DOCKET NO: A

- 98

- 49 ; II

- A1

- 117 EPA Air eDocket # EPA

- HQ

- OAR

- 2001

- 0012

- 0446

EPA AUDIT OF THE CARLSBAD FIELD O FFICE QUALITY ASSURANCE PROGRAM

JU LY 22

– 2 4 , 201 4

U. S. ENVIRONMENTAL PROTECTION AGENCY OFFICE OF RADIATION AND INDOOR AIR C ENTER FOR FEDERAL RE GULATIONS WASHINGTON, DC 20460

DEC EM BER 201 4ii 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

- 201 4

- 01C Attachment B Carlsbad Field Office Organization Chart, June 29, 2014 Attachment C Concern No. CBFO

- QA

- 201 4

- 02C R Attachment D Carlsbad Field Office Organization Chart, Draft provided August 21, 2014iii ACRONYMS AND ABBREVIATIONS

ABQ Albuquerque Operations Office

ASME American Society of Mechanical Engineers

CAR corrective action report

CBFO Carlsba d 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 En vironmental 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 Natio nal 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 A ssurance 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 transuraniciv

WIPP Wa ste Isolation Pilot Plant

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 Department of Energy’s (DOE’s) Carlsbad Field Of fice (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) Nu clear Quality Assurance (NQA) Standard NQA

- 1

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

. ” CBFO QA is responsible for ensuring that Waste Isolation Pilot Plant (WIPP) operations , including characterization of transuranic (TRU) was tes, 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 eva luated 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 Fede ral 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 p rogram continue s to comply with the se NQA

- 1

- 1989 e lement s 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 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 v acant 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 Mana ger, 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; ho wever, 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 Constitut ion 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 t he 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 responsi bility includes oversight of the characterization and emplacement of TRU waste at the WIPP disposal site near Carlsbad, New Mexico. As stated in the Quality As surance 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 e lement s of ASME NQA

- 1

- 1989. The scope of this EPA audit was limited to QA oversight of activiti es 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/CBFO

94

- 1012, Revision 11, June 20103

4.0 DEFINITIONS

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

es tablished 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 th at 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 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 progr ams working on the WIPP project in Carlsbad, New Mexico. For purposes of efficiency, E PA conducted the se audit s in two parallel tracks with one Lead QA Auditor responsible for each track. Track A included limited

scope 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 complet ed 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

- Carlsb ad Office (LANL

- CO) QA program ( see Docket No. A

98

- 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 add resses only t he 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 thr ee support contractors. Table 1 lists a ll 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 qualif ications 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 Respo nsibility 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.4

 Working knowledge and understanding of the NQA standards.

 Training.

 On

- the

-

job training.

In addition, Ms. Bender e valuated 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 understa nding 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 f r om all four audited organizations, identified in Table 2. Some of these personnel may have been interviewed during one of the other three audit s ; however, only the personnel interviewed as p art 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  
D ana 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 Audito r/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  5

6.0 PERFORMANCE OF THE A UDIT

The EPA audit team reviewed record s 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 c hecklists . 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 ev ents at the repository continues, QA oversight of the operations is especially important. During this audit, EPA evaluat ed 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 a llowed. 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

- 201 4

- 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 t he OQA . These two new posit ions 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 organiza tional 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 d id not require a response.

Concern No. CBFO

- QA

- 2014

- 02CR is also based on the CBFO organization chart dated June 29, 2014 (see Attachment s 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; II

A1

- 112 ). Because EPA had identified the same concern previously and it had not bee n adeq uately addressed, Concern No. CBFO

- QA

- 2014

- 02CR required a response.6

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 impact ed by the CBFO OQA staffing issues. However, the QA Director has deferred some generator site audits due to the necessity for performing additional audits a t 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 c orrective a ction r eports (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 bee n 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 d oes not adversely affect the CAR process

.
EPA determined that the C BFO 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 CONCERN S

The EPA audit team did not identify any findings relative to the NQA

- 1

- 19 89 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 au dit.

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 determine d that CBFO continues to compl y with the standard.7

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

C AR 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, Qualificat ion 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, 201 4 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 ap proval 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 Q ualification RecordA

- 1 ATTACHMENT A

EPA INSPECTION ISSUE TRA CKING FORM

CONCERN NO. CBFO

- QA

- 201 4

- 01C , FINAL Inspection No. QA

- CBFO

- 201 4

- 1 Concern Number: CBFO

- QA

- 201 4

- 01C Date: Draft

- July 22 , 2014; Final

- August 13, 2014 Inspector: D orothy Gill, L indsey 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 authorization s 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 ti me. 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 . Dis cussed 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 2 9 , 201 4C

- 1 ATTACHMENT C

EPA INSPE CTION ISSUE TRACKING FORM

CONCERN NO. CBFO

- QA

- 201 4

- 02C R , FINAL Inspection No. QA

- CBFO

- 201 4

- 1 Concern Number: CB FO

- QA

- 201 4

- 02C R Date: Draft

- June 20 , 2014; Final

- August 13, 2014 Inspector: D orothy Gill, L indsey 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 CBF O 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 d o 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 D ue Date: August 29, 2014D

- 1 ATTACHMENT D

CARLSBAD FIELD OFFIC E ORGANIZATION CHART , DRAFT PROVIDED AUG UST 21, 2014