Acceptability of Corrective 

Action Programs for Fuel 

Cycle Facilities

Draft Report for Comment

Office of Nuclear Material Safety and Safeguards

NUREG-2154
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Acceptability of Corrective 

Action Programs for Fuel 

Cycle Facilities

Draft Report for Comment

Manuscript Completed: January 2013

Date Published: January 2013

Prepared by:

Sabrina Atack

Office of Nuclear Material Safety and Safeguards

NUREG-2154
COMMENTS ON DRAFT REPORT

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U.S. Nuclear Regulatory Commission

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iii

ABSTRACT

The NRC staff has revised Section 2.3.2 of the NRC Enforcement Policy (ADAMS Accession 

No. ML12340A295) to disposition Severity Level IV violations for Fuel Cycle Facilities as noncited violations if the NRC determines that the licensee’s CAP is effective, the licensee enters 

the violation in its CAP, and other criteria in Section 2.3.2 of the Enforcement Policy are met. 

The purpose of this draft NUREG, “Acceptability of Corrective Action Programs for Fuel Cycle 

Facilities,” is to provide guidance to the NRC staff on how to determine, from a licensee’s CAP 

licensing submittal, that a CAP is acceptable. After the NRC staff determines that the CAP is 

acceptable, the CAP licensing submittal will be incorporated into the license and implementation 

of the CAP will be verified by an NRC inspection using a CAP inspection procedure. After the 

NRC inspection verifies that the licensee has implemented its CAP in accordance with the 

license and the licensee’s CAP implementing procedures, then the NRC will consider the CAP 

to be effective for the purposes of Section 2.3.2 of the Enforcement Policy.

v

CONTENTS

 Page

ABSTRACT...................................................................................................................................iii

CONTENTS...................................................................................................................................v

INTRODUCTION ....................................................................................................................... 1

1. PURPOSE OF REVIEW........................................................................................................ 3

2. RESPONSIBILITY FOR REVIEW ......................................................................................... 5

3. AREAS OF REVIEW............................................................................................................. 7

4. ACCEPTANCE CRITERIA.................................................................................................... 9

5. REVIEW PROCEDURES.................................................................................................... 11

5.1. Policies, Programs, and Procedures..................................................................... 11

5.2. Identification, Reporting, and Documentation of Safety and Security Issues......... 11

5.3. Significance Assessment and Causal Evaluation of Safety and Security Issues... 12

5.4. Development, Implementation, and Assessment of Corrective Actions................14

5.5. Assessment of Corrective Action Program Effectiveness...................................... 14

6. EVALUATION FINDINGS ...................................................................................................15

7. REFERENCES ................................................................................................................... 17

1

INTRODUCTION

In the staff requirements memorandum (SRM) for SECY-10-0031, “Revising the Fuel Cycle 

Oversight Process,” dated August 4, 2010 (Agencywide Documents Access and Management 

System (ADAMS) Accession No. ML102170054), the Commission directed the U.S. Nuclear 

Regulatory Commission (NRC) staff to consider how the NRC Enforcement Policy could best 

reflect that most fuel cycle licensees have voluntarily developed corrective action programs 

(CAPs). In response to the Commission’s direction, the staff revised the NRC Enforcement 

Policy to disposition Severity Level IV violations as noncited violations if the NRC determines 

that the licensee’s CAP is effective, the licensee enters the violation in its CAP, and other 

criteria are met, as delineated in Section 2.3.2 of the NRC Enforcement Policy (ADAMS 

Accession No. ML12340A295). In SRM-SECY-11-0140, “Enhancements to the Fuel Cycle 

Oversight Process,” dated January 5, 2012 (ADAMS Accession No. ML120050322), the 

Commission directed staff to proceed with the development and implementation of the 

incentives for licensees to maintain an effective CAP.

All licensees who wish to maintain an effective CAP must submit a license amendment request 

that includes a description of the proposed CAP. This NUREG provides guidance to the NRC 

staff on how to determine—from a licensee’s CAP license amendment request submittal (CAP 

submittal)—that the proposed CAP is acceptable. After the NRC staff determines that the 

licensee’s CAP is acceptable, the CAP submittal will be incorporated into the license through a 

license condition, in accordance with the evaluation findings in Section 6 of this NUREG. The 

NRC staff will then verify implementation of the CAP using a CAP inspection procedure. The 

purpose of the CAP inspection procedure is to verify that the licensee’s acceptable CAP is 

implemented in accordance with the approved CAP submittal and the licensee’s CAP 

implementing procedures. After the NRC inspection verifies CAP implementation, the NRC will 

consider the CAP to be effective. The conclusion that the licensee’s CAP has been determined 

to be effective will be documented in publicly available inspection reports. Once the licensee’s 

CAP is effective and the criteria in Section 2.3.2a in the NRC Enforcement Policy are met, the 

NRC staff will start dispositioning Severity Level IV violations as noncited violations. The CAP’s 

implementation will be verified periodically by NRC inspectors in accordance with CAP 

inspection procedure.

Once the NRC has accepted the licensee’s CAP and incorporated it into the license through a 

license condition, the licensee will be required to meet its CAP commitments. 

3

1. PURPOSE OF REVIEW

The purpose of the review is to determine whether the licensee’s corrective action program 

(CAP) is adequate to support the safe operation of the facility and to identify and correct 

conditions adverse to safety and security. 

This guidance expands on existing guidance in NUREG-1520, “Standard Review Plan for the 

Review of a License Application for a Fuel Cycle Facility,” and NUREG-1962, “Guidance on the 

Implementation of Integrated Safety Analysis Requirements for 10 CFR Part 40 Facilities 

Authorized to Possess 2,000 Kilograms or More of Uranium Hexafluoride—Draft Report for 

Comment,” in relation to what the U.S. Nuclear Regulatory (NRC) staff considers an acceptable 

CAP for fuel facilities.

Title 10 of the Code of Federal Regulations (10 CFR) 70.4, “Definitions,” defines management 

measures as including other quality assurance (QA) elements. Section 11.4.3.8, “Other Quality 

Assurance Elements,” of NUREG-1520 states that other QA elements may include some or all 

of the following elements: 

• organization

• QA program

• design control

• procurement document control

• instructions, procedures, and drawing control

• document control

• control of purchased items

• identification and control of items

• control of processes

• inspection

• test control

• control of measuring and test equipment

• handling, storage, and shipping

• inspection, test, and operating status

• control of nonconforming items

• corrective action

• QA records

• audits

For corrective action, Section 11.4.3.8 of NUREG-1520 states (see pages 11-19), “the applicant 

[or licensee] should specify provisions for promptly identifying conditions adverse to quality and 

correcting them as soon as practicable.”

5

2. RESPONSIBILITY FOR REVIEW

Primary: NRC quality assurance reviewer

Secondary: Licensing project manager

Supporting: Regional project inspector

7

3. AREAS OF REVIEW

The licensee’s CAP submittal should include the proposed license amendment and supporting 

program information necessary to address the acceptance criteria specified below. 

The specific areas of review of a licensee’s CAP submittal are as follows:

• policies, programs, and procedures

• identification, reporting, and documentation of safety and security issues

• significance classification and causal evaluation of safety and security issues

• development and implementation of corrective actions

• assessment of corrective action and program effectiveness

9

4. ACCEPTANCE CRITERIA

The CAP should be determined acceptable if:

(1) CAP policies and procedures are established and described indicating terminology 

definitions, CAP expectations, requirements, personnel responsibilities, and

implementation processes. 

The CAP organization is described and includes an independent reviewing organization1

that is auditable and independent of the licensee’s production organization. Facility 

management commits to provide the independent reviewing organization sufficient 

authority, access to work areas, and organizational independence to perform its 

responsibilities. The independent reviewing organization reviews and documents 

concurrence with CAP policies and procedures and revisions thereto.

Specific responsibilities within the CAP may be delegated, but the licensee retains the 

responsibility for the program’s effectiveness and for performing periodic audits and 

assessments. The CAP requires that delegation authority is documented in writing.

(2) The CAP includes prompt identification, documentation, and reporting of safety and 

security issues (i.e., conditions adverse to safety or security). The CAP requires all 

personnel to identify conditions adverse to safety or security.

(3) Criteria for classifying the significance of conditions adverse to safety or security (i.e., 

significant or non-significant) are established. Conditions adverse to safety or security 

include failures, malfunctions, deficiencies, defective items, out-of-control processes, 

and nonconformances. For significant conditions adverse to safety or security, the root 

and contributing causes are determined, the extent of condition and cause are 

evaluated, and preventive actions are taken to preclude recurrence. Significant 

conditions adverse to safety or security are those that, if left uncorrected, could have a 

serious effect on safety or operability.

(4) Corrective action is promptly developed and initiated following the identification of a 

condition adverse to safety or security. Conditions and trends that are adverse to safety 

or security are reported to the appropriate level of management. Follow-up action is 

taken by the independent reviewing organization, where appropriate, to verify proper 

implementation of the corrective action. A graded approach is taken to verify proper 

implementation and close out the corrective actions in a timeframe consistent with the 

safety or security significance of the issue, with the independent organization reviewing 

the corrective actions for significant conditions adverse to safety or security.

 1 The independent reviewing organization may be a separate, independent division of the licensee’s organization, 

such as a quality assurance or quality control organization. However, it is also acceptable for the licensee to 

assign independent review duties to an existing part of the licensee’s organization, such as Environmental Health 

and Safety, provided that the licensee describes this designation in its CAP and commits to ensure that the 

organization and/or individuals are sufficiently independent, trained, and able to meet the guidance established in 

this NUREG.
10

(5) The effectiveness of the CAP is evaluated by the licensee at regular, specified intervals. 

Reports of conditions that are adverse to safety or security are analyzed to identify 

adverse trends in performance. The licensee reviews the ability of the CAP to identify 

conditions adverse to safety and security, identify NRC reportable events, evaluate the 

significance, correct the condition, notify management, and prevent recurrence.
11

5. REVIEW PROCEDURES

For each review area specified in Section 3, the review procedure is provided below. These 

review procedures are based on the identified acceptance criteria in Section 4. For deviations 

from these specific acceptance criteria, the NRC staff should review the licensee’s evaluation of 

how the proposed alternatives to the acceptance criteria provide an adequate method to 

determine that the CAP submittal is acceptable. Figure 1 illustrates a generic corrective action 

process that can be used for reference by licensees in the development and implementation of 

their CAPs.

5.1 Policies, Programs, and Procedures

The NRC reviewer should confirm that the licensee describes the CAP expectations and 

requirements. The reviewer should confirm that the licensee commits to implementing 

processes in policies, programs, and/or procedures that apply to and are implemented across 

the licensee’s organization and licensed operations.

The reviewer should verify that the licensee describes terminology that will be used to 

implement its CAP. Terminology should include, as a minimum, conditions adverse to safety or 

security and significant conditions adverse to safety or security (or equivalent terminology 

designated by the licensee).

The reviewer should confirm that the licensee has described the independent reviewing 

organization, including identification of the organization, its responsibilities, and the commitment 

to provide the independent reviewing organization sufficient authority, access to work areas, 

and organizational independence to perform its responsibilities. In the case that the reviewing 

organization has concurrent duties, the reviewer should confirm that the licensee has described 

how the organization will address a possible conflict of interest.

The reviewer should ensure that personnel responsibilities are defined in sufficient detail 

to ensure effective processing of conditions adverse to safety and security. The reviewer 

should also verify that the CAP submittal describes the use of delegation authority. The 

licensee may delegate specific responsibilities within the CAP in writing; however, the licensee 

should retain responsibility for ensuring the program’s effectiveness and for performing periodic 

audits and assessments. 

5.2 Identification, Reporting, and Documentation of Safety and Security Issues

The reviewer should verify that the CAP submittal requires the licensee contractors, staff, 

supervisors, and managers to report safety and security issues in a manner that supports the 

timely and effective assessment and correction of the issues. The reviewer should verify that 

the CAP submittal describes training requirements for employees to ensure that they are able to 

identify adverse conditions and understand their CAP responsibilities. 

The reviewer should verify that the CAP submittal requires the documentation of safety and 

security issues from identification to closeout. The reviewer should verify that the CAP 

describes the licensee’s process for tracking and trending of issues and for reporting to the 

NRC, as needed. 
12

5.3 Significance Assessment and Causal Evaluation of Safety and Security 

Issues

The reviewer should verify that the licensee’s CAP submittal contains a process for evaluating

the actual and potential significance of issues. The licensee’s assessment should enable the 

organization to appropriately apply a graded risk approach, based on the issue’s significance, to 

the timing and scope of response to the issues, including the depth and detail of the causal 

evaluation. For significant conditions adverse to safety or security, the licensee’s application of 

its causal evaluation process routinely enables it to adequately identify the issue’s root cause 

and the contributing factors.

For example, criteria for assessing the significance of conditions adverse to safety and security 

may include the following:

• impact on health and safety of workers, the public, and environment

• importance in meeting regulatory requirements

• impact on reliability, availability, or maintainability of the equipment important to nuclear 

safety or security at the facility

• consequence of recurrence or likelihood of recurrence if not corrected

• potential to impact other items or activities beyond the specific occurrence where it may 

have greater impact

Significant conditions adverse to safety or security may include the following:

• trend of multiple conditions adverse to safety or security

• deficiencies in design, manufacturing, construction, testing, or process requiring 

substantial rework, repair, or replacement

• damage to a structure, system, component, or facility requiring substantial repairs

• a non-conservative error detected in a computer program or design input after it has 

been implemented or released for use;

• repeated failure to implement a portion of an approved procedure
13

Figure 1.- Corrective Action Flow Chart

Identify and document 

condition adverse to safety 

and security (CASS)

Assess significance of CASS, 

evaluate need for NRC 

reporting, and develop and 

implement corrective actions

Condition is 

significant

Determine root cause

Evaluate impact on related 

items or activities

Take action to preclude 

recurrence

Verify completion of 

corrective action

Evaluate effectiveness of 

corrective actions, as 

appropriate to significance of 

Perform trending 

Notify cognizant 

management 

Trend 

identified?

Corrective

actions 

effective?

Closeout

Yes No No

Yes 

Yes* 

No*

* Indicates that followup action is needed. Action may be determined at 

the discretion of the licensee and may warrant notification of facility 

management and initiation of a new CASS corrective action.
14

5.4 Development and Implementation of Corrective Actions

The reviewer should verify that the CAP submittal describes the licensee’s process for the 

development and implementation of corrective actions for safety and security issues. The 

description should include measures that will be taken by the licensee to prevent recurrence of 

the same issue or the occurrence of similar significant conditions adverse to safety or security. 

The licensee should also describe actions that will be taken to verify the completion and proper 

implementation of corrective actions, including involvement by the independent reviewing 

organization (or other designated party or position for non-significant safety and security 

issues).

The reviewer should verify that the CAP submittal describes the process by which the licensee 

will ensure timeliness of corrective action implementation, verification, and close out in a 

manner commensurate with the safety or security significance of the issues identified. The 

process should include timeliness expectations in order to ensure prompt resolution of safety 

and security issues. 

For significant conditions adverse to safety or security, the reviewer should verify that the CAP 

submittal includes measures that the licensee will take to evaluate the extent to which other 

items and activities, including work in progress, may be affected so that appropriate action can 

be taken. The reviewing organization should also review the corrective actions developed for 

significant conditions adverse to safety and security prior to their implementation. 

The reviewer should verify that the CAP submittal contains the commitment to report conditions 

and trends that are adverse to safety or security to the appropriate level of management. 

5.5 Assessment of Corrective Action and Program Effectiveness

The reviewer should verify that the CAP submittal describes a CAP assessment process that 

enables the organization to identify and correct program performance issues that reduce CAP 

effectiveness. The assessment process should evaluate the CAP’s effectiveness in the 

identification, reporting, assessment, and correction of safety and security issues and the 

prevention of the recurrence of the same issues or occurrence of similar issues.

The assessment process should include measures for reviewing conditions adverse to safety 

and security to determine the existence of adverse trends and repetitive problems. The process 

should describe the licensee’s commitments for ensuring the recognition and resolution of

ineffective corrective actions, trends, and performance issues. The assessment process should 

evaluate the timeliness of CAP elements and the ability of the CAP to follow up and enable 

close out of corrective actions that are past their due date.
15

6. EVALUATION FINDINGS

The NRC evaluation should verify that the information provided in the licensee’s CAP submittal 

satisfies the acceptance criteria in Section 4. Based on this evaluation, the staff should 

conclude that the licensee’s CAP is acceptable. The reviewer should write a safety evaluation 

report that includes a summary statement of what was evaluated and the basis for the 

reviewer’s conclusions that the acceptance criteria have been satisfied and the CAP is 

acceptable.

17

7. REFERENCES

American National Standards Institute/American Society of Mechanical Engineers Standard, 

“Quality Assurance Requirements for Nuclear Facility Applications,” ANSI/ASME NQA-1-2008. 

Code of Federal Regulations, Chapter I, Title 10, “Energy,” Part 70, “Domestic Licensing of 

Special Nuclear Material.”

Code of Federal Regulations, Chapter I, Title 10, “Energy,” Part 50, “Domestic Licensing of 

Production and Utilization Facilities.”

Code of Federal Regulations, Chapter I, Title 10, “Energy,” Part 40, “Domestic Licensing of 

Source Material.”

Code of Federal Regulations, Chapter I, Title 10, “Energy,” Part 21, “Reporting of Defects and 

Noncompliance.”

U.S. Nuclear Regulatory Commission, Chapter 11, “Management Measures,” NUREG-1520 

Revision 1, “Standard Review Plan for the Review of a License Application for a Fuel Cycle 

Facility,” May 2010. Agencywide Documents Access and Management System (ADAMS) 

Accession No. ML101390110.

U.S. Nuclear Regulatory Commission, Information Notice 96-28, “Suggested Guidance Relating 

to Development and Implementation of Corrective Action,” May 1996. ADAMS Accession 

No. ML003726705.

U.S. Nuclear Regulatory Commission, Section 17.1, “Quality Assurance during the Design and 

Construction Phases,” Revision 2, NUREG-0800, “Standard Review Plan for the Review of 

Safety Analysis Reports for Nuclear Power Plants: LWR Edition,” July 1981. ADAMS 

Accession No. ML052350349.

U.S. Nuclear Regulatory Commission, Section 17.2, “Quality Assurance during the Operations 

Phase,” Revision 2, NUREG-0800, “Standard Review Plan for the Review of Safety Analysis 

Reports for Nuclear Power Plants: LWR Edition,” July 1981. ADAMS Accession No. 

ML052350361.

U.S. Nuclear Regulatory Commission, Section 17.3, “Quality Assurance Program Description,” 

Revision 0, NUREG-0800, “Standard Review Plan for the Review of Safety Analysis Reports for 

Nuclear Power Plants: LWR Edition,” August 1990. ADAMS Accession No. ML052350376.

U.S. Nuclear Regulatory Commission, Section 17.5, “Quality Assurance Program Description—

Design Certification, Early Site Permit and New License Applicants,” Initial Issuance, 

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

Power Plants: LWR Edition,” March 2007. ADAMS Accession No. ML063190019.

U.S. Code of Federal Regulations, Chapter I, Title 10, “Energy,” Part 70, “Domestic Licensing of 

Special Nuclear Material.”

U.S. Code of Federal Regulations, Chapter I, Title 10, “Energy,” Part 50, “Domestic Licensing of 

Production and Utilization Facilities.”
18

U.S. Code of Federal Regulations, Chapter I, Title 10, “Energy,” Part 40, “Domestic Licensing of 

Source Material.”

U.S. Code of Federal Regulations, Chapter I, Title 10, “Energy,” Part 21, “Reporting of Defects 

and Noncompliance.”

U.S. Nuclear Regulatory Commission, “Management Measures,” Chapter 11 NUREG-1520 

Revision 1, “Standard Review Plan for the Review of a License Application for a Fuel Cycle 

Facility,” May 2010. ADAMS Accession No. ML101390110.

U.S. Nuclear Regulatory Commission, “Suggested Guidance Relating to Development and 

Implementation of Corrective Action,” Information Notice 96-28, May 1996. ADAMS Accession 

No. ML003726705.

U.S. Nuclear Regulatory Commission, “Quality Assurance During the Design and Construction 

Phases,” Section 17.1 Revision 2 NUREG-0800, “Standard Review Plan for the Review of 

Safety Analysis Reports for Nuclear Power Plants: LWR Edition,” July 1981. ADAMS 

Accession No. ML052350349.

U.S. Nuclear Regulatory Commission, “Quality Assurance During the Operations Phase,” 

Section 17.2 Revision 2 NUREG-0800, “Standard Review Plan for the Review of Safety 

Analysis Reports for Nuclear Power Plants: LWR Edition,” July 1981. ADAMS Accession No. 

ML052350361.

U.S. Nuclear Regulatory Commission, “Quality Assurance Program Description,” Section 17.3, 

Revision 0, NUREG-0800, “Standard Review Plan for the Review of Safety Analysis Reports for 

Nuclear Power Plants: LWR Edition,” August 1990. ADAMS Accession No. ML052350376.

U.S. Nuclear Regulatory Commission, “Quality Assurance Program Description – Design 

Certification, Early Site Permit and New License Applicants,” Section 17.5 Initial Issuance 

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

Power Plants: LWR Edition,” March 2007. ADAMS Accession No. ML063190019.





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Acceptability of Corrective Action Programs for Fuel Cycle Facilities