ML19242C433

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QA Program Insp Rept 99900353/79-01 on 790205-08. Noncompliance Noted:Incomplete QA Manual & Program, Unavailability of QA Files Re Auditor Training & Qualifications & Generic Batteries Not Fully Qualified
ML19242C433
Person / Time
Issue date: 03/07/1979
From: Agee J, Hunnicutt D
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV)
To:
Shared Package
ML19242C423 List:
References
REF-QA-99900353 99900353-79-1, NUDOCS 7908100399
Download: ML19242C433 (12)


Text

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U. S. N'JCLEAR REGULATORY COMMISSION OFFICE OF INSPECTION AND ENFORCEMENT REGION IV Report No. 99900353/79-01 Program No. 51400 Company:

Gould Incorporation Industrial Battery Division West Station Road Kankakee, Illinois Inspection at:

Kankakee, Illinois Inspection Conducted:

February 5-8, 1979 Inspector 7 f//

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?. R. Agee, Contractor Inspector, Vendor

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Inspection Branch Approved by:

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3/7/79 D. M. Hennicutt, Chief Components Section 11,

' Date Vendor Inspection Branch Sunmary 9

Inspection on February 5-8, 1979 (99900353/79-01)

Areas Insoected:

Initial Management Meeting and implementation of Quality Assurance Program to 10 CFR 50, App e dix B, ANSI NJ5.2, and applicable codes and standards relative to the following: Quality Assurance Manual / Program; Audits, Custemer Contracts; Desigr Control; and Peasurerents and Calibration.

The inspection involved twenty-eight (23) inspectcr-hours en site by cne (1)

NRC inspector.

Results:

In tne five (5) areas inspected, one (1) deviaticn was identified in each of three (3) areas while one (1) unresolved item was identified in each of two (2) areas and are described as follows:

Ceviations: Quality Assurance Manual /Pr gram - Records do not exist des-cribing the disposition of defect materials by the Material Review Board.

(See Enclosure, Item A.)

Audits - Followup audits had not been conducted on certain cudits nor had reaudits been made within the specified seven (7) day period to assure implementation of corrective action.

(fee Enclosure, Item B.)

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q 90s t o o 399 Measurements and Calibration - calibration resu had not been recorded on calibration data forms.

Unresolved Item: Audits - Division QA files concerning auditor training and qualifications were not available for verification (Details Section, paragraph D.3.b).

Design Control - Current generic batteries have not been fully qualifica-tion tested to meet criteria of current IEEE standards for Class 1E applications.

Current test programs in progress will be insp2cted in a subsequent inspection.

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o :,L Details Section A.

Persons Contacted

  • J. Corn, Plant Manager
  • G. E. Moon, Manager of Quality Assurance
  • L. J. Smith, Division, Qua!ity Assurance Manager
  • T. C. Theesfeld, Manager of Mcqufacturing
  • Attended the exit interview.

B.

Initial Management Meeting An initial maragement meeting was conducted to acquaint the vendor's management with the NRC responsibility to protect the health and safety of the public ( 1 to inform them of certain responsi'allities imposed 7n vendors by the " Energy Reorganization Act of 197 +" (Public Law 93-438) and 10 CFR 21.

1.

Objectives The objectives of the Initial Management Meeting were to:

a.

Meet with the vendor's management perscnnel and establish channels of,coi.nunication.

b.

Acquaint them with their responsibilities under Section 206 of Public Law 93-438.

c.

Learn how the ccmpany operates a.id its policies and practices concerning quality assurance a;.! yusiity control.

d.

Cbtain information related to the ccmpany's con:ribution to the nuclear industry.

2.

Method of Accccclishment The preceding objectives were accomplished by:

a.

Describing the historical events that indicated the need for the Vendor Inspection Program (VIP).

b.

Explaining the inspection base and how the inspections are conducted.

c.

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Describing hou inspection results are documented and how proprietary items are handled, including the vendor's opportunity to review the report for the purpose of identifying items considered to be proprietary.

d.

Describing the vendor's responsibility in responding to identified enforcement items relating to:

(1)

Correction of the identified de/iation.

(2' Action to be implemented to prevent recurrence.

(3) The date(s) when corrective action (s) for both (1) and (?.) above will be implemented or completed.

c.

Explaining that all reports and commurications are placed in the Public Document Room (PDR).

f.

Explaining the pub'.ication and function of the " White Book".

g.

Requesting the company's management to explain its policies and practices concerning quality assurance and its organi-zational structure.

h.

Requesting a brief summary of the company's operation, its contribution to the nuclear industry and management's involvement to assure adequate quality assurance for nuclear products.

3.

Findincs Management explained their organization ranufactures industrial batteries with a small percentage of the croduction going to safety related systems for Cia:s 1E aoplications in nuclear power generating stations. Historically the company has provided industrial batteries to approximately thirty-two (32) nuclear pcwer stations.

C.

Quality Assurance Manual / Program 1.

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

a.

QA Manual addresses the appropriate QA criteria stated in 10 CFR 50, Appendix B.

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The QA Program has been documented in writing and its implementation ensures completed products ace manufactured in compliance with electrical code requirecc.1ts and prescribed quality standards.

c.

The QA organization is structured to have sufficient aut'iority and organizational freedcm to identify quality prchlems; to initiate, recomend or provide solutions; and to verify implementation of solutions.

d.

Detailed written procedures are prcperly, reviewed, approved, released, and issued to control quality activities, as appropriate.

e.

A training and indoctrination program has been implemented to improve or maintain the proficiency of:

(1) Personnel performing quality activities.

(2) Personnel who verify that quality activities have been correctly performed.

2.

Method of Acccmplishment The preceding objectives were accomplist ed by:

a.

Discussions with the Division and Plant Quality Assurance Managers concerning the Quality Assurance Manual and the Division Quality Assurance Program as i.1plemented in the Kankakee Plant.

These discussions revealed the currently imolemented QA Program described in the QA Manual has been in effect approximately eighteen (13) months.

b.

Review of the Quality Assurance Manual which revealed the manual has not been thoroughly edited.

Generally, the mar.ual addresses the intent of the criteria of 10 CFR 50, At;endix B, but is tailored to the plant conventional manufactur'ng functions.

c.

Review of the QA Manual section utitled, " Quality Assurance Organization Chart."

d.

Review of the QA Manual, Quality Centrol Procedure Mumber 4, Revision 3, dated April 1,1977, e'1 titled " Materials Review Board."

e.

Review of randomly selected procedures frcm the Factory Procedures and Engineering Specification Manual.

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Findings a.

Deviations See Enclosure, Item A.

b.

. Unresolved Item None.

D.

Audits 1.

Objectives The object' s of this area of the inspection were to verify that:

a.

Pr cedures or policy documents clearly identify organizations r'.sponsible for audits ana define their responsibilities and authorities.

b.

Measures have been established to assure that auditors are independent of any direct responsibility for performance of activities which they art: auditing and that persons having direct responsibility for performance of the activities being audit _d 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 ccmpetence for performing required audits.

d.

Guidelines and requirements are estailished for audit scheduling and that they take into ctasideration the status and importance of the activitics to be audited.

e.

Sufficient instructicns cr guidance are available to tne auditors in the form of checklists or procedures to perform the audits effectively and in a:cordance with the audit plan.

Deficiencies identified by the audits are closed out by appropriate corrective action and timely follcwup, including reaudit of deficient areas.

g.

/.udit records are collected, stored and maintained in accotcance with applicable code and contract requirements.

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2.

Mcchod of Accamolishment The preceding objectives were accomplished by:

a.

Review of the QA Manual section entitled, " Quality Assurance Audit System." This section is not dated but represents the Division / Plant audit program.

b.

Review of audit records which revealed that seven (7) management audits had been made of the Kankakee Plant by Division Audit teams since November 1974.

These audit reports varied in thoroughness and completeness but fullfilled the annual audit commitments.

c.

Review of the plant internal audit files.

d.

Discussions with QA Management concerning plant auditor ~

training, which revealed that the Kankakee Plant has one professional quality assurance employee.

Internal audits are conducted by selected QA and Plant management personnel by use of a prepared checklist and form which requires follcwup action to audit findings.

e.

Discussions with QA management concerning Division auditor training.

f.

Review of internal audit records including internal audits that had been conducted on the following dates or periods:

November 1974, 1975; April, May, June, and September 1976, 1977; and February 1978. These audits do not include daily inspection records of manufacturing functions wnich represent QA overview of product quality.

3.

Findinas a.

Deviations See Enclosure, Item B.

b.

Unresolved Items Division QA files were not available at the Xankakee Plant.

Cetermination of division auditor training and qualifications could not be verified. Applicable files will be reviewed at the Divisicn Office facilities durin,, a st osequent inspection.

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_ _ _ _ _ - _. _. _ _.. _ _ _ _ _. _ _ _ _ _ _ _. E.

Customer Contracts 1.

Objectives The objectives of this a 'ea of the inspecticn were to verify that:

a.

Customer contracts (purchase orders) impose adequate technical and quality assurance requirements on the suppliers for equipment to be used in commercial nuclear pcwer industry applications.

b.

Technical Specifications require compliance to applicable codes and standards (specifically IEEE Standards for Class 1E equipment) of the proper revision and date for the nuclear facility in which the equipment will be installed.

2.

Method of Acccmolishment The preceding objectives were accomplished by:

a.

Review of the following contracts:

(1)

Purchase Order No. 194757 dated April 19, 1976, containing Technical Specification F-2819/L-2317 for 125V storage batteries and racks, Class 1E.

The specification required ccmpliance to the latest appli-cable industrial standards in effect en the date of the contract including IEEE Standards -323, -344, and

-450.

(2)

Purchase Order No. 73Ka-822334 dated November 2,1977, ccntaining Techaical Specification 510-05-A3 dated May 3, 1975 for 125V Satteries. Also, included was specification nt mber 3CC-03-AS dated Marcn 17, 1975, Seismic Qualification of Engineering Equipment.

These specificaticos required ccmpliance to the latest editions of IEEE Standards -3C8, -323, -336, -344, -450, and

-484.

(3)

Purchase Order No. C 91710 dated July 25, 1977, containing Technical Specification CNS-1356.01-00-CC01 dated September 1, 1976, for 125VCC I1C Vital Pcwer Patteries.

This specificaticn required ccepliance to

!EEE Standaris -323 (1971) and -450 (1975).

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-9 3.

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

F.

Design Control 1.

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

a.

Produe.ts are designed, qualification tested and manufactured in compliance with established national electrial codes and standards.

b.

Certified documentation is provided for all nuclear safety related products manufactured.

2.

Methods of Acccmolishment The preceding objectives were accomplished by:

Discussions with Plant and Division Quality Assurance 2.

Managers concerning:

(1) design and qualification testing of Class li battery and (2) manufacturing practices for Class 1E batteries, b.

Review of approximately twelve (12) drawings for manufacture of Class 1E batteries.

These drawings represented approved design concepts criginating frca Division headquarters.

3.

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

Cemr.en t No battery systems designatec as Class 1E that required ccepliance to the current edition of applicable IE standards have been manufactured and shipped by the Gould Ccapan, to commercial nuclear pcwer facilities.

The battery systems that have been shipped and installed have been designed, T ') 5 z,>

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- manufactured and tested to meet applicable codes and standards in effect at the date of the contract for manufacture of the batteries shipped. Some current contracts require comoliance to the latest code revisions of the IEEE standards such as

-323 (1974), -344 (1975), and -450 (1975).

The Gould Company does not currently have Class 1E batteries fully qualified to the latest IEEE standards referenced above; however, the company has ccmpleted initial qualification test procedures to which batteries will be fully qualification tested and certified for use in Class 1E applications.

This test program is in progress and is scheduled fcr completion before current contracts require shipment of Class 1E batteries fully qualification tested to the laust IEEE Standards.

Test procedures describing the curren' qualification test program were not at the Kankakee Plant for review but will be reviewed by an NRC inspector at Dis ision QA Offices during a subsequent inspection.

G.

Measurements and Calibration 1.

Ojbectives The objectives of this area of the inspection vere to verify thet:

a.

A system has been establisned and is maintained to assure that tools, gages, instrum.ents and other measuring devices used in activities affecung quaiity are properly controlled, calibrated and adjusted at specif Md periods to maintain accuracy within scecified limits.

b.

Calibraticn records are kept for cach instrument and that these records include the following information:

(1)

Purchase date and calibratio.1 history.

(2) Accuracy required and calibration results.

(3)

Location for use.

(4)

Present calibration interval and date due.

(5)

Al'1 maintenance and repair details.

(6)

Persons or agency performing all calibration.

(7) Serial r. umber or identification of each standard used to perform the calibration.

(8) Number or name of the calibration procedure.

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. (9)

Environmental conditions used during calibration.

(13) Equipment recall schedules.

(11) Disposition of obsolete.. unrepairable and unuseable test equipment.

2.

Methed of Accomolishment The preceding objectives.were accomplished by:

a.

Review of the QA Manual, Quality Control Procedure No. 7 Revision 3, entitled, " Equipment Calibration Procedure" dated April 1, 1977.

b.

Verification of calibration status of approximately twelve (12) volt 7eters and ammeters located in the calibration laboratory and manufacturing areas.

Inspection tour of the calibration 2.nd test iaboratory and c.

discussion with calibration technicians.

3.

Findings a.

Deviations See Enclosure, Item C.

b.

Unresolved Items None.

H.

Exit Interview The inspector meet with mAmagement reoresentatives denoted in para-graph A at the conclusion of the inspection at the Kankakee Plant on February 8, 1979. The inspector summarized the scope of the inspection concerning the folicwing areas:

1.

Qua'i y Assurance Manual /Progra.'.1.

t 2.

Audits.

3.

Custacer Contracts.

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. 4.

Design Control.

5.

Measurements and Calibration.

Management acknowledged statements made by the inspector.

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