August 6, 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-01-06, “OBSERVATION AUDIT OF THE OFFICE OF

CIVILIAN RADIOACTIVE WASTE MANAGEMENT, OFFICE OF QUALITY

ASSURANCE, AUDIT NO. BSC-ARC-01-10 OF THE BECHTEL SAIC

COMPANY, LLC”

Dear Mr. Milner:

Enclosed is the U.S. Nuclear Regulatory Commission’s (NRC’s) Observation Audit Report

(No. OAR-01-06), of the U.S. Department of Energy’s (DOE’s), Office of Civilian Radioactive

Waste Management (OCRWM), Office of Quality Assurance (OQA), audit of the Bechtel SAIC

Company, LLC (BSC). OQA conducted a two-part audit of BSC on June 11 through 20, 2001. 

The OQA audit team (audit team) conducted the first part of the audit on June 11 through 15,

2001, at four national laboratories supporting BSC: Lawrence Berkeley National Laboratory,

Lawrence Livermore National Laboratory, Los Alamos National Laboratory, and Sandia National

Laboratories. The audit team conducted the second part of the audit on June 18 through 20,

2001, at BSC’s facility at Las Vegas, Nevada. NRC observed the second part of the audit.

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

evaluate BSC’s 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 NRC observers (observers) determined that DOE’s 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. 

Although the audit team identified potential deficiencies, the observers believe that BSC’s

implementation of the QARD, in the areas reviewed, during the audit was generally acceptable. 

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

presented at the audit exit.
R.A. Milner 2

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 observations identified

in Section 5.2 of the enclosed report. If you have any questions, please contact Thomas Matula

at (301) 415-6602.

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, “Observation Audit

of the Office of Civilian Radioactive 

Waste Management, Office of Quality 

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

of the Bechtel SAIC Company, LLC”
R.A. Milner 2

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 observations identified

in Section 5.2 of the enclosed report. If you have any questions, please contact Thomas Matula

at (301) 415-6602.

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, “Observation Audit

of the Office of Civilian Radioactive 

Waste Management, Office of Quality 

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

of the Bechtel SAIC Company, LLC”

DISTRIBUTION:

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CWReamer DWMr/f LCampbell DBrooks TMatula

ADAMS Accession No.: ML012190095

DOCUMENT NAME: S/DWM/HLWB/tom/Observation Audit OAR-01-06.wpd 

*See Previous Concurrence This document is Non-Sensitive

OFC HLWB *Tech Editor HLWB HLWB

NAME TMatula tom EKraus ek NKStablein nks CWReamer cwr

DATE 07/25/01 07/23/01 08/05/01 08/06/01 

OFFICIAL COPY

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

1) This document should be made available to the PUBLIC. Yes -tom1

2) This document is related to the HLW program. It should be placed in the LSS. Yes -tom1
Letter to R.A. Milner from C.W. Reamer dated ____August 6, 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. OAR–01–06,

“OBSERVATION AUDIT OF THE OFFICE OF

CIVILIAN RADIOACTIVE WASTE MANAGEMENT

OFFICE OF QUALITY ASSURANCE

AUDIT NO. BSC-ARC-01-10

 BECHTEL SAIC COMPANY, LLC”

 /RA/ 07/25/01 /RA 07/24/01

Thomas Matula Robert Latta

Projects and Engineering Section Repository Site Section

High-Level Waste Branch High-Level Waste Branch

Division of Waste Management Division of Waste Management

Reviewed and Approved by:

 /RA/ 08/05/01

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 Commission (NRC) Division of Waste Management

observed the U.S. Department of Energy’s (DOE’s), Office of Civilian Radioactive Waste

Management (OCRWM), Office of Quality Assurance (OQA), audit of the Bechtel SAIC

Company, LLC (BSC). BSC is DOE’s Management and Operating contractor. OQA conducted

this two-part audit on June 11 through 20, 2001. The OQA audit team (audit team) conducted

the first part of the audit on June 11 through 15, 2001, at four national laboratories supporting

BSC: Lawrence Berkeley National Laboratory (LBNL), Berkeley, California; Lawrence Livermore

National Laboratory (LLNL), Livermore, California; Los Alamos National Laboratory (LANL), Los

Alamos, New Mexico; and Sandia National Laboratories (SNL), Albuquerque, New Mexico. The

audit team conducted the second part of the audit on June 18 through 20, 2001, at the BSC

facilities at Las Vegas, Nevada. NRC observed the second part of the audit.

The OQA audit team (audit team) performed a limited-scope compliance-based quality

assurance (QA) audit to evaluate BSC’s implementation of the OCRWM Quality Requirements

and Description (QARD) document, DOE/RW-0333P, Revision 10, and BSC’s compliance with

associated implementing procedures in the following areas:

• Section 12.0 “Control of Measuring and Test Equipment”

• Section 15.0 “Nonconformances“

• Supplement I “Software”

• Supplement III “Scientific Investigation”

• Supplement V “Control of the Electronic Management of Data”

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

procedures and to verify BSC’s, LBNL’s, LLNL’s, LANL’s, and SNL’s 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, “Quality Assurance,” to Part 60 of Title 10 of the U.S.

Code of Federal Regulations. 

This report addresses the NRC observers’ (observers’) 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-ARC-01-10 was effective in determining the

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

implementing procedures. The audit team identified six conditions adverse to quality that were

documented as potential deficiencies. The observers agreed with the audit team’s conclusions,

findings, and recommendations. 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 observers agreed with the audit team’s conclusion that the OCRWM QA program had been

satisfactorily implemented, except for the identified potential deficiencies. 

3.0 AUDIT PARTICIPANTS
3

3.1 Observers

Thomas Matula Observer NRC

Robert Latta Observer NRC

3.2 Audit Team

John Doyle Audit Team Leader OQA/Navarro Quality Services (NQS)

Samuel Archuleta Auditor OQA/NQS

Patrick Auer Auditor OQA/NQS 

George Harper Auditor OQA/NQS

Dennis Threatt Auditor OQA/NQS

Chet Wright Auditor 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, “Internal Audit Program,” and QAP 16.1Q, “Performance/Deficiency Reporting.”

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

Audits,” dated July 12, 2000.

4.1 Scope of the Audit

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

related to BSC’s implementation of the QARD. Audit activities included evaluation of the control

of measuring and test equipment, nonconformances, software, scientific investigations, and

control of the electronic management of data. 

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 

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

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

Qualification.” 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
4

OQA conducted a two-part audit of BSC on June 11 through 20, 2001. The audit team

conducted the first part of the audit on June 11 through 15, 2001, at four national laboratories

supporting BSC at LBNL, LLNL, LANL, and SNL. The audit team conducted the second part of

the audit on June 18 through 20, 2001, at the BSC facility at Las Vegas, Nevada. The audit

team identified the following potential deficiencies during the audit.

4.4.1 AP–SIII.1Q, “Scientific Notebooks”

DOE Procedure No. AP-SIII.1Q, “Scientific Notebooks,” Revision 1, Interim Change Notice

(ICN) 0, requires that Scientific Notebook (SN) Supplemental Records be referenced to the SN

number and that the Supplemental Record display the page of the associated SN. The audit

team reviewed SN-LANL-SCI-239 V1 and SN-SNL-SCI-021 V1 and found that the required

references between the SNs and the associated Supplemental Records were not maintained. 

The SNs referred to the Supplemental Records as a “loose-leaf binder,” with no identification of

the attachment number to the SN.

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

4.4.2 AP–SIII.4Q, “Development, Review, Online Placement and Maintenance of

Individual Reference Information Base Data Items”

DOE Procedure No. AP-SIII.4Q, “Development, Review, Online Placement and Maintenance of

Individual Reference Information Base Data Items,” Revision 0, ICN 2, requires that an Online

Review Checklist be approved and submitted with the Reference Information Base (RIB) records

package. The audit team reviewed RIB packages RIB0090 and RIB0093 and found that the

Review Checklists were not approved and were not included in the final records packages.

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

4.4.3 AP–12.1Q, “Control of Measuring and Test Equipment and Calibration Standards”

DOE Procedure No. AP–12.1Q, “Control of Measuring and Test Equipment and Calibration

Standards,” Revision 0, ICN 1, requires that Measuring and Test Equipment (M&TE) be tagged,

indicating calibration status, and that equipment used be tracked on a master M&TE list. The

audit team reviewed selected M&TE at LLNL Corrosion Studies Laboratory and found that

M&TE in use was not tagged, indicating calibration status, and was not listed on the master

M&TE list.

The observers agreed with the audit team’s findings in this area.
5

4.4.4 AP–2.21Q, “Quality Determinations and Planning for Scientific, Engineering and

Regulatory Compliance”

DOE Procedure No. AP–2.21Q, “Quality Determinations and Planning for Scientific,

Engineering and Regulatory Compliance,” Revision 1, ICN 1, requires that a Technical Work

Plan be approved and in place before an Analysis Model Report (AMR) is developed. The audit

team reviewed AMR ANL-EBS-MD-0049, Revision 00, ICN 01, and found that there was no

evidence of a technical review plan approved and in place for this AMR.

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

4.4.5 AP–3.10Q, “Analyses and Models”

DOE Procedure No. AP–3.10Q, “Analyses and Models,” Revision 2, ICN 4, requires an

evaluation to determine the need to control electronic data in accordance with QARD

Supplement V during AMR development. The audit team reviewed documentation associated

with AMR ANL-EBS-MD-00033 and found that there was no evaluation nor statement regarding

the need to control electronic data in accordance with QARD Supplement V.

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

4.4.6 AP–SIII.6Q, “Geophysical Logging Programs for Surface-Based Testing

Program Boreholes”

The audit team reviewed DOE Procedure No. AP–SIII.6Q, “Geophysical Logging Programs for

Surface-Based Testing Program Boreholes,” Revision 0, and found that the “Process” section

does not provide the management processes required to achieve the “Purpose” of the

procedure. Specifically, Procedure No. AP–SIII.6Q does not provide for a determination of

applicability of the data intended for use. The procedure also does not provide for an

identification of applicable portions of the Site Characterization Plan, and Sections III.2.1,

“Planning Scientific Investigations,” and III.2.4, “Data Review, Adequacy, and Usage,” of QARD

Supplement III.

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

5.0 NRC STAFF FINDINGS

The observers determined that OQA Audit BSC-ARC-01-10 was effective in determining the

level of compliance of BSC QA activities. The observers agreed with the audit team’s

conclusion that the OCRWM QA program had been satisfactorily implemented, except for the

identified potential deficiencies. 

5.1 NRC Audit Observer Inquiries

The observers did not generate any Audit Observer Inquiries (AOIs) during the audit.
6

5.2 Open NRC AOIs from Previous NRC Observations

The following AOIs remain open from previous DOE audits observed by NRC:

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

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).