DOCKET NO: A-98-49; II-A1-117

EPA Air eDocket # EPA-HQ-OAR-2001-0012-0446

EPA AUDIT OF THE CARLSBAD FIELD OFFICE QUALITY ASSURANCE 

PROGRAM

JULY 22–24, 2014

U. S. ENVIRONMENTAL PROTECTION AGENCY

OFFICE OF RADIATION AND INDOOR AIR

CENTER FOR FEDERAL REGULATIONS

WASHINGTON, DC 20460

DECEMBER 2014
ii

TABLE OF CONTENTS

Section Page

Acronyms and Abbreviations ........................................................................................................ iii

1.0 Executive Summary.............................................................................................................1

2.0 Background..........................................................................................................................2

2.1 Regulatory Background ...........................................................................................2

2.2 Organizational Background .....................................................................................2

3.0 Purpose and Scope ...............................................................................................................2

4.0 Definitions............................................................................................................................3

5.0 EPA Audit Logistics............................................................................................................3

5.1 Audit Schedule.........................................................................................................3

5.2 Team Members ........................................................................................................3

6.0 Performance of the Audit.....................................................................................................5

7.0 Findings and Concerns.........................................................................................................6

8.0 Conclusions..........................................................................................................................6

9.0 References............................................................................................................................7

TABLES

Table 1. EPA Quality Assurance Audit Team Members – Track A............................................... 3

Table 2. Personnel Participating in Audit Meetings....................................................................... 4

ATTACHMENTS

Attachment A Concern No. CBFO-QA-2014-01C

Attachment B Carlsbad Field Office Organization Chart, June 29, 2014

Attachment C Concern No. CBFO-QA-2014-02CR

Attachment D Carlsbad Field Office Organization Chart, Draft provided August 21, 2014
iii

ACRONYMS AND ABBREVIATIONS

ABQ Albuquerque Operations Office

ASME American Society of Mechanical Engineers

CAR corrective action report

CBFO Carlsbad Field Office

CFR Code of Federal Regulations

CTAC Carlsbad Field Office Technical Assistance Contractor

DOE U.S. Department of Energy

EMCBC Office of Environmental Management Consolidated Business Center

EPA U.S. Environmental Protection Agency

EPA/DC Environmental Protection Agency Docket Center

FPD/OAM Federal Project Director/Operations Activity Manager

FR Facility Representative

FRAM Functions, Responsibilities and Authorities Manual

FTE Full-Time Equivalent

HR Human Resources

LANL-CO Los Alamos National Laboratory-Carlsbad Office

NEPA National Environmental Policy Act

NQA nuclear quality assurance

NWP Nuclear Waste Partnership, LLC

OOM Office of Manager

OPM Office of Program Management

OQA Office of Quality Assurance

QA quality assurance

QAD Quality Assurance Division

QAPD Quality Assurance Program Document

RCRA Resource Conservation and Recovery Act

RL Richland Operations Office

RM Recovery Management

SNL-CO Sandia National Laboratory-Carlsbad Office

SSO Safety System Oversight

TRU transuranic
iv

WIPP Waste Isolation Pilot Plant

WJC West William Jefferson Clinton West
1

1.0 EXECUTIVE SUMMARY

This report presents results of the U.S. Environmental Protection Agency (EPA) audit of the 

Department of Energy’s (DOE’s) Carlsbad Field Office (CBFO) quality assurance (QA) 

program. EPA conducted this audit on July 22–24, 2014, at CBFO. The purpose of the audit was 

to verify implementation of CBFO’s QA program relative to the requirements of American 

Society of Mechanical Engineers (ASME) Nuclear Quality Assurance (NQA) Standard NQA-1-

1989,1“Quality Assurance Program Requirements for Nuclear Facilities.” CBFO QA is 

responsible for ensuring that Waste Isolation Pilot Plant (WIPP) operations, including 

characterization of transuranic (TRU) wastes, are performed in compliance with the requirements 

of the NQA-1-1989 standard.

During this audit, the EPA audit team reviewed documents and records provided by CBFO and 

interviewed applicable CBFO personnel in Carlsbad, New Mexico. EPA QA auditors evaluated 

the CBFO QA program against the NQA-1-1989 elements listed below to ensure compliance 

with EPA regulations at Title 40 of the Code of Federal Regulations (40 CFR) 194.22:

 Element 1, “Organization.” 

 Element 2, “Quality Assurance Program.”

 Element 16, “Corrective Action.”

Based on this audit, the EPA audit team determined that the CBFO QA program continues to 

comply with these NQA-1-1989 elements and continues to have sufficient independence, 

authority and resources to verify the quality of items and activities that are important to longterm isolation of TRU waste.

During the audit, the EPA audit team identified two concerns. One of these concerns required a 

response. 

1. EPA is concerned that the CBFO organization chart dated June 29, 2014, lists 28 vacant 

Full Time Equivalent (FTE) positions, including two new positions in the Office of 

Quality Assurance (OQA). These two new positions do not have official job descriptions 

or FTE authorizations, and they will not be filled until sometime in FY 2015 or FY 2016. 

EPA requested that CBFO review and revise the organization chart to reflect only 

authorized positions, whether filled or vacant.

2. EPA is concerned that the June 29, 2014, organization chart for CBFO shows the OQA 

reporting to the Office of the Manager, which includes additional staff in addition to the 

Manager and Deputy Manager. It was not clear to whom QA reported because of the 

additional staff. 

During the inspection, CBFO OQA personnel stated that they do report directly to the 

CBFO Manager; however, EPA requested that CBFO consider changing the organization 

to clarify this important reporting relationship. This concern required a response.

 

1 40 CFR 194.22(a)(1) states that DOE’s QA program shall comply with the requirements of the 1989 

version of the ASME NQA-1 standard.
2

CBFO responded to the concern on August 21, 2014, (see Attachment D).

Both concerns and CBFO’s response to the second concern are discussed in Section 6.0 of this 

report.

This report documents these audit activities. This information will be provided through EPA’s 

Electronic Docket (via regulations.gov) and the official Air Docket, in accordance with Title 40 

of the Code of Federal Regulation 40 CFR 194.22 (a)(1). EPA’s Air Docket A-98-49 is located 

at the Air and Radiation Docket in the EPA Docket Center (EPA/DC), WJC West, Room 3334, 

1301 Constitution Avenue, NW, Washington, DC, 20004. 

2.0 BACKGROUND

2.1 Regulatory Background

In accordance with 40 CFR 194.22(a)(1), EPA requires DOE to implement a QA plan that 

establishes the following NQA standards developed by ASME:

1. ASME NQA-1-1989.

2. ASME NQA-2a-1990 Addenda, Part 2.7, to ASME NQA-2-1989.

3. ASME NQA-3-1989 (excluding section 2.1(b) and (c) and section 17.1).

The regulation at 40 CFR 194.22(a)(2) requires DOE to implement its QA plan for all items and 

activities that are important to the long-term isolation of TRU waste within the WIPP. The 

regulation at 40 CFR 194.22(e) provides EPA with the authority to conduct audits to verify the 

proper establishment and implementation of QA programs for the WIPP.

2.2 Organizational Background

CBFO is responsible for management of the WIPP. This responsibility includes oversight of the

characterization and emplacement of TRU waste at the WIPP disposal site near Carlsbad, New 

Mexico. As stated in the Quality Assurance Program Document (QAPD),

2

“The mission of the 

CBFO is to protect human health and the environment by operating the WIPP for safe disposal of 

TRU waste and by establishing an effective system for management of TRU waste from 

generation to disposal.”

3.0 PURPOSE AND SCOPE

The purpose of this EPA audit was to verify that the CBFO QA program continues to properly 

implement selected elements of ASME NQA-1-1989. The scope of this EPA audit was limited to 

QA oversight of activities that are important to the long-term isolation of TRU waste as 

represented by records and documentation provided by CBFO.

 

2 Quality Assurance Program Document, U.S. Department of Energy Carlsbad Field Office, DOE/CBFO94-1012, Revision 11, June 2010
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4.0 DEFINITIONS

Finding: A determination that a requirement of the NQA standards has not been properly 

established or implemented. A finding requires a response. 

Concern: A judgment that a finding may occur in the future and, depending on the 

magnitude of the issue, may or may not require a response.

Quality: The reliability of a specific item or activity that is important to the long-term 

isolation of TRU waste in the WIPP. “Quality achievement” is the responsibility of 

operational groups that directly produce such an item or perform such an activity. 

“Quality assurance/verification” is the responsibility of QA groups that do not 

produce such an item or perform such an activity.

5.0 EPA AUDIT LOGISTICS

5.1 Audit Schedule

On July 22–24, 2014, EPA conducted QA audits of four DOE programs working on the WIPP 

project in Carlsbad, New Mexico. For purposes of efficiency, EPA conducted these audits in two 

parallel tracks with one Lead QA Auditor responsible for each track. Track A included limitedscope audits of the CBFO QA program (this report) and the Nuclear Waste Partnership (NWP)

QA program (see Docket No. A-98-49; II-A1-118 or eDocket EPA-HQ-OAR-2001-0012-0447). 

Track B completed audits of the Sandia National Laboratory-Carlsbad Office (SNL-CO) QA 

program (see Docket No. A-98-49; II-A1-115 or eDocket EPA-HQ-OAR-2001-0012-0444) and 

Los Alamos National Laboratory-Carlsbad Office (LANL-CO) QA program (see Docket No. A98-49; II-A1-116 or eDocket EPA-HQ-OAR-2001-0012-0445) both of which had been evaluated 

previously with remote audits. The other members of the EPA audit team participated in all four 

audits. This report addresses only the results of EPA’s audit of the CBFO QA program; the 

docket numbers cited above provide results of the other three EPA QA audits.

5.2 Team Members

The Track A audit team consisted of one EPA employee and three support contractors. Table 1 

lists all members of the EPA audit team, along with each person’s affiliation and function during 

this audit.

Prior to this audit, Lindsey Bender (EPA) evaluated the qualifications of the two SC&A auditors 

(Gill and Darlow) listed in Table 1. Ms. Bender found that the SC&A auditors were qualified 

based on their:

Table 1. EPA Quality Assurance Audit Team Members – Track A

Audit Team Member Audit Responsibility Affiliation

Lindsey Bender EPA QA Audit Team Leader EPA 

Dorothy Gill Lead QA Auditor SC&A, Inc.

Kira Darlow QA Auditor SC&A, Inc.

Karl Lindblad QA Auditor-in-Training SC&A, Inc.
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 Working knowledge and understanding of the NQA standards.

 Training.

 On-the-job training.

In addition, Ms. Bender evaluated the qualifications of Ms. Gill to be a Lead Auditor in oversight 

of DOE QA audits specific to Element 18 of NQA-1-1989 and found that she is qualified in this 

capacity based on her:

 Communication skills.

 Technical qualifications.

 Specific understanding of NQA-1, Element 18. 

Mr. Lindblad was an auditor-in-training during this audit; his qualifications as a QA auditor will 

be addressed in a subsequent EPA QA audit report. 

EPA held one Entrance Meeting and one Exit Meeting that included personnel from all four 

audited organizations, identified in Table 2. Some of these personnel may have been interviewed 

during one of the other three audits; however, only the personnel interviewed as part of this 

CBFO QA audit are identified in Table 2.

Table 2. Personnel Participating in Audit Meetings

Name Affiliation and Title/Position Entrance 

Meeting Interview Exit Meeting 

Berry Pace CTAC, QA Programs Manager 

Bill Allen NWP, QA 

Cindi Castillo CTAC, QA Auditor/Observer  

Dana C. Bryson CBFO, Deputy Manager  

Dennis Miehls CBFO, Senior QA Specialist   

Donna Sellmer CTAC, Training Records 

Fran Ito NWP 

Gene Safley SNL-CO, QA Lead 

Jim McVay NWP 

Laurie Smith LANL-CO, QA Manager  

Martin Navarrete CBFO, Senior QA Specialist   

Michael R. Brown CBFO, QA Director   

Ned Z. Elkins LANL-CO, Program Director 

Paul Shoemaker SNL-CO, Senior Manager 

Porf Martinez CTAC, Regulatory Assurance Manager 

Priscilla Y. Martinez CTAC, QA Auditor/Observer  

Regina Sides CBFO, QAD 

Shelly R. Nielsen SNL-CO, QA  

Steve Davis SNL-CO, QA Assessment Task Lead  

Steve Kouba URS, Manager EPA Compliance Program 

Tammy Reynolds NWP, Deputy Recovery Manager 

Val Cannon NWP, QA  
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6.0 PERFORMANCE OF THE AUDIT

The EPA audit team reviewed records provided by CBFO and interviewed CBFO personnel to 

evaluate implementation of the requirements in ASME NQA-1-1989 for the elements listed 

below, using NQA-1-1989 checklists. This information will be provided on line through the 

EPA’s Electronic Docket (via regulations.gov). Hard copies can also be obtained via the Reading 

Room/Information Center in the Agency’s Air and Radiation docket (at 1301 Constitution Ave., 

NW, Washington, DC, 20004). This in accordance with Title 40 of the Code of Federal 

Regulation 40 CFR 194.22 (a)(1).

 Element 1, “Organization.” 

 Element 2, “Quality Assurance Program.” 

 Element 16, “Corrective Action.” 

As recovery from the February 2014 events at the repository continues, QA oversight of the 

operations is especially important. During this audit, EPA evaluated selected aspects of the 

CBFO QA program to ensure that it has the appropriate independence, authority, and resources 

to oversee WIPP-related operations.

The EPA audit team performed a records and document review for the requirements of NQA-1-

1989 Elements 1, 2 and 16 and gathered objective evidence to support the proper implementation 

of these requirements throughout the audit as time allowed. The completed NQA-1-1989 

checklists are included as attachments to this report.

EPA’s review of CBFO’s organization chart identified several issues that should be addressed by 

CBFO. EPA generated Concern Nos. CBFO-QA-2014-01C and CBFO-QA-2014-02CR to 

identify these issues.

Concern No. CBFO-QA-2014-01C is based on the CBFO organization chart dated June 29, 2014 

(see Attachments A and B). This organization chart lists 28 vacant FTE positions, including two 

new positions in the OQA. These two new positions do not have official job descriptions or FTE 

authorizations and they will not be filled until next fiscal year at the earliest. EPA finds that the 

presense of these two OQA positions on the CBFO organizational chart implies a greater level of 

organizational depth than is actually present at the current time. EPA requests that CBFO review 

and revise the organization chart to reflect only authorized positions whether filled or vacant. 

This concern did not require a response.

Concern No. CBFO-QA-2014-02CR is also based on the CBFO organization chart dated June 

29, 2014 (see Attachments B and C). This organization chart shows the OQA reporting to the 

Office of the Manager, which now includes a Senior Strategist, Legal Counsel, Waste 

Management STA, Nuclear Safety STA, and two secretaries in addition to the Manager and 

Deputy Manager. CBFO QA personnel stated that they do report directly to the CBFO Manager; 

however, EPA requests that CBFO consider changing the organization to clarify this important 

reporting relationship. EPA previously identified the same issue in a June 2013 concern not 

requiring a response (see Concern No. CBFO-QA-2013-01C in EPA Docket No. A-98-49; IIA1-112). Because EPA had identified the same concern previously and it had not been

adequately addressed, Concern No. CBFO-QA-2014-02CR required a response.
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CBFO provided a draft revised organization chart on August 21, 2014, that separates the CBFO 

Manager and Deputy Manager from the rest of the Office of the Manager staff (see Attachment 

D). EPA found the revised organization chart to be acceptable and considers this concern closed.

The CBFO Technical Assistance Contractor (CTAC) is CBFO’s QA contractor for, among other 

duties, performing annual audits of waste generator sites. This program has been in place for 

many years and its performance does not appear to have been negatively impacted by the CBFO 

OQA staffing issues. However, the QA Director has deferred some generator site audits due to 

the necessity for performing additional audits at the WIPP facility as a result of the underground 

issues identified earlier this year.

During the EPA audit of CBFO’s QA program on June 18–20, 2013, the EPA audit team 

identified a concern regarding timely closure of corrective action reports (CARs) (see

Attachment D in EPA Docket No. A-98-49; II-A1-112). Implementing procedure MP 3.1, 

Revision 12, and Interim Change Notice No. 1 required that all CARs be closed within 60 days 

of implementation, but the EPA audit team identified two CARs that had both been open for over 

90 days. CBFO QA indicated at the time that MP 3.1 was scheduled for revision to remove the 

60-day requirement. EPA wrote Concern No. CBFO-QA-2013-03C and did not require further 

response. During the current audit (July 2014), the EPA audit team confirmed that CBFO has 

deleted the self-imposed requirement to close CARs within 60 days. This change does not 

adversely affect the CAR process.

EPA determined that the CBFO QA program continues to comply with these NQA-1-1989 

elements and continues to have sufficient independence, authority and resources to verify the 

quality of items and activities that are important to long-term isolation of TRU waste.

7.0 FINDINGS AND CONCERNS

The EPA audit team did not identify any findings relative to the NQA-1-1989 elements discussed 

above. The EPA audit team identified two concerns, one requiring a response. These concerns 

are discussed in section 6.0 above. These concerns are included as attachments to this report. 

There are no open issues as a result of this audit. 

8.0 CONCLUSIONS

The EPA audit team reviewed records and documentation and interviewed personnel to 

determine the continued compliance of the CBFO QA program with ASME NQA-1-1989. Based 

on the sample of records, documentation and elements reviewed during this audit, EPA 

determined that CBFO continues to comply with the standard.
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9.0 REFERENCES

6 month CAR Trend Report for July thru December 2013

Audit Report of SNL-CO Quality Assurance Program, Audit Number A-14-08, February 25–27, 

2014, performed by CTAC

CAR Nos. 13-042 and 14-009

CBFO CAR No. 14-054

CBFO Monthly Assessment Schedule, dated July 8, 2014

CBFO MP 10.3, Audits, Revision 7

CBFO Organization Chart, dated July 14, 2014

CBFO Semi-Annual CAR Trend Report, dated March 5, 2014

CBFO TP 10.1, Qualification of Audit Personnel and Certification of Lead Auditors, Revision 5, 

May 27, 2007

EPA Concern No. CBFO-QA-2013-03C

Lead Auditor Maintenance of Proficiency Record

Lead Auditor Maintenance of Proficiency Record

Listing of CARs still open as of July 18, 2014

Listing of CBFO CAR Trend Codes

Listing of CBFO CARs issued in the past 12 months (since June 2013)

Memorandum dated 8/7/2012, Interim Change Notice No. 1 to CBFO Management Procedure 

3.1, Revision 12, Corrective Action Reports

Memorandum dated 9/4/2013, Interim Change Notice No. 2 to CBFO Management Procedure 

3.1, Revision 12, Corrective Action Reports

Memorandum dated July 15, 2014, Full Time Equivalent CBFO Positions

MP 3.1, Corrective Action Reports, Revision 12, October 28, 2011

Organization Chart approval letter, dated June 9, 2014

QAPD, Quality Assurance Program Document, DOE/CBFO-94-1012, Revision 11, June 2010

Safety Management Functions, Responsibilities and Authorities Manual, DOE/CBFO 09-3441, 

Revision 2, January 10, 2013

Technical Specialist Qualification Record
A-1

ATTACHMENT A

EPA INSPECTION ISSUE TRACKING FORM

CONCERN NO. CBFO-QA-2014-01C, FINAL

Inspection No. QA-CBFO-2014-1 Concern Number: CBFO-QA-2014-01C

Date: Draft-July 22, 2014; Final-August 13, 2014

Inspector: Dorothy Gill, Lindsey Bender

Attachments? YES NO

Sample Size: 1

Population size (if known): 1

A. Description of Issue: The current CBFO organization chart dated 6/29/2014 lists 28 

vacant Full Time Equivalent (FTEs) positions, including two new positions in the Office of 

Quality Assurance (OQA). These two new positions do not have official job descriptions or 

FTE authorizations and we were informed that they will not be filled until next fiscal year at 

the earliest.

The presense of these two OQA positions on the CBFO organizational chart implies a greater 

level of organizational depth than is actually present at the current time. EPA requests that 

CBFO review and revise the organization chart to reflect only authorized positions whether 

filled or vacant.

B. Regulatory Reference: 40 CFR 194.22(e) 

C. NQA-1-1989 Element(s): 1

D. Discussed with: Dana Bryson and Mike Brown

E. Additional Comments: None

F. Site Response Information:

 Site Response Required? YES NO

 Site Response Due Date: 
B-1

ATTACHMENT B

CARLSBAD FIELD OFFICE ORGANIZATION CHART, JUNE 29, 2014
C-1

ATTACHMENT C

EPA INSPECTION ISSUE TRACKING FORM

CONCERN NO. CBFO-QA-2014-02CR, FINAL

Inspection No. QA-CBFO-2014-1 Concern Number: CBFO-QA-2014-02CR

Date: Draft-June 20, 2014; Final-August 13, 2014

Inspector: Dorothy Gill, Lindsey Bender

Attachments? YES NO

Sample Size: 1

Population size (if known): 1

A. Description of Issue: The 5/22/2013 CBFO organizational chart showed that the Office 

of Quality Assurance (OQA) had a direct reporting line to the Office of the Manager, which 

included the Deputy Manager and a secretary. In June 2013, EPA recommmended that CBFO 

revise the organization chart to exclude the deputy, manager and secretary such that this 

reporting line only included the Manager. (See EPA Concern No. CBFO-QA-2013-01C).

The 6/29/2014 organization chart for CBFO shows the OQA reporting to the Office of the 

Manager, which now includes a Senior Strategist, Legal Counsel, Waste Management STA, 

Nuclear Safety STA, and two secretaries in addition to the Manager and Deputy Manger.

CBFO QA personnel stated that they do report directly to the CBFO Manager; however, EPA 

requests that CBFO consider changing the organization to clarify this important reporting 

relationship.

B. Regulatory Reference: 40 CFR 194.22(e) 

C. NQA-1-1989 Element(s): 1

D. Discussed with: Dana Bryson and Mike Brown

E. Additional Comments: None

F. Site Response Information:

 Site Response Required? YES NO

 Site Response Due Date: August 29, 2014
D-1

ATTACHMENT D

CARLSBAD FIELD OFFICE ORGANIZATION CHART, DRAFT PROVIDED AUGUST 21, 2014