July 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-01-05, “OBSERVATION AUDIT OF THE OFFICE OF

CIVILIAN RADIOACTIVE WASTE MANAGEMENT, OFFICE OF QUALITY

ASSURANCE, AUDIT NO. EM-ARC-01-09"

Dear Mr. Milner:

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

(No. OAR-01-05) of the U.S. Department of Energy’s (DOE’s) Office of Civilian Radioactive

Waste Management (OCRWM), Office of Quality Assurance’s (OQA’s), audit of DOE’s Office of

Environmental Management (EM), Office of Safety, Health and Security (EM-5). This audit was

conducted on June 5 through 7, 2001, at the EM-5 facility in Germantown, Maryland. 

The purpose of this audit was to evaluate the effectiveness of EM-5’s implementation of the

High-Level Waste (HLW) Quality Assurance (QA) Program and to determine if applicable

requirements of the OCRWM Quality Assurance Program Description (QARD) were being met. 

The scope of the audit included evaluating the implementation of the QARD for EM-5 activities

controlling the processing of high-level waste at various sites such as the Savannah River

Operations Office Defense Waste Processing Facility and the Hanford Office of River

Protection. Also, the audit evaluated action taken as a result of the findings and

recommendations identified during previous OQA audits. 

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

deficiencies and recommending improvements for the EM-5 activities reviewed. During the

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

reviewed applicable documents, procedures, and activities within the audit’s scope. 

During the audit, the audit team identified two potential deficiencies. One potential deficiency

identified that certain Memoranda of Agreement, between affected organizations, did not reflect

current organizational structures. The second potential deficiency identified the following three

problems within the area of corrective action: 1) deficient conditions identified during EM-5

audits were being documented as observations and not deficiencies; 2) EM-5 was not

performing trending; and 3) EM-5 had not completed committed corrective action to address a

deficiency from the last OQA audit. Further, the audit team made the following two

recommendations: 1) additional surveillances should be performed by the high-level waste

processing site QA representatives; and 2) the current QARD revision should be formally

imposed for EM-5 and applicable site activities.
R. Milner -2-

The observers agreed with the audit team’s conclusions, findings, and recommendations

presented at the audit exit. Additionally, the observers believe that EM-5 management should

continue to review resources designated for QA activities to ensure that they are adequate. 

Although the OCRWM audit team identified two potential deficiencies, the observers believe

that the audits performed by EM-5 were well-planned and adequately evaluated the

implementation of the QARD at the various high-level waste processing sites. However, the

observers believe that EM-5 needs to refine the methods used for ensuring that deficiencies

found during its audits are properly documented. The staff will continue to interface with

OCRWM and follow the progress that EM-5 is making to address the issues identified during

this audit. 

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

that you respond to the open Audit Observer Inquiries from the previous NRC observations

identified in Section 5.3 of the attached report. 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-01-05, “Observation Audit

of the Office of Civilian Radioactive 

Waste Management, Office of Quality Assurance,

Audit No. EM-ARC-01-09"
R. Milner -2-

July 5, 2001

The observers agreed with the audit team’s conclusions, findings, and recommendations

presented at the audit exit. Additionally, the observers believe that EM-5 management should

continue to review resources designated for QA activities to ensure that they are adequate. 

Although the OCRWM audit team identified two potential deficiencies, the observers believe

that the audits performed by EM-5 were well-planned and adequately evaluated the

implementation of the QARD at the various high-level waste processing sites. However, the

observers believe that EM-5 needs to refine the methods used for ensuring that deficiencies

found during its audits are properly documented. The staff will continue to interface with

OCRWM and follow the progress that EM-5 is making to address the issues identified during

this audit. 

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

that you respond to the open Audit Observer Inquiries from the previous NRC observations

identified in Section 5.3 of the attached report. 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-01-05, “Observation Audit

of the Office of Civilian Radioactive 

Waste Management, Office of Quality Assurance,

Audit No. EM-ARC-01-09"

DISTRIBUTION:

File Center PUBLIC ACNW LSS CNWRA NMSS r/f HLWB r/f

SWastler CGlenn BMabrito WBelke RLatta CWReamer DWMr/f

JCiocco TCarter DBrooks TMatula BSpitzberg

ADAMS Accession No. This document is Non-Sensitive 

DOCUMENT NAME: S/DWM/HLWB/llc/Environment Management Obse Aud 6 2001.wpd

*See Previous concurrence

OFC HLWB* Tech Editor* HLWB* HLWB* HLWB*

NAME LLCampbell EKraus HArlt NKStablein CWReamer

DATE 06/26/01 0 6/25/01 06/26/01 07/02/01 07/03/01

OFFICIAL COPY

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

1) This document should be made available to the PUBLIC. Yes - llc3 

2) This document is related to the HLW program. It should be placed in the LSS. Yes - llc3
U.S. NUCLEAR REGULATORY COMMISSION 

OBSERVATION AUDIT REPORT NO. OAR-01-05

“OBSERVATION AUDIT OF THE 

OFFICE OF CIVILIAN RADIOACTIVE WASTE MANAGEMENT,

OFFICE OF QUALITY ASSURANCE

AUDIT NO. EM-ARC-01-09"

 /RA/ 06/26/01 /RA/ 06/28/01

Larry L. Campbell Thomas Matula 

Projects and Engineering Section Repository Site Section

High-Level Waste Branch High-Level Waste Branch

Division of Waste Management Division of Waste Management

 /RA/ 06/26/01 

Jeff Ciocco

Projects and Engineering Section

 High-Level Waste Branch

Division of Waste Management

Reviewed and Approved by:

 /RA/ 07/03/01

N. King Stablein, Chief

Projects and Engineering Section

High-Level Waste Branch 

Division of Waste Management
-2-

1.0 INTRODUCTION

Office of Environment Management (Background) 

In 1989, the Secretary of Energy created the Office of Environmental Restoration and Waste

Management, later named the Office of Environmental Management (EM), to consolidate

budgets and staff devoted to similar environmental tasks within the U.S. Department of Energy

(DOE) into a single program office. The major categories of wastes controlled by EM include

high-level waste; transuranic waste; low-level waste; mixed low-level waste; 11e(2) byproduct

material; hazardous waste; and other wastes. EM oversees all of DOE’s high-level waste at the

following four sites: a) Hanford Office of River Protection Site (Hanford); b) Idaho National

Environmental and Engineering Laboratory (INEEL); c) the Savannah River Site’s Defense

Waste Processing Facility (Savannah River); and d) West Valley Demonstration Project

(WVDP), a non-weapons site, owned by New York State and managed by DOE. Hanford

manages the largest volume of high-level waste while Savannah River manages a larger

amount of radioactivity in its high-level waste. 

Under Federal law, DOE high-level waste may eventually be disposed of in a potential geologic

repository at Yucca Mountain, Nevada, after it has been processed into a solid waste form. The

DOE Office of Civilian Radioactive Waste Management (OCRWM) is responsible for: 1)

characterizing the potential geologic repository at Yucca Mountain; 2) possibly constructing the

geologic repository; and 3) disposing of DOE high-level waste, DOE spent nuclear fuel, and

Naval spent nuclear fuel into the geologic repository. DOE began to vitrify the high-level waste

in May 1996 at Savannah River and in July 1996 at the WVDP. Final treatment of high-level

waste at Hanford and INEEL is now in the planning stage.

Performance of the Audit 

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

observed DOE’s OCRWM, Office of Quality Assurance’s,(OQA’s), audit of activities regarding

EM’s Office of Safety, Health and Security’s (EM-5's), implementation of the High-Level Waste

(HLW) Quality Assurance (QA) Program. This audit was conducted on June 5 through 7, 2001,

at the EM-5 facility in Germantown, Maryland. 

The purpose of this audit was to evaluate the effectiveness of EM-5’s implementation of the

HLW QA Program and to determine if applicable requirements of the OCRWM Quality

Assurance Program Description (QARD), DOE/RW-0333P, Revision 10, were being met. The

scope of the audit was to evaluate the implementation of the QARD for EM-5 activities

controlling the processing of high-level waste at various sites such as the Savannah River and

Hanford. Also, the audit evaluated action taken as a result of the findings and

recommendations identified during previous OQA audits. 

The NRC observers’ (observers’) objective was to assess whether OQA and EM-5 were

properly implementing 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) and the provisions

contained in the QARD. 

This report presents the observers’ determination of how effective the OQA audit was, and

whether EM-5 implemented adequate QARD controls in the audited areas.
-3-

2.0 MANAGEMENT SUMMARY 

Within the areas evaluated, the audit team identified two potential deficiencies. One potential

deficiency identified that certain Memoranda of Agreement (MOAs), between affected

organizations, did not reflect current organizational structures. The second potential deficiency

identified the following three problems within the area of corrective action: 1) deficient

conditions identified during EM-5 audits were being documented as observations and not

deficiencies; 2) EM-5 was not performing trending; and 3) EM-5 had not completed committed

corrective action to address a deficiency from the last OQA audit. Further, the audit team made

the following two recommendations: 1) additional surveillance should be performed by the site

QA representatives; and 2) the current QARD revision should be formally imposed for EM-5

and applicable site activities, and the various QARD matrixes should reflect that they meet the

current QARD requirements. Overall, the audit team concluded that the QARD program had

been satisfactorily implemented in the areas evaluated.

The observers determined that OQA Audit EM-ARC-01-09 was well-planned and effectively

executed. The audit team members were independent of the activities they audited and were

knowledgeable in the QA and technical disciplines within the scope of the audit. The audit team

member’s qualifications were reviewed and were found acceptable. 

In general, the observers agreed with the audit team’s conclusions, findings, and

recommendations presented at the audit exit. Additionally, the observers believe that EM-5's

management should continue to review resources designated for QA activities and to ensure

that they are adequate. Although the audit team identified two potential deficiencies in the

areas of organization and corrective action, the observers believe that the audits performed by

EM-5 were well-planned and adequately evaluated the implementation of the QARD at the

various high-level waste processing sites. However, the observers believe that EM-5 needs to

refine the methods used for ensuring that deficiencies found during its audits are properly

documented. 

The staff will continue to interface with OCRWM and follow the progress that EM-5 is making to

address the issues identified during this audit. 

3.0 AUDIT PARTICIPANTS

3.1 Observers

Larry L. Campbell Team Leader NRC

Jeff Ciocco (Part Time) Technical Specialist NRC

Thomas Matula (Part Time) QA Specialist NRC
-4-

3.2 OQA Audit Team

Marilyn A. Kavchak Audit Team Leader OQA/Navarro Quality Systems

(OQA/NQS)

Lester W. Wagner Auditor OQA/NQS

4.0 REVIEW OF THE AUDIT AND AUDITED ORGANIZATION

This OQA audit of EM-5 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 scope of the audit included the following QARD elements: 1) Organization; 2) QA Program;

3) Implementing Documents; 4) Document Control; 5) Corrective Action; 6) QA Records; 7)

Audits; and 8) High-Level Waste Form Production. Further, the audit evaluated the

implementation of the QARD for EM-5 activities controlling the processing of high-level waste at

various sites such as the Savannah River and Hanford. Also, the audit evaluated action taken

as a result of the findings and recommendations identified during previous OQA audits.

The observers focused their efforts on: 1) the organizational structure of EM-5 and the various

sites processing high-level waste; 2) the adequacy of EM-5's audits and oversight of the sites;

and 3) EM-5's review of the processing and packaging of high-level waste. 

The audit team and observers evaluated the implementation of the following procedures and

agreements for the audited activities during the audit:

Procedures

OCRWM Procedures

a) Quality Assurance Procedure (QAP)-18.1Q, “Auditor Qualification,” Revision 6, with 

ICN No. 0

b) QAP-18.2Q, “Internal Audit Program,” Revision 8, with ICN No. 0 

EM-5 Procedures

a) QARD Requirements Matrix, Draft Revision 4

b) Standard Practice Procedure (SSP) 1.02, Revision 5, “High-Level Waste Vitrification

Program Organization,” with ICN No. IC-5-1

c) SSP No. 2.01, “Procedures and QARD Requirements Matrix,” Revision 3

d) SSP No. 3.01, “Training,” Revision 3

e) SSP No. 4.01, “Evaluation and Assessment Activities,” Revision 2
-5-

f) SSP No. 4.02, “Audits,” Revision 5

g) SSP No. 4.03, “Readiness Reviews and Surveillance,” Revision 2

h) SSP No. 4.04, “Technical and QA Documents,” Revision 4

i) SSP No. 5.01, “ Deviations and Corrective Actions/Tracking System,” Revision 2

j) SSP No. 5.02, “Stop Work Orders,” Revision 2

k) SSP No. 6.01, “Distribution of Controlled Documents, Revision 3

l) SSP No. 7.01, “Quality Records,” Revision 3

m) SSP No 8.01, “Differing Staff Opinions,” Revision 2

MOAs

a) “MOA for Coordination of QA Activities between EM and OCRWM,” dated 

December 23, 1998

b) “MOA for Coordination and Implementation of High-Level Radioactive Waste QA

Activities between the Office of River Protection and EM,” dated June 23, 1999

4.2 Conduct and Timing of the Audit

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

the applicable EM-5 and OCRWM programs and procedures. The audit checklist was

developed using the QARD and applicable EM-5 implementing 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 EM-5 activities. The

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

team and EM-5 (with the observers present) were held, as necessary, to discuss the current

audit status and preliminary findings.

4.3 Audit Team Qualification and Independence 

The qualifications of the audit team were reviewed for accuracy and completeness in

accordance with the requirements of DOE 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 had the

necessary expertise to perform the audit and were qualified to audit EM-5 activities.

The observers reviewed organizational information and determined that the audit team

members were independent of any direct responsibility for performing audited activities. The

observers concluded that the auditors had sufficient authority and organizational freedom to

make the audit process meaningful and effective.

4.4 Examination of QA Elements
-6-

4.4.1 Organization

Organizationally, DOE manages the high-level waste program through its Headquarters

program offices and the many field and operations offices. Seven offices report to the Assistant

Secretary for Environmental Management. EM has overall responsibility for developing,

qualifying, and producing an acceptable HLW form for OCRWM. The HLW QA Program is

managed by EM-5. EM-5 consists of a Safety and Health Team, Package Certification Team,

Safeguards and Security Team, and Quality Systems Team. The Quality Systems Team

oversees the programs in QA, 3D (data, decision, and documentation), Emergency

Management, and Risk Management. QA in EM-5 has diverse responsibilities that include

providing guidance and support on matters affecting high-level waste acceptance QA and

interfacing and program coordination with other QA programs, both within EM and across the

DOE complex. The HLW QA Manager is located within EM-5. 

There are several other offices within EM that are involved in the budgeting, planning, and

execution of the high-level waste vitrification projects. The Office of Integration and Disposition

has the primary responsibility for coordinating the inventory of high-level waste for the potential

geological repository with OCRWM. The Office of Site Closure’s Ohio Office, is responsible for

WVDP. The Office of Project Completion’s Idaho Office, Savannah River Office, and River

Protection Office are responsible for the remainder of EM’s high-level waste vitrification

projects.

The audit team and observers reviewed several of the MOAs that describe, in part, the quality

and technical agreements for a defined scope of work. The audit team identified, and

discussed with EM-5, that the present MOAs do not reflect the current organization structure

within EM. The audit team identified this condition as a potential deficiency. 

The observers agreed with the audit team’s findings in this area.

4.4.2 QA Program and the QARD Requirements Matrixes

The audit team verified that the EM-5 QARD Requirements Matrix had been updated to reflect

the QARD requirements. Also, the audit team evaluated whether the appropriate justification

had been provided for any exceptions taken. The audit team verified that revisions to the

QARD had been evaluated by EM-5 and the sites processing high-level waste by reviewing

documented QARD revision impact statements. The audit team identified one potential

deficiency in this area: EM-5 has taken exception to the QARD requirements for trending. EM5 only performs oversight of the trending function and has delegated the responsibility for

trending to the QA organizations at the various high-level waste processing sites. The audit

team considered this to be an inappropriate delegation and not consistent with the intent of the

QARD. The audit team identified that trending should be at the EM-5 level as well as at the site

level. 

Also, the audit team found that: 1) The EM-5 and the various processing site QARD

Requirements Matrix do not reflect the current QARD revision level; and 2) EM-5 did not

formally invoke the latest QARD revision for the site QARD Requirements Matrix. Although

QARD revision impact reviews were performed by the processing site QA representatives, the

audit team recommended that EM-5 consider requiring all QARD Requirements Matrixes to

reflect that the current revision of the QARD needed to be met. 
-7-

The observers agreed with the audit team’s findings in this area.

4.4.3 EM-5 Audit Reports

During the audit, the audit team and observers reviewed the following EM-5 audit reports and

their completed checklists:

a) “Quality Assurance Program Audit by the Office of Safety, Health, and Security (EM-5)

at the DOE West Valley Demonstration Project (WVDP),” July 10-14, 2000

b) “Office of River Protection HLW QAP Audit,” August 22-25, 2000

c) “Savannah River (SR) Operations Office Defense Waste Processing Facility (DWPF),

High-Level Waste (HLW) Audit,” March 19-22, 2001

The audit team concluded that these audits were performed in accordance with applicable

QARD and EM-5 procedures requirements with one exception. The audit team identified that

certain deficient conditions discovered during the audits were incorrectly identified as

observations. The audit team identified this condition as a potential deficiency. The observers

agreed with this potential deficiency and believe that EM-5 needs to refine the methods used for

ensuring that deficiencies found during audits are properly documented. Further, the observers

discussed with the audit team that the previous OQA audit report for EM-5 identified a similar

condition. Also, the audit team recommended that the high-level waste site QA organizations

should implement additional surveillance activities to enhance the audit process. 

During the review of the audit reports, the observers found two versions of the nonconformance

report DCAR No. 00VP-RL-AU-01-D01. One version was dated August 24, 2000, and the other

dated August 25, 2000. Both versions contained the same essential information but were

different in format. This observer brought this information to the attention of the audit team and

later to the attention of EM-5. The EM-5 HLW QA Program Manager informed the audit team

that, when nonconformance reports are written, the auditor routinely prepares preliminary

copies, issues them to the organization being audited, and later issues the final versions with

the audit reports. The audit team noted that the preliminary version of DCAR No. 00VP-RL-AU01-D01 was not identified as “Draft” and, as such, could lead to confusion. The EM-5 HLW QA

Program Manager stated that EM-5 will change its procedures to mark preliminary copies of

nonconformance reports as “Draft” in the future. 

The observers agreed with the audit team’s findings in this area.

4.4.4 EM-5 Training and Qualification Records 

The audit team and observers reviewed the training and qualification records for several of the

EM-5 audit team members and found them acceptable. The observers agreed with the audit

team findings in this area. However, as discussed in Section 4.4.6 of this report, EM-5's

commitment to assign a full-time Federal employee, qualified to performs audits, at EM-5's

Germantown facility, remains an open issue.

4.4.5 Technical and QA Documents

The audit team and observers discussed the performance-based aspects of EM-5 audits and

were informed that EM-5 audit teams included at least one technical specialist. The observers
-8-

requested, and were provided with the “West Valley Demonstration Project (WVDP), West

Valley, New York, Production Records for Canistered Waste Form” boiler-plate-format

document, a typical example of a production record. EM-5 QA personnel informed the

observers that the technical specialists on EM-5 audit team reviewed production records during

the EM-5 audits.

The audit team and observers reviewed EM-5 audit reports and associated checklists and

found that the technical specialist’s review included canistered waste form production records

and the processing of high-level waste.

4.4.6 Review of Deficiencies from Past Audits

The audit team and observers reviewed EM-5's processing and corrective action for Deficiency

Report (DR) No. DR-EM-00-D-101, dated June 6, 2000. This DR was written during the last

OQA audit of EM-5 activities and identified that no objective evidence could be provided that

QA support personnel at the EM-5 Germantown facility “. . . have the requisite experience in QA

which supports the requirements for the position assigned.” The DR’s corrective action to

prevent recurrence included the following statement: “EM senior management has committed to

fully support the HLW QA Program and as part of this commitment, will provide necessary

Federal full-time personnel needed to support the HLW QA Program.” The audit team found

that the identified corrective action for DR-EM-00-D-101 had not been completed as committed

because no full-time Federal employee with QA experience had been hired. The audit team

identified this condition as a potential deficiency. 

The observers agreed with the audit team’s findings in this area.

4.4.7 Summary: Deficiencies and Recommendations Identified by the DOE Audit Team

The audit team identified two potential deficiencies. One potential deficiency identified that

certain MOAs, between affected organizations, did not reflect current organizational structures. 

The second potential deficiency identified the following three problems within the area of

corrective action: 1) deficient conditions identified during EM-5 audits were being documented

as observations and not deficiencies; 2) EM-5 was not performing trending; and 3) EM-5 had

not completed committed corrective action to address a deficiency from the last OQA audit. 

Further, the audit team made the following two recommendations: 1) The site QA

representatives should perform additional surveillance; and 2) the current QARD revision

should be formally imposed for EM-5, and applicable site activities and the various QARD

Requirements Matrixes should reflect that they meet the current QARD requirements.
-9-

5.0 NRC STAFF FINDINGS

The observers determined that OQA Audit EM-ARC-01-09 was effective in determining the

level of compliance of EM-5 activities associated with the oversight of high-level waste

processing activities. The observers agreed with the audit team’s conclusion that the QARD

had been satisfactorily implemented except for the identified potential deficiencies. The

following sections address the observers’ findings. 

5.1 NRC Audit Exit Summary

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

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

stated that, in general, they agreed with the audit team findings and recommendations, as

presented at the audit exit. Also, during the audit exit meeting, the observers discussed the

following:

 Notwithstanding the deficiencies and recommendations identified by the audit team, the

observers believed that the audits performed by EM-5 were well-planned and

adequately evaluated the implementation of the QARD at the various high-level waste

processing sites. However, the observers agreed with the audit team that EM-5 needs

to refine the methods used for ensuring that deficiencies found during its site audits are 

 properly documented. 

 The observers stated that should DOE file an application for a high-level waste

repository at Yucca Mountain, Nevada, it would be subject to NRC inspection, and that

EM activities would also be subject to inspection. Further, the observers stated that one

aspect of these inspections includes evaluating management support for activities

affecting quality, including the area of QA. Additionally, the observers stated that EM-5

management should continue to review resources designated for QA activities to ensure

that they are adequate. 

 NRC may observe EM-5 audit activities during fiscal year 2001, as provided for in the

various MOAs with the high-level waste sites. 

 The observers agreed with the OCRWM audit team’s conclusions, findings, and

recommendations presented at the audit exit. 

 The staff will continue to interface with OCRWM and follow the progress that EM-5 is

making to address the issues identified during this audit. 

5.2 NRC Audit Observer Inquiries

There were no Audit Observer Inquires (AOIs) written during this audit.

5.3 Open NRC AOIs from Previous NRC Observations

The following AOIs remain open from previous NRC audits:

a) 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
-10-

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).” 

b) 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).

5.4 AOIs Closed or Transferred

The following AOIs were transferred and are now being tracked as unsaturated zone issues to

be discussed during the Total System Performance Assessment Issues Technical Exchange.

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).”

Transferred: New Technical Exchange Tracking No. UZ1.3.1

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).” 

Transferred: New Technical Exchange Tracking No. UZ1.5.1

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
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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).” 

Transferred: New Technical Exchange Tracking No. UZ1.2.1