ML19250C580
| ML19250C580 | |
| Person / Time | |
|---|---|
| Issue date: | 06/25/1979 |
| From: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | |
| Shared Package | |
| ML19250C574 | List: |
| References | |
| REF-QA-99900366 99900366-79-1, NUDOCS 7911280391 | |
| Download: ML19250C580 (9) | |
Text
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ESB Incorporated - Exide Power Conversion Division Docket No.
99900366/79-01 NOTICE OF DEVIATION Based on the results of an NRC inspection conducted on June 11-14, 1979, it appeared that certain of your activities were not conducted in full accordance with NRC requirements as indicated belo..:
A.
Criterion VI of Appendix B to 10 CFR 50, states in part, " Measures shall be established to control the issuance of documents, such as instructions, procedures and drawings, including 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 and are distributed to and used at the location where the prescribed activity is performed."
Paragraph 6.4.3.3 of the Quality Control Procedures Manual, Revision D, dated April 8, 1977, states in part, " Marked Prints....The marked document shall contain the required information of the change, the signature of the Engineer making the change, the signature of the Inspection Supervisor, and the date. Marked drawings and documents shall be valid for a maximum of two weeks after which a CN or drawing change must be issued."
Contrary to'the above:
1.
A Change Notice (CN) or drawing change had not been issued for changes made on April 6, 1979, and May 9, 1979, to Dwg. No.
110603071, Revision A, dated August 25, 1978.
(This drawing was in use by personnel performing assembly of Silicon Controlled Rectifier Legs.)
2.
Each change was accompanied by only one set of initials.
B.
Criterion XV of Appendix B to 10 CPR 50, states in part " Measures shall be established to control materials, parts, or components which do not. conform to requirements in order to prevent their inadvertent use or installation.... Nonconforming items shall be reviewed and accepted, rejected, repaired or reworked in accordance with documented procedures."
Paragraph 7.3.1 of the Quality Control Procedures Manr.al, Revision D, dated April 8, 1977, states in part, "The DC0 has no authority to ' Accept as is' without explicit Engineering and Quality approval."
Contrary to the above, rejected material identified by the follow-ing Rejected Material tags was identified as, " Accept" (use as is) 1406 0159 791128039/
without explicit Engineering approval.
Tag Serial Numbers Disposition Verified Date 6225 April 24, 1979 6286 May 16, 1979 5735 January 23, 1979 5739 February 5,1978(s/b 1979) 6220 May 24, 1979 6255 May 7, 1979 6236 April 16, 1979 o
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DETAILS SECTION A.
Persons Contacted J. P. Alibrandi, Market Manager-UPS
- W. W. Campbell, Director-Engineering
- J. W. Finnegan, Manager-Quality Assurance P. Griffin, Assistant-Employee Relations R. Homolya, Engineer-Senior Project P. G. Pearson, Technician-Calibration I. J. Stone, Manager-Engineering Records
- 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.
Methods of Accomplishment The preceding objectives were accomplished by:
a.
Describing the historical events that indicated the need for the Vendor Inspection Program (VIP).
b.
Explaining the inspection base and how the inspections are conducted.
c.
Describing how inspection results are documented and how proprietary 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:
.e (1) Correction of the identified deviation.
(2) Action to be implemented to prevent recurrence.
(3) The dates when (1) and (2) above will be implemented or completed.
I406 061 e.
Explaining that all reports and communications are placed in the Public Document Room (PDR).
f.
Explaining the publication and function of the
" White Book."
3.
Findings The inspector was informed that hardware destined for nuclear power plant application amounted to one to two percent.
C.
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.
Flethods of Accomplishment The preceding objectives were accomplished by:
a.
Review of the following documents to verify the program had been documented by written policies, procedures, or instructions:
(1) Quality Control Procedures ?!anual, Revision D, dated April 8, 1977; Sections 4 and 5.
(2) Quality Control Procedures, Numbers 112A, dated April 11, 1978; 112B, dated April 12, 1978; 109, dated February 7, 1977.
b.
Review of hardware covered by the program to verify identification had been established.
c.
Review of the following activities to verify the program had been implemented: Control of Purchased flaterial, Equipment, and Services; Control of ?!easuring and Test Equipment; Audits; and Control of Special Processes.
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. 3.
Findings Within this area of the inspection, no deviations or unre-solved items were identified.
Customer orders require cabinets that have been seismically qualified and this hardware is purchased by the Power Con-version Division.
Consequently, the Power Conversion Di-vision's Quality Assurance Program identifies Control of Special Processes as not applicable.
D.
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 documented measures. Additionally, verification of indication of mandatory hold points in ap-propriate documents.
2.
Methods of Accomplishment The preceding objectives were accomplished by:
Review of the following documents to verify measures had a.
been established and documented to control manufacturing, inspection and test activities:
(1) Quality Control Procedures Manual, Revision D, dated April 8, 1977, paragraph 2.5; and Section III.
(2) Manufacturing Policy and Procedures No. 3.21, undated.
(3) Quality Control Procedures, Nos. 119, dated No-vember 8, 1978; 117, dated September 14, 1977; and 106 dated November 30, 1976.
(4) Quality Characteristics List, Nos. 701.1, dated March 9, 1976; 701, dated February 19, 1976; 702, dated February 19, 1976; 703, dated February 19, 1976; 1181.1 dated h vember 6, 1975; 1181.2 dated November 6, 1975; 1800.1 dated February 10, 1976; 1800.2, dated February 11, 1976.
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. b.
Review of the following activities and attendant documents to verify task accomplishment in accordance with established and documented measures:
(1) Printed Circuit Board Assembly and Drawing No.
110073078, Revision G, dated January 3, 1978.
(2) Silicon Controlled Rectifier Assembly and Drawing NO. 110603071, Revision A, dated August 25, 1978.
(3) Gate Timing No. 2 Module Test and Engineering Bulletin No. ET504.
3.
Findings Within this area of the inspection, no deviations or unre-solved items were identified.
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 additional phase was to verify the measures had been implemented.
2.
Methods of Accomplishment The preceding objectives were accomplished by:
a.
Review of the following documents to verify measures had been established to control changes to software and hardware:
(1) Quality Control Procedures Manual, Revision D, dated April 8, 1977, paragraphs 5.5; 6.0-6.4.3; and Section VII.
(2) Standard Practice Instruction No 324.1, dated April 17, 1972.
1406 064
- (3) Quality Control Procedure No. 107, dated January 27, 1977.
(4) Engineering Documentation Control Manual No. 164105001, Revision A, dated August 10, 1973, paragraphs 4.5 and 5.2.3.
(5) Manufacturing Policy and Procedures, Nos. 3.7, dated January 1, 1976; and 3.8, dated February 9, 1976.
(6) Nuclear Design Procedures Manual, dated September 12, 1978, paragraphs 3.2.2 and 3.3.
b.
Review of files located at three (3) area inspector stations to verify engineering documents had been distributed.
c.
Review of marked drawing 110603071, Revision A, dated August 25, 1978 to verify implementation of control measures.
3.
Findings a.
Deviations from Commitment (1) See Notice of Deviation, Item A.
(2)
See Notice of Deviation, Item B.
b.
Unresolved Item The inspector was unable to determine that distribution of Change Notices (CN) and retrieval of obsolete drawings by Quality Control had been conducted in accordance with Quality Control Procedure No. 107 because there was no list to indicate to whom CNs and drawings were distributed and when, and no log that identified returned drawings.
F.
Organization 1.
Objectives The objectives of this area of the inspection were to veri-fy that authority and duties of persons and organizations performing activities affecting safety-related functions (achievers and verifiers) had been clearly established and 1406 065
. delineated in writing. Also, to verify that performers of the quality assurance functions had sufficient authority and freedom to identify quality problems; to initiate, recommend or provide solutions; and to verify implementation of solutions.
Further, the individual (s) responsible for assuring effective execution of any portion of the quality assurance program had direct access to such levels of man,agement necessary to perform this function.
2.
Methods of Accomplishment The preceding objectives were accomplished by:
a.
Review of the following documents to verify authority and duties of persons and organizations had been clearly established and delineated in writing:
(1) Quality Control Procedures Manual, Revision D, dated April 8,1977,Section I.
(2) Manufacturing Policy and Procedures, Numbers 1.1, Effective Date (ED) September 22, 1975; and 1.2, ED September 22, 1975.
(3) Job Descriptions for: Toolmaker; Electrician; Tester; Metal Shop Mechanic; Quality Control Engineer; Product Engineer; and Project Engineer.
(4) Nuclear Design Procedures Manual, dated September 12, 1978, Section 1.
b.
Review of the following Rejected Material tags to verify performers of the quality assurance functions had suf-ficient authority and freedom to identify quality problems; initiate, recommend or provide solutions and to verify implementation of solutions: Nos.5764, dated February 26, 1979; 3742, dated January 12, 1978; 6248, dated April 23, 1979; and 5717, dated November 9, 1978.
3.
Findings Within this area of the inspection, no deviations or unresolved items were identified.
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. G.
Exit Interview 1.
The inspector met with management representatives denoted in paragraph A. at the conclusion of the inspection on June 14, 1979.
2.
The following subjects were discussed:
a.
Areas inspected.
b.
Deviations identified.
c.
Unresolved item 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 deviation. Additio o'ly, management repre-sentatives were requested to notify
."e Commission in writing if dates require adjustment, commitments require modification,etc.
3.
Management representatives acknowledged the comments made by the inspector.
W