ML19263A735

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IE Insp Rept 99900346/78-01 on 780912.No Noncompliance Noted.Major Areas Inspected:Review of QA Program,Mfg Process Control & Training
ML19263A735
Person / Time
Issue date: 10/03/1978
From: Kelly W, Sutton J, Whitesell D
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV)
To:
Shared Package
ML19263A732 List:
References
REF-QA-99900346 99900346-78-1, NUDOCS 7901020200
Download: ML19263A735 (11)


Text

VENDOR INSPECTION REPORT U.S. NUCLEAR REGULATORY COMMISSION OFFICE OF INSPECTION AND ENFORCEMENT REGION IV Report No.

99900346/78-01 Program No.

44060 Company:

Velan Valve Corporation Avenue "C" Grin.ald Industrial Park Inspection at: Williston, Vennont 05495 Inspection Conducted: September 12, 1978 Inspectors:

.w $ M b

/o-J-9B WiMiam D. KelleyvContractor inspector (Date Signed)

Vendor Inspection Branch

. t.J su N to -s - 72

. W. Sutton, Contractor Inspector, Vendor (Date Signed)

Inspection Branch Approved by: d,/

A/N

/0 M 0( E~. Whiteseli, Chief, Components (Date Signed)

~

Section I, Vendor Inspection Branch Suninary Inspection on September 12, 1978 (99900346/78-01)

Areas Inspected:

Implementation of 10 CFR 50, Appendix B and applicable codes and standards including, review of QA program, manufacturing process control, and training; also, held initial management meeting and interfaced with the Authorized Nuclear Inspector. The inspection involved sixteen (16) inspector-hours by two (2) NRC Inspectors.

Results:

In the four (4) areas insnected, no apparent deviations or unresolved items were identified.

790102D F

. DETAILS SECTION I (Prepared by William D. Kelley)

A.

Persons Contacted Velan Valve Corporation (VVC)

  • E. I. Francois - Corporate Manager of Quality issurance M. Huck - Welding Engineer
  • J. K. Metzger - Senior Quality Assurance Administrator
  • M. A. Parsons - Acting Plant Manager C. Sheard - Personnel & Office Manager
  • D. A. Winton - Quality Control Manager Velan Engineer Ltd. (VEL) Montreal, Que.
  • P. Velan - Plant Manager, Plant No. 2 Kemper Insurance Company (KIC)
  • G. P. Odom - Authorized Nuclear Inspector
  • Denotes those persons who attended Exit Interview (See paragraph E.).

B.

Initial Management Meeting 1.

Objectives The objectives of this meeting were to accomplish the following:

a.

To meet the Velan Valve Corporation management and those persons responsible for administration of the ASME QA program and to establish channels of communication.

b.

To detemine the extent of companies involvement in the commercial nuclear business.

c.

To explain NRC direct inspection program including LCVIP organization, VIB inspection methods and documentation.

d.

To describe the NRC evaluation of the ASME inspection system.

2.

Method of Accomplishment The preceding objectives were accomplished by a meeting on September 12, 1978.

The following is a summary of the meeting:

. a.

Attendees were:

Velan Valve Corporation (VVC)

E. I. Francois - Corporate Manager of Quality Assurance M. Huck - Welding Engineer J. K. Metzger - Senior Quality Assurance Administrator M. A. Parsons - Acting Plant Manager C. Sheard - Personnel & Office Manager D. A. Winton - Quality Control Manager Kemper Insurance Company (KIC)

G. P. Odom - Authorized Nuclear Inspector b.

The VIB organization was described and its relationship to NRC Region IV and the NRC Headquarters component of the Office of Inspection and Enforcement.

c.

The LCVIP was described including the reasons for its estab-lishment, its objectives, its implementation structure, and the more significant program changes as they may relate to Velan Valve Corporation.

d.

The conduct of VIB inspection was described and how our inspections are documented including the report, resporses to reports, how proprietary information is handled, the Public Document Room, and the White Book.

e.

The purpose, scope, and status of the NRC's two year program for evaluation of the ASME inspection system as an accept-able independent third party was discussed.

f.

The companies contribution to the nuclear industry was discussed including current and projected activitiy, status of ASME certificates of authorization and third party inspec-tion arrangements.

3.

Results a.

Management acknowledged the above presentation as being understood by them.

b.

Management informed the inspectors that:

(1) They have recieved ASME Certificate of Authorization No. N-2117 to use the "N" symbol for " Class 1, 2, and 3 Valve & Fluid Conditioning Devices" and ASME Certificate of Authorization No. N-2118 to use the "NPT" symbol for " Class 1, 2, and 3 Valve Parts and Appurtenances and Fluid Conditioning Devices." These Certificates expire on June 9,1981.

(2) The new plant at Williston started production of commer-cial valves in March 1978, and nuclear valves followed in August 1978.

Presently, the nuclear valves amount to approximately 5 percent of the production and are 3 inches and 4 inches in size and of the 600# and 1500#

Class.

C.

QA program Review 1.

Objectives The objectives of this inspection were to ascertain whether the QA program has been documented in writing, and if correctly im-plemented, will ensure that the completed components were manufac-tured in compliance with Code requirements and meet the prescribed quality standards. Also, to ascertain whether the program is consistent with NRC regulations and Code requirements.

2.

Method of Accomolishment The preceding objectives were accomplished by:

a.

Review of the ASME accepted VEC Quality Assurance Manual, Revision 1, to verify that it is consistent with NRC rules and regulations and the code requirements, b.

Review of appropriate organization charts to verify that the QA staff is independent from the pressures of cost and scheduling and has access to upper management.

c.

Review of the documents concerning the authority, du'ies, and independence of the Quality Assurance staff to verify that they have the independence to idcatify quality problems and initiate appropriate corrective action, and the authority to stop work.

d.

Review of documents to verify that appropriate review and approval by authorized personnel are provided for, e.

Review of the Training and Indoctrination program to verify its adequacy to improve and/or maintain the proficiency of the personnel.

f.

Interviews with cognizant personnel to ascertain whether they are knowledgeable in the procedures which control the activities for which they are responsible.

g.

Observation of work in progress to verify that the program is being implemented.

3.

Findings The evidence demonstrates that the QA program has been documented in writing and clearly defines the duties, authority, and organiza-tional independence and freedom of the QA staff.

Detailed written implementing documents are appropriately reviewed, approved, re-leased, and issued by authorized personnel. The QA staff has access to a level of management to ensure effective implementation of the program and timely and positive corrective action of enforcement items.

Within this area of the inspection no deviations or unresolved items were identified.

D.

Training 1.

Objectives The objectives of this area of the inspection were to ascertain whether approved procedures have been established for the indoctrination and training of personnel performing quality related activities, and that the procedures are consistant with the NRC regulations and applicable code requirements and the QA program commitments. Also, ascertain whether the indoctrination and training procedures are in place and are effectively implemented.

2.

Method of Accomolishment The objectives of this area of the inspection were accomplished by:

a.

Review of the ASME accepted VEC Quality Assurance Manual, VELW-QC-156, Revision 1:

(1) Section VELW-QC-156, Quality Assurance Program-Organization Charts, and (2) Section VELW-QC-156.14, Indoctrination and Training of Quality Related Personnel.

To verify that a training program prescribed by the QA program is consistent with the NRC rules and Code require-

ments, b.

Review of the following VEC Training and Indoctrination Program documents:

(1) Lesson 2.1, QA Administrator, (2) Lesson 3.3, Assembly Inspectors, and (3) Lesson 6.1, Auditor.

To verify that detailed instructions and procedures required by the Quality Assurance Manual have been prepared and are in place. Also, to ascertain that these instruction and procedures covers all personnel performing activities affecting quality.

c.

Review of the following documents:

(1) Organization charts, (2) Training personnel qualifications, and (3) Training schedules.

To verify that the training and indoctrination procedures are in place, and are properly administered for training by qualified personnel.

d.

Review of the training records of personnel assigned the following activities affecting quality:

(1) Quality Assurance, (2) Training, (3) Engineering and/or design, (4) Procurement, (5) Receiving, (6) Non-destructive examinations, and (7)

Internal and external audits.

. To verify that the training program has been properly implemented, and that the identified personnel has received appropriate training at intervals consistence with his needs to maintain er improve his proficiency n the performance of his assigned duties.

3.

Findings The evidence demonstrated that a viable training and indoctrina-tion program has been implemented for upgrading and maintaining proficiencies in specific areas of expertise. This includes corporate management, auditor, engineers, design, and procurement personnel, as well as shop personnel, welde s, and nondestructive examiners.

Within this area of tne inrpection no deviations or unresolved items were identified.

E.

Exit Interview The inspectors met with management representatives (denoted in para-graph A.) at the conclusion of the inspection on September 12, 1978.

The management representative acknowledged the statements by the inspectors that no deviations or unresolved items were identified in this inspection.

DETAILS SECTION II (Prepared by J. W. Sutton)

A.

Persons Interviewed Velan Valve Corporation (VVC)

D. Winton, QC Manager Kemper Insurance Comoanies G. Odom, Authorized Nuclear Inspector (ANI)

B.

Authorized Nuclear Inspector (ANI) Interface 1.

Objectives The objectives of this area of the inspection were to ascertain whether procedures had been prepared and approved, which describes the system to be implemented for the achievement of interface activities with the ANI, and that the identified activities are i

consistent with the NRC rules, Code requirements, and the QA Program commitments.

2.

Method of Accomplishment The objectives of this area of the inspection were accomplished as follows:

a.

Review of VVC QC Procedure, VELW-QC 156; to ascertain whether the system provides for interface with the ANI and/or the Authorized Inspection Agency (AIA) to review the Design Specification (DS), and provide the inspection services of all code items covered by the customer's order and DS.

b.

Review of VVC QC Procedure, VELW-QC 156.1, Paragraph 14; to verify that changes in the customer's design specifications (DS) are reviewed with the ANI to inform him of the status of the inspections and tests of the items when it is removed from the manufacturing process.

c.

Review of VVC QC Procedure, VELW-QC 156.4; to verify that measureshave been provided to make available for review by the ANI, Material Certifications and the QC Source and/or Receiving Inspection Reports, and that such reviews are documented.

_9 d.

Review of VVC QC Procedures, VELW-QC 156.5 and 156.9; to verify that a system has been provided to maintain the identification of materials, and that the identification is tranfered when it becomes necessary to divide the material, also, to verify that the ANI is provided the opportunity to verify that the identification of material is properly maintained and documented.

e.

Review of VVC QC Procedure, VELW-QC 156.6; to verify that the program provides for the 0&R and flVAR sheets to be reviewed with the ANI so that he may select the operations, inspections, and tests that he will witness. Also to verify that code parts cannot be processed beyond the ANI hold point until signed-off by him.

f.

Review of VVC QC Procedure, VELW-QC 156.7; to ascerto a whether measures have been established for the ANI to witness any welding procedure and/or any welder performance qualifica-tion tests and to verify that he may request the requalification of any procedure or welder.

g.

Review of VVC QC Procedure, VELW-QA 156.10; to verify that the program provides for the application of the code stamp i

only with the authorization of the ANI after acceptable pressure testing, and the certification of the Manufacturer's Data Report, and only in the presence of the A'il.

h.

Review of VVC QC Procedure, VELW-QC 156.6; to ascertain the designated personnel authorized and responsible for maintaining liaison with the AIA and the ANI. Also to verify that the design specifications (DS), drawings, and data sheets are made available for review by the ANI to enable him to verify and document that the DS are certified by professional Engineer (PE), that the size and code class of the component, or part, is within the scope of the certificate of authoriza-tion, and that the code jurisdiction is clearly established and that the code jurisdiction is clearly established and identified.

1.

Review of VVC QC Procedure, VELW-QC 156.13; to verify that the ANI is notified of all rejection or scrap items as indicated on Nonconforming Material Report Tag, where the ANI perviously participated in acceptance of quality actions.

Also, to verify that Material Review Board Report indicating its recommended corrective actions are made available for review by the ANI and the review documented.

' j.

Review of P.O. Order No. C7766, for class 2 valves.

It was verified that the ANI has reviewed the foregoing documents and had selected his hold points.

k.

The Daily Log Book maintained by the ANI was reviewed.

It was also observed that he documents his review of DS, drawings, 0&R and NVAR sheets, Welding Procedures, and Qualifications, and the qualifications of Weldors and NDE technicians, also that he witnessess hydro tests, and the application of the stamp.

3.

, Findings The ANI activities as documented in his bound log book, and by documents reviewed, supports a Finding that the vendor is properly implementing its interface responsibilities with the ANI in a manner consistent with the NRC rules, code requirements and its QA program commitments.

C.

Manufacturing Process Control 1.

Objectives The objectives of this area of the inspection were to ascertain whether approved procedures had been developed for the control of the manufacturing process, which is consistent with the NRC rules and regulations, the governing code requirements and the QA program commitments. Also to verify that the procedures are in place, and are effectively implemented.

2.

Method of Accomplishment The objective of this area of the inspection was accomplished by:

a.

Review of the ASME accepted VEC Quality Assurance Manual, VELW-QC 156, Revision 1:

(1) Section VELW-QC 156.5, Identification and Control of Materials and Items - Traceability, (2) Section VELW-QC 156.6, Control of Fabrication Process Operation and Routing Sheets, and (3) Section VELM-QC 156.7; Welding - Quality Assurance.

To verify that a system for the control of manufacturing processes has been prescribed by the vendor, and that it is consistent with the NRC rules and code requirements.

' b.

Review of the following documents:

(1) Purchase Order C-7766, (2) Operation and Routing Sheet (0&R) P3-7062-N, (3) Receiving Log Book, (4) Rejection Notices R-2898 and R-2908, and (5) NDE inspection Log Book.

To verify that the manufacturing process system provides for the use of process sheets, shop travelers, or equivalent, which provides for the documentation that a specific activity has been correctly performed and verified by the authorized personnel.

c.

Verify that manufacturing process system requires all special processes and tests, to be performed by qualified personnel, using qualified procedures, and ascertain whether the proce-dures are in place.

3.

Findinos a.

The evidence demonstrated that the manufacturing processes are controlled in a manner consistent with the NRC regulations, the ASME Code requirements and the QA Manual commitments.

b.

Within this area of the Inspection no deviations or unresolved items were identified.

.