October 12, 2001

Mr. Ronald A. Milner, Chief Operating Officer

Office of Civilian Radioactive Waste Management

U. S. Department of Energy

1000 Independence Avenue, SW

Washington, DC 20585

SUBJECT: U.S. NUCLEAR REGULATORY COMMISSIONíS OBSERVATION AUDIT

REPORT NO. OAR-01-08, ìOBSERVATION AUDIT OF THE OFFICE OF

CIVILIAN RADIOACTIVE WASTE MANAGEMENT, OFFICE OF QUALITY

ASSURANCE, AUDIT NO. BSC-ARP-01-04, OF THE BECHTEL SAIC

COMPANY, LLCî

Dear Mr. Milner:

Enclosed is the U.S. Nuclear Regulatory Commissionís (NRCís) Observation Audit Report

(No. OAR-01-08) of the U.S. Department of Energyís (DOEís) audit of BSC. This audit was

conducted August 20 through 24, 2001, at BSCís facility at Las Vegas, Nevada.

The audit team performed a limited-scope performance-based quality assurance (QA) audit, to

evaluate BSCís implementation of the applicable provisions of the OCRWM Quality

Requirements and Description (QARD) document, DOE/RW-0333P, Revision 10, and

associated implementing procedures. During the audit, the audit team assessed the adequacy

and effectiveness of the QARD procedures and verified compliance with requirements in the

areas reviewed.

The DOE audit team evaluated BSCís processes and activities that support the Total System

Performance Assessment for the Site Recommendation (TSPA-SR) technical report. The team

evaluated the quality of the report by examining the development/analyses of scenarios;

traceability/transparency of assumptions, uncertainties, and alternative conceptual models; data

and other input; and software control. The audit team also assessed the defensibility of the

TSPA-SR results/conclusions and evaluated the overall effectiveness of the TSPA-SR technical

report. 

The NRC observers (hereafter, observers) determined that DOEís audit of BSC was effective in

identifying potential deficiencies and recommending improvements for the documentation and

QA procedures reviewed. During the conduct of the audit, both the audit team and the

observers independently reviewed applicable QA procedures, analysis reports, models, and

software documentation. The observers did not submit any audit observer inquiries requesting

clarification and information on audited documents. 

The DOE audit team identified one potential deficiency in the area of software and one potential

significant deficiency in the area of traceability/transparency. The potential significant

deficiency was identified as a repetitive condition, based on similar deficiencies identified during

previous audits. The staff reviewed the DOE audit team findings and agreed with the results as

presented at the post-audit briefing to the DOE management. The staff believes that this DOE

audit was well-planned, thorough, and adequately evaluated BSCís activities supporting TSPASR.

The observers agreed with the audit teamís conclusions, findings, and recommendations

presented at the audit exit. Although the audit team identified potential deficiencies, the
R.A. Milner 2

observers believe that BSCís implementation of its quality program, in the areas reviewed

during the audit, was generally acceptable.

A written response to this letter and the enclosed report is not required. If you have any

questions, please contact Ted Carter at (301) 415-6684.

Sincerely,

/RA/

C. William Reamer, Chief

High-Level Waste Branch

Division of Waste Management

Office of Nuclear Material Safety

 and Safeguards

Enclosure: NRC Observation Audit Report

No. OAR-01-06, ìObservation Audit

of the Office of Civilian Radioactive 

Waste Management, Office of Quality 

Assurance, Audit No. BSC-ARC-01-10,

of the Bechtel SAIC Company, LLCî
R.A. Milner 2

The observers agreed with the audit teamís conclusions, findings, and recommendations

presented at the audit exit. Although the audit team identified potential deficiencies, the

observers believe that BSCís implementation of its quality program, in the areas reviewed

during the audit, was generally acceptable.

A written response to this letter and the enclosed report is not required. If you have any

questions, please contact Ted Carter at (301) 415-6684.

Sincerely,

/RA/

C. William Reamer, Chief

High-Level Waste Branch

Division of Waste Management

Office of Nuclear Material Safety

 and Safeguards

Enclosure: NRC Observation Audit Report

No. OAR-01-06, ìObservation Audit

of the Office of Civilian Radioactive 

Waste Management, Office of Quality 

Assurance, Audit No. BSC-ARC-01-10,

of the Bechtel SAIC Company, LLCî

DISTRIBUTION:

File Center PUBLIC ACNW LSS CNWRA NMSS r/f

HLWB r/f SWastler JDavis WBelke RLatta BMabrito

DWMr/f CWReamer LCampbell DEsh RKJohnson TCarter

ADAMS Accession No.: ML012880016

DOCUMENT NAME: S/DWM/HLWB/thc/OAR-01-08.wpd 

*See Previous Concurrence This document is Non-Sensitive

OFC HLWB *Tech Editor HLWB HLWB HLWB

NAME TCarter thc1 EKraus ek JBradbury jwb NKStablein nks CWReamer cwr

DATE 10/09/01 09/21/01 10/05/01 10/11/01 10/12/01 

OFFICIAL COPY

ACNW: YES X NO Delete file after distribution: Yes No 

1) This document should be made available to the PUBLIC. Yes -thc1

2) This document is related to the HLW program. It should be placed in the LSS. Yes -thc1
Letter to R.A. Milner from C.W. Reamer dated ____October 12, 2001__________

cc:

R. Loux, State of Nevada R. Massey, Lander County, NV

S. Frishman, State of Nevada J. Pitts, Lincoln County, NV

L. Barrett, DOE/Washington, DC M. Baughman, Lincoln County, NV

A. Brownstein, DOE/Washington, DC A. Funk, Mineral County, NV

S. Hanauer, DOE/Washington, DC J. Shankle, Mineral County, NV

C. Einberg, DOE/Washington, DC L. Bradshaw, Nye County, NV

J. Carlson, DOE/Washington, DC M. Murphy, Nye County, NV

N. Slater, DOE/Washington, DC J. McKnight, Nye County, NV

A. Gil, YMPO D. Weigel, GAO

R. Dyer, YMPO W. Barnard, NWTRB

S. Brocoum, YMPO R. Holden, NCAI

R. Clark, YMPO A. Collins, NIEC

S. Mellington, YMPO R. Arnold, Pahrump County, NV

C. Hanlon, YMPO J. Larson, White Pine County

T. Gunter, YMPO R. Clark, EPA

K. Hess, BSC F. Marcinowski, EPA

D. Krisha, BSC R. Anderson, NEI

S. Cereghina, BSC R. McCullum, NEI

N. Williams, BSC R. Henning, BSC

M. Voegele, BSC/SAIC S. Kraft, NEI

S. Echols, Winston & Strawn J. Kessler, EPRI

B. Price, Nevada Legislative Committee D. Duncan, USGS

J. Meder, Nevada Legislative Counsel Bureau R. Craig, USGS

D. Bechtel, Clark County, NV W. Booth, Engineering Svcs, LTD

E. von Tiesenhausen, Clark County, NV J. Curtiss, Winston & Strawn

A. Kalt, Churchill County, NV N. Rice, NV Congressional Delegation

G. McCorkell, Esmeralda County, NV T. Story, NV Congressional Delegation

L. Fiorenzi, Eureka County, NV J. Reynoldson, NV Congressional Delegation

A. Johnson, Eureka County, NV S. Joya, NV Congressional Delegation

A. Remus, Inyo County, CA J. Pegues, City of Las Vegas, NV

M. Yarbro, Lander County, NV L. Lehman, T-REG, Inc.

I. Zabarte, W.S.N.C.
U.S. NUCLEAR REGULATORY COMMISSION 

INPUT FOR THE OBSERVATION AUDIT REPORT NO. OARñ01ñ08,

ìOBSERVATION AUDIT OF THE OFFICE OF

CIVILIAN RADIOACTIVE WASTE MANAGEMENT

OFFICE OF QUALITY ASSURANCE

AUDIT NO. BSC-ARP-01-04

 BECHTEL SAIC COMPANY, LLCî

 /RA/ 10/09/01 /RA/ 10/09/01

Ted Carter Robert K. Johnson

Projects and Engineering Section Performance Assessment Section

High-Level Waste Branch Environmental and Performance 

Division of Waste Management Assessment Branch

Division of Waste Management

 /RA/ 10/10/01 /RA/ 10/03/01

David Esh Thomas C. Trbovich

Performance Assessment Section Center for Nuclear Waste Regulatory

Environmental and Performance Analyses

Assessment Branch

Division of Waste Management

 /RA/ 10/09/01 /RA/ 10/03/01

Patrick A. LaPlante Michael A. Smith

Center for Nuclear Waste Regulatory Center for Nuclear Waste Regulatory

Analyses Analyses

Reviewed and Approved by:

 /RA/ 10/11/01

N. King Stablein, Chief

Projects and Engineering Section

High-Level Waste Branch

Division of Waste Management

Enclosure
2

1.0 INTRODUCTION

Staff from the U.S. Nuclear Regulatory Commissionís (NRCís) Division of Waste Management

observed the U.S. Department of Energyís (DOEís), OQA, audit of BSC. BSC is DOEís

Management and Operating contractor. OQA conducted this audit on August 20 through 24, 

2001. 

The audit team performed a limited-scope performance-based quality assurance (QA) audit to

evaluate BSCís implementation of the applicable provisions of the OCRWM Quality

Requirements and Description (QARD) document, DOE/RW-0333P, Revision 10, and BSCís

compliance with associated implementing procedures in the following areas:

The DOE audit team evaluated BSCís processes and activities that support the Total System

Performance Assessment for the Site Recommendation (TSPA-SR) technical report. The team

evaluated the quality of the report by examining the development/analyses of scenarios;

traceability/transparency of assumptions, uncertainties, and alternative conceptual models; data

and other input; and software control. The audit team also assessed the defensibility of the

TSPA-SR results/conclusions and evaluated the overall effectiveness of the TSPA-SR technical

report. 

The objectives of the audit were to assess the adequacy and effectiveness of the QARD

procedures and to verify BSCís compliance with requirements in the areas reviewed. The

objective of the NRC observation was to assess whether BSC had properly implemented the

provisions contained in the QARD and the requirements contained in Subpart G, ìQuality

Assurance,î to Part 60 of Title 10 of the U.S. Code of Federal Regulations (10CFR). 

This report addresses the NRC observersí (hereafter, observersí) determination of the

effectiveness of the OQA audit, and whether BSC implemented adequate QARD controls.

2.0 MANAGEMENT SUMMARY

The observers determined that OQA Audit BSC-ARP-01-04 was effective in determining the

level of compliance of evaluated BSC QA activities with the QARD and associated

implementing procedures. During the conduct of the audit, both the audit team and the

observers independently reviewed applicable QA procedures, analysis reports, models, and

software documentation. The observers found that the audit team members were qualified,

independent of the activities that they reviewed, and knowledgeable of the QA requirements

and the technical disciplines in the areas in which they performed assessments. The audit

team identified two conditions adverse to quality that were documented as potential

deficiencies. The observers agreed with the audit teamís conclusion that the OCRWM QA

program had been satisfactorily implemented, except for the identified potential deficiencies.

The observers did not submit any audit observer inquiries requesting clarification and

information on audited documents.
3

3.0 AUDIT PARTICIPANTS

3.1 Observers

Ted Carter Observer NRC

Robert K. Johnson Observer NRC

David Esh Observer NRC

Thomas C. Trbovich Observer Center for Nuclear Waste Regulatory

Analyses (CNWRA)

Patrick A. LaPlante Observer CNWRA

Michael A. Smith Observer CNWRA

3.2 Audit Team

Marilyn Kavchak Audit Team Leader OQA/Navarro Quality Services (NQS)

Harvey Dove QA Auditor OQA/NQS

Donald Harris QA Auditor OQA/NQS 

Sam Archuleta Technical Specialist OQA/NQS

Mark Nutt Technical Specialist OQA/NQS

Frank Wong Technical Specialist OQA/NQS

Alf Wikjord Technical Specialist OQA/NQS

4.0 REVIEW OF THE AUDIT AND AUDITED ORGANIZATION

OQA conducted this audit of BSC in accordance with OCRWM Quality Assurance Procedure

(QAP) 18.2, ìInternal Audit Program,î and QAP 16.1Q, ìPerformance/Deficiency Reporting.î 

NRC observed this audit based on NRC Manual Chapter 2410, ìConduct of Observation

Audits,î dated July 12, 2000.

4.1 Scope of the Audit

The audit team conducted a limited-scope performance-based audit of activities and processes

related to BSCís implementation of the QARD. The DOE audit team evaluated BSCís

processes and activities that support the Total System Performance Assessment for the Site

Recommendation (TSPA-SR) technical report. The team evaluated the quality of the report by

examining the development/analyses of scenarios; traceability/transparency of assumptions,

uncertainties, and alternative conceptual models; data and other input; and software control. 

The audit team also assessed the defensibility of the TSPA-SR results/conclusions and

evaluated the overall effectiveness of the TSPA-SR technical report. 

4.2 Conduct and Timing of the Audit

The observers determined that the audit was performed effectively and that the audit team

demonstrated an understanding of the applicable DOE and BSC programs and procedures. 

The observers also determined that the audit team members conducted thorough interviews;

that they challenged responses, when appropriate; and that they effectively used their detailed

audit checklist. The observers concluded that the timing of the audit was appropriate for the

audit team to evaluate ongoing BSC activities. The audit team and the observers caucused at

the end of each day. The audit team held daily meetings with BSC management (with the

observers present) to discuss the current audit status and the preliminary audit findings.

4.3 Audit Team Qualification and Independence 
4

The observers reviewed the qualifications of the audit team members for accuracy and

completeness in accordance with the requirements of Procedure QAP 18.1, ìAuditor

Qualification.î The observers also examined the levels of training, education, and experience of

the audit team members. The observers concluded that the audit team members had the

necessary expertise and were well-prepared to audit the subject matter in the QA program.

4.4 Examination of the QA Elements

The OQA programmatic and technical activities were conducted simultaneously, using a team

consisting of one technical specialist and one programmatic QA auditor. Often, during the audit,

certain programmatic aspects of the documents audited were independently reviewed by an

audit team member. The observers determined that the limited-scope audit focused on the QA

elements closely associated with the significant process steps of technical report development.

The team evaluated the quality of the TSPA-SR report by examining the development and

analysis of scenarios; performance of calculations and sensitivity analysis; incorporation of

design changes; traceability/transparency of assumptions, uncertainties of and alternative

conceptual models; data and other input; and software control, while assuring compliance with

the QARD requirements, as implemented in the BSC quality procedures. In addition, a review

of the status of OCRWM deficiency documents LVMO-00-117 through 121 was also performed. 

4.4.1 AP-2.21Q, Rev. 0, ICN 0, ìQuality Determinations and Planning activities for

Scientific, Engineering, and Regulatory Compliance Activitiesî

The Technical Work Plan (TWP) for Total System Performance Assessment, TWP-MGR-PA000001, Rev 01, dated 2-27-01, was reviewed and found to be in compliance with the

procedural requirements. The OCRWM Activity Evaluation form had been properly executed.

The observers agreed with the audit teamís findings in this area.

4.4.2 AP-2.14Q, Rev. 1, ICN 0, ìReview of Technical Products and Dataî

The auditors examined the check and back check record copies of the report/ICN revisions and

determined the checking activities had been accomplished in accordance with procedural

requirements. Comment/resolution forms had been completed and check personnel had 

proper qualification and training. The review of these records was difficult because of the

disorganization of the individual record packages. Because of the late arrival of these records

from archival storage, the QA auditor will continue this review the week following the audit.

4.4.3 AP-SI.1Q, Rev. 3, ICN 0, ìSoftware Managementî

Two potential deficiencies were identified in this area. The software program, ASHPLUME, had

version 1.4LV and 2.0 identified in the report as being used. Version 1.4LV had been properly

qualified and validated. Since Version 2.0 had not undergone qualification and validation, this

was identified as the first deficiency. In addition, since the code had not been documented and

identified as unqualified ìfor interim use,î as described by the procedure, a second deficiency

was noted. 

The observers agreed with the audit teamís findings in this area.
5

4.4.4 AP-3.11Q, Rev. 1, ICN 3, ìTechnical Reportsî

AP-3.12Q, Rev. 0, ICN 3, ìCalculationsî

The review of the report Appendix G calculations revealed a potential discrepancy. It appears

the calculation review was not performed to the more stringent requirements of AP-3.12Q but

rather to the less restrictive requirements of AP-3.11Q. Discussions indicated disagreement

over the interpretation and applicability of the requirements of each procedure. The observers

agreed with this deficiency.

Further review of the data packages and models in this area led to the determination of

repetitive conditions that had been previously identified in LVMN-01-D-118 and LVMO-99-C001, dealing with transparency issues. The audit team determined that the TSPA-SR report

transparency is insufficient because of: process inadequacies, and ineffective and/or

undocumented checking; lack of data traceability; and the lack of supporting objective evidence

to sufficiently substantiate conclusions. This was identified as a potential significant condition

adverse to quality at the closing meeting. 

The observers agreed with the audit teamís findings in this area.

4.5 Technical Summary

The technical observers were satisfied by the technical expertise and overall performance of

the audit teams and technical staff participating in the audit. Audit team questions were

appropriate and thorough, leading to identification of issues important for confirming the

technical quality of the work reviewed. Staff were cooperative and candid in discussions with

the audit teams. Technical observers were provided ample freedom to ask questions pertinent

to the scope of the audit and were satisfied with the overall conduct of the audit sessions. 

Observers generally concur with the findings of the audit team. In particular, the lack of

transparency in the documentation of the modeling work for the TSPA-SR appears to create a

difficulty for independent technical reviewers in understanding the details of specific analyses

(e.g., difficult to understand the details of how some of the more complicated barrier

neutralization modeling efforts were done). The apparent misapplication of procedures or use

of inadequate procedures for checking calculations has also led to identification of a situation

where some TSPA calculations were not thoroughly checked by reviewers for technical

adequacy and correctness. Most of the calculations associated with the TSPA-SR technical

report were checked internally, according to the performance assessment staff. However little

or no documentation was created as a direct result of time constraints. Most auditees

expressed dissatisfaction with the amount of time allotted in the document development

process to ensure sufficient quality. The following are summaries for segments of the audit that

were observed.

4.5.1 Development of Potential Exposure Scenarios

The audit of development of potential exposure scenarios included a review of technical product

input. The primary topics addressed by the audit team were: (i) the method of scenario

development from the features, events, and processes database; (ii) scenario construction

comprehensiveness; (iii) procedures governing the scenario development process; (iv)

transparency of the scenario development process; (v) risk dilution introduced by the scenario

development process; (vi) lack of clarity of identification of the system boundaries; and (vii) use

of expert elicitation.
6

The audit team interviewed two technical staff members familiar with the scenario development

process. The audit team concluded that no formal procedure exists for conducting scenario

development, but the description of the process in reviewed documents was sufficiently

explained and conforms to international standards. The observers concurred with the audit

team finding that no issues were discovered for this part of the audit.

4.5.2 Planning and Quality Determinations

The audit of planning and quality determinations led to investigations related to transparency,

traceability, and the inability to reproduce model results. The primary concerns addressed by

the audit team were related to transparency and traceability and the review process used for

the TSPA-SR.

The audit team explored the documentation of sensitivity analyses reported in Appendix G of

the TSPA-SR. The process was determined to be transparent in the sense that the data and

model files that were used can be easily located. However, information on how a file was

modified for a particular task (i.e., degraded barrier analysis, sensitivity analysis) was not

formally documented, and could only be determined through a laborious comparison of

archived input files, leading to lack of transparency. This lack of transparency in TSPA

modeling documentation can adversely impact reviews of the technical adequacy of the TSPA

modeling work. 

Questions were also raised on the decision both to: (i) deviate from the work plan by using

AP3.11Q instead of AP3.12Q, for documentation and review of calculations; and (ii) not follow

the intent of AP3.11Q, by providing insufficient documentation of the calculation review process. 

Technical staff members were asked to describe the document review process. The author of

AP3.11Q stated that the intent of the procedure was to require the same level of review

required by AP3.12Q. However, this point was not clear from the auditor's review of the

AP3.11Q procedures (AP3.11Q contained fewer calculation check requirements overall and no

review of technical adequacy). The observers concurred with the audit team conclusion that

implementation of AP3.11Q by DOE was not documented to the same level of rigor as required

by AP3.12Q, and that the methods and results reported in Appendix G of the TSPA-SR were

not transparent and traceable. Without such documentation, there was no objective evidence

that the technical adequacy of the calculations had been checked. 

4.5.3 Review of Technical Product

The review of the technical product investigated the technical quality of the TSPA-SR. This part

of the audit intended to look at the technical work conducted for the sensitivity analyses

reported in Appendix G of the TSPA-SR. The audit team encountered immediate difficulty

because of the inaccessible records and questionable review documentation discussed in the

previous section.

The audit team also explored a concern raised by the observers about the lack of requirements

for technical specialists to respond to warnings and error messages recorded in the run log

produced during operation of the GoldSim model. The issue originated from observing

discussions among auditors and technical specialists where it was found that TSPA-SR

GoldSim error logs for stochastic calculations were not saved during code execution and

therefore were not reviewed by the staff. This circumstance caused observers to question how

staff was able to confirm that no significant run errors occurred during the TSPA-SR stochastic

GoldSim runs. A related question was raised by observers regarding why the existence of
7

errors in the log files did not lead to generation of a software deficiency notice. Technical staff

responded to the observer concerns. The technical staff members and the audit team agreed

that no requirement exists for operators of the GoldSim model to review, respond to, and

document run log messages. Although the technical staff members stated that a review of the

run log error and warning messages had been conducted for the median-value problem (and no

significant problems were identified), the observers concurred with the audit team

recommendation that this process should be formally documented. Technical specialists stated

that modifications to GoldSim since completion of the TSPA-SR work has provided the

capability to output error logs for stochastic runs. Therefore, staff will have the capability to

check this information in the future.

4.5.4 Software

The audit team reviewed the use of software for development of the TSPA-SR. The audit team 

discovered a problem with the use of ASHPLUME v2.0, which continues to be unqualified

software. The process for qualifying ASHPLUME v2.0 for interim use was initiated, but not

completed. The technical expert stated that results from ASHPLUME v2.0 were used as

corroborative evidence and the software would not need to be qualified. Further, the expert

stated that no data were generated, or included in the TSPA-SR, that originated from use of

ASHPLUME v2.0, and that no decisions were based on results of ASHPLUME v2.0. This

statement was the subject of debate and interpretation between the audit team and technical

staff members. The observers concurred with the audit team finding that the unqualified status

of ASHPLUME v2.0 was not properly documented in the TSPA-SR and, under the existing

documentation in TSPA-SR, the software should have been qualified before use. Technical

observers viewed the findings as primarily a procedural issue; however, the development status

of software used in technical reports can impact the assessment of technical adequacy of

calculations and confidence in results.

4.5.5 Records

The audit team reviewed the record package associated with the TSPA-SR ICN00 and TSPASR ICN01, to ensure that the appropriate QA procedures, specifically AP2.14Q, AP3.10Q, and

AP3.11Q, had been followed. The review of the record package for the TSPA-SR ICN01

indicated that procedures had been followed. The audit team reported that the record package

for TSPA-SR ICN00 was disorganized and made any assessment of technical adequacy

exceedingly difficult. The audit team reported that it was not satisfied with the way the ìstory

boardî method was used to track the review process. At the post-audit meeting, the audit team

indicated that no major problems had been discovered, but that this item would remain open

and the investigation of the TSPA-SR ICN00 record package would continue into the following

week.

5.0 NRC Staff Findings

During the audit exit, the observers expressed appreciation for the cooperation and

responsiveness provided to them during their observation activities. In addition, the observers

stated that they agreed with the audit team findings and recommendations, as presented at the

audit exit. Also, during the audit exit, the observers stated that they will continue to interface

with DOE and BSC and follow the progress that DOE and BSC are making to address the

issues identified during this audit. 
8

The NRC feels it is important to identify that the Phase 2 audit (August 20-24, 2001) discussed

in this report did not fully address all of the areas identified in the scope of the Phase 1 Audit

Report (M&O-ARP-00-13), dated October 23, 2000. Final planning for the Phase 2 audit

identified a more limited scope than initially planned. The NRC believes the audit team did fully

cover the more limited scope.

The scope of the Phase 1 Audit Report states: "Note that two activities planned for the audit

during phase 1 could not be assessed, i.e., development/analysis of scenarios and

performance/documentation of the TSPA-SR model." It further states: "The Phase 2 audit,

which is tentatively scheduled for the first quarter of fiscal year 2001, is to address the

incorporation of design changes, performance of calculations, sensitivity analysis, evaluation of

parameter ranges and uncertainties, transparency, and defensibility of TSPA-SR results and

conclusions." While the Phase 2 audit did cover many of these items, it only partially covered

the performance of the TSPA-SR model and performance of calculations. The NRC's

observation is that the Phase 2 audit did not cover evaluation of parameter ranges and

uncertainties, the TSPA-SR model report documentation and review, or the defensibility of the

TSPA-SR results and conclusions.

5.1 NRC Audit Observer Inquiries

The observers did not generate any Audit Observer Inquiries (AOIs) during the audit.

5.2 Closure of Previous NRC Audit Observation Inquiries

The following AOI has been closed: 

AOI No. M&O-APR-01-01-01, February 2001, was written to identify an observer inquiry

for ANL-EBS-MD-000033. Several agreements made at the NRC/DOE Technical

Exchange (January 9-12, 2001, Pleasanton, CA) on Evolution of the near Field

Environment (EMFE) indicate that new data and analysis will be presented in the "EBS:

Physical and Chemical Environment Model AMR (ANL-EBS-MD-000033)," expected to

be available in FY 02. The following NRC/DOE agreements point specifically to the FY

02 revision of this AMR: ENFE 2.04; ENFE 2.06; ENFE 2.08; ENFE 2.11; ENFE 2.13,

and ENFE 2.18. ENFE 2.05 and ENFE 2.17 also point to this AMR, although they state

the information can be provided in other documents as appropriate. During the M&OARP-01 audit of ANL-EBS-MD-000033, Rev. 01, in Las Vegas, NV (February 20-23,

2001), however, audit team members questioned the usefulness of producing additional

revisions of this AMR. If data and analyses required to fulfill NRC/DOE agreements

listed above are not presented in a FY 02 revision of the ANL-EBS-MD-000033 AMR,

where will this information be presented?" (Refer to U.S. NRC's Observation Audit

Report No. QAR-01-03).

This AOI has been closed based on DOEís response to the Office of Civilian

Radioactive Waste Management (OCRWM) Quality Assurance NRC Audit Observer

Inquiry (AOI) from Audit M&O-ARP-01-01-01 provided in a letter from S. Brocoum to

C.W. Reamer dated 10-01-01. The NRC reviewed the letter, and determined that the

DOE response to this AOI was satisfactory. The NRC considers the status of the AOI

from Audit M&O-ARP-01-01-01 to be closed.
9

5.2 Open NRC AOIs from Previous NRC Observations

The following AOI from a previous DOE audit observed by NRC, remains open:

AOI No. M&O-APR-01-02-4, dated February 9, 2001, was written to identify an observer

inquiry for ANL-NBS-HS-00032. The AOI states: "The work upon which this model is

based (Flint, et al., 1996, "Conceptual and Numerical Model of Infiltration at Yucca

Mountain") is unqualified. (See OCRWM QA Audit Report M&O APR-00-04)(p. 9). Was

information used to support conclusions made in the Infiltration AMR? If yes, describe

how the Flint, et al. (1996) data were qualified and assumptions verified. NRC requests

additional information and details. (Refer to U.S. NRC's Observation Audit Report

No. OAR-00-04)."