ML20056F230

Notice of Nonconformance from Insp on 930504-05 Nonconformance Noted:Qa Manual,Rev 10,dtd Dec 1992 Did Not Contain Provisions for Dedicating Items Purchased by Vendor as Commercial Grade

ML20056F230
Person / Time
Issue date:	07/16/1993
From:	Office of Nuclear Reactor Regulation
To:
Shared Package
ML20056F216	List: ML20056F215 ML20056F218 ML20056F230 ML20056F236
References
REF-QA-99901265 99901265-93-01, 99901265-93-1, NUDOCS 9308260206
Download: ML20056F230 (2)

Text

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Performance, Office of Nuclear Reactor Regulation, within 30 days of the date of the letter transmitting this Notice of Violation.

This reply should be clearly marked as a " Reply to Notice of Violation" and should include for each violation:

(1) the reason for the violation, or, if contested, the basis for disputing the violation, (2) the corrective steps that have been taken and the results achieved, (3) the corrective steps that will be taken to.. avoid further violations, and (4) the date when full compliance will be achieved. Where good cause is shown, consideration will be given to extending the response time.

s Dated a)"Rockville,-Earyland, this 16.

day of A d 4

, 1993 3

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_2-9308260206 930716 Ef j

PDR GA999 EECCONTD 99901265 PDR u

NOTICE OF NONCGNF0PMANCE Continuum Dynamics, Inc.

Docket No.:

99901265/93-01 Princeton, New Jersey Based on the results of an NRC inspection conducted on May 4-5, 1993, it appears that certain of your activities were not conducted in accordance with NRC requirements.

A.

Criterion III of Appendix B to 10 CFR Part 50, " Design Control,"

states, in part, that measures be established for the selection and review for suitability of materials, parts, equipment, and processes that are essential to the safety-related functions of structures, systems, and components.

Criterion V of Appendix B to 10 CFR Part 50, " Instructions, Procedures, and Drawings," states, in part, that 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.

Contrary to the above, the Continuum Dynamics, Inc. (CDI) Quality Assurance Manual, Revision 10, dated December 1992, did not contain provisions for dedicating items purchased by CDI as commercial grade and used as part of a safety-related activity subject to the requirements of 10 CFR Part 50, Appendix B.

(93-01-02)

B.

Criterion III of Appendix B to 10 CFR Part 50, " Design Control,"

states, in part, that measures be established for the selection and review for suitability of materials, parts, equipment,.and processes that are essential to the safety-related functions of structures, systems, and components.

Criterion VII of Appendix B to 10 CFR Part 50, " Control of Purchased Material, Equipment, and Services," states, in part, that measures shall be established to assure that purchased material, equipment, and services, whether purchased directly or through contractors and subcontractors, conform to the procurement documents, and that the effectiveness of the control of quality by contractors and subcontractors shall be assessed by the applicant or designee at e

intervals consistent with the importance, complexity, and quantity of the product or services.

Contrary to the above, inadequate measures were established for the selection and review for suitability of application of materials,

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parts, and equipment that are essential to the safety-related functions of systems and components.

Specifically:

1.

CDI's evaluation checkli:t of American Electronics Laboratories' (AEL's) commercial quality program and controls (performed by CDI on February 9, 1993)., did not adequately address AEL's basis for notifying CDI of conditions "significantly out of tolerance" during the t

calibration process.

Such basis may be critical since AEL's reporting threshold may not be consistent with that of CDI, thereby precluding reporting of such conditions which could have an adverse effect on CDI's evaluation of tests performed. Additionally, CDI's evaluation checklist did not document the training of AEL personnel involved in the calibration process.

2.

In commercial grade purchase orders 93044, 93060, and 93069 to AEL, CDI did not invoke or reference the observed commercial or quality controls for the items and services purchased.

3.

CDI purchased commercial grade instruments, including calibration services, from Omega Engineering, Inc. and Test Equipment Service, Inc., without performing any assessments or surveys to verify that the suppliers' quality programs and controls were effectively being implemented for the types of instruments and services purchased.

Instruments purchased and calibrated were used in tests conducted by CDI, in support of the Boiling Water Reactors Owners Group Reactor Water Level Monitoring Long Term Program, for the Electric Power Research Institute.

(93-01-03)

Please provide a written statement or explanation to the U.S. Nuclear Regulatory Commission, ATIN:

Document Control Desk, Washington, D.C. 20555 with a copy to the Chief, Vendor Inspection Branch, Division of Reactor Inspection and Licensee Performance, Office of Nuclear Reactor Regulation, within 30 days of the date of the letter transmitting this Notice of Nonconformance. This reply should be clearly marked as a " Reply to a Notice of Nonconformance" and should include for each nonconformance:

(1) a description of the steps that have or will be taken to correct these items; (2) a description of the steps that have been or will be taken to prevent recurrence; and (3) the dates your corrective actions and preventive measures were or will be completed.

Dated at(i_) '^ day of' '., (

Rockville, Maryland this 1

(t (,

1993 4

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