ML19309C275
| ML19309C275 | |
| Person / Time | |
|---|---|
| Issue date: | 01/24/1980 |
| From: | Foster W, Hunnicutt D NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | |
| Shared Package | |
| ML19309C253 | List: |
| References | |
| REF-QA-99900387 NUDOCS 8004080389 | |
| Download: ML19309C275 (11) | |
Text
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U.S. NUCI. EAR REGUI.ATORY COMMISSION OFFICE OF INSPECTION AND ENFORCEMENT REGION IV Report No. 99900387/79-01 Program No. 51400 Company:
General Atomic Company Electronic Systems Division P. O. Box 81608 San Diego, California 92138 Inspection at:
11085 Sorrento Valley Court - 92121 Inspection Conducted:
December 10-14, 1979 Inspector:
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W. E. Foster, Contractor Inspector Date ComponentsSection II l
Vendor Inspection Branch Approved by: N-[
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~[i D. M. Hunnicutt, Chief Date ComponentsSection II Vendor Inspection Branch Summary:
Inspection on December 10-14, 1979 (99900387/79-01).
Areas Inspected:
Implementation of 10 CFR 50, Appendix B criteria, and ap-plicable codes and standards, including quality assurance program; manu-facturing process control; and change control.
Implementation of 10 CFR 21 was also an area inspected.
The inspection icvolved thirty-three and one-half (33.5) inspector-hours on site.
Results:
In the four (4) areas inspected, the following violation, deviations,-
and unresolved items were identified:
Violation:
Implementation of 10 CFR 21 posting had not been accomplished as required by paragraph 21.6 of 10 CFR 21; Supplement No. 2, dated June 13, 1978, to-Texas Utilities Generating Company's Purchase Order No. CP-0480; and Revision 1, dated January 19, 1978, to Bechtel Power Corporation's 1
Purchase Order No. 10466-J-361-1.
This is a deficiency (Notice of Violation).
8004080 3 b
2 Deviations:
Quality Assurance Program practices were not consistent with Criterion V of Appendix B to 10 CFR 50; paragraphs 5 and 6 of Section iv, Issue D, dated June 1, 1979, of the Quality Manual (Notice of Deviation, Item A.).
Manufacturing Process Control practices were not consistent with Criterion V of Appendix B to 10 CFR.50; paragraphs 3.2.1, 3.4, and Table 3.4 of the Workmanship Inspection Standard No. E-286-127, Revision 6, dated April 1978 (Notice of Deviation, Items B., and C.).
Change Control practices were not consistent with Criterion V of Appendix B to 10 CFR 50; paragraph 5 of Section 5, Issue D, dated June 1, 1979, of the Quality Manual; paragraphs 5.1.2, 5.1.6, and 5.4, of Section 6, Issue D, dated June 1, 1979, of the Quality Manual (Notice of Deviation, Items D.,
E., and F.).
Unresolved Items:
Quality Assurance Program - Quality Control Instruction No. 201, Issue D, dated October 29, 1979, required the use of Manufacturing Operations Manual No. E-114-660; however, the Manufacturing Operations Manual had not been published (Details Section, paragraph D.3.b (1).
Multimeter calibrated by an Independent Calibration Laboratory failed to exhibit a Calibration Label (Details Section, paragraph D.3.b.(2)).
Independent Calibration Laboratory is not listed in the Suppliers List (Details Section, paragraph D.3.b.(3)).
Manufacturing Process Control - Document Revision in-formation not filled in on some travelers (Details Section, paragraph E.3.b).
3 DETAILS SECTION A.
Persons Contacted C. Braxtan, Supervisor - Calibration Laboratory J. G. Brogden, Engineer - Senior Quality Assurance
- W. J. Compas, Director - Electronic Systems Division L. Ellsworth, Supervisor - Material Control R. V. Fisher, Project Manager (Comanche Peak)
T. Hery, Supervisor - Microprocessor Engineering E. Jones, Clerk - Document Control Center
- C. Lingren, Manager - Reactor Instrumentation and Control Department D. McAndrew, Manager - Purcnasing T. F. Mulligan, Engineer - Quality Assurance C. C. Newsom, Analyst - Quality Assurance
- F. N. Paplawsky, Manager - Quality Assurance C. Phipps, Manager - Production W. D. Starkey, Specialist - Documentation Control
- F. C. Thrombley, Manager - Manufacturing
- J. R. Ward, Manager - Planning and Adminstration
- M. Warsicki, Supervisor - Quality Control R. Weddle, Project Manager (Palo Verde)
- J. H. Winso, Manager - Projects
- Attended exit interview.
- Attended initial management meeting and 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.
Method 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 inspecc. ions are conducted.
4 Describing how inspection results are documented and how pro-c.
prietary items are handled, including the vendor's opportunity to review the report for the purpose of identifying items con-sidered to be proprietary.
d.
Describieg the vendor's responsibility in responding to identif.cd enforcement items relating to:
i (1)
Correction of the identified deviation.
P (2) Action to be implemented to prevent recurrence.
r (3) The dates when (1) and (2) above will be implemented or completed.
I Explaining that all reports and communications are placed in e.
the Public Document Room.
f.
Explaining the publication and function of the Licensee Con-tractor and Vendor Inspection Status Report, NUREG-0040.
3.
Findings Products of the Division are solely for the nuclear industry.
Some manufacturing and quality functions are performed in the Mexico facility.
Currently, there are eleven (11) active contracts to manufacture radiation monitoring systems.
C.
Implementation of 10 CFR Part 21 1.
Objectives The objectives of this area of the inspection were to verify that suppliers of safety related equipment had established and implemented i
procedures in accordance with 10 CFR 21.
2.
Method of Accomplishment l
The preceding objectives were accomplished by:
E Review of the following customer orders to verify the equip-a.
ment was safety related and 10 CFR 21 had been invoked:
(1) Texas Utilities Generating Company, Purchase Order No. CP-0480, dated April 18, 1977, attendant changes, and specificaCions, (2) Arizona Public Service Company, Purchase Order No. 10407-13-JM-104, dated November 8, 1976, attendant changes, and specifications, and
5 (3) Bechtel Power Corporation, Purchase Order No. 10466-J-361-1, Revision 0, dated May 25, 1977, Revision 1, dated 1
Janua ry 19, 1978, attendant changes, and specifications.
b.
Review of General Atomic Company Policy No. 212, dated December 19, 1977, entitled - Reporting of Defects and Non-compliance.
t c.
Observation of Official Bulletin Boards located in the Admin-istrative and Manufacturing areas of Building No. 6, and the Engineering area, Building No. 2.
3.
Findings Supplement No. 2, dated June 13, 1978, to Texas Utilities Generating Company's Purchase Order No. CP-0480 invoked 10 CFR 21.
Revision 1
1, dated January 19, 1978, to Bechtel Power Corporation's Purchase Order No. 10466-J-361-1 invoked 10 CFR 21.
a.
Violation From Commitment See Notice of Violation.
b.
Unresolved Item None.
D.
Quality Assurance Program 1.
Objectives The objectives of this area of the inspection were to verify that the program had been documented, controls had been established and the program had been implemented.
2.
Methods of Accomplishment The preceding objectives were accomplished by:
Review of the following customers orders to verify that a a.
quality assurance program requirement had been invoked:
(1) Texas Utilities Generating Company, Purchase Order No. CP-0480, dated April 18, 1977, and attendant speci-fications.
(2) Arizona Public Service Company, Purchase Order No. 10407-13-JM-104, dated November 8, 1976, and attendant speci-fications, and,
6 (3) Bechtel Power Corporation, Purchase Order No.10466-J-361-1, Revision 0, dated May 25, 1977, and attendant specifications.
b.
Review of Sections iv, 3, 4, 9, 10, 12, 16, and 18, of the Quality Manual, No. E-307-642, Issue E, dated June 1, 1979, to verify the program had been documented by written policies, procedures, or instructions.
c.
Review of the following activities to verify the program had been implemented: Training; Design Centrol; Procurement Docu-ment Control; Control of Purruased Material, Equipment, and Services; Control of Special Processes:
Corrective Action; and Audits.
3.
Findings The Purchase Orders identified above (D.2.a), required establishment and implementation of a quality assurance program.
a.
Deviation From Commitment See Notice of Deviation, Item A.
b.
Unresolved Items (1) Paragraphs 1, 2.1, and 3.1, of Quality Control Instruc-tion No. 201, Issue D, dated October 29, 1979, reference and state that all applicable QC operations be performed as required by Manufacturing Operations Manual No. E-114-660. The NRC inspector observed that the Manufacturing Operations Manual had not been published.
The contrac-tor should take the action necessary to resc1ve this con-flict.
(2) Dana Digital Multimeter, Model 5900, S/N 110238 had been calibrated by an Independent Calibration Laboratory on November 19, 1979.
However, the instrument failed to exhibit a Calibration Label.
Section 12,.rssue D, dated l
June 1, 1979, of the Quality Manual requires Calibration i
Labels for equipment calibrated at General Atomic (GA),
j but is silent regarding such identification for those items calibrated outside GA.
The contractor should evaluate this practice and resolve this apparent omission.
7 (3) Comtel Corporation provides calibration services but is not listed in the Calibration Services section of the Suppliers List, dated August 8, 1979. The NRC inspector reviewed a Comtel Shipping document which indicated that National Astro Laboratories (which is listed in the Sup-pliers List) is a subsidiary.
The contractor should clarify this association in the Suppliers List.
E.
Manufacturing Process Control 1.
Objectives The objectives of this area of the inspection were to verify that measures had been established and documented to control manufacturing, inspection and test activities. Also, to verify these activities had been accomplished in accordance with the established and docu-mented measures. Additionally, verification of indication of man-datory hold points in appropriate documents.
2.
Method of Accomplishment The preceding objectives were accomplished by:
Review of the following customer orders to verify instructions, a.
procedutes, and drawings; control of special processes; inspec-tion; test control; and inspection, test, and operating status had been invoked:
(1) Texas Utilities Generating Company, Purchase Order No.
CP-0480, dated April 18, 1977, and attendant specifications, (2) Arizona Public Service Company, Purchase Order No. 10407-JM-104, dated November 8, 1976, and attendant specifications, and (3) Bechtel Power Corporation, Purchase Order No. 10466-J-361-1, Revision 0, dated May 25, 1977.
b.
Review of the following documents to verify measures had been established and documented to control manufacturing, inspection, and test activities:
(1) Sections 5, 9, 10, 11, and 14, of the Quality Manual No.
E-307-642, Issue E, dated June 1,-1979,-
8 (2) Quality Control Instructions, Nos.-200, Issue D, dated October 29, 1979; 201, Issue D, dated October 29, 1979; i
202, Issue B, dated April 27, 1978; 205, Issue C, dated April 27, 1978; 207, Issue A, dated February 26, 1975; and 213, Issue C, undated, (3) Quality Assurance Instructions, Nos.-004, Issue A, dated August 28, 1979; 007, Issue A, dated August 28, 1979; and 009, Issue A, dated August 28, 1979, and (4) Workmanship Inspection Standard No. E-286-127, Revision 6, dated April 1978.
c.
Observation of the following activities to verify tasks were accomplished in accordance with documented manufacturing, in-spection, and test requirements:
(1) Acceptance test of B0P ESFAS Cabinets, Part Nos. 342-1000-01E, and 342-2000-01E, in accordance with ATP No. 3420062, Revision B, dated August 31, 1979, (2) Assembly of a Pre-Amplifier Module Assembly, Part No. 362-1200, in accordance with a Traveler, Parts List, and Draw-ing No. 362-1200, all of correct revisions, (3) Assembly of a Keyboard Printed Circuit Assembly, Part No.
281-5860, in accordance with a Traveler, Parts List, and Drawing No. 281-5860, all documents of correct revision, (4) Burn-in test of Liquid Monitor Skid Assembly (w/o pump),
Part No. 3532601-2, with Traveler of the same number, j
(5) First Article Inspection of RM-11 System Assembly, Part No. 353-0601, in accordance with Traveler and Drawing of the same No.,
(6) First Article Fabrication of Mobile Airborne Radiation Monitoring System to Traveler for Motor Controller Modi-fication, Part No. 360-4026, and (7) First Article Fabrication of Control Room Cabinet Assembly, Part No. 356-0501, in accordance with Traveller and Drawing of correct revision.
3.
Findings The Purchase Orders identified above (E.2.a), required establishment and implementation of controls for instructions, procedures, and drawings; special processes; inspection; test; and inspection, test and operating status.
i 9
a.
Deviation From Commitment (1) See Notice of Deviation, Item B.
(2) See Notice of Deviation, Item C.
b.
Unresolved Item Revisions of some documents to be used are identified with a blank (
) on some Travelers.
The NRC inspector was informed that it is the intent that the blanks be filled -
in by personnel using the cited document; however, there were i
no apparent documented instructions for filling-in the blanks.
1 The contractor should initiate documented instructions for accomplishing this task.
F.
Change Control 4
1.
Objectives 4
The objectives of this area of the inspection were to verify that measures had been established to control changes to software and hardware. Also, to verify the measures for software changes in-cluded 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.
Method of Accomplishment The preceding objectives were accomplished by:
Review of the following customer orders to verify document con-a.
trol; and nonconforming materials, parts, or components require-ments had been invoked:
(1) Texas Utilities Generating Company, Purchase Order No.
CP-0480, dated April 18, 1977, and attendant specifications, (2) Arizona Public Service Company, Purchase Order No.10407-13-JM-104, dated November 8, 1976, and attendant specifi-cations, and (3) Bechtel Power Corporation, Purchase Order No.10466-J-361-1, Revision 0, dated May 25, 1977.
1 r
1
p 10 b.
Review of Sections 3, 4, 5, and 6, of the Quality Manual, No. E-307-642, Issue E, dated June 1, 1979, to verify mea-sures had been established to control changes to software and hardware.
c.
Review of the following to verify the procedures had been implemented:
(1) Travellers for-0281-0340-02; 0281-0910-02; 0351-1501-03; and 0281-0729-01.
(2) Test Procedures, Nos.-ATP 408, Issue B, dated October 6, 1979; 3539011, Revision A, dated November 9, 1979; 3572031,- Revision B, dated September 4, 1979; 2810822, Revision B, dated October 11, 1979; and 3573101, Revi-sion B, dated September 11, 1979.
(3) Drawing Approval Authorization forms, Nos.-0100, dated February 17, 1976; 0109, dated March 11, 1977; 0109A, dated June 14, 1979; 0113, dated May 22, 1978; 0113A, dated June 27, 1979; and 0119, dated June 19, 1978.
(4) Requests for Engineering Changes, Nos.-RMI 295, dated October 8, 1979; and RMI 268, dated July 31, 1979.
(5) Drawings, Nos.-304-5000, Revisions:
E, dated March 1, 1976; F, dated March 24, 1976; and G, dated May 7, 1976.
3534520, Revisions:
A, dated September 26, 1978; B, dated January 24, 1979; C, dated May 9, 1979; and D, dated November 5,1979.
3.
Findings The Purchase Orders identified above (F.2.a), required estab-lishment and implementation of measures for document control; and nonconforming materials, parts, or components.
a.
Deviations From Commitments (1)
See Notice of Deviation, Item D.
(2)
See Notice of Deviation, Item E.
(3)
See Notice of Deviation, Item F.
b.
Unresolved Item None.
11 G.
Exit Interview 1.
The inspector met with management representatives denoted in para-graph A at the conclusion of the inspection on December 14, 1979.
2.
The following subjects were discussed:
a.
Areas inspected, b.
Violation identified.
c.
Deviations identified.
d.
Unresolved items identified.
Contractor response to the report.
e.
The contractor was requested to structure his response under headings of corrective action, preventive measures, and dates for each deviation.
Additionally, management representatives were requested to notify the Commission in writing if dates require adjustment, commitments require modification, etc.
3.
Management representatives acknowledged the comments made by the inspector.
o