ML20148M669

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Notice of Nonconformance from Insp on 871116-20. Nonconformance Noted:Inadequate Translation of App B Into QA Program & Inadequate Translation of Design Requirements Into Testing Parameter Requirements
ML20148M669
Person / Time
Issue date: 01/25/1988
From:
Office of Nuclear Reactor Regulation
To:
Shared Package
ML20148M621 List:
References
REF-QA-99900779 NUDOCS 8801280337
Download: ML20148M669 (6)
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APPENDIX A Nutherm International Incorporated Docket No. 99900779/87-01 NOTICE OF NONCONFORMANCE- ,

This NRC inspection was performed as a result of allegations received by the J NRC in regard to disregard of the NRC quality assurance (QA) program require- L ments by Nutherm International Incorporated (NI). Based on the results of this inspection conducted on November 16-20, 1987, it appears that certain of your activities were not conducted in accordance with NRC requirements. These items are set forth below and have been identified and classified in accordance with I the requirements of Appendix B to 10 CFR Part 50.

1. Criterion II, "Quality Assurance Program" of Appendix B to 10 CFR Part 50 l requires, in part, that the applicant [or designee] shall establish a  !

quality assurance program which complies with the NRC requirements. j Contrary to the above, the following examples were noted where NI did not adequately translate the requirements of Appendix B into its QA program.

(a) Section 10, "Inspection," of the NI QA manual (QAM) does not prohibit a person from inspecting their own work; (b) Section 10. "Inspection," of the NI QAM, as written, does not require QA inspection / monitoring activities in the NI equipment testing lab facility; and (c) NI has not established procedures to control its periodic use of rented measuring and test equipment. Examples of typical rental equipment are as follows:

(1 NI #158, Bechman voltage meter; (2 NI #313, Waltow meter; (3 NI f103, Meghom meter; and (4 NI #315, B&K Scope l

2. Criterion III, "Design Control," of Appendix B to 10 CFP Part 50 requires, ,

in part, that measures shall be established to assure that the specified d design bases are correctly translated into procedures and instructions to assure that appropriate quality standards are specified and included.

Design control shall also provide measures for verifying or checking the adequacy of design, such as by the performance of design reviews.

Criterion VI, "Document Control," of Appendix B to 10 CFR Part 50 requires, in part, that measures shall be established to control issuance of documents and assure that documents are reviewed for adequacy and approved for release by authorized personnel.

8801280337 880125 00h [ E Q

Section 5 of the NI QAM, dated June 18, 1986, requires, in part, that:

(1) The project engineer shall be responsible for generating the project instructions, procedures and drawings necessary; (2) the QA manager shall be responsible for verifying that activities affecting quality are implemented in accordance with instruction; and (3) the engineering manager shall be responsible for review of all instructions, procedures and drawings that are generated.

Section 3 of the NI QAM, dated June 18, 1986, requires in part, that:

(1) the QA manager shall be responsible for verifying the implementation of an effective design control program; (2) the engineering manager shall be responsible for ensuring that the designers, engineers, analysts and verifiers are in confomance with the design control program; (3) design control measures shall be implemented to verify the adequacy of the design; and (4) verifying or checking the design consists of, at least, a fomal review of the design, spot checking of calculations / analyses, and assessing the results against the original design basis.

Section 4 of the previous revision nf the NI QAM, dated January 30, 1985, requires, in part, that: (1) the engineering design document review and approval shall be performed by qualified design engineers; and (2) the QA manager shall review procedures to assure that they include appropriate acceptance criteria and test prerequisites.

Paragraph 4.6 of NI QA procedure QAP No. 3.0.00, from revision 0, dated February 16, 1985 through revision 2 dated November 17, 1986, requires, in part, that once a project manager has completed a design drawing, in accordance with the required procedures, they shall submit it to the l engineering manager for approval.

Contrary to the above, the following items were noted:

(a) The below listed NI "Qualification Results Index" (QRI) fons, which are used as specific hardware instruction riders to NI's generic functional and test procedures that delineate the design parameters for testing, do not correctly and/or fully translate the design requirements into testing parameter requirements and quality standards, and do not indicate that an independent technical review was perfon'ad by qualified personnel.

QRI Number Prepared by/ Title Approved by/ Title Hardware (1)#1494,12/85 SDJ/ Design Engineer BE/QA Engineer Rotary Relay (GPU-1759 (2)#1495,12/85 SDJ/ Design Engineer BE/QA Engineer Control Switch

  1. GPU-1759 (3) #1403, 10/85 SS/ Engineer JH/Vice President Switch
  1. NMP-1841 (4)#1467,3/86 PB/EQ Secretary None Seleci.or Switch
  1. NMP-1841

ORI Number Prepared by/ Title Approved by/ Title Hardware (5)#1759,1/86 SDJ/ Design Engineer None Control Switch iGPU-1759 (6)#1514,12/85 GH/ Metallurgist None Rotary Relay

  1. GPU-1759 (7)#1579,1/86 PB/EQ Secretary None Thyrite Secondary f GPU-1897 Protector (8)#1526,1/86 GH/ Metallurgist None Current Alann AE/EQ Secretary J (9)#1570,3/86 SDJ/ Design Engineer None Signal Isolator i1759-63 (10) #1540, 1/86 DW/ Technical Asst. None OSA Relay
  1. FPL-1676 (b) Thefollowinglistedequipmentqualification(EQ)proceduresand functional test procedures did rot indicate that an independent technical review was performed to verify the adequacy of the 1 design requirements for testing: 1 Procedure Title / Number Prepared by/ Title Approved by/ Title l

(1) Operations Aging for PB/EQ Secretary RH/QA Manager Thyrite Protector,

  1. 9.7.10.30, 5/86 (2) Baseline Test for PB/EQ Secretary RH/QA Manager Cycle Duration of Thyrite Protector,
  1. 9.7.10.29,5/86 (3) Baseline Testing of LH/ President RH/QA Manager So11 tech Controllers,
  1. 9.7.10.22, 12/85 (4) Procedure for Mechanical MAM/QA Assistant RH/QA Manager Cycle Aging Airflow Switches, #9.7.10.17, l 11/85 1

(5) Baseline Testing of MAM/QA Assistant RH/QA Manager l Disconnect Switches, '

  1. 9.7.10.6,11/85 (6) Operational Aging of PB/EQ Secretary RH/QA Manager Push button Selector Switches, #9.7.10.10, 4/86

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Procedure Title / Number Prepared by/ Title Approved by/ Title HB/ Project Manager RH/QA Manager (7) Function Test for AC Transformers, #9.7.10.39, 9/29/86 i

(8) Baseline Testing for SDJ/Desiga Engineer RH/QA Manager Voltage Relays, #9.7.10.26, 1/86 q (9)FunctionalTestingfor BE/QA Engineer RH/QA Manager Temperature Controllers,

  1. 7.2.07, 2/85 (10)FunctionalTestingfor SDJ/ Design Engineer RH/QA Manager Analog and Digital Meters
  1. 7.2.0.6,3/86 (11) Functional Testing of SDJ/ Design Engineer RH/QA Manager Solid State Power Controllers, #7.2.13, 10/86 (c) Several design drawings in the pre-1986 time period indicated that the engineering manager did not perfom the required design verifi-cation activit]. Specifically:

(1 Dwg. f7023-56767-53, 11/12/85. GPU-1759 (2 Dwg. #7013-55215-53, 12/13/85, C-1167 Dwg. f5001-54983-43, 4/27/83, BE-1214 Dwg. #7023-56994-33, 8/21/86, GPU-2169 Dwg. f4033-56689-33, 10/3/85, GPU-1712 i (6 Dwg. #1023-55953-33, 10/30/84, TVA-1497

3. Criterion X, "Inspection," of Appendix B to 10 CFR Part 50 requires, ,

in part, that inspection activities to verify the quality of the work I shall be performed by persons other than those who performed the activity i being inspected and that such persons shall not report directly to l the immediate supervisors who are responsible for the work being inspected, i Additionally, if direct inspection is disadvantageous, indirect control by monitoring of the processing methods and personnel shall be provided. j Contrary to the above, the following areas were identified where NI is not l providing adequate QA inspection / verification controls of its quality l related activities. Specifically:

(a) HI has not implemented its program for the inspection or monitoring of activities affecting quality for any of the work activities that are perfomed in its.equiptreqt testing laboratory, except for its annually scheduled QA audit;

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(b) Discussions with NI lab personnel and a review of several of NI's current typical "functional test result" (FTR) foms for completed tests which had been verified by QA revealed that management is allowing the lab technicians that perfomed the work to sign the FTR form in the "QA inspector approval" block. Therefore, a review of a completed form would lead one to believe that QA had monitored and approved the testing results; however, in practice, the lab tech-nician is signing for the testing results that he has perfonned; and (c) Discussions with NI personnel and a review of records indicated that on the previous revision of the FTR foms, the testing lab supervisor used the "QA approval" block for his signature. Therefore, a review of these FTR foms would also appear to indicate that a QA approval had been obtained. However, in practice, the lab supervisor was i inserting his signature in the QA approval block.

4. Criterion XI, "Test Control," of Appendix B to 10 CFR Part 50, requires, in part, that a test program be established to assure that all of the required '

testing is performed in accordance with procedures / instructions which incor-porate the requirements and acceptance limits contained in applicable design documents. Additionally, the program requires that the procedures include provisions for ensuring that all prerequisites for the given test have been met, that adequate test instrumentation is used, and that the test results are documented and evaluated to assure that test requirements have been ,

satisfied, j Contrary to the above, the following items were noted during NRC inspections of the current in-house work activities being performed in the NI testing /

EQ area:

(a) During testing activities of an undervoltage relay device for NI project iTVA-2605, it was observed that the device was being tested with an electrical current value that was approximately 2.5 times less than required by the manufacturer's technical specification for the inductive load application of the relay; (b) During testing activities of an AC contactor device for NI project 1

  1. 8PC-2475, it was observed that a resistive load was being used in lieu of the required inductive load, and that the required adjustable AC power supply was not being used; ,

(c) A review of test results for NI project f1841, in conjunction with discussions with NI personnel, detemined that the voltage meter that was recorded as being used has a maximum readout capability '

of 10 airperes, but the test results indicated that the total load l of the perfomed test was 11 amperes; (d) Procedure 9.7.6,03, "Procedure for Issuing an Equipment Qualification Procedure or Report," does not reference or indicate that the IEEE-323 EQ report format requirements are necessary to prepare and establish NI's EQ reports; and

l (e) Even though typical NI procedures such as 9.7.10.10. "Operational Aging of Push Button and Selector Switches," require that the technician record the indicated voltage and current following each operation (cycle), it was revealed that this is typically not per-formed. An extreme example was noted where the lab technician recorded two out of 6000 cycles. One reading was the starting value and the other was the last cycle value.

5. Criterion XVII, "Quality Assurance Records," of Appendix B to 10 CFR c Part 50 requires, in part, that sufficient records shall be maintained to furnish evidence of activities affecting quality and shall include at least: results of reviews, inspections, tests, audits, monitoring of work perfortnance, and closely related data such as qualifications of personnel.

Contrary to the above, it was found that the NI personnel records did not indicate adequate evidence of qualifications for several current and past NI ernployees. The following NI employee files were found to be either incomplete, incorrect, or indeterminate as to the relevant job experience and education. The initials of the applicable personnel are: HB, CG, GW, SS DW, GJ, SDJ, LH, and PB.

6. Criterion XVIII, "Audits," of Appendix B to 10 CFR Part 50, requires, in part, that the audits be performed by personnel not having direct responsi-bilities in the areas being audited.

Section 4.4 of NI's QAP #18.10.00 "Auditor Training Program," requires, in part, that all personnel conducting an audit shall be independent of any direct responsibilities for performance of the activities which they audit.

Contrary to the above, NI management allowed a QA inspector, who had direct l QA department responsibilities, to be the lead auditor for the last two QA department annual audits. The report numbers are QA-86-AE, dated 12/23/86, and QA-85, dated 12/6/85.

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