NEI 06-14 QAPD Template
NEI 06-14 QAPD Template
NEI 06-14 QAPD Template
Quality Assurance
Program Description
Quality Assurance
Program Description
NEI 06-14, “Quality Assurance Program Description (QAPD)” provides a generic template for use
by early site permit (ESP) and combined license (COL) applicants to implement applicable
requirements related to the Quality Assurance Program. The QAPD template includes the QA
methods and administrative control requirements that meet 10 CFR 50, Appendix B, and 10 CFR
Part 52. The template is based on the requirements of ASME NQA-1-1994, “Quality Assurance
Requirements for Nuclear Facility Applications,” Parts I, II, and III, as specified in this document.
ASME NQA-1-1994 is the latest NRC approved standard for a Quality Assurance Program as
referenced in the Standard Review Plan (NUREG-0800).
NEI 06-14 is structured as a template for use in developing the applicant-specific QAPD required
as part of ESP and COL applications. The template consists of two documents: (1) a Policy
Statement, and (2) a Quality Assurance Program Description that consists of five Parts. The
applicant will format their specific QAPD in accordance with their process for developing such
documents. The QAPD template contains bracketed text that the applicants will modify with
specific information as necessary for the ESP or COL application. Owing to the NRC Safety
Evaluation (SE) accepting the generic QAPD, NRC staff review of applicant-specific QAPDs
based on NEI 06-14 is expected to focus on the specific information provided to replace the
bracketed text in the generic template.
This revision of NEI 06-14, addresses issues indentified in the NRC’s SE dated November 3, 2009
(ML092650695) and subsequent comments on Revision 8. In particular, a new Part V has been
added to describe the QA and administrative controls for the operational phase. Upon NRC
acceptance of Revision 98 in a new or revised SE, NEI will incorporate the SE and reissue the
document as NEI 06-14-A, Revision 1.
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[Nuclear Development]
Quality Assurance Program Description
[Company Name]
POLICY STATEMENT
[Company Name] ([Company Abbreviation - CA]) shall design, procure, construct and operate the
nuclear plant[s] in a manner that will ensure the health and safety of the public and workers.
These activities shall be performed in compliance with the requirements of the Code of Federal
Regulations (CFR), the applicable Nuclear Regulatory Commission (NRC) Facility Operating
Licenses, and applicable laws and regulations of the state and local governments.
The [CA] [Nuclear Development] Quality Assurance Program (QAP) is the Quality Assurance
Program Description (QAPD) provided in this document and the associated implementing
documents. Together they provide for control of [CA] activities that affect the quality of safety-
related nuclear plant structures, systems, and components (SSCs) and include all planned and
systematic activities necessary to provide adequate confidence that such SSCs will perform
satisfactorily in service. The QAPD may also be applied to certain equipment and activities that
are not safety-related, but support safe plant operations, or where other NRC guidance establishes
program requirements.
The QAPD is the top-level policy document that establishes the manner in which quality is to be
achieved and presents [CA]’s overall philosophy regarding achievement and assurance of quality.
Implementing documents assign more detailed responsibilities and requirements and define the
organizational interfaces involved in conducting activities within the scope of the QAP.
Compliance with the QAPD and implementing documents is mandatory for personnel directly or
indirectly associated with implementation of the [CA] QAP.
Signed
[NAME]
[President and Chief Executive Officer]
[CA]
[Date]
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TABLE OF CONTENTS
EXECUTIVE SUMMARY........................................................................................................................................ iii
POLICY STATEMENT ............................................................................................................................................ v
PART I INTRODUCTION ....................................................................................................................... 1
SECTION 1 GENERAL ......................................................................................................................... 1
1.1 Scope/Applicability .................................................................................................................... 1
PART II QAPD DETAILS........................................................................................................................ 4
SECTION 1 ORGANIZATION ............................................................................................................... 4
1.1 President and CEO ................................................................................................................... 6
1.2 Nuclear Development ............................................................................................................... 6
1.3 Technical Services .................................................................................................................... 6
1.4 Corporate Services .................................................................................................................... 7
1.5 Executive Vice President .............................................................................................................. 7
1.6 NSSS.......................................................................................................................................... 8
1.7 A/E ............................................................................................................................................ 8
1.8 Authority to Stop Work .................................................................................................................. 8
1.9 Quality Assurance Organizational Independence ......................................................................... 8
1.10 NQA-1-1994 Commitment .......................................................................................................... 9
Figure II.1-1 .......................................................................................................................................... 10
Figure II.1-2 .......................................................................................................................................... 11
SECTION 2 QUALITY ASSURANCE PROGRAM .............................................................................. 12
2.1 Responsibilities........................................................................................................................ 13
2.2 Delegation of Work .................................................................................................................. 13
[2.3 Site-specific Safety-Related Design Basis Activities............................................................... 13
2.4 Periodic Review of the Quality Assurance Program ............................................................... 13
2.5 Issuance and Revision to Quality Assurance Program ........................................................... 14
2.6 Personnel Qualifications ......................................................................................................... 14
2.7 NQA-1-1994 Commitment / Exceptions .................................................................................. 15
SECTION 3 DESIGN CONTROL ........................................................................................................ 17
3.1 Design Verification .................................................................................................................. 17
3.2 Design Records ....................................................................................................................... 18
3.3 Computer Application and Digital Equipment Software .............................................................. 18
[3.4 Setpoint Control ....................................................................................................................... 18
3.5 NQA-1-1994 Commitment ........................................................................................................ 18
SECTION 4 PROCUREMENT DOCUMENT CONTROL.................................................................... 20
4.1 NQA-1-1994 Commitment / Exceptions .................................................................................. 20
SECTION 5 INSTRUCTIONS, PROCEDURES, AND DRAWINGS ................................................... 22
5.1 Procedure Adherence.............................................................................................................. 22
5.2 Procedure Content .................................................................................................................. 22
5.3 NQA-1-1994 Commitment ........................................................................................................ 22
SECTION 6 DOCUMENT CONTROL ................................................................................................. 23
6.1 Review and Approval of Documents ....................................................................................... 23
6.2 Changes to Documents ........................................................................................................... 24
6.3 NQA-1-1994 Commitment ........................................................................................................ 24
SECTION 7 CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND SERVICES ................. 25
7.1 Acceptance of Item or Service ................................................................................................ 25
7.2 NQA-1-1994 Commitment / Exceptions .................................................................................. 26
SECTION 8 IDENTIFICATION AND CONTROL OF MATERIALS, PARTS, AND COMPONENTS .. 28
8.1 NQA-1-1994 Commitment....................................................................................................... 28
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SECTION 9 CONTROL OF SPECIAL PROCESSES ......................................................................... 29
9.1 NQA-1-1994 Commitment....................................................................................................... 29
SECTION 10 INSPECTION .............................................................................................................. 30
10.1 Inspection Program ................................................................................................................. 30
10.2 Inspector Qualification ............................................................................................................. 30
10.3 NQA-1-1994 Commitment / Exceptions .................................................................................. 31
SECTION 11 TEST CONTROL......................................................................................................... 32
11.1 NQA-1-1994 Commitment ........................................................................................................ 32
11.2 NQA-1-1994 Commitment for Computer Program Testing ...................................................... 32
SECTION 12 CONTROL OF MEASURING AND TEST EQUIPMENT ............................................ 33
[12.1 Installed Instrument and Control Devices ............................................................................... 33
12.2 NQA-1-1994 Commitment / Exceptions .................................................................................. 33
SECTION 13 HANDLING, STORAGE, AND SHIPPING .................................................................. 34
[13.1 Housekeeping .......................................................................................................................... 34
13.2 NQA-1-1994 Commitment / Exceptions .................................................................................. 34
SECTION 14 INSPECTION, TEST, AND OPERATING STATUS .................................................... 37
14.1 NQA-1-1994 Commitment....................................................................................................... 37
SECTION 15 NONCONFORMING MATERIALS, PARTS, OR COMPONENTS ............................. 38
15.1 Interface with the Reporting Program ...................................................................................... 38
15.2 NQA-1-1994 Commitment ........................................................................................................ 38
SECTION 16 CORRECTIVE ACTION .............................................................................................. 39
16.1 Interface with the Reporting Program ...................................................................................... 39
16.2 NQA-1-1994 Commitment ........................................................................................................ 39
SECTION 17 QUALITY ASSURANCE RECORDS .......................................................................... 40
17.1 Record Retention ..................................................................................................................... 40
17.2 Electronic Records .................................................................................................................. 40
17.3 NQA-1-1994 Commitment / Exceptions .................................................................................. 40
SECTION 18 AUDITS ....................................................................................................................... 41
18.1 Performance of Audits ............................................................................................................. 41
18.2 Internal Audits ......................................................................................................................... 42
18.3 NQA-1-1994 Commitment....................................................................................................... 43
PART III NONSAFETY-RELATED SSC QUALITY CONTROL............................................................ 44
SECTION 1 Nonsafety-Related SSCs - Significant Contributors to Plant Safety ............................... 44
SECTION 2 Nonsafety-Related SSCs Credited for Regulatory Events .............................................. 47
PART IV REGULATORY COMMITMENTS ............................................................................................... 48
NRC Regulatory Guides and Quality Assurance Standards ................................................................... 48
Regulatory Guides: .............................................................................................................................. 48
Standards: ............................................................................................................................................ 54
PART V ADDITIONAL QUALITY ASSURANCE AND ADMINISTRATIVE CONTROLS FOR
THE PLANT OPERATIONAL PHASE ....................................................................................................... 55
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Part I
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Quality Assurance Program Description
PART I INTRODUCTION
SECTION 1 GENERAL
[NOTE: The QAPD can be used for Early Site Permit (ESP)/Combined Operating License
(COL)/ construction/pre-operation and/or operations. When developing a QAPD using this
template, the bracketed text should be selected based on the intended application of the
QAPD (e.g., ESP, COL, construction phase, operations, or all). Text that is defined as a NOTE
is for information only, is not intended to be part of the QAPD, and should be removed.
NOTE: The QAPD template contains bracketed text that the applicants will select or modify
with specific information as necessary for the application. When the bracketed text is NOT
italicized, the text should be included if applicable to the scope without modification. This
nonitalicized bracketed text is reviewed and approved as part of the standard template
approval. See Part V, Section 2.2 for an example of the nonitalicized bracketed text. When
the bracketed text IS italicized, the text is considered to be example text that the
applicant/licensee will modify specific to their needs. This italicized text is subject to review by
the NRC to determine the acceptability of the QAPD submitted by the applicant. See Part II,
Section 1.1 for an example of the use of italicized bracketed text.]
The QA Program (QAP) is defined by the NRC-approved regulatory document that describes
the QA elements (i.e. the QAPD), along with the associated implementing documents.
Procedures and instructions that control [Nuclear Development] activities will be developed prior
to commencement of those activities. [Policies establish high-level responsibilities and authority
for carrying out important administrative functions which are outside the scope of the QAPD.
Procedures establish practices for certain activities which are common to all [CA] organizations
performing those activities so that the activity is controlled and carried out in a manner that
meets QAPD requirements. Procedures specific to a site, organization, or group establish
detailed implementation requirements and methods, and may be used to implement policies or
be unique to particular functions or work activities.]
1.1 Scope/Applicability
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Designing Storing Operating
Siting Constructing Maintaining
Procuring Erecting Repairing
Fabricating Installing Modifying
Cleaning Inspecting Refueling
Handling Testing Training
Shipping Startup Decommissioning
Receiving Pre-operational activities (including ITAAC)
[ITAAC are those Inspections, Tests, Analyses and Acceptance Criteria the applicant must
satisfy as determined by the commission in accordance with 10 CFR Part 52.]
Safety-related SSCs, under the control of the QAPD, are identified by design documents. The
technical aspects of these items are considered when determining program applicability,
including, as appropriate, the item's design safety function. The QAPD may be applied to certain
activities where regulations other than 10 CFR 50 and 10 CFR 52 establish QA requirements for
activities within their scope.
The policy of [CA] is to assure a high degree of availability and reliability of the nuclear plant[s]
while ensuring the health and safety of its workers and the public. To this end, selected
elements of the QAPD are also applied to certain equipment and activities that are not safety-
related, but support safe, economic, and reliable plant operations, or where other NRC guidance
establishes quality assurance requirements. Implementing documents establish program
element applicability.
The definitions provided in ASME NQA-1–1994, Part I, Section 1.4, apply to select terms as
used in this document.
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This section describes the [CA] organizational structure, functional responsibilities, levels of
authority and interfaces for establishing, executing, and verifying QAPD implementation. The
organizational structure includes [corporate/support/off-site] and on-site functions for [Nuclear
Development] including interface responsibilities for multiple organizations that perform quality-
related functions. Implementing documents assign more specific responsibilities and duties,
and define the organizational interfaces involved in conducting activities and duties within the
scope of the QAPD. Management gives careful consideration to the timing, extent and effects
of organizational structure changes.
[CA senior management position responsible for the Quality Assurance organization] is
responsible to size the Quality Assurance staff commensurate with the duties and responsibilities
assigned.
[NOTE: The following information will be utility specific but should follow the SRP for the content.
This also includes interface responsibilities for multiple organizations performing quality-related
functions. This section should be developed to include the organization that is to implement the
phase the QAPD is intended to cover e.g., ESP, COLA, Construction/Pre-operation/Test, and
Operations. The description should include levels of authority, interfaces, and functional
responsibilities for each position. In addition, for QAPDs that cover activities during both
construction and operations, it should include enough detail to distinguish the organizational
structure for construction and for operations. Include organization charts that describe the QA
organization that is/will be in place for all positions responsible for establishing, maintaining, and
implementing QA requirements from corporate positions through plant positions.]
[NOTE: Generic titles (e.g., Nuclear Development, Quality Assurance Manager) may be used in
the QAPD. However, the generic titles established in the Organization Section must be used
throughout the document.]
[NOTE: Structure Section 1, Organization, of the QAPD such that it clearly delineates 1) how
the QA program is implemented during all applicable phases such as the period of construction
and testing and the operations phase. The transition process from one phase to another must
be described. Position descriptions should clearly delineate these roles during each applicable
phase such as the construction/preoperation phase, the operations phase, as well as the
transition period between the phases. For example at the transition from construction to
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operations, the following text may be appropriate: No later than six months prior to fuel load of
the unit, those positions which are identified for Operations will be staffed and have the
appropriate authority required to perform operations activities. It is anticipated that even after
fuel load, construction activities will be ongoing. Those positions required to support these
activities will retain their applicable construction/preoperation responsibilities until it is deemed
that they are no longer necessary. As the construction of systems (or portions thereof) are
completed, control and authority (including oversight, configuration and operations) is
transferred from the contractor to the cognizant owner departments in the operations phase.
During the transition, responsibilities will be clearly defined in instructions and procedures to
ensure appropriate authority is maintained for each SSC.]
[NOTE: The QAPD describes the functions and responsibilities associated with the quality
assurance requirements of 10 CFR 50, Appendix B, Criteria I, Organization and Criteria II,
Quality Assurance. All positions associated with the establishment, implementation, and
verification of quality-related activities should be shown on the organization charts and
described in the QAPD. For the operations phase, the level of detail to be included should
include roles, responsibilities, and lines of authority for the positions necessary to implement the
requirements of Appendix B. (The typical operating structure includes a site executive with
overall responsibility for the execution of the administrative controls and quality assurance
program at the plant to assure safety. The site executive directs the activities of the plant
manager and nuclear support manager. An individual or organizational unit (often designated
as QA, Oversight, or Assessment) knowledgeable and experienced in nuclear power plant
operational phase activities and quality assurance practices is designated and assigned the
responsibility to verify that the program is being effectively implemented. Depending on the
organizational structure, this individual or organizational unit may report functionally to onsite
plant management or an offsite organization. Reporting to onsite plant management is
preferable since such an arrangement usually results in improved communications in identifying
problems and initiating corrective action. The individual or organizational unit in this case may
receive technical guidance from offsite support groups.) For example, this level of detail will
identify where the independent review functions report within the organization. Comparable
detail should be provided for the construction/preoperation phase. The onsite operating
organization must include one or more individuals knowledgeable in the following fields: nuclear
power plant operation; nuclear power plant mechanical, electrical and electronic systems;
nuclear engineering; chemistry and radiochemistry; radiation protection; and quality assurance.]
[NOTE: Sufficient detail must be included to fully describe how the organization will perform,
manage, and/or oversee activities affecting the quality and performance of safety-related SSCs,
including: testing, preoperational activities such as ITAAC, receiving, storing, repairing,
decommissioning, refueling, and shipping.]
[NOTE: Below is an example of a new plant organization, its independence, and its linking
within an existing utility. The sample organization presented here is for illustration only. This is
not representative of the level of detail sufficient to address all phases of potential applicability.]
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[The [CA] [Nuclear Development (ND)] organization is responsible for new nuclear plant
licensing, engineering, procurement, construction, startup and operations development activities.
Several organizations within [CA] implement and support the QAPD. These organizations
include, but are not limited to [Nuclear Development], Technical Services, Corporate Services
and Quality Assurance.
Design, engineering and environmental services are provided to the [CA] [Nuclear Development]
organization by two primary contractors in accordance with their QAPDs. These two contractors
are [A/E Firm] and [NSSS vendor].
The following sections describe the reporting relationships, functional responsibilities and
authorities for organizations implementing and supporting the [Nuclear Development] QA
Program. The [CA] organization and the [Nuclear Development] organization are shown in
Figures II. 1-1 and II. 1-2 respectively.
The president/CEO is responsible for all aspects of design, construction and operation of [CA]'s
nuclear plants. The president/CEO is also responsible for all technical and administrative
support activities provided by [CA] and contractors. The president/CEO directs the chief
nuclear officer/executive vice president, the [Senior Nuclear Development Officer], the vice
president corporate services, and the vice president technical services in fulfillment of their
responsibilities. The president/CEO reports to the [CA] Board of Directors with respect to all
matters.
[Company name], [Nuclear Development] ([ND]) organization is responsible for new nuclear
plant licensing, engineering, procurement, construction, startup and operational development
activities.
The Senior Nuclear Development Officer (SNDO) reports to the [CA] President and CEO and is
responsible for the administration of the [Nuclear Development] QAPD. The SNDO also directs
the planning and development of the [Nuclear Development] staff, and organization resources.
The SNDO is also responsible for establishing and managing the NSSS contract for the
development of new nuclear generation.
The Vice President - Technical Services reports to the [CA] President and CEO and is
responsible for the administration of engineering, nuclear fuel and nuclear licensing for the
existing plants and may provide support activities for [Nuclear Development] under the QAPD.
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1.4 Corporate Services
The Corporate Services organization is responsible for supporting the [Nuclear Development]
organization through performing activities related to procurement, safety and health and
information technology where applicable.
The Vice President Corporate Services, reports to the [CA] President/CEO and is responsible for
managing the overall Corporate Services organization including assuring that Supply Chain
Management, Safety and Health and Information Technology support [Nuclear Development]
activities in accordance with the QAPD.
The Executive Vice President is the Chief Nuclear Officer (CNO) and is responsible for the safe,
reliable, and efficient operation of [CA] nuclear plants. The CNO directs the operating plants'
Vice Presidents - Project (xxxx and yyyy), and the Quality Assurance Manager. The Executive
Vice President will support [Nuclear Development] activities through the Vice President - xxxx
and the Quality Assurance organization.
The Vice Presidents - Project report to the Executive Vice President and are responsible for
the overall safe and efficient operation of their operating plant, and for the implementation of
quality assurance requirements in the areas specified by the operations QAPD.
For the purposes of this program, the description of the duties of the Vice Presidents - Project
and their staff will be limited to those site activities that support the [Nuclear Development] new
nuclear generation activities.
The Site Project Organization is responsible for operations and maintenance of the respective
plant site. The Site Project Organization is responsible for operations quality inspection activities
of operations on-site work, including any that support [Nuclear Development] ESP and COL
application development, as well as controlling interfaces between the operating units and any
preconstruction or construction activities.
The [CA] Quality Assurance Organization is responsible for independently planning and
performing activities to verify the development and effective implementation of the [CA] QAPDs
including but not limited to [Nuclear Development], engineering, licensing, document control,
corrective action program and procurement that support new nuclear plant generation.
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1.5.2.1 Quality Assurance Manager
The Quality Assurance Manager reports to the Executive Vice President for the operations
activities and to the Senior Nuclear Development Officer] for the new reactor activities and
is responsible for developing and maintaining the [CA] QAPDs, evaluating compliance to
the programs and managing the QA organization resources.
1.6 NSSS
NSSS provides engineering services for plant design and licensing of Plant type plants on CA
sites. These engineering services for new nuclear generation include site-specific engineering
and design necessary to support development of ESP and COL applications, preconstruction
and construction activities.
1.7 A/E
A/E Firm provides engineering services for the development of the ESP and COL applications.
These engineering services include site-specific license engineering, and design activities
necessary to support development of the ESP and COL applications, and planning and support
for preconstruction and construction of new nuclear generation.]
Quality assurance and inspection personnel have the authority, and the responsibility, to stop
work in progress which is not being done in accordance with approved procedures or where
safety or SSC integrity may be jeopardized. This extends to off-site work performed by suppliers
that furnish safety-related materials and services to [CA].
For the [ESP/COL and/or construction], independence shall be maintained between the
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organization or organizations performing the checking (quality assurance and control) functions
and the organizations performing the functions. This provision is not applicable to design
review/verification.
In establishing its organizational structure, [CA] commits to compliance with NQA-1-1994, Basic
Requirement 1 and Supplement 1S-1.
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Figure II.1-1
[CA] Organization
[NOTE: This is a sample organization chart and should be replaced by actual organization.]
[NOTE: Organization charts should be included for all phases of applicability of the QAPD.
Organization Charts should show on-site and off-site organizations implementing the QA
Program.]
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Figure II.1-2
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SECTION 2 QUALITY ASSURANCE PROGRAM
[CA] has established the necessary measures and governing procedures to implement the QAP
as described in the QAPD. [CA] is committed to implementing the QAP in all aspects of work
that are important to the safety of the nuclear plant[s] as described and to the extent delineated
in the QAPD. Further, [CA] ensures through the systematic process described herein that its
suppliers of safety-related equipment or services meet the applicable requirements of 10 CFR
50, Appendix B. Senior management is regularly apprised of the adequacy of implementation
of the QAP through the audit functions described in Part II, Section 18.
The objective of the QAP is to assure that [CA]’s nuclear generating plant[s are/is] [designed,
constructed, and operated] in accordance with governing regulations and license requirements.
The program is based on the requirements of ASME NQA-1-1994, "Quality Assurance
Requirements for Nuclear Facility Applications," as further described in this document. The
QAP applies to those quality-related activities that involve the functions of safety-related
structures, systems, and components (SSCs) associated with the [design (excluding Design
Certification activities), fabrication, construction, and testing of the SSCs of the facility and to the
managerial and administrative controls to be used to assure safe operations]. [Examples of
ESP/COL program safety-related activities include, but are not limited to, site-specific
engineering related to safety-related SSCs, site geotechnical investigations, site engineering
analysis, seismic analysis, and meteorological analysis.] A list or system that identifies SSCs
and activities to which this program applies is maintained at the appropriate facility. [The Design
Certification Document is used as the basis for this list.] Cost and scheduling functions do not
prevent proper implementation of the QAP.
[As described in Part III of the QAPD, specific program controls are applied to nonsafety-
related SSCs, for which 10 CFR 50, Appendix B, is not applicable, that are significant
contributors to plant safety. The specific program controls consistent with applicable sections
of the QAPD are applied to those items in a selected manner, targeted at those characteristics
or critical attributes that render the SSC a significant contributor to plant safety. [NOTE: The
preceding sentences and Part III do not apply to an ESP-only QAP.]]
For the [ESP and/or COL] applications, the QAPD applies to those [Nuclear Development] and
[CA] activities that can affect either directly or indirectly the safety-related site characteristics or
analysis of those characteristics. In addition, the QAPD applies to engineering activities that are
used to characterize the site or analyze that characterization.
[New nuclear plant construction will be the responsibility of [CA]'s [Nuclear Development]
organization. Detailed engineering specifications and construction procedures will be
developed to implement the QAPD and [NSSS] QA programs prior to commencement of
[preconstruction (ESP) and/or construction (COL)] activities. Examples of Limited Work
Authorization (LWA) activities that could impact safety-related SSCs include impacts of
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construction to existing facilities and, for construction of [a] new plant[s], the interface between
nonsafety-related and safety-related SSCs and the placement of seismically-designed backfill.
[NOTE: This does not apply to an ESP-only or an Operations-only QAP.]]
In general, the program requirements specified herein are detailed in implementing procedures
that are either [CA] implementing procedures, or supplier implementing procedures governed by
a supplier quality assurance program.
A grace period of 90 days may be applied to provisions that are required to be performed on a
periodic basis, unless otherwise noted. Annual evaluations and audits that must be performed
on a triennial basis are examples where the 90 day general period could be applied. The
grace period does not allow the "clock" for a particular activity to be reset forward. The "clock"
for an activity is reset backwards by performing the activity early. Audits schedules are based
on the month in which the audit starts.
2.1 Responsibilities
Personnel who work directly or indirectly for [CA] are responsible for achieving acceptable
quality in the work covered by the QAPD. This includes the activities delineated in Part I,
Section 1.1. [CA] personnel performing verification activities are responsible for verifying the
achievement of acceptable quality. Activities governed by the QAPD are performed as directed
by documented instructions, procedures and drawings that are of a detail appropriate for the
activity's complexity and effect on safety. Instructions, procedures and drawings specify
quantitative or qualitative acceptance criteria as applicable or appropriate for the activity, and
verification is against these criteria. Provisions are established to designate or identify the
proper documents to be used in an activity, and to ascertain that such documents are being
used. The [Quality Assurance Project Manager] is responsible to verify that processes and
procedures comply with QAPD and other applicable requirements, that such processes or
procedures are implemented, and that management appropriately ensures compliance.
[CA] retains and exercises the responsibility for the scope and implementation of an effective
QAP. Positions identified in Part II, Section 1, may delegate all or part of the activities of
planning, establishing, and implementing the program for which they are responsible to others,
but retain the responsibility for the program's effectiveness. Decisions affecting safety are made
at the level appropriate for its nature and effect, and with any necessary technical advice or
review.
Site-specific safety-related design basis activities are defined as those activities, including
sampling, testing, data collection, and supporting engineering calculations and reports, that will
be used to determine the bounding physical parameters of the site. Appropriate quality
assurance measures are applied.[NOTE: This does not apply to an Operations-only QAP]]
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the adequacy of that part of the program for which they are responsible to assure its effective
implementation at least once each year or at least once during the life of the activity, whichever
is shorter. [However, the period for assessing QA programs during the operations phase may
be extended to once every two years.[NOTE: This does not apply to a non-Operations QAP]]
Administrative control of the QAPD will be in accordance with [10 CFR 50.55(f) and 10 CFR
50.54(a)[NOTE: Selection of regulation depends on the scope of the QAP. Select one or both
references , as appropriate]]. Changes to the QAPD are evaluated by the [ND Quality
Assurance Project Manager] to ensure that such changes do not degrade previously approved
quality assurance controls specified in the QAPD. This document shall be revised as
appropriate to incorporate additional QA commitments that may be established during the [ESP
and COL] application development process. New revisions to the document will be reviewed, at
a minimum, by the [CA] Quality Assurance Manager] and approved by the [Senior Vice
President - Nuclear Development].
[Regulations require that the Final Safety Analysis Report (FSAR) include, among other things,
the managerial and administrative controls to be used to assure safe operation, including a
discussion of how the applicable requirements of Appendix B will be satisfied. In order to
comply with this requirement, the FSAR references the QAPD and, as a result, the
requirements of 10 CFR 50.54(a) are satisfied by and apply to the QAPD. [NOTE: This does not
apply to a non-Operations QAP.]]
Personnel assigned to implement elements of the QAPD shall be capable of performing their
assigned tasks. To this end, [CA] establishes and maintains formal indoctrination and training
programs for personnel performing, verifying, or managing activities within the scope of the
QAPD to assure that suitable proficiency is achieved and maintained. [Plant and support staff
minimum qualification requirements are as delineated in the unit Technical Specifications.
Other qualification requirements may be established but will not reduce those required by
Technical Specifications. [NOTE: This does not apply to a non-Operations QAP.]] Sufficient
managerial depth is provided to cover absences of incumbents. When required by code,
regulation, or standard, specific qualification and selection of personnel is conducted in
accordance with those requirements as established in the applicable [CA] procedures.
Indoctrination includes the administrative and technical objectives, requirements of the
applicable codes and standards, and the QAPD elements to be employed. [Training for
positions identified in 10 CFR 50.120 is accomplished according to programs accredited by the
National Nuclear Accrediting Board of the National Academy of Nuclear Training that implement
a systematic approach to training. [NOTE: This does not apply to a non-Operations QAP.]]
Records of personnel training and qualification are maintained.
The minimum qualifications of the [[Quality Assurance Manager] and the [Nuclear Development
Quality Assurance Project Manager]] are that [he/each] holds an engineering or related science
degree and a minimum of four years of related experience including two years of nuclear power
plant experience, one year of supervisory or management experience, and one year of the
experience is in performing quality verification activities. Special requirements shall include
management and supervisory skills and experience or training in leadership, interpersonal
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communication, management responsibilities, motivation of personnel, problem analysis and
decision making, and administrative policies and procedures. Individuals who do not possess
these formal education and minimum experience requirements should not be eliminated
automatically when other factors provide sufficient demonstration of their abilities. These other
factors are evaluated on a case-by-case basis and approved and documented by senior
management.
The minimum qualifications of the individuals responsible for planning, implementing, and
maintaining the programs for the QAPD are that each has a high school diploma or equivalent
and has a minimum of one year of related experience. Individuals who do not possess these
formal education and minimum experience requirements should not be eliminated automatically
when other factors provide sufficient demonstration of their abilities. These other factors are
evaluated on a case-by-case basis and approved and documented by senior management.
• NQA-1-1994, Supplement 2S-1 [NOTE: The applicant may either adopt non-
mandatory Appendix 2A-1 as if it were part of the supplement by following option 1
below or take exception to 2A-1 following option 2.]
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years of this experience related to nuclear facilities.]
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[CA] has established and implements a process to control the design, design changes, and
temporary modifications (e.g., temporary bypass lines, electrical jumpers and lifted wires, and
temporary setpoints) of items that are subject to the provisions of the QAPD. The design
process includes provisions to control design inputs, outputs, changes, interfaces, records, and
organizational interfaces within [CA] and with suppliers. These provisions assure that design
inputs (such as design bases and the performance, regulatory, quality, and quality verification
requirements) are correctly translated into design outputs (such as analyses, specifications,
drawings, procedures, and instructions) so that the final design output can be related to the
design input in sufficient detail to permit verification. Design change processes and the division
of responsibilities for design-related activities are detailed in [CA] and supplier procedures. The
design control program includes interface controls necessary to control the development,
verification, approval, release, status, distribution, and revision of design inputs and outputs.
Design changes and disposition of nonconforming items as "use as is" or "repair" are reviewed
and approved by the [CA] design organization or by other organizations so authorized by [CA].
[CA] design processes provide for design verification to ensure that items and activities subject to
the provisions of the QAPD are suitable for their intended application, consistent with their effect
on safety. Design changes are subjected to these controls, which include verification measures
commensurate with those applied to original plant design.
Design verifications are performed by competent individuals or groups other than those who
performed the original design but who may be from the same organization. The verifier shall
not have taken part in the selection of design inputs, the selection of design considerations, or
the selection of a singular design approach, as applicable. This verification may be performed
by the originator's supervisor provided the supervisor did not specify a singular design approach,
rule out certain design considerations, and did not establish the design inputs used in the
design, or if the supervisor is the only individual in the organization competent to perform the
verification. If the verification is performed by the originator's supervisor, the justification of the
need is documented and approved in advance by management.
The extent of the design verification required is a function of the importance to safety of the item
under consideration, the complexity of the design, the degree of standardization, the state-of-the-
art, and the similarity with previously proven designs. This includes design inputs, design
outputs, and design changes. Design verification procedures are established and implemented
to assure that an appropriate verification method is used, the appropriate design parameters to
be verified are chosen, the acceptance criteria are identified, and the verification is satisfactorily
accomplished and documented. Verification methods may include, but are not limited to, design
reviews, alternative calculations and qualification testing. Testing used to verify the
acceptability of a specific design feature demonstrates acceptable performance under conditions
that simulate the most adverse design conditions expected for item's intended use.
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[CA] normally completes design verification activities before the design outputs are used by other
organizations for design work, and before they are used to support other activities such as
procurement, manufacture, or construction. When such timing cannot be achieved, the design
verification is completed before relying on the item to perform its intended design or safety
function.
[CA] maintains records sufficient to provide evidence that the design was properly accomplished.
These records include the final design output and any revisions thereto, as well as record of the
important design steps (e.g., calculations, analyses and computer programs) and the sources of
input that support the final output.
Plant design drawings reflect the properly reviewed and approved configuration of the plant.
The QAPD governs the development, procurement, testing, maintenance, and use of computer
application and digital equipment software when used in safety-related applications and
designated nonsafety-related applications. [CA] and suppliers are responsible for developing,
approving, and issuing procedures, as necessary, to control the use of such computer
application and digital equipment software. The procedures require that the application
software be assigned a proper quality classification and that the associated quality requirements
be consistent with this classification. Each application software and revision thereto is
documented and approved by [authorized personnel]. The QAPD is also applicable to the
administrative functions associated with the maintenance and security of computer hardware
where such functions are considered essential in order to comply with other QAPD
requirements such as QA records.
Instrument and equipment setpoints that could affect nuclear safety shall be controlled in
accordance with written instructions. As a minimum, these written instructions shall:
(1) Identify responsibilities and processes for reviewing, approving, and revising setpoints
and setpoint changes originally supplied by the [NSSS supplier, applicant for
certification, or DC holder], the A/E, and the plant's technical staff.
(2) Ensure that setpoints and setpoint changes are consistent with design and accident
analysis requirements and assumptions.
(3) Provide for documentation of setpoints, including those determined operationally.
(4) Provide for access to necessary setpoint information for personnel who write or
revise plant procedures, operate or maintain plant equipment, develop or revise
design documents, or develop or revise accident analyses.[NOTE: This does not
apply to an ESP-only QAP]]
In establishing its program for design control and verification, [CA] commits to compliance with
NQA-1-1994, Basic Requirement 3, and Supplement 3S-1, [the subsurface investigation
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requirements in Subpart 2.20,[NOTE: This does not apply to an Operations-only QAP]] and the
standards for computer software in Subpart 2.7.
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[CA] has established the necessary measures and governing procedures to assure that
purchased items and services are subject to appropriate quality and technical requirements.
Procurement document changes shall be subject to the same degree of control as utilized in the
preparation of the original documents. These controls include provisions such that:
In establishing controls for procurement, [CA] commits to compliance with NQA-1-1994, Basic
Requirement 4 and Supplement 4S-1, with the following clarifications and exceptions:
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procurement documents is satisfied through review of the applicable
procurement specification, including the technical and quality procurement
requirements, prior to bid or award of contract. Procurement document
changes (e.g., scope, technical or quality requirements) will also receive the
quality assurance review.
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[CA] has established the necessary measures and governing procedures to ensure that activities
affecting quality are prescribed by and performed in accordance with instructions, procedures or
drawings of a type appropriate to the circumstances and which, where applicable, include
quantitative or qualitative acceptance criteria to implement the QAPD as described in the QAPD.
Such documents are prepared and controlled according to Part II, Section 6. In addition, means
are provided to disseminate to the staff instructions of both general and continuing applicability,
as well as those of short-term applicability. Provisions are included for reviewing, updating, and
canceling such procedures.
[CA]’s policy is that procedures are followed, and the requirements for use of procedures have
been established in administrative procedures. Where procedures cannot be followed as
written, provisions are established for making changes in accordance with Part II, Section 6.
Requirements are established to identify the manner in which procedures are to be implemented,
including identification of those tasks that require: (1) the written procedure to be present and
followed step-by-step while the task is being performed, (2) the user to have committed the
procedure steps to memory, (3) verification of completion of significant steps, by initials or
signatures or use of check-off lists. Procedures that are required to be present and referred to
directly are those developed for extensive or complex jobs where reliance on memory cannot be
trusted, tasks that are infrequently performed, and tasks where steps must be performed in a
specified sequence.
In cases of emergency, personnel are authorized to depart from approved procedures when
necessary to prevent injury to personnel or damage to the plant. Such departures are recorded
describing the prevailing conditions and reasons for the action taken.
The established measures address the applicable content of procedures as described in the
introduction to Part II of NQA-1-1994. In addition, procedures governing tests, inspections,
operational activities and maintenance will include as applicable, initial conditions and
prerequisites for the performance of the activity.
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[CA] has established the necessary measures and governing procedures to control the
preparation of, issuance of, and changes to documents that specify quality requirements or
prescribe how activities affecting quality, including organizational interfaces, are controlled
to assure that correct documents are being employed. The control systems (including
electronic systems used to make documents available) are documented and provide for
the following:
(a) identification of documents to be controlled and their specified distribution;
(b) a method to identify the correct document (including revision) to be used and control of
superseded documents;
(c) identification of assignment of responsibility for preparing, reviewing, approving, and
issuing documents;
(d) review of documents for adequacy, completeness, and correctness prior to approval and
issuance;
(e) a method for providing feedback from users to continually improve procedures and work
instructions; and
(f) coordinating and controlling interface documents and procedures.
[During the operational phase, where temporary procedures are used, they shall include a
designation of the period of time during which it is acceptable to use them.]
Documents are reviewed for adequacy by qualified persons other than the preparer. [During the
[ESP or construction phase], procedures for design, construction, and installation are also -
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reviewed by [the organization responsible for quality verification] to ensure quality assurance
measures have been appropriately applied. [NOTE: This does not apply to an Operations-only
QAP.]] The documented review signifies concurrence.
[During the operations phase, documents affecting the configuration or operation of the station
as described in the SAR are screened to identify those that require review by the [IRB/IRC] prior
to implementation as described in Part VII, Section 2.2.
To ensure effective and accurate procedures during the operational phase, applicable
procedures are reviewed, and updated as necessary, based on the following conditions:
(a) following any modification to a system;
(b) following an unusual incident, such as an accident, significant operator error,
or equipment malfunction;
(c) when procedure discrepancies are found;
(d) prior to use if not used in the previous two years; or
(e) results of QA audits conducted in accordance with Part II, Section 18.1.] [NOTE: This
does not apply to a non-Operations QAP.]
Prior to issuance or use, documents including revisions thereto, are approved by the designated
authority. A listing of all controlled documents identifying the current approved revision, or date,
is maintained so personnel can readily determine the appropriate document for use.
In establishing provisions for document control, [CA] commits to compliance with NQA-1-1994,
Basic Requirement 6 and Supplement 6S-1.
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[CA] has established the necessary measures and governing procedures to control the
procurement of items and services to assure conformance with specified requirements. Such
control provides for the following as appropriate: source evaluation and selection, evaluation of
objective evidence of quality furnished by the supplier, source inspection, audit, and
examination of items or services.
[CA] establishes and implements measures to assess the quality of purchased items and
services, whether purchased directly or through contractors, at intervals and to a depth
consistent with the item's or service's importance to safety, complexity, quantity, and the
frequency of procurement. Verification actions include testing, as appropriate, during [design,
fabrication, construction, and operation] activities. Verifications occur at the appropriate phases
of the procurement process, including, as necessary, verification of activities of suppliers below
the first tier.
Measures to assure the quality of purchased items and services include the following, as
applicable:
• Items are inspected, identified, and stored to protect against damage, deterioration, or
misuse.
• Prospective suppliers of safety-related items and services are evaluated to assure that
only qualified suppliers are used. Qualified suppliers are audited on a triennial basis.
In addition, if a subsequent contract or a contract modification significantly enlarges the
scope of, or changes the methods or controls for, activities performed by the same
supplier, an audit of the modified requirements is conducted, thus starting a new triennial
period. [CA] may utilize audits conducted by outside organizations for supplier
qualification provided that the scope and adequacy of the audits meet [CA] requirements.
Documented annual evaluations are performed for qualified suppliers to assure they
continue to provide acceptable products and services. Industry programs, such as those
applied by ASME, Nuclear Procurement Issues Committee (NUPIC), or other
established utility groups, are used as input or the basis for supplier qualification
whenever appropriate. The results of the reviews are promptly considered for effect on
a supplier's continued qualification and adjustments made as necessary (including
corrective actions, adjustments of supplier audit plans, and input to third party auditing
entities, as warranted). In addition, results are reviewed periodically to determine if, as a
whole, they constitute a significant condition adverse to quality requiring additional
action.
• Provisions are made for accepting purchased items and services, such as source
verification, receipt inspection, pre- and post-installation tests, certificates of
conformance, and document reviews (including Certified Material Test
Report/Certificate). Acceptance actions/documents should be established by the
Purchaser with appropriate input from the Supplier and be completed to ensure that
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procurement, inspection, and test requirements, as applicable, have been satisfied before
relying on the item to perform its intended safety function.
• Controls are imposed for the selection, determination of suitability for intended use
(critical characteristics), evaluation, receipt and acceptance of commercial-grade
services or items to assure they will perform satisfactorily in service in safety-related
applications.
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- American Association for Laboratory Accreditation (A2LA);
- ACLASS Accreditation Services (ACLASS);
- International Accreditation Service (IAS);
- Laboratory Accreditation Bureau (L-A-B);
- Other NRC-approved laboratory accrediting body.
- For Section 8.1, [CA] considers documents that may be stored in approved
electronic media under [CA] or vendor control, not physically located on the
plant site, but are accessible from the respective nuclear facility site as
meeting the NQA-1 requirement for documents to be available at the site.
Following completion of the construction period, sufficient as-built
documentation will be turned over to [CA] to support operations. The [CA]
records management system will provide for timely retrieval of necessary
records.
- [CA] will also use other appropriate approved regulatory means and
controls to support [CA] commercial grade dedication activities. [CA]
will assume 10 CFR 21 reporting responsibility for all items that [CA]
dedicates as safety-related.
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[CA] has established the necessary measures and governing procedures to identify and control
items to prevent the use of incorrect or defective items. This includes controls for consumable
materials and items with limited shelf life. The identification of items is maintained throughout
fabrication, erection, installation and use so that the item can be traced to its documentation,
consistent with the item's effect on safety. Identification locations and methods are selected so
as not to affect the function or quality of the item.
In establishing provisions for identification and control of items, [CA] commits to compliance with
NQA-1-1994, Basic Requirement 8 and Supplement 8S-1.
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[CA] has established the necessary measures and governing procedures to assure that special
processes that require interim process controls to assure quality, such as welding, heat treating,
and nondestructive examination, are controlled. These provisions include assuring that special
processes are accomplished by qualified personnel using qualified procedures and equipment.
Personnel are qualified and special processes are performed in accordance with applicable
codes, standards, specifications, criteria or other specially established requirements. Special
processes are those where the results are highly dependent on the control of the process or the
skill of the operator, or both, and for which the specified quality cannot be fully and readily
determined by inspection or test of the final product.
In establishing measures for the control of special processes, [CA] commits to compliance with
NQA-1-1994, Basic Requirement 9 and Supplement 9S-1.
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SECTION 10 INSPECTION
[CA] has established the necessary measures and governing procedures to implement
inspections that assure items, services, and activities affecting safety meet established
requirements and conform to applicable documented specifications, instructions, procedures,
and design documents. Inspection may also be applied to items, services, and activities
affecting plant reliability and integrity. Types of inspections may include those verifications
related to procurement, such as [source, in-process, final, and receipt inspection, as well as
construction, installation, maintenance, modification, inservice, and operations] activities.
Inspections are carried out by properly qualified persons independent of those who performed
or directly supervised the work. Inspection results are documented.
The inspection program establishes requirements for planning inspections, such as the group or
discipline responsible for performing the inspection, where inspection hold points are to be
applied, determining applicable acceptance criteria, the frequency of inspection to be applied,
and identification of special tools needed to perform the inspection. Inspection planning is
performed by personnel qualified in the discipline related to the inspection and includes qualified
inspectors or engineers. Inspection plans are based on, as a minimum, the importance of the
item to the safety of the facility, the complexity of the item, technical requirements to be met,
and design specifications. Where significant changes in inspection activities for the facilities are
to occur, management responsible for the inspection programs evaluate the resource and
planning requirements to ensure effective implementation of the inspection program.
Inspection program documents establish requirements for performing the planned inspections,
and documenting required inspection information such as rejection, acceptance, and re-
inspection results, and the person(s) performing the inspection.
Inspection results are documented by the inspector, reviewed by authorized personnel qualified
to evaluate the technical adequacy of the inspection results, and controlled by instructions,
procedures, and drawings.
[CA] has established qualification programs for personnel performing quality inspections. The
qualification program requirements are described in Part II, Section 2. These qualification
programs are applied to individuals performing quality inspections regardless of the functional
group where they are assigned.
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10.3 NQA-1-1994 Commitment / Exceptions
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[CA] has established the necessary measures and governing procedures to demonstrate that
items subject to the provisions of the QAPD will perform satisfactorily in service, that the plant
can be operated safely and as designed, and that the coordinated operation of the plant as a
whole is satisfactory. These programs include criteria for determining when testing is required,
such as [proof tests before installation, pre-operational tests, post-maintenance tests, post-
modification tests, in-service tests, and operational tests (such as surveillance tests required by
Plant Technical Specifications)], to demonstrate that performance of plant systems is in
accordance with design. Programs also include provisions to establish and adjust test
schedules, and to maintain status for periodic or recurring tests. Tests are performed according
to applicable procedures that include, consistent with the effect on safety: (1) instructions and
prerequisites to perform the test, (2) use of proper test equipment, (3) acceptance criteria, and
(4) mandatory verification points as necessary to confirm satisfactory test completion. Test
results are documented and evaluated by the organization performing the test and reviewed by a
responsible authority to assure that the test requirements have been satisfied. If acceptance
criteria are not met, re-testing is performed as needed to confirm acceptability following
correction of the system or equipment deficiencies that caused the failure.
[The initial start-up test program is planned and scheduled to permit safe fuel loading and start-
up; to increase power in safe increments; and to perform major testing at specified power
levels. If tests require the variation of operating parameters outside of their normal range, the
limits within which such variation is permitted will be prescribed. The scope of the testing
demonstrates, insofar as practicable, that the plant is capable of withstanding the design
transients and accidents. For new facility construction, the suitability of facility operating
procedures is checked to the maximum extent possible during the pre-operational and initial
start-up test programs.[NOTE: This does not apply to an ESP-only QAP]]
Tests are performed and results documented in accordance with applicable technical and
regulatory requirements, including those described in the Technical Specifications and SAR.
Test programs ensure appropriate retention of test data in accordance with the records
requirements of the QAPD. Personnel that perform or evaluate tests are qualified in
accordance with the requirements established in Part II, Section 2.
In establishing provisions for testing, [CA] commits to compliance with NQA-1-1994, Basic
Requirement 11 and Supplement 11S-1.
[CA] establishes and implements provisions to assure that computer software used in
applications affecting safety is prepared, documented, verified and tested, and used such that
the expected output is obtained and configuration control maintained. To this end [CA] commits
to compliance with the requirements of NQA-1-1994, Supplement 11S-2, and Subpart 2.7 to
establish the appropriate provisions.
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[CA] has established the necessary measures and governing procedures to control the
calibration, maintenance, and use of measuring and test equipment (M&TE) that provides
information important to safe plant operation. The provisions of such procedures cover
equipment such as indicating and actuating instruments and gages, tools, reference and
transfer standards, and nondestructive examination equipment. The suppliers of commercial-
grade calibration services are controlled as described in Part II, Section 7.
For the operations phase of the facilities, [CA] has established and implements procedures for
the calibration and adjustment of instrument and control devices installed in the facility. The
calibration and adjustment of these devices is accomplished through the facility maintenance
programs to ensure the facility is operated within design and technical requirements.
Appropriate documentation will be maintained for these devices to indicate the control status,
when the next calibration is due, and identify any limitations on use of the device. [NOTE: This
does not apply to an ESP-only QAP.]]
In establishing provisions for control of measuring and test equipment, [CA] commits to
compliance with NQA-1-1994, Basic Requirement 12 and Supplement 12S-1 with the following
clarification and exception:
- Measuring and test equipment are not required to be marked with the
calibration status where it is impossible or impractical due to equipment size
or configuration (such as the label will interfere with operation of the device)
provided the required information is maintained in suitable documentation
traceable to the device. This exception also applies to the calibration labeling
requirement stated in NQA-1-1994, Subpart 2.4, Section 7.2.1 (ANSI/IEEE
Std. 336-1985).
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[CA] has established the necessary measures and governing procedures to control the handling,
storage, packaging, shipping, cleaning, and preservation of items to prevent inadvertent damage
or loss, and to minimize deterioration. These provisions include specific procedures, when
required to maintain acceptable quality of the items important to the safe operations of the plant.
Items are appropriately marked and labeled during packaging, shipping, handling and storage to
identify, maintain, and preserve the item's integrity and indicate the need for special controls.
Special controls (such as containers, shock absorbers, accelerometers, inert gas atmospheres,
specific moisture content levels and temperature levels) are provided when required to maintain
acceptable quality.
Special or additional handling, storage, shipping, cleaning and preservation requirements are
identified and implemented as specified in procurement documents and applicable procedures.
Where special requirements are specified, the items and containers (where used) are suitably
marked.
Special handling tools and equipment are used and controlled as necessary to ensure safe and
adequate handling. Special handling tools and equipment are inspected and tested at
specified time intervals and in accordance with procedures to verify that the tools and equipment
are adequately maintained.
Operators of special handling and lifting equipment are experienced or trained in the use the
equipment. [During the operational phase, [CA] establishes and implements controls over
hoisting, rigging and transport activities to the extent necessary to protect the integrity of the
items involved, as well as potentially affected nearby structures and components.[NOTE: This
does not apply to a non-Operations QAP.]] Where required, [CA] complies with applicable
hoisting, rigging and transportation regulations and codes.
[13.1 Housekeeping
Housekeeping practices are established to account for conditions or environments that could
affect the quality of structures, systems and components within the plant. This includes control
of cleanliness of facilities and materials, fire prevention and protection, disposal of combustible
material and debris, control of access to work areas, protection of equipment, radioactive
contamination control and storage of solid radioactive waste. Housekeeping practices help
assure that only proper materials, equipment, processes and procedures are used and that the
quality of items is not degraded. Necessary procedures or work instructions, such as for
electrical bus and control center cleaning, cleaning of control consoles, and radioactive
decontamination are developed and used.[NOTE: This does not apply to an ESP-only QAP.]]
In establishing provisions for handling, storage and shipping, [CA] commits to compliance with
NQA-1-1994, Basic Requirement 13 and Supplement 13S-1. [[CA] also commits, during the
construction and operational phase of the plant, to compliance with the requirements of NQA-1-
1994, Subpart 2.1, Subpart 2.2, Subpart 2.3, and Subpart 3.2, Appendix 2.1, with the following
clarifications and exceptions: [NOTE: This commitment and the following clarifications and
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exceptions do not apply to an ESP-only QAPD.]
- Subpart 2.1, Section 3.1 and 3.2 establish criteria for classifying items into cleanness
classes and requirements for each class. Instead of using the cleanness level
system of Subpart 2.1, [CA] may establish cleanness requirements on a case-by-
case basis, consistent with the other provisions of Subpart 2.1. [CA] establishes
appropriate cleanliness controls for work on safety-related equipment to minimize
introduction of foreign material and maintain system/component cleanliness
throughout maintenance or modification activities, including documented verification
of absence of foreign material prior to system closure. [NOTE: Optional
clarification/alternative to QA requirements that only applies to operational programs.
This clarification/alternative was approved for the NMC submittal discussed in the
NRC SE, reference ADAMS Accession number ML050700416.]]
- [Subpart 2.2, Section 2.2 establishes criteria for classifying items into protection levels.
Instead of classifying items into protection levels during the operational phase, [CA]may
establish controls for the packaging, shipping, handling, and storage of such items on a
case-by-case basis with due regard for the item’s complexity, use, and sensitivity to
damage. Prior to installation or use, the items are inspected and serviced as necessary
to assure that no damage or deterioration exists which could affect their function.
[NOTE: Optional clarification/alternative to QA requirements that only applies to
operational programs. This clarification/alternative was approved for the NMC submittal
discussed in the NRC SE, reference ADAMS Accession number ML050700416.]]
- Subpart 2.2, Section 6.6, "Storage Records:" This section requires written records be
prepared containing information on personnel access. As an alternative to this
requirement, [CA] documents establish controls for storage areas that describe those
authorized to access areas and the requirements for recording access of personnel.
However, these records of access are not considered quality records and will be retained
in accordance with the administrative controls of the applicable plant.
- Subpart 2.2, Section 7.1 refers to Subpart 2.15 for requirements related to handling of
items. The scope of Subpart 2.15 includes hoisting, rigging and transporting of items for
the nuclear power plant[s] during construction.
- Subpart 2.3, Section 2.3 requires the establishment of five zone designations for
housekeeping cleanliness controls. Instead of the five-level zone designation, [CA] bases
its control over housekeeping activities on a consideration of what is necessary and
appropriate for the activity involved. The controls are implemented through procedures or
instructions which, in the case of maintenance or modification work, are developed on a
case-by-case basis. Factors considered in developing the procedures and instructions
include cleanliness control, personnel safety, fire prevention and protection, radiation
control and security. The procedures and instructions make use of standard janitorial and
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work practices to the extent possible. [NOTE: Optional clarification/alternative to QA
requirements that only applies to operational programs. This clarification/alternative was
approved for the NMC submittal discussed in the NRC SE, reference ADAMS Accession
number ML050700416.]]
- Subpart 3.2, Appendix 2.1: Only Section 3 precautions are being committed to in
accordance with RG 1.37. In addition, a suitable chloride stress-cracking inhibitor should
be added to the fresh water used to flush systems containing austenitic stainless steels.]
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[CA] has established the necessary measures and governing procedures to identify the
inspection, test, and operating status of items and components subject to the provisions of the
QAPD in order to maintain personnel and reactor safety and avoid inadvertent operation of
equipment. Where necessary to preclude inadvertent bypassing of inspections or tests, or to
preclude inadvertent operation, these measures require the inspection, test or operating status
be verified before release, fabrication, receipt, installation, test or use. These measures also
establish the necessary authorities and controls for the application and removal of status
indicators or labels.
Administrative procedures also describe the measures taken to control altering the sequence of
required tests, inspections, and other operations. Review and approval for these actions is
subject to the same control as taken during the original review and approval of tests,
inspections, and other operations.
In establishing measures for control of inspection, test and operating status, [CA] commits
to compliance with NQA-1-1994, Basic Requirement 14.
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[CA] has established the necessary measures and governing procedures to control items,
including services, that do not conform to specified requirements to prevent inadvertent
installation or use. Instructions require that the individual discovering a nonconformance
identify, describe, and document the nonconformance in accordance with the requirements of
Part II, Section 16. Controls provide for identification, documentation, evaluation, segregation
when practical, and disposition of nonconforming items, and for notification to affected
organizations. Controls are provided to address conditional release of nonconforming items for
use on an at-risk basis prior to resolution and disposition of the nonconformance, including
maintaining identification of the item and documenting the basis for such release. Conditional
release of nonconforming items for installation requires the approval of the designated
management. Nonconformances are corrected or resolved prior to depending on the item to
perform its intended safety function. Nonconformances are evaluated for impact on operability
of quality structures, systems, and components to assure that the final condition does not
adversely affect safety, operation, or maintenance of the item or service. Nonconformances to
design requirements dispositioned repair or use-as-is are subject to design control measures
commensurate with those applied to the original design. Nonconformance dispositions are
reviewed for adequacy, analysis of quality trends, and reports provided to the designated
management. Significant trends are reported to management in accordance with [CA]
procedures, regulatory requirements, and industry standards.
[CA] has appropriate interfaces between the QAP for identification and control of nonconforming
materials, parts, or components and the non-QA Reporting Program to satisfy the requirements
of [10 CFR 52, 10 CFR 50.55 and/or 10 CFR 21 during [ESP/COL design and construction and
10 CFR 21 during operations].
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[CA] has established the necessary measures and governing procedures to promptly identify,
control, document, classify and correct conditions adverse to quality. [CA] procedures assure
that corrective actions are documented and initiated following the determination of conditions
adverse to quality in accordance with regulatory requirements and applicable quality standards.
[CA] procedures require personnel to identify known conditions adverse to quality. When
complex issues arise where it cannot be readily determined if a condition adverse to quality
exists, [CA] documents establish the requirements for documentation and timely evaluation of
the issue. Reports of conditions adverse to quality are analyzed to identify trends. Significant
conditions adverse to quality and significant adverse trends are documented and reported to
responsible management. In the case of a significant condition adverse to quality, the cause is
determined and actions to preclude recurrence are taken.
In the case of suppliers working on safety-related activities, or other similar situations, [CA] may
delegate specific responsibilities for corrective actions but [CA] maintains responsibility for the
effectiveness of corrective action measures.
[CA] has appropriate interfaces between the QAP for corrective actions and the non-QA
Reporting Program to satisfy the requirements of [10 CFR 52, 10 CFR 50.55 and/or 10 CFR 21
during ESP/COL design and construction, and 10 CFR 21 during operations].
In establishing provisions for corrective action, [CA] commits to compliance with NQA-1-1994,
Basic Requirement 16.
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[CA] has the necessary measures and governing procedures to ensure that sufficient records of
items and activities affecting quality are developed, reviewed, approved, issued, used, and
revised to reflect completed work. The provisions of such procedures establish the scope of the
records retention program for [CA] and include requirements for records administration,
including receipt, preservation, retention, storage, safekeeping, retrieval, access controls, user
privileges, and final disposition.
Measures are established that ensure that sufficient records of completed items and activities
affecting quality are appropriately stored. Records of activities for [design, engineering,
procurement, manufacturing, construction, inspection and test, installation, pre-operation,
startup, operations, maintenance, modification, decommissioning, and audits] and their retention
times are defined in appropriate procedures. The records and retention times are [based on
Regulatory Position C.2 and Table 1, of Regulatory Guide 1.28, Revision 3 for design,
construction, and initial start-up. Retention times for operations phase records are based on
construction records that are similar in nature.] [NOTE: The applicant/licensee must address the
records retention schedule for their plant by either referencing Table 1 of Regulatory Guide
1.28, Rev. 3, or including their specific table in the QAPD] In all cases where state, local, or
other agencies have more restrictive requirements for record retention, those requirements will
be met.
When using optical disks for electronic records storage and retrieval systems, [CA] complies with
the NRC guidance in Generic Letter 88-18, "Plant Record Storage on Optical Disks." [CA] will
manage the storage of QA Records in electronic media consistent with the intent of RIS 2000-18
and associated NIRMA Guidelines TG 11-1998, TG15-1998, TG16-1998, and TG21-1998.
In establishing provisions for records, [CA] commits to compliance with NQA-1-1994, Basic
Requirement 17 and Supplement 17S-1, with the following clarifications and exceptions:
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SECTION 18 AUDITS
[CA] has established the necessary measures and governing procedures to implement audits to
verify that activities covered by the QAPD are performed in conformance with the requirements
established. The audit programs are themselves reviewed for effectiveness as a part of the
overall audit process.
Internal audits of selected aspects of [licensing, design, construction phase and operating]
activities are performed with a frequency commensurate with safety significance and in a
manner which assures that audits of safety-related activities are completed. During the early
portions of [Nuclear Development] activities, audits will focus on areas including, but not limited
to, [site investigation], procurement, and corrective action. Functional areas of an
organization's QA program for auditing include, at a minimum, verification of compliance and
effectiveness of implementation of internal rules, procedures [(e.g., operating, design,
procurement, maintenance, modification, refueling, surveillance, test, security, radiation control
procedures, and the emergency plan), Technical Specifications, regulations and license
conditions, programs for training, retraining, qualification and performance of operating staff,
corrective actions, and observation of performance of operating, refueling, maintenance and
modification activities, including associated record keeping].
The audits are scheduled on a formal preplanned audit schedule. The audit system is reviewed
periodically and revised as necessary to assure coverage commensurate with current and
planned activities. Additional audits may be performed as deemed necessary by management.
The scope of the audit is determined by the quality status and safety importance of the activities
being performed. These audits are conducted by trained personnel not having direct
responsibilities in the area being audited and in accordance with preplanned and approved audit
plans or checklists, under the direction of a qualified lead auditor and the cognizance of the
[Quality Manager responsible for the day to day program as documented in Section 1]
[CA] is responsible for conducting periodic internal and external audits. Internal audits are
conducted to determine the adequacy of programs and procedures (by representative sampling),
and to determine if they are meaningful and comply with the overall QAPD. External audits
determine the adequacy of supplier and contractor quality assurance program.
The results of each audit are reported in writing to the responsible [Senior Executive
responsible for the Quality Assurance program at the Site/Plant/Company], or designee, as
appropriate. Additional internal distribution is made to other concerned management levels in
accordance with approved procedures.
Management responds to all audit findings and initiates corrective action where indicated.
Where corrective action measures are indicated, documented follow-up of applicable areas
through inspections, review, re-audits, or other appropriate means is conducted to verify
implementation of assigned corrective action.
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18.2 Internal Audits
Internal audits of organization and facility activities, conducted prior to placing the facility in
operation, should be performed in such a manner as to assure that an audit of all applicable QA
program elements is completed for each functional area at least once each year or at least once
during the life of the activity, whichever is shorter.
[Internal audits of activities, conducted after placing the facility in operation, should be
performed in such a manner as to assure that an audit of all applicable QA program elements is
completed for each functional area within a period of two years. Internal audit frequencies of
well established activities, conducted after placing the facility in operation, may be extended one
year at a time beyond the above two-year interval based on the results of an annual evaluation
of the applicable functional area and objective evidence that the functional area activities are
being satisfactorily accomplished. The evaluation should include a detailed performance
analysis of the functional area based upon applicable internal and external source data and due
consideration of the impact of any functional area changes in responsibility, resources, or
management. However, the internal audit frequency interval should not exceed a maximum of
four years. If an adverse trend is identified in the applicable functional area, the extension of the
internal audit frequency interval should be rescinded and an audit scheduled as soon as
practicable.
During the operations phase audits are performed at a frequency commensurate with the safety
significance of the activities and in such a manner to assure audits of all applicable QA program
elements are completed within a period of two years. These audits will include, as a minimum,
activities in the following areas:
(1) The conformance of facility operation to provisions contained within the Technical
Specifications and applicable license conditions including administrative controls.
(2) The performance, training, and qualifications of the facility staff.
(3) The performance of activities required by the QAPD to meet the criteria of 10 CFR 50,
Appendix B.
(4) The Fire Protection Program and implementing procedures. A fire protection equipment
and program implementation inspection and audit are conducted utilizing either a
qualified off-site licensed fire protection engineer or an outside qualified fire protection
consultant.
(5) Other activities and documents considered appropriate by the [Vice President of Nuclear
Operations, or the CNO].
Audits may also be used to meet the periodic review requirements of the code for the Security,
Emergency Preparedness, and Radiological Protection programs within the provisions of the
applicable code. [NOTE: This does not apply to a non-Operations QAP]]
Internal audits include verification of compliance and effectiveness of the administrative controls
established for implementing the requirements of the QAPD; regulations and license provisions;
provisions for training, retraining, qualification, and performance of personnel performing
activities covered by the QAPD; corrective actions taken following abnormal occurrences; and,
observation of the performance of [construction, fabrication, operating, refueling, maintenance,
and modification] activities including associated record keeping.
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In establishing the independent audit program, [CA] commits to compliance with NQA-1-1994,
Basic Requirement 18 and Supplement 18S-1.
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Specific program controls are applied to nonsafety-related SSCs, for which 10 CFR 50, Appendix
B is not applicable, that are significant contributors to plant safety. The specific program
controls consistent with applicable sections of the QAPD are applied to those items in a selected
manner, targeted at those characteristics or critical attributes that render the SSC a significant
contributor to plant safety.
The following clarify the applicability of the QA Program to the nonsafety-related SSCs and
related activities, including the identification of exceptions to the QA Program described in Part II,
Sections 1 through 18 taken for nonsafety-related SSCs.
1.1 Organization
The verification activities described in this part may be performed by the [CA] line
organization. The QA organization described in Part II is not required to perform
these functions.
1.2 QA Program
[CA] QA requirements for nonsafety-related SSCs are established in the QAPD and
appropriate procedures. Suppliers of these SSCs or related services describe the
quality controls applied in appropriate procedures. A new or separate QA program is
not required.
[CA] has design control measures to ensure that the contractually established design
requirements are included in the design. These measures ensure that applicable
design inputs are included or correctly translated into the design documents, and
deviations from those requirements are controlled. Design verification is provided
through the normal supervisory review of the designer's work.
Procurement documents for items and services obtained by or for [CA] include or
reference documents describing applicable design bases, design requirements, and
other requirements necessary to ensure component performance. The procurement
documents are controlled to address deviations from the specified requirements.
[CA] provides documents such as, but not limited to, written instructions, plant
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procedures, drawings, vendor technical manuals, and special instructions in work
orders, to direct the performance of activities affecting quality. The method of
instruction employed provides an appropriate degree of guidance to the personnel
performing the activity to achieve acceptable functional performance of the SSC.
[CA] controls the issuance and change of documents that specify quality
requirements or prescribe activities affecting quality to ensure that correct documents
are used. These controls include review and approval of documents, identification of
the appropriate revision for use, and measures to preclude the use of superseded or
obsolete documents.
[CA] employs measures where necessary, to identify purchased items and preserve
their functional performance capability. Storage controls take into account
appropriate environmental, maintenance, or shelf life restrictions for the items.
[CA] employs process and procedure controls for special processes, including
welding, heat treating, and nondestructive testing. These controls are based on
applicable codes, standards, specifications, criteria, or other special requirements for
the special process.
1.10 Inspection
[CA] employs measures to identify required testing that demonstrates that equipment
conforms to design requirements. These tests are performed in accordance with test
instructions or procedures. The test results are recorded, and authorized individuals
evaluate the results to ensure that test requirements are met.
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1.12 Control of Measuring and Test Equipment (M&TE)
[CA] employs measures to control M&TE use, and calibration and adjustment at
specific intervals or prior to use.
[CA] employs measures to identify items that have satisfactorily passed required tests
and inspections and to indicate the status of inspection, test, and operability as
appropriate.
[CA] employs measures to identify and control items that do not conform to
specified requirements to prevent their inadvertent installation or use.
1.17 Records
1.18 Audits
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requirements of this Section (Part III, Section 1.18).
[NOTE: The applicant should provide an evaluation of conformance with the guidance in NRC
regulatory guides in effect 6 months before the submittal date of the application. That
evaluation should also include an identification and description of deviations from the guidance
in the regulatory guides as well as suitable justifications for any alternative approaches
proposed by the applicant. Section 2 provides alternative approaches for satisfying the
following NRC guidance:
- Generic Letter 85-06, "Quality Assurance Guidance for ATWS Equipment That Is Not
Safety Related."
- Regulatory Position 3.5, "Quality Assurance and Specific Guidance for SBO
Equipment That Is Not Safety Related," and Appendix A, "Quality Assurance
Guidance for Nonsafety Systems and Equipment," in Regulatory Guide 1.155
Revision 0 August 1988, "Station Blackout."]
[NOTE: The specific program controls identified in Part III, Section1 for nonsafety-related SSCs,
for which 10 CFR 50, Appendix B is not applicable, are commensurate with the NRC Guidance
identified above.]
The following criteria apply to fire protection (10 CFR 50.48), anticipated transients without
scram (ATWS) (10 CFR 50.62), the station blackout (SBO) (10 CFR 50.63) SSCs that are not
safety-related;
- [CA] implements quality requirements for the fire protection system in accordance with
[Regulatory Position 1.7, "Quality Assurance," in Regulatory Guide 1.189, "Fire Protection
for Operating Nuclear Power Plants" as identified in FSAR Chapter 1.] [NOTE: The
applicant/licensee must address the conformance to Regulatory Guide 1.189. Part III
Section 1 may not adequately address regulatory position 1.7 of RG1.189. In reviewing
the Regulatory Positions the applicant should reference FSAR Section 9.5.]
- [CA] implements the quality requirements for ATWS equipment in accordance with Part
III, Section1.
- [[CA] implements quality requirements for SBO equipment in accordance with Part III,
Section1.
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This section identifies the NRC Regulatory Guides (RG) and the other quality assurance
standards which have been selected to supplement and support the [CA] QAPD. [CA]
complies with these standards to the extent described or referenced. Commitment to a
particular RG or standard does not constitute a commitment to other RGs or standards that may
be referenced therein.
[NOTE: NEI 06-14A was prepared and reviewed to NUREG 0800 Standard Review Plan
Section 17.5 March 2007; if there is a later version, an applicant would need to address
conformance to the later revision in the FSAR.]
[NOTE: The applicant should provide an evaluation of conformance with the guidance in NRC
regulatory guides in effect six months before the submittal date of the application. That
evaluation should also include an identification and description of deviations from the guidance
in the regulatory guides as well as suitable justifications for any alternative approaches
proposed by the applicant. The section on Regulatory Guides below identifies where the
template conforms with or provides alternative approaches for satisfying the identified NRC
guidance.]
Regulatory Guides:
[See FSAR Chapter 1 for the [CA] evaluation of conformance with the guidance in NRC
Regulatory Guides in effect six months prior to the submittal date of the application.]
[NOTE: The notes provide an applicant information to support addressing Regulatory Guide
conformance in Chapter 1 of the FSAR consistent with RG 1.206, section C.I.1.9. The
formatting of this section assumes the applicant will address conformance with RGs in a single
location in Chapter 1 of the FSAR. If an applicant elects to provide the identification of
conformance in this section for the identified RGs, conformance, exceptions, or alternatives for
all regulatory positions of each RG should be included. Once a QAPD is approved by the NRC
and the applicant/licensee makes changes in the RG conformance, such as new or different
clarifications or alternatives, the changes must be in accordance with the regulations for making
QAPD changes (10 CFR 50.54(a) or 10 CFR 50.55(f).]
[NOTE: The information below identifies where this template conforms with or provides
alternatives to the RGs and the indicated regulatory positions. Regulatory Positions determined
to not be directly applicable to the QAPD include a pointer to the potentially applicable Chapter
of the FSAR. The applicant is responsible to review this information and confirm its accuracy at
the time of submittal of an application. In addressing conformance with the Regulatory Guides,
the applicant must also consider the status of conformance for design and construction
consistent with the referenced DCD. The revisions used below were in effect when this
document was prepared. Use the appropriate revisions based on the time of application.]
Regulatory Guide 1.8, [Rev. 3, May 2000], Qualification and Training of Personnel for Nuclear
Power Plants
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Regulatory Guide 1.8 provides guidance that is acceptable to the NRC staff regarding
qualifications and training for nuclear power plant personnel.
[CA] identifies conformance and exceptions for the applicable regulatory position guidance
provided in this regulatory guide in [state location, e.g. FSAR Chapter 1.]
[NOTE: Regulatory Position C.2.1 (2.1.1, 2.1.2, and 2.1.3) address alternatives and
substitutions for education and experience for quality assurance personnel. Those alternatives
and substitutions are reflected in Part II, Section 2.6 of the QAPD template.]
[NOTE: Regulatory Position C.2.2 through C.2.10 are not directly applicable to quality
assurance personnel, but are relevant to the overall quality assurance organization described in
Part II, Section 1 of the QAPD and the operating organization described in FSAR Chapter 13.
Those Regulatory Positions should be addressed by FSAR Chapter 13.]
[NOTE: Regulatory Position C.2.13 is not directly applicable to quality assurance personnel, but
is relevant to the overall quality assurance organization described in Part II, Section 1 of the
QAPD and the operating organization described in FSAR Chapter 13. This Regulatory Position
should be addressed by FSAR Chapter 13.]
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[NOTE: Regulatory Positions C.2.14 and C.2.15 address ANSI/ANS-3.1-1993 Sections 4.7.1
and 4.7.2 relative to Independent Review qualifications. The QAPD identifies an alternative for
this regulatory position in Part VII, Section 2.27. As documented in SER ML070510300, the
QAPD template follows SRP Section 17.5, paragraph II.W for providing guidance to the
applicant to establish an independent review program for activities occurring during the
operational phase.]
Regulatory Guide 1.26, [Revision 4, March 2007] - Quality Group Classifications and
Standards for Water-, Steam-, and Radioactive-Waste-Containing Components of Nuclear
Power Plants
[CA] identifies conformance and exceptions for the applicable regulatory position guidance
provided in this regulatory guide in [state location, e.g. FSAR Chapter 1.]
[NOTE: This Regulatory Guide provides guidance on establishing quality group classifications
for components of the nuclear plant and the appropriate industry standards to apply that ensure
proper quality requirements. Regulatory Positions C.1 through C.3 provide guidance in
establishing quality group classifications of components that correspond to ASME Section III,
Class 2 and 3, and those that are not part of the reactor coolant system but may contain
radioactive material. Table 1 of the RG identifies the industry standards that would be applied
to establishing appropriate quality requirements. The classification of components would be
addressed through the FSAR (and associated DCD) Section 3.2. The application of specific
standards would be addressed in the FSAR/DCD sections that describe the identified
components.]
Regulatory Guide 1.28, [Rev. 3, August 1985], Quality Assurance Program Requirements
(Design and Construction)
Regulatory Guide 1.28 describes a method acceptable to the NRC staff for complying with the
provisions of Appendix B with regard to establishing and implementing the requisite quality
assurance program for the design and construction of nuclear power plants.
[CA] identifies conformance and exceptions for the applicable regulatory position guidance
provided in this regulatory guide in [state location, e.g. FSAR Chapter 1.]
[NOTE: This regulatory guide endorses the basic and supplementary requirements in
ANSI/ASME NQA-1-1983, “Quality Assurance Program Requirements for Nuclear Power
Plants” and the ANSI/ ASME NQA-1a-1983 Addenda along with the regulatory positions
discussed below for the establishment and execution of quality assurance programs during the
design and construction phases of nuclear power plants. The QAPD provides adequate
guidance for establishing a quality assurance program that complies with Appendix B to 10 CFR
Part 50 by using ASME NQA standard NQA-1-1994, as supplemented by additional regulatory
guidance and industry guidance. Reference approval for Exelon submittal to use NQA-1-1994
as documented in ADAMS Accession number ML023440300.]
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[NOTE: Regulatory Position C.1 addresses the qualification of inspection and test personnel.
The QAPD identifies an alternative for this regulatory position in Part II, Section 2.78. As
documented in SER ML070510300, the qualification criteria in the QAPD is acceptable and
consistent with SRP Section 17.5, paragraph II.T. Note that SRP Section 17.5 paragraph II.T.5
and 6 represent alternatives to this regulatory position that were approved in SER
ML050700416.]
[NOTE: Regulatory Position C.2 addresses quality assurance records. Guidance is included in
the QAPD, Part II, Section 17.1 for the applicant to address this regulatory position.]
Regulatory Guide 1.29 defines systems required to withstand a safe shutdown earthquake
(SSE).
[CA] identifies conformance and exceptions for the applicable regulatory position guidance
provided in this regulatory guide in [state location, e.g. FSAR Chapter 1.]
[NOTE: This Regulatory Guide describes an acceptable method for identifying and classifying
the features of nuclear power plants that must be designed to withstand the effects of the Safe
Shutdown Earthquake(SSE). Regulatory Positions C.1 through C.3 provide guidance in
establishing the SSCs, or portions thereof, classified as needing to meet seismic design
requirements. The seismic design classification of SSCs would be addressed through the
FSAR (and associated DCD) Section 3.2.]
[NOTE: Regulatory Position C.4 addresses the application of the QA requirements of Appendix
B to 10 CFR Part 50 to all activities affecting the safety-related functions of those portions of the
SSCs that are covered by Regulatory Positions 2 and 3. Those in Regulatory Position 1 are
considered safety-related. The QAPD described in Section 17.5 of the FSAR addresses the QA
program requirements applied to safety-related activities.]
[NOTE: Regulatory Position C.5 addresses the application of design requirements for portions
of the fire protection SSCs as discussed in Regulatory Guide 1.189. The design and quality
assurance requirements for fire protection SSCs is addressed in Section 9.5.1 of the FSAR (and
associated DCD).]
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Regulatory Guide 1.33 describes a method acceptable to the NRC staff for complying with the
Commission's regulations with regard to overall quality assurance program requirements for the
operation phase of nuclear power plants.
[CA] identifies conformance and exceptions for the applicable regulatory position guidance
provided in this regulatory guide in [state location, e.g. FSAR Chapter 1.]
[NOTE: This Regulatory Guide endorses ANSI N18.7-1976/ANS-3.2 for complying with the
quality assurance program requirements for the operation phase of nuclear power plants,
subject to five regulatory positions. Attachment 2 to NEI 06-14, Rev. 8 provides a comparison
of QA requirements established within NQA-1-1994 and the template to provide an alternate
method of meeting 10 CFR 50, Appendix B during the operational phase in lieu of committing to
the requirements of ANSI N18.7-1976/ANS-3.2. ]
[NOTE: Regulatory Position C.1 addresses “Typical Procedures for Pressurized Water Reactors
and Boiling Water Reactors.” QAPD Part II, Sections 5 and 6, and Part V, Section 3 address
requirements for procedures consistent with requirements addressed in SRP 17.5 section II.F
and ANSI N18.7-1976.]
[NOTE: Regulatory Position C.2 identifies additional standards referenced by ANSI N18.7-
1976/ANS-3.2 and provides a cross reference for a regulatory Guide that addressed each of
those standards. The QAPD identifies commitments to ASME NQA-1-1994 instead of the listed
ANSI N45.2 series standards listed. Regulatory Guides 1.28, 1.37, 1.38, 1.39, 1.30, 1.94, 1.58,
1.116, 1.88, 1.74, 1.64, and 1.123 are listed for positions on the ANSI N45.2 series standards.
RG 1.8, 1.17, and 1.54 are included as addressing other ANSI Standards. RG 1.8, 1.28, and
1.37 have been revised to reference newer standards and are discussed specifically in this
section. RG 1.17, 1.58, 1.64, 1.74, 1.88, and 1.123 have been withdrawn. For RG 1.30, 1.38,
1.94 and 1.116 the QAPD provides an acceptable alternative using ASME NQA-1-1994,
Subparts 2.2, 2.4, 2.5, and 2.8 as identified in Part II Sections 10.3 and 13.2 and SRP 17.5
Section II.U.2. For RG 1.39 the QAPD provides an acceptable alternative in Part II, Section
13.1, which is consistent with SRP Section 17.5, paragraph II.M. for operations; controls during
design and construction are addressed in the commitment in Section 13.2. For applicability of
RG 1.54, FSAR Chapter 6 should be consulted.]
[NOTE: Regulatory Position C.3 identifies a position related to Independent Review. The QAPD
provides an alternative for this position by addressing Independent Review requirements
specifically in Part V, Section 2.2 consistent with SRP 17.5 Section II.W rather than referencing
ANSI N18.7. Item 2.2 c. specifically relates to the concern of this regulatory position.]
[NOTE: Regulatory Position C.4 relates to provisions of the audit program. In establishing the
independent audit program, the QAPD provides an alternative for this position by committing the
applicant to comply with the quality standards described in NQA-1-1994, Basic Requirement 18
and Supplement 18S-1. Over the years, the utilities have modified their audit programs to
provide alternatives to the amplified requirements of this Regulatory Position through risk-
informed scheduling or controlling the scope of the scheduled audits. The licensee/applicant
will need to provide the NRC with the rationale for any alternative to the amplified frequencies
stated in the Regulatory Position. The QAPD template follows SRP Section 17.5, paragraph
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II.R, for establishing the necessary measures to implement audits to verify that activities
covered by the QAPD are performed in conformance with the requirements established.]
[NOTE: Regulatory Position C.5 identifies concerns of the NRC with the usage of the verbs
“should” and “shall” in ANSI N18.7-1976. The QAPD provides an alternative to this position by
providing adequate guidance for establishing a quality assurance program that complies with
Appendix B to 10 CFR Part 50 by using ASME NQA standard NQA-11994, as supplemented by
the QAPD provisions in NEI 06-14, Rev. 8. Additional regulatory guidance and industry
guidance is identified in SRP Section 17.5.]
[Regulatory Guide 1.37, [Revision 1, March 2007] – Quality Assurance Requirements for
Cleaning of Fluid Systems and Associated Components of Water-Cooled Nuclear Power Plants
Regulatory Guide 1.37 provides guidance on specifying water quality and precautions related to
the use of alkaline cleaning solutions and chelating agents.
[CA] identifies conformance and exceptions for the applicable regulatory position guidance
provided in this regulatory guide in [state location, e.g. FSAR Chapter 1.] [NOTE: Does not apply
to ESP-only or Operations-only QAP]]
[NOTE: This Regulatory Guide finds that the provisions and recommendations included in
ASME NQA-1-1994, Part II, Subpart 2.1 are generally acceptable for onsite cleaning of
materials and components, cleanness control, and preoperational cleaning and layup of water-
cooled nuclear power plant fluid systems with three regulatory positions. QAPD Part II,
Section13.2 addresses the commitment to NQA-1-1994, Part II, Subpart 2.1.]
[NOTE: Regulatory Position C.1 identifies that the applicability and acceptability of any of the
codes, standards, and specifications referenced in the text are or will be addressed through
other regulations or NRC guidance. FSAR Chapter 1 addresses the codes, standards, and
other documents that are used in the COL and any exceptions or alternatives to those
documents.]
[NOTE: Regulatory Position C.2 identifies the NRC position that the water quality for final
flushes of fluid systems and associated components should be at least equivalent to the quality
of the operating system water. The applicant will need to identify if there is a reason to deviate
from this regulatory position.]
[NOTE: Regulatory Position C.3 recommends following Sections 8.2.2 and 8.2.3 of ASME NQA-
1-1994, Part II, Subpart 2.1 precautions related to the use of alkaline cleaning solutions and
chelating agents, respectively, by the use of the guidance in nonmandatory Appendix 2.1 to
ASME NQA-1-1994, Part III, Subpart 3.2. In addition, this position recommends that a suitable
chloride stress-cracking inhibitor be added to the fresh water used to flush systems containing
austenitic stainless steels. QAPD Part II, Section13.2 addresses the commitment to NQA-1-
1994, Part II, Subpart 3.2. The applicant will need to identify if there is a reason to deviate from
this regulatory position.]
[Regulatory Guide 1.54, [Revision 1, July 2000] - Service Level I, II, and III Protective
Coatings Applied to Nuclear Power Plants
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Regulatory Guide 1.54 provide guidance for the application of protective coatings within nuclear
power plants to protect surfaces from corrosion, contamination from radionuclides, and for wear
protection.
[Note: For applicability of RG 1.54 and any clarifications or alternatives, FSAR Chapter 6
should be consulted.]]
Standards:
ASME NQA-1-1994 Edition - Quality Assurance Requirements for Nuclear Facility Applications
[CA] commits to NQA-1-1994, Parts I, II, and III, as described in Part[s] II [and V] of this
document.
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[CA] includes the requirements of Part V that follow when establishing the necessary measures
and governing procedures for the operations phase of the plant.
SECTION 1 Definitions
[CA] uses the definitions of terms as provided in Section 4 of the Introduction of NQA-1-1994 in
interpreting the requirements of NQA-1-1994 and the other standards to which the QAPD
commits. In addition, definitions are provided for the following terms not covered in NQA-1-1994:
experiments: performance of plant operations carried out under controlled conditions in order to
establish characteristics or values not previously known
independent review: review completed by personnel not having direct responsibility for the work
function under review regardless of whether they operate as a part of an organizational unit or as
individual staff members (see review)
nuclear power plant: any plant using a nuclear reactor to produce electric power, process
steam or space heating
on-site operating organization: on-site personnel concerned with the operation, maintenance
and certain technical services
operating activities: work functions associated with normal operation and maintenance of the
plant, and technical services routinely assigned to the on-site operating organization
operational phase: that period of time during which the principal activity is associated with
normal operation of the plant. This phase of plant life is considered to begin formally with
commencement of initial fuel loading, and ends with plant decommissioning
surveillance testing: periodic testing to verify that safety related structures, systems, and
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components continue to function or are in a state of readiness to perform their functions
system: an integral part of nuclear power plant comprising components which may be operated
or used as a separate entity to perform a specific function
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The [CA] onsite organization employs reviews, both periodic and as situations demand, to
evaluate plant operations and plan future activities. The important elements of the reviews are
documented and subjects of potential concern for the independent review described below are
brought to the attention of the [manager responsible for Plant Operations (plant manager)]. The
reviews are part of the normal duties of plant supervisory personnel in order to provide timely
and continuing monitoring of operating activities in order to assist the [manager responsible for
Plant Operations (plant manager)] in keeping abreast of general plant conditions and to verify
that day-to-day operations are conducted safely in accordance with the established
administrative controls. The [manager responsible for Plant Operations (plant manager)]
ensures the timely referral of the applicable matters discussed in the reviews to appropriate
management and independent reviewers.
Activities occurring during the operational phase shall be independently reviewed on a periodic
basis. The independent review program shall be functional prior to initial core loading. The
independent review function performs the following:
a. Reviews proposed changes to the facility as described in the safety analysis report
(SAR). The [Independent Review Body (IRB)/Independent Review Committee (IRC)]
also verifies that changes do not adversely affect safety and if a technical specification
change or NRC review is required.
b. Reviews proposed tests and experiments not described in the SAR prior to
implementation. Verifies the determination of whether changes to proposed tests and
experiments not described in the SAR require a technical specification change or license
amendment..
d. Reviews violations, deviations, and events that are required to be reported to the NRC.
This review includes the results of investigations and recommendations resulting from
such investigations to prevent or reduce the probability of recurrence of the event.
e. Reviews any matter related to nuclear safety that is requested by the [Site Vice
President, Site Director, Plant Manager,] [NOTE: the generic titles used here must match
those established in Part II, Section 1 Organization] or any [IRB/IRC] member.
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g. Reviews the adequacy of the internal audit program every 24 months.
[NOTE: Option I or Option II may be used. The generic terms Independent Review Body
(IRB) and Independent Review Committee (IRC) may be substituted with the specific
company terms.]
[NOTE: Option I - ]
A group may function as an independent review body (IRB). In discharging its review
responsibilities, the IRB keeps safety considerations paramount when opposed to cost or
schedule considerations. One or more organizational units may collectively perform this
function.
c. Competent individual(s) or group(s) other than those who performed the original
design but who may be from the same organization verify that changes to the
facility do not result in a loss of adequate design or safety margins.
2. The results of IRB reviews of matters involving the safe operation of the facility are
periodically independently reviewed. This review is intended to support management in
identifying and resolving issues potentially affecting safe plant operation. This review
supplements the existing corrective action programs and audits.
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(4) Metallurgy
(11) Training
[NOTE: Option II - ]
2. The independent review committee reports to [CA is to identify a management level above
the plant manager as described in the organization in Part II, Section 1].
3. The independent review committee is composed of no less than 5 persons and no more
than a minority of members are from the on-site operating organization.
For example, at least 3 of the 5 members must be from off-site if there are 5 members on
the committee. A minimum of the chairman or alternative chairman and 2 members must be
present for all meetings.
4. During the period of initial operation, meetings are conducted no less frequently than once
per calendar quarter. Afterwards meetings are conduced no less than twice a year.
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5. Results of the meeting are documented and recorded.
6. Consultants and contractors are used for the review of complex problems beyond the
expertise of the off site/on site independent review committee.
- nuclear engineering,
- metallurgy,
- nondestructive testing,
- radiological safety,
High school diploma for those independent review personnel who are required to review
problems in administrative control and quality assurance practices, training, and
emergency plans and related procedures and equipment.
The following is a description of the various types of procedures used by [CA] to govern the
design, operation, and maintenance of its nuclear generating plants. [CA] follows the guidance
of Appendix A to Regulatory Guide 1.33 in identifying the types of activities that should have
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procedures or instructions to control the activity. Each procedure shall be sufficiently detailed for
a qualified individual to perform the required function without direct supervision, but need not
provide a complete description of the system or plant process.
Procedure format and content may vary from one location to the other. However, procedures
include the following elements as appropriate to the purpose or task to be described.
x Title/Status
Each procedure is given a title descriptive of the work or subject it addresses, and
includes a revision number and/or date and an approval status.
x Purpose/Statement of Applicability/Scope
The purpose for which the procedure is intended is clearly stated (if not
clear from the title). The systems, structures, components, processes or
conditions to which the procedure applies are also clearly described.
x References
x Prerequisites/Initial Conditions
x Precautions
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x Main body
x Acceptance criteria
x Checklists
These include administrative procedures, directives, policies, standards, and similar documents
that control the programmatic aspects of facility activities. These administrative documents
ensure that the requirements of regulatory and license commitments are implemented. Several
levels of administrative controls are applied ranging from those affecting the entire Company to
those prepared at the implementing group level. These documents establish responsibilities,
interfaces, and standard methods (rules of practice) for implementing programs. In addition to
the administrative controls described throughout this QAPD, instructions governing the following
activities are provided:
x Operating Orders/Procedures
Instructions of general and continuing applicability to the conduct of business to the plant
staff are provided. Examples where these are applied include, but are not limited to, job
turnover and relief, designation of confines of control room, definition of duties of
operators and others, transmittal of operating data to management, filing of charts,
limitations on access to certain areas and equipment, shipping and receiving instructions.
Provisions are made for periodic review and updating of these documents, where
appropriate.
x Special Orders
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Procedures or instructions are developed to supplement features and physical barriers
designed to control access to the plant and, as appropriate, to vital areas within the plant.
Information concerning specific design features and administrative provisions of the plant
security program is confidential and thus accorded limited distribution. The security and
visitor control procedures consider, for example, physical provisions, such as: fences and
lighting; lock controls for doors, gates and compartments containing sensitive equipment;
and provisions for traffic and access control. Administrative provisions, such as: visitor
sign-in and sign-out procedures; escorts and badges for visitors; emphasis on inspection,
observation and challenging of strangers by operating crews; and a program of pre-
employment screening for potential employees are also considered.
x Temporary Procedures
Engineering Procedures
These documents provide instructions for the preparation of engineering documents, engineering
analysis, and implementation of engineering programs. This includes activities such as designs;
calculations; fabrication, equipment, construction, and installation specifications; drawings;
analysis and topical reports; and testing plans or procedures. They include appropriate
references to industry codes and standards, design inputs, and technical requirements.
Installation Procedures
These documents provide instructions for the installation of components generally related to new
construction and certain modification activities. They include appropriate reference to industry
standards, installation specifications, design drawings, and supplier and technical manuals for
the performance of activities. These documents include provisions, such as hold or witness
points, for conducting and recording results of required inspections or tests. These documents
may include applicable inspection and test instructions subject to the requirements for test and
inspection procedures below.
System Procedures
These documents contain instructions for energizing, filling, venting, draining, starting up,
shutting down, changing modes of operation, and other instructions appropriate for operations of
systems related to the safety of the plant. Actions to correct off-normal conditions are invoked
following an operator observation or an annunciator alarm indicating a condition which, if not
corrected, could degenerate into a condition requiring action under an emergency procedure.
Separate procedures may be developed for correcting off-normal conditions for those events
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where system complexity may lead to operator uncertainty. Appropriate procedures will also be
developed for the fire protection program.
Start-up Procedures
These documents contain instructions for starting the reactor from cold or hot conditions and
establishing power operation. This includes documented determination that prerequisites have
been met, including confirmation that necessary instruments are operable and properly set;
valves are properly aligned, necessary system procedures, tests and calibrations have been
completed; and required approvals have been obtained.
Shutdown Procedures
These documents contain guidance for operations during controlled shutdown and following
reactor trips, including instructions for establishing or maintaining hot shutdown/standby or cold
shutdown conditions, as applicable. The major steps involved in shutting down the plant are
specified, including instructions for such actions as monitoring and controlling reactivity, load
reduction and cooldown rates, sequence for activating or deactivating equipment, requirements
for prompt analysis for causes of reactor trips or abnormal conditions requiring unplanned
controlled shutdowns, and provisions for decay heat removal.
These documents contain instructions for steady-state power operation and load changing.
These type documents include, as examples, provisions for use of control rods, chemical shim,
coolant flow control, or any other system available for short-term or long-term control of reactivity,
making deliberate load changes, responding to unanticipated load changes, and adjusting
operating parameters.
These documents contain instructions for monitoring performance of plant systems to assure that
core thermal margins and coolant quality are maintained in acceptable status at all times, that
integrity of fission product barriers is maintained, and that engineered safety features and
emergency equipment are in a state of readiness to keep the plant in a safe condition if needed.
Maximum and minimum limits for process parameters are appropriately identified. Operating
procedures address the appropriate nature and frequency of this monitoring.
These documents contain instructions for core alterations, accountability of fuel and partial or
complete refueling operations that include, for example, continuous monitoring of neutron flux
throughout core loading, periodic data recording, audible annunciation of abnormal flux
increases, and evaluation of core neutron multiplication to verify safety of loading increments.
Procedures are also provided for receipt and inspection of new fuel, and for fuel movements in
the spent fuel storage areas. Fuel handling procedures include prerequisites to verify the status
of systems required for fuel handling and movement; inspection of replacement fuel and control
rods; designation of proper tools, proper conditions for spent fuel movement, proper conditions
for fuel cask loading and movement; and status of interlocks, reactor trip circuits and mode
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switches. These procedures provide requirements for refueling, including proper sequence,
orientation and seating of fuel and components, rules for minimum operable instrumentation,
actions for response to fuel damage, verification of shutdown margin, communications between
the control room and the fuel handling station, independent verification of fuel and component
locations, criteria for stopping fuel movements, and documentation of final fuel and component
serial numbers (or other unique identifiers) and locations.
Maintenance Procedures
These documents contain instructions for implementation of the radiation control program
requirements necessary to meet regulatory commitments, including acquisition of data and use
of equipment to perform necessary radiation surveys, measurements and evaluations for the
assessment and control of radiation hazards. These procedures provide requirements for
monitoring both external and internal exposures of employees, utilizing accepted techniques;
routine radiation surveys of work areas; effluent and environmental monitoring in the vicinity of
the plant; radiation monitoring of maintenance and special work activities, and for maintaining
records demonstrating the adequacy of measures taken to control radiation exposures to
employees and others.
These documents contain instructions for periodic calibration and testing of instrumentation and
control systems, and for periodic calibration of measuring and test equipment used in activities
affecting the quality of these systems. These documents provide for meeting surveillance
requirements and for assuring measurement accuracy adequate to keep safety-related
parameters within operational and safety limits.
These documents contain instructions for chemical and radiochemical control activities and
include: the nature and frequency of sampling and analyses; instructions for maintaining coolant
quality within prescribed limits; and limitations on concentrations of agents that could cause
corrosive attack, foul heat transfer surfaces, or become sources of radiation hazards due to
activation. These documents also provide for the control, treatment and management of
radioactive wastes, and control of radioactive calibration sources.
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These documents contain instructions for response to potential emergencies so that a trained
operator will know in advance the expected course of events that will identify an emergency and
the immediate actions that are should be taken in response. Format and content of emergency
procedures are based on regulatory NUREG and Owner’s Group(s) guidance that identify
potential emergency conditions and generally require such procedures to include, as appropriate,
a title, symptoms to aid in identification of the nature of the emergency, automatic actions to be
expected from protective systems, immediate operator actions for operation of controls or
confirmation of automatic actions, and subsequent operator actions to return the reactor to a
normal condition or provide for a safe extended shutdown period under abnormal or emergency
conditions.
These documents contain instructions for activating the Emergency Response Organization and
facilities, protective action levels, organizing emergency response actions, establishing
necessary communications with local, state and federal agencies, and for periodically testing the
procedures, communications and alarm systems to assure they function properly. Format and
content of such procedures are such that requirements of each facility’s NRC approved
Emergency Plan are met.
These documents provide the necessary measures to assure quality is achieved and maintained
for the nuclear facilities. The instructions for tests and inspections may be included within other
procedures, such as installation and maintenance procedures, but will contain the objectives,
acceptance criteria, prerequisites for performing the test or inspection, limiting conditions, and
appropriate instructions for performing the test or inspection, as applicable. These procedures
also specify any special equipment or calibrations required to conduct the test or inspection and
provide for appropriate documentation and evaluation by responsible authority to assure test or
inspection requirements have been satisfied. Where necessary, hold or witness points are
identified within the procedures and require appropriate approval for the work to continue beyond
the designated point. These procedures provide for recording the date, identification of those
performing the test or inspection, as-found condition, corrective actions performed (if any), and
as-left condition, as appropriate for the subject test or inspection.
Administrative procedures require the designated operating personnel to verify that the system or
equipment can be released and determine the length of time it may be out of service. In making
this determination, attention is given to the potentially degraded degree of protection where one
subsystem of a redundant safety system is not available for service. Conditions to be considered
in preparing equipment for maintenance include, for example: shutdown margin; method of
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emergency core cooling; establishment of a path for decay heat removal; temperature and
pressure of the system; valves between work and hazardous material; venting, draining and
flushing; entry into closed vessels; hazardous atmospheres; handling hazardous materials; and
electrical hazards.
When systems or equipment are ready to be returned to service, designated operating personnel
control placing the items in service and document its functional acceptability. Attention is given
to restoration of normal conditions, such as removal of jumpers or signals used in maintenance
or testing, or actions such as returning valves, breakers or switches to proper start-up or
operating positions from "test" or "manual" positions. Where necessary, the equipment placed
into service receives additional surveillance during the run-in period.
Independent verifications, where appropriate, are used to ensure that the necessary measures
have been implemented correctly. The minimum requirements and standards for using
independent verification are established in company documents.
[CA] establishes controls for the maintenance or modification of items and equipment subject to
this QAPD to ensure quality at least equivalent to that specified in original design bases and
requirements, such that safety-related structures, systems and components are maintained in a
manner that assures their ability to perform their intended safety function(s). Maintenance
activities (both corrective and preventive) are scheduled and planned so as not to unnecessarily
compromise the safety of the plant.
In establishing controls for plant maintenance, [CA] commits to compliance with NQA-1-1994,
Subpart 2.18, with the following clarifications:
x Where Subpart 2.18 refers to the requirements of ANS-3.2, it shall be interpreted to mean
the applicable standards and requirements established within the [ND] QAPD
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