ML20211F068

Insp Rept 99901320/97-01 for NUS Instruments,Inc on 970819-21.Nonconformances Noted.Major Areas Inspected:Review of Licensee 10CFR21 Implementing procedure,10CFR21 Posting & Licensee Records Re 10CFR21 Evaluations Performed

ML20211F068
Person / Time
Issue date:	09/26/1997
From:	NRC (Affiliation Not Assigned)
To:
Shared Package
ML20211E990	List: ML20211E984 ML20211F031 ML20211F068
References
REF-QA-99901320 99901320-97-01, 99901320-97-1, NUDOCS 9709300338
Download: ML20211F068 (9)

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U.S. NUCLEAR REGULATORY COMMISSION t

Docket No: 99901320 i

Report No: 97-01 Facility: NUS Instruments, Inc. ,

Location: 440 W. Broadway I Idaho Falls, Idaho 83402 Dates: . August 19 - 21,1997 Inspectors: B. Rogers, Team Leader R. Pettis, Senior Reactor Engineer Approved by: G. Cwalina, Section Chief Vendor Inspection Section Special Inspection Branch 4 9 Enclosure 2 9709300338 970926 Y PDR - GA999 EMV***** .J 99901320 PDR (. -

I inspection Summary 1.1 Bachuround and Basis NUS Instruments, Inc., (NUS) provides engineering and manufacturing capabilities for the replication, refurbishment, and redesign of electronic circuit card assemblies and modules which are provided to NRC licensecs as safety-related equipment and services.

NUS is owned by Scientech, Inc. (Scientech) which acquired NUS in October of 1996.

The basis for the NRC inspection of NUS included:

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e 10 CFR Part 50, Appendix B e 10 CFR Part 21 e American National Standards Institute /American Society of Mechanical Engineers Standard N45.2.6-1978," Qualification ofInspection, Examination, and Testing Personnel for Nuclear Power Plants" as committed to in the NUS Quality Assurance Manual 1.2 Nonconformances Nonconformance 99901320/97-01-01 was identified and is discussed in Sections 3.1 and 3.3 of this report 2 Status of Previous inspection Findings No previous inspections have been conducted at this facility.

3 Inspection Findings and Other Comments 3.1 10 CFR Part 21 Program and Corrective Actions

a. Scope The inspect' ors reviewed the NUS 10 CFR Part 21 implementing procedure,10 CFR Part 21 Posting, and the NUS records related to 10 CFR Part 21 evaluations performed by NUS or performed by customers and subsequently provided to NUS. The purpose of the review was to verify that NUS was meeting the requirements of 10 CFR Part 21 in the applicable activitics, 2

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b. Observation 1.And Findings On August 8,1996, Public Service Electric & Gas Co. (PSE&G) notified the NRC that numerous NUS Model OCA801 Signal isolator Modules and Model MTH801 Signal Summator Modules, used in the Salem Nuclear plant, Reactor Control and Protection System (US), were found have to unsolderi d or insumciently soldered internal electrical connections.

The documentation provided by PSE&G indicated that the isolator module function is to provide electrical separation between the Reactor Protection Systen (Class IE) and the Process Control System (non-Class IE) portions of the RPS instrument loops, and the summator module function is to algebraically combine analog signals. The reactor protection system is designed to assure that the system can perform its required functions in the event of a design basis earthquake. The defect could affect the modules' ability to function du dng a design basis earthquake and could result in a loss of redundancy sumcient to constitute a raajor degradation of essential safety-related equipment.

NUS documentation indicated that two reviews of the PSE&G modules had been performed: (1)" Corrective Action / Root Cause Evaluation," which was completed in September of 1996 by the NUS Quality Assurance Supervisor and (2)" Quality Assurance Review of NUS Instruments," which was completed in October 1996 by a three person review team contracted by Scientech (NUS's parent company) .

NUS Review The NUS review listed the root cause of the inadequate soldering to be an organizational breakdown caused by inadequate prioritization of work and inadequatejob skills, work practice, and decision making. Contributing causes included inadequate interface between organizations, inadequate supervisory program monitoring, inadequate self-veri 6 cation practices, and differences in the soldering workmanship criteria of NUS and PSE&G. Corrective actions were specified to include (1) removal of the dual assignment of the manufacturing lead person, (2) increasing manufacturing supervision, (3) hiring an additional QC Inspector, and (4) providing supervisory skills training to supervisors. The performance of the NUS review had occurred just prior to the Scientech purchase of NUS (October 1996). Scientech and NUS management indicated in a telephone conversation with the N'RC inspection team on August 26,1997, subsequent to the completion of the inspection, that they considered the NUS review's root cause investigation to be generally accurate but that the conclusions and corrective actions had not been specific enough to be useful to Scientech management to prevent recurrence of the situation.

In addition, the NUS review indicated that manufacturing operating sheets (which specified the manufacturing and inspection steps) were not being followed and that 3

part i al inspections were being performed in accordance with an agreement, between the manufacturing and inspection staff, to modify the operation process sheet Gow. The hianufacturir.g Supervisor stated that there had been some indication during the period of the PSE&G module production (approximately July 1995 to July 1996) that there had been some modiGcation of activities occurring at the stafflevel but that reorganization of the work actisities and reassignment of stat had addressed any potential concerns in this area. Other NUS personnel, assigned to NUS management positions during this time period, did not have indication that modiGeation of activities had occurred at the staff level. Scientech management stated that they had reviewed documentation and observed activities and did not agree with this conclusion of the NUS review. The inspectors noted that modiGcation of the operation process sheet Gow, to alter the specified inspections, would be, as denned by the NUS Quality Assurance hianual (QAhi), c Level 11 inspection function and that the QC Inspector performing the work at the time was certified to Level I .

The inspectors reviewed applicable work records and interviewed numerous personnel and determined that there was documentation that the work had been performed in accordance with the appicpriate procedures. Further, NUS had taken several corrective actions which would affect this area to prevent any potential for reoccurrence on modification of activities that might have occurred at the stafflevel.

Scientech Rexicy The Scientech review had some overlap with the conclusions and recommendation of the NUS review but was more detailed and specific. The contributing factors were i

determined to be related to organizational structure, training, att tude and awareness, fabrication overview, personnel qualiGcation, and work station adequacy. The recommer.dations made in the Scientech review included evaluation of client action requests, evaluation of work station ergonomics, increasing the frequency of trend analysis, improving the coordination of training activities, refining the wave soldering process, and improving supervisory skills. Discussion with Scientech and NUS management indicated t!~ there was agreement with the contents of the Scientech review and that the Scientech review (as opposed to the earlier NUS review) was the basis for the majority of the corrective actions taken by NUS to address the PSE&G soldering issue.

Immediate Corrective Actions The inspectors reviewed the corrective actions taken by NUS, following the PSE&G notification, to address the inadequate soldering of the PSE&G hiodules. The NUS hianufacturing Supervisor indicated that when PSE&G notified NUS in July of 1996 of the inadequate soldering, NUS had reviewed the manufacturing and inspection process and had taken numerous, immediate corrective actions.

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The Manufacturing Supervisor had reviewed the soldering process and had determined that the majority of the manufacturing line (referred to as " assemblers" by NUS) were soldering at the " preferred" level while two as.=emblers were soldering at the

" acceptable" level (a lesser quality level than " preferred"). While NUS had determined that the " acceptable" level was adequate for functioning electrical connections it did not meet the customer's (PSEaG) ext:et W m. All of the assemblers were retrained in the soldering techuique by being provided physical examples of" preferred" soldering, studying the applicable procedu.es, and undergoing a supervisory assessment of each person's soldecing ability. In addition, the Manufacturing Supervisor assumed the manufacturing lead person's responsibilities (that person was reassigned), which allowed the supervisor to directly observe the manufacturing work being performed. Of the two assemblers who were soldering at the " acceptable" level, one person was adequately retrained and the other was removed from the manufacturing activities and within one month of the PSE&G notiGcation the entire manufacturing line was soldering at the

" preferred" level. The inspectors noted that the requirement to solder at the " preferred" level of quality had not been procedurealized by NUS.

During the period of July 1995 to July 1996, all of the NUS assemblers had performed work on the PSE&G modules. The two assemblers previously identined as solde ing at the "acceptab!c" level had not performed any work on projects other than the PSE&G modules manufactured during that period. Work for customers other than PSE&G had been performed by two other assemblers, both of whom the Manufacturing Supervisor had considered excellent performers. NUS reviewed the work performed in the July 1995 to July 1996 time period, and had concluded that there was not a concern with work performed for customers other than PSE&G.

The inspectors noted that NUS had not documented the inadequate soldering discovered in the PSE&G modules in accordance with the requirements of the NUS QA program and had not documented the immediate corrective actions previously discussed.

Additional Corrective Actions in addition to the imiacdiate corrective actions taken by NUS to raise the level of soldering quality, NUS had taken additional corrective actions, based on the Scientech review, which included s corganizing the manufacturing line, installing a mechanical wave soldering machine, training the manufacturing supervisory and lead personnel, and upgrading the QC Inspector position to Level II. NUS also indicated that ongoing training of assembly and inspection personnel would occur, peer reviews had been instituted for manufacturing personnel, and deficiency logs had been established to track solde i rework, although these corrective actions had not yet been proceduralized at the tii "ihe inspection.

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c. Conclusions The inspectors noted the indication that modification of the operation process sheets, to alter specified inspections, had occured in the July 1995 to July 1996 period, that such a modification would have been a Level II inspection function, and that the QC Inspector performing the, work at the time was certified to Level I. Indication of this modification highlighted a potential weakness in the NUS Quality Assurance program.

The inspectors concluded that NUS had taken reasonable corrective actions in response to the identification ofinadequate soldering in the Salem rnodules. However, NUS had not adequately documenteu the corrective ections which NUS indicated were taken upon identification of the inadequate soldering. This was identified as an example of Nonconformance 99901320/97-01-01.

3.2 Manufacturing Procedure and implernentation of Sohdering Technique

a. Scope The inspectors reviewed the applicable procedures, discussed activities with manufacturing and inspection personnel, and observed ongoing inspection and manufacturing activities, to assess whether solderiag activities were being adequately controlled.

b. Observations and Findings The inspectors reviewed the training records for several assemblers to determine their qualifications to perform soldering. Training was documented on a " Certification of Training" which indicated that assembler was qualified to solder in accordance with the "Beckwith Training Course E- 5" and in accordance with the NUS Operating Procedures Manual, Appendix E," Soldering," Revision 0, dated March 12,1992. The certificate documented that the assembler had received the required instruction, had passed a written examination, and completed a practical demonstration of soldering ability.

The inspectors observed assemblers installing components, wrapping wire, and performing hand soldering. The inspectors also observed a demonstration by the QC Inspector on performance of an inspection of solder connections and discussed the levels of classification of soldering quality. The level of solder quality required for NUS product is the " preferred" level which is the premium level of sc,lder quality. _ NUS indicated that the " preferred" level of solder quality was mandated and strictly adhered to as a corrective action to the PSE&G Part 21 report (See section 3.1.2).

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c. Conclusions The inspectors concluded that NUS had in place a program to train manufacturing personnel to solder at the required level of soldering quality and to verify the manufacturing personnel's ability and that this program was being adequately implemeated. In addition, the QC Inspector possessed the ability to verify the adequacy of the soldered connections.

3.3 Review of Qualifications for QC Inspectors

a. kogc The inspectors reviewed QC Inspector qualification records and selected documentation to determine compliance with American National Standards institute /American Society of Mechani 11 Engineers (ANSI /A SME) N45.2.6 1978, "Quali6 cation of Inspection, Examination, and Testing Personr.el for Nuclear Power Plants" as committed to in the NUS QAM. The requirements included in the ANSI Standard are for the qualification of personnel who perform inspection, examination, and testing of nuclear power plant items used in safety-related applications.

b. Observations and Findings NUS required that the capabilities of a candidate for certification as a Level I, II, or III QC Inspector be initially determined by a suitable evaluation of the candidate's education, experience, training, test results, or capability demonstration. Once certified, the QC Inspector's job performance was reevaluated at periedic intervals not to exceed three years.

The NRC inspectors reviewed the training files of all QC Inspectors to verify that the above requirements were met. A total of seven QC Inspector files were reviewed and all appeared to be in compliance with the requirements for certification. One QC Inspector was certified to Level I, three QC Inspectors were certified to Level II, and three were certified to Level IIL However, as of the inspection, only one Level II QC Inspector remained active since the others had either been reassigned to other positions or were no longer employed at NUS. The present NUS QA Manager, certified to Level III, supervised the work of the Level II QC Inspector. A review of the files indicated that the QC Inspectors were certified primarily on the basis of education and related experience and that the qualification records were in compliance with ANSI Standard N45.2-6.

The inspectors reviewed the work being performed by the QC Inspector to determine whether the work met the definhion of Level I work as defined by ANSI standard N45.2-6 which states, in part, that Level 1 persons shall be capable of performing inspections, examinations, and tests in accordance with documented procedures. Level II persons l

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snall have, in addition to the Leve,1 I capabilities, demonstrated capabilities in planning, setting up, and supervising inspections and tests. The inspectors reviewed documentation for several POs which indicated that the QC Inspector had performed activities consistent with the Level I deGnition such as verifying component placement, veri 6 cation of soldering, and Gnal visual inspections. However, the inspectors cautioned NUS maaagement that allowing manufactt ring and inspection staff to modify the operation process sheet now without management approval, as discussed in detail in Section 3.1.2, would be a Level 11 inspection ftmetion and inappropriate if the QC Inspector performing the work at the time was certified to Level I or if such operation process modi 6 cations were disallowed by the NUS QA program.

During review of the training Gles to verify QC Inspector qualincations, two documents were identined which indicated a quality control inspection activity weakness. Two memoranda from the QA Supervisor identified weaknesses in the QC Inspector's performance and one recommended management action. These memoran h, initiated in January and July of 1996, and were currently in the QC Inspector's training file.

Discussion with the current NUS and Scientech management indicated agreement that the QC Inspector's performance was not adequate and that the QC Inspector had been subsequently reassigned shortly after the current management was made aware of the QC Inspector's performance in December of 1996. However, during the period of time from July 1996 until December 1996, NUS had been made aware of the inadequate performance of the QC Inspector and had not taken any corrective action. Subsequent to the new maaagement being placed, NUS had reassigned the QC Inspector, and had employed two additional persons in that position. The inspectors reviewed the training Gles of the two most recent QC Inspectors, discussed their performance with the QA Supervisor an ! the Manufacturing Supervisor, reviewed work c'ocumentation, and observed work performance of the current QC Inspector. The inspectors did not observe any indication ofinadequate perfonnance in the documentation or work observations of the current QC Inspector.

c. Conclusion

Although NUS had been made aware of the potentially inadequate work performance of a QC Inspector by the inspector's direct supervisor in January and July of 1996, and that this information was available in the QC Inspector's training file, NUS had not taken any corrective action for this situation adverse to quality until December of 1996. The failure to take corrective action to correct a signincant condition adverse to quality was identi6ed as an example of nonconformance 99901329/97-01-01.

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e 4 Personnel Contacted Dama Wirries, President, NUS John McGimpsey, General Manager, NUS

' Cheryl Allen, QA Supervisor, NUS Shauna Boyack, Manufacturing S"peyiw., NUS Heath Buckland, Testing Supervisor, NUS Ron Todd, Quality Control Lead, NUS Paul Stunn, Principal Engineer, Scientech, Inc.

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