DOCKET NO: A-98-49; II-A1-115

EPA AIR E-DOCKET NO: EPA-HQ-OAR-2001-0012-0444

EPA AUDIT OF THE SANDIA NATIONAL LABORATORY-CARLSBAD OFFICE

QUALITY ASSURANCE PROGRAM

MAY 1–29, 2014

JULY 22–24, 2014

U. S. ENVIRONMENTAL PROTECTION AGENCY

OFFICE OF RADIATION AND INDOOR AIR

CENTER FOR WASTE MANAGEMENT AND REGULATIONS

WASHINGTON, DC 20460

JANUARY 2015
ii

TABLE OF CONTENTS

Section Page

Acronyms....................................................................................................................................... iii

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

2.0 Background ..........................................................................................................................1

2.1 Regulatory Background ...........................................................................................1

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

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

4.0 Definitions............................................................................................................................2

5.0 EPA Audit Logistics ............................................................................................................2

5.1 Audit Schedule.........................................................................................................2

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

6.0 Performance of the Audit.....................................................................................................4

7.0 Findings and Concerns.........................................................................................................5

8.0 Conclusions..........................................................................................................................5

9.0 References............................................................................................................................6

TABLES

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

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

ACRONYMS

ASME American Society of Mechanical Engineers

B boron

Ca calcium

CAR Corrective Action Report

CBFO Carlsbad Field Office

CFR Code of Federal Regulations

Cs cesium

CTAC Carlsbad Field Office Technical Assistance Contractor

DOE U.S. Department of Energy

EDTA ethylenediaminetetraacetic acid

EPA U.S. Environmental Protection Agency

EPA/DC Environmental Protection Agency Docket Center

Fe iron

FY fiscal year

ICP-AES inductively coupled plasma atomic emission spectroscopy

ICP-MS inductively coupled plasma mass spectrometry

LANL-CO Los Alamos National Laboratory-Carlsbad Office

Mn manganese

Na sodium

NQA nuclear quality assurance

NWP Nuclear Waste Partnership, LLC

PA Performance Assessment

PPM parts per million

QA quality assurance

QAPD Quality Assurance Program Document

S/N serial number

SNL-CO Sandia National Laboratory-Carlsbad Office

TRU transuranic

WIPP Waste Isolation Pilot Plant
iv

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

Sandia National Laboratory-Carlsbad Office (SNL-CO), Waste Isolation Pilot Plant (WIPP) 

quality assurance (QA) program. EPA conducted this audit remotely from May 1–29, 2014, and 

onsite at SNL-CO from July 22–24, 2014. The purpose of the audit was to verify implementation 

of SNL-CO’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.” SNL-CO, a Department of Energy 

(DOE) facility, is responsible for evaluating the long-term performance of the WIPP repository.

During this audit, the EPA audit team reviewed documents and records provided by SNL-CO and 

interviewed SNL-CO personnel in Carlsbad, New Mexico. EPA QA auditors evaluated the SNLCO WIPP QA program against selected NQA-1-1989 elements to ensure compliance with EPA 

regulations at Title 40 of the Code of Federal Regulations (40 CFR) 194.22.

Based on this audit, the EPA audit team determined that the SNL-CO WIPP QA program 

complies with the NQA-1-1989 elements selected for this audit 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 transuranic (TRU) waste.

EPA did not identify any nonconformances in SNL-CO’s QA program relative to the 

requirements of ASME NQA-1-1989. This report documents these audit activities. 

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

Electronic Docket (via regulations.gov) at EPA-HQ-OAR-2001-0012-0444 and the official Air 

Docket, in accordance with 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 

 

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

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

DOE’s Carlsbad Field Office (CBFO) is responsible for management of the WIPP. This 

responsibility includes oversight of the characterization of TRU waste bound for the WIPP and 

emplacement of the waste at the disposal site near Carlsbad, New Mexico. As stated in the 

CBFO Quality Assurance Program Document (QAPD), “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.”

SNL-CO operates as scientific advisor to DOE regarding the long-term performance of the WIPP 

repository. SNL-CO conducts the Performance Assessment (PA) on behalf of DOE to 

demonstrate that the WIPP meets EPA’s release requirements for radionuclides. The PA is a riskbased assessment based on field and laboratory analyses, scientific models and software code 

developed and performed by SNL-CO. SNL-CO performs all activities supporting the WIPP 

under the CBFO QAPD. 

3.0 PURPOSE AND SCOPE

The purpose of this EPA audit was to verify that the SNL-CO WIPP QA program properly 

implements all applicable 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 documentation provided by SNL-CO.

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 the audits in two 

parallel tracks with one Lead QA Auditor responsible for each track. Track A included limited-
3

scope audits of the CBFO QA program (see Docket No. A-98-49; II-A1-117 or eDocket No. 

EPA-HQ-OAR-2001-0012-0446) and the Nuclear Waste Partnership (NWP) QA program (see 

Docket No. A-98-49; II-A1-118 or eDocket No. EPA-HQ-OAR-2001-0012-0447). Track B 

completed audits of the SNL-CO QA program (this report) and the Los Alamos National 

Laboratory-Carlsbad Office (LANL-CO) QA program (see Docket No. A-98-49; II-A1-116 or 

eDocket No. EPA-HQ-OAR-2001-0012-0445). EPA began the SNL-CO QA audit remotely in 

May 2014 and began the LANL-CO QA audit remotely in June 2014. 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 SNL-CO QA program; the docket numbers cited above provide results of the other 

three EPA QA audits.

5.2 Team Members

The Track B 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.

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

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

listed in Table 1. Ms. Bender found that the SC&A auditors were qualified based on their:

 Working knowledge and understanding of the NQA standards.

 Training.

 On-the-job training.

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

oversight of DOE QA audits specific to NQA-1-1989 and found that he is qualified in this 

capacity based on his:

 Communication skills.

 Technical qualifications.

 Specific understanding of NQA.

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 form 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 SNLCO QA audit are identified in Table 2.

Audit Team Member Audit Responsibility Affiliation

Lindsey Bender EPA QA Audit Team Leader EPA 

Patrick Kelly 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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Table 2. Personnel Participating in Audit Meetings

6.0 PERFORMANCE OF THE AUDIT

The EPA audit team reviewed records provided by SNL-CO and interviewed SNL-CO personnel 

to evaluate implementation of the requirements in ASME NQA-1-1989. SNL-CO stated, and 

EPA concurred, that NQA-1-1989, Element 3, “Design Control” and Element 18, “Audits” are

not applicable to work currently performed by SNL-CO.

The remaining 16 NQA-1-1989 elements listed below are applicable to work currently performed 

by SNL-CO and were therefore evaluated during this audit.

 Element 1, “Organization.”

 Element 2, “Quality Assurance Program.”

 Element 4, “Procurement Document Control.”

 Element 5, “Instruction, Procedures and Drawings.”

 Element 6, “Document Control.”

 Element 7, “Control of Purchased Items and Services.”

Name Affiliation and Title/Position Entrance 

Meeting Interview Exit Meeting 

Angela Guerin SNL-CO, Document Control 

Berry Pace CTAC, QA Programs Manager 

Bill Allen NWP, QA 

Cindi Castillo CTAC, QA Auditor/Observer  

Dana C. Bryson CBFO, Deputy Manager 

Denise Chacon SNL-CO, Procurement 

Dennis Miehls CBFO, Senior QA Specialist  

Fran Ito NWP 

Gene Safley SNL-CO, QA Lead  

Grace Duran SNL-CO, Records 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 RES, Manager EPA Compliance Program 

Tammy Reynolds NWP, Deputy Recovery Manager 

Val Cannon NWP, QA  

Vennessa Rodriguez SNL-CO, Records 
5

 Element 8, “Identification and Control of Items.”

 Element 9, “Control of Processes.”

 Element 10, “Inspection.”

 Element 11, “Test Control.”

 Element 12, “Control of Measuring and Test Equipment.”

 Element 13, “Handing, Storage, and Shipping.”

 Element 14, “Inspection, Test, and Operating Status.”

 Element 15, “Control of Nonconforming Items.”

 Element 16, “Corrective Action.”

 Element 17, “QA Records.” 

The EPA audit team reviewed documents and records provided by SNL-CO and interviewed 

SNL-CO personnel to evaluate implementation of the requirements in ASME NQA-1-1989 for 

these elements, using NQA-1-1989 checklists. The checklists and this report will be available on 

line through the EPA Electronic Docket (via regulations.gov) at EPA-HQ-OAR-2001-0012-0444 

and EPA’s Air Docket A-98-49, located at the Air and Radiation Docket in the EPA/DC WJC 

West, Room 3334, 1301 Constitution Ave., NW, Washington, DC, 20004. In addition to the 16

elements listed above as evaluated during EPA’s audit, EPA also reviewed SNL-CO procedure 

NP 18-1, Revision 9, Audits and Surveillances. However, SNL-CO is not currently performing 

any audits; therefore, the EPA audit team did not complete a checklist for Element 18.

The EPA audit team toured the SNL-CO laboratory facilities, which are located adjacent to the 

SNL-CO offices, and conducted a limited review of laboratory practices and records. EPA’s 

limited the laboratory evaluation to the extent necessary to complete the applicable NQA-1-1989 

checklists. EPA did not evaluate the technical adequacy of the laboratory or the usability of the 

data produced by the laboratory.

As a result of these audit activities, EPA determined that the SNL-CO WIPP QA program 

complies with these NQA-1-1989 elements and has 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 or concerns relative to the NQA-1-1989 

elements discussed above. 

8.0 CONCLUSIONS

The EPA audit team reviewed records and interviewed personnel to determine the compliance of 

the SNL-CO WIPP QA program with ASME NQA-1-1989. Based on the sample of records

reviewed and interviews conducted during this audit, EPA determines that SNL-CO complies

with the standard.
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9.0 REFERENCES

Calibration Record for Troll Pressure Transducer Model 700, S/N: 148736, Calibration 

Procedure SP-12-32, Revision 1; Mensor S/N: 611334 – Calibration Due 6/14/2014; 

Temperature Probe S/N: 307172 - Calibration Due 3/31/2015; records dated May 12, 2014 and 

May 28, 2014

Collection of Nuclear Waste Management Procedures, Activity/Project Specific Procedures, 

Analysis Plans and Test Plans

Contract between Boise State University and Sandia National Laboratories for Geophysical 

Investigation of the Shallow Subsurface, Section I, 8/11/11, ERMS557603, and Section II, June 

14, 2011

Contract between PerkinElmer Health Sciences, Inc. and Sandia National Laboratories for 

Nexlon 300D ICP-MS including S10Autosampler and Polyscience Recirculator, Section I, 

February 11, 2013, ERMS559544

Corrective Action Verification, CAR IS-13-08-CAR-01, ERMS561401

Description of Dual Storage Facilities, provided May 8, 2014

Document Review Package for AP-165, ERMS560703, ERMS560704, ERMS560705, 

ERMS560707 and ERMS561138

Document Review Package for AP-168, ERMS561954, ERMS561955, ERMS561956 and 

ERMS561957

Document Review Package for NP 17-1, ERMS559928 and ERMS559930

Document Review Package for NP 18-1, ERMS556852, ERMS556853 and ERMS561901

Document Review Package for NP 6-2, ERMS561678 and ERMS561680

Document Review Package for SP 12-19, ERMS554665, ERMS554666, ERMS554667, 

ERMS554669 and ERMS561483

Document Review Package for SP 12-32, ERMS561935, ERMS561936, ERMS561937 and 

ERMS561940

Document Review Package for TP 14-01, ERMS556855, ERMS561691, ERMS561692 and 

ERMS561693

Document Review Package for TP 14-03, ERMS561695, ERMS561896, ERMS561897 and 

ERMS561898

Documentation Package, CAR IS-13-08-CAR-01, ERMS561398

Documentation Package, CAR W-13-05, ERMS560433–ERMS560435 

Documentation Package, CAR W-13-12, in-process provided May 8, 2014

Documentation Package, CAR W-14-05, in-process provided May 8, 2014

Documentation Package, CARs April 2013 to April 2014, April 15, 2014

Experimental Determination of Lead Solubility in the Carbonate Systems to High Ionic 
7

Strengths: A Pitzer Model Description, ERMS561907

Field Check for a Solonist Brand Electric Sounder (1000 ft), Solonist Model 101 Water Level 

Meter, S/N: 202678, October 22, 2012, ERMS558471

Form 18-1-1, Auditor Qualifications for Angela Guerin, ERMS550905, S. Davis, ERMS528392, 

and M. Chavez, ERMS544910

Form 18-1-2, Lead Auditor Qualifications for S. Davis, ERMS528392, and M. Chavez, 

ERMS544910

Form 18-1-3, Maintenance of Lead Auditor for S. Davis, ERMS560667, and M. Chavez, 

ERMS560984

Form No. 4-1-1, Revision 11, Procurement Review, 1000 PPM Standards for Ca, Na, Mn, Fe, B, 

Cs, 1 PPM ICP-MS Standard for Cs from Government Scientific Source, January 14, 2014, 

ERMS561585

Form No. 4-1-1, Revision 11, Procurement Review, Service Contract with PerkinElmer for 

Nexlon 300D ICP-MS including S10Autosampler and Polyscience Recirculator, January 24, 

2013, ERMS559543

Form No. 4-1-2, Revision 11, Procurement Review, Geophysical Investigation of the Shallow 

Subsurface by Boise State University, March 6, 2013, ERMS559674

Form No. 4-1-2, Revision 11, Receipt Inspection, 1000 PPM Standards for Ca, Na, Mn, Fe, B, 

Cs, 1 PPM ICP-MS Standard for Cs from Government Scientific Source, January 23, 2014, 

ERMS561586

Form No. 4-1-2, Revision 11, Receipt Inspection, Geophysical Investigation of the Shallow 

Subsurface by Boise State University, March 6, 2013, ERMS559674

Form NP 17-1-2, Records Submittal, Receipt Inspection Training for C. Camphouse, 

ERMS558195

Form NP 17-1-2, Records Submittal, Receipt Inspection Training for B. Malama, ERMS554701

Form NP 18-1-4, Limited Scope Surveillance Report of Control of Samples and Standards/Chain

of Custody, IS 14-04, ERMS562299

Form NP 18-1-4, Limited Scope Surveillance Report of Core Sample Logging and Management, 

IS 13-01, ERMS558716

Form NP 2-1-1, Qualification and Training for C. Camphouse, ERMS548415, and B. Malama, 

ERMS557132

Form NP 2-1-2, Receipt Inspection Training Records for C. Camphouse, ERMS557696, and B. 

Malama, ERMS544536

ISO-9001 Certification, Procurement Package for Omega Engineering, Inc. Omega S-Beam Load 

Cell, Record-in-Progress, observed July 22, 2014

Limited Calibration Certificate, Document No: 56013_11596366, March 31, 2014, 

ERMS561916

Limited Calibration Certificate, Document No: 56013_11622752, April 2, 2013, ERMS599801
8

Memorandum evaluating M. Chavez, ERMS560985

Memorandum from Paul Shoemaker to WIPP Records Center, re: Approved Access List for SNL 

WIPP Records Center and SNL WIPP Proprietary and Privileged Records, January 28, 2013, 

ERMS559128

NP 1-1, Organization and QA Program, Revision 7, February 12, 2008

NP 12-1, Control of Measuring and Test Equipment, Revision 8, August 17, 2010

NP 13-1, Control of Samples and Standards, Revision 6, November 22, 2011, and Revision 7, 

November 10, 2014

NP 16-1, Corrective Action, Revision 6, June 19, 2007

NP 17-1, Records, Revision 9, April 17, 2013 

NP 18-1, Audits and Surveillances, Revision 9, January 5, 2012

NP 20-1, Test Plans, Revision 5, September 17, 2008

NP 20-2, Scientific Notebooks, Revision 10, April 9, 2013

NP 2-1, Qualification and Training, Revision 9, September 29, 2006

NP 4-1, Procurement, Revision 11, October 30, 2012

NP 5-1, Implementing Procedures, Revision 6, April 3, 2013

NP 6-1, Document Review Process, Revision 8, October 13, 2009

NP 6-2, Document Control Process, Revision 5, February 18, 2014

NP 9-1, Analyses, Revision 9, December 18, 2012

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

Quality Levels for WIPP Activities - FY14 (Approved Suppliers List), downloaded April 24, 

2014

Sandia National Laboratories Scientific Notebook, Balance Calibration Log Book Balance 

Calibration Records, Leslie Kirkes, June 13, 2013, Balance Nos. Mettler PM 4000, AT 4000 and 

Mettler Toledo AT 261

Sandia National Laboratories Scientific Notebook, ICP-AES Logbook-2, November 2006iii

SNL WIPP Program Description, November 4, 2011

SNL WIPP QA Surveillance IS-14-04, ERMS562299

SNL-CO Organizational Structure, April 23, 2013

SP 1-1, QA Grading, Revision 7, April 7, 2008

SP 12-32, Pressure Transducer Calibration Using the Mensor CPC 6000, Revision 1, April 8, 

2014

SP 12-5, Depth-to-Water Measurement Using a Solonist Brand Electric Sounder, Revision 2, 

February 1, 2010
9

SP 13-1, Chain of Custody, Revision 5, April 12, 2012

SP 13-2, Core Sample Logging and Management, Revision 4, December 14, 2006

SP 17-1, Records Center Operations, Revision 8, January 28, 2010

SP 5-1, Engineering Drawings, Revision 2, January 21, 2008

TP 03-01, Test Plan for Testing of Wells at the WIPP Site, Revision 3, July 13, 2010

TP 08-02, Iron, Lean, Sulfide and EDTA Solubilities, Revision 0, March 25, 2008

Visual confirmation of markings to indicate calibration status: Weights S/N: 34855 and 

Thermometer CPC 6000, observed July 22, 2014

Visual Confirmation of Tag Out for FLUM E System Data Acquisition System, Tag No. 820, 

October 13, 2013, observed July 22, 2014

Well H-9bR Video Log, ERMS558348

WIPP Receipt Inspectors, April 8, 2014