AUDIT REPORT 

Audit of NRC’s Quality Assurance 

Planning for New Reactors 

OIG-10-A-02 November 16, 2009 

All publicly available OIG reports (including this report) are accessible through 

NRC’s Web site at: 

http:/www.nrc.gov/reading-rm/doc-collections/insp-gen/ 
UNITED STATES 

NUCLEAR REGULATORY COMMISSION 

WASHINGTON, D.C. 20555-0001 

OFFICE OF THE 

INSPECTOR GENERAL 

 November 16, 2009 

MEMORANDUM TO: R. William Borchardt 

Executive Director for Operations 

FROM: Stephen D. Dingbaum /RA/ 

 Assistant Inspector General for Audits 

SUBJECT: AUDIT OF NRC’S QUALITY ASSURANCE PLANNING FOR 

NEW REACTORS (OIG-10-A-02) 

Attached is the Office of the Inspector General’s (OIG) audit report titled, Audit of NRC’s 

Quality Assurance Planning for New Reactors. 

The report presents the results of the subject audit. Agency comments provided during 

and subsequent to a September 1, 2009, exit conference have been incorporated, as 

appropriate, into this report. 

Please provide information on actions taken or planned on each of the 

recommendations within 30 days of the date of this memorandum. Actions taken or 

planned are subject to OIG followup as stated in Management Directive 6.1. 

We appreciate the cooperation extended to us by members of your staff during the 

audit. If you have any questions or comments about our report, please contact me at 

415-5915 or Sherri Miotla, Team Leader, Nuclear Safety Audit Team, at 415-5914. 

Attachment: As stated 
Electronic Distribution

Edwin M. Hackett, Executive Director, Advisory Committee on Reactor 

 Safeguards 

E. Roy Hawkens, Chief Administrative Judge, Atomic Safety and 

 Licensing Board Panel 

Stephen G. Burns, General Counsel 

Brooke D. Poole, Jr., Director, Office of Commission Appellate Adjudication 

James E. Dyer, Chief Financial Officer 

Margaret M. Doane, Director, Office of International Programs 

Rebecca L. Schmidt, Director, Office of Congressional Affairs 

Eliot B. Brenner, Director, Office of Public Affairs 

Annette Vietti-Cook, Secretary of the Commission 

R. William Borchardt, Executive Director for Operations 

Bruce S. Mallett, Deputy Executive Director for Reactor 

 and Preparedness Programs, OEDO 

Martin J. Virgilio, Deputy Executive Director for Materials, Waste, Research, 

 State, Tribal, and Compliance Programs, OEDO 

Darren B. Ash, Deputy Executive Director for Corporate Management 

 and Chief Information Officer, OEDO 

Nader L. Mamish, Assistant for Operations, OEDO 

Kathryn O. Greene, Director, Office of Administration 

Patrick D. Howard, Director, Computer Security Officer 

Roy P. Zimmerman, Director, Office of Enforcement 

Charles L. Miller, Director, Office of Federal and State Materials 

 and Environmental Management Programs 

Cheryl A. McCrary, Director, Office of Investigations 

Thomas M. Boyce, Director, Office of Information Services 

James F. McDermott, Director, Office of Human Resources 

Michael R. Johnson, Director, Office of New Reactors 

Michael F. Weber, Director, Office of Nuclear Material Safety and Safeguards 

Eric J. Leeds, Director, Office of Nuclear Reactor Regulation 

Brian W. Sheron, Director, Office of Nuclear Regulatory Research 

Corenthis B. Kelley, Director, Office of Small Business and Civil Rights 

James T. Wiggins, Director, Office of Nuclear Security and Incident Response 

Samuel J. Collins, Regional Administrator, Region I 

Luis A. Reyes, Regional Administrator, Region II 

Mark A. Satorius, Regional Administrator, Region III 

Elmo E. Collins, Jr., Regional Administrator, Region IV 
Audit of NRC’s Quality Assurance Planning for New Reactors 

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EXECUTIVE SUMMARY

BACKGROUND 

The Nuclear Regulatory Commission (NRC) regulates the design, siting, 

construction, and operation of nuclear power plants. Title 10 Code of 

Federal Regulations (CFR) Part 52 (Part 52) establishes the process to 

apply for a combined license, which, if approved by the NRC, allows the 

applicant to construct and operate a nuclear power plant. The Office of 

New Reactors (NRO) is responsible for reviewing combined license 

applications. 

Under Part 52, each combined license applicant is required to submit a 

final safety analysis report that describes the facility and presents a safety 

analysis of the facility as a whole. This report must include a description 

of the applicant’s quality assurance (QA) program to be applied to the 

design, fabrication, construction, and testing of the structures, systems, 

and components of the facility. Part 52 references the QA program 

requirements, which are described in Title 10 CFR Part 50, Appendix B 

(Appendix B). Appendix B applies to all activities affecting safety-related 

functions of the facility. NRO staff reviews, which include an evaluation of 

QA, are performed in accordance with NUREG-0800, the standard review 

plan. 

During the application process, applicants often conduct activities 

associated with new nuclear power plant construction, including 

developing processes that will be used during construction, testing, and 

operations; establishing programs for areas such as corrective action, 

security, and training; and procuring materials and parts. The applicant 

must provide oversight of vendor programs if safety-related parts are 

procured. Many nuclear vendors are now foreign-based companies and 

oversight of these foreign-based companies can present new challenges, 

such as overcoming cultural and language barriers. 

PURPOSE 

The audit objective was to determine the extent to which NRC provides 

oversight of applicant and licensee new nuclear power plant QA programs. 

RESULTS IN BRIEF 

The purpose of Appendix B QA programs is to ensure the nuclear power 

plant safety-related systems perform adequately in service. Given that the 

interest to build new nuclear power plants is in its infancy, NRO is 

appropriately focusing on QA as it relates to design and procurement 

activities. The Office of the Inspector General (OIG) has identified areas 
Audit of NRC’s Quality Assurance Planning for New Reactors 

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needing management attention while NRO continues its ongoing QA 

review activities. Specifically, 

 Coordination of QA reviews among NRO branches is informal. 

o The coordination among NRO branches of QA reviews during 

the combined license application review process, when it 

occurs, is informal. Sections of the standard review plan specify 

that the responsible technical reviewer will coordinate the 

applicable QA reviews with the NRO’s QA branches. However, 

this coordination is not clearly defined and there is no process in 

place to ensure that it occurs. Consequently, there is no way to 

verify that the QA review coordination has occurred, nor that all 

the QA portions of the standard review plan technical chapters 

have been fully satisfied. 

 NRC’s QA oversight does not include a review for accurate 

translations. 

o NRC’s oversight of applicant and licensee QA programs and 

activities does not include a review for accurate document 

translations, and NRC has not fully assessed the impact of 

translated document quality on QA oversight. Consequently, 

NRC and its new nuclear power plant applicants and licensees 

could be relying on inaccurate translations. Furthermore, the 

accuracy of translated documents used for design, construction, 

and operation of new nuclear power plants could be called into 

question. 

RECOMMENDATIONS 

This report makes four recommendations to help NRC improve its 

oversight of combined license applicant and licensee QA programs. A 

consolidated list of recommendations appears in Section VI. 

AGENCY COMMENTS 

On August 25, 2009, OIG provided a draft report to the Executive Director 

for Operations. OIG held an exit conference with the agency on 

September 1, 2009. During that meeting agency management provided 

informal comments to the draft report. Also, on September 8, 2009, OIG 

held an additional meeting with NRC staff to discuss the agency’s informal 

comments to the draft report. 
Audit of NRC’s Quality Assurance Planning for New Reactors 

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On September 24, 2009, OIG provided the agency a final draft report, and 

on October 1, 2009, the agency declined to provide any formal comments. 

The final report incorporates revisions made, where applicable, as a result 

of meetings with NRC staff. 
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ABBREVIATIONS AND ACRONYMS 

ABWR Advanced Boiling Water Reactor 

AP1000 Advanced Passive 1000 

Appendix B Title 10 Code of Federal Regulations, Part 50, Appendix B, 

Quality Assurance Criteria for Nuclear Power Plants and 

Fuel Reprocessing Plants 

ASME American Society of Mechanical Engineers 

B&PV Boiler and Pressure Vessel 

CFR Code of Federal Regulations 

EPC Engineering Procurement Construction 

EPR United States Evolutionary Power Reactor 

ESBWR Economic Simplified Boiling-Water Reactor 

NRC Nuclear Regulatory Commission 

NRO Office of New Reactors 

OIG Office of the Inspector General 

Part 50 Title 10 Code of Federal Regulations, Part 50, Domestic 

Licensing of Production and Utilization Facilities 

Part 52 Title 10 Code of Federal Regulations, Part 52, Licenses, 

Certifications, and Approvals for Nuclear Power Plants 

QA Quality Assurance 

US-APWR United States Advanced Pressurized-Water Reactor 
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TABLE OF CONTENTS

 EXECUTIVE SUMMARY .................................................................................... i 

 

 ABBREVIATIONS AND ACRONYMS................................................................ v 

I. BACKGROUND ....................................................................................... 1 

II. PURPOSE .............................................................................................. 5 

III. FINDINGS................................................................................................ 6 

A. COORDINATION OF QA REVIEWS AMONG NRO BRANCHES 

IS INFORMAL................................................................................ 6 

B. NRC’S QA OVERSIGHT DOES NOT INCLUDE A REVIEW FOR 

ACCURATE TRANSLATIONS ......................................................... 11 

IV. CONCLUSION....................................................................................... 16 

V. AGENCY COMMENTS.......................................................................... 17 

VI. CONSOLIDATED LIST OF RECOMMENDATIONS .............................. 18 

APPENDIX 

SCOPE AND METHODOLOGY ...................................................................... 19
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Audit of NRC’s Quality Assurance Planning for New Reactors 

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I. BACKGROUND 

The Nuclear Regulatory Commission (NRC) protects the health and safety 

of the public and the environment by regulating the design, siting, 

construction, and operation of nuclear power plants. With a renewed 

interest in nuclear energy in the United States, energy providers have 

submitted applications to NRC for nuclear power plant standard design 

certifications and for the construction and operation of new nuclear power 

plants. NRC reviews applications submitted by prospective licensees and 

issues, as appropriate, standard design certifications, early site permits, 

and combined licenses. As of May 2009, NRC had received 17 license 

applications for 26 new nuclear power plants using 5 different designs. A 

map of the projected new nuclear power plant locations is shown in Figure 

1, below. 

Figure 1: Location of Projected New Nuclear Power Plants 

Source: Information depicted based on NRC public Web site as of July 9, 2009. 

Source: NRC Public Web site. 
Audit of NRC’s Quality Assurance Planning for New Reactors 

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The Office of New Reactors (NRO) is responsible for reviewing early site 

permit, standard design certification, and combined license applications. 

For fiscal year 2009, the agency budgeted $243.5 million, including 819 

full-time equivalent staff, for all activities associated with reviewing new 

nuclear power plant applications. Among NRO’s activities are quality 

assurance (QA) licensing and inspection, which is primarily performed by 

two QA and vendor branches. 

NRC regulations establish the process for obtaining approval to construct 

and operate new nuclear power plants. All of the 104 operating nuclear 

power plants were licensed under the two-step process described in Title 

10 Code of Federal Regulations (CFR) Part 50, Domestic Licensing of 

Production and Utilization Facilities (Part 50). Under that regulation, 

applicants were first required to submit an application for a construction 

permit for NRC approval. For the second step, the applicant submitted an 

application for an operating license, usually during construction. In an 

effort to improve efficiency and reduce potential regulatory risks during 

licensing of new nuclear power plants, NRC established a one-step 

licensing process under Title 10 CFR Part 52, Licenses, Certifications, and 

Approvals for Nuclear Power Plants (Part 52). Part 52 establishes the 

combined license, which is made up of a construction permit and an 

operating license. Part 52 also describes the rules and procedures for 

issuing standard design certifications for new nuclear power plants, in 

which NRC approves a nuclear power plant design independent of an 

application to construct or operate a plant at a specific site. The 17 

applications for new nuclear power plants under NRC review utilize the 

Part 52, one-step licensing process. 

Under Part 52, each applicant is required to submit a final safety analysis 

report that describes the facility, presents the design bases,1

 as well as 

presents a safety analysis of the facility as a whole. The final safety 

analysis report must include a description of the applicant’s QA program to 

be applied to the design, fabrication, construction, and testing of the 

structures, systems, and components of the facility. Part 52 references 

the QA program requirements, which are described in Part 50, Appendix 

B, Quality Assurance Criteria for Nuclear Power Plants and Fuel 

Reprocessing Plants (Appendix B). Appendix B applies to all activities 

affecting safety-related functions of structures, systems, and components 

that prevent or mitigate the consequences of accidents that could cause 

undue risk to the health and safety of the public. QA comprises all 

planned and systematic actions necessary to provide adequate 

 

1

 Design bases means that information which identifies the specific functions to be performed by a 

structure, system, or component of a facility, and the specific values or ranges of values chosen for 

controlling parameters as reference bounds for design. These values may be (1) restraints derived from 

generally accepted "state of the art" practices for achieving functional goals, or (2) requirements derived 

from analysis (based on calculation and/or experiments) of the effects of a postulated accident for which a 

structure, system, or component must meet its functional goals. 
Audit of NRC’s Quality Assurance Planning for New Reactors 

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confidence that a structure, system, or component will perform 

satisfactorily in service. A QA program includes elements such as 

procedures, recordkeeping, inspections, corrective actions, and audits. 

Applicants often conduct activities associated with new nuclear power 

plant construction during the application process. These activities include 

developing processes that will be used during construction, testing, and 

operations; establishing programs for areas such as corrective action, 

security, and training; and procurement of materials and parts for nuclear 

power plant construction. The applicant must provide oversight of vendor 

programs if safety-related parts are procured. Many nuclear vendors are 

now foreign-based companies and oversight of these foreign-based 

companies can present new challenges, such as overcoming cultural and 

language barriers as well as technical standards for parts fabrication. 

Industry Role in QA 

QA of every safety-related component and service used in a nuclear 

power plant, including those provided by vendors and sub-suppliers, is 

ultimately the responsibility of the applicant or the licensee. In practice, 

the applicant or licensee oversees its Engineering Procurement 

Construction (EPC)2

 contractor’s QA program; the EPC oversees its 

vendors’ QA programs; the vendors oversee their suppliers’ QA programs; 

the suppliers oversee their sub-suppliers’ QA programs; and so on, as 

shown in Figure 2 below. Ultimately, the applicant or licensee must 

ensure that applicable regulatory requirements, which are necessary to 

assure adequate quality, are included in the documents for procurement of 

material, equipment, and services, whether purchased by the applicant, or 

licensee, or by its vendors or sub-suppliers. 

 

2

 Typically, an EPC is a company, or a consortium of companies, hired by a new nuclear power plant 

applicant to manage all, or most, of the new nuclear power plant project, including engineering design, 

preparation of construction drawings, procurement of parts and materials, construction management, and 

pre-operational testing. 
Audit of NRC’s Quality Assurance Planning for New Reactors 

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Figure 2: QA Program Oversight Process 

Source: OIG analysis and NRC documents. 

NUREG-0800, the Standard Review Plan 

NRO staff conduct reviews that result in a safety evaluation report 

describing the staff’s review, findings, and conclusions. These reviews, 

which include an evaluation of QA, are performed in accordance with 

NUREG-0800, Standard Review Plan for the Review of Safety Analysis 

Reports for Nuclear Power Plants. In all, there are 19 standard review 

plan chapters, which are broken down into sections. The individual 

sections are assigned to an NRO branch to perform the review. For each 

section of the standard review plan, the responsible reviewer from the 

assigned NRO branch writes the corresponding section of the safety 

evaluation report. 

In general, the standard review plan chapters correspond to the final 

safety analysis report chapters in the power plant standard design 

certification and combined license applications. Chapter 1 is the 

introduction and general description of the plant. Chapter 17 pertains to 

QA. Chapters 2 through 16, 18, and 19 guide the review of specific 

technical aspects, components, or systems, and are referred to in this 
Audit of NRC’s Quality Assurance Planning for New Reactors 

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report as “technical chapters.” The 2 NRO branches—Quality & Vendor 

Branch 1 and Quality & Vendor Branch 2—responsible for the chapter 17 

reviews are referred to in this report as the “QA branches.” The 34 NRO 

branches responsible for reviewing the technical chapters of the 

application are referred to in this report as the “technical branches.” 

Growing Dependency on Foreign Suppliers 

There have been many changes in the nuclear industry since the previous 

generation of nuclear power plants. One of the most significant 

differences is the current prevalence of foreign vendors and suppliers. 

The change in the composition of companies accredited by the American 

Society of Mechanical Engineers (ASME) to supply parts to U.S. nuclear 

plants illustrates this change. As of July 2009, 100 of the 210 existing 

ASME-accredited companies were foreign firms. Moreover, there are 

many components that are available only from foreign companies, such as 

reactor vessels and other critical parts and systems. Under NRC 

regulations, some safety-related components must meet the requirements 

of the ASME Boiler and Pressure Vessel (B&PV) Code. In order to supply 

components that meet the ASME code, an ASME N-type or material 

organization accreditation is required.3

 The number of companies 

accredited by ASME as N-type providers or material organizations has 

decreased from more than 600 in 1980 to fewer than 200 in 2007. That 

decline was due almost entirely to the reduction of the number of 

American firms accredited by ASME. 

This necessary reliance by the United States on foreign vendors as a 

significant source for nuclear plant components is likely to have important 

implications for quality in new nuclear plant construction. For example, 

foreign vendors bring new challenges, such as language and cultural 

differences and technical standards that may need adjustments to meet 

code requirements for U.S. reactors. This new global environment makes 

the translation of documents from foreign languages to English an 

essential aspect of the nuclear industry, as NRC and its applicants must 

rely on documents that were originally written in a foreign language. 

II. PURPOSE 

The audit objective was to determine the extent to which NRC provides 

oversight of applicant and licensee new nuclear power plant QA programs. 

The appendix provides information on the audit scope and methodology. 

 

3

 ASME provides many different types of B&PV code certifications for suppliers to nuclear plants and 

other industries. N-type accredited firms supply B&PV code-certified components to nuclear power 

plants, such as vessels, pumps, valves, and other supports. Material organizations supply the 

materials—such as tubes, plates, and fasteners—to be used by N-type accredited firms. 
Audit of NRC’s Quality Assurance Planning for New Reactors 

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III. FINDINGS 

NRO conducts reviews of applicant QA programs for new nuclear power 

plant design, construction, and operation, as well as reviews of vendor QA 

programs. Given that the interest to build new nuclear power plants is in 

its infancy, NRO is appropriately focusing on QA as it relates to design 

and procurement activities. The Office of the Inspector General (OIG) has 

identified areas needing management attention while NRO continues its 

ongoing QA review activities. Specifically: 

A. Coordination of QA reviews among NRO branches is informal. 

B. NRC’s QA oversight does not include a review for accurate 

translations. 

A. Coordination of QA Reviews Among NRO Branches Is Informal 

The coordination among NRO branches of QA reviews during the license 

application review process, when it occurs, is informal. Sections of NRC’s 

standard review plan—a document to assure the quality and uniformity of 

staff safety reviews—specify that the responsible technical reviewer will 

coordinate the applicable QA reviews with the QA branches. However, 

this coordination is not clearly defined and there is no process in place to 

ensure that it occurs. Consequently, there is no way to verify that the QA 

review coordination has occurred, and therefore that all the QA portions of 

the standard review plan technical chapters have been fully satisfied. 

NUREG-0800, the Standard Review Plan 

The principal purpose of the standard review plan is to assure the quality 

and uniformity of staff safety reviews. It is intended to be a 

comprehensive and integrated document that provides the reviewer with 

guidance that describes methods or approaches that are acceptable for 

meeting NRC requirements. The standard review plan was also designed 

to make information about regulatory matters widely available as well as to 

improve communication among NRC, interested members of the public, 

and the nuclear power industry, in order to increase understanding of 

NRC’s review process. 

The standard review plan was developed from many years of NRC 

experience in establishing and applying safety requirements for various 

nuclear power plant designs. It was first issued in 1975 as a routine tool 
Audit of NRC’s Quality Assurance Planning for New Reactors 

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for NRC staff to use in evaluating nuclear plant designs. According to an 

Office of Nuclear Reactor Regulation office instruction, the standard 

review plan was established to document: 

 “the integrated result of the hundreds of conscious choices made by 

the staff and by the nuclear industry in developing design criteria and 

design requirements for nuclear power plants,” and 

 “the most definitive basis available for specifying the NRC's 

interpretation of an acceptable level of safety for light-water reactor 

facilities.” 

Although the standard review plan is guidance as opposed to a regulation, 

it is NRC management’s expectation that it be used by reviewers, and that 

deviations from its use, if any, be based on consultations between 

reviewers and their supervisors. 

 QA Review Coordination According to the Standard Review Plan 

Sections of the standard review plan specify that the responsible technical 

reviewer will coordinate the applicable QA reviews with the QA branches. 

This coordination is described in the standard review plan in different 

ways, assigning responsibility for the QA review coordination to different 

entities. For example: 

 Chapter 2, Site Characteristics, specifies that the QA branch reviewers

will coordinate the review of geotechnical engineering QA aspects with 

the staff members responsible for reviewing the stability of slopes.4

 Chapter 3, Design of Structures, Components, Equipment, and 

Systems, specifies that the review for QA is coordinated and 

performed in accordance with the standard review plan chapter 17.5

 Chapter 5, Reactor Coolant System and Connected Systems, specifies 

that the responsible technical reviewer for reactor coolant pump 

flywheels will coordinate with the staff member responsible for 

performing QA. 

 Chapter 7, Instrumentation and Controls, specifies that parts of the 

chapter 7 review should be coordinated with the QA branches as part 

of the QA branches’ primary review responsibility. 

 

4

 This refers to the stability of all natural and man-made earth and rock slopes whose failure could 

adversely affect the safety of the nuclear power plant. 

5

 Chapter 17 of the standard review plan is titled, “Quality Assurance.” 
Audit of NRC’s Quality Assurance Planning for New Reactors 

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QA Review Coordination Among Branches Is Informal

Coordination of QA reviews among the technical reviewers and the QA 

branch reviewers, when it occurs, is actually informal communication. 

Some individual reviewers informally communicate through phone calls 

and e-mail, usually to address a specific issue rather than to coordinate a 

QA review. For example, OIG learned that a QA reviewer may ask a 

technical reviewer to provide assistance with a technical issue, or to 

participate in a QA audit or inspection. Similarly, a technical reviewer may 

have a question for the QA branch regarding QA requirements. This 

interaction is dependent on the initiative of an individual reviewer. 

OIG attempted to obtain evidence of more formal QA review coordination 

among NRO branches by reviewing safety evaluation reports associated 

with standard design certification applications. The safety evaluation 

reports contain sections that correspond to sections in the standard review 

plan. The reports are intended to describe the staff’s safety review, 

findings, and conclusions. OIG reviewed selected final and draft sections 

of various safety evaluation reports and found that none documented any 

coordination of QA review. Some of these reports described the use of 

QA guidance and regulations, but otherwise did not indicate that any QA 

review coordination occurred. 
Audit of NRC’s Quality Assurance Planning for New Reactors 

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Figure 3: Cutaway View of the U.S. EPR Standard Design 

 Source: NRC public Web site. 

No Definition of or Process for QA Review Coordination 

There is no definition of, or process for, the QA review coordination 

described in the standard review plan. Specifically, NRO staff members 

could not explain what QA review coordination means or how it is 

supposed to occur. There is no definition in the standard review plan that 

clarifies what is meant by QA review coordination, nor are there any office 

instructions explaining the coordination language. NRO staff also could 

not identify any system that alerts license application reviewers of the 

necessity of QA review coordination. 

Moreover, some staff members were either unaware of the QA review 

coordination language in the standard review plan, or opted not to follow it 

due to a lack of understanding of what it means or what is expected. One 

NRO manager pointed out that QA review coordination may be necessary. 

However, the manager added that coordination, when it occurs, is more 

the exception rather than the rule. Another NRO manager said that there 
Audit of NRC’s Quality Assurance Planning for New Reactors 

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would be no way for the QA branch reviewers to become aware of the 

expectation to coordinate with the technical branches unless they read the 

entire standard review plan, which the manager said is unreasonable. 

QA Review of Technical Chapters Cannot Be Verified 

Without a definition of, or process for, QA review coordination, there is no 

way to verify that any necessary coordination between branches has 

occurred. The QA review coordination described in the standard review 

plan cannot be ensured due to the fact that it is not defined in the first 

place. Therefore, there is no way to know if all QA aspects of the 

standard review plan have been satisfied. This could cause missed 

opportunities for component-specific QA reviews. This is important 

because the QA program is the primary measure used by the nuclear 

industry to provide assurance that errors are found and corrected. 

For example, the standard review plan specifies that the responsible 

technical reviewer for a certain safety-related system will coordinate with 

the staff members responsible for performing QA. The QA review of this 

system is important because the component’s failure would have 

significant safety consequences, as it could lead to possible damage to 

the reactor coolant system, the containment, or the engineered safety 

features. The draft safety evaluation report for a standard design 

certification application makes no mention of a QA review for this safetyrelated system. Because it is unclear what is meant by QA review 

coordination, there is no way to verify that all QA portions of the standard 

review plan have been met. One reviewer responsible for this safetyrelated system stated that QA was not reviewed as part of the evaluation. 

Therefore, because NRC has not performed a QA review for this safetyrelated system, the agency unnecessarily accepts increased risk that this 

system may not be able to perform its safety-related function. 

Recommendations: 

OIG recommends that the Executive Director for Operations: 

1. Clearly define the QA review coordination requirements of the standard 

review plan. 

2. Develop a process for reviewers to coordinate QA reviews and a 

method to determine that the QA coordination has occurred. 
Audit of NRC’s Quality Assurance Planning for New Reactors 

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B. NRC’s QA Oversight Does Not Include a Review for Accurate 

Translations 

NRC’s oversight of applicant and licensee QA programs and activities 

does not include a review for accurate document translations. Translation 

service companies and an international translation guide emphasize the 

importance of QA for translations. However, NRC has not fully assessed 

the impact of translated document quality on QA oversight. Consequently, 

NRC and its new nuclear power plant applicants and licensees could be 

relying on inaccurate translations. Furthermore, the accuracy of translated 

documents used for design, construction, and operation of new nuclear 

power plants could be called into question. 

The Importance of QA for Translations 

Translation service companies and an international translation guide 

emphasize the importance of QA for translations. Applying a QA process 

to translations can help ensure that the translation is accurate and meets 

the needs of the requester. 

ASTM International, one of the largest voluntary standards development 

organizations in the world, provides an important new guide for the 

professional translation industry and its clients. The Standard Guide for 

Quality Assurance in Translation defines translation as the “process 

comprising the creation of a written target text based on a source text in 

such a way that the content . . . can be considered to be equivalent.”6

 The 

guide notes that translation QA includes writing clear translation 

specifications and adhering to them throughout the process. It provides 

that translation quality is the degree to which the translation fulfills the 

specifications of the customer. The guide also identifies attributes of 

quality language translation services, which include selecting the 

appropriate translator(s), utilizing specific methodologies for editing and 

formatting the translation, and undertaking proofreading and verification 

steps. 

Translation service companies also use QA processes that include 

translation by a professional translator, editing by a native language 

speaker, and proofreading. Additionally, translation service companies 

and translators stated that when translating a highly technical document, 

knowledge of that subject matter is key. Moreover, some translation 

experts contend that translations of foreign language documents into 

English should be produced by translators whose native language is 

English. 

 

6 Standard Guide for Quality Assurance in Translation, Designation F 2575-06, ASTM International, 

approved May 1, 2006, published June 2006. 
Audit of NRC’s Quality Assurance Planning for New Reactors 

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NRC Does Not Verify QA for Translations 

NRC’s QA oversight for new nuclear power plants does not include 

verifying whether applicants, licensees, and vendors assure the quality of 

translations. This includes documents submitted to NRC as part of an 

application review or inspection activity, as well as documents submitted 

to applicants and licensees from vendors. Individual NRC staff members 

had varying opinions regarding the applicability of Title 10 CFR Part 50, 

Appendix B QA criteria to translations. Most NRC staff members 

interviewed during this audit did not consider the quality of translations to 

be covered by Appendix B, particularly for licensing activities.7

 However, 

some staff members and managers acknowledged that there may be 

instances where Appendix B does apply to translation. 

Given the current industry reliance on foreign vendors and sub-suppliers 

for the design and manufacture of safety-related components, such as 

reactor vessels, the accuracy of translated design basis and other 

documentation, such as technical manuals, becomes more relevant for 

applicants/licensees and NRC alike. Indeed, OIG discovered one large 

nuclear vendor with a QA procedure for translation that it uses in-house for 

foreign language document translation. The vendor does not, however, 

apply the same QA procedure to its foreign suppliers, and simply requires 

its suppliers to provide documentation in English, without regard for the 

translation process. 

Like applicants and licensees, NRC relies on translated documents to 

conduct QA oversight activities. During new nuclear power plant licensing 

and inspection,8

 NRC staff sometimes need documents to be translated 

from a foreign language into English. For example, NRC staff requested 

that a vendor supplying the digital instrumentation and control system for a 

new nuclear power plant design translate several documents from 

Japanese into English. Also, one NRC QA inspector told OIG that during 

inspections in France and Spain, each vendor translated documentation 

into English for the purposes of the inspections. Furthermore, in 

anticipation of an upcoming NRC inspection of a Japanese vendor working 

for new nuclear power plant applicants, an inspector said that the vendor 

would need to translate all its audits into English. 

 

7

 According to NRC managers, NRC reviews application information in English no matter the source of 

that information. Any license granted would be based on the information provided in the English 

documentation. Managers stated that if a licensee misrepresented information in an application due to an 

erroneous translation of a licensing document, the licensee would have to apply to NRC for a licensing 

amendment. 

8

 NRC conducts QA oversight through licensing activities, which includes reviewing combined license 

applications and certified design applications, as well as inspections of combined license applicants’ and 

vendors’ implementation of QA. 
Audit of NRC’s Quality Assurance Planning for New Reactors 

13 

In isolated instances, some NRC staff members attempted to verify 

translated documents, but through inadequate means such as comparing 

word and page counts and document formats between the source and the 

translation. One NRC staff member said that NRC document translations 

are reviewed by counting the number of words in the source document 

and the translated document. Another NRC staff member said that the 

accuracy of a document translated from a foreign language and submitted 

to NRC is sometimes verified by comparing the graphics and numbers in 

the source document and the translated document. Comparing the 

similarity of graphics and numbers or counting words in the two versions 

does not assure that the translation accurately reflects the message of the 

source document. 

NRC Has Not Assessed Impact of Translated Document Quality 

NRC has not fully assessed the impact of translated document quality on 

QA oversight. On the whole, NRC has undertaken some efforts to assess 

impacts of the changing nuclear industry on its vendor inspection 

program.9

 However, NRC has not assessed how translated documents 

from foreign providers of safety-related systems might impact the quality of 

safety-related components supplied to new nuclear power plant applicants 

and licensees in the United States. 

Many suppliers of designs and major components are based in foreign 

countries where English is not the predominant language. For example, 

as of June 2009, the reactor pressure vessel closure head and three 

complex steam generator parts for the AP1000 standard design could only 

be manufactured by firms in Korea and Japan. NRO managers were not 

aware of any formal activity where NRC analyzed the impact of 

documents translated into English for NRC’s licensing and inspection 

purposes. 

 

9

 See, for example, SECY-07-0105: Enhancement to the Vendor Inspection Program within the Office of 

New Reactors. 
Audit of NRC’s Quality Assurance Planning for New Reactors 

14 

Figure 4: Cutaway View of the AP1000 Pressurized Water 

Reactor Standard Design 

Source: NRC public Web site. 

NRC and Applicants Could Rely on Inaccurate Translations 

NRC and its new nuclear power plant applicants could be relying on 

inaccurate translations and, thus, the accuracy of documents used for 

design, construction, and operation of new nuclear power plants could be 

called into question. Without applying a QA process to document 

translation, there is no way to be certain that a document translated into 

English meets the customer’s requirements. This could result in NRC 

basing licensing decisions on inaccurate documents. 

During the course of licensing and inspections for new nuclear power 

plants, NRC staff members discovered documents written awkwardly in 

English. This could be a result of a faulty translation. For example, one 

NRO technical reviewer described encountering translation problems, 

including broken English. Similarly, an NRO manager described an 

instance where NRC technical staff members were frustrated when 

reviewing a standard design certification application with obvious 

translation problems. Awkwardly written English documents may be an 
Audit of NRC’s Quality Assurance Planning for New Reactors 

15 

indicator of a faulty translation, and NRC should continue to identify these 

errors to applicants and vendors submitting the translated documents to 

NRC. However, an awkwardly written English document is not the only 

indicator of poor translation. Word choice in a translated document 

reveals nothing about the qualifications of the translator or the efficacy of 

the review process, if any, applied to the translation. Therefore, without a 

means to ensure quality translations, nuclear power plant applicants and 

NRC may be missing instances where documents are written in English 

with correct style and grammar, but do not accurately reflect the meaning 

of the source document. 

Recommendations: 

OIG recommends that the Executive Director for Operations: 

 

3. Determine how the quality of translated documents impacts: 

a). NRC and industry ability to assess the quality of foreign-supplied 

safety-related parts and services to new nuclear power plants. 

b). NRC and industry QA oversight, including licensing and 

inspection activities. 

4. Incorporate results of the assessments into NRC’s QA oversight 

activities. 
Audit of NRC’s Quality Assurance Planning for New Reactors 

16 

IV. CONCLUSION 

The early stages of new nuclear power plant licensing present an 

opportunity for NRC and industry to improve QA oversight and therefore 

reduce the likelihood of problems during construction and operation. Even 

at this early stage, there are some challenges associated with 

implementation of the regulatory vision articulated in Part 52, as well as 

ongoing changes in the nuclear industry and global supply chain. In the 

spirit of engaging these early challenges at an opportune moment, OIG 

has identified areas needing management attention, such as QA review 

coordination and document translation. 
Audit of NRC’s Quality Assurance Planning for New Reactors 

17 

V. AGENCY COMMENTS 

On August 25, 2009, OIG provided a draft report to the Executive Director 

for Operations. OIG held an exit conference with the agency on 

September 1, 2009. During that meeting agency management provided 

informal comments to the draft report. Also, on September 8, 2009, OIG 

held an additional meeting with NRC staff to discuss the agency’s informal 

comments to the draft report. 

On September 24, 2009, OIG provided the agency a final draft report, and 

on October 1, 2009, the agency declined to provide any formal comments. 

The final report incorporates revisions made, where applicable, as a result 

of meetings with NRC staff. 
Audit of NRC’s Quality Assurance Planning for New Reactors 

18 

VI. CONSOLIDATED LIST OF RECOMMENDATIONS 

OIG recommends that the Executive Director for Operations: 

1. Clearly define the QA review coordination requirements of the standard 

review plan. 

2. Develop a process for reviewers to coordinate QA reviews and a 

method to determine that the QA coordination has occurred. 

3. Determine how the quality of translated documents impacts: 

a). NRC and industry ability to assess the quality of foreign-supplied 

safety-related parts and services to new nuclear power plants. 

b). NRC and industry QA oversight, including licensing and inspection 

activities. 

4. Incorporate results of the assessments into NRC’s QA oversight 

activities. 
Audit of NRC’s Quality Assurance Planning for New Reactors 

19 

Appendix 

SCOPE AND METHODOLOGY 

The audit objective was to determine the extent to which NRC provides 

oversight of applicant and licensee new nuclear power plant QA programs. 

To address the audit objective, OIG observed three NRC QA 

implementation inspections, which include NRC’s review of the applicants’ 

oversight of vendors according to certain Title 10 CFR Part 50, Appendix 

B criteria. OIG also reviewed NRC regulations and guidance, and 

interviewed NRC staff members and industry officials. Additionally, OIG 

identified and reviewed QA-related reports, reviewed nuclear and 

translation industry standards, and analyzed NRC QA implementation 

audit and inspection reports. Some of the key documents reviewed 

include: 

 NUREG-0800, Standard Review Plan for the Review of Safety 

Analysis Reports for Nuclear Power Plants. 

 NUREG-1055, Improving Quality and the Assurance of Quality in the 

Design and Construction of Nuclear Power Plants: A Report to 

Congress. 

 Title 10 CFR Part 50, Domestic Licensing of Production and Utilization 

Facilities. 

 Title 10 CFR Part 52, Licenses, Certifications, and Approvals for 

Nuclear Power Plants.

 Inspection Manual Chapter 2502, Construction Inspection Program: 

Pre-Combined License (Pre-COL) Phase. 

 Inspection Procedure 35017, Quality Assurance Implementation 

Inspection. 

 Management Directive 3.12, Handling and Disposition of Foreign 

Documents and Translations. 

 Regulatory Guide 1.28, Quality Assurance Program Requirements 

(Design and Construction). 

 Regulatory Guide 1.33, Quality Assurance Program Requirements 

(Operation). 

 NRC Information Notices. 

 Agency Office Instructions. 
Audit of NRC’s Quality Assurance Planning for New Reactors 

20 

 QA implementation audit and inspection plans and reports. 

 Nuclear industry QA standards and translation industry standards. 

 Commissioners’ speeches and NRC press releases. 

Auditors conducted interviews with 47 agency and industry employees, 

including NRC managers and staff members at headquarters and one 

region, members of the nuclear industry, and members of the translation 

industry. 

OIG conducted this audit at NRC headquarters, one region, and selected 

new nuclear power plant applicants’ facilities between December 2008 

and July 2009 in accordance with generally accepted Government 

auditing standards. Those standards require that we plan and perform the 

audit to obtain sufficient, appropriate evidence to provide a reasonable 

basis for our findings and conclusions based on our audit objectives. We 

believe that the evidence obtained provides a reasonable basis for our 

findings and conclusions based on our audit objectives. 

Major contributors to this report were Sherri Miotla, Team Leader; 

R.K. Wild, Audit Manager; Kevin Nietmann, Technical Advisor; 

Michael Zeitler, Senior Management Analyst; Rebecca Ryan, 

Management Analyst; and Vidya Sathyamoorthy, Student Management 

Analyst.