ML20215N564

Notice of Nonconformance from Insp on 860825-29

ML20215N564
Person / Time
Issue date:	10/27/1986
From:	NRC OFFICE OF INSPECTION & ENFORCEMENT (IE)
To:
Shared Package
ML20215N560	List: ML20215N559 ML20215N563 ML20215N564 ML20215N566
References
REF-QA-99900296 NUDOCS 8611060349
Download: ML20215N564 (3)

Text

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APPENDIX B The Amerace Corporation Control Products Division Docket No. 99900296/86-01 NOTICE OF NONCONFORMANCE An NRC inspection conducted on August 25-29, 1986 found that certain of the Amerace Corporation, Control Products Division (CPD) activities were not conducted in accordance with NRC requirements. The following nonconformances were identified:

A. Criterion I, " Organization," of Appendix B to 10 CFR Part 50 states, in part:

... The persons and organizations performing quality assurance functions shall have sufficient authority and organizational freedom to identify quality problems . . . Such persons and organizations performing quality assurance functions shall report to a management level such that this required authority and organization freedom, including sufficient independence from cost and schedule when opposed to safety considerations, are provided ... the individual assigned the responsibility... of the quality assurance program... shall have direct access to such levels of management as may be necessary to perform this function."

Contrary to the above, the CPD quality assurance (QA) manager and the quality control organization lack sufficient authority and organizational freedom to identify quality problems and are not independent from produc-tion cost and schedule considerations. Additionally, the 0A manager does not have direct access to a management level sufficient to assure that effective execution of the QA program is performed. Specifically, the QA manager reports directly to the production facility plant manager (86-01-02).

B. Criterion III, " Design Control," of Appendix B to 10 CFR Part 50 states, in part: " Measures shall be established to assure that ... the design basis ... are corectly translated into specifications, drawings, procedures, and instructions. These measures shall include provisions to assure that applicable quality standards are specified and included in design documents and that deviations from such standards are controlled ..."

Contrary to the above, Agastat relay manufacturing area inspections revealed that CPD has failed to translate several important design requirements into applicable quality requirements or rtandards (86-01-03).

C. Criterion V, " Instructions, Procedures, and Drawings," of Appendix B to I 10 CFR Part 50 states: " Activities affecting quality shall be prescribed by documented instructions, procedures, or drawings, of a type appropriate to the circumstances and shall be accomplished in accordance with these instructions, procedures, or drawings. Instructions, procedures, or drawings shall include appropriate quantitative or qualitative acceptance criteria for determining that important activities have been satisfactorily accomplished."

8611060349 861027 PDR GA999 EMVAMEC 99900296 PDR

s Contrary to the above, inspections of the Amerace facility determined that CPD has failed to establish QC inspection instructions or procedures for its material receiving area and its Agastat relay assembly / fabrication areas-(86-01-04).

D. Criterion VI, " Document Control," of Appendix B to 10 CFR Part 50 states, in part: " Measures shall be established to control the issuance of docu-ments ... which prescribe all activities affecting quality. These measures shall assure that documents are reviewed for adequacy, and approved for release by authorized personnel . .. ."

Contrary to the above, discussions with the QC inspectors determined that they were writing their own material receipt inspection checklists without any management overview to either control the issuance or verify the ,

l adequacy of the QC inspection checklists (86-01-05).

E. Criterion VII, " Control of Purchased Material, Equipment, and Services," of Appendix B to 10 CFR Part 50 states, in part:

" Measures shall be established to assure that purchased material, i i

equipment and services ... conform to the procurement documents. '

These measures shall include provisions, as appropriate, for source evaluation and selection ..." l Contrary to the above, CPD procured the calibration services of the Sheffield Measurement Division of the Warner and Swassey Company l without performing a source evaluation or selection of same. The calibration services were for the material receipt inspection departments "Cordax" 1000 dimensional measuring machine (86-01-06).

F. Criterion X, " Inspection," of Appendix B to 10 CFR Part 50 states, in part: "A program for inspection of activities affecting quality shall be established and executed... to verify conformance with the documented instructions, procedures, and drawings for accomplishing the activity...

Examinations, measurements, or tests of material or products processed shall be performed for each work operation where necessary to assure quality...."

Contrary to the above, discussions with CPD QA/QC personnel in ~ conjunction ,

with observations of the manufacturing and receiving areas determined that  !

CPD has failed to adequately establish or implement a QA/QC inspection l program to verify conformance to its requirements as necessary to assure quality (86-01-07). l G. Criterion XII, " Control of Measuring and Test Equipment," of Appendix B to 10 CFR Part 50 states: " Measures shall be established to assure that tools, gages, instruments, and other measuring and testing devices used in activities affecting quality are properly controlled, calibrated, and adjusted at specified periods to maintain accuracy within necessary limits."

Contrary to the above, CPD failed to adequately control its measuring and test equipment as evidenced by the 17 out of 32 M&TE items that were found to be either uncontrolled or out of calibration (86-01-08).

H. Criterion XV, " Nonconforming Materials, Parts, or Components," of Appendix B to 10 CFR Part 50 states: " Measures shall be established to control materials, parts, or components which do not conform to the requirements in order to prevent their inadvertent use or installation.

These measures shall include, as appropriate, procedures for identifi-cation, documentation, segregation, disposition, and notification to affected organizations. onconforming items shall be reviewed and accepted, rejected, re' ; red or reworked in accordance with documented procedures."

Contrary to the above, CPD failed to adequately control approximately 7,800 out of 68,500 defective contact arm assemblies, Part Number 32356-01, for its Agastat E-7000 series relays. The nonconforming condition was first noted on 1/22/85, but the CPD defective material report (DMR) to control the nonconforming parts to prevent their inadvertent use was not written until 9/20/85. Additionally, the CPD DMR's (three were written on 9/20/85) identified only 60,660 out of 68,500 nonconforming contact arm assemblies that were received (86-01-09).

I. Criterion XVIII, " Audits," of Appendix B to 10 CFR Part 50 states, in part: "A comprehensive system of planned and periodic audits shall be carried out to verify compliance with all aspects of the quality assurance program and to determine the effectiveness of the program ..."

Contrary to the above, CPD had not established a planned comprehensive system of periodic audits to verify their QA prcgram implementation and effectiveness (86-01-10). 1 1

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