Mr. Ronald A. Milner, Chief Operating Officer

Office of Civilian Radioactive Waste Management

U. S. Department of Energy

1000 Independence Avenue, SW

Washington, DC 20585

SUBJECT: U.S. NUCLEAR REGULATORY COMMISSIONíS OBSERVATION AUDIT

REPORT NO. OAR-02-03, ìOBSERVATION AUDIT OF THE OFFICE OF

CIVILIAN RADIOACTIVE WASTE MANAGEMENT, OFFICE OF QUALITY

ASSURANCE, AUDIT NO. EM-ARC-02-01"

Dear Mr. Milner:

I am transmitting the U.S. Nuclear Regulatory Commissionís (NRCís) Observation Audit Report

(No. OAR-02-03) of the U.S. Department of Energyís (DOEís) Office of Civilian Radioactive

Waste Management (OCRWM), Office of Quality Assuranceís (OQAís), audit of DOEís Office of

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

conducted on December 11 through 14, 2001, at the EM offices in Germantown, Maryland. 

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

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

requirements of the OCRWM Quality Assurance Requirements and 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 HLW 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 a previous OQA audit conducted in June 2001. 

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 auditís scope. 

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

identified that the files for certain memoranda of agreements, between affected organizations,

did not contain the revision history required by applicable EM-5 procedures. The second

potential deficiency identified the following three problems within the area of training: 1) Certain

training files were missing experience and education documentation; 2) QARD requirements for

position descriptions were not met; and 3) Training matrixes do not address job responsibilities

and functions.
R. Milner -2-

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

presented at the audit exit. However, during the conduct of the audit, the observers initiated an

audit observer inquiry (AOI) identifying concerns about the current practice used by OQA and

EM-5 for reviewing and approving exceptions to the QARD. 

Additionally, the observers discussed OQAís and EM-5's roles in overseeing contractor

activities at the various EM field offices. The EM-5 QA Director explained that EM-5 may no

longer participate in audits of site contractors and that the field offices may have the

responsibility to perform these audits. The observers recommended that, should EM-5 decide

not to participate in audits of site contractors, either OQA or the EM-5 QA organization evaluate

the need to oversee the initial field office audits and to determine the effectiveness of these

audits. 

Although the 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 HLW processing sites. NRC 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 AOI No. EM-ARC-02-01, Sequence No. 1, provided to the audit team

during audit and discussed in the attached report. If you have any questions, please contact

Larry L. Campbell, of my staff 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-02-03, ìObservation Audit

of the Office of Civilian Radioactive 

Waste Management, Office of Quality Assurance,

Audit No. EM-ARC-02-01"

cc: See attached list
Letter to R. Milner from C.W. Reamer dated 

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. Davis, YMPO A. Collins, NIEC

S. Mellington, YMPO R. Arnold, Pahrump Paiute Tribe

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 S. Kraft, NEI

M. Voegele, BSC/SAIC J. Kessler, EPRI

R. Henning, BSC D. Duncan, USGS

B. Price, Nevada Legislative Committee R. Craig, USGS

J. Meder, Nevada Legislative Counsel Bureau W. Booth, Engineering Svcs, LTD

I. Navis, Clark County, NV L. Lehman, T-REG, Inc

E. von Tiesenhausen, Clark County, NV S. Echols

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 R. Bahe, Benton Paiute Indian Tribe

I. Zabarte, W.S.N.C. C. Bradley, Kaibab Band of Southern Paiutes

C. Anderson, Las Vegas Paiute Tribe R. Joseph, Lone Pine Paiute-Shoshone Tribe
J. Birchim, Yomba Shoshone Tribe L. Tom, Paiute Indian Tribes of Utah

L. Jackson, Timbisha Shoshone Tribe E. Smith, Chemehuevi Indian Tribe

C. Meyers, Moapa Paiute Indian Tribe J. Charles, Ely Shoshone Tribe

V. Miller, Fort Independence Indian Tribe D. Crawford, Inter-Tribal Council of Nevada

A. Bacock, Big Pine Paiute Tribe of

 the Owens Valley

H. Blackeye, Jr., Duckwater Shoshone Tribe

R. Quintero, Inter-Tribal Council of Nevada

(Chairman, Walker River Paiute Tribe)

D. Eddy, Jr. Colorado River Indian Tribes

M. Bengochia, Bishop Paiute Indian Tribe J. Leeds, Las Vegas Indian Center

J. Egan, Egan & Associates, PLLC W. Briggs, Ross, Dixon & Bell
R. Milner -2-

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

at the audit exit. However, during the conduct of the audit, the observers initiated an audit observer

inquiry (AOI) identifying concerns about the current practice used by OQA and EM-5 for reviewing and

approving exceptions to the QARD. 

Additionally, the observers discussed OQAís and EM-5's roles in overseeing contractor activities at

the various EM field offices. The EM-5 QA Director explained that EM-5 may no longer participate

in audits of site contractors and that the field offices may have the responsibility to perform these

audits. The observers recommended that, should EM-5 decide not to participate in audits of site

contractors, either OQA or the EM-5 QA organization evaluate the need to oversee the initial field

office audits and to determine the effectiveness of these audits. 

Although the 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 HLW processing sites. NRC 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 AOI No. EM-ARC-02-01, Sequence No. 1, provided to the audit team during audit and

discussed in the attached report. If you have any questions, please contact Larry L. Campbell, of my

staff 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-02-03, ìObservation Audit

of the Office of Civilian Radioactive 

Waste Management, Office of Quality Assurance,

Audit No. EM-ARC-02-01"

cc: See attached list

DISTRIBUTION:

FILE CENTER HLWB r/f DWM r/f ACNW PUBLIC OSRs

LSN CNWRA CWReamer KStablein DBrooks TEssig

SWastler BSpitzberg DDambly MYoung DHiggs WSmith

KNaidu

ADAMS Accession No.: ML 

DOCUMENT NAME: S/DWM/HLWB/llc/EM Germantown Dec 2001.wpd

*See Previous concurrence This document is Non-Sensitive

OFC HLWB* Tech Editor* HLWB HLWB

NAME LLCampbell EKraus NKStablein CWReamer

DATE 12/31/01 12/31/01 01/10/02 01/10/02 

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-02-03

ìOBSERVATION AUDIT OF THE 

OFFICE OF CIVILIAN RADIOACTIVE WASTE MANAGEMENT,

OFFICE OF QUALITY ASSURANCE

AUDIT NO. EM-ARC-02-01"

 /RA/ 12/31/01 /RA/ 12/26/01 

Larry L. Campbell Kamalakar Naidu

Projects and Engineering Section Projects and Engineering Section

High-Level Waste Branch High-Level Waste Branch

Division of Waste Management Division of Waste Management

 /RA/ 12/26/01 

Wilkins Smith

Projects and Engineering Section

High-Level Waste Branch

Division of Waste Management

Reviewed and Approved by:

 /RA/ 01/10/02

N. King Stablein, Chief

Projects and Engineering Section

High-Level Waste Branch 

Division of Waste Management
-2-

1.0 INTRODUCTION

Office of Environmental 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 (HLW); transuranic waste; low-level waste; mixed low-level waste; 11e(2) byproduct

material; hazardous waste; and other wastes. EM oversees all of DOEís HLW 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 Siteís 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 HLW

while Savannah River manages a larger amount of radioactivity in its HLW. 

Under Federal law, DOE HLW 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 HLW, DOE spent nuclear fuel, and Naval spent nuclear fuel into the

geologic repository. DOE began to vitrify the HLW in May 1996 at Savannah River and in July

1996 at the WVDP. Final treatment of HLW 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

(DWM), observed DOEís OCRWM, Office of Quality Assuranceís (OQAís), audit of activities

regarding EMís Office of Safety, Health and Securityís (EM-5's), implementation of the HLW

Quality Assurance (QA) Program. This audit was conducted on December 11 through 14, 2001,

at the EM offices in Germantown, Maryland. 

The purpose of this audit was to evaluate the effectiveness of EM-5ís implementation of the HLW

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

Requirements and 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 HLW 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 observersí (observersí) objective was to assess whether OQA and EM-5 were properly

implementing the requirements contained in Subpart G, ìQuality Assurance,î to Part 63, of Title 10

of the U.S. Code of Federal Regulations (10 CFR Part 63) and the provisions contained in the

QARD. 

This report presents the observersí 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 the files for certain Memoranda of Agreements (MOAs), between affected

organizations, did not contain the revision history required by applicable EM-5 procedures. The

second potential deficiency identified the following three problems within the area of training: 1)

Certain training files were missing experience and education documentation; 2) QARD

requirements for position descriptions were not met; and 3) Training matrixes do not address job

responsibilities and functions.

The observers determined that OQA Audit EM-ARC-02-01 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

membersí qualifications were reviewed before the conduct of the audit, and found acceptable. 

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

presented at the audit exit. However, during the conduct of the audit, the observers initiated an

audit observer inquiry (AOI) identifying concerns about OQAís and EM-5's current practice for

reviewing and approving exceptions to the QARD identified on an affected organizationís QARD

Requirements Matrix. 

Additionally, the observers discussed OQAís and EM-5's roles in overseeing contractor activities at

the various EM field offices. The EM-5 QA Director explained that EM-5 may no longer participate

in audits of site contractors and that the field offices may have the responsibility to perform these

audits. The observers recommended that, should EM-5 decide not to participate in audits of site

contractors, either OQA or the EM-5 QA organization evaluate the need to oversee the initial field

office audits and to determine the effectiveness of these audits. 

Although the OQA 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 HLW processing sites. 

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

Kamalakar Naidu Team Member NRC

Wilkins R. Smith (Part-Time) Team Member NRC

Jack D. Parrott (Entrance Meeting Only) DWM Staff NRC
-4-

3.2 OQA Audit Team

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

Marilyn A. Kavchak Auditor OQA/NQS

James E. Flaherty 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, ìInternal Audit Program,î and QAP 16.1Q, ìManagement of Conditions

Adverse to Quality.î The NRC staffís observation of this audit was based on NRC Manual Chapter

2410, ìConduct of Observation Audits,î 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 HLW at various sites

such as 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

field offices processing HLW; 2) The adequacy of EM-5's audits and oversight of the sites; and 3)

EM-5's response and processing of past OQA audit findings. 

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

audited activities during the audit:

Procedures

OCRWM Procedures

a) QAP-18.1Q, ìAuditor Qualification.î 

b) QAP-18.2Q, ìInternal Audit Program.î

c) QAP-16.1Q, ìManagement of Conditions Adverse to Quality.î

EM-5 Procedures

a) QARD Requirements Matrix.

b) Standard Practice Procedure (SPP) No. 1.02, ìHigh-Level Waste Vitrification Program

Organization,î Revision 5.

c) SPP No. 2.01, ìProcedures and QARD Requirements Matrix,î Revision 3.

d) SPP No. 3.01, ìTraining,î Revision 3.
-5-

e) SPP No. 3.02, ìQualification and Certification Records,î Revision 3.

f) SPP No. 4.01, ìEvaluation and Assessment Activities,î Revision 2.

g) SPP No. 4.02, ìAudits,î Revision 5.

h) SPP No. 4.03, ìReadiness Reviews and Surveillance,î Revision 2.

i) SPP No. 4.04, ìTechnical and QA Documents,î Revision 4.

j) SPP No. 5.01, ì Deviations and Corrective Actions/Tracking System,î Revision 2.

k) SPP No. 5.02, ìStop Work Orders,î Revision 2.

l) SPP No. 6.01, ìDistribution of Controlled Documents,î Revision 3.

m) SPP No. 7.01, ìQuality Records,î Revision 3.

n) SPP No 8.01, ìDiffering Staff Opinions,î Revision 2.

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 

Before the conduct of the audit, the qualifications of the audit team were reviewed for accuracy

and completeness, in accordance with the requirements of QAP 18.1, ìAuditor Qualification.î The

observersí and the NRC On-site Representativesí reviews 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.
-6-

4.4 Examination of QA Elements

4.4.1 Organization

Organizationally, DOE manages the HLW program through its Headquarters program offices and

the many field and operations offices. Seven offices report to the Assistant Secretary for EM. 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 HLW 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 HLW vitrification projects. The Office of Integration and Disposition has the

primary responsibility for coordinating the inventory of HLW for the potential geological repository

with OCRWM. The Office of Site Closureís Ohio Office is responsible for WVDP. The Office of

Project Completionís Idaho Office, Savannah River Office, and River Protection Office are

responsible for the remainder of EMís HLW 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. During the previous audit (EM-ARC-01-09

performed in June 2001) of EM-5, the audit team identified, and discussed, with EM-5, that the

MOAs did not reflect the current organizational structure within EM. The previous audit team

identified this condition as a potential deficiency. During this audit, it was found that this deficiency

remained open, and that OCRWM would be responsible to close out this deficiency.

During this audit, OQA and EM-5 discussed EM-5 QA resources for implementing its oversight

activities. The EM-5 QA Manager explained that, presently, all contractor monies for QA support

had been frozen and that management had asked him to evaluate and review the resources

available within EM for supporting QA activities. Further, it was explained that should qualified QA

resources not be available within EM and justification provided, EM management would release

monies for contract support. 

Also, the EM-5 QA Manager discussed the possibility that EM-5 may no longer participate in EM

field office audits of their contractors, and that the field offices may have all responsibility for

ensuring that their contractors are effectively implementing the QARD. The observers

recommended that, should EM-5 no longer participate in the audits of site contractor activities,

OQA and EM-5 evaluate the need to oversee the initial field office audits of their contractors and

to determine the effectiveness of these audits. 

The observers agreed with the audit teamís findings in this area.
-7-

4.4.2 QA Program and the QARD Requirements Matrixes

During the previous OQA audit (June 2001) of EM-5, the audit team evaluated whether EM-5 had

provided acceptable, appropriate justifications for any exceptions to the QARD. The June 2001

audit team identified one deficiency in this area: 

EM-5 had taken exception to the QARD requirements for trending. EM-5 only oversaw the

trending function and had delegated the responsibility for trending to the QA organizations at

the various HLW processing sites. The audit team considered this to be an inappropriate

delegation, inconsistent 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.

The above OQA audit finding could not be closed during this audit and remains open. 

During this audit, OQA and EM-5 audit personnel stated that their present practice for reviewing

the QARD Requirements Matrixes was to review the matrixes during their annual audits of the

affected organizations responsible for the matrixes.

The observers noted that reviewing QARD Requirements Matrixes, including any exceptions taken

by the affected organizations and any requirements identified as not applicable, once a year,

during the conduct of an audit, is a concern. The observers noted that this practice may result in

an unacceptable exception or a requirement incorrectly identified as not applicable being

implemented for almost a year.

Further, the observers noted that the OQA audit checklist for Audit EM-ARC-02-01 and several

fiscal year 2001 EM-5 audit checklists, used for reviewing QARD Requirements Matrixes, do not

appear to meet applicable review provisions contained in Section 2.2.10 of the QARD. For

example, QARD Section 2.2.10.A requires that review criteria be established before performing

the QARD Requirements Matrix review and that the criteria shall consider applicability,

correctness, technical adequacy, completeness, accuracy, and compliance with established

requirements. Based on the observersí review of the audit checklists, it was found that the

checklist did not appear to address or identify acceptance criteria to be used by the audit team

when reviewing the matrixes. Further, the observers noted that, as required by QARD Section

2.2.10.A, the audit checklist should contain acceptance criteria or guidance to evaluate the

acceptability of exceptions or alternatives to QARD requirements. 

During the audit, the observers noted that they believed these acceptance criteria could include

considerations such as the following: applicable regulations are not violated; applicable DOE

policies and practices are met; equivalent levels of QA are provided; exceptions or alternatives are

or are not within the affected organizationís work scope; and under certain circumstances, obtain

guidance from the OQA QA Director for acceptance of alternatives and exceptions. Further, it was

not clear to the observers if the review provisions contained in Section 2.2.10 are entirely

applicable for reviewing exceptions, alternatives, or requirements not within the scope of the

affected organizationís work scope. Because some exceptions or alternatives may result in a

reduction of a QARD requirement, the observers suggested that OQA evaluate the review

provisions contained in QARD Section 2.2.10 and determine if they need to be revised or

supplemented when they are used for the review of QARD Requirements Matrixes.

As a result of the above discussion, the observers generated AOI No. EM-ARC-02-01, Sequence

No. 1, Exhibit 1 to this report, which states in part:
-8-

ìIt appears that the review and acceptance of exceptions or alternatives to QARD

requirements, and the review of QARD [Requirements] Matrixes, as presently performed

during OQA and EM-5 audits, is an area [are areas] requiring improvement. It is

recommended that, as a minimum, OQA evaluate the need for the QARD be revised to

require formal approval of exceptions or alternatives to QARD requirements (as applicable by

OQA or EM-5) before they are implemented by the affected organization. Further, it is

recommended that OQA evaluate the review requirements contained in QARD Section 2.2.10

and determine if they are acceptable when used for the review of QARD Requirements

Matrixes. If QARD Section 2.2.10 is determined to be to be acceptable for this review, then

applicable OQA and EM-5 audit checklists, used to review QARD Requirements Matrixes,

need to be revised to address QARD Section 2.2.10 review requirements.î

Other than the generation of the above AOI, the observers agreed with the audit teamís findings in

this area.

4.4.3 EM-5 Audit Reports

During the audit, the audit team and observers reviewed several fiscal year 2001 EM-5 audit

reports and their completed checklists. The audit team concluded that these audits were

performed in accordance with applicable QARD and EM-5 procedures requirements. Further, the

audit team confirmed that findings were properly classified as deviations and observations.

The observers agreed with the audit teamís findings in this area with the exception that the audit

checklists do not appear to provide the acceptance criteria for the review of QARD Requirements

Matrixes, as discussed in Section 4.4.2 of this report.

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. The audit team and observers found it difficult to relate the training

matrix developed by EM-5 to individuals performing quality functions. The EM-5 QA Manager

described the method he uses to ensure individuals are qualified to perform assigned quality

activities and explained the contents of personnel training and qualification files. Notwithstanding

these discussions and explanations, the audit team identified three problems resulting in a

potential deficiency in this area: 1) Certain training files were missing experience and education

documentation; 2) QARD requirements for position descriptions were not met; and 3) Training

matrixes do not address job responsibilities and functions.

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

4.4.5 Review of Deficiencies from Past Audits

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

deficiency reports (DRs) identified during the June 2001 OQA audit:

DR No. EM-01-D-89, dated June 21, 2001, identified that the MOA for coordination of QA

activities between OCRWM and the Office of Waste Management had not been revised to

reflect the current organizational structure. Likewise, the MOAs for the coordination and

implementation of QA activities between the HLW Field Offices and EM were found to be

outdated.
-9-

DR No. EM-01-D-90, dated June 21, 2001, identified that no process existed for EM-5 to

evaluate trends.

DR No. EM-01-D-91, dated June 21, 2001, identified that EM-5 failed to take timely corrective

action for DR No. EM-00-D-101 (scheduled for completion by March 1, 2001).

Although EM-5 had been working to close these DRs, the audit team found the actions taken to

date were not adequate to close out the DRs. During the audit, EM-5 indicated that it would

request extensions for closing out the DRs. 

The observers agreed with the audit teamís findings in this area and expressed a concern about

timely corrective action because the DRs were still open.

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

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

identified that the files for certain MOAs, between affected organizations, did not contain the

revision histories required by applicable EM-5 procedures. The second potential deficiency

identified the following three problems within the area of training: 1) Certain training files were

missing experience and education documentation; 2) QARD requirements for position descriptions

were not met; and 3) Training matrixes do not address job responsibilities and functions.

5.0 NRC STAFF FINDINGS

The observers determined that OQA Audit EM-ARC-02-01 was effective in determining the level of

compliance of EM-5 activities associated with the oversight of HLW processing activities. 

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

presented at the audit exit. However, during the conduct of the audit, the observers initiated an

AOI identifying concerns about the current practice used by OQA and EM-5 for reviewing and

approving exceptions to the QARD. 

The observers discussed OQAís and EM-5's roles in overseeing contractor activities at the various

EM field offices. The EM-5 QA Director explained that EM-5 may no longer participate in audits of

site contractors and that the field offices may have the responsibility to perform these audits. The

observers recommended that, should EM-5 decide not to participate in audits of site contractors,

either OQA or the EM-5 QA organization evaluate the need to oversee the initial field office audits

and to determine the effectiveness of these audits. 

Although the OQA 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 HLW processing sites. 

The observers agreed with the audit teamís conclusion that the QARD had been satisfactorily

implemented except for the identified potential deficiencies. NRC will continue to interface with

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

this audit. 
-10-

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

audit exit. Also, during the audit and audit exit meetings, the observers discussed the following:

! Notwithstanding the findings 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 HLW processing sites. However, the observers noted that they were

concerned about the methods used by OQA and EM-5 for reviewing and approving

exceptions to the QARD as previously discussed in this report and documented in AOI No.

EM-ARC-02-01, Sequence No. 1.

! The observers noted that during the audit, they had discussed with EM-5 management the

resources available for implementing the HLW QA program. EM-5 management agreed that

QA should be pro-active rather reactive, thus detecting problems before they evolve into

significant conditions adverse to quality. Additionally, the observers stated that EM-5

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

they are adequate. 

! Should EM-5 decide to not participate in EM field office audits of its contractors, the observers

recommended that OQA and EM-5 evaluate the need to provide oversight of the initial EM

field office audits of its contractors and to determine the effectiveness of these audits.

! NRC may observe EM-5 and EM field office audit activities during fiscal year 2002, as

provided for in the various MOAs with the HLW sites. 

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

to address the issues identified during this and previous OQA audits.

5.2 AOIs

During the audit, the observers initiated AOI No. EM-ARC-02-01, Sequence No. 1, as discussed in

Section 4.4.2 of this report, and provided as Exhibit 1 to this report. OCRWM is requested to

provide a response to this AOI. 

5.3 Open AOIs from Previous NRC Observations

There are no open AOIs from previous NRC audits. 

6.0 EXHIBITS

Exhibit 1: AOI No. EM-ARC-02-01, Sequence No. 1