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NRC INSPECTION MANUAL NMSS/FCSS

INSPECTION PROCEDURE 88071

CONFIGURATION MANAGEMENT PROGRAM 

88071-01 INSPECTION OBJECTIVES

The objectives of this procedure are to provide the requirements and guidance for evaluating 

the licensee’s or certificate holder’s configuration management and change control program. 

Specifically the evaluation is to determine whether the following aspects of the licensee’s or 

certificate holder’s configuration management and change control program meet U.S. Nuclear 

Regulatory Commission (NRC) issued license or certificate requirements:

01.01 The licensee or certificate holder has established an effective configuration 

management system to evaluate, implement, and track plant modifications which could affect 

safety.

01.02 The licensee’s or certificate holder’s configuration management system ensures that 

plant modifications are evaluated to determine the effect of each modification on the 

performance capabilities of items relied on for safety (IROFS), or other safety controls that are 

part of the safety design basis.

NOTE: As the safety and safeguards inspection program is applied to facilities certified under 

Title 10 of the Code of Federal Regulations (10 CFR) Part 76, “license” shall read as 

“certificate,” and “licensee” shall read as “certificate holder” for such facilities.

88071-02 INSPECTION REQUIREMENTS AND GUIDANCE

02.01 The requirements and guidelines for evaluating the facility Configuration Management 

Program Records are: 

a. Inspection Requirement. Verify that the licensee has established and maintained 

adequate records of the existing facility configuration as required by 10 CFR 70.62 and

70.64 (or 76.35).

b. Inspection Guidance. The licensee should have a well-developed and documented 

configuration management program for generation and retention of documents that 

define the establishment and maintenance of the Integrated Safety Analysis (ISA) and 

other safety systems not part of the ISA.

Review whether the configuration management program documents define the site and 

facility licensing bases and unit process descriptions, including:
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1. Piping and instrumentation diagrams;

2. Process materials flows;

3. Floor plans;

4. Special nuclear material movement controls;

5. Safety analyses for postulated accident pathways including safety limits and 

control systems to prevent accidents;

6. Maintenance requirements for the IROFS and other safety control systems;

7. Training requirements for the safety limits and control systems; 

8. Maintenance, calibration and surveillance for safety control systems; and

9. Inspection and audit requirements.

The records generated and maintained should include ISAs and other safety analyses, 

facility and process descriptions, IROFS, procedures, training requirements, and 

internal inspection/audit procedures.

Review the configuration management program to evaluate the extent to which it is 

formalized and institutionalized, its capabilities, and the extent to which it involves 

coordination between safety and other plant functions. The configuration management 

program is expected to keep design basis documentation current and maintain 

associated technical support information.

02.02 The requirements and guidelines for evaluating the facility Configuration Management 

Program Change Control process are:

a. Inspection Requirement. Verify that the licensee has written effective procedures to 

properly address the following aspects of modifications in accordance with 10 CFR 

70.72 (or 76.68):

1. Technical basis for the modification,

2. Impact of the change on safety and health or control of licensed material,

3. Revisions to existing operating procedures including any necessary training or 

retraining before operations,

4. Authorization requirements for the modification,
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5. For temporary changes, the approved duration (e.g., expiration date) of the 

change, and

6. Impact or revision to existing program documents including the application, 

safety analysis reports, integrated safety analysis, or other safety program 

information developed.

b. Inspection Guidance. The programmatic review of the configuration management 

change control process focuses on the effectiveness of the written procedures to 

accomplish the above requirements.

1. Determine if the licensee’s procedures detail how to evaluate the basis for a 

modification so that the licensee’s reviewers and evaluators are empowered to

properly assess the change.

2. Confirm by observation, discussion, and document review that written 

procedures exist for safety system/ISA change control. Determine whether the 

procedures identify the process for carrying out changes. Evaluate whether the 

procedures include adequate instructions including who has responsibility for 

preparing process descriptions, IROFS, safety limits and controls, maintenance 

and surveillance procedures, inspection and verification procedures and records, 

nuclear criticality safety (NCS) postings, and updated inspection and audit 

requirements.

3. Determine whether the procedures identify the process for carrying out 

procedure changes, maintenance and surveillance procedures, pre- and 

post-inspection and verification procedures and records, training, postings, and 

post-change inspection and audit requirements.

4. Determine whether the program requires an appropriate level of supervisory 

review of procedure development, including a requirement for Operations to 

approve a change request, who has responsibility for preparing documents for 

certain process descriptions, and what safety/ISA limits and controls are 

involved.

5. All safety evaluations/ISAs should be maintained in the configuration 

management system and should identify the processes, process equipment, 

accident pathways, IROFS, safety limits on controlled parameters, NCS control 

systems and postings, and training requirements. The safety evaluations/ISAs 

should clearly document all assumptions, analysis methods, and staff members 

who performed them. The configuration management program should include 

the engineered control systems in the maintenance program. It should include 

the required schedules for preventive maintenance, calibrations, and 

surveillances. It should provide adequate controls to ensure appropriate 

replacement parts are used in safety control systems.
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02.03 The requirements and guidelines for evaluating the facility Configuration Management 

Program Records of Modifications are:

 

a. Inspection Requirement. Verify that the licensee has written effective procedures to 

properly maintain records of modifications for specified periods, including the evaluation 

on which the change was based, as required by 10 CFR 70.72 (or 76.68).

b. Inspection Guidance. Licensees should maintain records of any changes made to their 

facilities under 10 CFR 70.72 until license termination, including a written evaluation 

that provides the bases for determining that no prior NRC approval under 10 CFR 

70.72(c) or (d) is required.

The licensee’s criteria for making the determinations below should be captured in the 

licensee’s procedures so that the originator, internal reviewers, and inspectors can 

follow the logic and reach the same conclusion. Types of changes that may warrant 

more detailed evaluations to demonstrate that prior NRC approval is not required 

include the following: 

1. For changes that require the addition of accident sequences to the ISA summary, 

the records should document whether the ISA summary already lists accident 

sequences of the same type.

2. For changes that will remove an IROFS, the records should document either that 

the IROFS or IROFSs being removed are not needed to meet the performance 

requirements or that they will be replaced with an IROFS or IROFSs that provide 

at least an equivalent safety function.

3. For changes to a sole IROFS, the records should document whether the change 

is an alteration (i.e., whether the change will modify, positively or negatively, any 

of the attributes associated with the safety function of the IROFS).

4. For changes that include new processes, technologies, or control systems, the

records should document whether the licensee has relevant prior experience and

whether the license authorizes this activity.

02.04 The requirements and guidelines for evaluating the licensee’s performance of notifying 

NRC of changes made without prior NRC approval are: 

a. Inspection Requirement. Verify that the licensee has written effective procedures to 

properly inform the NRC of changes made without NRC prior approval and that the 

licensee provides revisions to program documents at specified intervals, as required by 

10 CFR 70.72 (or 76.68).

b. Inspection Guidance. Keep in mind that licensees are required to annually provide the 

NRC with summaries of modifications that affect records required by 10 CFR 

70.62(a)(2) and modifications to the ISA.
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88071-03 RESOURCE ESTIMATE

An inspection performed using this inspection procedure is estimated to require 32 hours of 

inspector resources. 

88071-04 REFERENCES

American National Standards Institute/American Nuclear Society (ANSI/ANS)-8.1-1998, 

"Nuclear Criticality Safety in Operations with Fissionable Materials Outside Reactors," American 

Nuclear Society, La Grange Park, IL, dated 1998.

NUREG-1513, ‘Integrated Safety Analysis Guidance Document,’ dated May 2001.

NUREG-1520, ‘Standard Review Plan for the Review of a License Application for a Fuel Cycle 

Facility,’ dated March 2002.

Regulatory Guide 3.74, “Guidance for Fuel Cycle Change Processes,” dated January 2012.

88070-05 PROCEDURE COMPLETION

Implementation of each applicable inspection requirement will constitute completion of this 

procedure. Individual inspection samples and breadth of review will be determined by the 

inspector based on requirement compliance, risk- significance of activity, and extent of the 

activity or records available, when specific sample sizes were not provided in the inspection 

guidance section.

END

Attachment:

 Revision History for IP 88071
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Attachment 1 - Revision History for IP 88071

Commitment 

Tracking 

Number

Accession 

Number

Issue Date

Change Notice

Description of Change Description of 

Training Required 

and Completion 

Date

Comment and 

Feedback 

Resolution 

Accession Number

N/A 07/28/06

CN 06-019

IP 88071 has been issued because of the need for 

a new Inspection Procedure for Configuration 

Management Programmatic Review.

N/A ML061780381

N/A ML13233A188

03/06/14

CN 14-007

The format of the IP was changed to comply with 

IMC 040; including the addition of the ‘Procedure 

Completion’ section. Certain language was 

removed which dictated when the IP should be 

performed as it’s not part of the annual, core 

inspection program.

N/A ML13347B015