ML19318A728

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QA Program Insp Rept 99900703/80-01 on 800219-21. Noncompliance Noted:Practices Not Consistent w/10CFR21.21, 10CFR50,App B,Criterion 5 & QA Manual,Revision E
ML19318A728
Person / Time
Issue date: 03/26/1980
From: Foster W, Hunnicutt D
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV)
To:
Shared Package
ML19318A709 List:
References
REF-QA-99900703 99900703-80-1, NUDOCS 8006240080
Download: ML19318A728 (10)


Text

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~'(3 U. S. NUCLEAR REGULATORY COMMISSION OFFICE OF INSPECTION AND ENFORCEE.NT REGION IV 4

Report No.

99900703/80-01 Program 51400 Company:

RTE-Delta Corporation 705 North Carlton Avenue Stockton, California 95201 Inspection Conducted: February 19-21,1980 Inspector:

8 /. [

3/tt,/fo W. E. Foster, Contractor Inspector Date ComponentsSection II Vendor Inspection Branch Approved by:

hf unaila#

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D. M. Hunnicutt, Chief

/ Date/

ComponentsSection II Vendor Inspection Branch Summary:

Inspection on February 19-21, 1980 (99900703/80-01).

Areas Inspected:

Implementation of 10 CFR 50, Appendix B criteria, and applicable codes and standards, including quality assurance program; change control; and manufacturing process control.

Implementation of 10 CFR 21 was also inspected. The inspection involved twenty-four (24) inspector hours on site.

l Results:

In the four (4) areas inspected, the following violation, two (2) deviations; and three (3) unresolved items were identified:

1 Violation:

Implementation of 10 CFR 21 practices were not consistent

{

with paragraph 21.21 of 10 CFR Part 21; and paragraph 9.0 of Appendix B, Revision B, dated January 14, 1980, of De Laval Engine and Compressor 1

Division Purchase Order No. 59008. This is an infraction (See Notice of Violation).

s ochs2 4 0(24tC) '

2 Deviations:

Change Control - practices were not consistent with Criterion V of Appendix B to 10 CFR 50; paragraph 6.1.2, and its subparagraphs (a) and (b); paragraph 3.2, and its subparagraphs (a) and (b) of the Quality Assurance Manual, Revision E, dated February 1980 (See Notice cf Deviation, Item A.).

Manufacturing Process Control practices were not consistent with Criterion V of Appendix B to 10 CFR 50; paragraph 10.2, and its subparagraph (a),

of the Quality Assurance Manual, Revision E, dated February 1980 (See Notice of Deviation, Item B).

Unresolved Items: Quality Assurance Program - the Quality Assurance Manual, Revision E, dated February 1980; identifies the calibration interval for test equipment used by the Production Department but is silent regarding the calibration interval for test equipment used by the Test Department (See Details Section, paragraph D.3.b. (1)); the Quality Assurance Manual, Revision E, dated February 1980, identified specific minimum areas to be audited; however, Audit Logs and Audit Reports did not contain such areas (See Details Section, paragraph D.3.b.(2)).

Manufacturing Process Control - the Quality Assurance Manual, Revision E, dated February 1980, indicates that In-Production Quality Check Lists are used during manufacture; however, the documents being used during manufac-ture are identified as In Process Inspection (See Details Section, para-graph F.3.b.).

e

3 DETAILS SECTION

'A.

Persons Contacted A. N.-Fallows, Manager - Manufacturing J. F. Hey, Manager - 0.E.M. Marketing D. R. Prochazka, Manager -~ Quality Assurance H. C. Schmidt, Jr., General Manager (Acting)

These persons attended the initial management meeting and the exit 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. above.

2.

Methods of Accomplishment 4

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 are conducted.

i 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.;urpose of identifying items con-sidered to be proprietary.

-d.-

Describing the vendor's responsibility in responding to identi-fled enforcement items relating to:

9

-(1) Correction of the identified deviation.

I (2) Action to be Laplemented to prevent recurrence.

(3) The dates when (1) and (2) above will be implemented or E completed.

4 r-e'

4 e.

Explaining the.t all reports and communications are placed in the Public Document Room.

f.

Explaining the publication and function of the Licensee Con-tractor and Vendor Inspection Status Report, NUREG-0040.

3.

Findings The supplier is a fabricator of generator control panels.

Currently, they have three (3) purchase orders to provide hardware for commercial nuclear generating stations; however, no work was in process on these orders during the course of this inspection.

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-a.

ment was safety related and 10 CFR 21 had been invoked:

(1) De Laval Engine and Compressor Division Purchase Order No. 59008, dated April 7, 1976, attendant changes and specifications, (2) De Laval Engine and Compressor Division Purchase Order No. 86934, dated September 29, 1978, attendant changes and specifications, and (3) Bechtel Power Corporation Purchase Order No. 9645-E-021.0 dated October 3, 1974,-attendant changes and specifications.

b.

Discussion with the cognizant individual regarding contractual requirements and established procedures for implementing 10 CFR 21.

3.

Findings The Purchase' Orders identified above (C.2.a), involved safety related equipment and invoked 10 CFR Part 21.

1

5 a.

Violation From Commitment See Notice of Violation.

b.

Unresolved Item None.

D.

Quality Assurance Progrsa 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 Laplemented.

2.

Methods of Accomplishment The preceding objectives were accomplished by:

Review of the following customer orders to verify that a a.

quality assurance program had been invoked:

(1) De Laval Engine and Compressor Division Purchase Order No. 59008, dated April 7, 1976, attendant changes and specifications, (2) De Laval Engine and Compressor Division Purchase Order No. 86934, dated September 29, 1978, attendant changes and specifications, and (3) Bechtel Power Corporation Purchase Order No. 9645-E-021.0, dated October 3, 1974, attendant changes and specifications.

-b.

Review of-Sections 4.0, 7.0, 12.0, 16.0, and 18.0 of the Quality Assurance Manual, Revision E, dated February 1980, 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: Procurement Document Control; Control of Purchased Material, Equipment, and Services; Control of Measuring and Test Equipment; Corrective Action; and Audits.

3.

Findings The Purchase Orders identified above (D.2.a), required establishment 4

6 and Laplementation of a QA program that satisfied 10 CFR 50, Appendix B or ANSI N45.2 -1971.

.a.

Deviation From Commitment

.None.

b.

Unresolved Items (1) Paragraph 12.2 of the Quality Assurance Manual, Revision E, dated February 1980, indicates that production test equipment is calibrated at six (6) months intervals.

The majority of the test equipment is other than production test equipment; i.e.,

it is used by the Test Department.

However, the Quality Assurance Manual is silent regarding the calibration interval of test equipment used by the Test Department.

The contractor should specify, in the QA Manual, the cali-bration interval of test equipment used by the Test Depart-ment.

(2) Section 18.0 of the QA Manual, Revision E, dated February 1980, states that " Audits shall cover at least.

Finished product quality... Special manufacturing pro-cesses... Inspection and test procedures...."

The NRC inspector observed that the Audit Log and Audit Reports did.not contain such subjects. The Log and Reports are aligned to the eighteen (18) criteria of Appendix B to 10 CFR 50.

The contractor should take the steps necessary to effect agreement between his procedure and his practice.

E.

Change Control

1. - Objectives

.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 included provisions for review, approval, and distribution to and usage at the location'where the prescribed activity is performed.

An addi-tional phase was to verify the measures had been implemented.

2.

Methods of Accomplishment s

The preceding ' objectives were accomplished by:

i

7 Review of the following customer orders to verify that document a.

control; and nonconforming materials, parts, or components requirements had been invoked:

(1) De Iaval Engine' and Compressor Division Purchase Order No. 59008, dated April 7, 1976, attendant changes and specifications, (2) De Laval Engine and Compressor Division Purchase Order No. 86934, dated September 29, 1978, attendant changes and specifications, and (3) Bechtel Power Corporation Purchase Order No. 9645-E-021.0, dated October 3, 1974, attendant changes and specifications.

b.

Review of Sections 3.0, 6.0, and 15.0 of the QA Manual, Revision E, dated February 1980, to verify measures had been established to control changes to softwara and hardware.

c.

Review of the following to verify that the measures had been implemented:

-(1) Drawing No. D52986 - Sheet No. 1, Revision No. 6, dated January 14, 1980; and Revision No. 5, dated October 30, 1979.

Sheet No. 2, Revision No. 4, dated October 30, 1979; and Revision No. 5, dated January 14, 1980. Sheet No. 4, Revision No. 4, dated October 30, 1979; and Revision No. 5, dated January 14, 1980.

(2) Material Summary No. B52986 Sheet No. 1, Revision No. 3, dated October 26, 1979; and Revision No. 4, dated January 14, 1980.

(3) Drawing No. D10325 - Sheet No. 2, Revision No. 2, dated July 11, 1979; and Revision No. 3, dated January 18, 1980.

Sheet No. 3, kevision No. 2, dated July 11, 1979; and Revision 3, dated January 18, 1980.

(4) Material Summary No. B10325 Sheet No. 1, Revision No. 1, dated July 5, 1979; and Revision No. 2, dated January 18, 1980.

Review of the foregoing also included review of respective Drawing Review and Transmittal Forms (QC15) to verify review by Engineering and Quality Assurance Personnel.

i l

l V

.j

8 3.

Findings The Purchase Orders-identified above (E.2.a), required establishmens and implementation of measures for document control; and nonconforming

~

materials, parts, or components.

a.

-Deviation From Commitment See Notice of Deviation, Item A.

b.

Unresolved Items None.

F.

Manufacturing Process Control 1.

Objectives The objectives of this area of the inspection were to verify that

.measu-been established and docmnented to control manufacturing,

'-d insp

..J test activities. Also, to verify these activities had. e accomplished in accordance with the established and docu-mented measures. Additionally, verification of indication of manda-tory hold points in appropriate documents.

2.

Methods of Accomplishment

.The preceding objectives were accomplished by:

a, Review of the following customer orders to verify instructions,

-procedures, and drawings; control of special processes; inspec-tion; test control; and inspection, test, and operating status had been-invoked:

(1) De Laval Engins and Compressor Division Purchase Order No. 59008, dated April 7,1976, attendant changes and specifications, (2) De Laval Engine and Compressor Division Purchase Order No. 86934, dated September 29, 1978, attendant changes and specifications, and (3) Bechtel Power Corporation Purchase Order No. 9645-E-021.0, dated October 3,1974, attendant changes and specifications.

b.

Review of Sections 5.0, 9.0, 10.0, 11.0, and 14.0 of the QA Manual, Revision E, dated February 1980 to verify measures had l

l l

e

~

9 been established and documented to control manufacturing, inspection and test activities.

c.

Review of the completed data package for Bechtel Power Corpo-ration Purchase Order No. 9645-E-021.0 (Sales Order No. 49788) to verify tasks had been accomplished in accordance with docu-mented manufacturing, inspection, and test requirements.

d.

Cursory review of manufacturing activities to verify tasks were accomplished in accordance with documented instructiens, pro-cedures, or drawings.

3.

Findings The Purchase Orders identified above (F.2.a.), required establishment and Laplementation of controls for instructions, procedures, and drawings; special processes; inspection; tests; and inspection, test, and operating status.

No hardware was being fabricated for the identified 2urchase o ders.

r a.

Deviation From Commitment See Notice of Deviation, it,ne B.

b.

Unresolved Item Paragraph 10.2(a) of the QA Manual, Revision E, dated February 1980, identifies the In-Production Quality Check List as being used during manufacturing of nuclear jobs, t > reflect task accomplishment and inspection.

4 The NRC inspector observed that there were no documents identi-fled as, In-Production Quality Check Lists. He was informed that the documents referred to are identified as, In Process Inspection.

The contractor should take the steps necessary to effect agree-ment between the titles of the forms.

G.

Exit Interview

~

1.

The inspector met with management representatives denoted in para-graph A. above at the conclusion of the inspection on February 21, 1980.

i '

o

10 2.

The following subjects were discussed:

a.

Areas inspected.

b.

Violation identified.

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 devi-ation.

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.

I

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