ML20137H824

Requests Review of Exo Sensors,Inc QA Program.Qa Program Insp Rept 99901015/85-01 Re Allegations of Exo Sensors,Inc Failure to Report Part 21 Deficiency to Facilitate Review Encl

ML20137H824
Person / Time
Site:	Point Beach
Issue date:	11/26/1985
From:	Norelius C NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III)
To:	Fay C WISCONSIN ELECTRIC POWER CO.
References
NUDOCS 8512020484
Download: ML20137H824 (2)

Text

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I NOV 2 61965 i

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Docket No. 50-266 ,

Docket No. 50-301 Wisconsin Electric Power Company ATTN: Mr. C. W. Fay Vice President i Nuclear Power Department 231 West Michigan, Room 308  :

j Milwaukee, WI 53201  :

Gentlemen:

l On May 28-31, 1985, an inspection of the implementation of Exo Sensors, Inc. i

! Quality Assurance program (QA) was conducted by the Vendor Program Branch l of the Office of Inspection and Enforcement. Exo Sensors, Inc., is a supplier '

I of hydrogen sensors, analyzers, and other instrumentation. It is our understanding that Exo Sensors, Inc. products were supplied to and may be in use at your facility. A copy of the Inspection Report (99901015/85-01) is enclosed.

. The inspection was conducted to investigate. allegations that Exo Sensors, i Inc. had failed to report a deficiency under 10 CFR Part 21 and that there existed a complete breakdown of their QA Program. During the inspection, it was determined that significant deficiencies exist in the implementation of the Exo Sensors QA Program and that the allegations were, for the most part, substantiated. .

The deficiencies identified in the enclosed report should have been identified ,

during QA audits and source inspections of the Exo Sensors facility. The '

results of the NRC inspection, while focused on the deficiencies within the Exo Sensors QA Program, nevertheless, may be indicative of potential weaknesses within your own QA organizations.

'l The enclosed report is sent to you to facilitate your review of this matter.

We expect that through your review, you will confirm the acceptability of items at your facility, if any, which were procured from Exo Sensors, Inc.

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j Wisconsin Electric Power Company 2

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] You are requested to submit a written reply to this letter, within thirty l 4

(30) days, identifying the results of your review and the actions you have , ,

j taken or plan to undertake.  !

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We will gladly discuss any questions you have concerning this matter. l l Sincerely, .

S I

i " Original Signed by E.G. Greenr.an" r l

1 Charles E. Norelius, Director

• DivisionofReactorProjects (

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Enclosure:

Vendor Report

. No. 99901015/85-01 dtd 08/26/85  :

! i j cc w/ enclosure:  !

! J. J. Zach, Plant Manager  !

l DCS/RSB (RIDS)  !

I Licensing Fee Management Branch I i Resident Inspector, RIII . . l

! John J. Duffy, Chief .

l j Boiler Section Ness Flores, Chairperson I Wisconsin Public Service  !

Commission  :

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G dner/jp F W CNissotimos Greenaan Noreklus 11/25/85

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/o** *%9'q, uMTED STATES i

! s '% NUCLE AR REGULATORY COMMISSION i,

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August 26, 1985 Docket No. 99931015/85-01 Exo Sensors, Inc.

ATTN: Mr. Don Stevens President 1220-B Simon Circle Anahiem, California 92806 Gentlemen:

This refers to the inspection conducted by E. T. Baker of this office on May 28-31, 1935, of your facility in Anahiem California and to the discussions of our findings with you and mer.bers of your staff at the conclusion of the inspection.

This inspection was conducted as a result of allegations that- Exo Sensors, Inc.

had not implemented a quality assurance program which met the requirements of Appendix B to 10 Part CFR 50. Areas examined during the inspection and our findings are discussed in the enclosed report. Within these areas, the inspection consisted of an examination of procedures and representative reccrds, interviews with personnel, and observations by the inspector.

During the inspection it was determined that significant deficiencies exist in the implementation of the Exo Sensors QA program and that the allegations were, for the most part, substantiated. Deficiencies identified included the following:

Exo Sensors has failed to train and qualify their inspectors; annual eye exam-inations were not performed; there were no controls on the origination of, modifications to, or issuance of shop travellers; rework and repairs were perforned without documenteo procedures; design changes were implemented prior to approval; purchases were made from suppliers not on the approved vender list; and nonconforming material was shipped to customers. The specific findings and references to the pertinent requirements are identified in the enclosures to this letter.

The enclosed Notice of Violation is sent to you pursuant to the provisions of Section 206 of the Energy Reorganization Act of 1974. You are required to submit to this office within 30 days from the date of this letter a written statement containing: (1) a description of steps that have been or will be taken to correct these items; (2) a description of 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. Consideration may be given to extending your response time for good cause shown.

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Emo Sensors, Inc. August 26, 1985 You are also requested to submit a similar written statement for each item which appears in the enclosed Notice of Nonconformance. Please reference the -

report number in all correspondence.

Should you have any questions concerning this inspection, we will be pleased to discuss them with you.

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Sincerel ,

2 Gary G. Zech, Chief Vendor Program Branch Division of Quality Assurance Vendor, and Technical Training Center Programs Office of Inspection and Enforcement i

Enclosures:

1. Appendix A - Notice of Violation

2. Appendix B - Notice of Nonconformance

3. Appendix C - Inspection Report No. 99901015/85-01 . .

4 Appendix 0 - Inspection Data Sheets -

cc w/ enclosures:

All Affected Plants All Regicns w/ effected Plants P. Fredrickson, RII -

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l APPENDIX A Exo Sensors, Inc.

Docket No. 99901015/85-01 NOTICE OF VIOLATION As a result of the inspection conducted on May 28-31, 1985, and in accordance with Section 206 of the Energy Reorganization Act of 1974 and its implementing regulation 10 CFR Part 21, the following violation was identified and categorized in accordance with the NRC Enforcement Policy (10 CFR Part 2, Appendix C),

49 FR 8583 (March 8, 1984):

Section 21.21 of 10 CFR Part 21. dated January 1, 1985 states, in part:

"Each individual, corporation ... subject to the regulations in this part shall adopt procedures to: (1) Provide for: (1) Evaluating deviations or (ii) informing the licensee or purchaser of the deviation..."

Contrary to the above, Exo Sensors did not have any Part 21 proctdures at the time of the inspection. However, procedure $ were developed during the inspection and reviewed and found acceptable by the inspector.

This is a Severity Level V violation (Supplement VII).

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APPENDIX B Exo Sensors, Inc.

Docket No. 99901015/85-01 ,

NOTICE OF NONCONFORMANCE Ba_$td on the results of an NRC inspection conducted on May 28-31, 1985, it appears that certain of your activities were not conducted in accordance with NRC requirements. Nonconfor1 nances with these requirements are as follows:

A. Criterion I, " Organization," of Appendix B to 10 CFR Part 50 states, in part: "The authority and duties of persons and organizations performing activities affecting the safety related functions of structures, systems, and components shall be clearly established and delineated in writing."

Contrary to the above, the position of Vice President of Engineering and Quality Assurance was created in August 1984, but the authority and duties of the position have not been documented nor has the position been added to the organization chart.

B. Criterion II, " Quality Assurance Program," of Appendix B to 10 CFR Part 50 states, in part:

... shall establish ... a quality assurance program

which complies with the requirements of this appendix. The program shall

be documented by written policies, procedures, or instructions and ...

shall be carried out ... in accordance with those policies, procedures, or instructions .... The quality assurance program shall provide control over activities affecting quality of the identified components .... The prograr shall take into account the need for special ... skills to attain the required quality .... The program shall provide for indoctrination and training of personnel performing activities affecting quality as necessary to assure that suitable proficiency is achieved and maintained."

Contrary to the above, Exo Sensors failed to establish and implement a quality assurance program to provide control over activities affecting quality as described below.

1. Paragraph 1.3.3 of Exo Sensors Quality Assurance Manual (OAM) states that the OA Manager: " Supervises all training of Exo Sensors, Inc.

visual and mechanical inspectors."

A footnote to paragraph 20.1 of Exo Sensors' QAM states: " Evidence of training shall include, but not be limited to: lesson plans, course completion records, and employee training records."

Contrary to the above, a training program for Exo sensors visual and mechanical inspectors had not been established nor was there any evidence of training or qualification of these inspectors.

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2. Criterion VI, " Document Control" of Appendix B to 10 CFR Part 50 states: " Measures shall be established to control the issuance of ,

documents, such as instructions, procedures, and drawings, including l changes thereto, which prescribe all activities affecting quality.

These measures shall assure that documents, including changes, are reviewed for adequacy and approved for release by authorized personnel .... Changes to documents shall be reviewed and approved

. .. by the same organizations that performed the original review and approval..."

Paragraph 5.3.1 of Exo Sensors' QAr. states, in part: " Changes to released drawings will be initiated by Engineering Change Notice and will require approval by Engineering, Manufacturing, and Quality Assurance prior to implementation."

Quality Operating Procedure. QOP-024, requires that a Procedure Change Notice (PCN) be used to document changes to a 00P and that PCNs be recorded.

Contrary to the above,

a. Exo Sensors has no controls on the revision of or approval of revisions to shop travellers. _This resulted in travellers being modified after approval without subsequent approval of the changes.

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The modifications included addition of manufacturing steps and inspections and deletion of manufacturing steps and inspections.

In addition, work was performed prior to travellers being approved and issued.

b. Exo Sensors was using Engineering Change Notices (ECNs) to document changes to procedures rather than PCNs. In addition, on ECN #2 to QOP-052, the ECN was implemented 4/3/84 but approval of the ECN by Engineering. Design, QA, and Manufacturing did not occur until 5/31/84.

3. Criterion VII, " Control of Purchased Material Equipment, and Services," of Appendix 8 to 10 CFR Part 50 states, in part:

i " Measures shall be established to assure that purchased material, equipment, and services ... confnrm to the procurement documents.

These measures shall include provisions as appropriate, for source evaluation and selection, objective evidence of quality furnished by the contractor or subcontractor, inspection at the contractor or subcontractor source, and examination of products delivered."

Paragraph 4.4 of Exo Sensors' QAM states: "No order for safety related materials, goods, or services shall be issued to a source not referenced on the Exo Sensors. Inc. " Approved Supplier List"."

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Paragraph 7.1 of Exo Sensors' QAM states: "All materials, goods, and services obtained by Exo Sensors. Inc. for incorporation into ,

safety essential product designs shall be obtained from suppliers /

agents identified on the Exo Sensors, Inc. " Approved Suppliers List"."

Paragraph 7.4 of Exo Sensors' QAM states, in part: " Initial approval and retention of sources, agents, or manufacturers for use on specialty safety related essential equipment shall be accomplished,in one of the following ways by the QA Manager or his designated consultant ,or Exo Sensors, Inc. designee.

7.4.1 Acceptable A. Successful completion of a Quality Survey or Questionnaire ..."

Contrary to the above,

a. Paragraph 7.6 of Exo Sensors' QAM conflicts with the above requirements in that it allows purchases of materials / goods for use in safety related equipment from companies not on Exo Sensors' " Approved Suppliers List". . .

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b. Exo Sensors placed an order with Air Dimensions Inc. on 8/25/83, P0 E-002, for a Class 1E containment suction pump although Air Dimensions was not approved and placed on Exo Sensors' " Approved Suppliers List" until 12/1/83.

c. Exo Sensors failed to place any quality controls on electrical equipment purchased from distributors for use in safety related equipment. Distributors are placed on Exo Sensors " Approved Suppliers List" without a Quality Survey or Questionnaire being completed and Exo Sensor does not perfonn any kind of verification testing upon receipt of the equipment.

4. Criterion IX " Control of Special Processes", of Accendix. B to 10 CFR Part 50 states: " Measures shall be established to assure that special processes, including welding, heat treating, and nondestructive testing, are controlled and accomplished by qualified personnel using qualified procedures in accordance with applicable codes, standards, specifications, criteria, and other special requirements."

Paragraph 9.3 of Exo Sensors' QAM states: "Special processes shall be accomplished under controlled conditions in accordance with

• applicable codes, standards, specifications, criteria and other special requirements using qualified personnel and approved procedures."

Paragraph 10.9.1 of Exo Sensors' QAM states: " Authorization to l perform inspections, examinations and testing shall be granted only

! to those personnel meeting the requirements of ANSI /AShE N45.2.6."

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4 Paragraph 10.9.2 of Exo Sensors' QAM states: " Personnel qualification records shall be maintained." ,

Ebasco PO NY-435288 ' requires that structural welding be perfomed in accordance with AWS D1.1 and tubing and fittings be welded in accordance with Section IX of the ASME Boiler and Pressure Vessel Code and ANSI B31.1. AWS D1.1 and ANSI E31.1 require that personnel perfoming nondestructive examinations be qualifico to ASNT $NT-TC-1A.

Contrary to the above,

a. Unqualified personnel were used to perfom soldering operations on equipment supplied to Femi 2 and Fitzpatrick nuclear plants,

b. At the time of the inspection Exo Sensor did not have any inspectors qualified to either SNT-TC-1A or ANSI /ASME N45.2.6.

c. Personnel qualification records did not meet the requirements of either SNT-TC-1A or N45.2.6.

d. Annual vision tests required by SNT-TC-1A had never been performed nor were they required by Exo Sensors' procedures.

5. 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 confomance with the documented instructions, procedures, and drawing for accomplishing the activity .... If mandatory inspection hold points, which require witnessing or inspecting ... beyond which work shall not proceed ...

are required, the specific hold points shall be indicated in appropriate documents."

Paragraph V.2 of QOP-065, " Insulation Test Procedure," states:

" Prior to removal of jumpers. Quality Engineer will verify that all

- circuits subject to test were connected. Verification will be initialed on shop traveller."

Contrary to the above, Exo Sensors was not consistent in indicating inspection hold points for the insulation test. On shop travellers for assembly of hydrogen analyzer cabinets 4004 and 4005, Operation

23. Insulation Test, was not denoted as being an inspection hold point.

6. Criterion XI', " Test Control", of Appendix B to 10 CFR Part 50 states, in part: " Test procedures shall include provisions for assuring that all prerequisites for the given test have been met, that adequate I

test instrumentation is available and used .... Test results shall

} be documented and evaluated to assure that test requirements have been satisfied".

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i Paragraph 12.18 of Exo Sensors' QAM states: "All QOP and Acceptance Test Procedures requiring the use of test equipment and gauges shall include provisions to record the type of instrument, serial number, '

and calibration due date."

Contrary to the above.

. _. a. QOPs 012, 023. 063, 064 and 066 do not require or have provisions for recording type of instrument, serial number, and calibration due date. In addition, completed data sheets for instrument valve' seat closure test (QOP-064) for valves SV-7 and SV-8 en hydrogen analyzers 4004 and 4005 did not include the required data.

b. QOP-064 only requires documenting of test data if the valve passes the test. The procedure does not address documenting j the failure of a valve to pass the valve seat closure test.

7. Criterion XIV, " Inspection, Test, and Operating Status," of Appendix B to 10 CFR Part 50 states, in part: " Measures shall be established to indicate, by use of markings such as ... routing cards ... the status of inspections and tests perfomed upon individual items ....

These measures shall provide for the identification-of-items which l have satisfactorily passed required inspections and tests, where necessary to preclude inadvertent bypassing of such inspections and tests ...."

Paragraph 5.1.1 of Exo Sensors' QAM states: "All Exo Sensors, Inc.

Production and Inspection personnel are responsible for completing the required sign-offs entries provided for each shop operation.

All sign-offs require initials and dating."

Contrary to the above,

, a. In reviewing shop travellers for Hydrogen Analyzer Cabinets 4004 and 4005, Remote Control Cabinets 4006 and 4007, Relay Tray Assemblies 3007 and 3009, and Microprocessor Assemblies 3008 and 3010 there were four instances where tests requiring inspections prior to continuation of work were not signed off and four instances where manufacturing operations were not signed off,

b. In addition, the QAM has no provisions for tracking " Conditional Release" material.

8. Criterion XV, " Nonconforming Materials, Parts, or Components", of Appendix 8 to 10 CFR Part 50 states, in part: " Measures shall be established to control materials, parts or components which do not conforin to requirements in order to prevent their inadvertent use or installation .... Nonconfoming items shall be reviewed and accepted, rejected, repaired or reworked in accordance with documented procedures."

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6-Paragraph 15.2 of Exo Sensors' QAM states: "Said notice when discrepant materials, parts, or service reports are concerned, ,

will be documented within Exo Sensors Inc. by the use and completion of a nonconformance report or defect report which is logged and tracked for crmpletion of corrective action. Repaired or re-worked items shall De re-inspected with results documented."

.. Contrary to the above,

a. Exo Sensors was performing repairs and rework but did not have any procedures covering these activities.

b. Exo Sensors' QAM does not address how nonconformances discovered as a result of Quality Surveys or Questionnaires are dccumented,

c. On defect report DR-473, there was no indication that the 21 circuit boards rejected were re-inspected after the rework was performed.

9. Criterion XVI, " Corrective Action", of Appendix B to 10 CFR Part 50 states, in part: " Measures shall be established to assure that

! conditions adverse to quality, such as failures, malfunctions, deficiencies, deviations, defective material and equipment, and nonconformances are promptly identified and corrected."

Paragraph 16.2.8 of Exo Sensors' QAM states: "All Exo Sensors, Inc.

DR and NCR Forms calling for Corrective Action on the part of Shop Personnel, Suppliers, Agents or others, must also , include a reference date for completion of the recorrended action."

Contrary to the above,

a. Exo Sensors' QAM does not address how corrective action is achieved for nonconformances discovered as a result of Quality Surveys or Questionnaires. -

b. On defect report DR-473, 21 circuit boards were rejected because the soldering was performed by an unqualified person. Disposition was to rework the beards. However, there was no indication that the boards were ever reworked on the Defect Report, yet the boards were used in analyzers shipped to Fermi 2 and Fitzpatrick nuclear plants.

c. Most Defect Report forms had not been signed off by the company president or the corrective action designator upon completion of corrective action as required.

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10. 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 i quality assurance program and to determine the effectiveness of the

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l program .... Audits shall be documented and reviewed by management having respcnsibilities in the area audited. Followup action, including teaulit of deficient areas, shall be taken where indicated'."

Paragraph 2.2 of Exo Sensors' QAM states: "The program described in the Exo Sensors, Inc. Quality Assurance Manual will be periodically reviewed for compliance with any of the specifications that might be

_, invoked by Eso sensors, Inc. clients, contract proposals, co'de regulations, or national standards requirements. As a minimum, this review sha'l be conducted on an annual basis."

Paragraph 18.1.1 of Exo Sensors' QAM states: "The purpose of periodic audits perfomed within Exo Sensors, Inc. is to provide an assessment by audit review into the effectiveness of the Quality Assurance System described, initiated, and governed by this manual."

Paragraph 18.1.5 of Exo Sensors' QAM states: "Outside Consultant fims or auditors shall be appointed to conduct an overall audit of the Quality 4 Assurance program at Exo Sensors Inc."

Contrary to the above,

a. Exo Sensors never estabiished a schedule for perfoming periodic audits untiT March 1985. No audits were performed in 1980 and 1981. Audits of engineering and procurement were perfomed in 1982 and a periodic audit was perfomed on special processes in 1983. No periodic audits were perfomed in 1984

b. The December 10, 1982 audit of engineering revealed a number of significant nonconformances, yet the QA Audit Notice forms were not completed. The cause of the nonconfomance had not been listed, the required corrpletion date was not given, no followup action had been taken, acceptability of corrective action was not indicated, and none of the findings had been closed out

. as of May 31, 1985.

ORGANIZATION: EX0 SENSORS, INC.

ANAHEIM, CALIFORNIA l

REPORT INSPECTION INSPECTION NO.: 99901015/85-01 DATE(S): May 28-31, 1985 ON-SITE HOURS: 62 ,

i CORRESPONDENCE ADDRESS: Exo Sensors, Inc.

i 1220-B Simon Circle Anahier, California 92806 ORGANIZATIONAL CONTACT: Don W. Stevens, President TELEPHONE NUMBER: 714 632-8289 PRINCIPAL PRODUCT: Hydrogen Sensors and Analyzers and other instrumentation.

NUCLEAR INDUSTRY ACTIVITY: 60-70%.

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ASSIGNED INSPECTOR: I[ -

E. T. Baker, Reactive Inspection Section (RI5)

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'Da~te OTHER INSPECTOR (S): J. C. Harper, RIS .

APPROVED BY: s-E. W. Merschof f gGEM 1ef, RIS, Vencor Program Branch Date lhSPECT10N BASES AND SCOPE:

A. BASES: 10 CFR Part 50 Appendix B and 10 CFR Part 21.

B. SCOPE: The inspection was conducted to investigate an allegation that fio 5ensors, Inc. had failed to report a deficiency under 10 CFR Part 21 and that a complete breakdown of their Quality Assurance program existed.

PLANT SITE APPLICABILITY: Prairie Island 1 and 2 (50-282/306), San Onofre

. 1 (50-206) Salem 1 and 2 (50-272/311), Comanche Peak 1 and 2 (50-445/446),

Point Beach 1 and 2 (50-266/301), Beater Valley 1 and 2 (50-334/412), Shearon Harris 1 and 2 (50-400/401), Millstone 3 (50-423), James A. Fit 2 Patrick i

Qf( / 3

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l ORGANIZATION: EXO SENSORS, INC. i ANAHEIM, CALIFORNIA I REPORT INSPECTION NO.: 99901015/85-01 RESULTS: PAGE 2 of 16 '

PLANT SITE APPLICABILITY: (continued)

(50-333), Fermi 2 (50-341), Arkansas 1 (50-313), Davis-Besse (50-460),

Brunswick 1 and 2 (50-325/324), LaSalle (50-373/374), Browns Ferry (unit not known), WNP-2 (50-397), Grand Gulf (50-416/417), Crystal River 3(50-302).

A. INSPECTION ISSUES The NRC had received allegations that a breakdown of the Quality Assurance Program existed at Exo Sensors, Inc. and that Exo Sensors, Inc. knowingly and willingly violated 10 CFR Part 21 reporting requirements.

B. INSPECTION FINDINGS .

1. Violations:

Contrary to 10 CFR Part 21. Exo Sensors, Inc. did not.have any procedures for evaluating deficiencies for reportability under 10 CFR Part 21 or reporting the deficiencies to their customers for e.aluation. A Severity Level V violation was issued in this area.

2. Nonconfomances: .

a. Contrary to Appendix B, Exo Sensors had not documented the authority and duties associated with the position of Vice President of Engineering and Quality Assurance which was established in August 1984

b. Contrary to Appendix B, ANSI N45.2.6, ASNT SNT-TC-1A, and Paragraph 1.3.3 of Exo Sensors' Quality Assurance Manual (QAM) Exo Sensors failed to establish and implement a training program which met Appendix B and failed to adequately train and cualify the production, inspection, and test personnel,

c. Contrary to Appendix B, Paragraph 5.3.5 of the QAM and Quality Operating Procedure QOP-024. Exo Sensors failed to control the issuance and modification of shop travellers, used Engineering Change Notices (ECNs) rather than Procedure' Change Notices (PCNs) to control changes to 00Ps, and implemented ECNs prior to their approval.

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. ORGANIZATION: EX0 SENSORS, INC.

, ANAHE!M CALIFORNIA REPORT INSPECTION j NO.: 99901015/85-01 RESULTS: PAGE 3 of 16 i

d. Contrary to Appendix B. Paragraphs 4.4, 7.1, and 7.4 of the QAM, Exo Sensors placed a purchase order with Air Dimensions prior to approving them and placing them on the Approved

- .. Suppliers List, and failed to place any controls on distributors who supplied components for safety related equipment. In addition, paragraph 7.6 of the QAM conflicts with paragraphs 4.4. 7.1, and 7.4 of the QAM.

! e. Contrary to Appendix B, paragraphs 9.3, 10.9.1, and 10.9.2 4 of the QAM, and Ebasco purchase order (PO) NY-435288, 1 unqualified personnel performed soldering operations, l inspections of soldered joints, and other visual examinations. In addition, annual vision examinations for inspectors had never been performed and qualification records did not meet specified requirements.

f. Contrary to Appendix B and paragraph V.2 of QOP-065 Exo Sensors failed to consistently establish inspection hold i points or perform the inspections. ,

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g. Contrary to Appendix B and paragraph 12.18 of the QAM, Exo Sensors failed to include instrument calibration data recording requirements in some QOPs. In addition, QOP-064 does not require recording test results if the valves fail the test. Only if the valves pass the test I are the results required to be recorded.

I h. Contrary to Appendix B and paragraph 5.1.1 of the QAM, production and inspection personnel were not signing off on the shop travellers when operations and inspections were completed. In addition, the QAM has no provisions for tracking " conditional release" material.

1. Contrary to Appendix B and paragraph 15.2 of the QAM, Exo Sensors was performing repairs and rework without written procedures. In addition, the QAM does not address how nonconformances discovered as a result of Quality Surveys

or Questionnaires are documented.

j. Contrary to Appendix B and paragraph 16.2.8 of the QAM, I most Defect Report (DR) forms had not been signed off upon completion of any required corrective action and on Defect I

Report DR-473 there was no indication that the rejected circuit boards covered by the DR were ever reworked or re-inspected although the boards were used in equipment

, supplied to Fermi 2 and Fitzpatrick plants.

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ORGANIZATION: EX0 SENSORS, INC.

ANAHEIM, CALIFORNIA REPORT INSPECTION NO.: 99901015/85-01 RESULTS: PAGE 4 of 16

k. Contrary to Appendix B and paragraphs 2.2, 18.1.1, and 18.1.5 of the QAM Exo Sensors failed to perfom periodic audits on an annual basis and also failed to close out audit findings for the audits that were performed.

! 3. Allegations The following allegations were investigated during the inspection:

a. Allegation:

The corporate organizational chart is not up-to-date.

Observation:

The allegation was substantiated and nonconfomance B.2.a was issued in this area. At the time of the inspection, the

position of Vice President of Quality Assurance and Engineering, which was created in August 1984, had not been added to the organization chart, nor had.the duties and authorities associated with the position been documented.

b. Allegation:

• There exists insufficient organizational freedom in that the Vice President of Engineering is also in charge of Quality Assurance. In addition, he is also the Chief Designer verifying his own work.

Observation: -

The allegation was not substantiated. The organization's structure is sufficient to provide the necessary degree of organizational freedom and independence between Quality Assurance and other departments. Each division (Quality Assurance Engineering Manufacturing, and Marketing) has a separate manager. The Manager of OA and the Manager of Engineering both report to the Vice President of QA and Engineering who reports to the President. As with most small companies, there were instances where due to absences or position vacancies a single employee performed in more than one capacity. However, it was not evident that this had an adverse impact on product quality.

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i ORGANIZATION: EX0 SENSORS, INC.

ANAHEIM, CALIFORNIA l REPORT INSPECTION NO.: 99901015/85-01 RESULTS: PAGE 5 of 16 l

c. Allegation:

The Quality Assurance Manual does not contain provisions for

-- independent checking and verification of design; independent checking and verification of design is not being accomplished.

Observation:

The allegation was not substantiated. The Quality Assurance Manual (QAM) contains adequate provisions for independent checking and verification of design. The implementation of these requirements was not consistent for the reasons stated in b. above, errployees perfonning in more than one capacity due to absences or vacancies. Again, it was not evident that this condition had an adverse impact on product quality.

d. Allegation:

There are few provisions in .the. Quality Assura~nce Manual requiring that procurement docurents impose or require compliance with 10 CfR 21. The alleger indicates that these requirements are not being imposed on suppliers in the procurement process.

Observation:

The allegation was not substantiated. The QAM does require passing Part 21 requirements down to suppliers of safety .

related parts. Purchase orders (p0s) for safety related I parts, which were reviewed, did pass Part 21 requirements down to subtier suppliers. However, the majority of i materials and components purchased are connercial grade, i to which Part 21 is not applicable. '

e. Allegation:

No Approved Vendors List exists at Exo Sensors and there are no provisions implemented to detennine whether vendors are qualified and that procurement is from approfriately qualified vendors.

ORGANIZATION: EX0 SENSOR $ INC.

ANAHEIM, CALIFORNIA REPORT INSPECTION NO.: 99901015/85-01 RESULTS: PAGE 6 of 1,6 Observation:

This allegation was partially substantiated and nonconfomance

-. B.2.d was issued in this area. An Approved Vendors List (AVL) does exist at Exo Sensors, however, the QAM allows unapproved vendors to be used. In addition, the QAM allows certain categories of vendors, i.e., distributors to be placed on the AVL without adequate justification.

f. Allegation:

The company does not have a design manual. Two engineers perfom design as they feel necessary and this design is not documented. The design process is not controlled.

Observation:

This allegation was partially substantiated arid conconfomance B.2.c was issued in this area.. There are no requirements, either contractural or regulatory, that a company must have a design manual, only that the design process be controlled and the design documented. There were instances where the QAM requirements for control of design changes were not followed, i.e., the issuance of Engineering Change Notjces prior to approval,

g. Allegation:

Procedures for document control and filing are non-existent and practices are not consistently implemented. There exists no femal system to maintain document control.

Observation:

This allegation was partially substantiated and nonconfomance 8.2.c was issued in this area. There are no procedures for cor. trolling shop travellers. Work was started prior to generating shop travellers and changes were made to the travellers after initial approval without subsequent approval.

In addition. Exo Sensors was using the incorrect fom to document changes to Quality Operating Procedures (QOPs).

ORGANIZATION: EX0 SENSOR $. INC.

ANAHEIM, CALIFORNIA REPORT INSPECTION NO.: 99901015/85-01 RESULTS: PAGE 7 of 16

h. Allegation:

No hold or QC witness points are used on shop travellers.

Observation:

This allegation was partially substantiated and nonconformance 8.2.f was issued in this area. The QAM and 00Ps have require-ments for hold points, but the hold points are not consistently indicated on the shop travellers nor are they consistently complied with,

1. Allegation:

There was no program in place for nonconformance reporting prior to March of 1985. Further, many of the nonconformance reports initiated since March of 1985 are still open and corrective action has not been implemented. , ,

i Observation:

This allegation was partially substantiated and nonconformances 8.2.1 and 8.2.j were issued in this area. A review of the QAM indicates that a program for documenting nonconformances did exist prior to March 1985. However, there Were numerous Defect Reports that had never been closed out, including those initiated both prior to and after March 1985. An example of the Defect Reports not closed out is Defect Report DR-473. OR-473 was issued on 10/15/84 for 21 DAC Boards which were soldered by an unqualified individual. At the time of the inspection there was no indication on the OR that the boards had ever been corrected or reinspected. Nor had the President or Corrective Action Designator signed off that the OR was closed, as required. In addition, the QAM does not address how nonconformances discovered as a result of Quality Surveys or Questionnaires are documented.

j. Allegation:

There is no provision in the Quality Assurance Manual for quality assurance audits.

I

ORGANIZATION: EX0 SENSORS, INC.

ANAMEIM, CALIFORNIA REPORT INSPECTION NO.: 99901015/85-01 RESULTS: PAGE 8 of 16 Observation:

This allegation was not substantiated. The QAM does contain requirements for conducting audits. However, periodic audits of the complete quality program have never been performed, as

• required by the QAM. Nonconformance B.2.k was issued in this area.

k. Allegation:

The alleger indicates that equipment with "short support rails" was supplied on 'out of containment' racks. The rails do not conform to drawing requirements; further, the alleger indicated that one of these rails failed at FitzPatrick Station.

Observation:

This allegation was not substantiated. A review of the correspondence and tne trip report written by.the investigating engineer, including photographs, indicated that the failures discovered at FitzPatrick were due to shipping damage and not design deficiencies or nonconforming hardware.

1. Allegation:

General Electric's vendor audits of Eso Sensors have not identified any of these problems indicating to the alleger that either General Electric is not looking closely or that audits were performed by incompetent auditors. In fact, the ,

4 411eger indicates a recent audit by Northern States Power was performed by an incompetent auditor.

Observation: i The inspectors reviewed the audits performed by Gener al Electric .

and Northern States Power. None of these audits detected any '

nonconformances of significance. As such, the allegation was l partially substantiated. Qualificatiens of the audienrs were i not examined during this inspection, j

m. Allegation: j I

General Electric vendor surveillance representatives have allowed shipment of equipment before the paperwork is completed. .

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ORGANIZATION: EXO SENSORS, INC.

ANAHEIM, CALIFORNIA REPORT INSPECTION NC.: 99901015/05-01 RESULTS: PAGE 9 of 16 Observation:

This allegation was partially substantiated. Equipment was shipped prior to completion of all papemork. However, as long as GE controlled the eouipment properly this would not necessarily create any quality problems. Correspondence to  !

GE indicates that '.he papemork was sent to GE shortly after the hardware was e. hipped,

n. Allegation:

The alleger indicates that a Mill Certification was falcified in that infonnation was removed from another certification and added to a different certification by hand.

Observation:

The allegation was not substantiated. The Mill Certification the alleger rade reference to was reviewed by ~the inspectors.

The addition to the Certified Material Test Report (CMTR) was hand written in ink and included the initials of the person who

,dded the inferination and the date it was added. In addition, tSa r.MTR from which the hand written infomation was taken was Available to the inspectors and indicated that the handwritten information was accurate. Therefore, the CMTR had been altered, not falsified. There was no intent to defraud,

o. Allegation:

i Material on hold in the warehouse is used before accomplisheent of receipt inspections. The alleger indicates that he wrote an NCR on this practice.

Observation:

The allegation was substantiated through a review of the NCRs and discussione with management personnel. The inspectors did not observe any fsrther instances of this type of nonconfomance during the inspection. However, there was insufficient time to detemine to what extent this problem existed in prior production.

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, ORGAN!IATION: EX0 SENSORS, INC.

ANAHEIM, CALIFORNIA 1

RE?CRT INSPECTION NO.: 99901015/85 01 PESULTS: PAGE 10 of 16

p. Allegation:

Based on these examples of nonconformance the alleger stated

- -- that a breakdown of the Quality Assurance Program exists at Exo Sensors, Inc.

Observation:

This allegation was substantiated to the entent that significant deficiencies in the implementation of the Exo Sensors QA program were identified. In addition, based on record review, a Quality Assurance Program which complies with Appendix 8 to 10 CFR Part 50 has never existed at Exo Sensors, Inc.

q, Allegation:

The alleger was of the opinion that such a breakdown of the Quality Assurance Program was reportable under.10, CFR Part 21, that company officials were aware of the breakdown and Part 21 reporting requirements and were consciously not reporting as required.

Observation:

This allegation was na' substantiated. A breakdown of a Quality Assurance program is not required to be reported under 10 CFR Part 21 due to the subjective nature of determining when a breakdown has occurred. However, in investigating this allegation it was determined that Exo Sensors did not have any Part 21 procedures and violation 8.1 was written in this area.

C. Supplementary Information In determining whether or not the allegations could be substantiated, the inspectors, (1) reviewed the OAM, some QOPs, Eno Sensors' P0s to subtier suppliers, drawings, utility / utility agents audits of Eno Sensors, Carolina Power and Light (CP&L) PO to Exo Sensors, and associated production and qualtty records, and (2) performed an inspection of hardware on the shop floor. A description of the inspectors efforts and conclusions in each of these areas is sunnarized below. ,

9

ORGANIZATION: EX0 SENSORS. INC.

ANtHEIM. CALIFORNIA

)

REPORT INSPECTION ,

NO.: 99901015/85-01 RESULTS: PAGE 11 of 16

1. Organization .

A review of Emo Sensors current operations indicates that the

.. position of Vice President of Engineering and Quality Assurance was created in August 1984. However, at the time of the inspection the company organization chart had not been updated nor had the i

duties and authorities associated with the position been spelled i out. Nonconfomance 2.s was written covering this area.

2. Quality Assurance Program Based on the numbers and significance of the nonconfomances

, identified during the inspection it was determined that Exo Sensors does not have nor has it ever had a quality assurance program which complies with Appendia B to 10 CFR Part 50.

Nonconfomance 2.b was written covering this area.

I

3. Training  ;

1 The inspectors reviewed the training foms for all production and l inspection personnel. The review of production personnel training 1 folders revealed well-organized and documented training and i qualification records with the exception of one person perfoming soldering operations (see " Corrective Action" and "Nonconfoming 4

Material ). At the time of the inspection, Emo Sensor had no one in their employ with any Quality Assurance experience. The positions of OA Manager and Quality Engineer were vacant. The President and Vice president of the company were perfoming receiving and in-process inspections. There were no records of training or qualification which established their ability to perfom adequately in the capacity of inspector. Nonconfomance 2.b was written covering this area.

4 Design Control The inspectors reviewed section 3.0 of the QAM on desig' n control and various engineering change notices and shop travel ers. The provisions of the QAM appeared sufficient for controlling design and personnel appeared to be complyinq with provisions to the extent possible in a small company. n certain instances the person who prepared the design or design change also signed off as the company official in another capacity, e.g., Qual'ty Assurance or Manufacturing. However, in no instance among those documents i reviewed did the same person sign off as the preparer and as the Engineering representative.

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- - - - . . - _ , . , . - - - a- . - - - - - - ~ - - .

ORGANIZATION: EX0 SENSORS, INC.

ANAME!M. CALIFORNIA l

REe0RT INSPECTION NO.: 99901015/85 01 -

RESULT 5: PAGE 12 of 16

5. Procurement Doewnent control The inspectors reviewed the QAM in this area and found the QAM

- -- requirements acceptable. However, implementation of the QAM in this area was not checked due to time constraints.

1

6. Instructions. Procedures and Drawino The review of instructions, procedures and drawings and the control thereof is covered under the applicable specific criteria.

7. Document Control i In reviewing production and quality records associated with CP&L PO NY 435288 the following problems were identified:

a. Eno Sensors has no controls on the revision of or the approval of revisions to shop travellers, in reviewing shop travellers for Hydrogen Analyzer Cabinet-Allemblies 4004 and 4005 Remote Control Cabinets 4006 and 4007 Relay Tray Assemblies 3007 and 3009, and Microprocessor Assemblies 3008 and 3010, the following deficiencies were observed:

(1) work and inspections being perforced prior to i approval of the Shop Traveller (2) revisions to drawings and procedures Itsted on the travellers were being made af ter approval of shop travellers and perforwance of inspections with no evidence of subsequent re approvals of shop travellers or re inspections of hardware.

(3) deletion of operations and inspections, including inspection hold points, af ter shop traveller approval without subsequent re approval of the shop traveller.

(4) addition of operations and inspections, including inspection hold points, after approval of shop traveller without subsequent re. approval of the  !

shop traveller.

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ORGANIZATION: EX0 SENSORS, INC.

ANAHE!M. CALIFORNIA REPORT INSPECTION N0.: 99901015/85 01 RESULT 5: PAGE 13 of 16

b. Engineering Change Notice (ECN) #2 tc 00P 052 was added to travellers 3008 and 3010 on 4/3/84. but the ECN was not approved by Engineering, QA, and Manufacturing untti 5/31/84 In addition, according co 00P 024 a Procedure Change Notice (PCN) fom should have been used rather than an ECh. It was determined by discussions with the Vice President of Engineering and Quality Assuiance that PCNs had never been used. 00P 024 had been forgotten or ignored since its I

origination on 12/8/81.

Noncenformance 2,c was written covering this area.

8. Control of Purchased Material. Equipment, and Services The inspectors reviewed sections 4.0 and 7.0 of the OAM, 00P 040, the Approved Suppliers List, and P0s for safety related parts <

issued by Eso Sensor to Air Dirensions, General Electric, Control Specialist, and Amerae Corporation. , ,

The review of the OAM revealed conflicting requirements.

Paragraph 7.5 and 7.6 allow purchases of material, gooos, and services for use in' safety related equipment from companies '

which do not have quality programs and are not on Eno Sensors l Approved Suppliers List (ASL). In addition. QOP 040 allows distributors to be placed on the ASL without a questtent. aire of a survey by Eso Sensor and Eso Sensor does not perf arm any verification testing upon receipt. A review of the Eso Sensors PO to Air Dioensions revealed that the P0 was placed

, on 8/25/83. but Air Dimensions was not placed on the AVL until 12/1/83. Nonconfomance 2.d was written covering this area.

9. Identification and Control of Material. Parts, and Corponents The inspectors reviewed section 8.0 of the OAM and the requirements appear sufficient. There was insufficient time to review the implementation of these provisions, however, there were several Defect Reports written in this area which had not been closed at the time of the inspection.

10. Control of Special Processes The it.spectors reviewed sections 9.0 and 10.0 of the OAM, AWS '

D1.1 AN5!/ASME M45.2.6, SNT-TC 1A, Ebasco P0 NY.435288 and i related documents. Welding Procedures 101 103,200,201,203, Weld Procedure Qualificat'ons, Walder QuaIifications, Soldering

. . - . - - . _ - . _ . _ , - - - - _ . - - - . _ - - _ _ ~ - - . - . - - - - _ - - - - _ - , - _ - _ . - - - . . -

ORGAN!ZATION: EX0 SENSOR $ INC.

ANAHEIM, CALIFORNIA REPORT INSPECTION NO.: 99901015/85 01 RESULTS: PAGE 14 of 16 Personnel Qualifications, and Soldering and Welding Inspector Qualifications.

- -. In addition, a visual examination of welded joints on production units on the shop floor was conducted.

As a result of this review it was detemined that the annual eye eneminations required for visual inspectors had never been perfonned and there was no documentation for soldering and welding inspector qualification. The visus) esamination of the structural and piping welds revealed no deficiencies.

During the review of Defect Reports it was discovered that an unqualified person had perfomed soldering on 21 circuit boards (see 16 and 17 below). This issue was not pursued to detemine if the unqualified person had perfomed other soldering operations due to time constraints. Nonconformance 2.e was written covering this area.

11. Inspection

• The inspectors reviewed Section 10 of the OAM and found the provisions sufficient to comply with Appendix 8. Shop travellers were reviewed to detemine compliance with the provisions of the OAM. During the review it was noted that Eso Sensors was not consistent in indicating when Inspection Hold Points were necessary nor in signing off the traveller indicating that the inspections were perfonned. Nonconformance 2.f was written covering this area.

12. Test Control .

The inspectors reviewed Section 11 of the QAM and various 00Ps.

QOPs 012. 023, 063 and 064 did not have the required provisions for recording the type, serial number, and calibration due date of any instrumentation used. In addition, QOP 064 only required recording the results of the valve seat closure test if the valves passed, not if they failed. Nonconformance 2.g was written covering this area.

13. Control of Measurina and Test fautoment .

l The inspectors reviewed Section 12 of the QAM and found that the provisions met the requirements of Appendia 8. Implementation of the provisions was not reviewed due to time constraints. l

ORGANIZATION: EX0 SENSOR $ INC.

ANAHEIM, CALIFORNIA I

REPORT INSPECTION N0.: 99901015/85 01 RESULTS: PAGE 15 of 16 14 Handline. 5torane and Shipping This area was not reviewed during the inspection.

15. Inspection. Test, and Operatina Status

! The inspectors reviewed Section 14 of the QAM and found the provisions acceptable with the enception of how material released

) under a " Conditional Release," paragraph 7.16, will be tracked.

Provisions for tracking " Condition 4? Release" material were lacking. Implementation of QAM provisions was reviewed during the review of the shop travellers for the CPAL job. On shop travellers 4004, 4005, 4006, 4007, 3007, 3008, 3009, and 3010 there were four instances where tests / inspections required prior to continuation of work were not signed off and four instances where manufacturing operations were not signed off. Nonconfomance 2.h was illued covering this area.

16. konconfomsacina Materials. Parts, or Components "

• The inspectors reviewed Section 15 of the QAM, Defect Reports issued for 1983,1984, and 1985, and the Defect Report Log. The review indicated that Eso Sensors was not cloting Defect Reports

+

in a timely manner, that Eno Sensors was pe foming repairs and rework without documented procedures, and that the QAM does not

! address how nonconformances discovered as a result of Quality Surveys or Questionnaires are to be documented. Nonconfomance 2.1 was issued covering this area.

17. Correettve Action i The inspectors reviewed Section 16 of the QAM, Defect Reports f for 1983, 1984, and 1985, and Audit Reports for 1982, 1983, and 1984 The review revealed that the QAM does not address how corrective action is achieved for nonconfomances discovered as a result of Quality surveys or Questionnaires nor does the QAM require that prior production be reviewed to detemine if additional corrective action is necessary. As an esemple, on l 04 473, 21 circuit boerds were rejected because they were soldered by an unqualified person. However, there was no indication what i corrective action and been taken er that the boards had been ,

reinspected. Yet the boards were used in units shipped to Femt '

and FittPatrick Nuclear Plants. Additional prior production .

boards may have been soldered by the same person but there was l

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ORGANIZATION: EX0 5tN50R5, INC.

l ANAMEIM, CALIFORN!A REPORT INSPECTION h0.: 19901015/85 01 RESULTS: PAGE 16 of 16 i

no evidence that Eno Sensors had investigated prior work performed by the employee. In addition, most Defect Report forms have not been signed off by the company President or the Corrective Action ,

.. Designator as required by the form. Nonconformance 2.j was issued I covering this area.

18. Audits The inspectors reviewed Section 18 of the QAM and found the provisions acceptable encept that the QAM did not require a schedule be established for internal audits until March 1985.

A review of the audits conducted revealed that no periodic audits were performed in 1980 and 1981, two areas were audited in 1982, one area was audited in 1983 and no periodic audits were l conducted in 1984 t The audits of engineering in 1982 revealed a number of significant deficiencies, but to date there was no evidence that any action has been taken to correct them or close out the audit f$edings. An esternal auditor was brought in in 1983 and 1984 to perform an overall audit of the QA program in addition to the internal periodic audits. The audits lasted two days each and had no significant l findings. The audits were of questionable quality because they did not detect that internal audits were not being performed, that travellers were not controlled or that Defect Reports were not being closed out in a timely manner. Nonconformance 2.k was issued covering this area.

i .

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