ML19259B449
| ML19259B449 | |
| Person / Time | |
|---|---|
| Issue date: | 10/13/1978 |
| From: | Kelly W, Sutton J, Whitesell D NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | |
| Shared Package | |
| ML19259B445 | List: |
| References | |
| REF-QA-99900061 99900061-78-2, NUDOCS 7902090377 | |
| Download: ML19259B449 (13) | |
Text
VENDOR INSPECTION REPORT U.S. NUCLEAR REGULATORY C0f@lISSION OFFICE OF INSPECTION AND ENFORCEMENT REGION IV Report No. 99900061/78-02 Program No. 44060 Company: Velan Engineering, Ltd.
2145 Ward Avenue Inspection at: Montreal, Quebec, H4M-1T6, Canada Inspection Conducted: September 13-14, 1978 Inspectors:
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Wm. 'D. Kelley, Contractor Inspector Date Vendor Inspection Branch Yn(b l
,0~.T-?8 y W. Sutton, Contractor Inspector Date Vendor Inspection Branch Approved b i'
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D. E. Whitesell, Chief, Components Date Section I, Vendor Inspection Branch Summary Inspection on September 13-14,1978 (999000E1/78-02)
Areas Inspected:
Implementation of 10CFR50, Appendix B and applicable codes and standards including, design document control, procurement control, manu-facturing process-control-machining, control of special processes inspection and tests, and audit; also, ve,'ified action on previous inspection findings.
The inspection involved 32 inspector-hours.
Results:
In the six (6) areas inspected, no apparent deviations or unre-solved items were identifed in three (3) areas. The following were identi-fied in the remaining three (3) areas.
Deviations:
Design Document Control (DetailsSection I, Paragraph C.3.a. ;
Audits (DetailsSection I, Paragraph C.3.a.) and Control of Special Processes (DetailsSection II, Paragraph D.3.a.).
r/90209Cs3 7~/
DETAILS SECTION I (Prepared by Wm. D. Kelley)
A.
Persons Contacted Velan Engineering, Ltd. (VEL)
F. Andrade, Audit Manager (Acting)
E. Feldman, Welding QA Administrator E. L. Francois, Corporate Manager of Quality Assurance A. McKay, Chief Purchasing Agent Plant #2
- M. J. Richards, Quality Assurance Manager
- M. Rodier, Manager Quality Control
- A.
K. Velan, President
- I. C. Velan, General Manager
- P. I. Velan, Plant h nager, Plant #2 W. Wexler, Purchasing Agent
- Denotes those persons who attended Exit Interview (See paragraph F)
B.
Action on Previous Inspection Findings (Closed) Deviation (Report No. 78-01):
Contrary to Criterion IX of Appendix B to 10CFR50 and paragraph QW201.2 of Section 17 to the ASME Code, the PQR for WPS number VEL-P-597, Revision 8 had " paste on" correction which displayed the qualification date as being September 25, 1970, and certified by an individual who was no'; employed by Velan Engineering Ltd., on this date.
The inspector verified that the original qualification records were attached to the procedures and those procedures whose qualification records could not be found were requalified.
In addition, procedures VEL-QCI-577, Revision 0, " General Requirements for the Generation of Quality Assurance Records for Nuclear Applications" was prepared and approved and states in part, "d). Records showing cross-offs, erasures, printovers, written additional information, white-outs... shall not be acceptable and shall not be signed."
(Closed) Unresolved Item (Report 78-01) VEL's evaluation whether to change from its existing method of analyzing the stress in the pressure seal bonnets to the finite method of evaluating thcse stresses.
The inspector verified that VEL used the finite method for evaluating the stresses in the pressure seal bonnets, to verify that their analyti-cal method of analysis met ASME Code requirements.
(Closed) Unresolved Item (Report No. 78-01) VEL Reports of in-process design review meetings were not readily retrievable.
The inspector verified that the reports of in-process design review meetings are now filed in a folder marked Design Review Meetings, and are readily retrievable. Also that all unresolved items in the previous report, are included on the agenda for the next meeting.
(Closed) Unresolved item (Report No. 78-01) VEL was to review all welding procedures and correct the empere ranges to agree with data they obtained b) actual measurements.
The inspector v rified that welding procedures were being revised to agree with the electrode manufactures data and submitted for appropriate review at d approval.
C.
Design Document Control 1.
Objectives The objectives of this area of the inspection were to ascertain whether procedures had been developed and properly implemented to control the review, approval, release and issuance, of design documents in a manner consistent with NRC rules and regulations, ASME Code requirements, and the vendor's QA program commitments.
2.
Method of Accomolishment The objectives of this area of the inspection were accomplished by:
a.
Review of the ASME accepted VEC QA Manual, Revision 7:
(1) Section VEL-QC-152A, Revision 7 - Quality Assurance
- Program, (2) Section VEL-EP-109, Revision 4 - Design Control, to verify that the vendor had established procedares to prescribe a system for design document control.
b.
Reviewed procedures:
(1) VEL-QCL-451, Revision 4, Manufacturing & Inspection Instructions, (2) VEL-QCL-415, Revision 1, Manufacturing & Inspection Instructions, to verify that they had been prepared by the cesignated personnel, reviewed by QA, and approved
's management.
c.
Review of VEL-QC-050, Revision 4, Preparation Identification, Distribution & Revision of Quality Related Procedure, and Instruction to verify that it provided for the identi.ication of personnel responsible for preparing, reviewing, approving, and issuing the design documents; and that the review and approval of significant changes were performed by the same personnel. Also to ascertain whether minor changes to design documents, that do not require review and approval, are identified.
d.
Interviewed personnel tc verify whether they were knowledge-able in the procedures applicable to design document control.
3.
Findinas Within this area of the inspection, no deviations or unresolved items were identified.
D.
Evaluation of Supplier Performance 1.
Objectives The objectives of this area of the inspection were to verify that procedures had been prepared and approved by the vendor to prescribe a system for evaluation of suppliers perfonnance which is consistent with NRC rules, Code requirements, and the comit-ments of the QA Program.
Also, to verify that the procedures for evaluation of suppliers performance is being properly and effec-tively implemented by the vendor.
2.
Method of Accomolishment The objectives of this area of the inspection were accomplished by:
a.
Review of VEC Quality Assurance Manual, Revision 8, Section VEL-QC-506A, Procurement Control - Receiving Inspection Materials, Parts and Services, to verify that the vendor had established procedures for the evaluation of suppliers, that is consistent with NRC rules and Code requirements.
b.
Review of six (6) sets of documents applicable to three (3) suppliers to verify that the procedures, and necessary procurement documents, were available to the persons respon-sible for perfonning the prescribed quality activities, and that the procedures were properly impleme,nted.
c.
Interviews with personnel to verify whether they were knowl-edgeable in the procedures applicable to the evaluation of the suppliers' performances.
3.
Findings It was determined that the system prescribed for the evaluation of suppliers is consistent with the NRC rules and Code requirements.
However, the evidence demonstrated that the system was not imple-mented in a manner consistent with the vendor's QA commitments.
a.
Deviation See Enclosure, Item A.
b.
Within this area of the inspection, no unresolved items were identified.
E.
Audits 1.
Objectives The objectives of this area of the inspection were to verify that procedures had been prepared ad approved by the vendor that prescribed a system for auditing which is consistent with NRC rules, Code requirements, and the com.itments of the ASME accepted QA Manual. Also, to verify whether these audit pro-cedures were being properly and effectively implemented by the vendor.
2.
Method of Accomplishment The objectives of this area of the inspection were accomplishd by:
a.
Resiet: of the ASME accepted VEC QA Manual, Revision 8; Section VEL-QC-750A, Quality Control Audits, to verify that procedures had been established to prescribe a system for auditing, which is consistent with NRC regulation.
b.
Review of VEL-QC-750A, Quality Control Audits to verify it had been prepared by the designated personnel, reviewed by QA, and approved by management.
c.
Review of Internal Audit Check Lists and External Audits to verify that the organizations responsible for auditing, and their responsibilities are identified, and that the audits are performed by qualified personnel.
Also, to verify that the essential elements of the audit system is established.
d.
Review of the audit schedules to assure that the audits of quality activities during design, procurement, and manufacture are planned, docu:nented, and conducted in the prescribed manner, and assures coverage of all aspects of the QA program.
e.
Review of audit reports to verify that they include provisions for written plans, team selection, team orientation, audit notifications, pre-audit conferences, audit performances, and post-audit conferences.
f.
Review of audit reports to verify that they are properly distributed to management for review, and the audited organi-zation. Also and that follow-up audits to verify corrective action are documented.
g.
Revica of selective internal and exter.'al audit reports to verify the applicable procedures were tvailable to the audit team personnel, and that the audit procedures were properly and effectively implemented.
3.
Findings It was deter:ained that the system prescribed for conducting audits is consistent with the NRC rules and Code requirements.
- However, the system was not being implemented consistent with the vendor's QA commitments, a.
Deviation See Enclosure Item B.
b.
Within this area of the inspection, no unresolved items were identi fied.
F.
Exit Interview At the conclusion of the inspection on September 14, 1978, the inspector met with the company's management, identified in paragraph A, for the purpose of infoming them as to the results of the inspection. During this meeting each identified deviation was discussed and the evidence which supported the findings were identified.
The company's management acknowledged the findings and supporting evidence as being understood, but had no additional comments.
DETAILS SECTION II (Prepared by J. W. Sutton)
A.
Persons Contacted Velan Engineering, Ltd. (VEL)
E. Feldman, QA Administrator, Welding M. J. Richards, QA Manager M. Rodier, QC Manager L. Wozniak, Chief Inspector J. Fudalowski, Inspector (Final)
M. Dias, Insoector (Final)
R. Zaremba, Inspector (Testing)
J. Trudeau, Inspector (Receiving)
J. Bellerose, Foreman, Machining)
S. Boulais, Welding Technician B.
Inspection and Tests 1.
Objectives The objectives of this area of the inspection were to verify that products are assembled in accordance with approved procedures and drawings, and that all materials comply with the specifications.
Also that the required functional tests of the products were correctly per formed and properly documented.
2.
Method of Accomolishment The objectives of this area of the inspection were accomplished by:
(1) Review of the VEL QA Manual, Revision 8, QC Procedure VEL-QCl-136A, Revision 5, titled " Examination, Tests and Inspection" and VEL QA Procedures VEL-QCl-174, Revision 7, titled " Nameplates, Stamping and Reports for Nuclear Valves and Ports,"
to verify that a system exists to control the testing, inspection, documentation, and stamping of completed parts / components.
(2) Review of the test documentation:
(a) Nuclear assembly sheet, P.O.PZ-3288NA Valve Serial No. 1356, (b) Assembly QC1398, Revision 7,
. (c) 0 & R Inspec. tion Logbook, (d) Certification of test and inspection sheets, to verify that test procedures and/or instructions were available at the test stations and had been approved by Engineering and Quality Assurance.
(3) Review of the following documentation:
(a) P.0.PZ-3551N Valve Serial No.1679, (b) Review of NDE Test Materials, (c) NDE Procedure VEL NDT-564W, Revision 1, (d) Qualification of four (4) NDE Technicians, to verify that the test had been performed in accordance with the procedures and/or instructions, and evaluated against the specified acceptance criteria.
(4) Review of the following documentation:
(a) P.O.PZ-6432N Valve Serial No. 544 and 1228, (b)
Procedure VEL-NDT-640A, Revision 10, (c) QC1 455, Revision 7, (d) Test Gages 2853 and 2095, (e)
Log of Tests, (f) Assembly and Final Inspection Checklists, (g) Cleaning and Packaging Procedure 672, Revision 1, (h) Water Test Logbook, to verify that:
(a) Tne test data was documented and dispositioned in accordance with the procedure and/or instructions,
. (b) The limits of acceptability of test results had been established and were being used for rejection or acceptance of the product.
(c) The test instrumentation used is as specified by the procedures and was in calibration.
3.
Findings It was determined that the products are manufactured and assembled in accordance with procedures, drawings and specifications, and that the materials comply with Code and specification requirements; and that the functional tests are correctly performed, evaluated, and documented, in a manner consistent with the QA commitments.
C.
Manufacturing Process Contr31 - Machining 1.
Objectives The objectives of this area of the inspection were to verify that the machining operations are performed under a controlled system of manufacturing which meets the ASME Code requirements, NRC regulations, and contract requirements, and is effective in assuring product quality.
2.
Method of Accomolishment The objectives of ~this area of the inspection were accomplished by:
a.
Review of the ASME accepted VEL QA Manual, Revision 8, Section VEL-QC1-130A, to verify that procedures had been established to prescribe a control system of operation.
b.
Review of the 0 & R Sheets for P.O.7357 Valve Serial No. 3159, to verify that they had been prepared by the designated authority, approved by management, and reviewed by QA, and are consistent with NRC regulation, Code requirements, and QA commitments.
c.
Review of the documents:
(1) 0 & R Sheet for P.O.2-8993K Valve Serial No.1317, (2) Drawing No. 8928-071, Revision 0, (3) Shop Order Logbook,
. (4)
In-process Inspection Logs, to verify that they provide drawing / document control in the shop, and also provide for part identification and trace-
- ability, d.
Examined three (3) representative samples of finished machined parts to verify that they were properly identified, and machined to conform to tne drawings and specifications.
3.
Findings The evidence demonstrated that the machining operations are controlled in a manner which is consistent with NRC rules, Code requirements, and the QA commitments.
Within this area of the inspection, no deviations or unresolved items were identified.
D.
Control of Special Processes 1.
Objectives The objectives of this area of the inspection were to verify that specialwelding specifications (cladding, hard surfacing, seal welding, and weld repair without postweld heat treatment) conform with the requirements established by ASME Code,Section III and IX, and complies with NRC regulations, and the vendor's QA program commi tments.
2.
Meihod of Accomolishment The objectives of this area of the inspection were accomplished by:
Review of the ASME accepted VEL QA Manual, Revision 8, to verify a.
that the vendor had established procedures to prescribe a system for the development and qualification of special welding specifications, and for qualifying welders and/or welding machine operators.
b.
Review of the following documents:
(1) Welding procedures, Welding Specifications VEL-P-621, Revision 2, 622 Revision 2 and 8, 623 Reivsion 4, and 642 Revision 0, (2) Material Certification, Stadex, 3A-15A-1A,
.. (3) Welders qualification, WA27-WA-4, (4) Shop orders 15BGN-R1752, Part No. 9018-008-013, 18PSG-3002, Part No. 9019-003-002, to verify that the special requirements governing special welding application procedures, and perfonnance qualification, imposed by ASME Code regarding test sample size, examination of test sample, and special essential variables are satisfied.
c.
Interviews with personnel to verify that they were knowl-edgeable in the procedures applicable to special welding.
d.
VEL QC procedure VEL-QCl-138A, Revision 7, cated April 7, 1977, titled " Welding Quality Assurance," Paragraph 5,
" Inspection," requires that verification be made, by a roving Patrol QC Inspector, of the following inspection requirements, (1) Verification that the procedure and welder are qualified (patrol inspector stamps logbook).
(2) Verification of base material and filler metal (patrol inspector stamps logbook).
(3) Periodic check cf preheat, interpass and heat treatment temperatures at random (patrol inspector stamps log-book).
(4) Visual examination of finished weld (patrol inspector stampslogbook).
(5) Periodic check on voltage, amperage and speed to compute heat input of austenitic welds, and' ferrite content of production welds at random (patrol inspector stamps logbook).
(6) Periodic monitoring of conformance to the welding procedure specification by the welder at random (patrol inspector stamps logbook).
(7) Welds shall be released by means of the Shop Inspector's stamp in the welding logbook.
e.
Reviewed the current weld logbook to detennine if the above inspection requirements were being implemented and properly documented.
. 3.
Findings It was observed that inspection points (d, (1) to (7) above) established by VEL QC Procedure VEL-QCI-138A were not being documented as required, and also tnat the interpass temperature of 2500-3500F, established by the VEL Welding Procedure Specifi-cation (WPS) VEL-P-642 (P8) Large Parts, dated January 17, 1978, was not being monitored.
The process is a semi-automatic plasma welding procedure, and the welder informed the inspector that he only checks the preheat temperature using a TempStik.
Interpass temperature was not being checked.
From the documents and records reviewed, and the inspections and observations made, it could be determined that the Vendor's QA commitments for controlling welding processes, complies with NRC rules and regulations and the Code requirements. However, it was found that the system was not being implemented in a manner consistent with the Vendor's QA program commitments.
a.
Deviations See Enclosure, Item C.
b.
Unresolved Items None.
m*Me4e1