**NRC INSPECTION MANUAL** CQV

MANUAL CHAPTER 2508

CONSTRUCTION INSPECTION PROGRAM:

DESIGN CERTIFICATION

TABLE OF CONTENTS

2508-01 PURPOSE 1

2508-02 OBJECTIVES 1

2508-03 DEFINITIONS 1

2508-04 RESPONSIBILITIES AND AUTHORITIES 2

2508-05 DISCUSSION 3

> 05.01 Design Certification Manual Chapter Scope 3
>
> 05.02 Quality Assurance Program Reviews 3
>
> 05.03 Pre-Docketing Audit 3
>
> 05.04 Post-Docketing Inspection 3
>
> 05.05 Design Qualification Testing Inspection. 4
>
> 05.06 10 CFR Part 21 Inspection. 4
>
> 05.07 Inspection Specifics. 4

2508-06 ENFORCEMENT ACTIONS 4

2508-07 INSPECTION REPORTS 5

2508-08 REFERENCES 5

ATTACHMENT 1 Inspection Guidance A1-1

ATTACHMENT 2 Revision History A2-1

2508‑01 PURPOSE

This Manual Chapter (MC) provides guidance for the review of Design
Certification (DC) applications, and audits and inspections to support
this review activity.

This MC establishes audit and inspection guidance for activities
directed towards the review of a DC application and related applicant
activities governed by NRC regulations.

2508‑02 OBJECTIVES

02.01 To provide assurance that the application for a DC meets
requirements specified in Subpart B to 10 CFR Part 52.

02.02 To verify that the quality assurance (QA) program that is being
applied to DC project activities satisfy the appropriate provisions of
Appendix B to 10 CFR Part 50.

02.03 To verify, by inspection and audit, that the QA program supporting
the DC application is adequately implemented.

02.04 To verify whether the qualification testing activities supporting
the application are conducted in accordance with the requirements of
Appendix B to 10 CFR Part 50.

2508‑03 DEFINITIONS

Definitions of terms used in this inspection program are as follows:

03.01 [Audit]{.underline}. A planned and documented activity performed
by the staff before the application is docketed to determine, by
investigation, examination, or evaluation of objective evidence, the
adequacy of and compliance with established procedures, instructions,
drawings, and other applicable documents and the effectiveness of
implementation of the QA program used in the development of the
application.

03.02 [Contractor]{.underline}. Any organization or individual that is
under contract to furnish items or services to an applicant. This
includes, where appropriate, the terms consultant, vendor, supplier, and
other titled subtier organizations.

03.03 [Design Qualification Testing]{.underline}. A test to assure that
a system and/or a component performs as designed. For example, thermal
hydraulic testing provides thermal hydraulic data for computer code
validation and simulates the operation of the design safety systems
including anticipated accidents conditions.

03.04 [Documentation]{.underline}. Any written, pictorial, or electronic
information describing, defining, specifying, reporting, or certifying
activities, requirements, procedures, or results.

03.05 [Inspection]{.underline}. An NRC planned and documented activity
performed during the review of the application once docketed to
determine, by investigation, examination, or evaluation of objective
evidence, the adequacy of and compliance with established procedures,
instructions, drawings, and other applicable documents and the
effectiveness of implementation of the QA program.

03.06 [Nonconformance]{.underline}. The failure of a contractor or
non-licensee (applicant) to meet a commitment that has not been made a
legally binding requirement.

03.07 [NRC Quality Assurance Guidance]{.underline}. Guidance either
developed or endorsed by the NRC - through issuance of regulatory
guides, review standards, or national standard documents - that
discusses acceptable methods of implementing a QA program consistent
with Appendix B to 10 CFR Part 50. Standard Review Plan (SRP) 17.5,
\"Quality Assurance Program Description - Design Certification, Early
Site Permit and New License Applicants,\" provides QA guidance for
Design Certification reviews.

03.08 [Objective Evidence]{.underline}. Any documented statement of
fact, other information, or record, either quantitative or qualitative,
pertaining to the quality of an item or activity, based on direct
observations, measurements, or tests that can be verified.

03.09 [Quality Assurance]{.underline}. QA comprises all those planned
and systematic actions necessary to provide adequate confidence that a
structure, system or component (SSC) will perform satisfactorily in
service. QA includes quality control.

03.10 [Quality Assurance Program Description]{.underline}. A compilation
of quality assurance documents that defines the quality assurance policy
and program, describes the method(s) by which the policy will be
implemented through procedures and instructions, and identifies the
parties responsible for implementation.

03.11 [Quality Control]{.underline}. Quality Control (QC) comprises QA
actions related to the physical characteristics of an SSC. This provides
a means to control the quality of the SSC to applicant-predetermined
design requirements.

03.12 [Safety Evaluation Report]{.underline}. The safety evaluation
report (SER) provides the technical, safety, and legal basis for the
NRC=s disposition of a license request or license amendment request.

03.13 [Standard Design]{.underline}. Standard design means a design that
is sufficiently detailed and complete to support certification in
accordance with Subpart B of 10 CFR Part 52 and that is usable for a
multiple number of units or at a multiple number of sites without
reopening or repeating the review.

03.14 [Standard Design Certification]{.underline}. Standard design
certification, design certification, or certification means a Commission
approval, issued pursuant to Subpart B of 10 CFR Part 52, of a standard
design for a nuclear power facility. A design so approved may be
referred to as a certified standard design.

03.15 [Tendered (Docketed) Application]{.underline}. An application that
has been submitted but not accepted for docketing.

03.16 [Violation]{.underline}. For the purposes of this manual chapter,
the failure to comply with any portion of a legally binding regulatory
requirement, such as a statute, regulation, order, license condition, or
technical specification.

2508-04 RESPONSIBILITIES AND AUTHORITIES

04.01 [Director, Office of New Reactors (NRO)]{.underline}. Provides
overall direction for the NRC construction inspection program.

04.02 [Director, Division of Construction Inspection and Operational
Programs (DCIP)]{.underline}.

> a\. Directs the implementation of this MC.
>
> b\. Assesses the effectiveness, uniformity, and completeness of the
> implementation of this MC.

2508‑05 DISCUSSION

05.01 [DC Manual Chapter Scope]{.underline}. This MC applies to the
applicant and the applicant\'s contractors, and to activities related to
NRC regulations related to the DC review process. The principal
regulations for this phase are those described by Subpart B to 10 CFR
Part 52. The DC review phase begins when the NRC receives notification
of an applicant=s intention to apply for a DC.

Where activities associated with the DC phase have been contracted to
other organiza­tions, this program applies to the organizations
conducting the activities for the applicant organization.

05.02 [QA Program Reviews]{.underline}. The QA program will be reviewed
in accordance with the guidance contained in SRP 17.5. The staff should
encourage an early submittal of the applicant=s quality assurance
topical report (QATR) or their quality assurance program description
(QAPD) for staff review and issuance of an SER (provided the QAPD was
not previously approved in an SER).

Departures from accepted QA process controls or deviations from accepted
industry standards may require independent evaluations and additional
communications with the applicant. This could extend the NRC review
process. Where the QAPD contains significant deviations from NRC QA
guidance (SRP 17.5) that could adversely impact the integrity or
reliability of the design, the applicant should provide sufficient
justification for the staff to address/consider the deviation.
Significant deviations from NRC guidance could extend the NRC review
process.

Based on the information provided by the applicant, and from audits and
inspections performed under this MC, as appropriate, an SER will be
issued. The SER documents the NRC approval of the QAPD, if not
previously approved in another SER. In addition, as appropriate, the SER
includes the inspection results to support the staff\'s disposition
regarding the adequacy of the QAPD implementation.

05.03 [Pre-Docketing Audit]{.underline}. Typically one QA audit is
performed prior to the docketing of an application to verify that the
development of the application is performed in a manner to ensure
accuracy and completeness of the application in accordance with the
requirements of 10 CFR 50.9. In addition, the regulations in 10 CFR Part
52 require that an Appendix B to 10 CFR Part 50 quality assurance
program be implemented during DC quality-related activities. The
pre-docketing QA audit provides assurance that a quality assurance
program is being adequately implemented to control information that will
be submitted as part of a DC application in accordance with the
applicant\'s Appendix B to 10 CFR Part 50 QA program.

The Pre-Docketing QA program audit also provides for a review of the
applicant=s oversight of any contracted activities. The inspectors will
review a representative sample of documents of the applicant and its
contractors to provide assurance the quality assurance programs are
being adequately implemented.

05.04 [Post-Docketing Inspection]{.underline}. Typically one inspection
is conducted to verify the implementation of the applicant=s QA program
and to support the staff\'s SER input. Follow-up inspections are
performed as necessary.

The objective of a Post-Docketing QA program inspection is to provide
the staff with reasonable assurance that the QA program has been
adequately implemented. This objective is consistent with regulations
that govern all stages of the licensing process. Assigned NRC inspectors
will verify whether DC activities are conducted under the appropriate
provisions of Appendix B to 10 CFR Part 50. Effective implementation of
the QA program provides reasonable assurance of the integrity and
reliability of the DC data or analyses that would affect the performance
of safety related systems, structures, and components.

05.05 [Design Qualification Testing Inspection]{.underline}. 10 CFR
52.47(b)(2)(i)(A) requires, in part, that a standard design that differs
significantly from light water reactor designs, such as by using passive
means to accomplish its safety functions, must demonstrate either
through analysis, appropriate test programs, experience, or a
combination thereof, the performance of each safety feature. This
provision requires that the applicant develop and perform a design
certification test program of sufficient scope that includes both
separate-effects and integral-system testing to provide data to assess
the computer codes used to analyze plant behavior over a range of normal
operating conditions, transient conditions, and specified accident
sequences.

In addition, Criterion III, \"Design Control,\" of Appendix B to 10 CFR
Part 50 states, in part, that where a test program is used to verify the
adequacy of a specific design feature, the design control measures shall
include suitable qualification testing of a prototype unit under the
most adverse design conditions.

As necessary, and based on the design considerations, one or more design
qualification testing inspections are performed. The objective of a
design qualification testing inspection is to verify that test
activities performed to support the design certification were conducted
under the appropriate provisions of Appendix B to 10 CFR Part 50, and
the applicant\'s QA program. Also as part of the inspection, the staff
from the appropriate technical discipline will verify that the test
program demonstrates the appropriate sequence of events and key
phenomena influencing system (or component) behavior required to provide
acceptable data to assess computer codes.

05.06 [Inspection of Part 21 Program]{.underline}. The DC QA program
inspections will include a review of the applicant=s program associated
with 10 CFR Part 21. This will provide assurance that the applicant has
established appropriate procedures and programs to effectively implement
10 CFR Part 21 requirements for reporting defects and noncompli­ance.

05.07 [Inspection Specifics]{.underline}. Inspections will be led by the
Quality and Vendor Branches of NRO. Technical support, as needed, will
be obtained from NRO technical staff or contractors. Enclosure 1 of this
MC contains a list of all the inspection procedures that support DC
inspection and audit activities.

2508-06 ENFORCEMENT ACTIONS

Enforcement actions associated with a DC application are not anticipated
in the pre-docketing phase. However, the information submitted with the
application will become subject to NRC regulations, including
enforcement actions for willful wrongdoing or fraudulent information.
During the post-docketing phase, the applicant will be subject to 10 CFR
Part 21 and Appendix B to 10 CFR Part 50 requirements and may be subject
to enforcement actions, such as notices of violation and nonconformance.

2508-07 INSPECTION REPORTS

Audits reports will be issued by CQV as required by IMC-614,
\"Documenting 10 CFR Part 52 Construction Audit Activities.\" Inspection
reports will be issued by CQV as required by IMC-0612, \"Power Reactor
Inspection Reports.\"

2508-08 REFERENCES

10 CFR Part 50, Appendix B, \"Quality Assurance Criteria for Nuclear
Power Plants and Fuel Reprocessing Plants\"

10 CFR Part 21, \"Requirements for Reporting Defects and Noncompliance\"

NUREG 0800, Standard Review Plan, Section 17.5, \"Quality Assurance
Program Description - Design Certification, Early Site Permit and New
License Applicants\"

END

Attachments:

1\. Inspection Guidance

2\. Revision History

ATTACHMENT 1

INSPECTION GUIDANCE

  -----------------------------------------------------------------------
  IP \#    INSPECTION GUIDANCE
  -------- --------------------------------------------------------------
  35005    Quality Assurance Program Audit

  35017    Quality Assurance Implementation Inspection

  35034    Design Qualification Testing Inspection

  36100    Inspection of 10 CFR Parts 21 and 50.55(e) Programs for
           Reporting Defects and Noncompliance
  -----------------------------------------------------------------------

ATTACHMENT 2

[Revision History for IMC 2508]{.underline}

+--------+-------+----------------+----------+----------+--------------+
| Comm   | Issue | Description of | Training | Training | Comment      |
| itment | Date  | Change         | Required |          | Resolution   |
| Tr     |       |                |          | Co       | Accession    |
| acking |       |                |          | mpletion | Number       |
| Number |       |                |          | Date     |              |
+--------+-------+----------------+----------+----------+--------------+
| N/A    | 10/   | Researched     | None     | N/A      | N/A          |
|        | 03/07 | commitments    |          |          |              |
|        |       | for 4 years    |          |          |              |
|        | CN    | and found      |          |          |              |
|        | 0     | none.          |          |          |              |
|        | 7-030 |                |          |          |              |
|        |       | Issued to      |          |          |              |
|        |       | provide        |          |          |              |
|        |       | initial        |          |          |              |
|        |       | guidance for   |          |          |              |
|        |       | design         |          |          |              |
|        |       | certifi­cation  |          |          |              |
|        |       | inspections.   |          |          |              |
+--------+-------+----------------+----------+----------+--------------+
|        |       |                |          |          |              |
+--------+-------+----------------+----------+----------+--------------+