ML19318C192
| ML19318C192 | |
| Person / Time | |
|---|---|
| Issue date: | 03/26/1980 |
| From: | Foster W, Hunnicutt D NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | |
| Shared Package | |
| ML19318C172 | List: |
| References | |
| REF-QA-99900384 99900384-80-1, NUDOCS 8007010171 | |
| Download: ML19318C192 (10) | |
Text
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U. S. NUCLEAR REGULATORY COMMISSION OFFICE OF INSPECTION AND ENFORCEMENT REGION IV Report No.
99900384/80-01 Program No. 51400 Company:
Gulf & Western Manufacturing Company Eagle Signal Division 736 Federal Street Davenport, Iowa 52803 Inspection Conducted:
March 3-7, 1980 Inspector:
N[
M4L/F-W. E. Foster, Contractor Inspector Date ComponentsSection II Vendor Inspection Branch Approved by:
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Eudt(4-Ed d
D. M. Hunnicutt, Chief
/ Date/
ComponentsSection II Vendor Inspection Branch S, nea ry:
Inspection on March 3-7, 1980 (99900384/80-01)
Areas Inspected:
Implementation of 10 CFR 50, Appendix B criteria, and applicable codes and standards; including quality assurance program; manufacturing process control; and quality assurance manual review.
Im-plementation of 10 CFR 21 was also an area inspected.
The inspection involved twenty-nine and one-half (29.5) inspector-hours on site and two (2) hours at the motel.
Results:
In the four (4) areas inspected, the following violation, five (5) deviations, and two (2) unresolved items were identified:
Violation:
Implementation of 10 CFR Part 21-practices were not consistent with paragraph 21.21 of 10 CFR Part 21 and General Electric Company, Nuclear Energy Division Purchase Order No. 282-TG108, Revision 99, dated January 2, 1980.
This is an infraction (See Notice of Violation).
Deviations:
Quality Assurance Program practices wer. not consistent with Criterion V of Appendix B to 10 CFR 50; paragraphs 1.d. and 1.e. of Section 9.3.4.1, dated May 18 and August 2, 1978, of the Quality Systems Manual (See Notice of Deviation, Item A); items 6. and 9. under CALIBRATION 8007010
2 PROCEDURES, and Annex III of Section 9.3.7.3, dated June 22, 1978, of the Quality Systems Manual (See Notice of Deviation, Item B).
Manufacturing Process Control practices were not consistent with Criterion V of Appendix B to 10 CFR 50; and Section 9.3.6.1, dated May 19, 1978, of the Quality Systems Manual (See Notice of Deviation, Item C).
Quality Assurance Manual Review-program was not consistent with Criteria II and XII of Appendix B to 10 CFR 50 (See Notice of Deviation, Items D and E).
Unresolved Items: Quality Assurance Program-two forms with the same title but different designations were in use at Receiving Inspection; also, in-spection stamping is other than provided (Details Section, paragraph D.3.b).
Manufacturing Process Control-Section 9.3.1.5, dated January 1973, of the Quality Systems Manual Referenced a document that had not been generated s
(Details Section, paragraph E.3.b).
3 DETAILS SECTION A.
Persons Contacted
- R. Erickson, Technical Assistant to the President K.- J. Fersch, Clerk-Inventory Control F. W. Graham, Senior Technician-Quality Assurance
- J. M. Hawkinson, Supervisor-Quality Assurance J. R. Keyoth, Engineer-Manufacturing J. Moore, Section Leader-Standard Cost T. Morgan, Inspector-Electromechanical
- F. Newburn, General Manager-Acting A. Noppe, Inspector-Gauge R. W, Smart, Foreman-Assembly G. Thomas, Group Leader-Receiving Inspection
- W. L. Thompson, Operations Manager H. Wallace, Group Leader-Electromechanical Inspection
- Attended Exit Interview.
- Attended Initial Management Meeting and Exit Interview.
- Attended Initial Management Meeting.
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 c,* b?w the inspections are conducted.
c.
Describing how inspectico 21,$ 1., are documented and how proprietary items are handled, in0luding the vendor's opportunity to review the report for.th.' purpose of identifying items considered to be proprietary.
d 4
d.
Describing _the vendor's responsibility in responding to identified enforcement items relating to:
(1) Correction of the identified deviation.
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(2). Action to be implemented to prevent recurrence.
1 (3).The dates.when1(1).and (2).a~oove will be. implemented or: completed.
Explaining that all reports and communications are placed e.
in the Public Document Room.
f.
Explaining the publication and function of the Licensee Contrac-tor and Vendor Inspection Status Report, NUREG-0040.
3.
Findings Eagle Signal Division supplies timers which are used in safety related applications. Most procurements are made through Eagle Signal dealers but occasionally a purchase order will be sent directly to Eagle Signal.
i Currently, management of the Division is through a committee and Technical Assistant to the President. This committee has been consisting of the:
Sales Manager, Operations Manager, Comptroller, active about six (6) months because the President is incapcitated.
The members rotate the role of Acting General Manager.
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 procedures in accordance with 10 CFR 21.
2.
Methods of Accomplishment The preceding objectives were accomplished by:
_ Review of the following customer orders to verify the equip-l a.
ment was safety related and 10 CFR 21 had been invoked:
(1) : General Electric' Company, Nuclear Energy Division Purchase Order No. 282-TG108, Revision 99, dated January 2, 1980,
)
_and related specifications,.
I
5 (2) Harlo Corporation, Control Panel Division Purchase Order No. 27487S, dated November 10, 1978, and (3) Campbell and George Company, Purchase Orders E4362, dated December 5, 1979; E4308, dated October 18, 1979; E4217, dated August 17, 1979; and E4020, dated March 5, 1979.
Note: This is the company through whom General Electric Company, Nuclear Energy Division, San Jose, California, makes most of its purchases for Eagle Signal Timers which are used in safety related applications.
3.
Findings The General Electric Company purchase order invoked 10 CFR Part 21.
The Harlo Corporation purchase order was for timers to be used in safety related applications; therefore, it is concluded that 10 CFR Part 21 was applicable.
It was not apparent to the in-spector that the Campbell and George Company purchase orders identified technical, discounting the catalog number, or quality requirements.
See Notice of Violation.
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:
Reviewing the following customer orders to verify that 10 CFR a.
50, Appendix B, ANSI N45.2-1971; or an adequate interpretation had been invoked:
(1) General Electric Company, Nuclear Energy Division Purchase Order No. 282-TG108, Revision 99, dated January 2,1980, and related specifications, (2) Harlo Corporation, Control Panel Division Purchase Order No. 27487S, dated November 10, 1978, and
6 (3) Campbell and George Company, Purchase Orders E4362, dated December 5,1979; E4308, dated October 18, 1979; E4217, dated August 17, 1979; and E4020, dated March 5, 1979.
Note: This is the company through whom General Electric Company, Nuclear Energy Division, San Jose, California, makes most of its purchases for Eagle Signal Timers which are used in safety related applications.
b.
Reviewing the following sections of the Quality Systems Manual to verify the program had been documented by written policies, procedures, or instructions:
(1) Section 9.3.4.1, dated May 18, 1978 (page 1) and August 2, 1978 (pages 2-7)-Receiving Inspection, and (2) Section 9.3.7.3, dated June 22, 1978-Instrumentation Calibration Control.
Reviewing Control of Purchased Material, Equipment, and Services; c.
and Control of Measuring and Test Equipment to verify the program had been implemented.
d.
Reviewing hardware covered by the program to verify that identi-fication had been established.
3.
Findings The General Electric Company purchase order invoked an adequate interpretation of 10 CFR 50, Appendix B.
The Harlo Corporation purchase order identified 10 CFR 50 as the quality standard.
It was not apparent to the inspector that the Campbell and George
' Company purchase orders identified technical, discounting the catalog number, or quality requirements.
a.
Deviations From Commitment (1) See Notice of Deviation, Item A.
(2) See Notice of Deviation, Item B.
b.
Unresolved Item Two (2) forms with the same title (Material Inspected Record) but with different designations (EWB-270 and EAG-270) are being used by personnel in Receiving Inspection.
Section 9.3.4.1, dated May 18, 1978 (page 1) and August 2, 1978 (pages 2-7) of the Quality Systems Manual, identifies the
7 Material Inspected Record as EWB-270 and the Historical Records as EAG-270. Also, both forms provide for inspection disposition (usually stamped) of each line item; however, the current practice is one inspection stamp per page.
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 mandatory hold points in appropriate documents.
2.
Methods of Accomplishment The preceding objectives were accomplished by:
Reviewing the following customer orders to verify that 10 CFR a.
50, Appendix B; ANSI N45.2-1971; or an adequate interpretation had been invoked:
(1) General Electric Company, Nuclear Energy Division Purchase Order No. 282-TG108, Revision 99, dated January 2,1980, and related specifications, (2) Harlo Corporation, Control Panel Division Purchase Order No. 27487S, dated November 10, 1978, and 1
(3) Campbell and George Company, Purchase Orders E4362, dated December 5, 1979; E4308, dated October 18, 1979; E4217, dated August 17, 1979; and E4020, dated March 5, 1979.
Note: This is the company through whom General Electric Company, Nuclear Energy Division, San Jose, California, makes most of its purchases for Eagle Signal Timers which are used in safety related applications.
b.
Reviewing the following sections of the Quality Systems Manual to verify measures had been established and documented to control manufacturing, inspection and test activities:
(1) Section 9.3.1.5, dated January 1973-Quality Auditing, (2) Section 9.3.6.1, dated May 19, 1978-Inspection Procedures, b
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8 (3) Section 9.3.6.3, dated May 19, 1978-Inspection Stamps, and (4) Section 9.3.6.6, dated June 24, 1975-Lot Plot Inspection.
Observing fabricating, inspecting, and testing activities to c.
applicable Route Sheet, Job Instruction Sheets, Inspection Checklists, Inspection Reports and Drawings.
3.
Findings The General Electric Company purchase order invoked an adequate interpretation of 10 CFR 50 Appendix B.
The Harlo Corporation purchase order identified 10 CFR 50 as the quality standard.
It was not apparent to the inspector that the Campbell and George Company purchase orders identified technical, discounting the catalog number, or quality requirements.
a.
Deviation From Commitment See Notice of Deviation, Item C.
b.
Unresolved Item Section 9.3.1.5, dated January 1973, of the Quality Systems Manual, indicates that product audit characteristics refer to standards provided in the Inspection Manual, No. 9.2.0.0.
The NRC inspector was informed that the Inspection Manual had not been generated.
F.
QA Manual Review 1.
Objectives The objectives of this area of the inspection were to verify that the QA Manual addressed the eighteen (18) criteria of Appendix B to 10 CFR 50 and had been endorsed by management.as an authoritative document.
2.
Methods of Accomplishment The preceding objectives were accomplished by:
Reviewing the following customer orders to verify that 10 CFR a.
50, Appendix B; ANSI N45.2-1971; or an adequate interpretation had been invoked:
i l
i 9
(1) General Electric Company, Nuclear Energy Division Purchase Order No. 282-TG108, Revision 99, dated January 2, 1980, and related specifications, (2) Harlo Corporation, Control Panel Division Purchase Order No. 27487S, dated November-10, 1978, and (3) Campbell and George Company, Purchase Orders E4362, dated December 5, 1979; E4308, dated October 18, 1979; E4217, dated August 17, 1979; and E4020, dated March 5, 1979.
Note: This is the company through whom General Electric Company, Nuclear Energy Division, San Jose, California, makes most of its purchases for Eagle Signal Timers which are used in safety related applications.
b.
Reviewing the Quality Systems Manual with a Table of Contents with the last entry dated December 6, 1979.
3.
Findings The General Electric Company purchase order invoked an adequate interpretation of 10 CFR 50, Appendix B.
The Harlo Corporation purchase order identified 10 CFR 50 as the quality standard.
It was not apparent to the inspector that the Campbell and George Company purchase orders identified technical, discounting catalog number, or quality requirements.
a.
Deviations From Commitment (1) See Notice of Deviation, Item D.
(2) See Notice of Deviation, Item E.
b.
Unresolved Items None.
G.
Exit Interview 1.
- The inspector met with management representatives denoted in para-graph A. above at the conclusion of the inspection on March 7, 1980.
2.
The following subjects were discussed:
a.
Areas inspected.
b.
Violation identified.
10 c.
Deviations identified.
d.
Unresolved Items identified.
e.
Contractor response to the report.
The contractor was requested to structure his response under headings of corrective action, preventive measures, and dates for each deviation.
Additionally, management representatives were rr. quested to notify the Commission in writing if dates require adjustment, commitments require modification, etc.
3.
Management representatives acknowledged the comments made by the inspector.
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