ML20154H035

Notice of Nonconformance from Insp on 880627-0701. Nonconformance Noted:Qa Dept Director Does Not Rept to Mgt Level Which Provides Adequate Independence from Cost & Schedule When Opposed to Safety Considerations

ML20154H035
Person / Time
Issue date:	09/14/1988
From:	Office of Nuclear Reactor Regulation
To:
Shared Package
ML20154H032	List: ML20154H028 ML20154H034 ML20154H035 ML20154H042
References
REF-QA-99900369 NUDOCS 8809210151
Download: ML20154H035 (2)

Text

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APPENDIX B Tt va )JW Automatic Switch Company Docket No. 99900369/88-01 NOTICE OF NONCONFORMANCE During an inspection conducted June 27 through July 1,1988, the implementatien of the quality assurance (QA) progran at the Automatic Switch Company (ASCO) facility in Florhan Park, New Jersey was reviewed. The results of the inspec-tion revealed that certain of its activities were not conducted in accordance with NRC requirements, These items are set forth below and have been classified as nonconformances with the requirements of Appendix B to 10 CFR Part 50.

1. Criterion I, "Organization," of 10 CFR Part 50 requires, in part, that persons and organizations performing quality assurance functions shall report to a management level such that the required organizational freedom and authority, including sufficient independence from cost and schedule when opposed to safety considerations are provided.

Contrary to this, the QA department director does not report to a management level which provides adequate independence from cost and schedule when opposed to nuclear plant safety considerations (88-01-03).

2. Criterion III, "Design Control," of Appendix 8 to 10 CFR Part 50 requires, in part, that design changes including field changes be subject to design control measures commensurate with those applied to the original design and be approved by the same organization that performed the original design.

Contrary to this, it was noted that the ASCO manufacturing department is allowed to modify its solenoid valve fabrication procedures and implement the changes to the product line without the benefit of ASCO engineering 5 department review and concurrence to assure technical adequacy prior to implementation (88-01-04).

3. Criterion XVI, "Corrective Action," of Appendix B to 10 CFR Part 50 requires, in part, that conditions adverse to quality such as failures, malfunctions, deviations, deficiencies, and nonconformances be promptly identified and corrected. Significant conditions adverse to quality will be controlled to assure the cause of the condition is determined and corrective actions to preclude repetition are accomplished. The cause and corrective actions shall be documented and reported to appropriate levels of management.

Contrary to this, ASCO has failed to establish adequate measures to control its product nonconformances to assure that the issues are properly identified, i reported to appropriate levels of management and processed to include cor-rective action to preclude recurrence and identify potentially indeterminate hardware that may be installed. TheASCO10CFRPart21grocedureallows ASCO documents such as "engineering investigation reports to process non-conformances and deviations. However, the document administrative controls l for "valve troubleshooting procedures," "engineering investigation requests,"

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and "change and issuing of investigation reports," are not adequate to pro-cess deviations and nonconformances pursu:nt to the regulations (i.e., does not address generic applicability er previously installed hardware) (88-01-05).

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