ML19273B540
| ML19273B540 | |
| Person / Time | |
|---|---|
| Issue date: | 06/21/1978 |
| From: | Barnes I, Hunnicutt D, Verrios P NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | |
| Shared Package | |
| ML19273B533 | List: |
| References | |
| REF-QA-99900318 99900318-78-1, NUDOCS 7904090107 | |
| Download: ML19273B540 (12) | |
Text
VENDOR INSPECTION REPORT U. S. NUCLEAR REGULATOP,Y COMMISSION OFFICE OF INSPECTION AND ENFORCEMENT REGION IV Report No. 99900318/78-01 Program No. 44040 Company: Breda Temomeccanica, S.p. A.
Viale Sarca, 336 Milano, 20126 ITALY Inspection Conducted: May 30 - June 2, 1978 Inspector'^
/d hN uun lof b!2/f78
/' P. I. Verrios, Contractor Inspector,
/
Date Vendor Inspection Branch
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b 'tX ? Iu w a f d/2//78
/> 1. Barnes, Contractor Inspector, Vendor
/
Date Inspection Branch b
Approved by:
b fA' $
,, w n N hfi/f70 D. P. Hunnicutt, Chief, Components
/
Date Section II, Vendor Inspection Branch Sumary Insoection on May 30 - June 2,1978 (99900318/78-01)
Areas Insoected:
Implementation of 10 CFR 50, Appendix B, criteria and applicable codes and standards, including action on previous inspection findings; nonconformances and corrective action; procurement document control; internal audits; training; control of welding and control of forming. The inspection involved fifty-four (54) inspector-hours on site by two (2) NRC inspectors.
Results:
In the seven (7) areas inspected the following deviations and unresolved items were identified:
7904090/07 M
gur Deviations: Procurement Document Control - Purchase order review not consistent with Criterion IV of 10 CFR 50, Appendix B, and Section 6 of the QA Manual (Enclosure, Item A).
Nonconformances and Corrective Action -
Procedures for control of nonconfomances and corrective action not developed as required by Criterion V and XV of 10 CFR 50, Appendix B, and Section 9 of the QA Manual (Enclosure, Item B). Training - Scheduling of training not consistent with Criterion II of 10 CFR 50, Appendix B, and Section 19 of the QA Manual (Enclosure, Item C).
Control of Welding - QA Manual requirements for maintenance of qualification of welders not in agreement with Criterion IX of 10 CFR 50, Appendix B, and Section IX of the ASME Code (Enclosure, Item D); perfomance of calibration of manual welding machines not in accordance with Criterion V of 10 CFR 50, Appendix B, and Section 17 of the QA Manual (Enclosure, Item E); improper heat treatment perfomed relative to the requirements of Criterion IX of 10 CFR 50, Appendix B, and Section 12 of the QA Manual (Enclosure, Item F); quali-fication of overlay cladding procedure specification not consistent with Criterion IX of 10 CFR 50, Appendix B, Section 10 of the QA Manual and Section IX of the ASME Code (Enclosure, Item G).
Unrasolved Items:
Internal Audits - Section 20 of the QA Manuf requires clarification of subjective wording (DetailsSection I, paragraph C.3.b.).
Control of Foming - QA Manual does not address control of bending and faming (DetailsSection II, paragraph C.3.b.(1)); Breda specifications do not provide fomalized instructions relative to achieving correct final radius of curvature adjacent to weld joints (DetailsSection II, paragraph C.3.b.(2)).
DETAILS SECTION I (Prepared by P. I. Verrios)
A.
Pe_rsons Contacted L. Cenzato, General Manager
- T. Badino, Manager, QA
- P. Pineschi, QA Engineer R. Rolla, Manager of Purchasing C. Mazzoca, Manager, Calibration Services A. Maccallini, QA Engineer
- A. Tognoni. QA Engineer
- Denotes those attending the exit interview.
B.
Action on Previous Inspection Findings 1.
(Resolved) Unresolved Item (Report 77-01):
It was verified that all checklists for internal audits were translated from Italian into English.
2.
(Closed) Deviation (Report 77-01): It was verified that the required evaluation was performed on measuring tools that had exceeded the permissible tolerances.
3.
(Closed) Deviation (Report 77-01): The inspector verified that an internal procedure describing the control and identi-fication actions to be performed on base materials for nuclear components upon receipt was issued and implemented.
C.
Internal Audits 1.
Objectives The objectives of this area of the inspection were to verify that:
a.
Procedures or policy documents clearly identify organiza-tions responsible for audits and define their responsi-bilities and authorities.
_4_
b.
Measures have been established to assure that auditors are independent of any direct responsibility for performance of activities which they are auditing and that persons having direct responsibility for performance of the activities being audited are not involved in the selection of the audit team.
c.
All auditing personnel including technical specialists are required to receive appropriate training or orientation to develop their competence for performing required audits.
d.
Guidelines and requirements are established for audit scheduling and that they take into consideration the status and importance of the activities to be audited.
e.
Sufficient instructions or guidance are available to the auditors in the form of checklists or procedures to perfom the audits effectively and in accordance with the audit
- plan, f.
Deficiencies identified by the audits are closed out by appropriate corrective action and timely follow-up including reaudit of deficient areas.
g.
Audit records are collected, stored and maintained in accordance with applicable code and contract requirements.
2.
Method of Accomplishment The preceding objectives were accomplished by:
a.
Review of QA Manual, Section 20, Revision 1, dated April 4, 1975.
b.
Review of QAP Number 8, Revision 0, dated May 3,1976.
c.
Review of the following internal audits:
(1) Nuclear Shop, dated February 15, 1978.
(2) Material Receiving Department, dated February 16, 1978.
(3) NDE Area, dated February 21, 1978.
(4) Specification Control, dated March 7,1978.
. (5) Calibration Department, dated March 14, 1978.
(6) Welding Engineering, dated March 30, 1978.
(7) Nuclear QC Departnent, dated April 11, 1978.
(8) Design Control, dated May 4, 1978.
(9) Documentation Control, dated May 23, 1978.
d.
Interviews with cognizant personnel.
3.
Inspection Findings a.
Deviations from Comnitments None.
b.
Unresolved Item Criterion XVIII of Appendix B to 10 CFR 50 states in part,
"... Audit results shall be documented and reviewed by management having responsibility in the area audited.
Followup action including reaudit of deficient areas, shall be taken where indicated."
QA Manual, Section 20, paragraph 20.7.1 states in part,
" Periodic QA Department meetings will be held to discuss and review recurring and serious problems related to Quality Assurance.
These meetings will normally be attended by the QA Manager and his group leaders...."
Section 20 of the QA Manual contains subjective wording such as Periodic, Normally, From Time to Time, etc.
Breda management agreed to review Section 20, of the QA Manual and make appropriate clarifications.
D.
Procurement Document Control 1.
Objectives The objectives of this area of the inspection were to verify that:
a.
Measures had been established and documented to assure that the applicable regulatory reauirements, design bases, and other requirements necessary to assure adequate quality had been included or referenced in the documents for procurement of items and services.
b.
Changes in procurement documents had been subjected to the same degree of control utilized in orgination.
c.
Procurement documents required contractors to provide a quality assurance program consistent with the pertinent requirement of A'4SI N45.2-1971, as necessary.
d.
Procurement documents included provisions for the following, as applicable:
(1) Supplier Quality Assurance Program, (2) Basic Technical Requirements, (3) Source Inspection and Audit, (4) Documentation Requirements, (5) Lower Tier Procurements.
2.
Method of Accomplishment The preceding objectives were accomplished by:
a.
Review of the Quality Assurance Manual, Section 6, Revision 3, dated May 5, 1976.
b.
Review of twenty (20) randomly selected Nuclear Purchase Orders.
c.
Review of the Approved Vendors List.
d.
Discussions with Purchasing Department management personnel.
3.
Insoection Findings a.
Deviations from Commitments See Enclosure Item A.
_7 b.
Unresolved Items tione.
E.
Nonconformances and Corrective Action 1.
Objectives The objectives of this area of the inspection were to verify that:
a.
A system has been established for identifying and reporting nonconformances and that this system is consistent with the QA program as described in QAM, Section 15.
b.
The system for nonconformance identification contains as a minimum, the following elements:
(1)
Identification of item.
(2) Description of nonconformance.
(3) Segregation of the item, as appropriate.
(4) Signature of the reporting party.
c.
The assigned responsibilities are carried out by the designated persons.
d.
The system for identifying and reporting nonconfonnances, and for evaluating and enacting corrective action is timely and effective.
e.
Corrective action follow-up was effectively performed.
f.
Corrective procedures on generic type items and changes thereto are developed, reviewed and approved by personnel assigned to that responsibility by management.
2.
Method of Accomplishment The preceding objectives were accomplished.by:
a.
Review of the Quality Assurance Manual, Section 15, Revision 3, dated May 26, 1976.
b.
Review of the Quality Assurance Manual, Section 16, Revision 3, dated May 26, 1976.
c.
Review of twenty-five (25) randomly selected Reports of Devir.ti on.
d.
Review of thirty (30) randomly selected nonconformity resolution requests.
e.
Review of ten (10) randomly selected Repair Requests.
f.
Interviews with cognizant personnel.
3.
Inspection Findings a.
Deviations from Commitments See Enclosure Item B.
b.
Unresolved Items None.
F.
Training 1.
Objectives The objectives of this area of the inspection were te verify that:
a.
Procedures have been prepared and approved by the company to prescribe a system for personnel training activities which is consistent with the commitments of the QA Program.
b.
Procedures for training activities are being properly and effectively implemented by the company.
2.
Method of Accomplishment The preceding objectives were accomplished by:
a.
Review of the Quality Assurance Manual, Section 19, Revision 1, dated April 4, 1975.
b.
Review of Quality Assurance Procedure Number 7, Revision 6, dated May 26, 1976.
. c.
Review of the master training schedule for year 1977, and 1978.
d.
Review of training records for the following departments:
Material Receiving Department; Sales Department; Welding Engineering; QC NDE Department; Calibration Department; and QC Department.
3.
Inspection Findings a.
Deviations from Com.mitments See Enclosure Item C.
b.
Unresolved Items None.
G.
Exit Interview The inspectors met with management representatives (denoted in para-graph A.) at the conclusion of the inspection on June 2,1978. The inspectors swaaarized the scope and findings of the inspection.
Management acknowledged the statements by the inspectors with respect to the deviations and unresolved items.
. DETAILS SECTION II (Prepared by I. Barnes)
A.
Persons Contacted P. Pineschi, OA Engineer F. Giardina, Manager, Specification Office D. Gregorin, Manager, Welding Engineering F. Mariani, Welding Supervisor, Nuclear Shop C. Mazzocca, Manager, Calibration N. Corradi, Manager, Nuclear Production Coordination G. Bogani, Lead QA Engineer B.
Control of Welding 1.
Objectives The objective of this area of the inspection was to verify that welding was controlled in accordance with NRC and ASME Code requirements.
2.
Method of Accomolishment The preceding objectives were accomplished by:
a.
Review of QA Manual, Section 10, Revision 2, dated May 1976, " Control of Welding."
b.
Review of Specification No. 79701/13, Revision 2, dated February 2,1977, " Procedure For Storage And Conditioning Of Covered Welding Electrodes."
c.
Observation of temperature control and electrode segrega-tion in electrode and flux ovens.
d.
Examination of calibration status and review of applicable calibration records and procedures for six (6) welding machines, four (4) ovens, and mechanical test equipment used for welding materials qualification tests, e.
Review of system used for maintenance of ASME welder quali-fications and examination of process qualifications for three (3) welders.
, f.
Examination of welding precedure specifications and supporting procedurc qualification records applicable to ASME submerged arc butt welds and overlay cladding, gas metal arc overlay cladding and shielded metal arc welding.
g.
Review of QA Manual, Section 12, Revision 3, dated May 1976, " Control Of Heat Treatment."
h.
Observation of furnace controls and calibration status of temperature recorders.
1.
Review of Specification No. 79100/13, Revision 1, dated September 14,1976, "Interstage Post Weld Heat Treatment Of Low Alloy Steel Components."
j.
Examination of six (6) heat treat charts and documentation for ASME components.
3.
Findings a.
Deviations from Commitment (1) See Enclosure, Item D.
(2) See Enclosure, Item E.
(3) See Enclosure, Item F.
(4) See Enclosure, Item G.
b.
Unresolved Items None.
C.
Control of Forming 1.
Objectives The objectives of this area of the inspection were to verify that; a.
Manufacturing process control provisions had been made for forming or bending of pressure retaining material in accord-ance with ASME Code requirements.
. b.
Operations were conducted in accordance with appl: cable procedure and ASME Code requirements.
2.
Method of Acccrolishment The preceding objectives were accomplished by:
a.
Review of Specification No. 76200/14, Revision 0, dated October 15, 1975, " Course Plate Cold And Warm Sending Procedure."
b.
Review of Specification No. 76015/13. Revision 1, dated April 8,1976, " Course Plate Cold Bending Procedure."
c.
Examination of Inspection Point Program (IPP) No. 34.15, Revision 4, dated April 13, 1976, for process control provisions made for assuring dimensional compliance with ASME Code requirements.
3.
Findings a.
Deviation from Commitment None.
b.
Unresolved Items (1) The QA Manual does not describe either control of bending and forming special processes, or provide a reference to applicable controlling procedures.
(2)
Breda specifications, applicable to the rolling of shell courses, do not provide formalized instructions on the method of achieving correct final radius of curvature adjacent to weld joints.