surveillance report ocrw-hq-sr-89-015, 'quality assurance ... · the scope of this surveillance was...

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OCRW-EQ QUALITY ASSURANCE SURVEILLANCE REPORT

SURVEILLANCE OF TEE YMP QA AUDIT (89-05) OFREYNOLDS ELECTRICAL AND ENGINEERING CO., INC. (REECo)

SURVEILLANCE NUMBER OCRM-EQ-SR-89-015

CONDUCTED SEPTEMBER 25-29, 1989

Prepared by:Surveillance Teaz Leader

Date (lbAlki

Approved by:,Diec r OA

Date %% \s I"-. , .

I 9004190212 900413PDR WASTEWM-11 PDC

SURVEILLANCE REPORT NUMBEROCRWM-SQ-SR89-015

A. INTRODUCTION

A surveillance to assess the adequacy (compliance and effectiveness) ofthe YP QA audit of REEbo as performed by the Office of QualityAssurance from September 25 through 29, 1989.

The surveillance was performed by Robert W. Clark (WESTON).

Personnel contacted during the surveillance included as follows:

J. Blaylock, DOE B. Camp, SAICE. Wilmot, DOE F. Ruth, SAICD. edges, SAIC N. Cox, SAIC

This surveillance was performed in accordance with QAAP 18.3, Rev. 0,"Surveillance Program".

B. SURVEILLANCE SCOPE

The scope of this surveillance was the IMP QA audit (89-05) of REECo.The purpose of the surveillance was to assess the adequacy of the YMP QAaudit program. To a lesser degree (based on results of the audit), thesurveillance included an assessment of those aspects of REECo's programwhich were included within the scope of the audit.

The surveillance included investigation of the following elements:

1. Audit team.2. Audit planning.3. Pre and post audit conferences.4. Audit conduct.5. Audit results.6. Interfaces.

Note: Due to lack of actual QA program implementation by REECo,evaluation of implementation and overall QA program effectiveness waslimited.

C. REQUIREMENTS SURVEILLED

1. YMP Quality Assurance Plan 88-9, Rev. 22. YMPO Quality Assurance Program Plan 88-1, Rev. 03. QMP-16-03, Rev. , Standard Deficiency Reporting System4. QMP-18-01, Rev. 3, Audit System for the Waste Management Project

Office

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D. RESULTS OF SURVEILLANCE

There were no deficiencies and no observations identified as a result ofthis surveillance. The overall conclusion was that the audit wasperformed in accordance with YMP QA Program requirements. The followingis a summary of the specific areas included in the surveillance:

Audit Team

Due to Privacy Act concerns, objective evidence of the qualifications ofthe audit team was not made available during this surveillance;therefore, the qualification of the audit team members were not evaluated.

Observation of the entire audit process and interview with audit teammembers indicated that the team members were knowledgeable in the areasaudited and of the audited organization's program and that the audit wasconducted in a professional and effective manner.

Audit Planning

Based on interview with the audit team leader and review of the auditscope and checklist, it is concluded that the audit was effectivelyplanned. The scope was appropriate for REECo's scope of work and thechecklist was comprehensive enough to fully address the stated purposeand scope of the audit.

Pre/Post Audit Conferences

The pre and post audit conferences were conducted in an appropriatemanner. At the pre-audit conference, the scope of the audit was clearlyexplained, team members and observers were introduced to REECo staff, andcontacts between the audit team and REECo staff were established. At thepost-audit conference, the audit team provided clear explanations of thedeficiencies and opportunity for REECo to respond.

Audit Conduct

The audit was conducted in a professional and effective manner. Thetechniques utilized by the audit team were appropriate and objectiveevidence was reviewed to the depth required to determine the extent ofprogram adequacy.

Interfaces

The auditors kept REECo personnel informed of potential findings. Theaudit team (including observers) had daily caucuses to discuss theresults of each day's auditing activities and to allow questions/commentsfrom observers. The audit team leader held daily "ITPO meetings" toinform REECo senior management of the audit results. Overall, theinteraction between the audit team, REECo, and the observers wassatisfactory.

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Audit Results

Five (5) deficiencies were identified during the audit. One (1) of thesewas under Criterion 2, "Quality Assurance Program" and identifieddeficiencies with personnel position descriptions. One () was underCriterion 6, "Document Control" and identified failure to develop arequired "controlled documents list." One (1) was under Criterion 16,"Corrective Action" and identified REECo's failure to identifysignificant deficiencies on corrective action reports. One () was underCriterion 17, "A Records" and identified quality assurance records thatwere not identified as such. The final deficiency was under Criterion18, "Audits" which identified several discrepancies (classified asnon-significant) in the implementation of the REECo audit process. Therevere also five (5) observations identified during this audit.

The overall evaluation of the REECo Q Program, by the audit team, wasthat, for the most part, the appropriate controls were in-place and wereadequate to support quality affecting work. However, due to the lack ofattention to YMP QA Program requirements by one (1) REECo matrixorganization supporting the REECo YMP work, the audit team could notrecommend that the REECo QA Program was fully qualified to support newsite characterization activities.

Two (2) specific areas of the REECo QA Program were concentrated onduring the audit, "procurement" and "the standards and calibrationlaboratory". The audit team members responsible for those areasconcluded that both were satisfactory. With respect to the investigationof the standards and calibration lab, the audit team commended REECo andhighly recommended to the YMPQ that the REECo lab be considered as themechanical calibration facility for the entire Yucca Mountain Project.

E. DEFICIENCIES/REQUIRED ACTION

There were no deficiencies or observations identified during thissurveillance; therefore, no action is required by the YMU in response tothis report.

Department of EnergyNevada Operations Office WBS 1.2.9.3

P. Box 98518-~ Las Ve~W . NV 89183-8518

D0UJ 1990

Night . Shelor, Acting Director, Quality Assurance Division, Q (W-3) US

=MCA. NOUNThIN PRECT OFFICE (PROJECT OFFICE) A=CPTANC OF THE REYNWSELECTRICAL CO., NC. (REECO) QUALITY ASSURANCE (A) PROGAM

Reference: Letter, Gertz to Shelor, dtd. 12/26/9

The purpose of this memorandum is to provide an update documenting the ProjectOffice acceptance of the Yucca Mountain Project OA Program of REECo. Iisacceptance is based upon the following:

1. The U.S. Nuclear Regulatory Commdssion (NRC) has accepted the REECoQuality Assurance Project Plan (AP), Revision 8, based upon the safetyevaluation letter dated October 3, 1989, from Linehan to Stein. All NRCstaff comments were resolved before issuance of the safety evaluationletter.

2. Project Office aA surveillance of the REECo oA Program procedures foradequacy to control the subject activities and conformance withapplicable EECo OAPP requirements (reference enclosure forsurveillance report numbers, scope, and summary of results).

3. Project office performance of the REECo OA Program Qualification Audit89-5, cnducted September 25-29, 1989 (reference letter, Wilmot toPritchett, dated October 24, 1989). To date, any NRC observationsgenerated as a result of the audit have not been received. This auditconcluded that the A Program is capable of identifying, tracking, andclosing deficiencies.

4. Project Office review of outstanding REECo CA Program deficiencies thatcould have technical or quality impact on output products (referenceenclosure 2 for outstanding deficiency numbers and descriptions).

The Severity Level Checklist criteria established in Project Office QualityManagement Procedure-16-03 were used to determine impact of the opendeficiencies (reference enclosure 3). If the deficiency did not meetSeverity Level I criteria, it was regarded as not having significant impacton the start of Title II activities or in support of new sitecharacterization activities.

Dight E. Shelor -2- MIR 01 1990

Based on the above, the Project Office has concluded that the EECo OA Programis in conformance with the applicable requirements of the Yucca MountainProject OA Plan, NNWSI/88-9, and s adequate to support the start of Title IIor new site characterization activities, with the following exception:

Records Management - This activity should not constrain the start of new* site characterization activities or Title II; however, Standard

Deficiency Report (SDR) 453, initiated during Project office CA ProgramQualification Audit 9-5, will require prompt resolution and follow-up.The SDR does not involve a Severity Level I condition.

The Project Office will verify and document resolution of this exception* by Yucca Mountain Project CA surveillances.

If you have any questions or cosments regarding the Project Office position onthis matter, please contact Donald G. Horton of my staff at TS 544-7504 or(702) 794-7504.

Carl P. Gertz, Project ManagerYMP:DGH-2175 Yucca Mountain Project Office

Enclosures:1. Task Force Surveillances of

the REECo QA Program2. REECo Open QA Deficiencies3. SDR Severity Level Checklist

cc w/encls:Ralph Stein, HQ (ER-30) FRSJ. W. Gilray, NRC, Las Vegas, NVS. R. Dippner, SAIC, Las Vegas, NV, 517/T-08R. F. Pritchett, REECo, Las Vegas, NVM. A. Fox, REECo, Las Vegas, NV

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TASK FORCE SURVEILLANCES OF THE REECo QA PROGRAM____________________________________________________________________________________________________________

SURVEILLANCE DEFICIENCIESNUMBER PROCEDURE AND SCOPE SUMMARY OF RESULTS ISSUED

YMP-SR-89-085 QP, 4.0, R-5, "Procurement Document Control" Project Office generated SDR-3111 SDR which encompassed: (Closed)

QP, 4.0 did not address:

- submittal and correc-tion of supplier qualityprograms .

- requirements for thepurchase of test equip-ment

- review of changes topurchasing documents oraccess to pertinentinformation by thosepersons performing reviews

- factoring changes madeduring the bid processinto the procurementdocuments

QP, 7.0, R-5, "Control of Purchased Materials, QP, 7.0 did not address:Equipment and Services'

- conformance of purchasedmaterial to procurementdocuments

- supplier interfacemeasures

Enclosure 1

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TASK FORCE SURVEILLANCES OF THE REECo QA PROGRAM


YMP-SR-89-085 QP 7.0, R-5 "Control of Purchased Materials, - details of verification SDR-311(continued) Equipment, and Services" activities (Closed)

- documentation for con-formance of services,source surveillanceactivities, and correctiveactions

- control of supplierdocumentation

- methods of acceptancefor items or services

- post-installation testing

- alternate commercial-grade items

YMP-SR-89-086 QP 6.0,R-4, "Document Control" Procedural deficiencies SDR-311identified were: (Closed)

- methods were not delin-eated to control thepreparation, review, andapproval of QualityProcedures or Work Pro-cedures

- exhibits referenced with-in the procedure were notavailable for reviews

Enclosure 1Page 2 of 13

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YMP-SR-89-087 QP 5.0, R-4, "Instructions, Procedures, and - six deficient items were SDR-311Drawings" identified in QP 5.0 deal- (Closed)

ing with lack of specificsor details within theprocedure to delineate howrequirements were to beimplemented

QP 5.1, R-0, "Preparation, Review, and Approval - three deficient itemsof Quality Procedures" were identified in QP 5.1

which concerned the lackof specifics for issuanceof documents and controlthereof, and not distin-guishing between major andminor changes

QP 5.2, R-0, "Preparation, Issue, and Control - two deficient items wereof Work Procedures" identified in QP 5.2 which

regarded the lack of anindependent review by theoriginating organizationand improper format of theprocedure


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YMP-SR-89-088 Deficient items SDR-311identified included: (Closed)

QP 1.0, R-5, "Organization" QP 1.0

- lack of organizationalcharts

- lack of specificsregarding organizationalresponsibilities towardQA policy

QP 1.1, R-2, "Resolution of Disputes" QP 1.1

- improper format

QP 1.2, R-0, "Stop Work Order" QP 1.2

- stop work authority ofthe QA Manager was notexplicit

- lack of reference orattachment of a Correc-tive Action Request eventhough it is identifiedin several places

- improper format


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YMP-SR-89-088 QP 2.0, R-4, "Quality Assurance Program" QP 2.0 SDR-311(continued) (Closed)

- procedure does not (continued)delineate or define thereview and approval processfor the QAPP or Qualitydocumentation

- improper format

YMP-SR-89-089 Deficient items identified SDR-311included: (Closed)

QP 2.2, R-4, "Personnel Qualification and QP 2.2 NoneCertification"

QP 2.4, R-0, "Indoctrination and Training" QP 2.4

- lack of training priorto assignment to conductquality affecting activi-ties.

- improper proceduralformat

QP 8.0, R-3, "Identification and Control of QP 8.0Materials, Parts, and Components"

- physical separationnot addressed

- procedural control


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YMP-SR-89-089 QP 10.0, R-4, "Inspection" QP 10.0 (continued) SDR-311(continued) (Closed)

- maintenance of qualifi- (continued)cation examinations forinspectors of qualityrecords

QP 11.0, R-4, "Test Control" QP 11.0 Deficient in areasof:

- requiring preparation ofinstructions, procedures,and drawings for tests

- criteria for determiningwhen a test is required andhow it is to be performed

QP 13.0, R-4, "Handling, Storage, and Shipping" QP 13.0

- packaging, shipping, andcleaning are not addressed

- marking and labelingrequirements for itemsnot addressed


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YMP-SR-89-089 QP 14.0, R-4, "Inspection, Test, and Operating QP 14.0 SDR-311(continued) Status" (Closed)

- operating status require- (continued)ments not addressed


YMP-SR-89-090 QP 10.1, R-4, "Surveillance" QP 10.1 Deficient areas SDR-311identified were: (Closed)

- accuracy of equipmentused in surveillancesnot recorded

- entries on the surveil-lance report form arenonspecific and unclear

- "Surveillance Report Log"not adequately describedin the procedure

- insufficient instructionsfor completing the refer-enced exhibits.

- procedure not specific asto what action the PAMtakes upon rejection of acorrective action of asurveillance


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YMP-SR-89-090 QP 15.0, R-5, "Nonconformances" QP 15.0 SDR-311(continued) (Closed)

- procedure did not includean exhibit of a hold tagnor instructions forcompleting one


- a Technical InspectionReport (TIR) is notadequately described inthe procedure

QP 16.0, R-5, Corrective Action" QP 16.0

- references inadequate

- exhibits referenced inthe procedure not avail-able for review

QP 18.0, R-5, Audits" QP 18.0

- trending and thetracking system are notaddressed

- supplier evaluations notaddressed


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TASK FORCE SURVEILLANCES OF THE REECo A PROGRAMSURVEILLANCENUMBER

DEFICIENCIESISSUEDPROCEDURE AND SCOPE SUMMARY OF RESULTS

YM-SR-89-090(continued)

QP 18.0, R-5, "Audits" QP 18.0 (continued) SDR-311(Closed)

- multi-discipline auditsnot addressed

- exhibit of the auditreport not availablefor review

- maintenance of auditorcertifications notaddressed

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YMP-SR-89-097 QP 2.3, R-0, "Management Assessment"

QP 16.2, R-1, "Trend Analysis"

QP 17.0V,-R-4, "Quality Assurance Records"

Project Office issued oneStandard Deficiency Reportto document five deficientareas of TPO-4 whichincluded:

SDR-338(Closed)

TPO-3, R-2,

TPO-4, R-1,

"Procedure for Litigation DiscoveryProcess of Yucca Mountain ProjectRecords"

"Yucca Mountain Project RecordsManagement"

- prevention of damage torecords from moisture,temperature, and pressurenot addressed

- not addressing replace-ment of lost or damagedrecords

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- not addressing plannedretrieval times

- definitions not consis-tent with Appendix A ofNNWSI/88-9, Rev. 2.


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YMP-SR-89-097 TPO-4, R, "Yucca Mountain Project Records - no QA Records section SDR-338(continued) Management" is included (Closed)

YMP-SR-89-098 QP 2.1, R-3, "Certification of Inspection and QP 2.1 NONEPersonnel"

- process for certifyingpersonnel not detailedenough


- specific QA Recordsnot listed

NOTE: All of thesedeficient conditionswere resolved byissuance of Revision 4to this procedure

QP 9.0, R-4, "Control of Processes" QP 9.0

- process control appli-cable to scientificinvestigations notaddressed

- processes not control-led in accordance withinstructions/procedures


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YMP-SR-89-098 NOTE: All of these NONE(continued) deficient conditions were

resolved by issuance ofRevision 4 to thisprocedure

YMP-SR-89-103 AP-3.0, R-0, "Readiness Review" Procedures QP 3.0 and 3.1 SDR-342were deleted because (Closed)

QP 3.0, R-2, "Scientific Investigation Control REECo has no design SDR-344and Design Control" function for the Yucca (Closed)

Mountain ProjectQP 3.1, R-2, "Design Review"

Project Office issuedQP 3.2, r-0, "Change Control" two SDRs which encompassed:

QP 3.3, R-0, "Technical Assessment Review" *(1) The use of a qualitydocument without providing

QP 5.3, R-0, "Preparation, Review, and Approval for unique identificationof Implementing Procedures" or tracking in a log book

for accountability. Thiscondition was identifiedin QP 16.0 which wasreviewed during surveil-

QP 16.0, R-6, "Corrective Action'* lance YMP-SR-89-090.The quality document,"Deficiency Notice',Exhibit I, was notavailable for review atthat time; it was avail-able during this surveil-lance, and hence the SDRwas generated.


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YMP-SR-89-103 QP 12.0, R-5, "Control of Measuring and Test (continued) SDR-344 (continued) Equipment" (2) Storage and handling (Closed)

was not addressed in theimplementing procedures ofthe calibration laboratory.

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REECo OPEN QA DEFICIENCIES

DEFICIENCY NO. ISSUED BY DESCRIPTION OF DEFICIENCY COMMENTS

SDR-451 Project Office A Corrective Action Report (CAR) was not Amended response pending(Audit) issued as a result of an audit finding. evaluation by the Project

Office; As the eval-uation pertains to a matterof interpretation as to whena CAR is required and ade-quate controls are in placevia the participant's AuditFinding Report, which addresscausative factors andcorrective action, there isno impact to Title II work.In addition, this SDR waspreviously evaluated forseverity level and it wasdetermine to be Level 2.This evaluation concludedthat the deficiency did notresult in a loss of licensingdata, an error in the designor construction of an engi-neered item nor the potentialfor an adverse impact to thepublic health and safety orsafety of the operationspersonnel.

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REECO OPEN QA DEFICIENCIES


SDR-452 Project Office Audit requirements as detailed in Amended response pending(Audit) accordance with QP 18.0, Rev. 6, were not evaluation by Project Office;

fully implemented for REECo Audit The deficiencies identifiedare typical of items

REECo-001-89. detected during proram-matic and implementationaudits and surveillances.In addition, this SDR waspreviously evaluated forseverity level and it wasdetermined to be Level 2.This evaluation concludedthat the deficiency did notresult in a loss of licensingdata, an error in the designor construction of an engi-neered item nor the potentialfor an adverse impact to thepublic health and safety orsafety of the operationspersonnel. Consequently,there is no impact toTitle II work.

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SDR-453 Project Office The REECo Records Management Program has Amended response pending(Audit) not developed implementing procedures of evaluation by the Project

the (matrix) division level. Office; As the REECo/YMPRecords Management Manualwill be issued as an imple-menting procedure for matrixlevel personnel and trainedto by Feb. 1990, there willbe no impact to Title IIwork. In addition, this SDRwas previously evaluated forseverity level and it wasdetermined to be Level 2.This evaluation concludedthat the deficiency did notresult in a loss of licensingdata, an error in the designor construction of an engi-neered item nor the potentialfor an adverse impact to thepublic health and safety orsalfety of the operationspersonnel.

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SDR-454 Project Office Various records were not appropriately Amended response pending(Audit) designated as QA, non-QA or indeterminate. evaluation by the Project

Office; As corrective mea-sures are in place toinclude printed guidelinesfor designation of recordsand retraining of personneland the deficiency identi-fied is not severe in naturebut rather one of day-to-dayimplementation, there is noimpact to Title II work.In addition, this SDR waspreviously evaluated forseverity level and it wasdetermined to be Level 2.This evaluation concludedthat the deficiency did notresult in a loss of licensingdata, an error in the designor construction of an engi-neered item nor the potentialfor an adverse impact to thepublic health and safety orsafety of the operationspersonnel. Consequently,there is no impact toTitle II work.

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SDR-455 Project Office All controlled documents were not included An extension request for(Audit) on the master list of controlled documents completion of the corrective

and there is no mechanism provided for action to 2/28/90 is pendingnotifying QA of controlled documents being evaluation by the Projectgenerated. Office. As the remedial/

investigative actions havebeen determined satisfactoryand the only item pending iscompletion of training by2/28/90, there is no impactto Title II work. Inaddition, this SDR was pre-viously evaluated forseverity level and it wasdetermined to be Level 2.This evaluation concludedthat the deficiency didnot result in a loss oflicensing data, an errorin the design or construc-tion of an engineered itemnor the potential for anadverse impact to the publichealth and safety or safetyof the operations personnel.Consequently, there is noimpact to Title II work.

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AFR 1-89 REECo Due to a lack of Management attention, the Corrective Action to be(Audit) Operation Equipment Dept., a matrix support completed by the Operations

group to REECo, failed to adequately Equipment Dept. by 2/28/90.implement the YMP QA Program. Based on evaluation given in

SDR-451, previously, therewill be no impact toTitle II work.

CAR 90-005 REECo 1) Qualification Records of the Property Awaiting response from the(Surveillance) and Supply Dept. not on file with the REECo Property and Supply

REECo/YMP Training Administrator. Dept. This SDR was evaluatedfor severity level in

2) Implementing Procedures of the Property accordance with QMP-16-03 andand Supply Dept. not in the proper it was determined to beformat as required by QP 5.3. Level 2. This evaluation

concluded that the deficiencydid not result in a loss oflicensing data, an error inthe design or construction ofan engineered item nor thepotential for an adverseimpact to the public healthand safety or safety of theoperations personnel. Basedon the above, there is noimpact to Title II work.

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-. '-j XCCA MOUNTAIN PROJECT OFFICEQUALITY MANAGEMENT PROCEDURE &1m

Title Mo. Q@-16-03 Rev. 1STANDARD DEFICIENCY REPORTING SYSTEM

Effective Date 65/89

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surveillance report ocrw-hq-sr-89-015, 'quality assurance ... · the scope of this surveillance was...

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