DOCKET NO: A

- 98

- 49 ; II
- A1

- 115 EPA AIR E
- D OCKET NO: EPA

- HQ

- OAR

- 2001

- 0012

- 0444

EPA AUDIT OF THE SANDIA NATIONAL LABORATORY

- CARLSBAD OFFICE

QUALITY ASSURANCE PROGRAM

MAY 1

– 29 , 2014 JU LY 2 2

– 2 4 , 201 4

U. S. ENVIRONMENTAL PROTECTION AGENCY OFFICE OF RADIATION AND INDOOR AIR CENTER FOR WASTE MANAGEMENT AND REGULATIONS

WASHINGTON, DC 20460

JANUARY 201 5ii 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 Member s
................................ ................................ ................................ ........ 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

................................ ................................ ....... 4iii ACRONYMS
ASME American Society of Mechanical Engineers B boron Ca calcium CAR Corrective Actio n 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 e thylenediaminetetraacetic acid EPA U.S. Environmental Protection Agency EPA/ DC Envi ronmental Protection Agency Docket Center Fe iron FY fiscal year ICP

- AES i nductively coupled plasma atomic emission spectroscopy ICP

- MS i nductively coupled plasma mass spectrometry LANL

- CO Los Alamos National Laboratory

- Carlsbad Office Mn manganese Na sodi um 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 transur anic WIPP Waste Isolation Pilot Plantiv

WJC West William Jefferson Clinton West1

1.0 EXECUTIVE SUMMARY This report presents results of the U.S. Environmental Protection Agency ( EPA ) audit of the Sandia National Laboratory

- Carlsbad Office ( S NL

- CO ) , Waste Isolation Pilot Plant (WIPP) quality assurance (QA) program
. EPA conducted this audit remotely from May 1

– 29 , 2014, and onsite at S NL

- CO from July 2 2

– 24, 2014

. The purpose of the audit was to verify implementation of SNL

- CO’s QA prog ram relative to the requirements of American Society of Mechanical Engineers (ASME) N uclear Quality Assurance (NQA) Standard NQA

- 1

- 1989, 1 “Quality Assurance Program Requ irements for Nuclear Facilities

. ” S NL

- CO, a Departme nt of Energy (DOE) facility, is res ponsible for evaluating the long

- term performance of the WIPP repository

. During this audit, t he EPA audit team reviewed documents and records provided by S NL

- CO and interviewed S NL

- CO personnel in Carlsbad, New Mexico. EPA QA auditors evaluated the SNL

CO WIPP QA program against selected NQA

- 1

- 1989 elements to ensure compliance with EPA regulations at Title 40 of the Code of Fede ral Regulations (40 CFR) 194.22. Based on this audit, the EPA audit team determined that the S NL

- CO WIPP QA p rogram compl ies with the NQA

- 1

- 1989 e lement s selected for this audit and continue s 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 no t identif

y 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 (vi a 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 Constitu tion 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 standar ds 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 s ection 2.1(b) and (c) and s ection 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 si te 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 sy stem for management of TRU waste from generation to disposal.”
S NL

- CO operates as scientific ad visor 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 risk

based assessment based on field and laboratory analyses, scientific models and software code developed and performed by SNL

- CO. S NL

- CO performs all activities supporting the WIPP
un der the CBFO QAPD.
3.0 PURPOSE AND SCOPE The purpose of this EPA audit was to verify that the S NL

- 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 S NL

- 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, ma y 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 a chievement ” is the responsibility of operational groups that directly produce such an item or perform such an activity.

“ Quality a ssurance/ v erification ” is the respon sibility 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, N ew M exico

. For purposes of ef ficiency, EPA conducted the audit s 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 pr ogram (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 au dits. 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 a ll 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 (E PA) evaluated the qualifications of the SC&A a uditors listed in Table 1. Ms. Bender found that the SC&A auditors were qualified based on their :

 W orking knowledge and understanding of the NQA standards

.  Training

.  On

- the

-

job training

. In addition, Ms. Bender evaluated the qualifications of M r
. 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 h is :

 Communication skills

.  Technical qualifications

.  Specific understanding of NQA

. M r
. Lindblad was an a uditor

- i n
- t raining during this audit ; his qualifications as a QA auditor will be addressed in a subsequent EPA QA audit report.
EPA held one e ntrance m eeting and one e xit m eeting that included personnel form all four audited organi zations, 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 SNL

CO 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

- i n
- Training SC&A, Inc.4 Table 2
. Pers onnel Participating in Audit Meetings

6.0 PERFORMANCE OF THE A UDIT
The EPA audit team reviewed record s provided by S NL

- CO and interviewed S NL

- CO personnel to evaluate impl ementation of the requirements in ASME NQA

- 1

- 1989

. S NL

- 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 1 6 NQA

- 1

- 1989 elements listed below are applicable to work currently performed by S NL

- 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 Audi tor/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 , S enior 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 Assuran ce 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 S NL

- CO and interviewed S NL

- 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 availab le 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 a ddition to the 1 6 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 complet e a checklist for Element 18.
The EPA audit team toured the S NL

- CO laboratory facilities, which are located adjacent to the SNL

- CO offices , and conducted a limited review of la boratory practices and records . EPA’s limited the laboratory evaluation to t he e xtent 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 S NL

- CO W IPP QA program compl ies with the se 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 CONCERN S
The EPA audit team d id 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 S NL

- CO WIPP QA p rogram with ASME NQA

- 1

- 1989

. Based o n the sample of records reviewed and interviews conducted during this audit, EPA determine s that S NL

- CO complies with the standard.6

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 Pla ns 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 Facilit ies, 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, ERMS55992 8 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 Do cument 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 ERMS5 61898 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 Ionic7

Strengths: A Pitzer Model Description, ERMS561907 Field Check for a Solonist Brand Electric Sounder (1 000 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. Davi s, 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 C s 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 I CP

- 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 Cert ificate, Document No: 56013_11596366, March 31, 2014, ERMS561916 Limited Calibration Certificate, Document No: 56013_11622752, April 2, 2013, ERMS5998018

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 Surveillance s, Revision 9 , January 5, 2012 NP 20

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

- 2, Scientific Notebooks, Revision 10, April 9, 20 13 NP 2

- 1, Qualification and Training, Revision 9, September 29, 2006 NP 4

- 1, Procurement, Revision 11 , October 30, 20 12 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 Assura nce 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, 20 13, 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 Surveil lance IS

- 14

- 04, E R MS562299 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 Usin g a Solonist Brand Electric Sounder, Revision 2, February 1, 20109

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, 2 010 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 marki ngs 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, ER MS558348 WIPP Receipt Inspectors, April 8, 2014