ML19345C152

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QA Program Insp Rept 99900410/80-02 on 800826-28.No Noncompliance Noted.Major Areas Inspected:Implementation of 10CFR21 & 10CFR50,App B Re QA Records & Action on Previous Insp Findings
ML19345C152
Person / Time
Issue date: 10/17/1980
From: Agee J, Donna Anderson, Brickley R, Hale C
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV)
To:
Shared Package
ML19345C148 List:
References
REF-QA-99900410 NUDOCS 8012040023
Download: ML19345C152 (10)


Text

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

99900401/80-02 Program No. 51100 Company:

Combustion Engineering, Incorporated 1000 Prospect Hill Road Windsor, Connecticut 06095 Inspection conducted: August 26-28, 1980 Inspectors:

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f)atd R.H.Brickley,PrycipalInspector Program Evaluation Section Vendor Inspection Branch W. Na S MkohO J.R.Agee,ContracgrInspector Ifatd Program Evaluation Section Vendor Inspection Branc

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/$)6/Bo D. G. Anderson, Principal Inspector Date Program Evaluation Section Vendor Inspection Branch Approved by:

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!&I7-N C.J.(Hjle,' Chief Date Prgram Evaluation Section Vendor Inspection Branch Summary Inspection conducted on August 26-28, 1980 (99900401/80-02)

Areas Inspected:

Implementation of 10 CFR 21 and 10 CFR 50, Appendix B in the area of QA records and action on previous inspection findings.

The inspection involved sixty-four (64) inspector hours on-site by three (3) NRC inspectors.

Results:

In the areas inspected no deviations or unresolved items identified.

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DETAILS SECTION I (Prepared by R. H. Brickley and D. G. Anderson)

A.

Persons Contacted E. C. Gobell, Supervisor, ICE Product Design

  • F.

G.' Harvey, Auditor, EQA S. C. Hatfield, Supervisor, Fuel Design Group

  • J. J. Herbst, Manager, Reliability Systems
  • G. Hess, Licensing
  • E. H. Kennedy, Manager, Licensing
  • A. N. Major, Manager, Plant Components J. C. Matthews, Supervisor, Primary System Equipment V. A. Paggen, Supervisor, Corrective Actions T. L. Patterson, Corrective Actions Engineer T. J. Quigley, Supervisor, Computer Systems J. G. Rich, Supervisor, ICE Product Design F. C. Sernatinger, Project Manager D. L. Sigler, ICE QA Representative E. M. Weisel, Cognizant Engineer P. W. Wielhouwer, Supervisor, Vessel Group H. Winterson, President, Power Systems Group
  • Denotes those present at the exit interview.

B.

Action on Previous Inspection Findings 1.

(Closed) Deviation (Report No. 80-01) Audit reports not issued within the required time.

The inspector verified the corrective action and preventive measures described in the letter of response dated May 30, 1980, i.e. the Manager GQS issued a directive to the Complainee Supervisor to establish a target date of twenty (20) days following the post audit conference for publishing the report.

If the target date is exceeded the Manager, GQS or the Director, GQA shall be notified.

2.

(Closed) Deviation (Report No. 80-01) Corrective action on a previous inspection finding was not taken as committed.

The inspector verified the corrective action and preventive measures described in the letter of response dated May 30, 1980, i.e.

The Director, Mechanical Design issued a memo to mechanical design managers and supervisors emphasizing that QA corrective actions must be completed within the time frame specified and a memo from the Manager, Fuels i

'3 Engineering to the Supervisor, Auxiliary Components documenting their discussion of the incident to assure that it will not be repeated.

3.

(0 pen). Unresolved Item (Report No. 80-01)

It could not be demonstrated that-API-17 (Reporting of Safety Hazards) is sufficient to provide effective implementation of 10 CFR Part 21.

This item is considered

'further and expanded in paragraph C below.

C.

Compliance with 10 CFR Part 21 1.

Inspection Objective To determine whether Combustion Engineering and appropriate responsible officers had established and implemented procedures and other instruc-4 tions as required to ensure compliance with 10 CFR Part 21 require-ments relative to the reporting of defects.

Inspector determinations are based on the requirements of 10 CFR Part 21 as clarified by USNRC staff positions in NUREG-0302, Revision 1.

2.

Method of Accomplishment The preceding objective was accomplished by an examination of:

a.

The following procedures:

API-17, Reporting of Safety Hazard, January 23, 1979.

API 18.13, PSG Nuclear Safety Committee, January 26, 1978.

QAP 16.3, Reporting of Safety Hazards, October 16, 1978.

1 QADP 5.7, Design Changes and Corrective Action, October 1, 1976.

QADP 6.2, Technical Change Request (TCR), May 1, 1980.

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NPS-12, Engineering Concerns and Customer Notification, December j

14, 1979.

b.

The following Field Action Requests (FAR) and supporting documentation:

(1) FAR 6370-356, High Pressure Injection Valves, October 3, 1978.

This item was identified at Arkansas Nuclear One, Unit 2 during tests in June 1977 and involved the flow resistance in the high pressure safety injection system (HPSI) header valves being higher than the design value. This item was

. generic to San Onofre 2 and 3, Waterford 3, and St. Lucie 2.

(2) FAR 6370-338W, Pressurizer Pressure Transmitter Mounting Bracket Qualification, July 18, 1978. This item was

4 identified at Combustion Engineering and involved the brackets which support the Foxboro Pressure Transmitter.

The brackets had not been seismically qualified. This item was reported to the NRC under the requirements of 10 CFR 50.55(a) on September 23, 1978, and was generic to San Onofre 2 and 3, Millstone 2, Waterford 3, Fort Calhoun, and Palisades.

(3) FAR 6370-371W, Fuel Assembly Guide Tube Sleeving, June 12, 1978. This item was identified at AN02 and involved wear in the full length guide tubes for the CEA fingers in a 16X16 fuel assembly.

(4) FAR 6370-300, Modification of Steam Generator Tube Support, May 9, 1978. This item involved the buildup of corroaion in the annuli through which the steam generator tubing passes, and the subsequent crimping of the tubing. This item was originally identified at Millstone and the modification was made at AN02.

(5) FAR 6370-273W, Control Element Assembly Wiring Change, March 16, 1978.

This item was identified at AN02 and involved the control board indications for CEA 6 and 7, 22 and 23, 58 and 59, being reversed in both channels A and B.

(6) FAR 8973-104, Shutdown Heat Exchanger Weld Cladding, November 19, 1979.

This item was identified by WPPS-Unit 3 and involved chloride contamination, below minimum design weld overlay thickness, and cracking of weld overlays on two (2) Shutdown Heat Exchangers (SDHX) manufactured by the Ametek, Schutte &

Koerting Division, Bethayres Plant.

This item was reported to the NRC by the Licensee under the requirements of 10 CFR 50.55(e) on June 25, 1980.

Ametek, Schutte & Koerting have manufactured SDHXs for WPPS 3 and 5, Cherokee 1 and 2, and Yellow Creek 1 and 2.

The two (2) SDEXs for Cherokee I were inspected and found to have similar problems. Three (3) SDHXs have been delivered for Yellow Creek 1 and 2 of which two (2) were inspected prior to delivery with no defects noted (Surveillance Reports No. 5 and 12).

3.

Findings a.

Field Action Request (FARs) are originated by CE Field or Windsor personnel to document and obtain approvals of field changes or I

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modifications to CE. furnished systems, equipment, material, pro-cedures, or documentation applicable to site operations. They are used to. describe any nonconforming conditions discovered in the field e.g.

(1)- Deviations from purchase order, contract, specifications, or i

drawing requirements.

(2) Inability of CE systems, equipment or material to meet require-ments of installation, test or operating procedures, or tech-nical specifications.

The Reliability and Safety Assurance Section reviews and analyzes all completed FARs~to determine if the problem is of a generic or repeti-tive nature and if it~is reportable under the provisions of 10 CFR 50.55(e). They do not review the FARs for 10 CFR 21 reportability nor could the inspectors' find documented evidence that any other organi-

.zation performs a review or evaluation of FARs for Part 21 report-i ability. Since FARs contain the type of information that deals with deviations and performance limitations of components and systems, it appears that the FAR should be a document that is subject to the review and reporting requirements of CE's procedure API-17, which is intended by CE to implement the requirements of 10 CFR Part 21.

10 CFR 21.51(b) states in part "Each individual, corporation, partnership, or other entity subject to the regulations in this part shall prepare records... sufficient to assure compli nce with the regulations in this part."

Additionally staff posign 21.51.1 presented in NUREG-0302, Revision 1 dated July 1977, states that records should include the following:

(1) Information sufficient to describe the deviation.

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(2) An analysis of the effect of such deviation in a basic com-ponent if used in a facility or activity subject to Part 21.

(3) A conclusion based on this analysis as to whether the devi-ation could create a substantial safety hazard.

Based on the results of our inspection, it appears that records sufficient to assure compliance with the regulations in this part were not maintained on the following Field Action Requests (FAR).

(1) FAR 63790-356, High Pressure Injection Valves.

(2) FAR 6370-338W, Pressurizer Pressure Transmitter Mounting Bracket Qualification.

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6 (3) FAR 6370-317W, Fuel Assembly Guide Tube Sleeving.

l (4) FAR 6370-300, Modification of Steam Generator Tube Support.

l (5) FAR 6370-273W, Control Element Assembly Wiring Change.

(6) FAR'8973-104, Shutdown Heat Exchanger Weld Cladding.

l (Additional information contained in DetailsSection I, paragraph C.2)

This area of concern was initially identified as an unresolved item in Report No. 80-01..This inspection has expanded the concern of the previous unresolved item relative to compliance with Part 21.

It is apparant that the subject matter of some FARs identify deviations and/or defects in basic components;

.however, the current procedures for review and evaluation of FARs do not require documentation-of these actions as would be the case if procedure API-17 was applicable. Therefore, this unresolved item will remain open and our future inspections will examine in more depth CE's evaluation of certain FARs and the appropriateness of CE's exclusion of this source of field i

identified problems from consideration as potentially reportable items under the requirements of 10 CFR Part 21.

i b.

No deviations or unresolved items were identified.

t D.

Exit Interview i

j An exit interview was held with management representatives on August 28,

.1980..In addition to those individuals indicated by an asterisk in para-graph A of each Details-Section, those in attendance were:

l W. R. Corcoran, Director, Systems Engineering J. D. Crawford, Director, Plant Engineering M. R. Etheridge, Vice President, General-Services C. W. Hoffman, Director, GQA C. J. Huba, Manager, EQA D. M. Mayer, Supervisor, Planning and Procedures The inspector summarized the scope and findings of the inspection. Manage-ment comments were generally for clarification only, or acknowledgement:

of the statements by the inspector.

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7 DETAILS SECTION II (Prepared by J. R. Agee)

A.

Persons Contacted G. A. Brucker - Supervisor, Group Quality Controls, Electrical Suppliers

  • P. D. Ford - Quality Assurance Engineer W. J. Rose - Quality Assurance Engineer
  • T. R. Swift - Manager, Group Quality Systems
  • Attended the exit interview.

B.

QA Records 1.

Objectives The objective of this area of the inspection was to examine the establishment and implementation of quality related procedures for collecting, filing, storing, maintaining, and dispoistioning of QA records to verify that:

A QA records system is defined, implemented, and enforced in a.

accordance with approved procedures, instructions, or other documentation for all groups performing safety related activities including QA, design, procurement, administration, and services.

b.

QA records are legible, completely filled out, adequately identi-fiable to the item involved, validated, and listed in an index that indicates:

the record retention time, where the record is to be stored, and the location of'the record in the storage area.

Any changes or modifications to these records are controlled.

A specific submittal plan for QA records is established between c.

the licensee and contractor and records exist that acknowledge the licensee's receipt of QA records.

d.

A designated authority has been assigned to control the receipt of QA records by a system which includes a list of QA records required, a record of QA records received, and an inspection of incoming records including a current assessment of the status of incoming records.

A custodian has been designated to assure that QA records are in e.

accordance with b. above and to enforce a QA record storage filing system which includes a system description of the filing technique and stroage area, rules for access and control or fecord files, accountability of records removed rrom record files and security requirements.

8 f.

The QA record storage facility is in compliance with aplicable codes, standards, and regulations consistent with NRC Regulatory Guide 1.88.

g.

The QA record storage system is periodically audited to assure the record control system is implemented.

2.

Method of Accomplishment The preceding objectives were accomplished by:

Examination of the following Quality Assurance Procedures (QAPs) a.

and documents; (1) 17.1 Group Quality Assurance (GQA) Quality Records, Revision A. June 8, 1978.

(2) 2.1 Training and Certification Program, Revision A, June 8, 1978.

(3) 6.4 GQC Document Filing Procedure, Revision A, October 16, 1978.

(4) 18.1 Internal Audits, Revision A, June 8, 1978.

(5) 18.2 External. adits, Revision A, June 8, 1978.

(6) Engineering QA Manual (Orange Book), Section 7.0, Collection, Storage and Maintenance of Quality Records, Revision'4, May 6, 1977.

b.

Examination of the QA records in the following areas:

GQA records, training, industrirl relations, QA records storage, vendor surveillance reports, design (enginering) and project management (two projects) files.

3.

Findings a.

General (1) All of the QA records examined in the areas identified in item 2b. above, were legible adequately identifiable and retrieveable, controlled and updated, as required.

(2) All QA procedures that were reviewed had been approved by QA management consistent with QAP 5.1 Preparation and Control of Group Quality Assurance (GQA) Procedures.

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9 (3) Review was made of QA records in the following areas to verify compliance to QAP 17.1 GQA Quality Records.

(a) Audit Records (Internal) - Permanent records for 1976 through 1978 located in the library were closed: The records for 1979 were not in permanent folders since several findings were outstanding and are currently included in Revision 2 of the 198C Audit Schedule and Status.

(b) Audit Records (External) - Permanent records for 1976 through 1979 were filed in permanent folders located in the library under the librarian's control.

(c) Surveillance Reports - Surveillance reports were main-tained by GQC. The reports contained vendor current evaluations and capability in compliance with QAP 7.1 Vendor Evaluation.

(d) Vendor QA Manuals - QA Manuals from the Vendor QA Manual files were compared with the approved vendor list and vendor surveillance reports. One (1) QA Manual (ITT Barton) could not be located.

Subsequent to that portion of the inspection the GQC supervisor for vendor surveillance requested a replacement copy of the manual from ITT Barton.

(e) Personnel (GQA) Training Records - Training records had been generated and maintained current for all GQA/

GQC auditors. Duplicate copies of these training records were identified and examined in the Industrial Relations Department.

(f) QA Records Storage - The QA records custodian records all incoming records and provides cross-referenced index data for identity and location of the records. Microfilm copies of the records are maintained locally with dup-licate copies transmitted to the permanent files in another state. Access to these records are controlled by the QA records custodian at all times.

This facility and system appear to be in compliance with NRC regulatory guide 1.88 and ANSI standard N45.2.9. for the Collection, Storage and Maintenance of Quality Assurance Records for Nuclear Power Plant.

The QA organization internal audit records were not examined specifically for audit records of the QA records storage facility; however, noticeably absent

10 from the 1980 Audit Schefule and Status schedule dated August-19, 1980, was.the schedule or requirement for auditing the QA Records storage facility for 1980.

(g) Project Management Files - Project management (two projects) maintains a log of licensee /C-E corresponce and exchange of all contract documents.

Copies of project records and documents are maintained current in temporary files while duplicate copies of all project documents are marked " Quality Records" and submitted to QA Records Storage for retention in the QA records system.

.(h) Procurement Records - These records were not examined due to limited and available inspection time and the remote location of the procurement files.

b.

Deviations and Unresolved Items None were identified.

c.

Follow-up Items None.

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