UNITED STATES 

NUCLEAR REGULATORY COMMISSION 

WASHINGTON, D.C. 20555-0001 

March 5, 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 COMMISSION'S OBSERVATION AUDIT 

REPORT NO. OAR-01 -03, "OBSERVATION AUDIT OF THE OFFICE OF 

CIVILIAN RADIOACTIVE WASTE MANAGEMENT, QUALITY ASSURANCE 

DIVISION, AUDIT NO. M&O-ARP-01 -02" 

Dear Mr. Milner: 

I am transmitting the U.S. Nuclear Regulatory Commission's (NRC's) Observation Audit Report 

(No. OAR-01-03), of the U.S. Department of Energy's (DOE's), Office of Civilian Radioactive 

Waste Management (OCRWM), Quality Assurance Division's,(OQA's), audit of activities 

regarding to the "Unsaturated Zone Flow and Transport Model Process Model Report" (UZ 

PMR). The UZ PMR was prepared by, and the supporting activities performed by, the OCRWM 

Management and Operating Contractor (M&O), and the U.S. Geological Survey. This audit was 

conducted on February 5 through 9, 2001, at the M&O facilities in Las Vegas, Nevada. 

UZ PMR activities and selected Analysis Model Reports (AMRs) were previously audited on 

January 24 through 28, 2000, and at that time, several of the documents audited were in the 

process of being developed. The purpose of this performance-based audit was to evaluate the 

effectiveness of the implementation of the OCRWM Quality Assurance Program described in 

the Quality Assurance Requirements and Description document, and its implementing 

procedures for the UZ PMR and selected AMRs supporting the UZ PMR. Also, the audit 

evaluated action taken as a result of the findings and recommendations from the January 2000 

UZ audit. 

The NRC observers (observers) determined that this audit was effective in identifying potential 

deficiencies and recommending improvements for the PMR and AMRs reviewed. During the 

conduct of the audit, both the OQA audit team (audit team) and the observers independently 

reviewed applicable analysis reports and supporting data, models, and software. 

Within the areas evaluated, the audit team identified four potential deficiencies, of which two 

were corrected during the conduct of the audit. Subsequent to the audit, one potential 

deficiency was resolved. The remaining potential deficiency identified procedure compliance 

problems with processing input transmittals for UZ PMR and AMR activities.
R.A. Milner

Although the UZ PMR appeared to satisfactorily compile the results of the supporting AMRs, 

the audit team made 20 recommendations regarding the content of AMR No. ANL-NBS-HS

000017 (U0085), "Analysis of Geochemistry Data," Revision 0, with Change Notice No. 1. 

Except for AMR No. U0085, there were very few audit team recommendations. Although not 

discussed during the audit nor the audit exit, the Division of Waste staff is concerned that the 

number of audit team recommendations for AMR No. U0085 may reflect some inattention to 

detail by the AMR preparers and reviewers. 

As discussed in the attached report, the observers submitted four audit observer inquiries 

(AOIs) requesting clarification and information on audited documents. The AOIs addressed 

outstanding recommendations identified in the NRC observation report from the January 2000 

UZ PMR audit activities. 

Although the audit team identified some potential deficiencies, and four AOIs requesting 

clarification and information were generated, the observers believe that the AMRs and PMR 

reviewed during the audit were technically sound and that these products indicated an 

improving trend over several AMRs and PMRs audited during the past year. The observers 

agreed with the audit team's conclusions, findings, and recommendations presented at the 

audit exit. 

During the audit, the observers met with the M&O personnel responsible for the qualification of 

data and software supporting the potential DOE site recommendation for a high-level waste 

repository. The observers were informed that as of January 30, 2001, 85 percent of the data 

and 97 percent of the software supporting site recommendation were fully qualified. 

A written response to this letter and the enclosed report is not required; however, we do request 

that you respond to the four AOIs. The responses to the AOIs should be entered on the 

appropriate AOI form and forwarded either to the NRC Onsite Representatives or to Larry L. 

Campbell at NRC headquarters. If you have any questions, please contact Larry L. Campbell 

at (301) 415-5000. 

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 -03, "Observation Audit 

of the Office of Civilian Radioactive 

Waste Management, Quality Assurance 

Division, Audit No. M&O-ARP-01-02" 

DISTRIBUTION: 

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JWinterle TCarter DBrooks Tmatula HArlt 

ADAMS Accession No. (later) This document is Non-Sensitive 

DOCUMENT NAME: S/DWM/HLWB/llc/Unsaturated Zone Audit Observation Feb 2001.wpd *See Previous concurrence 

OFC HLWB *Tech Editor I HL 4 - I4e I HLWB iiii 

NAME LLCampbell •( EKraus NKSta/ "e CWReamer (JVV 

DATE 02/f'/0 1 I 02/22/01 I 3/ I I8 01 

OFFICIAL COPY 

ACNW: YES X NO Delete file after distribution: Yes_ No__ 

1) This document should be made available to the PUBLIC. Yes - Iic3 

2) This document is related to the HLW program. It should be placed in the LSS. Yes - I1c3

2
R.A. Milner

Although the UZ PMR appeared to satisfactorily compile the results of the supporting AMRs, 

the audit team made 20 recommendations regarding the content of AMR No. ANL-NBS-HS

000017 (U0085), "Analysis of Geochemistry Data," Revision 0, with Change Notice No. 1. 

Except for AMR No. U0085, there were very few audit team recommendations. Although not 

discussed during the audit nor the audit exit, the Division of Waste staff is concerned that the 

number of audit team recommendations for AMR No. U0085 may reflect some inattention to 

detail by the AMR preparers and reviewers. 

As discussed in the attached report, the observers submitted four audit observer inquiries 

(AOIs) requesting clarification and information on audited documents. The AOIs addressed 

outstanding recommendations identified in the NRC observation report from the January 2000 

UZ PMR audit activities. 

Although the audit team identified some potential deficiencies, and four AOIs requesting 

clarification and information were generated, the observers believe that the AMRs and PMR 

reviewed during the audit were technically sound and that these products indicated an 

improving trend over several AMRs and PMRs audited during the past year. The observers 

agreed with the audit team's conclusions, findings, and recommendations presented at the 

audit exit. 

During the audit, the observers met with the M&O personnel responsible for the qualification of 

data and software supporting the potential DOE site recommendation for a high-level waste 

repository. The observers were informed that as of January 30, 2001, 85 percent of the data 

and 97 percent of the software supporting site recommendation were fully qualified. 

A written response to this letter and the enclosed report is not required; however, we do request 

that you respond to the four AOIs. The responses to the AOls should be entered on the 

appropriate AOI form and forwarded either to the NRC Onsite Representatives or to Larry L. 

Campbell at NRC headquarters. If you have any questions, please contact Larry L. Campbell 

at (301) 415-5000. 

Sincerely, 

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-01-03, "Observation Audit 

of the Office of Civilian Radioactive 

Waste Management, Quality Assurance 

Division, Audit No. M&O-ARP-01-02"

2
Letter to R. Milner from C.W. Reamer dated:

cc: 

R. Loux, State of Nevada 

S. Frishman, State of Nevada 

L. Barrett, DOE/Washington, DC 

A. Brownstein, DOE/Washington, DC 

S. Hanauer, DOE/Washington, DC 

C. Einberg, DOE/Washington, DC 

J. Carlson, DOE/Washington, DC 

N. Slater, DOE/Washington, DC 

A. Gil, YMPO 

R. Dyer, YMPO 

S. Brocoum, YMPO 

R. Clark, YMPO 

S. Mellington, YMPO 

C. Hanlon, YMPO 

T. Gunter, YMPO 

K. Hess, BSC 

D. Krisha, BSC 

S. Cereghino, BSC 

M. Voegele, BSC/SAIC 

S. Echols, Winston & Strawn 

B. Price, Nevada Legislative Committee 

J. Meder, Nevada Legislative Counsel Bureau 

D. Bechtel, Clark County, NV 

E. von Tiesenhausen, Clark County, NV 

A. Kalt, Churchill County, NV 

G. McCorkell, Esmeralda County, NV 

L. Fiorenzi, Eureka County, NV 

A. Johnson, Eureka County, NV 

A. Remus, Inyo County, CA 

M. Yarbro, Lander County, NV

R. Massey, Lander County, NV 

J. Pitts, Lincoln County, NV 

M. Baughman, Lincoln County, NV 

A. Funk, Mineral County, NV 

J. Shankle, Mineral County, NV 

L. Bradshaw, Nye County, NV 

M. Murphy, Nye County, NV 

J. McKnight, Nye County, NV 

D. Weigel, GAO 

W. Barnard, NWTRB 

R. Holden, NCAI 

A. Collins, NIEC 

R. Arnold, Pahrump County, NV 

J. Larson, White Pine County 

R. Clark, EPA 

F. Marcinowski, EPA 

R. Anderson, NEI 

R. McCullum, NEI 

S. Kraft, NEI 

J. Kessler, EPRI 

D. Duncan, USGS 

R. Craig, USGS 

W. Booth, Engineering Svcs, LTD 

J. Curtiss, Winston & Strawn 

N. Rice, NV Congressional Delegation 

T. Story, NV Congressional Delegation 

J. Reynoldson, NV Congressional Delegation 

S. Joya, NV Congressional Delegation 

J. Pegues, City of Las Vegas, NV 

L. Lehman, T-Reg, Inc.

March 5. 2001
U.S. NUCLEAR REGULATORY COMMISSION

OBSERVATION AUDIT REPORT NO. OAR-01 -03 

"OBSERVATION AUDIT OF THE 

OFFICE OF CIVILIAN RADIOACTIVE WASTE MANAGEMENT 

OFFICE OF QUALITY ASSURANCE 

AUDIT NO. M&O-ARP-01-02"

/R/ 02/27/01 

Robert Latta 

Repository Site Section 

High-Level Waste Branch 

Division of Waste Management 

/R/ 02/26/01 

James Winterle 

Center for Nuclear Waste Regulatory 

Analyses

/R/ 02/27/01

Hans Arlt 

Repository Site Section 

High-Level Waste Branch 

Division of Waste Management

Reviewed and Approved by: 

_ 031/0401 

4Ný.ng ýStablein, Chief 

Projects and Engineering Section 

High-Level Waste Branch 

Division of Waste Management

Enclosure
1.0 INTRODUCTION

Staff from the U.S. Nuclear Regulatory Commission (NRC) Division of Waste Management and 

contractors from the Center for Nuclear Waste Regulatory Analyses (CNWRA) observed the 

U.S. Department of Energy's (DOE's), Office of Civilian Radioactive Waste Management 

(OCRWM), Quality Assurance Division's (OQA's), audit of activities regarding to the 

"Unsaturated Zone Flow and Transport Model Process Model Report" (UZ PMR). The UZ PMR 

was prepared by and the supporting activities performed by the OCRWM Management & 

Operating Contractor (M&O) and the U.S. Geological Survey (USGS). This audit, M&O-.ARP

01-02, was conducted on February 5-9, 2001, at the M&O facilities in Las Vegas, Nevada. 

The UZ PMR activities and selected Analysis Model Reports (AMRs) were previously audited on 

January 24-28, 2000 (OQA Audit No. M&O-ARP-00-04), and at that time, several of the 

documents audited were still in the process of being developed. The purpose of this audit was 

to evaluate the implementation of the applicable provisions contained in the OCRWM Quality 

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

evaluating the UZ PMR and selected AMRs supporting the UZ PMR. Also, the audit evaluated 

action taken as a result of the findings and recommendations from the January 2000 UZ audit. 

During the audit, the PMR and four AMRs were subjected to a technical evaluation as well as 

evaluation to ensure that the applicable programmatic requirements contained in the QARD and 

implementing procedures were met. 

The NRC observers' (observers') objective was to assess whether the M&O, USGS, and OQA 

are properly implementing the provisions contained in the QARD and the requirements 

contained in Subpart G, "Quality Assurance," to Part 60, of Title 10 of the U.S. Code of Federal 

Regulations (10 CFR Part 60). Because of the anticipated DOE submittal of the Site 

Recommendation (SR) for a high-level waste repository, the following observation activities 

were emphasized: 1) confirming that data, software, and models supporting SR are properly 

qualified; 2) evaluating the progress being made by DOE and its contractors in meeting the 

data and software qualification goals for SR; and 3) ensuring the technical adequacy of the 

PMR and AMRs within the scope of the OQA audit. 

This report addresses the observers' determination of how effective the OQA audit was, and 

whether the M&O implemented adequate QARD controls in the audited areas of the UZ PMR 

and the adequacy of implementation of QARD controls by the M&O in the audited areas of UZ 

PMR and AMR development. 

2.0 MANAGEMENT SUMMARY 

The observers agreed with the audit team's (audit team's) conclusions, findings, and 

recommendations. The observers determined that OQA Audit M&O-ARP-01 -02 was well

planned and effectively implemented. The audit team members were independent of the 

activities they audited and were knowledgeable in the quality assurance (QA) and technical 

disciplines within the scope of the audit. The audit team qualifications were reviewed and were 

found acceptable.

I
Within the areas evaluated, the audit team identified four potential deficiencies. Two 

deficiencies were corrected during the audit; one was determined, subsequent to the audit, not 

to be a deficiency; and the following potential deficiency remained open: input transmittals were 

not processed in accordance with procedure. The audit team made several recommendations 

about the content of the documents reviewed including: a) justification for selection of base

case models over alternative models; b) exemption of a software package from procedure 

requirements; and c) several recommendations, for the AMR, addressing the analysis of 

geochemistry data, including changes in text of the AMR to improve traceability, transparency, 

justification of assumptions, clarity of the AMR purpose, and the need for additional discussion 

of alternative models (see Section 4.5.3 of this report). 

As discussed in the attached report, the observers submitted four audit observer inquiries 

(AOIs) requesting clarification and information on audited documents. The AOIs addressed 

outstanding recommendations identified in the NRC observation report from the January 2000 

UZ audit. 

Although the audit team identified some potential deficiencies, and four AOls requesting 

clarification and information were generated, the observers believe that the AMRs and PMR 

reviewed during the audit were technically sound and that these products indicated an 

improving trend over several AMRs and PMRs audited during the past year. 

Overall, the audit team concluded that the OCRWM QA program had been satisfactorily 

implemented in the areas evaluated. The observers generally agreed with the audit team's 

conclusion. 

3.0 AUDIT PARTICIPANTS 

3.1 Observers

Robert Latta 

Hans Arlt 

James Winterle

Team Leader 

Technical Specialist 

Technical Specialist

Robert Hartstern 

Samuel Archuleta 

Robert Hasson 

Richard Powe 

Richard Weeks 

Keith Kersch 

Thomas Doe 

Levy Kroitoru

Audit Team Leader 

Auditor 

Auditor 

Auditor 

Auditor 

Technical Specialist 

Technical Specialist 

Technical Specialist

OQA/Quality Assurance Technical 

Support Services (OQA/QATSS) 

OQA/QATSS 

OQA/QATSS 

OQA/QATSS 

OQA/QATSS 

SAIC 

Management & Technical Services 

Management & Technical Services

2

3.2 OQA Audit Team

NRC 

NRC 

CNWRA
4.0 REVIEW OF THE AUDIT AND AUDITED ORGANIZATION

This OQA audit of the M&O was conducted in accordance with OCRWM Quality Assurance 

Procedure (QAP) 18.2, "Internal Audit Program," and QAP 16.1Q, "Performance/Deficiency 

Reporting." The NRC staff's observation of this audit was based on NRC Manual Chapter 

2410, "Conduct of Observation Audits," dated July 12, 2000. 

4.1 Scope of the Audit 

The UZ PMR activities and selected AMRs were previously audited on January 24-28, 2000, 

and at that time, several of the documents audited were in the process of being developed. 

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

related to the development of the AMRs supporting the UZ PMR. Audit activities included 

evaluation of the UZ PMR, four AMRs, selected software, and associated data. The audit also 

included review of the programmatic controls governing the AMRs and technical requirements 

contained in the AMRs. Further, the audit evaluated action taken as a result of the findings and 

recommendations from the January 2000 UZ PMR audit. 

The implementation of the following procedures for the audited activities, and the preparation of 

the following AMRs and the UZ PMR were evaluated by the audit team and the observers 

during the audit: 

Procedures 

a) AP-2.1Q, "Indoctrination and Training of Personnel," Revision 0, with Interim Change 

Notice (ICN) No. 0 

b) AP-2.2Q "Establishment and Verification of Required Education and Experience of 

Personnel," Revision 0, with ICN No. 0 

c) AP-2.13Q, "Technical Product Development Planning," Revision 0, with ICN No. 4 

d) AP-2.14Q, "Review of Technical Products," Revision 1, with ICN No. 1 

e) AP-2.15Q, "Work Package Planning Summaries," Revision 0, with ICN No. 1 

f) AP-3.4Q, "Level 3 Change Control," Revision 2, with ICN No. 0 

g) AP-3.10Q, "Analysis and Models," Revision 2, with ICN No. 3 

h) AP-3.11Q, "Technical Reports," Revision 1, with ICN No. 1 

i) AP-3.14Q, "Transmittal of Input," Revision 0, with ICN No. 2 

j) AP-3.15Q, "Managing Technical Product Inputs," Revision 2, with ICN No. 0 

k) AP-3.17Q, "Impact Reviews," Revision 1, with ICN No. 0 

I) AP-SI.1Q, "Software Management," Revision 2, with ICN No. 4, ECN No. 1 

m) AP-SIII-1Q, "Scientific Notebooks," Revision 1, with ICN No. 0

3
n) AP-SIII.2Q, "Qualification of Unqualified Data and the Documentation of Rationale for 

Accepted Data," Revision 0, with ICN No. 2 

o) AP-SIII.3Q, "Submittal and Incorporation of Data to the TDMS," Revision 0, with ICN 

No. 3 

p) AP-SV.1Q, "Control of the Electronic Management of Data," Revision 0, with ICN No. 2 

q) QAP-2.0, "Conduct of Activities," Revision 0 

r) QAP 16.1Q, "Management of Conditions Adverse to Quality," Revision 4, with ICN No. 1 

s) QAP-18.1Q, "Auditor Qualification," Revision 6, with ICN No. 0 

t) QAP-18.2Q, "Internal Audit Program," Revision 8, with ICN No. 0 

u) AP-2.21, "Quality Determinations and Planning for Scientific, Engineering, and 

Regulatory Compliance Activities," Revision 0 

PMR 

a) TDR-NBS-HS-000002, "Unsaturated Zone Flow and Transport Process Model Report," 

Revision 00, with ICN No. 02 

AMRs 

a) U0010 (ANL-NBS-HS-00032), "Simulation of Net Infiltration for Modern and Potential 

Future Climates," Revision 00, with ICN No. 01 

b) U0085 (ANL-NBS-HS-000017), "Analysis of Geochemistry Data," Revision 00, with 

ICN No. 01 

c) U01 1 0/NO1 20 (MDL-NBS-HS-000001), "Drift Scale Coupled Processes (DST and THC 

Seepage) Models," Revision 01 

d) U01 75 (MDL-NBS-GS-00001 1), "Future Climate Analysis - 10,000 Years To 1,000,000 

Years After Present," Revision 00 

4.2 Conduct and Timing of the Audit 

The audit was performed effectively and the audit team demonstrated a sound knowledge of 

the applicable M&O and DOE programs and procedures. Audit team members conducted 

thorough interviews, they challenged responses, when appropriate, and they effectively 

employed their detailed audit checklists. The observers concluded that the timing of the audit 

was appropriate for the auditors to evaluate ongoing UZ PMR activities. The audit team and 

the observers caucused at the end of each day. Meetings between the audit team and M&O 

management (with the observers present) were also held to discuss the current audit status and 

preliminary findings.

4
4.3 Audit Team Qualification and Independence

The qualifications of the audit team leader and the audit team were reviewed for accuracy and 

completeness in accordance with the requirements of Procedure QAP 18.1, "Auditor 

Qualification." The observers' review included an examination of the training, education, and 

experience of the audit team members. The observers concluded that the audit team 

members, including the technical specialists, had the necessary expertise and were well

prepared to audit the subject matter in the PMR and AMRs. 

4.4 Examination of QA Elements 

The OQA programmatic and technical audit activities were conducted simultaneously using 

sub-audit teams generally consisting of at least one technical specialist and one QA auditor. 

Often during the audit, certain programmatic aspects of the documents audited were 

independently reviewed by a audit team member. The observers determined that the limited

scope audit focused on the QA elements closely associated with the development of the AMRs. 

The observers evaluated the audit team's review of the following QA elements. 

4.4.1 AP-2.13Q, "Technical Product Development Planning" 

The audit team reviewed technical development plans and work product planning sheets 

applicable to the subject AMRs. In addition, the audit team reviewed the methodology for the 

product development, including the tracking of unresolved issues such as inputs requiring 

qualification, to be verified (TBV). The observers agreed with the audit team's findings in 

this area and made no additional findings nor observations. 

4.4.2 AP-SI.1Q, "Software Management" 

Software controls associated with the UZ PMR and AMRs were discussed during each of the 

technical interviews. The audit team reviewed qualification documentation and determined that 

the requirements of the software management procedure had been met, with the exception of 

computer software package ARCINFO, Version 6.1.2, for AMR No. U0010, on infiltration. 

However, the audit team concluded, that use of the ARCINFO software was limited to visual 

display of data. Therefore, the audit team recommended that the use of the ARCINFO 

software be evaluated to determine if it is exempt from AP-SI.1Q because of its use in the 

AMR. Notwithstanding this recommendation, the audit team made a positive comment that 

software routines in the AMR No. U0010 were well-documented. The observers agreed with 

the audit team findings in this area and made no additional observations nor inquiries. 

4.4.3 AP-3.15Q, "Managing Technical Product Inputs" 

Each of the AMRs examined included document input reference sheets that list the inputs to 

and references cited in the AMR. The document input reference sheets also identify the status 

of the input (e.g., qualified, TBV). The audit team examined the TBV status and determined 

that it generally included the appropriate statements in accordance with the "Analysis/Model 

Documentation Outline." The observers agreed with the audit team findings in this area and 

made no additional findings nor observations.

5
4.4.4 AP-3.100, "Analysis and Models"

The audit team used Procedure No. Ap-3.1OQ to evaluate the activities covered during the 

audit. By definition, this procedure applies to activities pertaining to the development, 

documentation, checking, review, approval, and revision of analyses or models, and the 

calibration, validation, or use of models to support scientific, engineering, or performance

assessment work activities. 

The audit team generally concluded that the requirements of Procedure AP-3.1OQ had been 

appropriately implemented for AMR Nos. U0010, U0085, U01 75, and U01 10/N0120. The 

observers agreed with the audit team findings in this area and made no additional findings 

nor observations. 

4.4.5 AP-2.14Q, "Review of Technical Products" 

The observers held discussions with cognizant individuals in the Data/Software Qualification 

Department and reviewed selected data tracking number (DTN) sets to gain insights into the 

verification methodology to resolve TBVs. As a result of reviews and discussions, the 

observers determined that significant progress was being made. The observers were informed 

that on January 31, 2001, approximately 85 percent of the data and 97 percent of the software 

supporting site recommendation were fully qualified. 

4.4.6 Potential Deficiencies 

The audit team identified the following potential deficiencies: 

One potential deficiency identified that the Technical Data Management System (TDMS) 

database access list was not being submitted to the Records Processing System, as 

required by Procedure No. AP-S.III.3Q. Subsequent to the audit exit, the audit team 

determined that the TDMS access list was maintained electronically and that Procedure 

No. AP-S.III.3Q had been satisfied because the access list was being electronically 

submitted. 

The second potential deficiency identified two examples where the responsible M&O 

manager failed to follow the provisions contained in Paragraph 5.4.3 of Procedure No. 

AP-3.14Q. Specifically, the responsible manager failed to sign a copy of the PMR and 

AMR input transmittal and forward the completed transmittal to the Input Tracking 

Coordinator. These two examples of this deficiency were corrected during the conduct 

of the audit. However, as a result of these two examples, the audit team performed 

additional reviews and identified additional examples of the apparent failure to follow 

procedure. As a result of the investigation of the input transmittals referenced in the UZ 

PMR, the audit team issued a potential deficiency to evaluate the extent of this 

condition. 

4.5 Examination of Technical Activities 

The technical specialists on the audit team performed detailed reviews of the technical 

adequacy of the UZ PMR and AMRs audited. The observers assessed the audit team's 

performance of these reviews and were given an opportunity to perform a review of the

6
technical adequacy of the documents. Also, the observers were given an opportunity to ask 

questions during the audit. 

As discussed in the following paragraphs, the observers generally agreed with the audit team 

findings in this area; however, the observers identified and discussed a few areas of concern, 

as discussed in the following sections, with the audit team. 

4.5.1 PMR No. TDR-NBS-HS-000002, "Unsaturated Zone Flow and Transport Model," 

Revision 00, ICN 02 

The UZ PMR documents the integration of outputs from submodels for climate, infiltration, 

unsaturated flow, drift seepage, and radionuclide transport to develop a simplified, yet robust 

approach for considering these processes in total-system performance assessments. 

The audit team technical specialist assigned to review the UZ PMR was well-prepared to 

conduct the audit. The PMR originator and cognizant PMR-development staff were available to 

answer the audit team's technical questions and provide information about software, data, and 

model documentation. The audit team technical specialist emphasized the importance of 

understanding how data outputs from the various submodels are treated to become input for 

the process model and other submodels. The audit team made two recommendations in this 

area: 1) justification should be provided for selecting the transport model with matrix diffusion 

over an alternative model with no matrix diffusion, because the use of matrix diffusion over no 

matrix diffusion in the transport models is not justified either in the PMR or in the supporting 

AMRs; and 2) review other alternative models in the PMR and add statements of justification for 

their exclusion, as necessary. The NRC observers agreed with the audit team 

recommendations. 

Several questions were focused on understanding how the "active fracture" concept is used to 

scale the effective fracture-matrix interface area as a function of percolation flux. An observer 

noted that since fracture-matrix interface area is greatly reduced by the active-fracture model, it 

seemed surprising that sensitivity studies show the process of matrix diffusion significantly 

delays transport of radionuclides to the water table. The observers discussed that since matrix 

diffusion is emerging as an important process, there is a strong need to verify that the active

fracture and matrix-diffusion models are properly integrated. During ensuing discussions, the 

audit team technical specialist suggested that a study of the sensitivity of the transport model to 

the active fracture parameter would be a useful. Also, the observers suggested that a 

sensitivity study be carried out showing that the active-fracture and matrix-diffusion models are 

properly integrated. The PMR authors agreed that this sensitivity study would enhance 

confidence in the model. 

4.5.2 AMR No. U0010 (ANL-NBS-HS-000032), "Simulation of Net Infiltration for Modern 

and Potential Future Climates," Revision 00, ICN 01 

This AMR produces spatially heterogeneous infiltration maps of average, high, and low 

infiltration rates for modern, monsoonal, and glacial transition climates for Yucca Mountain. 

The estimates of net infiltration are used for defining the upper boundary condition for the site

scale 3-dimensional flow model for the unsaturated zone.

7
The audit team technical specialist assigned to review this AMR was well-prepared to conduct 

the audit. The AMR checker and cognizant AMR-development staff were available to answer 

the audit team's technical questions and provide information about software, data, and model 

documentation. The technical specialist's questions were focused on the editorial changes that 

had been made since the last revision, and on the method of tracking the changes. The audit 

team did not identify any technical deficiencies in this AMR. The observers agreed with the 

audit team's findings. 

The observers evaluated whether recommendations made during a previous audit (NRC's 

Observation Audit Report No. OAR-00-04) were adequately addressed. The observer 

concluded that all but four of the previous recommendations were incorporated into the 

Infiltration AMR. The four exceptions are summarized as follows: 1) provide a technical basis 

for predicting how future climate might affect vegetation cover, and therefore infiltration, at 

Yucca Mountain; 2) validate assumptions stated in the distributed-parameter water-balance 

model to ensure that mean annual shallow infiltration estimates are not under-predicted; 3) 

provide a justification for not using time-steps smaller than 24 hours when performing surface

water flow routing and calculating daily net infiltration; and 4) describe how a previous infiltration 

model report (Flint et al., 1996, as identified in Section 6.0 of this report) was used in the 

Infiltration AMR. The audit team identified, as a concern, the unqualified nature of the Flint, et 

al. (1996) report during the previous audit of this particular AMR, in January 24-28, 2000. This 

concern was identified, as such, in the OCRWM QA Audit Report M&O APR-00-04. The AMR 

checker commented that the revised AMR supplants the Flint, et al. (1996) report entirely; 

however, the stated purpose in the AMR is that it "...describes enhancements made to the 

infiltration model documented in Flint, et al. (1996) and documents an analysis using the 

enhanced model." Further, it was discussed that Flint, et al. (1996) is also used as a reference 

for many assumptions asserted in the revised Infiltration AMR. The observers generated four 

AOls to document these omitted recommendations. Section 5.1 of this report provides 

additional detailed discussion on these four AOls. 

At the time of the AMR revision, an analysis of model sensitivity to uncertainty in input 

parameters and of the impact of parameter accuracy on model results, for this AMR, was not 

complete. Considering the relatively high level of uncertainty associated with the infiltration 

model results, the observers emphasized that this analysis needs to be completed and 

documented as provided for on Page 77 of the AMR. 

4.5.3 AMR No. U0085 (ANL-NBS-HS-000017), "Analysis of Geochemistry Data," Revision 

00, ICN 01 

This AMR provides a summary of geochemistry data for the UZ at Yucca Mountain that are 

derived from a variety of sources. None of the data in this AMR is used as direct input to other 

AMRs or the UZ PMR. Rather, the data are used for model validation or to support conceptual 

model development. 

The audit team technical specialist assigned to review this AMR was well-prepared to conduct 

the audit. The AMR originator and cognizant AMR-development staff were available to answer 

the audit team's technical questions and provide information about software, data, and 

model documentation.

8
During the audit, the observers raised a concern regarding infiltration estimates, in the AMR, 

that are based on the chloride mass balance (CMB) method. Specifically, Assumption No. 19 in 

Table 2 of the AMR states that the CMB approach is assumed to be valid for flow in a fractured

rock system. This assumption was listed as TBV, but the observer questioned whether this 

assumption can be verified since the CMB approach is applicable to plug flow in a homogenous 

porous medium. In ensuing discussion it was agreed that this assumption results in a limitation 

that the CMB infiltration estimates in this AMR represent lower-bounds. This limitation was 

acknowledged in the text of the AMR. Also, the observer found that the CMB infiltration 

estimates in this AMR were not used for input to, or validation for, any other AMR or PMR. This 

was a discussion of whether it may be possible to close the TBV status of Assumption No. 19, 

because the resulting limitations are acknowledged and made clear to potential end users of 

the CMB analysis. The audit team technical specialist recommended that an approach should 

be developed to address the TBV status of assumptions in this AMR. The observer asked how 

the TBV status of this assumption is tracked; an M&O staff member demonstrated how 

assumptions are tracked through the DIRS system. The observer found that Assumption No. 

19 from this AMR was listed in the DIRS system with the identifier TBV-4766, and appropriate 

points of contact were listed. 

No deficiencies were identified in this AMR; however, the technical specialist made several 

formal recommendations for improving the traceability, transparency, defensibility, and 

reproducibility of the analyses in this AMR. Although the UZ PMR appeared to satisfactorily 

compile the results of the supporting AMRs, the audit team made 20 recommendations 

regarding the content of AMR No. U0085. Except for AMR No. U0085, there were very few 

audit team recommendations. Although not discussed during the audit nor the audit exit, the 

DWM staff is concerned that the number of audit team recommendations for AMR No. U0085 

may reflect some inattention to detail by the AMR preparers and reviewers. The observers 

agree with the audit team findings and recommendations. 

4.5.4 AMR No. U0110/N0120 (MDL-NBS-HS-000001), "Drift-Scale Coupled Processes 

(DST and THC Seepage) Models," Revision 01 

The purpose of this AMR is to provide the framework to evaluate THC coupled processes at the 

drift scale, to predict flow and transport behavior for specified thermal loading conditions, and 

predict the chemistry of waters and gases entering potential waste-emplacement drifts. 

The audit team technical specialist assigned to review this AMR was well-prepared to conduct 

the audit. The AMR originator and cognizant AMR-development staff were available to answer 

the audit team's technical questions and provide information about software, data, and 

model documentation. 

For this AMR, the scope of the audit team review was limited to evaluating whether 

recommendations made during a previous audit (OCRWM Audit Report M&O-ARP-00-08) were 

adequately addressed. The technical specialist concluded that most of the previous 

recommendations have been incorporated into the current AMR and he complimented the 

originator on a much improved document. The technical specialist made some minor 

suggestions, such as incorporation of an additional reference and confirmation of an 

assumption regarding the percentage of heat removal for modeling the drift-scale heater test.

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An observer asked if confirmation of this assumption is being tracked. The AMR originator was 

able to show the observer that the assumption in question is listed in the DIRS as TBV and will 

be closed on completion of an ongoing study. 

The audit team did not identify any deficiencies in this AMR. The observers agree with the audit 

team's findings. 

4.5.5 AMR No. U0175 (ANL-NBS-GS-000011), "Future Climate Analysis - 10,000 Years To 

1,000,000 Years After Present," Revision 00 

The purpose of this AMR is to provide input to the infiltration model of Yucca Mountain for the 

period from 10,000 to 1,000,000 years after closure of the proposed repository. Key inputs 

include calcite mineral data from Devil's Hole, south of Yucca Mountain, and fossil records from 

lake-bed sediments from Owen's Lake, CA. The technical approach taken for this AMR is 

patterned after a similar AMR developed for the postclosure period from zero to 10,000 years. 

The technical specialist was well-prepared to conduct the audit. The AMR originator and 

cognizant AMR-development staff were available to answer the audit team's technical questions 

and provide information about software, data, and model documentation. 

The AMR was in draft form at the time of the audit, undergoing the late stages of the technical 

review process. This gave the audit team an opportunity to evaluate the technical review and 

revision processes as specified in AP-3.10Q. 

The technical specialist's questions were focused on the traceability, transparency, defensibility, 

and reproducibility of model inputs and outputs. One concern the audit team technical 

specialist raised was that the AMR did not address how future climate might affect vegetation 

cover at Yucca Mountain. The audit team questioned whether there is sufficient technical basis 

for the parameters in the infiltration model that are used to account for vegetation changes 

during future climates. The AMR originator answered that climate-induced changes in 

vegetation were beyond the scope of this AMR. The effects of climate on vegetation, and 

hence, infiltration, are addressed in the AMR on infiltration, which was also reviewed during the 

audit (see Section 4.5.2 of this report). 

The audit team did not identify any deficiencies for this AMR that had not already been noted 

during the technical review process. The audit team commended the originators and checkers 

for compliance with the AP-3.10Q technical review process. Specifically, the auditors were 

impressed with the word-processing approach that provided color-coded reviewer comments, 

made it easy to see which portions of AMR text were affected, and also provided a convenient 

summary of all comments. The observers agree with the audit team's findings.

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5.0 NRC STAFF FINDINGS

The observers determined that OQA Audit M&O-ARP-01 -02 was effective in determining the 

level of compliance of M&O activities associated with the subject AMRs. The observers agreed 

with the audit team's conclusion that the OCRWM QA program had been satisfactorily 

implemented except for the identified potential deficiencies. The following sections address the 

observers' findings. 

5.1 NRC Audit Observer Inquiries 

The following AQIs were generated during the audit: 

a) AOI No. M&O-APR-01 -02-1, dated February 9, 2001, was written to identify an observer 

inquiry for ANL-NBS-HS-00032. The AOI states: "Arbitrary upper-bound vegetation 

cover percentages and bedrock root-zone thicknesses were assigned: 20% and 2.0 m 

for the modern climate; 40% and 2.5 m for the monsoon climate and 60% and 3.0 m for 

the glacial transition climate. A more detailed discussion of the assumed values is 

needed since the values may be excessive, thus leading to an over-prediction of ET and 

under-prediction of shallow infiltration. (Refer to U.S. NRC's Observation Audit Report 

No. OAR-00-04)." 

b) AOI No. M&O-APR-01 -02-2, dated February 9, 2001, was written to identify an observer 

inquiry for ANL-NBS-HS-00032. The AOI states: "The instantaneous flow routing (IFR) 

method assumes that the duration of surface-water flow at Yucca Mountain is less than 

24 hours and episodic in nature. This assumption is the basis for not using time-steps 

smaller than 24 hours when performing surface-water flow routing and calculating daily 

net infiltration. Please provide the NRC with adequate justification. (Refer to U.S. 

NRC's Observation Audit Report No. OAR-00-04)." 

c) AOI No. M&O-APR-01 -02-3, dated February,9, 2001, was written to identify an observer 

inquiry for ANL-NBS-HS-00032. The AOI states: "An implicit assumption of the 

distribution-parameter water-balance model is that capillarity is not an important 

component of UZ flow processes for the objective of estimating annual average 

infiltration rates in the semi-arid climate of Yucca Mountain. The INFIL ver. 2.0 contains 

both the distribution-parameter water-balance module and the Richards module and 

could readily be used to confirm the basis for this assumption for a small scale region. 

The NRC recommends that the assumptions in the distribution-parameter water-balance 

model be validated by comparison against a numerical Richards equation-based code to 

assure that mean annual shallow infiltration estimates are not under-predicted. (Refer 

to U.S. NRC's Observation Audit Report No. OAR-00-04)." 

d) 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

1I
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)." 

5.2 NRC Audit Exit Summary 

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

responsiveness provide to them during their observation activities. Also, the observers stated 

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

exit. Also, the observers identified that they had provided the audit team four audit observer 

inquiries. Further, it was explained that these inquiries related to the subject of net infiltration 

as discussed in AMR No.UO010, and that these inquiries had been discussed with the audit 

team and cognizant technical leads. 

Although not directly within the scope of the UZ PMR audit, the observers became aware of a 

project initiative that may roll up technical information related to the consideration of cool 

repository design referred to as an "Integrated AMR." The observers stated that DWM staff 

would appreciate a presentation to better understand the proposed Integrated AMR and 

proposed that this presentation be discussed at the next quarterly management meeting in 

March 2001. 

Except for AMR No. U0085, there were very few audit team recommendations. Although not 

discussed during the audit nor the audit exit, the Division of Waste Management staff is 

concerned that the 20 audit team potential recommendations for AMR No. U0085, identified by 

the audit team and discussed in Section 4.5.3 of this report, may reflect some inattention to 

detail by the AMR preparers and reviewers. 

6.0 References 

Flint, A.L.; J.A. Hevesi, and L.E. Flint, Conceptual and Numerical Model of Infiltration for the 

Yucca Mountain Area, Nevada, Milestone 3GUI623M, 1996. Denver, Colorado: U.S. 

Geological Survey, ACC: MOL.19970409.0087 

U.S. Nuclear Regulatory Commission's Observation Audit Report No. OAR-00-04, "Observation 

of the Office of the Civilian Radioactive Waste Management, Quality Assurance Division, Audit 

No. M&O-ARP-00-004," March 20, 2000

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