ML19259D585

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QA Program Insp Rept 99900275/79-01 on 790618-20. Noncompliance Noted:Reaudits Not Made of Deficiencies Identified in 780815 Audit Repts Afr 21 & 22
ML19259D585
Person / Time
Issue date: 08/22/1979
From: Agee J, Hunnicutt D
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV)
To:
Shared Package
ML19259D586 List:
References
REF-QA-99900275 99900275-79-1, NUDOCS 7910250138
Download: ML19259D585 (8)


Text

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

99900275/79-01 Company:

Reuter-Stokes, Inc.

18530 S. Miles Road Cleveland, Ohio 44128 Inspectica Conducted:

June 18-21, 1979 p

p/2.z[f g

Inspector:

J. K. Agee, ' Contractor Insleector Date ComponentsSection II Vendor Inspection Branch

{

1 N/

_dh 2./Q Approved by:

D. M. Hunnicutt, Chief

~Date ComponentsSection II Vendor Inspection Branch

.m m

Summary Inspection on June 18-21, 1979 (99900275/79-01) i Areas Inspected:

Implementation of 10 CFR 50, Appendix B, including audits; design control; manufacturing process control including training, receiving inspection, test control measurement and calibration. The inspection involved twenty-seven (27) inspection hours on site by one (1) NRC inspector.

Results:

In the four (4) areas inspected one (1) deviation and one (1) unresolved item were identified in two (2) areas while no deviations or unresolved items were identified in the remaining areas. A description of the findings includes the following:

Deviations:

Audits - QA department records did not show that reaudits had been made (See Notice of Deviation).

Unresolved Item: Quality Assurance Manual / Program. Use of the subjective wording, " Management will periodically audit the quality assurance system,"

in the QA Manual policy statement concerning Criterion II of 10 CFR 50, Appendix B, criteria no commitment is made to a definite regular review of the quality assurance program.

(See Details Section Item B.3.b.).

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)

2 DETAILS SECTION A.

Persons Contacted J. P. Doyle - Project Engineer Quality A ssurance T. B. Fleming - Vice President Marketing, C. H. Ford - Testing Supervisor R. A. Kempe - President J. C. Kroon - Vice President Applied Re: search G. Palko - Vice President Operations R. L. Simon - Manager Quality Assurante B.

Quality Assurance Manual / Program 1.

Objectives The objectives of this area of the inspection were to verify that:

The QA program had been implemented by the use of approved a.

QA Manual and procedures.

b.

The QA Manual had been maintained current.

c.

Audits had been conducted in compliance with an established audit program.

2.'

Method of Accomplishment The preceding objectives were accomplished by:

a.

Review of the following QA dccuments:

(1) Quality Assurance Program Manual, Revision E, da'

_.. n 25, 1974.

(2) Quality Assurance Supplement II, Revision A, dated November 16, 1976.

(3) Amendment No. I to " Quality Assurance Program, Revision E, dated March 25, 1974," dated July 12, 1978.

Also by review of a rough draft of the QA Manual to verify that its format and contents are being revised to the features of 10 CFR 50 Appendix B.

b.

Discussions with marketing and senior management representatives regarding the company position on quality assurance.

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3 c.

Review of S0P (Standard Operating Procedure) - 250.1 The Qualification Program and verified that personnel responsible for verifying quality receive orientation, instructions, supervised on-the-jot training in their respective functional areas; examples: welders are qualified according to special written standards and inspection of work; inspection / testers are qualified according to written procedures and observation of work performed during training period.

d.

Discussions with the QA manager regarding applicable department functional SOPS that have been implemented but which are being compiled into separate department operating manuals such as engineering, manufacturing procurement, etc.

3.

Findings a.

Deviations None b.

Unresolved Item Criterion II of 10 CFR 50, Appendix B, requires regular review of the status and adequacy of the quality assurance program.

The QA Macual Supplement II, Quality Assurance Policy Statement, states in part on this subject, "... Management will periodically audit the quality assurance system and recommend improvements

." Use of non-specific terminology sucn as " periodically" does not adequately address the Criterion II requirement, in that it provides no definitive frequency of review.

It was additionally noted during the inspection, that no records were available of past manage = enc quality assurance system audits, which would confirm a continui0g program review was in effect.

This item is considered unresolved, pending appropriate clarification of QA Manual intent.

C.

Audits 1.

Objectives The objectives of this area of the inspection were to verify that:

a.

Audits are conducted on a periodic basis and in compliance with an established audit program.

b.

Audit procedures had been approved and implemented.

121.3 178

4 Sufficient audit traintig is provided to maintain qualified c.

auditors.

d.

Management reviews audit programs and reports.

Management audits are conducted periodically.

e.

2.

Method of Accomplishment The preceding objectives were accomplished by:

Review of the QA Manual, Sections 23.0 quality audits and a.

Quality Assurance Supplement II, Revision A, November 16, 1976.

b.

Discussions with the QA Manager and Project Engineer concerning audit practices.

Review of Proced.;e No. RS-S.O.P.-290.23, Administration of c.

Quality Assurance Internal Audit, Revision B, November 1, 1978, including Check Lists, Sets A & B entitled (1) Qualttative Audit - Organization, planning and (2) Compliance Audit - Personnel Certification, respectively.

d.

Review of Internal Audit Report, A.F.R. #22.

I Review of nine (9) customer audit reports.

e.

3.

Findings a.

Deviations See Notice of Deviation.

h.

Unresolved Items None D.

Design Control 1.

Objectives The objectives of this area of the inspec tion were to:

a.

Review current customer contracts (purchase orders) for nuclear detectors and verify the status of design and production.

121.5 179

9 5

b.

Verify the detectors are being designed, tested and manufactured to meet customer and applicable code requirements.

2.

Method of Accomplishment The preceding objectives were accouplished by:

a.

Review of the customer purchase order (P.O.) No. 10908 dated June 15,1978 including technical specification LY-CCG-0478, Revision 1 and the approved drawing RS-C6-1100-201, Revision E.

These contract documents were for procurement of replacement.

Local Power Range Monitors (LPRMs) for Niling water reactors (B'JRs).

b.

Review of customer letter CCG 78-72, VY-RS-78-3, dated March 17, which approved the LPRM drawings for manufacture of the designated LPRMs.

Discussions with company research and development management c.

regarding the design and development of LPRM detectors. These disc"ssions revealed the LPRMs developed by Reuter-Stokes were developed while using the extensive operating experience of a licensed BWR facility. The LPRMs were developed to meet the operating need of currently operating BWRs and the criteria of such authoritative documents as the following:

, (1) International Electrotechnical Commission (IEC) Standard 568, entitled, "In-core Instrumentation for Neutron Fluence Rate (Flux) Measurements in Power Reactors."

(2) ANSI /ANS Standard -52.1-1978, entitled, " Nuclear Safety Criteria for the Design of Stationary Boiling Water Reactor Plants."

(3) Stress Analysis Calculation for an In-core Local Power Range Monitoring (LPRM) assembly. Stress Report No.

ER-1530 (Revision 0), July 1976. This stress report (a Reuter-Stokes document) is certified to meet the requirements of paragraphs NA-3352 and NA-3354 and Appendix C of the ASME Bciler and Pressure Vessel Code,Section III, 1971 issue.

d.

Review of the documentation and test and certification data of the Electronic and Nuclear Testing Department that verifies the final electrical and mechanical integrity and the nuclear sensitivity of the detectors (LPRMs).

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6 e.

Review of the radiograph negatives of the welds made on che detectors (LPRMs) during their progressive manufacture and assembly.

f.

Verifying that R-S maintains complete historical data on each LPRM manufactured and shipped including:

(1) Serial numbers.

(2) Certificate of Compliance.

(3) Bills of Materials.

(4) Drawings numbers.

(5) Insulatica resistance report.

(6) Hydrostatic test report.

(7) Final inspection test results.

(8) Test report on the integrity of welds and brazes.

(9) Certification of NDT personnel, Certification of LPT personnel, qualification records for Helt (helium leak test) personnel and vision test results.

(10) Record of Welding Procedure Qualification.

(11) Record of Welding Performance Qualification.

(12) Material certifications for pressure boundry elements.

(13) Welding Procedure Specifi<.stiots.

(14) Braze Procedure Specification.

(15) Neutron sensitivity results.

(16) Stress report.

(17) Radiograph negatives.

l 3.

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

E.

Manufacturing Process Control 1.

Objectives The objectives of this area of the inspection were to examine the manufacturing process starting with the receiving inspection function and continuing through manufacturing to final test and inspection while reviewing procurement, training, cable assembly, detector assembly, leak and pressure testing, electrical tests, welding, x-rays, measurement and calibration and sensitivity tests.

2.

Method of Accomplishment The preceding objectives were accomplished by:

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7 a.

Review of the design of neutron detectors with research and development management including applicable codes and standards.

b.

Review of the manufacturing process with the QA manager and project engineer.

c.

Review of the following documentation (1) Procedure RS-SOP-240.1/.2/.3/ Leak Detection by:

(a) Vacuum Testing (b) Sniffing (c) Vacuum Chamber Method (2) Procedure RS-SOP-243.1, Revision B, Hydrostatic Testing of C6-1100-2XX-21 (Fission Chamber).

(3) Procedure RS-0P-C6-0201-280-2, Cable Assembly.

(4) Procedure MP-C6-1100-2XX-1, Straightening LPRM Housing.

(5) Production Process Instruction Number 18.1, General Procedure for Leak Testing No. 113031-9.

(6) Procedure RS-0P-C6-0201-280-1, Detector Assembly.

I (7) Procedure Measurement and Calibration SOP-230.

(8) Procedure RS-SOP-860.1, Neutron Sensitivity Testing of Miniature Fission Chambers.

d.

Examination of incoming materials as they are inspected and compared with the purchase order then inspected and tested, as required, by inspection / test personnel, to applicable procedures.

e.

Examination of cable assembly from initial continuity and resistance check to weld seals and leak checks, radiographs, exhaust and fill, and final resistance / continuity /high voltage breakdown tests and data.

f.

Examination of detector assembly from initial welds and helium leak tests to radiographs, pinch off, exhaust and fill, electrical tests including resistance and high voltage breakdown, 1213 182

8 visual inspection, results of reactor testing (sensitivity calibration) and final data review. At each production stage the latest revised procedure and/or drawings were available for reference, as needed.

3.

Findings Within this area no deviations or unresolved items were identified.

F.

Exit Interview The inspector met with management representatives (denoted by an asterisk in paragraph A) at the conclusion of the inspection on June 21, 1979.

In this meeting the inspector discussed the scope and the findings of the inspection relative to the following functions:

1.

Quality Assurance Manual / Program.

2.

Audits.

3.

Design Control.

4.

Manufacturing process including training, receiving inspection test control and measurement and calibration.

Managementacknowledgedthediscussionsbytheinspector.

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