DOCKET NO: A-98-49; II-A1-116

EPA Air eDocket # EPA-HQ-OAR-2001-0012-0445

EPA AUDIT OF THE LOS ALAMOS NATIONAL LABORATORY-CARLSBAD 

OFFICE QUALITY ASSURANCE PROGRAM

JUNE 10–JULY 8, 2014

JULY 22–24, 2014

U. S. ENVIRONMENTAL PROTECTION AGENCY

OFFICE OF RADIATION AND INDOOR AIR

CENTER FOR WASTE MANAGEMENT AND REGUALTIONS

WASHINGTON, DC 20460

DECEMBER 2014
ii

TABLE OF CONTENTS

Section Page

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

1.0 Executive Summary.............................................................................................................4

2.0 Background ..........................................................................................................................5

2.1 Regulatory Background ...........................................................................................5

2.2 Organizational Background .....................................................................................5

3.0 Purpose and Scope ...............................................................................................................5

4.0 Definitions............................................................................................................................6

5.0 EPA Audit Logistics ............................................................................................................6

5.1 Audit Schedule.........................................................................................................6

5.2 Team Members ........................................................................................................6

6.0 Performance of the Audit.....................................................................................................8

7.0 Findings and Concerns.........................................................................................................9

8.0 Conclusions........................................................................................................................10

9.0 References..........................................................................................................................11

TABLES

Table 1. EPA Quality Assurance Audit Team Members – Track B............................................... 6

Table 2. Personnel Participating in Audit Meetings....................................................................... 8

ATTACHMENTS

Attachment A: Concern No. LANL-CO-QA-2014-01C
iii

ACRONYMS

AC administrative change

ACRSP Actinide Chemistry and Repository Science Program

ASME American Society of Mechanical Engineers

CAQ condition adverse to quality

CBFO Carlsbad Field Office

CEMRC Carlsbad Environmental Monitoring and Research Center

CFR Code of Federal Regulations

CTAC Carlsbad Field Office Technical Assistance Contractor

DOE U.S. Department of Energy

EPA U.S. Environmental Protection Agency

EPA/DC Environmental Protection Agency Docket Center

FR finding report

IC ion chromatography

ICP-MS inductively coupled plasma mass spectrometry

LANL-CO Los Alamos National Laboratory-Carlsbad Office

LSC liquid scintillation counter

NIST National Institute of Standards and Technology

NQA nuclear quality assurance

NWP Nuclear Waste Partnership, LLC

Pu plutonium

QA quality assurance

QAPD Quality Assurance Program Document

QL-1 Quality Level One

RSS Record Submittal System

RTS Record Tracking System

S/N serial number

SNL-CO Sandia National Laboratory-Carlsbad Office

TRU transuranic

WIPP Waste Isolation Pilot Plant

WJC West William Jefferson Clinton West
4

1.0 EXECUTIVE SUMMARY

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

Alamos National Laboratory-Carlsbad Office (LANL-CO), Waste Isolation Pilot Plant (WIPP) 

quality assurance (QA) program. EPA conducted this audit remotely from June 10–July 8, 2014, 

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

implementation of LANL-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.” LANL-CO, a Department of 

Energy (DOE) facility, is responsible for providing WIPP transuranic (TRU) waste inventory

estimates and laboratory research and program support on actinide-related issues to the DOE 

Carlsbad Field Office (CBFO) to maintain EPA’s certification of the WIPP.

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

and interviewed LANL-CO personnel in Carlsbad, New Mexico. EPA QA auditors evaluated the 

LANL-CO WIPP 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 4, “Procurement Document Control.”

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

 Element 6, “Document Control.”

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

 Element 9, “Control of Processes.”

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

 Element 16, “Corrective Action.”

 Element 17, “QA Records.”

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

complies 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.

EPA identified one concern not requiring a response in LANL-CO’s QA program relative to the 

requirements of ASME NQA-1-1989. NQA-1-1989, Element 16, states that "conditions adverse 

to quality [(CAQ)] shall be identified promptly and corrected as soon as practical." EPA found 

that LANL-CO is correcting CAQs in a timely manner; however, LANL-CO procedure LCOQP16-1, Revision 4-AC1, does not include the NQA-1 requirements that CAQs be identified 

promptly and corrected as soon as practical. EPA requests that LANL-CO review the language in 

the applicable section of LCO-QP16-1 and make whatever changes they deem appropriate. 

 

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.
5

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 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 

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 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.”

LANL-CO provides three categories of quality-affecting work for the DOE CBFO in support of 

the WIPP: 1) LANL-CO conducts research, testing and experimentation (predominately in the 

field of actinide chemistry) in support of the CBFO WIPP Repository Investigations Program; 

2) LANL-CO provides the WIPP program with the technical expertise to solve challenging waste 

issues in the packaging, certification, transportation, or emplacement of defense TRU Waste; and 

3) LANL-CO manages the WIPP TRU waste inventory for WIPP recertification and provides 

TRU waste management and strategic planning using a complex-wide container-specific 

inventory.

LANL-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 LANL-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 
6

as represented by documentation provided by LANL-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 limitedscope audits of the CBFO QA program (see Docket No. A-98-49; II-A1-117; EPA-HQ-OAR2001-0012-0446) and the Nuclear Waste Partnership (NWP) QA program (see Docket No. A-98-

49; II-A1-118; 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; EPA-HQ-OAR-2001-0012-0444) and the Los Alamos National Laboratory-Carlsbad Office 

(LANL-CO) QA program (this report). EPA had begun remote audits of the SNL-CO QA 

program in May 2014 and the LANL-CO QA program 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 LANL-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

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.
7

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-1.

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 

LANL-CO QA audit are identified in Table 2.
8

Table 2. Personnel Participating in Audit Meetings

6.0 PERFORMANCE OF THE AUDIT

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

LANL-CO personnel to evaluate implementation of the requirements in ASME NQA-1-1989. 

LANL-CO stated, and EPA concurred, that the following NQA-1-1989 elements are not 

applicable to work currently performed by LANL-CO:

 Element 3, “Design Control.”

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

 Element 10, “Inspection.”

 Element 11, “Test Control.”

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

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

 Element 15, “Control of Nonconforming Items.”

Name Affiliation and Title/Position

Entrance 

Meeting Interview Exit Meeting 

April Heiser LANL-CO, Records Manager 

Berry Pace CTAC, QA Programs Manager 

Bill Allen NWP, QA 

Cindi Castillo CTAC, QA Auditor/Observer  

Cliff Stroud LANL-CO, Deputy Group Leader 

Dana C. Bryson CBFO, Deputy Manager 

Danielle Cleveland LANL-CO 

Dave Guerin LANL-CO, TRU Waste Inventory/QA 

Dennis Miehls CBFO, Senior QA Specialist  

Fran Ito NWP 

Gene Safley SNL-CO, QA Lead 

Grace Duran SNL-CO, Records Lead 

Jean Francois Lucchini LANL-CO 

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  
9

 Element 18, “Audits.” 

The NQA-1-1989 elements listed below are applicable to work currently performed by LANLCO 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.”

 Element 9, “Control of Processes.”

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

 Element 16, “Corrective Action.”

 Element 17, “QA Records.”

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

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

these elements, using NQA-1-1989 checklists. The checklists will be available on line through 

the EPA’s Electronic Docket (via regulations.gov) or in hard copy via the Reading 

Room/Information Center in the Agency’s Air and Radiation docket as described in section 1.0 

above. In addition to the 10 elements listed above as evaluated during EPA’s audit, EPA also 

reviewed LANL-CO procedure LCO-QP18-1, Audits, Revision 3. However, LANL-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 LANL-CO laboratory facilities, which are located at the Carlsbad 

Environmental Monitoring and Research Center at the New Mexico State University Carlsbad 

campus, and conducted a limited review of laboratory practices and records. EPA 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 LANL-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 relative to the NQA-1-1989 elements discussed 

above. The EPA audit team identified one concern not requiring a response related to NQA-1-

1989, Element 16. 

Concern No. LANL-CO-QA-2014-01C regards LANL-CO procedure LCO-QP16-1, Revision 4-

AC1, “Conditions Adverse to Quality.” NQA-1-1989, Element 16, states that "[CAQs] shall be 
10

identified promptly and corrected as soon as practical." Procedure LCO-QP16-1, Revision 4-

AC1, does not include the NQA-1 requirements that CAQs be identified promptly and corrected 

as soon as practical. Through interviews with LANL-CO personnel and review of corrective 

action closure dates, EPA found that even though its procedure does not explicitly require 

timeliness, LANL-CO is correcting CAQs in a timely manner. 

EPA is not concerned about the current implementation of the process to address CAQs at 

LANL; however, EPA requests that LANL-CO review the language in the applicable section of 

LCO-QP16-1 and make the changes they deem appropriate.

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

8.0 CONCLUSIONS

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

compliance of the LANL-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

LANL-CO complies with the standard.
11

9.0 REFERENCES

2013 Peer Inspector Training Attendance Record, TRN-1302-01-01-01, January 28, 2013

ACP-EXP-003, Balance Performance Check, Revision 3, January 7, 2011

ACP-EXP-005, Thermometer Calibration and Performance Check, Revision 4, September 18, 

2013

ACP-EXP-006, Ultra-Violet, Visible and Near Infra-Red Spectrophotometer Calibration and 

Performance Check, Revision 4, September 18, 2013

ACP-EXP-011, Inductively Coupled Plasma-Mass Spectrometry, Revision 3-ACI, September 19, 

2013

ACP-IMP-003, Test Plans and Task Implementation Plans, Revision 5, September 18, 2013

ACP-IMP-004, Measuring and Test Equipment, Revision 5, September 18, 2013

ACRSP ICP-MS Model 7500, S/N: JP51201393 (also showing S/N: 211306), labeled: “Calibrate 

Prior to Use”, observed July 24, 2014, in CEMRC Laboratory, Room 151

ACRSP Scientific Notebook No. ICP-MS 4, ACP-1312-05-09-01, May 21, 2013

Beckman Multi-Purpose Liquid Scintillation Counter, System ID No. 477965, labeled: 

“Performance Check-Prior to Use, 1/5/12”, observed July 24, 2014, in CEMRC Laboratory, 

Room 151

Calibration Certificates for PC-0491122, ACP-1405-02-04-08, April 8, 2014

Calibration Standard-Modified (ICP-MSCS-M) for ICP-MS, High Purity Standards Lot No. 

1328419, ACP-1406-01-12-97, April 15, 2014

Certificate of Analysis for PC-0429249, ACP-1210-02-04-02, February 29, 2012

Certificate of Analysis for PC-0450072, ACP-1305-01-04-03, October 11, 2012

Demonstration of document review request, demonstrated July 23, 2014

Email from A. Heiser to N. Elkins, et. al., re: Finding Report FR-13-02 Regarding ACRSP data, 

with Attachment CAQ-1312-01-01-01.pdf, December 18, 2013

Email from L. Sparks to P. Kelly, re: FR closure times, July 24, 2014

Grading for FY11 and FY12, GRD-1204-01-01-01, April 3, 2012

Grading for FY13, GRD-1301-01-01-01, January 23, 2013

Grading for FY14, GRD-1312-01-01-01, December 10, 2013

Henry Troemner, LLC requalification, QSL-1306-02-01-01, June 12, 2013

High-Purity Standards requalification, QSL-1210-01-01-01, September 10, 2012

ICP-MS Iridium Standard, High Purity Standards Lot No. 1307214, ACP-1305-03-12-15, May 7, 

2013

ICP-MS Thorium Standard, High Purity Standards Lot No. 1234128, ACP-1305-03-12-16, May 

7, 2013
12

Interference Check Solution A (ICP-MS-ICS 3, solution A) Standard for ICP-MS, High Purity 

Standards Lot No. 1405548, ACP-1406-01-12-95, April 15, 2014

INV-SP-03, Requests for Quality Level 1 Inventory Information, Revision 11, May 14, 2014

Key Position Descriptions, provided June 2, 2014

LANL-CO Finding Report FR-13-01, CAQ-1305-01-01-01

LANL-CO Finding Report FR-13-02, CAQ-1312-01-01-01

LANL-CO Material/Service Acceptance and Quality Level Determination for Procurement 

Request CEMRC 01/10/2012 to Eckert & Ziegler Analytics for LSC Calibration Standards (C14; H-3 and Background), ACP-1205-03-04-01, March 27, 2012

LANL-CO Organization Chart for EPA Audit, provided June 2, 2014

LANL-CO Qualified Supplier List, Updated April 24, 2014

LCO-ACP-01, LANL-CO/CEMRC Interface Document, Revision 4, April 5, 2012

LCO-MP18-1, Management Assessments, Revision 4, October 29, 2012

LCO-MP7-1, Procurement, Revision 7-AC1, September 20, 2013

LCO-QP16-1, Conditions Adverse to Quality, Revision 4-AC1, September 12, 2013

LCO-QP17-1, Record Management, Revision 12, September 3, 2013

LCO-QP18-1, Audits, Revision 3, July 12, 2011

LCO-QP18-2, Qualification of Audit Personnel, Revision 3, September 24, 2013

LCO-QP2-1, Establishing Quality Controls, Revision 5, September 24, 2013

LCO-QP2-2, Quality Assurance Requirements for Quality Level One Activities, Revision 5, 

September 24, 2013

LCO-QP2-3, Qualification and Training, Revision 5, May 16, 2014

LCO-QP6-1, Controlled Document Development, Change, and Revision, Revision 11, 

September 3, 2013

LCO-QP6-2, Controlled Document Review and Approval, Revision 11, September 3, 2013

LCO-QP6-3, Document Control and Distribution, Revision 11, September 3, 2013

LCO-QP9-1, Analyses, Revision 5, December 19, 2013

LCO-QPD-04, LANL-CO Document and Record Management Plan, Revision 8, September 3, 

2013

LCO-QPD-06, LANL-CO Organization and Interface, Revision 2, May 14, 2014 

Lead Auditor Maintenance of Proficiency for L. Sparks, TRN-1310-02-01-01, September 25, 

2013

Lead Auditor Qualification for L. Sparks, TRN-0510-01-01-01, October 7, 2005

List of Measuring and Test Equipment, provided June 2, 2014
13

List of Qualified Audit Personnel, provided 6/2/2014

LSC Standard Set B, Eckert & Ziegler Lot Nos. 90474, 90475, 90476, ACP-1205-04-12-07, 

March 21, 2012

M&TE Data Sheet for Digital Hygro/Thermometer with Timer, DHT34 Control Company, S/N: 

122454202, ACP-1301-02-12-35, October 10, 2012

M&TE Data Sheet for Inductively Coupled Plasma-Mass Spectrometer, S/N: JP51201393; 

M&TE Data Sheet for Software, ACP-0706-03-12-48, May 10, 2007

M&TE Data Sheet for Pu-242 Standard Reference Material, NIST, Lot No. 721-Pu242, ACP1104-01-12-16, March 10, 2011

Management Assessment MA-12-01, MAR-1203-01-01-01, March 15, 2012

Management Assessment MA-12-02, MAR-1205-02-01-01, May 30, 2012

Management Assessment MA-12-03, MAR-1210-01-01-01, October 25, 2012

Management Assessment MA-12-04, MAR-1209-01-01-01, September 10, 2012

Management Assessment MA-12-05, MAR-1208-01-01-01, August 23, 2012

Management Assessment MA-12-06, MAR-1303-02-01-01, March 25, 2013

Management Assessment MA-13-01, MAR-1303-01-01-01, March 14, 2013

Management Assessment MA-13-02, MAR-1310-01-01-01, October 29, 2013

Management Assessment MA-13-03, MAR-1305-01-01-01, May 6, 2013

Management Assessment MA-13-04, MAR-1404-01-01-01, April 7, 2014

Management Assessment MA-14-01, MAR-1403-01-01-01, March 12, 2014

Material Acceptance Form for PC-0429249, ACP-1210-02-04-02, September 4, 2012

Material Acceptance Form for PC-0450072, ACP-1305-01-04-03, March 20, 2013

Material Acceptance Form for PC-0491122, ACP-1405-02-04-08, April 23, 2014

Memo to the Quality Assurance File, QAM-13-04, March 25, 2013

Mettler Toledo requalification, QSL-1208-01-01-01, July 25, 2012

Posted records access list, observed July 23, 2014

Procurement Request PC-0429249 to Fisher for Sodium Chloride for QL1 work, ACP-1210-02-

04-02, August 27, 2012

Procurement Request PC-0450072 to High Purity Standards for Multi-Element IC Standard and 

Oxalate Standard for IC and LANL-CO Material/Service Quality Level Determination Form, 

ACP-1305-01-04-03, March 11, 2013

Procurement Request PC-0455212 to High Purity Standards for Multiple Standards for ICP-MS 

and IC Analysis and LANL-CO Material/Service Quality Level Determination Form, ACP-1309-

02-04-01, April 23, 2013
14

Procurement Request PC-0491122 to Troemner for ACRSP Weights No. B and No. C 

Recertification, ACP-1405-02-04-08, March 12, 2014

QA Index of Quality Assurance Controlled Documents, May 16, 2014

QA-DL-01, LANL-CO QA Distribution and Required Reading List, TRN-1406-01-01-01, 

Revision 11, June 4, 2014

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

Quality Assurance Project Leader Qualification for L. Sparks, TRN-0502-05-01-01, February 21, 

2005

Records filing demonstration, July 23, 2014

Review Package for INV-SP-03, Revision 10

Review Package for INV-SP-03, Revision 11 

Review Package for LCO-QP2-1, Revisions 0 and 5

Review Package for LCO-QPD-04, Revision 7

Review Package for LCO-QPD-04, Revision 8

RSS and RTS demonstration, July 23, 2014

Supplier Evaluation of Bruker AXS, Inc., QSL-1403-01-01-01, March 25, 2014

Supplier Evaluation of Michell Instruments, Inc., QSL-1312-01-01-01, December 12, 2013

Tour of laboratory offices, July 24, 2014

Tour of record storage room, July 23, 2014

Training records for B. Ams, D. Guerin D, A. Heiser, D. Reed, C. Stroud

Varian Cary 5000 UV/VIS/NIR Spectrometer S/N: ELO6113131, labeled: “Frequency of 

Performance Check-Monthly” and Maintenance Log, observed July 24, 2014, in CEMRC 

Laboratory, Room 151

Visual confirmation of expiration date labels, ICP-MS Standard Solutions or dilutions thereof 

stored in fume hood, on open laboratory bench or in laboratory glove box, observed July 24, 

2014, in CEMRC Laboratory, Room 151

Visual confirmation of markings on equipment, Liquid Scintillation System, Beckman LS6500, 

System ID 474965, observed July 24, 2014, in CEMRC Laboratory, Room 151

Working Document Cover Sheet, Liquid Scintillation System, Beckman LS6500, ACP-0502-11-

12-04, October 11, 2004
A-1

ATTACHMENT A

EPA INSPECTION ISSUE TRACKING FORM 

CONCERN NO. LANL-CO-QA-2014-01C, FINAL

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

Date: July 23, 2014

Inspector: Kira Darlow, Patrick Kelly

Attachments? YES NO

Sample Size: 1

Population size (if known): 1

Description of Issue: NQA-1-1989, Element 16, states that "conditions adverse to quality 

[(CAQ)] shall be identified promptly and corrected as soon as practical." EPA found that in 

practice, LANL-CO is correcting CAQs in a timely manner. However, procedure LCO-QP16-1, 

Revision 4-AC1, does not include the NQA-1 requirements that CAQs be identified promptly 

and corrected as soon as practical.

EPA requests that LANL-CO review the language in the applicable section of LCO-QP16-1 

and make whatever changes they deem appropriate.

B. Regulatory Reference: 40 CFR 194.22(e)

C. NQA-1-1989 Element(s): 16

D. Discussed with: Laurie Smith and David Guerin

E. Additional Comments: None

F. Site Response Information:

 Site Response Required? YES NO

 Site Response Due Date: Not Applicable