ML20148K443
| ML20148K443 | |
| Person / Time | |
|---|---|
| Issue date: | 08/14/1978 |
| From: | Agee J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | |
| Shared Package | |
| ML20148K407 | List: |
| References | |
| REF-QA-99900279 44075, NUDOCS 7811170156 | |
| Download: ML20148K443 (11) | |
Text
o-G VENDOR INSPECTION REPORT U. S. NUCLEAR REGULATORY COMMISSION OFFICE OF INSPECTION AND ENFORCEMENT REGION IV Report No. 99900279/78-01 Program No. 44075 Company: Gould, Incorporated Electrical Apparatus Division 2002 Bethel Road Finksburg, Maryland 21048 Inspection Conducted: June 27-29,1978 N'l )
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$'[/0/78 Inspector:
' 04te m J. R. Agee, Contractor Inspector, Vendor c
l Inspection Branch
'I Approved by:
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EcuW-f!/b[78 D. M. Hunnicutt, Chief, Components
/ Date i
Section II, Vendor Inspection Branch Sumary Inspection on June 27-29,1978(99900279/78-01)
Areas Inspected:
Implementation of the Quality Assurance (QA) Program including the following areas: action on previous inspection findings; internal audits; vendor audits; procurement document control; quality assurance records; control of test and measuring equipment; design and document contol. The inspection involved twenty-four (24) inspector l
hours on site by one (1) NRC inspector.
Results:
In the six (6) areas inspected, no apparent deviations were found in three (3) areas, while two (2) unresolved items and two (2) deviations were identified in the remaining areas.
Deviations: Quality Assurance Records - contract documents were filed in an open area in non-fireproof cabinets (Enclosure, Item A.);
Control of Test and Measuring Equipment - certain equipment marked "Out of Service" with no identification or calibration sticker attached, was stored intenningled with properly calibrated and useable test equipment (Enclosure, Item B.).
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Unresolved Items: Control of Test and Measuring Equipment (Details Section, paragr ph G.3.b.);; Design and Document Control (Details Section, paragraph
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. i DETAILS SECTION A.
Persons Contacted M. M. Finneteau, Engineering Supervisor, Systems P. M. Higgins, Development Engineer, Circuit Protection Division W. G. Long, Operation Manager D. A. Sorflaten, Buyer
- R. P. Walthen, Jr., Manager, Quality Assurance
- Attended exit interview.
B.
Action on Previous Inspection Findings (Closed) Unresolved Item (Report 77-01): Revision of the Quality Assurance Manual. The inspector verified that the QA Manual had been revised as Revision 3, dated July 22, 1977.
(Closed) Unresolved Item (Report 77-01): Equipment had been certified to a " general position" relative to compliance to IEEE-323. The inspector verified that a formal review and approval of documents which require the application of specific codes, standards, and QA i
requirements to a specific checklist is completed prior to initiation of production. Certification to compliance to applicable codes and standards are supplied upon customer request.
C.
Internal Audits 1.
The objectives of this area of the inspection were to verify that:
a.
Procedures or policy documents clearly identify organiza-tions responsible for audits and define their responsibil-ities and authorities.
b.
Measures have been established to assure that auditors are independent of any direct responsibility for perform-ance of activities which they are auditing and that persons having direct responsibility for performance of the activities being audited are not involved in the selection of the audit team.
c.
All auditing personnel including technical specialists are required to receive appropriate training or orientation to develop their competence for performing required audits.
. d.
Guidelines and requirements are established for audit scheduling and that they take into consideration the status and importance of the activities to be audited.
e.
Sufficient instructions or guidance ^ are available to the auditors in the form of checklists or procedures to per-form the audits effectively and in accordance with the audit plan, f.
Deficiencies identified by the audits are closed out by appropriate corrective action and timely follow-up i-including reaudit of deficient areas.
g.
Audit records are collected, stored and maintained in accordance with applicable code and contract requirements.
2.
Method of Accomolishment I
The preceding objectives were accomplished by:
a.
Review of the Quality Assurance Manual,Section XVIII, Audits, Revision 3 (July 22, 1977).
b.
Review of Quality Assurance Procedure (QAP) 18.3, Auditor Qualification and Training.
c.
Review of 1977 internal audit reports, d.
Discussions with technical and management personnel con-cerning audit personnel, e.
Review of 1978 Master Audit Schedule.
3.
Findings Within this area of the inspection, no deviations or unresolved items were identified.
j D.
Vendor Audits 1.
Objectives The objectives of this area of the inspection were to verify that:
. a.
Written procedures for this activity are available and in use.
b.
Evaluations were performed prior to award of contracts and at the specified frequency.
c.-
Sufficient instructions or guidance is available to the auditors in the form of checklists or procedures to per-L form the audits effectively and in accordance with the g
audit plan.
a 2.
Method of Accomplishment y
'i The preceding objectives were accomplished by:
a.
Discussions with quality assurance management personnel.
b.
Review of Cur.ent List of Approved Vendors (Nuclear Class IE items) dated May 20, 1978.
c.
Review of QAP No. 7.1, Control of Purchased Material, Equipment and Services - Vendor Selection and Control, Revision 4 April 14,1978.
i d.
Review of random selection of purchase orders to suppliers of products for use in Class IE equipment.
3.
Findings Within this area of the inspection, no deviations or unresolved items were identified.
E.
Procurement Document Control 1.
Objectives '
The objectives of this area of the inspection were to verify that:
a.
Measures had been established and documented to assure that the applicable regulatory requirements, design bases, and
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other requirements necessary to assure adequate quality had been included or referenced in the documents for pro-curement of items and services.
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b.:
Changes-in procurement' documents had been subjected to the same degree of control utilized in orgination.
c.
- Procurement documents required contractors lto provide a quality assurance program consistent with customer requirements.:
j d.
Procurement documents included provisions for the following,
- as. applicable:
(1). Supplier Quality Assurance Program, (2) Basic Technical Requirements.
(3) Source Inspection and Audit.
(4) Documentation Requirements, o
(5) Lower Tier Procurements.
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Method of Accomplishment i
The preceding objectives were accomplished by:
a.-
Review of the Quality Assurance Manual, Section:IV, Procure-ment Document Control,. dated July 22, 1977.,
b.
QAP 4.1, Procurement Document'. Control, dated July 1 1978.
c.
Review of Current List of Approved Vendors, dated May 20, 1978.
d.
Review of forty '(40)' randomly selected Nuclear Purchase Orders.
.t e.
ReviewofCustomerSpecification10466-E-018(Q), dated December 2, 1976.
f.
Interviews with cognizant personnel.-
3.
Findings Within this area of the inspection, no 'devia'tions or unresolved items were identifies.-
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. F.
Quality Assurance Records 1.
Obj ectives The objectives of this area of the inspection were to verify that:
a.
Records are prepared and completed at the time verification work and activities are perfonned.
b.
Records are filed and maintained in facilities that provide adequate protection.
c.
Inspection and test records identify sufficient data for indexing and filing to provide retrievability.
d.
QA records are filed and maintained in such a manner that the docunents are identifiable, retrievable, and deterior-ation of damages are minimized.
2.
Method of Accomplishment The preceding objectives were accomplished by:
a.
Review of the QA Meanal,Section XVII, Quality Assurance Records, Revision 3, dated July 22, 1977.
b.
Inspectionofrecordsstorageattwo(2)separatelocations, namely, (1) Electrical Apparatus Division Building and (2)
Circuit' Protection Division Building.
c.-
Discussions with QA, R&D Engineering and Systems Engineering personnel.
3.
Findings a.
Deviations See Enclosure, Item A.
b.
Unresolved Items None.
I.
G.
Control of Test & Measuring Equipment j
1.
Obj ectives The objectives of this area of the inspection were to verify that:
1 a.
A system has been established and is maintained to assure that tools, gages,-instruments and o!.her measuring devices used in activities affecting quality are properly controlled, calibrated and adjusted at specified psrfods te maintain accuracy within specified limits, b.
Calibration records are kept for each instrument and that these records include the following information:
(1) Calibration history.
(2) Accuracy required and calibration results.
(3) Location for use.
(4) Present calibration interval and date due.
(5) All. maintenance and repair details.
(6) Persons or' agency performing all calibration.
(7) Serial number or identification of each standard used to perform the calibration.
(8) Number or name of the calibration procedure.
(9) Environmental conditions used during calibration.
(10) Equipment recall schedules.
2.
Method of Accomplishment The preceding objectives were accomp1f,ned by:
a.
Review of the QA Manual,Section XII, Control of Measuring l
and Test Equipment, Revision 3. July 22, 1977.
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b.
Review of the Kardex File Card System.
c.
Verification of calibration status of randomly selected outside micrometers, calipers, master blocks, depth micro-meters, and inside micrometers.
d.
Inspection of the storage cabinets in the mechanical L
calibration laboratory.
e.
Inspection of the multi-purpose final inspection test panels at the final inspection test stations.
3.
Findings a.
Deviations See Enclosure, Item B.
b.
Unresolved Item The electrical test and calibration laboratory is located in the Circuit Protection Division Building.
Due to recent corporate organizational changes this now places the electri-cal test and calibrated laboratory in a separate cost center.
Pending corporate decisions regarding the location of the laboratory, additional inspection and test QA procedures will be required to be implemented.
H.
Design and Document Control 1.
Objectives The objectives of this area of the inspection were to:
a.
Verify that the overall designs, including calculations, material selection, stress analysis reports, are reviewed for compliance with the design specification and code requi rements.
b.
Verify that the reviews and checking of the design Scu-ments are perfonned by qualified personnel other than those responsible for the original, c.
Verify the avisions, changes, and/w addenda to design
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documents ai reviewed in the same manner as the origin 1,
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Verify that the. reviews and checks of design documents are appropriately documented in a manner that is auditable.
e.
Verify that procedures are implemented for the review, approval, release and distribution of design documents including changes thereto, by participating design organi-zations.
f.
Verify that measures established require that any deviations from the design document identified by qualification testing
' be reported to the responsible design organization and the customer for review, evaluation and appropriate disposition.
2.
Method of Accomplishment The preceding objectives were accomplished by:
a.
Review of the QA Manual,Section III, Revision 3, dated July 22, 1977.
b.
Review of the Customer Specification 10466-E-018(Q),
Revision 8 (March 29,1978)' and Purchase Order No.
10466-E-018-5(December 20,1977) for low and medium voltage motor control centers (MCC's).
c.
Interviews with contract and R&D engineering personnel.
d.
Review of Supplier Deviation Disposition Request for P.O.
No.10466-E-018-2, dated January 27, 1978.
e.
Review of Seismic Certification Report for Class IE Electrical Equipment, SC-147, Revision 3, May 2,1978.
3.
Findinas a.
Deviations None.
b.
Unresolved Items A customer for low and medium voltage MCC's has agreed to accept shipment of unqualified equipment, pending satis-factory completion of qualification testing of similar U
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prototype equipnent for which certified documentation will be provided. Verification of completion of the qualifica-tion test program and issuance of the certified test reports.
I.
Exit Interview The inspector met with the Quality Assurance Manager (denoted in paragraph A.) at the conclusion of the inspec< Jn on June 29, 1978, at the Finksburg, Maryland, Plant. The inspector summarized the scope of the inspection and identified the findings. On June 28, 1978, the inspector met with the Current Operation Manager and dis-cussed the status of the inspection. Management acknowledged the statements by the inspector with respect to the inspection findings.
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