ML20004E387

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QA Program Insp Rept 99900529/81-01 on 810209-12.No Noncompliance Noted.Major Areas Inspected:Design Process Mgt,Design insp-control of Computer Programs,Technical Personnel Background Verification & Design Change Control
ML20004E387
Person / Time
Issue date: 03/12/1981
From: Breaux D, Brickley R, Hale C
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV)
To:
Shared Package
ML20004E380 List:
References
REF-QA-99900529 NUDOCS 8106120119
Download: ML20004E387 (18)


Text

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O U.S. NUCLEAR REGULATORY COMMISSION OFFICE OF INSPECTION AND ENFORCEMENT REGION IV Report No. 99900529/81-01 Company:

Reactor Controls, Inc.

1245 South Winchester Blvd.

San Jose, California 94070 Inspection Conducted:

February 9-12, 1981 Inspectors:

/C M N 3/!7/

R. H. Brickley, Contr Q r Inspector

'Date Reactor Systems Section Vendor Inspection Branch

3. G, W

3/It[8]

0. G. Breaux, Inspector Date Reactor Systems Section Vendor Inspection Branch 5

l)

S'/M I r

j C. J. y LChief Date Reactor Systems Section Vendor Inspection Branch Approved by:

Q C.J.H7e Chier Date Reactor s = ems Section Vendor Inspection Branch Summary Inspection on February 9-12, 1981 (99900529/81-01)

Areas Inscected:

10 CFR Part 50, Appendix B in the areas of initial management meeting, cesign process management, design inspection-control of computer programs, technical personnel background verification, design change control, design inter-faces, and audits.

The inspection involved 61 inspector nours on site by three NRC inspectors.

Results:

There were no nonconformances or unresolved items icentified.

810612016

2 DETAILS SECTION I (Prepared by R. H. Brickley and C. J. Hale)

I A.

Persons Contacted

  • R. K. Crum, Quality Assurance Manager
  • J.

C. Millett, Vice President

  • G. Secchi, Engineering and Construction Manager
  • A. W. Vonstockhausen, Stress Analysis Manager
  • De' les attendance at the exit interview.

B.

Initial Management Meeting 1.

Objectives The objectives of this meeting were to acquaint management of Reactor Controls, Inc. with the following:

a.

The Licensee Contractor Vendor Inspection Program. (LCVIP).

b.

NRC organization relative to the Vendor Inspection Branch.

c.

Implementation of the LCVIP.

d.

Types of documents generated and processed in implementing the LCVIP.

2.

Meeting Results The preceding objectives were accomplished during a meeting on February 9, 1981.

Those individuals present at that meeting in addition to the inspection team, were:

R. K. Crum. Quality Assurance Manager J. C. Millett, Vice President J. C. Murray, Engineering and Construction Manager G. Secchi, Engineering and Construction Manager R. C. Weitenstein, Engineering and Construction Manager The following is a summary of the presentation made curing tnis meeting.

The presentation was made by Mr. C. J. Hale.

a.

The general LCVIP was described and how the Vendor Inspection Branch (VIB) organizationally interfaces with the Office of Inspection and Enforcement (IE) and the regional offices.

3 b.

The three phases of our inspection program were described and the three components of our inspections, i.e. programmatic, technical, and reactive.

The basis of our inspections was identified as 10 CFR Part 50, Apperfix B, as implemented by topical QA programs or SARs and 10 UR Part 21.

c.

The documentation and records generated and processed as a result of our program were described, and incit Je:

(1) Reports resulting from each inspection and issued within 30 days following the inspection; (2) Responses due from the inspected organization

  • Lnin 25 days of the date of issue of the Inspectica Report containing the results of their proprietary review, and responses to the inspection findings (nonconformances and violations) that include (1) actions taken to correct the identified problem (including the generic assessment of the problem), (2) action taken to prevent recurrence of the problem, and (3) the dates the corrective and pre-ventive actions were.or will be completed; (3) White Book - this publication is issued quarterly and summarizes the previous quarter's activities of the VIB; and (4)

IE Bulletins, Circulars, and Information Notices - these documents will be distributed as they are issued by IE.

d.

The Public Cocument Room (PDR) was described and RCI personnel were advised that all reports and correspondence relating to VIB activities will be placed in the POR.

e.

Mr. R. H. Brickley, was identified as the team leader for this inspection and any necessary follow up discussions.

C.

Background Information Reactor Controls. Inc.

l Reactor Controls, Inc. (RCI) is an organization consisting of about 100 employees, 30 of which are located in the home office and the remainder at various reactor construction sites.

Their activities have been concen-trated in two areas:

1.

Control Rod Drive Hydraulic System (CRDHS):

a.

Fabrication and installation of the system per the system design by the A&E.

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4 b.

Design, fabrication, and installation of piping supports, c.

Stress analysis of piping arrangements.

2.

Installation only of reactor pressure vessel (RPV) internal items designed, fabricated, and supplied by others.

RCI is currently performing work on Grand Gulf, Limerick, La Salle, Zimmer, Hartsville, Phipps Bend, Clinton, Nine Mile, and Hope Creek.

This work is being done under contracts with Bechtel, G.E., Niagara Mohawk, Illinois Power Co., TVA, and Commonwealth Edison.

RCI is currently a holder of Certificates of Authorization for NA

(#N-1300, expires January 5,1982) and NPT (#N-1299, expires January 5, 1982).

l Previous inspections of RCI conducted by the Licensee (Commonwealth Edison) and Region III personnel on April 1-2, 1980 (Report No. 50-373/80-02; 50-374/80-13), and November 5, 1980 (Report No. 50-373/80-48; 50-374/80-30),

indicated that their QA/QC program was inadequate and resulted in the issu-ence of a "stop work" order on the CROHS activities.

(Note:

Stop work l

orders are also in effect in the same area for Grand Gulf and Zimmer).

l A follow up inspection by the Licensee and Region III personnel on January 12-14, 1981 (Report No. 50-373/81-02; 50-374/81-02), revealed that RCI had revised existing procedures and developed new procedures to imple-ment the 18 criteria of 10 CFR Part 50, Appendix B; however, the new and revised procedures had not been issued at the time of that inspection.

Reportedly, these revised and new procedures reflected practices that had l

been followed by RCI; however, the procedures had not been formally docu-f mented.

(Note:

R. H. Brickley was present during the January 12-14, inspection).

As a result of the findings, Region III requested that the l

Vendor Inspection Branch conduct an inspection of RCI to verify implementa-tion of their quality assurance program for accomplishing safety related work.

D.

Design Process Management 1.

Objectives The objectives of this area of inspection were to examine the establishment and implementation of quality related procedures for the cesign process to verify that:

a.

The design process system is defined, implemented, and l

enforced in accordance with approved procedures, instruc-tions, or other documentation for all groups performing safety related design activities.

b.

Design inputs are properly prescribed and used for translation into specifications, drawings, instructions, or procedures.

l l

5 c.

Appropriate quality standards for items important to safety are identified, documented, and their selection reviewed and approved.

d.

Final design can be related to the design input with this traceability documentad, including the steps performed from design input to final design.

4 e.

Design activities are documented in sufficient detail to permit design verification and auditing.

f.

The methods are prescribed for preparing design analysis, drawings, specifications, and other design documents so that they are planned, controlled, and correctly performed.

2.

Method of Accomplishment The preceding objectives were accomplished by an examination of:

a.

The applicable sections of the RCI Quality Assurance Manual, Revision 4, dated October 31, 1980.

b.

The following Quality Assurance Instructions (QAI) to verify that the design process has been adequately described.

(1) QAI-1 (Organization) Revision 0, dated December 4, 1980.

(2) QAI-2-1 (Quality Assurance Program) Revision 0, dated December 4, 1980.

(3) QAI-3-1 (Interfaces Between Engineering and Stress Analysis) Revision 0, dated December 4, 1980.

(4) QAI-3-2 (Orawing Changes) Revision 0, dated December 4, 1980.

(5) QAI-3-3 (Subcontractor Design Drawing Review) Revision 0, dated December 4, 1980.

(6) QAI-3-4 (Stress Analysis Design Control) Revision 1, dated December 4, 1980.

(7) QAI-3-5 (Stress Analysis / Design Analysis) Revision 1, dated December 4, 1980.

(8) QAI-3-6 (Preparation, Review, Aoproval and Issuance of the Design Analysis Outline and Design Report) Revision 1, dated December 4, 1980.

6 (9) QAI-3-7 (Stress Analysis Design Change Control) Revision 1, December 4, 1980.

(10) QAI-3-8 (Stress Analysis Independent Design Review)

Revision 1, dated December 4, 1980.

(11) QAI-3-12 (Review of Design or Stress Analysis Reports Submitted by Vendors or Subcontractors) Revision 0, cated December 4, 1980.

(12) QAI-5-1 (Precedure Control) Revision 0, dated December 4, 1980.

(13) QAI-5-2 (Engineering Drawings & Engineering Change Notices)

Revision 0, dated December 4, 1980.

(14) QAI-6-1 (Document Control Headquarters) Revision 0, dated December 4, 1980.

(15) QAI-6-2 (ECCL Control) Revision 0, dated December 4, 1980.

(16) QAI-6-3 (Occument Transmittal for Approval) Revision 0, dated December 4, 1980.

c.

Commonwealth Edison Co. purchase order No. 194865 dated March 12, 1976, to RCI, and Sargent & Lundy specification No. J-2912 (Reactor Internals Installation and Control Rod Drive System Erection - La Salle County Station Units 1 and 2), Issue -

Revised CA, dated September 13, 1976, to determine RCI's contractural requirements.

d.

The following documents for conformance with the applicable QAIs:

(1) Earthquake Engineering Systems, Inc. (EES) document titled, Proposal for the Analysis of the CROHS, La Salle County Station Units 1 & 2, dated July 22, 1976.

(2) Purchase order No. 2009-45 dated August 12, 1976, from RCI to EES.

(3) Engineering Control Check List, Revision 100, dated February 9, 1981, for La Salle County Station Units 1 & 2.

(4) RCI Design Occument Transmittal Notices and acknowledgement 1 (wnere required) for RCI Specification No. LA-VS-01 (Design Specification for the CROHS Insert and Withdraw Vent Valves)

Revision 1, dated February 6, 1977; GE Specification No.

21A878 (CR0 Design and Performance Requirements) Revision 2; and S&L Specification 05-RD-01-LS (Certification of Design Specification for the CRDHS) Revision 2, dated September 27, 1977.

7 (5) RCI Orawing No. LA-008, Sheet 2 (Spec. J-2922 CRDHS Hanger and Restraint 7.nside Containment) Revision 6, dated September 16, 1980.

3.

Findings a.

There were no nonconformances, unresolved, or follow up items identified.

I b.

Although RCI had not previously formalized their design process via procedures and/or instructions it appears, from the items examined, that their previous safety related activities were in accordance with existing and imposed requirements that are now adequately reflected in their QAIs.

E.

Control of Computer Programs 1.

Objectives The objectives of this area of the inspection were to determine that:

a.

Cr..nputer programs have been develoced, verified, qualified, and are being used in accordance with procedures which have been prepared, reviewed, and approved by authorized management.

b.

A computer program custodian has been designated ano has the responsibility for maintaining the security of the program.

c.

Each computer program that has been authorized for use has been qualified, has an appropriate users manual, and this 4

manual (or another manual) provides a detailed description of the mathematical model(s), empirical data (if any),

assumptions used, and applicable references.

d.

Each computer program has been verified / qualified and that documentation exists which includes:

(1) A description of the program version and option (s) validated; (2) A detailed description of the test (benchmark) problem (s),

including boundary conditions, mathematical models, and all key parameters; (3) A listing of the test (benchmark) problem input data checks and a reprint of the program input and output, or reference to the location where this is stored; and v--e-r

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8 (4) The comparison of solutions, evaluation of the program validity, and an analysis of any identified errors.

e.

Technically qualified individuals have reviewed and approved the verification / qualification of each computer program prior to its use in safety related applications.

f.

Revisions and modifications have been subjected to the same review and approval as the original version of the program.

g.

Errors identified in computer programs are promptly corrected and appropriately verified prior to use.

h.

Errors which could result in significant deficiencies in nuclear plant design are reported to the NRC under the requirements of 10 CFR Part 21, 10 CFR Part 50.55(e), and 10 CFR Part 50, Appendix K, as appropriate.

2.

Method of Accomolishment The preceding objectives were accomplished by an examination of the User and Verification Manuals for the computer program "TPIPE".

In addition, the inspector examined applicable RCI instructions i.e.

QAI-3-9 (Computer Program Development, Modification, and Approval for Use) Revision 0, dated December 1, 1980; and QAI-3-10 (Verifica-tion of Computer Programs) Revision 0, datM December 1,1980.

3.

Findings a.

There were no nonconformances, unresolved, or follow up items identified.

b.

TPIPE is a special purpose computer program capable of performing static and dynamic linear elastic analysis of power related piping systems.

The major computational algorithms from SAP IV (University of California - Berkley) were used by PMB Systems Engineering, Inc.

to develop this program.

This program is available to RCI througn the Boeing Computer Services Co. via terminal access.

c.

RCI has subcontracted the analysis work on the La Salle project to EES which uses their own program (PSA) therefore the inspector could not examine a TPIPE program run.

However, the examination of the TPIPE User and Verification Manuals revealed that they satisfied the requirements of paragraph E.1 above.

d.

The examination of QAI-3-9 and QAI-3-10 revealed that they adequately implemented the requirements of paragraph E.1.

above.

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9 F.

Technical Personnel Background Verification 1.

Objectives The objectives of this area of the inspection were to verify that measures have been established and are being effectively implemented that assure:

4 a.

, The education and work experience information contained in employee's job applications are being verified by the employing organization; b.

There is objective, documented evidei::'rt::rds that attest to the employee's education and experience.

2.

Method of Accomolishment The preceding objectives were accomplished by an examination of:

a.

An RCI policy statement (Employee Qualification) Revision 0, dated February 5, 1981.

b.

The resumes and personnel records of 13 members of the RCI tech-nical staff.

3.

Findings a.

There were no nonconformances, unresolved, or follow up items identified.

b.

The policy statement, identified in paragraph F.2.a. above, was found to document the minimum qualification requirements for each technical position at RCI.

Reportedly, these qualification requirements had been used since the founding of RCI,but he.d been formally documented only recently.

Additionally, the policy now requires formal documentation of verification results.

c.

All personnel are hired by either the President or Vice Pres-ident of RCI.

The verification of education and exp2rienca, although undocumented in most cases, was cone telephonically or by the recommendation of an RCI employee who had knowledge of the individual's capability.

In some cases copies of degrees, diplomas, certificates of training etc. were maintained in the files.

G.

Exit Interview An exit interview was held with management representatives on February 12, 1981.

In addition to those individuals indicated by an asterisk in para-graph A of each Oetails Section, those in attendance were:

-1 10 J. K. Boyer, QA Administrative Assistant J. C. Murray, Engineering and Construction Manager J. Perrin, Purchasing Manager R. C. Weitenstein, Engineering and Construction Manager The inspector discussed the scope and findings of the inspection. Manage-ment comments were generally for clarification only, or acknowledgement of the statements by the inspector.

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11 DETAILS SECTION II (Prepared by O. G. Breaux)

A.

Persons Contacted

  • R.

K. Crum

  • G. Secchi - Engineering and Construction Manager
  • Denotes those attending the exit meeting.

B.

Design Change Control 1.

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

a.

Procedures have been established and implemented for controlling changes to approved design documents.

b.

Design changes are:

(1) reviewed for the impact of the change (2) documented as to the action taken, and (3) transmitted to all affected persons and organizations.

c.

The design changes are justified and subjected to review and approval by the same groups or organizations as for the origi-nal design.

I d.

When responsibility has been changed, the designated organi:ation shall have access to the pertinent information, competence in the specific area of design, and an understanding of the requirements i

l and intent of the original design.

2.

Method of Accomplishment The preceding objectives were accomplished by review of the following documents.

a.

Reactor Controls Inc. " Quality Assurance Manual" Revision 4, dated October 31, 1980.

The organizations with their specific duties delegated to them for performing the function of Design Change Control were identified in this manual.

b.

The following RCI Quality Assurance Instructions, that describe activities relative to Design Change Control, were reviewed for proper implementation content:

l

12 (1) QAI-3-1 Revision 0, dated December 4, 1980, " Interfaces between Engineering and Stress Analysis."

(2) QAI-3-2 Revision 0, dated December 4, 1980, " Drawing Changes."

(3) QAI-3-7 Revision 1, dated December 4, 1980, " Stress Analysis Design Change Control."

(4) QAI-5-2 Revision 0, dated December 4, 1980, " Engineering Drawings and Engineering Change Notices."

(5) QAI-6-1 Revision 0, dated December 4, 1980, "Occument Control Headquarters."

(6) QAI-6-2 Revision 0, dated December 4, 1980, " ECCL Contr<1."

c.

To assure that procedural requirements are being properly '.nd effectively implemented, the following documents were reviewed.

(1) Reactor Control Inc., " Engineering Control Check List",

(ECCL) Revision 100, dated February 9, 1981, for the La Salle County Station Unit 1 and 2 which included the following design documents:

General Electric Drawings (internals)

General Electric Specifications AE Specifications RCI Specifications (internal)

RCI Specifications (07H system)

General Electric Drawings (CROH system) i (2) Document control computer listing, "Occument File List,"

was reviewed for proper status of design documents with respect to inclusion of the ECCL.

(3) Five (5) RCI drawings for the La Salle Country Station unit 1 and 2 control rod drive system.

(4) Five (5) specifications for the La Salle Project control I

rod drive system.

l (5) Three (3) Stress Analysis Grouc calculation packages for engineered changes on the Limerick Project.

l l

l l

13 (6) The following design document transmittal notices on the La Salle project were reviewed for evidence of distribution.

Also, verified was proper documentation of evidence that these design documents were transmitted, received, and properly dis-positioned.

The design documents reviewed included:

Document transmittals from RCI to General Electric.

Document transmittals from RCI to Commonwealth Edison (Ceco)

Document transmittals from RCI to site Document transmittals from RCI to EES (Earthquake Engineering Systems).

Document transmittals from RCI to shop.

(7) Five client approvals of design documents.

These approvals by the client of the La Salle Project, Ceco, were examples of external design interface.

3.

Findings a.

In this area of inspection, no nonconformances, unresolved items or follow up items were identified.

RCI is developing a document control system that will enhance the effectiveness of design change control.

The following is a description of this document control system.

All design documents held by the RCI headquarters office are in the process of being placed in a computer assisted document control system.

All documents that are placed in this system are verified as current.

This effort will result in a centralized design document filing system with a computer aided input control.

This total effort is scheduled for completion in March 1981.

A Stop Work Order imposed on RCI by the licensee, Commonwealth Edison, was a catalyst for placing this document control system into operation.

Reasons for the Stop Work Order and specific actions taken by RCI to rescind this Stop Work Order are:

(1) Review and approval of certain design documents were not obtained from the client, Commonwealth Edison (Ceco) in the past.

RCI is now submitting all design documents to CECO for their review and approval.

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14 (2) An AE client of RCI was transmitting design related infor-mation directly to an RCI subcontractor without prior interface with RCI.

All of the design related documents transmitted to the RCI subcontractor have been returned to the AE for resubmittal to RCI.

Engineering Change Notices (ECNs) will be written by RCI on these re-submitted design related documents and issued to RCI's subcontractor.

(3) To alleviate Engineering Change Notice (ECN) control problems, expressed as a concern by CECO, all RCI design drawings are being revised to reflect the as-built condi-tion based on actual installations at the site.

All ECNs previously written on the drawings being revised will be voided and stored in an inactive file in RCI Headquarters Document Control.

All ECNs written in the future will be incorporated by RCI Headquarters in accordance with the applicable QAIs recently developed.

C.

Design Interfaces 1.

Objectives The objectives of this area of the inspection for both internal and external interfaces were to determine that procedures have been established and implemented that:

a.

Require the design organizations identify, in writing, their interfaces for managing the flow of design information.

b.

Define and document the responsibilities of each organizational unit for the preparation, review, approval, distribution, and revision of documents involving design interfaces.

c.

Establ'sh methods of systematically communicating needed design l

i nforr,.

lon, including changes thereto, across design interfaces l

as work progresses.

d.

Require documentation of information transmitted between organi-zations which identified the status of the design information or documents and incomplete items which require further evaluation, review or approval.

e.

Require that design information transmitted orally or by other informal means is promptly documented, and the documentation confirmed and controlled.

f.

Identify the external organizations providing criteria, designs, specifications, and technical direction.

i l

15 g.

Identify the positions and titles of key personnel in the communi-cations channel and their responsibilities for decision making, problem resolution, providing and reviewing information.

2.

Method of Accomolishment The preceding objectives were acccmplished by review of the following documents:

a.

Reactor Controls Inc. " Quality Assurance Manual" Revision 4, dated October 31, 1980.

Certain interfaces pertinent to design were identified in this manual.

b.

The following RCI Quality Assurance Instructions, that describe activities relative to design interfaces were reviewed for proper programatic implementation content:

(1) QAI-3-1 Revision 0, dated December 4, 1980, " Interfaces Between Engineering and Stress Analysis."

(2) QAI-3-12 Revision 0, dated December 4,1980, " Review of Design or Stress Analysis Report Submitted by Vendors or Subcon-tractors."

(3) QAI-6-3 Revision 0, dated December 4, 1980, "Occument Trans-mittal for Approval."

(4) QAI-3-8 Revision 1, dated December 4, 1980, " Stress Analysis Independent Design Review."

c.

To assure that procedural requirements are being properly and effectively performed, the following documents were reviewed:

l (1) Five design document transmittals from RCI on the La Salle project.

(2) Five design document approvals sent from RCI to the client (CECO).

l l

(3) Three stress analysis interfaces with Project Engineering:

l (a) Transmittal of engineering documents to stress analysis group.

l (b) Transmittal of calculation analysis of an Engineering l

Change Notice (ECN) from stress analysis group to Project Engineer.

(c) Preliminary Safety Analysis Report.

l I

l 1

16 (4) La Salle project interface between EES stress analysis group and RCI which included:

(a) Transmittal of project manual from EES to RCI.

(b) Review of analysis results from EES by RCI.

(c) Conference reports between EES and RCI.

(d) Transmittal notices of documents received by RCI from EES.

(5) Five Document Control Request forms.

(6) Occument Log Book (La Salle Project Engineer).

(7) Three RCI generated drawings for La Salle project.

3.

Findings In this area of inspection no nonconformances, unresolved items, or follow up items were identified.

The recently prepared Reactar Control Inc. (RCI) Quality Assurance Instructions (QAIs) properly address design organization interfaces.

This formalized documentaf. ion of interface activity instructions was initiated by RCI in response to an NRC finding concerning a lack of detailed organizational interface definition.

This noncompliance with NRC requirements was identified in Inspection and Enforcement reports 50-373/80-48 and 50-374/80-30.

This formulation of detailed organizational interface definition is also a condition imposed by the client, Commonwealth Edison, on RCI in order for their Stop Work Order on the La Salle project to be removed.

The client will inspect RCI headquarters the wiek of February 16, 1981, to review the issued QAIs and their implemer,tation.

E.

Audits j

1.

Objectives l

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

a.

Audit system is established whicn has organizational incepencence, authority, and is documented in procedures and/or instructions in accordance with commitments.

b.

Audit records include a written audit plan, team selection, audit schedule, and audit notification to the person or organization to be audited.

17 c.

Members of the audit team are independent of any direct respons-ibility for the activities being audited.

d.

Provisions exist for the reporting of the effectiveness of the Quality Assurance program to responsible management.

e.

The audit includes the use of checklists or procedures, detailed audit reports, and timely identification, acknowledgement, documentation of nonconformances, and subsequent corrective action and verification.

f.

Audit reports contain the audit scope, identification of auditors, persons or organizations contacted, summary of the results of the audit, the details of any nonconformances noted, the recommendations for correction, and distribution of the report to rtsponsible management.

2.

Method of Accomolishment The preceding objectives were accomplished by review of the following documents:

a.

Reactor Controls Inc. " Quality Assurance Manual", Revision 4, dated October 31, 1980.

The organization involved was identified in this manual along with the specific duties delegated to them for performing the function of Quality Assurance audits.

j b.

QAI-18-1 Revision 0, dated December 4, 1980, " Instructions for l

Audit Program" c.

To assure that procedural requirements are being properly and effectively implemented; the following documents were reviewed:

(1) Five RCI Quality Assurance internal audits.

(2) Five RCI Quality Assurance Audit Check its.

(3) Three Licensee audits of RCI activities.

(4) RCI. responses to Licensee audit findings.

(5) RCI responses to internal Quality Assurance audit findings.

l (6) RCI Quality Assurance Manager Audit Schedule.

3.

Findings In this area of inspection no nonconformances, unresolved items, or follow up items were identified.

1

a 18 In reviewing RCI Quality Assurance Audit Checklists, it was noticed that there was no reference to the review of the newly issued QAIs.

RCI Quality Assurance is in the process of incorporating the refer-ence of these QAIs in their audit checklists.

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