99900318-78-1, NUDOCS 7904090104 | |
| Download: ML19273B539 (3) | |
Text
Breda Termomeccanica, S.p.A.
Docket flo. 99900318/78-01 tiOTICE OF DEVIATION Based on the results of an flRC inspection conducted on May 30 - June 2, 1978, it. appeared that certain of your activities were not conducted in full accordance with tiRC requirements as indicated below:
A.
Criterion IV of Appendix B to 10 CFR 50 states in part, " Measures shall be established to assure that applicable regulatory require-ments, design bases, and other requirements which are necessary to assure adequate quality are suitably included or referenced in the documents for procurement of material, equipment, and services QA Manual, Section 6, paragraph 6.5.1 states, " Prior to be released to vendor the P0 must be reviewed and approved, by:
a) Den Manager, b) QA Manager."
Contrary to the absve, the following released to the vendor Purchase Orders had not been reviewed and approved by Design and Ngineering Department (Den).
Purchase Orders 703203, 701690, 701756, 702753, 80343, 80344, and 80313.
B.
Criterion V of Appendix B to 10 CFR states in part, " Activities affecting quality shall be prescribed by documented instructions, procedures, or drawings...."
Criterion XV of Appendix B to 10 CFR states in part, "... fion-confonning items shall be reviewed and accepted, rejected, repaired or reworked in accordance with documented procedures."
QA Manual, Section 9.2.1 states, "All testing inspections, examina-tions and manufacturing activities affecting quality are described by written procedures or specifications."
Contrary to the above, procedures had not been developed relative to handling of nonconformances and corrective action.
C.
Criterion II of Appendix B to 10 CFR 50 states in part, "... The program shall provide for indoctrination and training of personnel performing activities affecting quality as necessary to assure that suitable proficiency is achieved and maintained...."
c 790409OIOY QA Manual, Section 19.3.3 states in part, " Training courses shall be scheduled every 12 months to maintain the proficiency of personnel Contrary to the above, training courses had not been scheduled every 12 months.
Example: QC NDE personnel, Welding Engineering personnel, Calibration personnel, and Specification Control personnel.
D.
Criterion IX of Appendix B to 10 CFR 50 states in part, " Measures shall be established to assure that special processes, including welding,... are controlled and accomplished by qualified personnel
... in accordance with applicable codes...."
Paragraph QW-322 in Section IX of the ASME Code states in part,
" Renewal of qualification of a perfomance qualification is required (1) when a welder or welding operator has not used the specific process... for a period of three months or more except when employed on some other welding process the period may be extended to 6 months...."
Contrary to the above, paragraph 10.3.4.2 in the QA Manual requires review of use of processes by a welder only towards the end of a six month qualification period, irrespective of whether the welder was qualified in only one (1) or more processes.
During review of Walder Check Records, the inspector observed, that a welder qualified in only one (1) process, had not used the process for four (4) months.
It was also observed that another welder had not used a particular process for which he had been qualified for in excess of six (6) months, without any notation on the records being made to indicate loss of qualification.
E.
Criterion V of Appendix B to 10 CFR 50 states in part, " Activities affecting quality shall be prescribed by documented instructions, procedures, or drawings... and shall be accomplished in accordance with these instructions, procedures, or drawings...."
Paragraph 17.8.5 in Section 17 of the QA Manual requires calibration of manual welding machines at least every 120 days.
Contrary to the above, manual welding machine,12Q-20, was observed to have been last calibrated on January 4,1978.
F.
Criterion IX of Appendix B to 10 CFR 50 states in part, " Measures shall be established to assure that special processes, including
.... heat treating... are controlled and accomplished...
using qualified procedures in accordance with applicable...
specifications.... "
paragraph 12.2.4.2 in Section 12 of the QA Manual states, " Heat Treatment Supervisor (see paragraph 4.3.7.c) controls the heat treating per approved procedures and provides the propar docunen-tation (see paragraph 12.2.4)."
Paragraph 12.2.4.3 states, "'
QC Supervisor is responsible for obtaining the records, and cerci-fying as required, to assure that the propar heat treating was perfonned. "
Contrary to the above, proper heat treating was not performed on certain nozzles (Heat Treatment Certificates HE 4096 and HE 4097),
although certified to be correct, in that the maximum temperature permitted by the applicable heat treatment specification was exceeded by 100C during the hold portion of the heat treatment cycle.
G.
Criterion IX of Appendix B to 10 CFR 50 states in part, " Measures shall be established to assure that special processes, including welding,... are controlled and accomplished... using qualified procedures in accordance with applicable codes...."
Paragraph 10.4.5.1 in Section 10 of the QA Manual states in part, "Each Welding Procedure Qualification is documented in a certificate form for compliance with essential variables... of Section III and Section IX of the A9tE Code...."
Paragraph QW-281.2(d) in Section IX of the ASME Code defines that the addition of other welding positions than those already qualified is an essential variable for all welding processes used for corrosion resistant weld metal overlay.
Contrary to the above, Welding Procedure Specification 78701/13, Revision 1, permitted shielded metal arc corrosion resistant weld metal overlay in the 1G and 2G positions, although the supporting procedure qualification was qualified only in the 1G position.