Z1/M,•

41 UNITED6STATES 

NUCLEAR REGULATORY COMMISSION 

WASHINGTON, D.C. 20555-0001 

December 21, 2000 

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-01-02, -OBSERVATION AUDIT OF OFFICE OF CIVILIAN 

RADIOACTIVE WASTE MANAGEMENT, QUALITY ASSURANCE DIVISION, 

AUDIT NO. OQA-SA-01-006" 

Dear Mr. Milner: 

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

(OAR) No. OAR-01-02, of the U.S. Department of Energy's (DOE), Office of Civilian Radioactive 

Waste Management (OCRWM), Office of Quality Assurance (OQA) supplier audit of Beta 

Analytic Inc. (BAI). The audit, OQA-SA-01-006, was conducted on November 16-17, 2000, at 

BAI's facility in Miami, Florida. 

The scope of the audit evaluated the effectiveness of the BAI Quality Assurance Program for 

Yucca Mountain Project Activities, as delineated in U.S. Geological Survey Purchase Order 

99CRSA1014 and associated implementing procedures. BAI prepares USGS samples for the 

Accelerated Mass Spectrometry (AMS) analysis for the purpose of Carbon-14 age dating of the 

samples. The AMS is performed by LLNL Center for Accelerator Mass Spectrometry which is 

on the OCRWM approved suppliers list. 

The NRC observers concluded that Audit No. OQA-SA-01-006 was effective in determining the 

level of compliance of BAI activities associated with the Yucca Mountain Project. Within the 

areas evaluated, the DOE audit team identified a minor potential deficiency which was corrected 

and verified prior to the writing of the DOE audit report. 

The NRC staff determined that this DOE audit was effective in conducting the audit. The NRC 

staff also agrees with the audit team conclusions, findings, and recommendations, as presented 

at the audit exit. The NRC observers generated no audit observer inquiries during this audit. 

"1
J. Carlson

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

questions, please contact Ted Carter of my staff at 301-415-6684. 

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-01-02, "Observation Audit of the Office 

of Civilian Radioactive Waste Management, Quality Assurance Division, Audit 

No. OQA-SA-01-006"

cc See attached list.

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Letter to J. Carlson from C. W. Reamer dated: December 21. 2000

cc: R. Loux, State of Nevada 

S. Frishman, State of Nevada 

L. Barrett, DOE/Wash, DC 

A. Brownstein, DOE/Wash, DC 

S. Hanauer, DOE/Wash, DC 

C. Einberg, DOE/Wash, DC 

J. Carlson, DOE/Wash, DC 

N. Slater, DOE/Wash, DC 

A. Gil, DOE/Las Vegas, NV 

R. Dyer, YMPO 

S. Brocoum, YMPO 

R. Clark, YMPO 

C. Hanlon, YMPO 

T. Gunter, YMPO 

G. Dials, M&O 

J. Bailey, M&O 

D. Wilkins, M&O 

M. Voegele, M&O 

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. Remus, Inyo County, CA 

B. Duke, Lander County, NV 

J. Pitts, Lincoln County, NV 

J. Wallis, Mineral County, NV 

L. Bradshaw, Nye County, NV 

M. Murphy, Nye County, NV 

J. McKnight, Nye County, NV 

B. Ott, White Pine County, NV 

D. Weigel, GAO 

W. Barnard, NWTRB 

R. Holden, NCAI 

A. Collins, NIEC 

R. Arnold, Pahrump County, NV 

J. Lyznicky, AMA 

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
U.S. NUCLEAR REGULATORY COMMISSION

OBSERVATION AUDIT REPORT NO. OAR-01-02 

OBSERVATION AUDIT OF THE 

OFFICE OF CIVILIAN RADIOACTIVE WASTE MANAGEMENT 

QUALITY ASSURANCE DIVISION 

AUDIT NO. OQA-SA-01-006

/_ 12//9/00 

Ted Carter 

Projects and Engineering Section 

High-Level Waste Branch 

Division of Waste Management

M,;? 12//90/00 

Center for Nuclear Waste 

Regulatory Analyses

Reviewed and Approved by: 

/ý4-12I19//00 

N. Wng Stablein, 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, 

observed the U.S. Departmerfi of Energy (DOE), Office of Civilian' Radioactive Waste 

Management (OCRWM), Office of Quality Assurance (OQA) supplier audit of Beta Analytic Inc. 

(BAI). Audit No. OQA-SA-01-006, was conducted on November 16-17, 2000, at the facility in 

Miami, Florida. 

The objective of this audit was to evaluate the implementation of the applicable provisions 

contained in the BAI Quality Assurance Program, by reviewing documentation and interviewing 

BAI staff supporting BAI work activity. 

The NRC staff objective was to gain confidence that BAI and OQA are properly implementing the 

applicable provisions contained in the Quality Assurance Requirements and Description 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). 

2.0 MANAGEMENT SUMMARY 

The NRC staff has determined that OQA Audit No. OQA-SA-01-006 was useful, effective, and 

conducted in a professional manner. Audit team members were independent of the activities they 

audited and appeared to be knowledgeable in the quality assurance (QA) and technical disciplines 

within the scope of the audit. The audit team members' qualifications were previously reviewed 

and the members were found to be qualified earlier in their respective disciplines. 

The audit team concluded that the BAI QA program had been satisfactorily implemented in the 

areas evaluated. The NRC staff determined that this audit was effective. The NRC staff also 

agrees with the audit team conclusions and recommendations. 

3.0 AUDIT PARTICIPANTS 

3.1 NRC Observers 

Ted Carter Team Leader NRC 

Bruce Mabrito Team Member Center for Nuclear Waste 

Regulatory Analyses) 

3.2 OQA Audit Team 

Richard Maudlin Audit Team Leader OQA/Quality Assurance 

Technical Support Services 

(OQA/QATSS) 

F. Harvey Dove, Ph.D., P.H. Technical Specialist OQA/QATSS 

3.3 Observer 

Bruce Parks Observer U.S. Geological Survey (USGS), 

Denver, CO

I
4.0 REVIEW OF THE AUDIT AND AUDITED ORGANIZATION

This OQA audit of BAI was conducted in accordance with OCRWM Quality Assurance Procedure 

(QAP) 18.2, "Internal Audit Program," and QAP 16.1Q, "Performance/Deficiency Reporting." The 

NRC staffs observation of this audit was based on the NRC Manual Chapter 2410, dated July 12, 

2000. 

4.1 Scope of the Audit 

The scope of the audit was to evaluate the effectiveness of the BAI QA program, Revision 

QA_5.00, dated January 2000, and associated implementing procedures as delineated in USGS 

Purchase Order 99CRSA1014. BAI prepares USGS samples for the Accelerated Mass 

Spectrometry (AMS) analysis for the purpose of Carbon-14 age dating of the samples. The AMS 

is performed by LLNL Center for Accelerator Mass Spectrometry which is on the OCRWM 

approved suppliers list. 

4.2 Conduct and Timing of the Audit 

The audit was performed in a professional manner and the audit team demonstrated a sound 

knowledge of the applicable M&O and DOE programs and procedures. Audit team personnel 

were persistent in their interviews, challenged responses when appropriate, and performed an 

acceptable audit. The NRC staff believes the timing of the audit was appropriate for the auditors 

to evaluate the pertinent BAI activities associated with the past and on-going activities and 

implementation of the QA Program. 

The DOE audit team and NRC observers caucused at the end of each day of auditing. Also, 

meetings of the audit team and BAI management (with the NRC observers always present) were 

held to discuss the audit status and preliminary findings. 

A USGS staff member was present during most of the audit to observe and assist in information 

transfer and to respond to questions pertaining to the USGS Purchase Order to BAI. 

4.3 Audit Team Qualification and Independence 

The qualifications of the DOE audit team I6ader and the OQA audit team member had been 

reviewed earlier and were then found to be acceptable in that they met the requirements of QAP 

18.1, "Auditor Qualification," as verified by an NRC observation audit lead. The audit team 

members did not have prior responsibility for performing the activities they audited. In addition, 

training, education, and experience records for the two DOE audit team members were previously 

reviewed and found acceptable. NRC observers had previously reviewed the technical 

specialist's qualifications and found that the technical specialist had sufficient technical education, 

training, and experience. 

4.4 Examination of QA Programmatic Elements 

The NRC staff observed that each of the audit team members reviewed appropriate documentation 

and interviewed key BAI personnel to determine their understanding of implementing procedures and 

processes. Training, education, and experience records were reviewed to assure BAI personnel met

2
the requirements of their individual position descriptions. Objective evidence was provided and 

reviewed by the auditor and it was determined that all personnel were in compliance. 

4.5 Examination of Technical and Programmatic Activities 

After an introductory BAI explanation of the general processes used to determine radiocarbon 

dating information, the DOE auditors used their checklists as a tool to determine if the QA program 

was being effectively implemented. In addition to specific questions from the prepared 

programmatic and technical checklists, the auditors used acceptable sampling techniques to 

determine if traceability of prepared radiocarbon dating specimens was adequate. 

Various "Beta numbers" were identified as discrete tasks specifically for the USGS and those were 

traced back through the BAI documentation chain. These included USGS water samples and other 

samples submitted in Fiscal Year (FY) 2000, which were traced from initial receipt through to final 

age determination. Specifically, the DOE audit team tracked 15 water samples that were prepared 

for the Yucca Mountain program during the FY and found the documentation complete, including 

the sampling bags, labels, forms, and paperwork. No inconsistencies were noted by the audit team 

and this was concurred in by the NRC observers. 

The BAI management explained that the calibration of radiocarbon dating of samples is 

accomplished by regular and periodic "round robin" testing at eight Accelerated Mass Spectrometric 

laboratories worldwide. The DOE audit team and NRC observers were shown documentation to 

explain how the round robin radiocarbon (or 14C) consortium system functions and how it maintains 

an age dating calibration control on the labs performing such work. 

Preparation of radiocarbon samples in the BAI laboratory was observed by the DOE technical 

specialist and one of the NRC observers. The sample preparation process is now commercialized 

by BAI and the technicians followed a standard procedure which was developed in a university 

laboratory setting by 1970. BAI claims to be the largest radiocarbon dating laboratory in the world 

now, having produced over 120,000 analyses. The BAI technicians answered the DOE audit team 

technical specialist questions while performing the preparation activities. The DOE technical 

specialist also checked the qualifications of the BAI technicians and stated they were well qualified 

for their positions. The NRC observer concluded that the sample-preparation technicians used 

approved procedures. 

During the programmatic portion of the audit, the DOE audit team leader checked the current BAI QA 

Program and the applicable criteria for the tasks being performed. The areas of concentration 

included: the qualification of personnel; certification and documentation; procurement issues; 

application of appropriate quality requirements in accordance with the USGS Purchase Order; 

generated nonconformance reports and related corrective actions; calibration of equipment; 

electronic and hard copies of records; software used; traceability of samples; and use of scientific 

notebooks when developing new processes. There were no areas of noncompliance noted by the 

DOE team leader. 

The audit team leader's investigations were watched by an NRC observer and there was agreement 

in the line of questions and concurrence with the stated results.

3
The DOE audit team technical specialist reviewed sample tracking sheets for USGS/Yucca Mountain 

program work, along with those for a national museum. The documentation was readily available, 

easily presented, and well kept according to the DOE audit team member. The NRC observer 

agreed with the assessment. 

During the first day of the audit, it was mentioned by the DOE audit team leader that the latest 

version of the BAI proprietary implementing procedures, which are part of the QA manual, had a 

problem of incorrect headers on some of the manual sections. This item was specifically covered in 

the second day of the audit. Due to the specific text software program in use at BAI and the age of 

some of the QA manual sections, making the header changes so that the manual was consistent 

throughout, was not an easy process. In the post-audit meeting the DOE audit team leader stated 

that if the BAI QA implementing procedures could be made consistent through manipulation of 

software within approximately 10 days, he would not carry that over as an open item to audit OQA

SA-01-006. BAI management agreed to this arrangement and the DOE audit team leader confirmed 

that the corrections were made to the BAI proprietary implementing procedures within the time 

frame. NRC observers were present to see this method of securing compliance and concurred in its 

application. 

The NRC observers concluded that the methods used by the audit team members provided an 

adequate approach and was effective in determining the level of compliance of the BAI activities. 

4.6 NRC Staff Findings 

The NRC staff has determined that OQA Audit No. OQA-SA-01-006 was effective in determining the 

level of compliance of BAI activities associated with the radiocarbon dating services. The NRC staff 

agreed with the audit team conclusion that the BAI QA program had been satisfactorily implemented. 

The NRC staff also determined the following: 

"* The NRC staff found OQA Audit No. OQA-SA-01-006 thorough, comprehensive, technically 

detailed, and professional. 

"* The DOE audit team technical specialist did an acceptable job with the technical portion of 

the audit. He demonstrated an acceptable level of understanding of the technical methods 

that were the subject of the audit. The radiocarbon dating services BAI was offering were 

determined to be traceable and acceptable. 

"* The NRC observers were allowed to question the BAI technical staff as needed. 

"* The NRC observers were present when the commitment was made by BAI management to 

correct the BAI implementing procedure header inconsistency. 

4.6.1 Audit Observer Inquiries 

There were no audit observer inquires issued during this audit observation, and there were no 

previous audit observer inquiries at BAI to be closed.

4
J. Carlson

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

questions, please contact Ted Carter of my staff at 301-415-6684. 

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-01-02, "Observation Audit of the Office 

of Civilian Radioactive Waste Management, Quality Assurance Division, Audit 

No. OQA-SA-01-006"

cc: See attached list. 

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