ML20011A057
| ML20011A057 | |
| Person / Time | |
|---|---|
| Issue date: | 05/05/1981 |
| From: | Barnes I, Foster W NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | |
| Shared Package | |
| ML20011A038 | List: |
| References | |
| REF-QA-99900745 NUDOCS 8110060426 | |
| Download: ML20011A057 (14) | |
Text
U.S. NUCLEAR REGULATORY COMMISSION OFFICE OF INSPECTION AND ENFORCEMENT REdION IV Report No. 99900745/81-01 Program No. 51400 Company:
E-Max Instruments, Incorporated 14 Inverness Drive East (1H)
Englewood, Colorado 80112 Inspection Conducted:
March 23-27, 1981 Inspector:
F-E- P i j4-W. E. Foster, Contractor Inspector Date Reactive Inspection Section Vendor Inspection Branch Approved by:
8%
5 -s-Pt I. Barnes, Chief Date Reactive Inspection Section Vendor Inspection Branch Summary:
Areas Int.pected:
Implementation of 10 CFR Part 50, Appendix B criteria, and applicable codes and standards; including an initial management meeting; follow up on regional requests; implementation of 10 CFR Part 21; manufacturing process control; change control; organization (limited);- training (limited); audits; control of measuring and test equipment; and corrective action.
The inspec-tion involved 36 inspector-hours on site by one NRC inspector.
Results:
In the ten areas inspected, the following two violations and 12 nonconformances were identified.
Violations:
Implementation of 10 CFR Part 21 practices were not consistent with:
Paragraph 21.6 of 10 CFR Part 21 (See Notice of Violation, Item A); Paragraph 21.21(a) of 10 CFR Part 21 (See Notice of Violation, Item B).
Nonconformances: Manufacturina Process Control practices were not consistent with:
Criterion V of Appendix B to 10 CFR Port 50, item numbers three ed six ot the Optical Isolator Shop Traveler Instructions, undated (See Notice of Noncon-formance, Item A); Criterion V of Appendix B to 10 CFR Part 50, and paragraph 8.5.5 of TVA Specification No. 3611, Revision 0, undated (See Notice of Nonconformance, Item B); Criterion V of Appendix B to 10 CFR Part 50, paragraph 2 and its subparagraph 2.1 of Quality Procedure No. 14, dated May 12, 1980 (see Notice of Nonconformance, Item C); Criterion V of Appendix B to 10 CFR Part 50, and item number 5 of the In-Process Inspection section of Quality Control Plan No. 006A001, dated May 12, 1980 (See Notice of Nonconformance, Item D).
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3 Change Control practices were nc; consistent with:
Criterion V of Appendix B to 10 CFR Part 50, paragraph 4 and its subparagraph 4.5 of the Introduction to the QA Manual, dated May 12, 1980 (See Notice of Noxonformance, Item E); Criterion V of Appendix B to 10 CFR Part 50, and Quality Procedure No. 24, dated January 14, 1980 (See Notice of Nonconformance, Item F); Criterion V of Appendix B to 10 CFR Part 50, and item No. 6 of the Engineering section of QC Procedure No.
006A002, dated January 14, 1980, (See Notice of Nonconiormance, Item G);
Criterion V of Appendix B to 10 CFR Part 50, paragraphs 5.1 and 5.3 of the Quality Procedure No. 25, dated May 12, 1980 (See Notice of Nonconformance, Item H); Criterion V cf Appendix B to 10 CFR Part 50, paragraph 2 and its subparagraph d of Quality rocedure No. 3, dated May 12, 1980 (See Notice o
of Nonconformance, Item I).
Organization practices were not consistent with Criterion V of Appendix B to 10 CFR Part 50, and paragraph 3.7 of the Introduction, dated January 14, 1980, of the QA Manual (See Notice of Nonconformance, Item J).
Training practices were not consistent with Criterion V of Appendix B to 10 CFR Part 50, and paragraph 4.17 of Quality Procedure No. 29, dated January 14, 1980 (See Notice of Nonconformance, Item K).
Audits practices were not consistent with Criterion V of Appendix B to 10 CFR Part 50, and Quality Procedure No. 27, dated January 14, 1980 (See Notice of Nonconformance, Item L).
l l
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4 DETAILS SECTION A.
Persons Contacted W. A. Ames, Supervisor - Drafting Department M. Lessar, Production Lead
- C. Lumpkin, Vice President and General Manager H. D. Romero, Electronic Technician
- J. Tarnosky, Manager - Quality Control
- M.
A. Xavier, President M. A. Xavier, Production Supervisor
- Attended the Initial Management Meeting and the Exit Interview.
B.
Initial Management Meeting 1.
Objectives An initial management meeting was conducted to acquaint the vendor's management with the NRC responsibility to protect the health and safety of the public and to inform them of certain responsibilities imposed on vendors by the " Energy Reorganization Act of 1974" (Public Law 93-438).
Those in attendance are denoted in paragraph A.
2.
Methods of Accomplishment The preceding objectives were accomplished by:
a.
Describing the historical events that indicated the need for the Vendor Inspection Program.
b.
Explaining the inspection base and how the inspections ore con-ducted.
c.
Describing how inspection results are documented and how proprie-tary items are handled, including the vendor's opportunity to review the report for the purpose of identifying items considered to be proprietary.
d.
Describing the vendor's responsibility in responding to identified enforcement items relating to:
(1) Correction of the identified violations and nonconformances.
(2) Actions to be implemented to prevent recurrence.
(3) The dates when (1) and (2) above will be implemented or completed.
5 e.
Explaining that all reports and commun1 cations are placed in the Public Document Room.
f.
Explaining the publication and function of the Licensee Contrac-ter and Vendor Inspection Status Report, NUREG-r040.
3.
Findings E-Max Instruments, Incorporated supplies AC and DC, Analog and Digital Optical Isolation Devices.
Current production consist of orders from Duke Power Company and the Tennessee Valley Authority.
The company intends to continue supplying the nuclear industry.
Production devoted to nuclear ranges from 20 to 40 percent.
C.
Follow up on Regional Requests
===1.
Background===
On August 28, and September 12, 1980, Dt:Pe Power Company (DPC) personnel notified the Office of Inspection and Enforcement, Region II (0IE, RII) personnel, of a problem at the Catawba and McGuire Nuclear Generating Stations, respectively. The problem involved failure of Model No. 175C141 Optical Isolators.
On November 18, 1980, DPC personnel notified OIE, RII personnel of an identical problem with Model No. 175C115 Optical Isolators at McGuire Station.
Both models are scheduled for replacement with Model No. 175C146.
t 2.
Objectives The objectives of this area of the inspection were to verify that:
(1) adequate corrective actions and preventive measures had been taken or planned, and (2) generic implication had been assessed.
3.
Methods of Accomplishment The preceding objectives were accomplished by:
a.
Reviewing the following Mill Power Supply Company Purchase Orders and attendant Specification No. CNS 1338.00-00-0001, through Revision 4, dated October 3, 1980, to determine the output require-ments:
(1) F26832-31, dated July 3, 1980, and its change dated November 10, 1980, (2) C91539, dated August 26, 1977, and (3) E-84190-31, dated January 31, 1981.
6 b.
Reviewing the following drawings to verify that the design satisfied the specification:
(1) 175C141, dated October 20, 1977, and (2) 175C146, dated December 5, 1980.
c.
Reviewing a-Telex dated October 14, 1980, To:
Duke Power Company; From: 'M. A. Xavier (E-Max), to assess the position of E-Max Instruments, Incorporated regarcing the problem with the Digital Optical Isolators.
4.
Findings a.
Within this area of the inspection, no nonconformances or unresolved items were identified.
b.
The NRC inspector was informed that the problem with the Digital Optical Isolator (DOI), Part No. 175C141 had been verbalized to personnel of E-Max Instruments by personnel of Duke Power Company.
No documentation of the problem had been provided to E-Max Instruments.
As defined to the inspector by the E-Max QA Manager, the problem became evident when the DOI was used to drive a Cutler-Hammer relay located in the battery charging circuit; however, not all DOIs failed in this application.
During opera-tion, the relay surges to a minimum of one ampere while the DOI was designed to drive a load of 140 milliamperes nominal.
In summary, the problem is not the DOI but its application.
A redesign of DOI, Part No. 175C141, has resulted in 001, Part No. 175C146.
The latter devices have been supplied to Duke Power Company for the Catawba and McGuiro Nuclear Generating
- Stations, c.
Specification No. CNS 1338.00-00-0001 had been revised October 3, 1980, to accommodate the current surge of the Cutler-Hammer relay.
d.
E-Max Instruments is not in a position to assess generic aspects because they are not aware of the application of the devices.
Part No. 175C141 had not been supplied to other purchasers.
D.
Implementation of 10 CFR Part 21 1.
Objectives The' objectives of this area of the inspection were to verify that supplierr of safety related equipment had established and implemented procedures in accordance with 10 CFR Part 21.
2.
Metho2 of Accomplishment Tiie preceding objectives were accomplished by:
7 a.
Reviewing the following customer orders to verify that the equipment was safety related and 10 CFR Part 21 had been invoked:
(1) Mill Power Supply Company Purchase Order, Nos. - E-84190-31, and Change Order No. 002, dated February 25 and August 25, 1980, respectively; and F-26832-31, and Changa Order No. 001, dated July 3, 1980, and November 10, 1980, respectively, (2) Northeast Utilities Purchase Order No. 706867, dated July 14, 1980, and (3) Commonweal +' Edison Company Purchase Order No. 244827, dated September 15, 1980.
3.
Findings a.
Comment The purchase orders identified in paragraph D.2.a.(1) and (2) were for safety related hardware and invoked 10 CFR Part 21.
Violations i
b.
.(1) 2: Notice of Violation, Item A.
(2) See Notice of Violation, Item B.
E.
Manufacturing Process Control 1.
Objectives The objectives of this F.rea of the inspection were to verify that measures had been estaolished and documented to control manufacturing, inspection and test activities.
Also, to verify these activities had been accomplished in accordance with the established and documented measures Additionally, verification of indication of mandatory hold points ir appropriate documents.
2.
Metheds or Accomplishment The preceding objectives were accomplished by:
a.
Heviewing the following documents to verify measures had been established and documented to control manufacturing, inspection and test activities:
(1) Quality Procedures, Nos. -
(a) 10, dated May 12, 1980, entitled - Fabrication and Assembly In-Process Inspection,
8 (b) 13, dated January 14, 1980, entitled - Quality Assurance Operaticns Performed by Other Departments, Facilities, or Vendors, (c) 14, dated May 12, 1980, entitled - Final Inspection and Test, (d) 15, dated January 14, 1980, entitled - Test Instruc-tions, and (e) 19, dated May 12, 1980, entitlec - Quality Assurance Stamps.
(2) Quality Control Plan No. 006A001, dated May 12, 1980.
(3) Quality Control Procedure No. 006A002, dated January 14, 1980.
(4) Quality Control Standard Procedure QA Inspectors Guide, No. 006A004, dated January 14, 1980.
(5) Undated documents, entitled - (a) Steps fo. Stuffing Board, (b) Steps for Touch-up, and (c) Optical Isols
- Shop Traveler Instruct'ons.
b.
Observing the following activities and reviewing the a
' dant documents ta verify that the established and documentea tsures were being implemented: (1) Insertion of Components on Printed Circuit Bcards, (2) Touch up of PCBs, (3) Continuity Check of Wiring in Cabinet No. 156B, (4) System Burn-in Test of Cabinet No. 25CA, and (5) Inspected PCBs, Serial Nos. 0240 through 0248 far Part No. 175C311.
3.
Findings a.
Nonconformances (1) See Notice of Nonconformance, Item A.
(2) See Notice of Nonconformance, Item B.
(3) See Notice of Nonconformance, Item C.
(4) See Notice of Nonconformance, Item D.
Additional information regarding Notice of Nonconformance, Item B - The System Test Procedure did not specify the required time and temperature of the burn-in test.
The unit was not being subjected to the required temperature; rather, the internals were being heated by means of an internal lamp bulb with no
)
9 means of controlling the temperature.
Further, the test procedure did not require temperature monitoring.
C-The NRC inspector was informed that the preliminary electrical test, on the ider.tified items, was conducted on the basis of verbal instructions because the published procedure specified a test fixture that was no longer available.
During a review of the customer Purchase Order No. 79KJ2-822988, attendant specifi-cation, supplier submittals and customer returns, the NRC inspector observed that the Test Procedure, Revision A, for Part No. 175C307, had been approved by the customer (TVA) on l
July 9, 1980.
However, personnel interviewed were not aware of this procedure or its approval; further, the test procedure had not been incorporated into the test program as evidenced by its non-inclusion into the master file of test procedures, b.
Unresolved Items None.
F.
ChangeControl 1.
Objectives The objectives of this area of the inspection were to verify that t
measu"es had been established to control changes to software and hardware.
Also, to verify the measures for software changes included provisions for review, approval, and distribution to and usage at the location where the prescribed activity is performed.
An additional phase was to verify the measures had been implemented.
2.
Methods of Accomplishment The preceding objectives were accomplished by:
a.
Reviewing the following documents to verify measures had been established to control changes to software and hardware:
(1). Quality Procedures, Nos. -
(a) 3, dated May 12, 1980, entitled - Purchase Requisition And/0r Purchase Order, (b) 4, dated May 12, 1980, entitled - Customer Inspection At Vendors' Facilities, (c) 24, dated January 14, 1980, entitled - Engineering Change Control, and 1
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10 (d) 25,-dated May 12, 1980, entitled - Design and Document Control:
(2) Quality Control Procedure No. 006A002, dated January 14, 1980.
(3)
Introcketion, dated January 14, 1980, to the Quality Assurance Manuai.
b.
Reviewing the following documents to verify that the established-i measures had been implemented:
(1) Engineering Change Orders, Nos. -
(a) 0283, dated June 10, 1980, (b) 0299, dated July 17, 1980, (c) 0300, dated July 17, 1980, (d) 0301, dated November 12, 1980, (e) 0303, dated July 21, 1980, (f) 0325, dated February 2, 1981, and (g) 0329, dated March 3, 1981.
(2) Drawings, Nos. -
(a) 175C115, Revision C, dated December 5, 1980, (b) 175C146, dated December 5, 1980, (c) 175C147, dated December 5, 1980, (d) 175D2020-300, Revision D, dated July 29, 1980; and Revision E, undated, and (e) 175C145, dated December 5, 1980.
(3) Material Lists, Nos. -
(a) 175C115, dated December 5, 1980,
-(b) 175C131, dated December 5, 1980,
-(c) 175C145, dateu v.onber 5,1980, and (d) 175C146, dated December 5, 1980.
11 (4) Material Inspection Reports for Part Nos. -
(a) 175D123, dated January 28, 1980, (b) 175C141, dated March 28, 1980, (c) 175C143, entry dated April 1, 1980, (d) 1-148A, dated January 12, 1981, and (e) 1-154A, dated January 12, 1981.
3.
Findings a.
Nonconformances (1) See Notice of Nonconformance, Item E.
(2) See Notice of Nonconformance, Item F.
(3) See Notice of Nonconformance, Item G.
(4) See Notice of Nonconformance, Item H.
(5) See Notice of Nonconformance, Item I.
G.
Organization 1.
Objectives The objectives of this area of the inspection were to verify that performers of the quality assurance functions reported to a management level that provided organizational freedom from cost and schedule when opposed to safety considerations.
2.
Methods of Accomplishment The preceding objectives were accomplished by:
a.
Reviewing the Quality Assurance Manual, dated May 12, 1980, to verify that the objectives had been addressed.
b.
Interviewing performers of the quality assurance functions 4
to verify that organizational freedom was a reality.
3.
Findings a.
Nonconformance See Notice of Nonconformance, Item J.
12 It was determined that one of the individuals responsible for inserting components in printed circait boards is also responsible for inspecting those same boards as a quality assurance function.
Similarly, the individual responsible for performing tests is also responsible for acceptance of those same tests and final inspection as quality assurance functions.
b.
Unresolved Items None.
H.
Training 1.
Objectives The objectives of this area of the inspection were to verify that performers of the quality assurance functions had been indoctrinated and trained to obtain suitable proficiency for performance of the quality assurance functions.
2.
Methods of Acconylishment The preceding objectives were accomplished by:
a.
Reviewing the Quality Assurance Manual, dated May 12, 1980, to verify that the objectives had been addressed.
b.
Interviewing performers of the quality assurance functions to verify that indoctrination and training had been accomplished.
c.
Revieving the personnel folder of the persons performing inspec-tioa and testing.
3.
Findings a.
Nonconformance See Notice of Nonconformance, Item K.
During the effort to determine accomplishment of indoctrination.
and training, the NRC inspector asked the following questions of the persons responsible for inspecting and testing:
(1) What i
is the date of the latest revision to the QA Manual; (2) How many Quality Procedures are in the QA Manual; (3) How many additions are there to the QA Manual; and (4) What are the contractual QA requirements of the TVA Purchase Order? The responses were negative.
13 b.
Unresolved Item None.
I.
Audits 1.
Objectives The objectives of this area of the inspection were to verify that:
(a) A comprehensive system of planned and periodic audits had been carried out to (1) verify compliance with all aspects of the quality assurance program, and (2) determine the effectiveness of the program; (b) Audits had been performed in accordance with written procedures or checklists by appropriately trained personnel not having direct responsi-bilities in the areas being audited; (c) Audit results had been docu-mented and reviewed by management having responsibility in the area audited; and (d) Follow-up action, including re-audit of deficient areas, had been taken.
2.
Methods of Accomplishment The preceding objectives were accomplished by:
Reviewing the following documents to verify that the objectives had been addressed and implemented:
(1) Quality Procedure No. 27, dated January 14, 1980, entitled -
Quality Assurance Audit Program (For In-House Audits), and (2) Audit Report dated May 8, 1980.
3.
Findings a.
Nonconformance See Notice of Nonconformance, Item L.
b.
Unresolved Items None.
J.
Control of Measuring and Test Equipment 1.
Objectives The objectives of this area of the inspection were to verify that measures had been established to assure that tools, gages, instruments, and other measuring and testing devices used in activities affecting r
quality had been properly controlled, calibrated, and adjusted at specified periods to maintain accuracy within necessary limits.
14 2.
Methods of Accomplishment The preceding objectives were accomplished by:
a.
Reviewing the following documents to verify that objectives had been addressed:
Quality Crocedures, Nos. -
(1) 20, dated May 12, 1980, entitled - Traceable Cel:5 ration Schedule for Test Equipment and Standards...,
(2) 21, dated January 14, 1980, entitled - Test Equipment and Standards, (3) 22, dated January 14, 1980, entitled - Inspection Measuring Equipment and Inspection Equipment Standards, and (4) 23, dated May 12, 1980, entitled - Calibration Schedule for Inspection Measuring Equipment and... Standards.
b.
Observing the following eqeipment and reviewing the associated records to verify implementation of the ebjectives:
(1) Fluke Multimeter, Model No. 8020, Serial No. 0806310, (2) Fluke Temperature Probe, Model No. 80T-150, Serial No. 2200130, and (3) Fluke High Voltage Probe, Model No. 80k-40, Serial No. - None.
3.
Findings Within this area of the inspection, no nonconformanccs or unresolved i
items were identified.
K.
Corrective Action l
l 1.
Objectives l
l The objectives of this area of the inspection were to verify that:
(a) Measures had been established to assure that conditions adverse to quality (failures, malfunctions, deficiencies, deviations, defective
(
material and equipment, and nonconformances), had been promptly identi-l fied and corrected; (b) Established measures assured that the cause of the condition had been determined and corrective action taken to preclude repetition in the case of significant conditions adverse to quality; (c) The identification of the significant condition adverse to quality, the cause of the condition and the corrective action had been documented and reported to appropriate levels of management.
15 2.
Methods of Accomplishment The preceding objectives were accomplished by:
Reviewing the following documents to verify that the objectives had been addressed and implemented:
(1) Quality Procedure No.18. dated January 14, 1980, entitled -
Corrective Action, and (2) Internal Memorandum, dated November 1, 1981 (sic), To: S. M. X6 vier; From:
J. Tarnosky;
Subject:
Spectrol Trimpots.
3.
Findings In this area of.the inspection, no nonconformances or unresolved items were identified.
L.
Exit Interview 1.
The inspector met with management representatives denoted in para-graph A. at the conclusion of the inspection on March 27, 1981.
2.
The following subjects were discussed:
a.
Areas inspected.
b.
Violations identified.
c.
Nonconformances identified.
d.
Contractor response to the report.
The contractor was requested to structure his response under headings of corrective action, preventive measures, and dates for each non-conformance.
Additionally, management representatives were requested to notify the Commission in writing if dates require adjustnent, commitments require modification, etc.
3.
Management representatives acknowledged the remarks made by the inspector.