ML19343A498
| ML19343A498 | |
| Person / Time | |
|---|---|
| Issue date: | 07/25/1980 |
| From: | Hunter V, Whitesell D NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | |
| Shared Package | |
| ML19343A490 | List: |
| References | |
| REF-QA-99900321 NUDOCS 8009180085 | |
| Download: ML19343A498 (5) | |
Text
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U. S. NUCLEAR REGULATORY COMMISSION OFFICE OF INSPECTION AND ENFORCEMENT REGION IV Report No.
99900321/80-01 Program No. 51300 Company:
AMETEK Incorporated Straza Division 790 Greenfield Drive El Cajon, California 92021 Inspection conducted: July 7-10, 1980 Inspectors:
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V."lC Hunter, Date Vendor Inspection Branch Observer:
j X 8b F. Visco,
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Date PAEC, Philippines M
7.2g-/d Approved o.
1 D. E. Whitesell, Date Vendor Inspection Branch Summary Inspection on July 7-10, 1980 (9990032/80-01)
Areas Inspected:
Inplementation of 10 CFR 50, Appendix B Criteria and applicable Codes and standards including Records Control, Audits, Calibration, and documenta-tion Control.
The inspection involved twenty nine (29) inspector hours on site.
Results:
In the four (4) areas inspected, there were no deviations or unresolved items identified in three (3) areas. The following two (2) deviations were identified in the remaining area.
Deviations - Calibration Control:
Contrary to the requirements of Criterion V of Appendix B to 10 CFR 50 and Section 15.0 of the ASME accepted QA Manual,
- 1) The QA Manager does not maintain a calibration log and 2) hand ton 1 with j
S/N 15 was overdue for calibration.
(Notice of Deviation, items A and B) l 80091800%5 y,,,._
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2 DETAILS SECTION 4
A.
Principal Persons Contacted
+
- H. W. Krickhol, Vice President - Operations R. E. Davis, Vice President - Mechanical Products
- L. R. Ferguson, Directe2 - Quality Assurance
- M. E. Brown, Quality Assurance Manager J. M. Wilkins, NDE Supervisor j
G. F. Anderson, Calibration Inspector j
A. J. Russo, Supervisor - Document Control 4
R. E. Fisher, Nuclear Quality Engineer Also in attendance, as an observer, was P. G. Wisco, Nuclear Technologist representing PAEC, Philippines.
l
- Denotes those present at the exit meeting.
l B.
Quality Assurance Records 1.
Inspection Objectives The objectives of the inspection were to verify that quality assurance records were maintained for fabrication, manufacturing, or installation
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'and provide traceability, and the records contained as a minimum docu-3 ments pertaining to materials manufacturing, examination and test data, procedures, drawings and Stress Report, qualification of personnel, procedures and equipment, and these records are maintained in a manner that allows ready access.
2.
Method of Accomplishment The preceding objectives were accomplished by:
Review of Section 17.0 of the ASME accepted QA Manual.
a.
b.
Review of selective QC plans and checklists.
c.
Review of completed data packages for required records.
d.
Interviews with technical and management personnel.
3.
Inspection Results I
There were no deviations or unresolved items identified.
C.
Audit Control 1.
Objectives I
.I 3
The objectives of this area of the inspection were to verify that i
procedures had been prepared and approved by the vendor that pre-scribed a system for auditing which is consistent with the commit-ments of the ASME accepted Quality Assurance Manual.
Also, verify i
that these audit procedures were being properly and effectively implemented by the vendor.
2.
Method of Accomplishment The objectives of this area of the inspection were accomplished by:
a.
Review of the ASME accepted Quality Assurance Manual, Section 14.0, titled " Audits" to verify that procedures had been estab-lished to prescribe a system for auditing.
b.
Review of the following documents:
1 (1) Current audit check list (2) Current audit schedule (3) Audit personnel qualifications to verify that they had been prepared by the designated authority, approved by management, and reviewed by quality assurance.
Review of selective audit reports to verify that they identify c.
the written plan, team selection, team orientation, audit notification, pre-audit conference, audit performance, and post-audit conference.
d.
Review of randomly selected audit reports to verify that the distribution to management, and the audited organization, and a
i follow-up regarding corrective action had been accomplished.
Review of internal and external audit reports to verify that e.
the applicable procedures were available to the' audit team j
personnel, and that the audit procedures were properiy and effectively implemented.
3.
Findings There were no deviations or unresolved items identified.
D.
Calibration 1.
Inspection Objectives
- The objectives of this inspection were to:
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4 a.
Ascertain that a system has been established and is maintained to assure that tools, gages, instruments and other measuring devices used in activities affecting quality are properly con-trolled, calibrated and adjusted at specified periods to maintain accuracy with specified limits.
b.
Verify that the system described in (1) above, has been adequately documented with approved precedures and that these procedures are being implemented.
2.
Objectives Accomplished by:
Review of Section 15.0 of the ASME accepted QA Manual.
a.
b.
Review of calibration master file.
c.
Review of identifying codes and tool recall system.
d.
Visual observation of calibrated tools and gages in all major work stations.
Interviews with cognizant technical and management personnel.
e.
3.
Inspection Findings a.
Deviations See Notice of Deviation, items A and B b.
Unresolved Items None were identified.
E.
Design Document Control 1.
Objectives The objectives of this area of the inspection were to ascertain whether procedures had been developed and properly implemented to control the review, approval, release and issuance, of design documents in a manner consistent with NRC rules and regulations, and the vendor's commitments, in the ASME accepted Quality Assurance Program.
2.
, Method of Accomplishment The objectives of this area of the inspection were accomplished by:
a.
Review of the ASME accepted QA Manual, Section 4.0 titled
" Document Control" o
5 to verify that the vendor had established procedures to prescribe a system for design document control.
b.
Reviewed these selective documents:
(1) Procedure No. 8-530270 (2) Welding specification No. NUC-167 (3) Drawing No. 7-050363 (4) X-Ray Specification No. 180-01 to verify that they had been prepared by the designated authority, approved by management, and reviewed by QA.
c.
Review of design specification number 8-500009, revision B, to verify that it provided for identification of personnel respon-sible for preparing, reviewing, approving, and issuing design documents; and that the review and approval of significant changes were performed by the same personnel.
Also to ascertain whether minor changes to design documents, that do not require review and approval, are identified.
d.
Review of twelve (12) shop travelers, to verify that the distri-bution lists are current and that the proper documents are identified, accessible, and are being used.
Interviewed personnel to verify whether they were knowledgeable e.
in the procedures applicable to design document control.
3.
Inspection Findings No deviations or unresolved items were identified.
F.
Exit Interview The inspector met with management representatives at the conclusion of the inspection ca July 10, 1980.
The inspector summerized the scope and findings identified during the inspection.
Management ackownledged the inspector's comments regarding the scope and findings as presented.
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