Issue Date: 06/20/14 1 65001.16

ATTACHMENT 65001.16

INSPECTION OF ITAAC-RELATED ENGINEERING

PROGRAM APPLICABILITY: 2503

65001.16-01 INSPECTION OBJECTIVES

01.01 To evaluate the adequacy of the processes used for ITAAC engineering

implementation. 

01.02 To determine whether design drawings, specifications, and records reflect work 

accomplishment consistent with the design basis, committed standards, and approved 

procedures.

01.03 To verify the implementation of the quality assurance (QA) program related to

Engineering activities and records control.

65001.16-02 INSPECTION REQUIREMENTS

This inspection procedure (IP) is intended to verify that design requirements are being

controlled and applied in accordance with licensee procedures, to verify ITAAC-related 

engineering activities are being conducted in accordance with the licensee’s QA program and 

related engineering procedures, and to verify that the licensee’s QA organization is reviewing 

and auditing engineering activities and records in accordance with the licensee’s QA 

procedures. The reviews and following steps in this IP apply to the ITAAC and associated 

design information for row 16 of the ITAAC matrix. 

02.01 Design Procedures. Review the licensee’s engineering and QA procedures related to 

engineering design control and design change. Inspectors should select approximately 12 

engineering design products for safety-related SSCs for use in the remainder of this inspection 

procedure. The engineering design products should, to the extent practicable, cover a range of 

different engineering disciplines (i.e. civil, electrical, mechanical, etc.). The number of 

engineering design products reviewed may vary depending on their complexity.

Guidance. Ensure that the work activities discussed in sections 02.02 through 02.06 below are 

being properly performed in compliance with the approved engineering procedures and 

applicable design documents such as specifications, drawings, and calculations. Particular 

emphasis should be placed on those procedures that control configuration management. 

Engineering personnel should be appropriately trained in the applicable procedural and 

programmatic requirements. Obtain an understanding of QA procedures, as well as applicable 

codes, standards and Regulatory Guides, to confirm QA verification of engineering work and 

compliance with commitments. Specifications, analyses, and other design documents must be 

integrated to ensure adequate control and consistent practices.
Issue Date: 06/20/14 2 65001.16

02.02 Design Input. Review the ITAAC Matrix for the inspected facility to determine the

ITAAC residing in “families” along Row (16) for “Engineering.” Select specific design criteria for 

inspection based upon those ITAAC. For the selected inspection criteria, verify that design 

inputs are identified and documented and that their selection was reviewed, verified, and

approved by the responsible engineering group.

Guidance. Design inputs are crucial to ensuring that design activities are carried out in a correct 

manner. Consequently, design inputs must be identified and documented. Design inputs should 

consider the bases behind the approved design, including safety function, performance 

requirements, regulatory requirements, and applicable codes and standards. The inspector 

should also ensure that design inputs appropriately consider both normal operations and 

anticipated operational occurrences, maintenance, and testing, external events and postulated 

accident conditions. Ensure design inputs and assumptions are correctly selected, incorporated 

into the design, maintained, controlled and updated as required, and are readily available to the 

design organization. Any design inputs which deviate from established industry standards are 

identified, controlled and evaluated through effective design control procedures.

Verify that changes made to the design after initial approval remains consistent with the 

licensing basis, and that the changes were made consistent with licensee procedures and 

regulatory requirements. If the change is a departure from the licensing basis, verify that the 

departure was screened properly (i.e. per the approved COL) and, if applicable, a license 

amendment was obtained prior to implementation of the change.

02.03 Design Documents. Verify that a sample of the design documents address the

following provisions:

a. The design documents provide sufficient details to adequately support implementation 

and facility construction; and are adequate to support proper operation of systems, 

components, and structures (SSCs).

Guidance. The design of risk significant SSCs should be consistent with the risk analysis

assumptions and should include the integration of human factors engineering with human

reliability analysis and the results of any human-system interface reviews. Additionally, the 

design documents should be properly controlled, updated, revised, and managed to ensure 

fidelity with the as-built SSC. The most current drawings should be available and be in use 

by the construction organization. Ensure that design change documents are consistent with 

related calculations and that the design change is consistent with the applicable design 

basis for the affected SSC. 

ITAAC acceptance criteria included in SSC design documents or licensee procedures, and 

their bases, should be reviewed to ensure consistency with the licensee’s Design Control 

Document (DCD) and the FSAR.

b. Appropriate codes and standards are identified and documented in the design 

documents, and their selection is reviewed, verified, and approved.
Issue Date: 06/20/14 3 65001.16

Guidance. Ensure that the applicable codes and standards, as identified in the UFSAR, are 

properly incorporated into the design documents with the correct edition year. Ensure that 

any regulatory guides that are applicable to the activity and committed to in the UFSAR are 

properly incorporated into the design documents.

c. The design documents address the methods, materials, parts, equipment, and

 processes, essential to the function of an SSC.

Guidance. Procedures that control the content and distribution of listed materials,

parts, equipment, and processes that are essential to the function of an item should

require that they are properly identified and used for design, procurement,

construction and operations activities. Commercial grade items must be identified

with the acceptance criteria defined for such items to be verified.

02.04 Design Analysis. Verify that a sample of design analyses is subject to the following:

a. Calculations are controlled and identified by subject, originator, reviewer, approver

and date such that they are readily retrievable. Changes posted to the calculations

are easily retrievable and were subjected to the same rigor of the original approval.

b. Documentation includes the objective, inputs and their sources, background data,

assumptions, and computer inputs and conclusions.

Guidance. Design packages should contain information sufficient so that a technically

qualified person could verify the results without recourse to the originator. Computer 

code names and versions (i.e. revisions) should be identified. 

c. Computer program acceptability has been previously verified or the results verified

with the design analysis for each application. Ensure that any programs used for

analysis or calculations have been properly verified in accordance with QA program

requirements.

Guidance. Computer program verification should show that the program produces

correct solutions for the encoded mathematical model within defined limits for each

parameter employed. The inspector should verify the encoded mathematical model

produces a valid solution to the physical problem for the particular application.

02.05 Design Verification. Ascertain whether a sample of the design products of

engineering are subject to the following:

a. Design verification is performed by methods which include, but are not limited to, any 

one or a combination of design reviews, alternate calculations, and qualification testing. 

If utilized, qualification testing should demonstrate the adequacy of performance under 

conditions that simulate the most adverse design conditions. Verify the design provides 

reasonable assurance that the SSC is capable of continuously meeting the ITAAC 

acceptance criteria.
Issue Date: 06/20/14 4 65001.16

Guidance. The inspector should use judgment and consider that the extent of design

verification should be a function of the importance to safety, the complexity of the 

design, the degree of standardization, the state of the art, and the similarity with 

previously approved designs. Some of the documents that could require design 

verification by the licensee or its contractors are the following: seismic analyses, various 

software plans required from development to installation and testing, equipment 

qualification reports, ASME Code stress reports, pipe break analyses, and human 

factors analyses and plans. As an example of an SSC requiring seismic margin 

analysis, verify that the engineering analysis report : (1) includes related fragilities and 

high confidence low probability of failure (HCLPF) analysis, (2) provides adequate 

information consistent with the requirements of FSAR Tier 2 Chapter 19, and the 

guidance of DC/COL-ISG-03, “Probabilistic Risk Assessment Information to Support 

Design Certification and Combined License Applications,” and DC/COL-ISG-020, 

“Seismic Margin Analysis for New Reactors Based on Probabilistic Risk Assessment,” 

(3) uses the methodology, assumptions, modeling, and material properties which comply 

with relevant requirements of FSAR Chapter 19 and consistent with applicable 

provisions of SRP Sections 3.7, 3.8, and 19 as well as DC/COL-ISG-03 and DC/COLISG-020 guidance, and (4) has the HCLPF values evaluated in the analysis equal to or 

greater than the review level earthquake.

b. Design verification is performed by any competent individual or group other than those 

who performed the original design. In most cases, the verifier may be from the same

organization.

02.06 Audits. Verify that a sample of the audits performed on design documents ensure

the effectiveness of the design control program.

Guidance. The inspector should review at least the last QA audit report of the design

program and any other surveillances or audits which may have been conducted. The

Inspector should determine if there were any significant findings, and if so, the adequacy of the 

corrective actions which were taken.

65001.16-03 RESOURCE ESTIMATE

Resource estimates are currently under development for this inspection procedure. This

document will be revised to add this information as it becomes available.

65001.16-04 REFERENCES

NUREG 0700, Rev. 2, "Human System Interface Design Review Guidelines."

NUREG 0711, "Human Factors Engineering Program Review Model."

END

Attachment:

 Revision History for IP 65001.16
Issue Date: 06/20/14 Att1-1 65001.16

Attachment 1 - Revision History for IP 65001.16

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

10/03/07

CN 07-030

Initial Issuance. 

Researched commitments for 4 years and 

found none.

N/A N/A

N/A ML14098A240

06/20/14

CN 14-013

Periodic Update N/A ML14098A241