Addenda To ASME NQA-1-2004: Quality Assurance Requirements For Nuclear Facility Applications

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ASME NQA-1b–2007
Addenda to
ASME NQA-1–2004
Quality Assurance Requirements
for Nuclear Facility Applications
A N A M E R I C A N N AT I O N A L S TA N D A R D
Three Park Avenue • New York, NY 10016
Copyright c 2007 by the American Society of Mechanical Engineers.

No reproduction may be made of this material without written consent of ASME. A105EB
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Date of Issuance: June 1, 2007
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No reproduction may be made of this material without written consent of ASME.
ASME NQA-1b–2007
Following approval by the Standards Committee of the Committee on Nuclear Quality Assurance,
and after public review, ASME NQA-1b–2007 was approved by the American National Standards
Institute on April 5, 2007.
Addenda to ASME NQA-1–2004 are issued in the form of replacement pages. Revisions, additions,
and deletions are incorporated directly into the affected pages. It is advisable, however, that this
page, the Addenda title and copyright pages, and all replaced pages be retained for reference.
SUMMARY OF CHANGES
This is the second Addenda to be published to ASME NQA-1–2004.
Replace or insert the pages listed. Changes given below are identified on the pages by a margin
note (b07), placed next to the affected area. Changes made in ASME NQA-1–2004 are indicated
by (04). Previous addenda changes are indicated by (a05). The pages not listed are the reverse
sides of the listed pages and contain no changes.
Page Location Change
5, 6 Part I, Introduction (1) Definition of design input revised
(2) Definition of quality standard added
7 Requirement 1, 201(d) Revised
8–10 Requirement 2, 201 and 301 Revised
Requirement 2, 305 Added
11–13 Requirement 3, 300(a) Last sentence added
Requirement 3, 501.3 Second sentence added
Requirement 3, 600(a) Revised
Requirement 3, 700 Revised
16 Requirement 5 First sentence revised
18 Requirement 7, 501 Revised
24 Requirement 10 (1) Paragraph 604 added
(2) New para. 700 added
(3) Former para. 700 redesignated as
para. 800
26 Requirement 11, 600 Revised in its entirety
30 Requirement 15, 405 First sentence revised
32, 33 Requirement 17 Revised in its entirety
34 Requirement 18, 303 Last sentence added
37 Contents Updated to reflect addenda
108–112 Subpart 2.21 Moved to Part III and redesignated as
Nonmandatory Appendix 2.21
114 Contents Updated to reflect addenda
116 Nonmandatory Appendix Revised
1A-1, 303
(c)
Page Location Change
127–129 Nonmandatory Appendix (1) Paragraph 200(c) revised
3A-1 (2) New para. 200(d) added, subsequent
paragraphs redesignated
(3) Paragraphs 500 and 600 revised
137 Nonmandatory Appendix (1) Former para. 601 deleted
7A-1, 600 (2) Former para. 602 redesignated as
para. 601
143 Nonmandatory Appendix (1) Paragraph 300 revised
10A-1 (2) Paragraph 400 deleted
144 Nonmandatory Appendix Paragraph 300 deleted
11A-1
148, 149 Nonmandatory Appendix Revised in its entirety
17A-1, 100
153, 154 Nonmandatory Appendix Revised
18A-1, 302.1
164.1–164.5 Nonmandatory Appendix Added
2.21
(d)
PART I, INTRODUCTION ASME NQA-1b–2007
commercial grade service: 1, 2 a service that was not pro- design authority: the organization having the responsibil-
vided in accordance with the requirements of this ity and authority for approving the design bases, the
Standard. configuration, and changes thereto.
computer program: 3, 4, 5 a combination of computer design bases: that information which identifies the spe-
instructions and data definitions that enables computer cific functions to be performed by a structure, system,
hardware to perform computational or control func- or component of a facility, and the specific values or
tions. ranges of values chosen for controlling parameters as
condition adverse to quality: an all-inclusive term used in reference bounds for design. These values may be
reference to any of the following: failures, malfunctions, (a) restraints derived from generally accepted “state-
deficiencies, defective items, and nonconformances. A of-the-art” practices for achieving functional goals; or
significant condition adverse to quality is one which, if (b) requirements derived from analysis (based on cal-
uncorrected, could have a serious effect on safety or culations and/or experiments) of the effects of a postu-
operability. lated accident for which a structure, system, or
component must meet its functional goals.
configuration: the physical, functional, and operational
characteristics of the structures, systems, components, design change: any revision or alteration of the technical
or parts of the existing facility. requirements defined by approved and issued design
output documents and approved and issued changes
configuration item (software):4 a collection of hardware or
thereto.
software elements treated as a unit for the purpose of
configuration control. design input: those criteria, performance requirements, (b07)
codes and standards, design bases, regulatory require-
configuration management: the process that controls the
ments, or other design requirements upon which
activities, and interfaces, among design, construction,
detailed final design is based.
procurement, training, licensing, operations, and main-
tenance to ensure that the configuration of the facility design output: drawings, specifications, and other docu-
is established, approved, and maintained. ments used to define technical requirements of struc-
corrective action: measures taken to rectify conditions tures, systems, components, and computer programs.
adverse to quality and, where necessary, to preclude design process: technical and management processes that
repetition. commence with identification of design input and that
critical characteristics: important design, material, and lead to and include the issuance of design output docu-
performance characteristics of a commercial grade item ments.
or service that, once verified, will provide reasonable design review: a critical review to provide assurance that
assurance that the item or service will perform its the final design is correct and satisfactory.
intended safety function. deviation: a departure from specified requirements.
dedication: an acceptance process performed in accor-
document: any written, pictorial, or electronic informa-
dance with this Standard to provide reasonable assur-
tion describing, defining, specifying, reporting, or certi-
ance that a commercial grade item or service will
fying activities, requirements, procedures, or results. A
successfully perform its intended safety function and, in
document is not considered to be a quality assurance
this respect, is deemed equivalent to an item or services
record until it satisfies the definition of a quality assur-
provided under the requirements of this Standard.
ance record as defined in this Standard.
dedicating entity: the organization that performs the dedi-
document control: the act of assuring that documents are
cation process.
reviewed for adequacy, approved for release by author-
design, final: approved design output documents and ized personnel, and distributed to and used at the loca-
approved changes thereto. tion where the prescribed activity is performed.
electronic document: a document stored in a form (i.e.,
3
Computer programs covered by this Standard are those magnetic or optical media) that is typically accessible
used for:
(a) design analysis;
only by a computer.
(b) operations or process control; or guidance: a suggested practice that is not mandatory in
(c) data base or document control registers when used as the
controlled source of quality information for (a) or (b) above.
programs intended to comply with this Standard. The
4
This definition has been copied from ANSI/IEEE 610.12-1990, word should denotes guidance; the word shall denotes
Glossary of Software Engineering Terminology, with the permission a requirement.
of IEEE.
5 inspection: examination or measurement to verify
To the extent that computer programs are a physical part of
plant systems (e.g., digital reactor protection systems, digital whether an item or activity conforms to specified
instrumentation, etc.) they are included in the term item. requirements.
5
ASME NQA-1b–2007 PART I, INTRODUCTION
item: an all-inclusive term used in place of any of the affecting quality. Records may also include specially pro-
following: appurtenance, assembly, component, equip- cessed documents such as radiographs, photographs,
ment, material, module, part, structure, subassembly, negatives, or microforms.
subsystem, system, or unit.
quality standard: a code or standard that provides design (b07)
measuring and test equipment (M&TE): devices or systems inputs, acceptance criteria, or other criteria necessary to
used to calibrate, measure, gage, test, or inspect in order assure the quality of the designated item.
to control or acquire data to verify conformance to speci- receiving: taking delivery of an item at a designated
fied requirements. location.
nonconformance: a deficiency in characteristic, documen- repair: the process of restoring a nonconforming charac-
tation, or procedure that renders the quality of an item teristic to a condition such that the capability of an
or activity unacceptable or indeterminate. item to function reliably and safely is unimpaired, even
though that item still does not conform to the original
objective evidence: any documented statement of fact, requirement.
other information, or record, either quantitative or quali-
tative, pertaining to the quality of an item or activity, rework: the process by which an item is made to conform
based on observations, measurements, or tests that can to original requirements by completion or correction.
be verified.
safety function: the performance of an item or service
Owner: the organization legally responsible for the con- necessary to achieve safe, reliable, and effective utiliza-
struction and/or operation of a nuclear facility including tion of nuclear energy and nuclear material processing.
but not limited to one who has applied for, or who has service: the performance of activities such as design, fab-
been granted, a construction permit or operating license rication, inspection, nondestructive examination, repair,
by the regulatory authority having lawful jurisdiction. or installation.
procedure: a document that specifies or describes how shall: see guidance.
an activity is to be performed.
should: see guidance.
procurement document: purchase requisitions, purchase software:4 computer programs and associated documen-
orders, drawings, contracts, specifications, or instruc- tation and data pertaining to the operation of a computer
tions used to define requirements for purchase. system.
Purchaser: the organization responsible for establishment special process: a process, the results of which are highly
of procurement requirements and for issuance or admin- dependent on the control of the process or the skill of
istration, or both, of procurement documents. the operators, or both, and in which the specified quality
cannot be readily determined by inspection or test of
qualification, personnel: the characteristics or abilities the product.
gained through education, training, or experience, as
measured against established requirements, such as Supplier: any individual or organization who furnishes
standards or tests, that qualify an individual to perform items or services in accordance with a procurement doc-
a required function. ument. An all-inclusive term used in place of any of
the following: vendor, seller, contractor, subcontractor,
qualified automated means: automated methods of control- fabricator, consultant, and their subtier levels.
ling or monitoring processes that have been demon-
strated to produce required quality within controlled testing: an element of verification for the determination
limits. of the capability of an item to meet specified require-
ments by subjecting the item to a set of physical, chemi-
qualified procedure: an approved procedure that has been cal, environmental, or operating conditions.
demonstrated to meet the specified requirements for its
traceability: the ability to trace the history, application,
intended purpose.
or location of an item and like items or activities by
quality assurance (QA): all those planned and systematic means of recorded identification.
actions necessary to provide adequate confidence that use-as-is: a disposition permitted for a nonconforming
a structure, system, or component will perform satisfac- item when it has been established that the item is satis-
torily in service. factory for its intended use.
quality assurance record: a completed document that fur- waiver: documented authorization to depart from speci-
nishes evidence of the quality of items and/or activities fied requirements.
6
ASME NQA-1b–2007
REQUIREMENT 1
Organization
100 BASIC those verifying activities affecting quality have sufficient

authority, direct access to responsible levels of manage-
Responsibilities for the establishment and implemen-
ment, organizational freedom, and access to work to
tation of the quality assurance program shall be defined.
perform this function, including sufficient independence
The organizational structure, functional responsibilities,
from cost and schedule when opposed to safety function
levels of authority, and lines of communications for
considerations
activities affecting quality shall be documented.
202 Delegation of Work
200 STRUCTURE AND RESPONSIBILITY The individual(s) or organization(s) responsible for
201 General establishing and executing a quality assurance program
The organizational structure and responsibility under this Standard may delegate any or all of the work
assignments shall be such that to others but shall retain responsibility therefor.
(a) senior management establishes overall expecta-
tions for effective implementation of the quality assur-
300 INTERFACE CONTROL
ance program and is responsible for obtaining the
desired end result Where more than one organization is involved in the
(b) quality is achieved and maintained by those execution of activities, the responsibilities, interfaces,
assigned responsibility for performing work and authority of each organization shall be clearly
(c) quality achievement is verified by those not defined and documented.
directly responsible for performing the work The external interfaces between organizations and the
(b07) (d) those responsible for assuring that an appropriate internal interfaces between organizational units, and
quality assurance program has been established and changes thereto, shall be documented.
7
ASME NQA-1b–2007
REQUIREMENT 2
Quality Assurance Program
100 BASIC 202 Training

The need for a formal training program for personnel
(a) A documented quality assurance program shall
performing or managing activities affecting quality shall
be planned, implemented, and maintained in accordance
be determined. Training shall be provided, if needed,
with this Part (Part I), or portions thereof. The program
to achieve initial proficiency, maintain proficiency, and
shall identify the activities and items to which it applies.
adapt to changes in technology, methods, or job respon-
The program shall provide control over activities affect-
sibilities.
ing quality to an extent consistent with their importance.
The program shall include monitoring activities against
acceptance criteria in a manner sufficient to provide 300 QUALIFICATION REQUIREMENTS
assurance that the activities affecting quality are per-
formed satisfactorily. The program shall be established The responsible organization shall designate those
at the earliest time consistent with the schedule for activities that require qualification of personnel and the
accomplishing the activities. minimum requirements for such personnel. The respon-
The program shall provide for the planning and sible organization shall establish written procedures for
accomplishment of activities affecting quality under the qualification of personnel, and for the assurance that
suitably controlled conditions. Controlled conditions only those personnel who meet the requirements are
include the use of appropriate equipment, suitable envi- permitted to perform these activities.
ronmental conditions for accomplishing the activity, and Specific qualification requirements for personnel per-
assurance that prerequisites for the given activity have forming nondestructive examination inspection and
been satisfied. The program shall provide for any special tests to verify quality and auditing are specified in paras.
controls, processes, test equipment, tools, and skills to 301 through 304 of this Requirement.
attain the required quality of activities and items and
for verification of that quality. The organization shall 301 Nondestructive Examination (NDE) (b07)
establish and implement processes to detect and correct This section specifies requirements for the qualifica-
quality problems. tion of personnel who perform radiographic (RT), mag-
(b) The program shall provide for indoctrination, netic particle (MP), ultrasonic (UT), liquid penetrant
training, and qualification as necessary of personnel per- (PT), electromagnetic (ET), neutron radiographic (NR),
forming or managing activities affecting quality to leak testing (LT), acoustic emission (AE), and visual
ensure that suitable proficiency is achieved and main- testing (VT) to verify conformance to the specified
tained. requirements. The American Society of Nondestructive
(c) Management shall regularly assess the adequacy Testing (ASNT) Recommended Practices or Standards
and effective implementation of the quality assurance provide acceptable qualification requirements for NDE
program. personnel. Applicable Codes and Standards or design
criteria controlling the qualification of NDE personnel
shall be utilized to establish the applicable ASNT qualifi-
200 INDOCTRINATION AND TRAINING cation requirement and edition or to specify an equiva-
Indoctrination and training shall be commensurate lent alternative requirement.
with scope, complexity, importance of the activities, and
the education, experience, and proficiency of the person. 302 Inspection and Test
The initial capabilities of a candidate shall be deter-
(b07) 201 Indoctrination mined by an evaluation of the candidate’s education,
Personnel performing or managing activities affecting experience, training, and either test results or capability
quality shall receive indoctrination in their job responsi- demonstration. The job performance of inspection and
bilities and authority that includes general criteria, tech- test personnel shall be reevaluated at periodic intervals
nical objectives, requirements of applicable codes and not to exceed 3 years. Reevaluation shall be by evidence
standards, regulatory commitments, company proce- of continued satisfactory performance or redetermina-
dures, and quality assurance program requirements. tion of capability in accordance with the requirements
8
PART I, REQUIREMENT 2 ASME NQA-1b–2007
of section 200 of this Requirement. If during this evalua- (d) results that are documented and reported to man-
tion or at any other time, it is determined by the responsi- agement
ble organization that the capabilities of an individual (e) appropriate corrective action initiated and tracked
are not in accordance with the qualification requirements to resolution
specified for the job, that person shall be removed from Such participation shall be subject to review and
that activity until such time as the required capability acceptance by the organization responsible for quality
has been demonstrated. Any person who has not per- assurance audits and/or the certifying authority prior
formed inspection or testing activities in the qualified to their use for qualification.
area for a period of 1 year shall be reevaluated.
303.4 Examination. Prospective Lead Auditors shall
303 Lead Auditor pass an examination which shall evaluate comprehen-
sion of and ability to apply the body of knowledge
The Lead Auditor organizes and directs audits, identified above. The examination may be oral, written,
reports audit findings, and evaluates corrective action. practical, or any combination thereof.
An individual shall meet the requirements of paras. 303.1
through 303.6 of this Requirement prior to being desig- 303.5 Maintenance of Proficiency. Lead Auditors
nated a Lead Auditor. shall maintain their proficiency through one or more of
the following:
303.1 Communication Skills. The prospective Lead
(a) regular and active participation in the audit
Auditor shall be capable of communicating effectively,
process
both in writing and orally. These skills shall be attested
(b) review and study of codes, standards, procedures,
to in writing by the Lead Auditor’s employer.
instructions, and other documents related to quality
303.2 Training. Prospective Lead Auditors shall assurance program and program auditing
receive training to the extent necessary to assure (c) participation in training program(s)
auditing competence including Based on annual assessment, management may
(a) knowledge and understanding of this Standard extend the qualification, require retraining, or require
and other nuclear-related codes, standards, regulations, requalification.
and regulatory guides, as applicable
303.6 Requalification. Lead Auditors who fail to
(b) general structure of quality assurance programs
maintain their proficiency for a period of 2 years or
as a whole and applicable elements as defined in this
more shall require requalification. Requalification shall
Standard
include retraining in accordance with the requirements
(c) auditing techniques of examining, questioning,
of para. 303.2 of this Requirement, reexamination in
evaluating, and reporting; methods of identifying and
accordance with para. 303.4 of this Requirement, and
following up on corrective action items; and closing out
participation as an Auditor in at least one nuclear quality
audit findings
assurance audit.
(d) planning audits of activities affecting quality
(e) on-the-job training to include applicable elements 304 Auditors
of the audit program
Auditors are participants in an audit. Auditors shall
(04) 303.3 Audit Participation. Prospective Lead Auditors have, or be given, appropriate training or orientation to
shall participate in a minimum of five quality assurance develop their competence for performing audits. Com-
audits within a period of time not to exceed 3 years petence of personnel for performance of the various
prior to the date of qualification, one audit of which auditing functions shall be developed by one or more
shall be a nuclear quality assurance audit within the of the following methods:
year prior to qualification. (a) orientation to provide a working knowledge and
Participation in independent assessments including understanding of this Standard and the auditing organi-
team assessment activities such as operations readiness zation’s procedures for implementing audits and
reviews and regulatory inspections/surveys may be reporting results.
used to satisfy up to four of the five required quality (b) general and specialized training in audit perform-
assurance audits, provided that the activities can dem- ance where the general training shall include fundamen-
onstrate the following: tals, objectives, characteristics, organization,
(a) independence from the functional areas being performance, and results of quality auditing and the
assessed specialized training shall include methods of examining,
(b) planning that establishes the scope of the activities questioning, evaluating, and documenting specific audit
and associated evaluation criteria items and methods of closing out audit findings.
(c) performance by technically qualified and experi- (c) on-the-job training, guidance, and counseling
enced personnel under the direct supervision of a Lead Auditor. Such
9
ASME NQA-1b–2007 PART I, REQUIREMENT 2
training shall include planning, performing, reporting, (8) date of certification or recertification and certifi-
and follow-up action involved in conducting audits. cation expiration
(b) The responsible organization shall identify any
(b07) 305 Technical Specialists special physical characteristics needed in the perform-
The responsible auditing organization shall establish ance of each activity, including the need for initial and
the qualifications and requirements for use of technical subsequent physical examination.
specialists to accomplish the auditing of quality assur- The employer may delegate qualification examination
ance programs. activities to an independent certifying agency, but shall
retain responsibility for conformance of the examination
and its administration. Integrity of the examination shall
400 CERTIFICATION OF QUALIFICATION be maintained by the employer or certifying agency
through appropriate confidentiality of files and, where
(a) The qualification of inspection, test, and Lead
applicable, proctoring of examinations. Copies of the
Auditor personnel shall be certified in writing and
objective evidence regarding the type(s) and content of
include the following information:
the examination(s) shall be retained by the employer in
(1) employer’s name
accordance with the requirements of section 500 of this
(2) identification of person being certified Requirement.
(3) activities certified to perform
(4) basis of qualification
(a) education, experience, indoctrination, and 500 RECORDS
training Records of the implementation for indoctrination and
(b) test results, where applicable training may take the form of attendance sheets, training
(c) capability demonstration results logs, or personnel training records. Records of qualifica-
(5) results of periodic evaluation tion, including requalification, for Auditors and Lead
(6) results of physical examinations, when required Auditors and for inspection and test personnel shall be
(7) signature of employer’s designated representa- established and maintained by the employer and for
tive who is responsible for such certification indoctrination and training.
10
ASME NQA-1b–2007
REQUIREMENT 3
Design Control
100 BASIC Critical characteristics to be verified are those which

provide reasonable assurance that the item will perform
The design shall be defined, controlled, and verified.
its intended function. If a commercial grade item, prior
Design inputs shall be specified on a timely basis and
to its installation, is modified or selected by special
translated into design documents. Design interfaces
inspection and/or testing to requirements that are more
shall be identified and controlled. Design adequacy shall
restrictive than the Supplier ’s published product
be verified by individuals other than those who designed
description, the component part shall be represented as
the item or computer program. Design changes shall be
different from the commercial grade item in a manner
governed by control measures commensurate with those
traceable to a documented definition of the difference.
applied to the original design.
200 DESIGN INPUT 400 DESIGN ANALYSES

Applicable design inputs shall be identified and docu- Design analyses shall be sufficiently detailed such that
mented, and their selection reviewed and approved. The a person technically qualified in the subject can review
design input shall be specified to the level of detail and understand the analyses and verify the adequacy
necessary to permit the design activities to be carried of the results without recourse to the originator.
out in a correct manner and to provide a consistent
401 Use of Computer Programs
basis for making design decisions, accomplishing design
verification measures, and evaluating design changes. To the extent required in paras. 401(a) and (b) of this
Requirement, computer program acceptability shall be
preverified or the results verified with the design analy-
(04) 300 DESIGN PROCESS sis for each application. Preverified computer programs
(b07) (a) The responsible design organization shall pre- shall be controlled in accordance with the requirements
scribe and document the design activities to the level of this Standard.
of detail necessary to permit the design process to be (a) The computer program shall be verified to show
carried out in a correct manner, and to permit verifica- that it produces correct solutions for the encoded mathe-
tion that the design meets requirements. Design docu- matical model within defined limits for each parameter
ments shall support facility design, construction, and employed.
operation. Appropriate quality standards shall be identi- (b) The encoded mathematical model shall be shown
fied and documented, and their selection reviewed and to produce a valid solution to the physical problem asso-
approved. ciated with the particular application.
(b) The design methods, materials, parts, equipment,
402 Documentation of Design Analyses
and processes that are essential to the function of the
items shall be selected and reviewed for suitability of Documentation of design analyses shall include the
application. Applicable information derived from expe- following:
rience, as set forth in reports or other documentation, (a) the objective of the analyses
shall be made available to cognizant design personnel. (b) design inputs and their sources
(c) The final design shall (c) results of literature searches or other applicable
(1) be relatable to the design input by documenta- background data
tion in sufficient detail to permit design verification. (d) assumptions and indication of those assumptions
(2) specify required inspections and tests and that must be verified as the design proceeds
include or reference appropriate acceptance criteria. (e) identification of any computer calculation, includ-
(3) identify assemblies and/or components that are ing identification of the computer type, computer pro-
part of the item being designed. When such an assembly gram name, and revision, inputs, outputs, evidence of
or component part is a commercial grade item, the criti- or reference to computer program verification, and the
cal characteristics of the item to be verified for accept- bases (of reference thereto) supporting application of
ance and the acceptance criteria for those characteristics the computer program to the specific physical problem
shall be documented. (f) review and approval
11
500 DESIGN VERIFICATION by addressing, where applicable, paras. 501.1(a) through

(g) of this Requirement.
(04) (a) The responsible design organization shall identify (a) Were the design inputs correctly selected?
and document the particular design verification meth- (b) Are assumptions necessary to perform the design
od(s) used. The results of design verification shall be activity adequately described and reasonable? Where
documented with the identification of the verifier clearly necessary, are the assumptions identified for subsequent
indicated. Design verification shall be performed by any reverifications when the detailed design activities are
competent individual(s) or group(s) other than those completed?
who performed the original design but who may be (c) Were appropriate design methods and computer
from the same organization. This verification may be programs used?
performed by the originator’s supervisor, provided (d) Were the design inputs correctly incorporated into
(1) the supervisor did not specify a singular design the design?
approach or rule out certain design considerations and (e) Is the design output reasonable compared to
did not establish the design inputs used in the design; or design inputs?
(2) the supervisor is the only individual in the orga- (f) Are the necessary design inputs for interfacing
nization competent to perform the verification. organizations specified in the design documents or in
Cursory supervisory reviews do not satisfy the intent supporting procedures or instructions?
of this Standard. (g) Have suitable materials, parts, processes, and
(b) Design verification shall be performed prior to inspection and testing criteria been specified?
releasing the design for procurement, manufacture, con-
struction, or use by another design organization, except 501.2 Alternate Calculations. Alternate calculations
where this timing cannot be met, such as when insuffi- shall use alternate methods to verify correctness of the
cient data exist. In those cases, the unverified portion original calculations or analyses. The appropriateness
of the design shall be identified and controlled. In all of assumptions; input data used; and the computer pro-
cases the design verification shall be completed prior gram, its associated computer hardware and system
to relying upon the component, system, structure, or software, or other calculation method used shall also be
computer program to perform its function. reviewed.
(c) If the design is modified to resolve verification 501.3 Qualification Tests. Testing shall demonstrate (b07)
findings, the modified design shall be verified prior to adequacy of performance under conditions that simu-
release or use. late the most adverse design conditions. Operating
(d) Extent of Design Verification. The extent of the modes and environmental conditions shall be consid-
design verification shall be a function of the importance ered in determining the most adverse conditions. Where
to safety, the complexity of the design, the degree of the test is intended to verify only specific design fea-
standardization, the state of the art, and the similarity tures, the other features of the design shall be verified
with previously proved designs. Where the design has by other means. When tests are being performed on
been subjected to a verification process in accordance models or mockups, scaling laws shall be established
with this Part (Part I), the verification process need not and verified. The results of model test work shall be
be duplicated for identical designs. However, the appli- subject to error analysis, where applicable, prior to use
cability of standardized or previously proven designs, in the final design.
with respect to meeting pertinent design inputs, shall
be verified for each application. Known problems affect-
ing the standard or previously proved designs and their
600 CHANGE CONTROL
effects on other features shall be considered. The original (a) Changes to design inputs, final designs, field (b07)
design and associated verification documentation shall changes, and temporary and permanent modifications
be referenced in records of subsequent application of to operating facilities shall be justified and subject to
the design. design control measures commensurate with those
applied to the original design. These measures shall
501 Methods include evaluation of effects of those changes on the
Acceptable verification methods include, but are not overall design and on any analysis upon which the
limited to, any one or a combination of the following: design is based. The evaluation shall include facility
(a) design reviews configurations that occur during operation, mainte-
(b) alternate calculations nance, test, surveillance, and inspection activities.
(c) qualification testing Changes shall be approved by the same affected groups
or organizations that reviewed and approved the origi-
501.1 Design Reviews. Design reviews shall provide nal design documents. When the organization originally
assurance that the final design is correct and satisfactory responsible for review and approval of the orginal
12
PART I, REQUIREMENT 3 ASME NQA-1b–2007
design documents is no longer responsible, the owner 601.8 Approval by the design authority shall be
or his designee shall have responsibility or designate a required prior to implementation of a change to the
new responsible organization. The design organization design bases.
approving the change shall have demonstrated compe-
601.9 The configuration of the facility shall be docu-
tence in the specific design area of interest and have an
mented in drawings, specifications, procedures, and
adequate understanding of the requirements and intent
other documents that reflect the operational status of
of the original design.
the facility. The process used to control the current revi-
(b) When a design change is approved other than
sion and issuance of these documents shall take into
by revision to the affected design documents, measures
account the use of the document and the need for revi-
shall be established to incorporate the change into these
sion in support of operation.
documents, where such incorporation is appropriate.
(c) Where a significant design change is necessary
because of an incorrect design, the design process and 700 INTERFACE CONTROL (b07)
verification procedure shall be reviewed and modified Interface controls shall include assignment of respon-
as necessary. sibility and establishment of procedures among partici-
pating design organizations for review, approval,
601 Configuration Management of Operating release, distribution, and revision of documents involv-
Facilities ing design interfaces.
Design information transmitted across interfaces shall
Procedures implementing configuration management
identify the status of the design information or docu-
requirements shall be established and documented at the
ment provided, and identify incomplete items that
earliest practical time prior to facility operation. These
require further evaluation, review, or approval. Where
procedures shall include the responsibilities and author-
it is necessary to initially transmit design information
ity of the organizations whose functions affect the con-
orally or by other informal means, the transmittal shall
figuration of the facility including activities such as
be confirmed promptly by a controlled document.
operations, design, maintenance, construction, licens-
ing, and procurement.
800 SOFTWARE DESIGN CONTROL
601.1 Configuration management requirements
shall include measures to ensure changes that may affect The requirements of section 800 apply to computer
the approved configuration are recognized and pro- software design control and shall be used instead of
cessed. section 200, Design Input; section 300, Design Process;
section 500, Design Verification; and section 600, Change
601.2 The configuration shall be established and Control.
approved at the earliest practical time prior to initial
operation of the facility, and maintained for the life of 801 Software Design Process
the facility. The software design process shall be documented,
601.3 The configuration shall include, as applicable, approved by the responsible design organization, and
characteristics derived from regulatory requirements controlled. This process shall include the activities
and commitments, calculations and analyses, design described in paras. 801.1 through 801.5 of this
inputs, installation and test requirements, supplier man- Requirement.
uals and instructions, operating and maintenance 801.1 Identification of Software Design Require-
requirements, and other applicable sources. ments. Software design requirements shall be identified
601.4 Interface controls shall include the integration and documented and their selection reviewed and
of activities of organizations that can affect the approved approved. The software requirements shall identify the
configuration. operating system, function, interfaces, performance
requirements, installation considerations, design inputs,
601.5 Documentation shall identify the design bases
and any design constraints of the computer program.
and the approved configuration for the approved modes
of operation. 801.2 Software Design. The software design shall be
documented and shall define the computational
601.6 Measures shall be established and imple-
sequence necessary to meet the software requirements.
mented to ensure that proposed changes to the configu-
The documentation shall include, as applicable, numeri-
ration are evaluated for their conformance to the design
cal methods, mathematical models, physical models,
bases.
control flow, control logic, data flow, process flow, data
601.7 The implementation sequence for approved structures, process structures, and the applicable rela-
configuration changes shall be reviewed to determine tionships between data structures and process struc-
that the configuration conforms to the design bases. tures. This documentation may be combined with the
13
documentation of the software design requirements, or baseline. A baseline shall define the most recently
the computer program listings resulting from imple- approved software configuration.
mentation of the software design. A labeling system for configuration items shall be
implemented that
801.3 Implementation of the Software Design. The
software design shall be translated into computer pro- (a) uniquely identifies each configuration item
gram(s) using the programming organization’s or design (b) identifies changes to configuration items by
organization’s programming standards and conven- revision
tions. (c) provides the ability to uniquely identify each con-
figuration of the revised software available for use
(04) 801.4 Software Design Verification. Software design
verification shall be performed by a competent individu- 802.2 Configuration Change Control. Changes to soft-
al(s) or group(s) other than those who developed and ware shall be formally documented. The documentation
documented the original design, but who may be from shall include
the same organization. This verification may be per- (a) a description of the change
formed by the originator’s supervisor, provided (b) the rationale for the change
(a) the supervisor did not specify a singular design (c) the identification of affected software baselines
approach or rule out certain design considerations and The change shall be formally evaluated and approved
did not establish the design inputs used in the design, or by the organization responsible for the original design,
(b) the supervisor is the only individual in the organi- unless an alternate organization has been given the
zation competent to perform the verification. authority to approve the changes. Only authorized
Cursory supervisory reviews do not satisfy the intent changes shall be made to software baselines. Appro-
of this Standard. priate verification activities shall be performed for the
The results of verification shall be documented with change. The change shall be appropriately reflected in
the identification of the verifier indicated. Software veri- documentation, and traceability of the change to the
fication methods shall include any one or a combination software design requirement shall be maintained.
of design reviews, alternate calculations, and tests per- Appropriate acceptance testing shall be performed for
formed during computer program development. The the change.
extent of verification and the methods chosen are a func-
802.3 Configuration Status Control. The status of con-
tion of the complexity of the software, the degree of
figuration items resulting from software design shall be
standardization, the similarity with previously proved
maintained current. Configuration item changes shall be
software, and the importance to safety.
controlled until they are incorporated into the approved
801.5 Computer Program Testing. Computer program product baseline. The controls shall include a process
testing shall be performed and shall be in accordance for maintaining the status of changes that are proposed
with Requirement 11. and approved, but not implemented. The controls shall
also provide for notification of this information to
802 Software Configuration Management affected organizations.
Software configuration management includes, but is
not limited to: configuration identification, change con-
trol, and status control. Configuration items shall be 900 DOCUMENTATION AND RECORDS
maintained under configuration management until the
Design documentation and records shall include not
software is retired.
only final design documents, such as drawings and spec-
802.1 Configuration Identification. A software base- ifications, and revisions to those documents, but also
line shall be established at the completion of each activ- documentation that identifies the important steps in the
ity of the software design process. Approved changes design process, including sources of design inputs that
created subsequent to a baseline shall be added to the support the final design.
14
ASME NQA-1b–2007
REQUIREMENT 4
Procurement Document Control
100 BASIC 205 Documentation Requirements

Applicable design bases and other requirements nec- The procurement documents shall identify the docu-
essary to assure adequate quality shall be included or mentation required to be submitted for information,
referenced in documents for procurement of items and review, or approval by the Purchaser. The time of sub-
services. To the extent necessary, procurement docu- mittal shall also be established. When the Purchaser
ments shall require Suppliers to have a quality assurance requires the Supplier to maintain specific records, the
program consistent with the applicable requirements of retention times and disposition requirements shall be
this Standard. prescribed.
200 CONTENT OF THE PROCUREMENT 206 Nonconformances

DOCUMENTS The procurement documents shall specify the Pur-
Procurement documents issued at all tiers of procure- chaser’s requirements for the Supplier’s reporting of
ment shall include provisions for the following, as nonconformances.
deemed necessary by the Purchaser.
207 Spare and Replacement Parts
201 Scope of Work
Procurement documents shall include a statement of The procurement documents shall specify the Suppli-
the scope of the work to be performed by the Supplier. er ’s requirements to identify spare and replacement
parts or assemblies and the related data required for
202 Technical Requirements ordering these parts or assemblies.
Technical requirements shall be specified in the pro-
curement documents. These requirements shall be speci-
fied, as appropriate by reference to specific drawings, 300 PROCUREMENT DOCUMENT REVIEW
specifications, codes, standards, regulations, proce-
dures, or instructions, including revisions thereto that A review of the procurement documents, and changes
describe the items or services to be furnished. The pro- thereto, shall be made and documented prior to award
curement documents shall identify appropriate test, to assure that documents transmitted to prospective
inspection, and acceptance criteria for determining Supplier(s) include appropriate provisions to assure that
acceptability of the item or service. items or services will meet the specified requirements.
Technical or quality assurance program changes made
203 Quality Assurance Program Requirements as a result of bid evaluations or negotiations shall be
Quality assurance program requirements shall be incorporated into the procurement documents prior to
specified in the procurement documents. These require- their issuance to the Supplier.
ments shall be consistent with importance and/or com- Procurement document review shall be performed by
plexity of the item or service being procured. The personnel who have access to pertinent information and
procurement documents shall require the Supplier to who have an adequate understanding of the require-
incorporate appropriate quality assurance program ments and intent of the procurement documents.
requirements in subtier procurement documents.
204 Right of Access

400 PROCUREMENT DOCUMENT CHANGES
The procurement documents shall provide for access
to the Supplier’s and subtier Supplier’s facilities and Procurement document changes affecting the techni-
records for surveillance, inspection, or audit by the Pur- cal or quality assurance program requirements shall be
chaser, its designated representative, and others author- subject to the same degree of control as utilized in the
ized by the Purchaser. preparation of the original documents.
15
ASME NQA-1b–2007
REQUIREMENT 5
Instructions, Procedures, and Drawings
(b07) 100 BASIC activity shall be described to a level of detail commensu-

rate with the complexity of the activity and the need to
Activities affecting quality and services shall be pre- assure consistent and acceptable results. The need for,
scribed by and performed in accordance with docu- and level of detail in, written procedures or instructions
mented instructions, procedures, or drawings that shall be determined based upon complexity of the task,
include or reference appropriate quantitative or qualita- the significance of the item or activity, work environ-
tive acceptance criteria for determining that prescribed ment, and worker proficiency and capability (education,
activities have been satisfactorily accomplished. The training, experience).
16
ASME NQA-1b–2007
REQUIREMENT 6
Document Control
100 BASIC (e) a method to ensure the correct documents are

being used
The preparation, issue, and change of documents that
specify quality requirements or prescribe activities
affecting quality such as instructions, procedures, and 300 DOCUMENT CHANGES
drawings shall be controlled to ensure that correct docu- 301 Major Changes
ments are being employed. Such documents, including Changes to documents, other than those defined as
changes thereto, shall be reviewed for adequacy and minor changes, are considered major changes and shall
approved for release by authorized personnel. be reviewed and approved by the same organizations
that performed the original review and approval unless
other organizations are specifically designated. The
200 DOCUMENT CONTROL reviewing organization shall have access to pertinent
background data or information upon which to base
The following controls shall be applied to documents
their approval.
and changes thereto:
(a) the identification of controlled documents 302 Minor Changes
(b) the specified distribution of controlled documents Minor changes to documents, such as inconsequential
for use at the appropriate location editorial corrections, shall not require that the revised
(c) the identification of individuals responsible for the documents receive the same review and approval as the
preparation, review, approval, and distribution of con- original documents. To avoid a possible omission of a
trolled documents required review, the type of minor changes that do not
(d) the review of controlled documents for complete- require such a review and approval and the persons who
ness, and approval prior to distribution can authorize such a decision shall be clearly delineated.
17
ASME NQA-1b–2007
REQUIREMENT 7
Control of Purchased Items and Services
100 BASIC 500 ACCEPTANCE OF ITEM OR SERVICE

The procurement of items and services shall be con- 501 General (b07)
trolled to ensure conformance with specified require- Prior to offering the item or service for acceptance,
ments. Such control shall provide for the following as the Supplier shall verify that the item or service being
appropriate: source evaluation and selection, evaluation furnished complies with the procurement requirements.
of objective evidence of quality furnished by the Sup- The extent of the verification activities by the Purchaser
shall be a function of the relative importance, complex-
plier, source inspection, audit, and examination of items
ity, and quantity of the item or services procured and
or services upon delivery or completion.
the Supplier’s quality performance. Where required by
code, regulation, or contract requirement, documentary
200 SUPPLIER EVALUATION AND SELECTION evidence that items conform to procurement require-
ments shall be available at the nuclear facility site prior
Prior to award of a contract, the Purchaser shall evalu- to installation or use.
ate the Supplier’s capability to provide items or services
in accordance with the requirements of the procurement 502 Methods of Acceptance
documents. Supplier evaluation and selection and the Purchaser methods used to accept an item or service
results therefrom shall be documented and shall include from a Supplier shall be a Supplier Certificate of Confor-
one or more of the following: mance, source verification, receiving inspection, or post-
(a) Supplier’s history of providing an identical or sim- installation test at the nuclear facility site, or a
ilar product that performs satisfactorily in actual use. combination of these methods.
The Supplier’s history shall reflect current capability. 503 Certificate of Conformance
(b) Supplier’s current quality records supported by When a Certificate of Conformance is used, the mini-
documented qualitative and quantitative information mum criteria of paras. 503(a) through (f) of this Require-
that can be objectively evaluated. ment shall be met.
(c) Supplier ’s technical and quality capability as (a) The certificate shall identify the purchased mate-
determined by a direct evaluation of the facilities, per- rial or equipment, such as by the purchase order number.
sonnel, and the implementation of the Supplier’s quality (b) The certificate shall identify the specific procure-
assurance program. ment requirements met by the purchased material or
equipment, such as codes, standards, and other specifi-
cations. This may be accomplished by including a list
300 BID EVALUATION of the specific requirements or by providing, on-site, a
If bids are solicited, the bid evaluation shall include copy of the purchase order and the procurement specifi-
a determination of the Supplier’s capability to conform cations or drawings, together with a suitable certificate.
to the technical and quality assurance requirements. The procurement requirements identified shall include
any approved changes, waivers, or deviations applicable
Prior to the award of the contract, the Purchaser shall
to the subject material or equipment.
resolve or obtain commitments to resolve unacceptable
(c) The certificate shall identify any procurement
technical and quality assurance conditions resulting
requirements that have not been met, together with an
from the bid evaluation. explanation and the means for resolving the noncon-
formances.
400 CONTROL OF SUPPLIER-GENERATED (d) The certificate shall be signed or otherwise
DOCUMENTS authenticated by a person who is responsible for this
quality assurance function and whose function and posi-
Controls shall be implemented to ensure that the sub- tion are described in the Purchaser’s or Supplier’s qual-
mittal and evaluation of Supplier-generated documents ity assurance program.
are accomplished in accordance with the procurement (e) The certification system, including the procedures
document requirements. These controls shall provide for to be followed in filling out a certificate and the adminis-
the acquisition, processing, and recorded evaluation of trative procedures for review and approval of the certifi-
the quality assurance, technical, inspection, and test doc- cates, shall be described in the Purchaser’s or Supplier’s
umentation or data against acceptance criteria. quality assurance program.
18
ASME NQA-1b–2007
REQUIREMENT 9
Control of Special Processes
100 BASIC 203 Special Requirements

Special processes that control or verify quality, such as For special processes not covered by existing codes
those used in welding, heat treating, and nondestructive and standards or where quality requirements specified
examination, shall be performed by qualified personnel exceed those of existing codes or standards, the neces-
using qualified procedures in accordance with specified sary requirements for qualifications of personnel, proce-
requirements. dures, or equipment shall be specified or referenced in
procedures or instructions.
200 PROCESS CONTROL
201 Special Processes
Special processes shall be controlled by instructions,
procedures, drawings, checklists, travelers, or other 300 RESPONSIBILITY
appropriate means. Special process instructions shall
include or reference procedure, personnel, and equip- It is the responsibility of the organization performing
ment qualification requirements. Conditions necessary the special process to adhere to the approved procedures
for accomplishment of the process shall be included. and processes.
These conditions shall include proper equipment, con-
trolled parameters of the process, specified environment,
and calibration requirements.
400 RECORDS
202 Acceptance Criteria
The requirements of applicable codes and standards, Records shall be maintained as appropriate for the
including acceptance criteria for the process, shall be currently qualified personnel, processes, and equipment
specified or referenced in procedures or instructions. of each special process.
23
ASME NQA-1b–2007
(b07)
REQUIREMENT 10
Inspection
100 BASIC qualified personnel or qualified automated means. Both

inspection and process monitoring shall be provided
Inspections required to verify conformance of an item
when control is inadequate without both.
or activity to specified requirements or continued
acceptability of items in service shall be planned and
executed. Characteristics subject to inspection and 600 FINAL INSPECTIONS
inspection methods shall be specified. Inspection results
shall be documented. Inspection for acceptance shall be 601 Resolution of Nonconformances
performed by qualified persons other than those who Final inspections shall include a records review of the
performed or directly supervised the work being results and resolution of nonconformances identified by
inspected. prior inspections.
602 Inspection Requirements

200 INSPECTION REQUIREMENTS
Completed items shall be inspected for completeness,
Inspection requirements and acceptance criteria shall markings, calibration, adjustments, protection from
include specified requirements contained in the applica- damage, or other characteristics as required to verify
ble design documents or other pertinent technical docu- the quality and conformance of the item to specified
ments approved by the responsible design organization. requirements.
300 INSPECTION HOLD POINTS 603 Modifications, Repairs, or Replacements

Any modifications, repairs, or replacements of items
If mandatory inspection hold points are required
performed subsequent to final inspection shall require
beyond which work shall not proceed without the spe-
reinspection or retest, as appropriate, to verify accept-
cific consent of the designated representative, the spe-
ability.
cific hold points shall be indicated in appropriate
documents. Consent to waive specified hold points shall 604 Acceptance
be recorded prior to continuation of work beyond the
designated hold point. The acceptance of the item shall be approved by
authorized personnel.
400 INSPECTION PLANNING

700 INSPECTIONS DURING OPERATIONS
401 Planning
Periodic inspections (e.g., in-service inspections) or
Characteristics to be inspected, methods of inspection,
surveillances of structures, systems, or components shall
and acceptance criteria shall be identified during the
be planned and executed to assure the continued per-
inspection planning process.
formance of their required functions.
402 Sampling
Sampling procedures, when used, shall be based upon 800 RECORDS
valid statistical methods.
Appropriate records shall be established, maintained,
and, as a minimum, identify the following:
500 IN-PROCESS INSPECTION (a) item inspected
Inspection of items under construction or otherwise (b) date of inspection
in process shall be performed as necessary to verify (c) inspector
quality. If inspection of processed items is impossible (d) type of observation
or disadvantageous, indirect control by monitoring of (e) results or acceptability
processing methods, equipment, and personnel shall be (f) reference to information on action taken in connec-
provided. Process monitoring shall be performed by tion with nonconformances
24
ASME NQA-1b–2007
REQUIREMENT 11
Test Control
100 BASIC (1) calibrated instrumentation

Tests required to collect data such as for siting or (2) appropriate equipment
design input, to verify conformance of an item or com- (3) trained personnel
puter program to specified requirements, or to demon- (4) condition of test equipment and the item to be
strate satisfactory performance for service shall be tested
planned and executed. Characteristics to be tested and (5) suitable environmental conditions
test methods to be employed shall be specified. Test (6) provisions for data acquisition
results shall be documented and their conformance with
(b) As an alternative to para. 300(a) of this Require-
test requirements and acceptance criteria shall be eval-
ment, appropriate sections of related documents, such
uated.
as ASTM methods, Supplier manuals, equipment main-
tenance instructions, or approved drawings or travelers
200 TEST REQUIREMENTS with acceptance criteria, can be used.
(a) Test requirements and acceptance criteria shall be

provided or approved by the responsible design organi-
zation. Required tests, including, as appropriate, proto-
400 COMPUTER PROGRAM TEST PROCEDURES
type qualification tests, production tests, proof tests The requirements of section 400 of Requirement 11
prior to installation, construction tests, preoperational
apply, instead of section 300, Test Procedures, to testing
tests, operational tests, and computer program tests
of computer programs, and as appropriate, the com-
such as software design verification, factory acceptance
puter hardware and operating system.
tests, site acceptance tests, and in-use tests shall be con-
trolled. Required tests shall be controlled under appro- (a) Computer program test procedures shall provide
priate environmental conditions using the tools and for demonstrating the adherence of the computer pro-
equipment necessary to conduct the test in a manner to gram to documented requirements. For those computer
fulfill test requirements and acceptance criteria. The tests programs used in design activities, computer program
performed shall obtain the necessary data with sufficient test procedures shall provide for assuring that the com-
accuracy for evaluation and acceptance. puter program produces correct results. For those com-
(b) Test requirements and acceptance criteria shall be puter programs used for operational control, computer
based upon specified requirements contained in applica- program test procedures shall provide for demonstra-
ble design documents, or other pertinent technical docu- ting required performance over the range of operation
ments that provide approved requirements. of the controlled function or process. The procedures
(c) If temporary changes to the approved configura- shall also provide for evaluating technical adequacy
tion of a facility are required for testing purposes, through comparison of test results from alternative
approval by the design authority is required prior to methods such as hand calculations, calculations using
performing the test. comparable proven programs, or empirical data and
information from technical literature.
(b) In-use test procedures shall be developed and doc-
300 TEST PROCEDURES (OTHER THAN FOR
umented to permit confirmation of acceptable perform-
COMPUTER PROGRAMS)
ance of the computer program in the operating system.
(a) Test procedures shall include or reference the test In-use test procedures shall be performed after the com-
configuration and test objectives. Test procedures shall puter program is installed on a different computer, or
also include provisions for assuring that prerequisites when there are significant changes in the operating sys-
and suitable environmental conditions are met, ade- tem. Periodic in-use manual or automatic self-check in-
quate instrumentation is available and used, appropriate use tests shall be prescribed and performed for those
tests and equipment are used, and necessary monitoring computer programs in which computer program errors,
is performed. Prerequisites shall include the following, data errors, computer hardware failures, or instrument
as applicable: drift can affect required performance.
25
500 TEST RESULTS (f) action taken in connection with any deviations
(g) person evaluating test results
Test results shall be documented and evaluated by a
responsible authority to ensure that test requirements 602 Computer Program Test Records
have been satisfied. Test results for design qualification
(a) Verification Test Records
tests and software design verification shall be evaluated
(1) computer program tested
by the responsible design organization.
(2) computer hardware tested
(3) test equipment and calibrations, where appli-
(b07) 600 TEST RECORDS cable
(4) date of test
Test records shall be established and maintained to (5) tester or data recorder
indicate the ability of the item or computer program to
(6) simulation models used, where applicable
satisfactorily perform its intended function or to meet
(7) test problems
its documented requirements. Test records vary
(8) results and applicability
depending on the test type, purpose, and application,
(9) action taken in connection with any deviations
but shall contain the following information, as a mini-
noted
mum, for the specified application identified in paras.
(10) person evaluating test results
601 and 602.
(b) In-Use Test Records
601 Test Records (1) computer program tested
(2) computer hardware tested
(a) item tested (3) test equipment and calibrations, where appli-
(b) date of test cable
(c) tester or data recorder (4) date of test
(d) type of observation (5) tester or data recorder
(e) results and acceptability (6) acceptability
26
ASME NQA-1b-2007
REQUIREMENT 14
Inspection, Test, and Operating Status
100 BASIC as physical location and tags, markings, shop travelers,

The status of inspection and test activities shall be stamps, inspection records, or other suitable means. The
identified either on the items or in documents traceable authority for application and removal of tags, markings,
to the items where it is necessary to ensure that required labels, and stamps shall be specified. Status indicators
inspections and tests are performed and to ensure that shall also provide for indicating the operating status of
items which have not passed the required inspections systems and components of the nuclear facility, such as
and tests are not inadvertently installed, used, or oper- by tagging valves and switches, to prevent inadvertent
ated. Status shall be maintained through indicators, such operation.
29
ASME NQA-1b-2007
REQUIREMENT 15
Control of Nonconforming Items
100 BASIC 402 Responsibility and Authority

Items that do not conform to specified requirements The responsibility and authority for the evaluation
shall be controlled to prevent inadvertent installation or and disposition of nonconforming items shall be
use. Controls shall provide for identification, documen- defined. Responsibility for the control of further pro-
tation, evaluation, segregation when practical, and dis- cessing, delivery, installation, or use of nonconforming
position of nonconforming items, and for notification items shall be designated in writing.
to affected organizations.
403 Personnel
Personnel performing evaluations to determine a dis-
200 IDENTIFICATION position shall have
Nonconforming items shall be identified by legible (a) demonstrated competence in the specific area they
marking, tagging, or other methods not detrimental to are evaluating
the item, on either the item, the container, or the package (b) an adequate understanding of the requirements
containing the item. (c) access to pertinent background information
404 Disposition
300 SEGREGATION A disposition, such as use-as-is, reject, repair, or
rework of nonconforming items shall be made and docu-
(a) Nonconforming items shall be segregated, when
mented. Technical justification for the acceptability of a
practical, by placing them in a clearly identified and
nonconforming item dispositioned repair or use-as-is
designated hold area until properly dispositioned.
shall be documented. Nonconformances to design
(b) When segregation is impractical or impossible due
requirements dispositioned use-as-is or repair shall be
to physical conditions such as size, weight, or access
subject to design control measures commensurate with
limitations, other precautions shall be employed to pre-
those applied to the original design. Required as-built
clude inadvertent use of a nonconforming item.
records shall reflect the use-as-is or repair condition.
400 DISPOSITION 405 Reexamination (a05)

Reworked items shall be reexamined in accordance (b07)
401 Control with applicable procedures and with the original accept-
Nonconforming items shall be evaluated and recom- ance criteria.
mended dispositions shall be proposed. Further pro- Repaired items shall be reexamined in accordance
cessing, delivery, installation, or use of a nonconforming with applicable procedures and with the original accept-
item shall be controlled pending the evaluation and an ance criteria unless the disposition has established alter-
approved disposition by authorized personnel. nate acceptance criteria.
30
ASME NQA-1b-2007
REQUIREMENT 16
Corrective Action
100 BASIC action taken to preclude recurrence. The identification,

Conditions adverse to quality shall be identified cause, and corrective action for significant conditions
promptly and corrected as soon as practicable. In the adverse to quality shall be documented and reported
case of a significant condition adverse to quality, the to appropriate levels of management. Completion of
cause of the condition shall be determined and corrective corrective actions shall be verified.
31
ASME NQA-1b-2007
(b07) REQUIREMENT 17
Quality Assurance Records
100 BASIC 401 Lifetime Records

The control of quality assurance records shall be con- 401.1 Lifetime records are those that meet one or
sistently established with the schedule for accomplish- more of the following criteria:
ing work activities. Quality assurance records shall (a) those that would be of significant value in demon-
furnish documentary evidence that items or activities strating capability for safe operation
meet specified quality requirements. Quality assurance (b) those that would be of significant value in main-
records shall be identified, generated, authenticated, and taining, reworking, repairing, replacing, or modifying
maintained, and their final disposition specified. Record an item
control requirements and responsibilities for these activ- (c) those that would be of significant value in
ities shall be documented. The term records, used determining the cause of an accident or malfunction of
throughout this section, is to be interpreted as quality an item
assurance records. (d) those that provide required baseline data for in-
service inspections
200 GENERATION OF RECORDS 401.2 Lifetime records are required to be maintained

by or for the Owner for the life of the particular item
(a) Records shall be legible. while it is installed in the plant or stored for future use.
(b) Records shall be traceable to associated items and
activities and accurately reflect the work accomplished
402 Nonpermanent Records
or information required. Nonpermanent records are those required to show
(c) Records to be generated, supplied, or maintained evidence that an activity was performed in accordance
shall be specified in applicable documents, such as with the applicable requirements but need not be
design specifications, procurement documents, test pro- retained for the life of the item because they do not meet
cedures, and operational procedures. the criteria for lifetime records. Nonpermanent records
shall be maintained for the identified retention period.
300 AUTHENTICATION OF RECORDS

500 RECEIPT CONTROL OF RECORDS
(a) Documents shall be considered valid records only Each organization responsible for the receipt of rec-
if stamped, initialed, or signed and dated by authorized ords shall designate a person or organization responsible
personnel or otherwise authenticated. Corrections to for receiving the records. The designee shall be responsi-
documents shall be reviewed and approved by the ble for organizing and implementing receipt controls for
responsible individual from the originating or author- permanent and temporary storage. Receipt controls shall
ized organization. provide a method for identifying the records received,
(b) Electronic documents shall be authenticated with receipt and inspection of incoming records, and sub-
comparable information as in para. 300(a), as appro- mittal of records to storage.
priate:
(1) with identification on the media; or
600 STORAGE
(2) with authentication information contained
within or linked to the document itself. 601 General
(a) Records shall be stored at a predetermined loca-
tion(s) in facilities, containers, or a combination thereof,
400 CLASSIFICATION
constructed and maintained in a manner that minimizes
Records shall be classified as lifetime or nonpermanent the risk of loss, damage, or destruction from
and maintained by the Owner, or authorized agent, in (1) natural disasters such as winds, floods, or fires
accordance with the criteria given in paras. 401 and (2) environmental conditions such as high and low
402 of this Requirement and consistent with applicable temperatures and humidity
regulatory requirements. (3) infestation of insects, mold, or rodents
32
PART I, REQUIREMENT 17 ASME NQA-1b-2007
(4) dust or airborne particles or container shall provide a one-hour fire rating, unless
(b) Activities deterimental to the records shall be pro- dual storage requirements of para. 602.2 are met.
hibited in the storage area.
(c) Access to the processing, storage, and retrieval of
700 RETENTION
records shall be limited to authorized personnel.
(d) Provisions shall be made to prevent damage from (a) Record retention periods shall be documented.
harmful conditions (such as excessive light, stacking, (b) Records shall be maintained for their retention
electromagnetic fields, temperature, and humidity), as periods.
applicable to the specific media utilized for record
storage.
800 MAINTENANCE OF RECORDS
602 Facility Types
There are two equally satisfactory methods of provid- (a) Records shall be protected from damage or loss.
ing storage, single or dual. (b) Record controls shall provide for retrievability
within planned retrieval times based upon the record
602.1 Single storage consists of a storage facility, type or content.
vault, room, or container(s) with a minimum two-hour (c) The methods for record changes shall be docu-
fire rating. The design and construction of a single stor- mented.
age facility, vault room, or container shall be reviewed (d) Provisions shall be established to ensure that no
for adequacy by a person competent in fire protection unacceptable degradation of the electronic record media
or contain a certification or rating from an accredited occurs during the established retention period.
organization. (e) Provisions shall be made to ensure that the records
602.2 Dual facilities, containers, or a combination remain retrievable after hardware, software, or technol-
thereof shall be at locations sufficiently remote from each ogy changes.
other to eliminate the chance exposure to a simultaneous (f) Provisions shall be established to ensure the fol-
hazard. Facilities used for dual storage are not required lowing when records are duplicated or transferred to
to satisfy the requirements of para. 602.1, but shall meet the same media or to a different media for the purposes
the requirements of para. 601. of maintenance or storage:
(1) duplication or transfer is appropriately
603 Temporary Storage authorized
When temporary storage of records (such as for pro- (2) record content, legibility, and retrievability are
cessing, review, or use) is required, the storage facility maintained
33
ASME NQA-1b-2007
REQUIREMENT 18
Audits
100 BASIC 400 PERFORMANCE

Audits shall be performed to verify that performance Elements selected for audit shall be evaluated against
criteria are met and to determine the effectiveness of the specified requirements. Objective evidence shall be
program. These audits shall be performed in accordance examined to the depth necessary to determine if these
with written procedures or checklists by personnel who elements are being implemented effectively. Conditions
do not have direct responsibility for performing the requiring prompt corrective action shall be reported
activities being audited. Audit results shall be docu- immediately to management of the audited organi-
mented and reported to and reviewed by responsible zation.
management. Follow-up action shall be taken where
indicated.
500 REPORTING
200 SCHEDULING The audit report shall be signed or otherwise endorsed
by the Lead Auditor and issued to the audited organiza-
Audits shall be scheduled in a manner to provide
tion. The contents of the report shall
coverage and coordination with ongoing activities,
based on the status and importance of the activity. (a) describe the audit scope
Scheduled audits shall be supplemented by additional (b) identify Auditors and persons contacted
audits of specific subjects when necessary to provide (c) summarize audit results, including a statement on
adequate coverage. the effectiveness of the elements audited
(d) describe each reported adverse audit finding
300 PREPARATION
301 Audit Plan 600 RESPONSE
The auditing organization shall develop an audit plan Management of the audited organization or activity
for each audit. This plan shall identify the audit scope, shall investigate adverse audit findings, schedule correc-
requirements, audit personnel, activities to be audited, tive action, including measures to prevent recurrence of
organizations to be notified, applicable documents, significant conditions adverse to quality, and notify the
schedule, and written procedures or checklists. appropriate organization in writing of action taken or
planned. Audit responses shall be evaluated by or for
302 Personnel the auditing organization.
Audit personnel shall have sufficient authority and
organizational freedom to make the audit process mean-
ingful and effective. 700 FOLLOW-UP ACTION
(b07) 303 Selection of Audit Team Follow-up action shall be taken to verify that correc-
tive action is accomplished as scheduled.
An audit team shall be identified prior to the begin-
ning of each audit. This team shall contain one or more
Auditors, one being designated Lead Auditor who orga- 800 RECORDS
nizes and directs the audit. The audit team shall have
experience or training commensurate with the scope, Audit records shall include audit plans, audit reports,
complexity, or special nature of the activities to be written replies, and the record of completion of correc-
audited. tive action.
34
ASME NQA-1b-2007
900 Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
Subpart 2.16 Requirements for the Calibration and Control of Measuring and Test
Equipment Used in Nuclear Facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
Subpart 2.18 Quality Assurance Requirements for Maintenance of Nuclear
Facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
100 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
200 General Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
300 Preventive Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
400 Corrective Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
500 Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
Subpart 2.20 Quality Assurance Requirements for Subsurface Investigations for Nuclear
Power Plants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
100 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
200 General Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
300 Verification Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
400 Field Investigation Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
500 Laboratory Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
600 Evaluation and Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
700 Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
(b07)
37
ASME NQA-1b-2007
PART II
INTRODUCTION
100 PURPOSE required to comply with the requirements of the defined

Part II supplements the quality assurance require- work scope.
ments of Part I for the planning and execution of identi- Planning for activities such as fabrication, installation,
fied tasks during siting, design, construction, operation, operation, modification, repair, maintenance, decom-
and decomissioning of nuclear facilities. Applicable non- missioning, inspection, testing, and software verifica-
mandatory guidance for various subparts is provided tion and validation shall include a review of structure,
in Part III. system or component design and procurement specifica-
tions, materials lists, drawings, construction work plans,
and schedules to ensure that appropriate activities have
200 APPLICABILITY been incorporated; that the work can be accomplished
An appropriate quality assurance program, based on as specified; and that time and resources, plus training,
the nature and scope of the work to be performed and are sufficient to accomplish the work in accordance with
the relative importance of the items or services, shall be the specified requirements.
specified in contractual documents by selective applica- Planning shall define the operations to be performed,
tions of portions of Part I for programmatic activities the systematic sequential progression of operations, and
and of this Part for work-oriented activities. The require- the overall measures to be employed to preserve the
ments of this Part (Part II) apply to siting, design, con- quality of the work.
struction, operation, and decommissioning activities
that affect the quality of structures, systems, and compo- 402 Procedures
nents for nuclear facilities. These activities include the
Procedures and work instructions identified during
performing function of attaining quality objectives and
planning shall be prepared. Preparation and approval
verifying that activities affecting quality have been cor-
of the procedures/instructions shall be in advance of
rectly performed. These activities include planning, sit-
ing investigation, designing, procuring, fabricating, the need to use the documents. The documents shall be
handling, shipping, storing, cleaning, erecting, install- kept current and revised as necessary to assure that
ing, inspecting, testing, operating, maintaining, the work is performed in accordance with the latest
repairing, modifying, and decommissioning. To the approved information.
extent applicable to the activities being performed, the The documents shall include the following as appli-
application of this Part, or portions thereof, and the cable:
provisions of Part I shall be specified in written contracts, (a) personnel safety and structure or facility protec-
policies, procedures, or instructions. tion considerations
(b) precautions to be observed
300 RESPONSIBILITY (c) work requirements such as those included in speci-
fications, procedures, and instructions for performing
The organization invoking this Part shall be responsi-
an activity
ble for specifying which section, or portions thereof,
(d) sequence of activities to be followed and steps
apply and appropriately relating them to specific items
within a given activity
and services. To the extent necessary, this organization
(e) prerequisites
shall invoke the applicable provision of Part I to specify
(f ) software verification and validation, test and
a complete quality assurance program appropriate for
inspection objectives
the specific items or services.
(g) special equipment required
The organization upon which this Part, or portions
thereof, is invoked shall be responsible for complying (h) identification of inspection and test equipment
with the specified requirements. and related calibration requirements including recali-
bration dates
(i) sequence and frequency of activities for verifying
400 PLANNING AND PROCEDURES
(j) acceptance criteria and methods for verifying
401 Planning (k) responsibility and required qualifications of per-
A plan shall be developed outlining the work to be sonnel
performed and the work procedures or instructions (l) approvals and authorizing or verifying signatures
38
PART II, SUBPART 2.20 ASME NQA-1b-2007
of Part I. This organization shall be responsible for fur- loading responses, and the structural foundations for
nishing the necessary resources such as personnel, the facilities at the site
equipment, documented procedures and instructions,
603 Report of Evaluation and Analysis
and other services necessary to implement the require-
ments of the quality assurance program. A report of the analysis and evaluation of the founda-
tion aspects of the site shall be presented along with the
602 Analysis of Subsurface Conditions basic data supporting all conclusions and recommenda-
tions. Sufficient information shall be provided to allow
Procedures shall be established to develop a general- for independent analyses and evaluations for design
ized model of the subsurface conditions at the site for verification consistent with Part I.
use in performing various engineering design analyses
and evaluations. The development of the subsurface 700 RECORDS
model shall include, but not be limited to, consideration
and assessment of the following areas: Record copies of procedures; program or design plans;
qualified investigation procedures; procurement control
(a) the basic seismic, geologic, and hydrologic fea-
records; measuring and test equipment control and cali-
tures in the vicinity of the site
bration records; work instructions and orders; field and
(b) the specific soil, rock, and groundwater conditions laboratory logs and test data; test deviations or excep-
encountered at the site tion records; results of engineering analyses and evalua-
(c) the static and dynamic engineering properties and tions; checks, verifications, and examination records;
loading responses of the materials and strata underlying reports; and other specified documents shall be pre-
the site pared. These records shall be retained with other project
(d) the interrelationship of the above geophysical fea- records as required by code, standard, specification, or
tures, subsurface conditions, engineering properties, project procedures.
107
ASME NQA-1b-2007
(b07) SUBPART 2.21

Quality Assurance Guidelines for Decommissioning
Nuclear Facilities
Subpart 2.21 has been moved to Part III and redesignated as Nonmandatory Appendix 2.21.
108–112
ASME NQA-1b–2007
PART III: NONMANDATORY APPENDICES

(FROM FORMER NQA-1 AND NQA-2)
CONTENTS
(a05) Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114.1

100 Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114.1
200 Applicability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114.1
Subpart 3.1 Nonmandatory Guidance on Quality Assurance Programs for Nuclear
Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
Nonmandatory Appendices
1A-1 Guidance on Organization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116
2A-1 Guidance on the Qualifications of Inspection and Test Personnel . . . . . . . . . . 117
2A-2 Guidance on Quality Assurance Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
2A-3 Guidance on the Education and Experience of Lead Auditors . . . . . . . . . . . . . 122
2A-4 Guidance on Surveillance for Use in Assessment of Processes and
Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124
3A-1 Guidance on Design Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127
4A-1 Guidance on Procurement Document Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131
7A-1 Guidance on Control of Purchased Items and Services . . . . . . . . . . . . . . . . . . . . 136
7A-2 Guidance on Commercial Grade Items and Services . . . . . . . . . . . . . . . . . . . . . . 139
10A-1 Guidance on Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
11A-1 Guidance on Test Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144
16A-1 Guidance on Corrective Action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
17A-1 Guidance on Quality Assurance Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148
(a05) 17A-2 Guidance for Electronic Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151.1
18A-1 Guidance on Audits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152
Figures
2A-3.1 Sample Form for Record of Lead Auditor Qualification . . . . . . . . . . . . . . . . . . . 123
4A-1.1 Logic Chart for Determining Appropriate Quality Requirements . . . . . . . . . . 134
16A-1.1 Corrective Action Flow Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
Subpart 3.2 Nonmandatory Guidance on Quality Assurance Programs for Nuclear Facility
Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
Nonmandatory Appendices
2.1 Guidance on Cleaning of Fluid Systems and Associated Components
for Nuclear Power Plants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156
2.15 Recommendations for Hoisting, Rigging, and Transporting of Items for
Nuclear Power Plants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157
2.17 Guidelines for Transition From Construction to Operation for Nuclear
Facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158
2.18A Guidance on Establishing and Maintaining Equipment Histories . . . . . . . . . . 161
2.18B Guidance on Performing Engineering Evaluations of Equipment
Failures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162
113
ASME NQA-1b–2007
2.20 Guidance on the Quality Assurance Requirements for Identification and

Control of Samples Obtained for Subsurface Investigations of Nuclear
Power Plants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164
(b07) 2.21 Quality Assurance Guidelines for Decommissioning Nuclear Facilities . . . . . 164.1
Subpart 3.3 Nonmandatory Guidance on Quality Assurance Program Requirements for
Collection of Scientific and Technical Information for Site
Characterization of High-Level Nuclear Waste Repositories . . . . . . . . . . . . . . . . 165
(a05) Nonmandatory Appendices
3.1 Guidance on Qualification of Existing Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166
3.2 Guidance on the Control of Scientific Investigations . . . . . . . . . . . . . . . . . . . . . . 168
114
ASME NQA-1b–2007
SUBPART 3.1
Nonmandatory Guidance on Quality Assurance Programs
for Nuclear Applications
(Formerly Nonmandatory Appendices to NQA-1)
The following Appendices provide nonmandatory

guidance that may be used in conjunction with the appli-
cable Requirements of Part I.
115
ASME NQA-1b–2007
NONMANDATORY APPENDIX 1A-1

Guidance on Organization
100 GENERAL (b) characteristics to be verified and acceptance cri-

teria
This Appendix provides nonmandatory guidance on
(c) actions to resolve quality problems
organization as specified in Requirement 1 of Part I.
(d) determination of the validity and disposition of
nonconforming items and services
200 ORGANIZATIONAL STRUCTURE
302 Quality Achievement Functions
In structuring the organization and assigning respon- Those performing quality achievement functions
sibility, quality assurance should be recognized as an should have
interdisciplinary function involving many organiza-
(a) means or information, or both, to monitor or check
tional components and, therefore, should not be
the quality of their work
regarded as the sole domain of a single quality assurance
(b) authority and responsibility to identify and control
group. The quality assurance group (or groups), how-
defective work products
ever, should be designated to describe, integrate, and
(c) responsibility to correct quality problems in their
monitor the agreed-upon quality assurance activities of
area of responsibility, whether self-identified or reported
the various disciplines and functions.
to them by others
Quality assurance encompasses many functions and
(d) freedom to provide or recommend solutions to
extends to various levels in all participating organiza-
quality problems outside their area of responsibility
tions, from the top executive to workers, such as design-
ers, computer programmers, welders, inspectors, facility 303 Quality Verification Functions (b07)
operators, craftsmen, and Auditors, who perform activi-
Verification of quality achievement includes assuring
ties affecting quality.
that an appropriate quality assurance program has been
Different organizational structures may be effective,
established and verifying that activities have been cor-
depending on the portion of the project or job in which
rectly performed.
the implementing organization is involved.
The authority of those performing quality verification
functions should include freedom to
300 BASIC PRINCIPLES (a) identify quality problems
(b) recommend solutions to quality problems
301 Management Functions (c) verify implementation of solutions
Designated management should have the authority (d) ensure that further processing, delivery, installa-
and responsibility to identify or approve tion, or use is controlled until proper disposition of a
(a) quality assurance program scope and appropriate nonconformance, deficiency, or unsatisfactory condition
quality levels has occurred
116
ASME NQA-1b–2007
NONMANDATORY APPENDIX 3A-1 (b07)
Guidance on Design Control
100 GENERAL (1) ASME Codes and Standards

(2) ACI, AISC, ANSI, ASNT, ASTM, AWS, IEEE,
ISO, NFPA, and others by similar societies or organiza-
design control as specified in Requirement 3 of Part I.
tions
Some factors to be considered in establishing the
(e) design conditions such as pressure, temperature,
design control measures may include the following:
flow, fluid chemistry, and voltage
(a) nature of the organization, such as the facility
(f) loads such as seismic, wind, thermal, and dynamic;
Owner(s), major equipment designer(s) or facility
the cumulative effect of design changes on the analytical
designer, and the design interfaces among them
design basis, e.g., the addition of a load to an existing
(b) importance of design activity to safety
wall or the addition of an instrument to a cabinet
(c) state of the art such as experimental, develop-
(g) environmental conditions anticipated during stor-
mental, or standard design
age, construction, operation, and accident conditions,
(d) nature of design activity, such as conceptual, pre-
such as pressure, temperature, humidity, corrosiveness,
liminary, detailed design, field engineering, or modifica-
site elevation, wind direction, exposure to weather,
tions to operating facilities
flooding, nuclear radiation, electromagnetic radiation,
(e) nature of interaction between design, operation, and duration of exposure; qualification test require-
and construction activities ments; shelf or service life limitations
(f) the effect of design change implementation on the (h) interface requirements including definition of the
safe operation of the facility functional and physical interfaces involving structures,
systems, and components:
200 DESIGN INPUT (1) the effect on existing plant equipment capability,
such as DC battery loads, AC bus capacity, available
Design inputs include many characteristics and func- stored water inventory, service instrument air capacity,
tions of an item or system. These inputs vary depending water systems capability (intake, service, and compo-
on the application; however, the nuclear industry has nent cooling water), and HVAC capability
found it desirable to consider at least the following listed (2) the effect of cumulative tolerances in the design
inputs as they apply to specific items or systems: (3) the effect on design and safety analyses to
(a) basic functions of each structure, system, and com- ensure the analytical bases remain valid
ponent (4) the compatibility with unimplemented design
(b) performance requirements such as capacity, rat- changes to specify any required sequence for implemen-
ing, and system output tation
(c) regulatory requirements, and commitments or (5) compatibility with technical specification
responses to federal, state, and local regulations. For requirements
example, these may include, but are not limited to (i) material requirements including such items as
(1) safety analysis report compatibility, electrical insulation properties, protective
(2) NRC’s Safety Evaluation Report and supple- coating, and corrosion resistance
ments thereto (j) mechanical requirements such as vibration, stress,
(3) environmental report shock, and reaction forces
(4) NRC’s environmental statement and supple- (k) structural requirements covering such items as
ments thereto equipment foundations and pipe supports
(5) technical specifications (l) hydraulic requirements such as pump net positive
(6) regulatory guides suction heads (NPSH), allowable pressure drops, and
(7) code of federal regulations allowable fluid velocities
(8) NRC bulletins, circulars, notices, and generic (m) chemistry requirements including provisions for
letters system flushing, batch sampling, and in-line sampling;
(9) commitments in correspondence with NRC power plant water chemistry treatment for primary sys-
(d) codes and standards. For example, these may tems, steam generator, and plant limitations on water
include, but are not limited to chemistry
127
ASME NQA-1b–2007 PART III, NONMANDATORY APPENDIX 3A-1
(n) electrical requirements such as source of power, (z) handling, storage, cleaning, and shipping require-
load profile voltage, electrical insulation, motor requirements
ments, physical and electrical separation of circuits and (aa) other requirements to prevent undue risk to the
equipment; the effect of cable routing or rerouting on health and safety of the public
the cable tray system (loading, seismic capability, and (bb) materials, processes, parts, and equipment suit-
capacity limitations) able for application
(o) layout and arrangement requirements (cc) safety requirements for preventing personnel
(p) operational requirements under various condi- injury including such items as radiation safety, minimiz-
tions, such as startup, normal operation, shutdown, ing radiation exposure to personnel, criticality safety,
maintenance, abnormal or emergency operation, special restricting the use of dangerous materials, escape provi-
or infrequent operation including installation of design sions from enclosures, and grounding of electrical
changes, and the effect of system interaction systems
(q) instrumentation and control requirements includ- (dd) quality and quality assurance requirements
ing indicating instruments, controls, and alarms (ee) reliability requirements of structures, systems,
required for operation, testing, and maintenance, other and components including their interactions, which may
requirements such as the type of instrument, installed impair functions important to safety
spares, range of measurement, and location of indication (ff) interface requirements between equipment and
are included operation and maintenance personnel
(r) security requirements to include access and (gg) requirements for criticality control and account-
administrative control requirements and system design ability of nuclear materials
requirements including redundancy, power supplies, (hh) load path requirements for installation, removal,
support system requirements, emergency operational and repair of equipment and replacement of major com-
modes, and personnel accountability ponents
(s) redundancy, diversity, and separation require-
ments of structures, systems, and components
(t) failure effects requirements of structures, systems, 300 DESIGN PROCESS
and components including a definition of those events
The design activities may be prescribed in job specifi-
and accidents that they must be designed to withstand
cations, work instructions, planning sheets, procedure
(u) test requirements including preoperational and manuals, test procedures, or any other typed or written
subsequent periodic tests and the conditions under form that provides adequate control and permits
which they will be performed reviewing, checking, or verifying the results of the
(v) accessibility, maintenance, repair, and preservice activity.
and inservice inspection requirements for the facility
(a) Subjects normally covered by procedures for the
including the conditions under which these will be per-
preparation and control of drawings include the fol-
formed
lowing:
(w) personnel requirements and limitations including
(1) drafting room standards
the qualification and number of personnel available for
(2) standardized symbols
operation, maintenance, testing and inspection, and
(3) identification system
radiation exposures to the public and facility personnel
(4) indication of status
(x) transportability requirements such as size and
shipping weight, limitation, and I.C.C. regulations (5) checking methods
(y) fire protection or resistance requirements: (6) review and approval requirements
(1) safe shutdown analyses, the introduction of safe (7) issuance and distribution control
shutdown equipment into fire areas (8) storage and control of originals or master copies
(2) routing of piping and electrical cables and the (9) revisions
necessity for cable fireproofing and/or fire stops (10) as-built drawings
(3) fire detection and fire suppression capability (b) Subjects normally covered by procedures for the
(4) fire barrier capability including fire door instal- preparation and control of specifications and other
lation design documents include the following:
(5) fire dampers (1) format requirements
(6) access to fire fighting and emergency equipment (2) identification system
(7) use of noncombustible materials (3) review and approval requirements
(8) introducing combustible materials into safe (4) issuance and distribution
shutdown areas by design or during installation or oper- (5) revisions
ation (6) indication of status
(9) smoke and toxic gas generation (7) storage and control of originals or master copies
128
PART III, NONMANDATORY APPENDIX 3A-1 ASME NQA-1b–2007
(c) Design documents should include information modified and retested or otherwise verified to ensure
that may subsequently be needed to support facility satisfactory performance.
operations such as:
(1) control room operations 600 CHANGE CONTROL
(2) maintenance
(3) spare and replacement parts Design documents should be maintained current to
(4) environmental qualification of equipment ensure their availability to support facility design, con-
(5) outage planning and scheduling struction, and operation. However, design changes may
be approved without revision to the affected docu-
(6) safety evaluations
ment(s). When this occurs, procedures should be estab-
(7) facility modifications
lished to ensure that a determination of the final design
(8) personnel training and qualification
or as-built condition can be made, consistent with the
user’s needs. Since not all affected documents require
400 DESIGN ANALYSIS revision, procedures should identify those design docu-
ments that are subject to revision. Measures may include,
Design analysis should be performed in a planned, but are not limited to, imposing a time limit for updating
controlled, and documented manner. Design analysis the affected document(s), limiting the number of design
should identify the purpose, methods, assumptions, changes allowed to accumulate prior to revising the
design inputs, references, and units used. Calculations affected document, or providing for a process that con-
should be identifiable by subject (including structure, tinually updates the affected document(s).
system, or component to which the calculation applies), During the operational phase, attention should be
originator, reviewer, and dates or by other data such given to system modifications, mechanical and electrical
that calculations are retrievable. temporary alterations and instrument setpoint changes
to ensure that design changes are processed in accor-
500 DESIGN VERIFICATION dance with design control requirements. Proposed modi-
fications, alterations, and changes may overlap and may
The purpose of design verification is to provide a not be installed in the sequence that they were designed;
confirmatory check of design adequacy by a person(s) therefore, it is incumbent upon the design organization
competent to have prepared the design being verified and plant/facility Owner to control approved (but not
but sufficiently independent such that they are not veri- installed) design changes to ensure that changes do not
fying their own work. Accordingly, design verifiers may conflict with each other. Where modifications, alter-
be a supervisor, a subordinate, or any other individual ations, or changes must be installed in a particular
from inside or outside the organization, provided they sequence, the sequence should be specified. Partial
are competent, they are not verifying their own work, installation of design changes should be approved by
and they have access to the necessary design infor- the design organization. Controls should ensure that
mation. documents that are required to support operation reflect
Design verification for some designs or specific design the as-built condition of the facility. Temporary and per-
features may be achieved by suitable qualification test- manent repair work and parts replacement should be
ing of a prototype or initial production unit. reviewed to determine if these activities constitute
Qualification testing may be used in combination with design changes.
other verification methods. For example, it may be most
effective to verify that an instrumentation cabinet is 700 INTERFACE CONTROL
designed to withstand the maximum earthquake-caused
vibratory motions by actually subjecting the cabinet and During the construction and operational phases,
its associated components to shaker tests that corre- attention should be given to defining and controlling the
spond to these vibratory motions. The shaker tests will design interfaces between organizations participating
not, however, verify that the circuitry is designed cor- in design changes/modifications and to defining the
rectly or that the component in the cabinet will perform responsibility for the overall control of the design. The
its intended function. Other tests or verification means responsibility for the design of the facility should be
are required to confirm that remaining design functions divided in a way that is suited to the individual capabili-
are adequately performed by the instrumentation and ties of the participating organizations and the status
that those components perform the intended functions ofconstruction or operations. Participating organiza-
under the varying conditions to which they are sub- tions may include
jected. (a) Owner’s design organization
If qualification testing indicates that modifications to (b) construction engineering group
the item are necessary to obtain acceptable performance, (c) operating organization
the modification should be documented and the item (d) architect engineer
129
(e) reactor manufacturer (NSSS) are to become lifetime or nonpermanent records. As-
(f) equipment design built documents may include documents such as the
(g) other design contractor following:
The documentation of the assignment of design (a) drawings required for facility operation
responsibilities may be accomplished in procedures, (b) modification packages
(c) manufacturer operation and maintenance instruc-
internal or external correspondence, contracts or other
tions
suitable documents.
(d) manufacturer vendor manuals
(e) manufacturer technical bulletins
(f) equipment and instrumentation listings
800 DOCUMENTATION AND RECORDS (g) environmental qualification listings
(h) spare and replacement parts listings
The documentation and records for a facility should The status of the approved design should be readily
include provisions for as-built documentation. These available to the participating design organization(s). In
provisions should address what documents are required, addition, for the operation phase, the as-built configura-
the depth of information required for the as-built docu- tion and the status of modifications being implemented
mentation, and the internal or other measure for updat- should be readily available to the operating organi-
ing, and the identification of those documents which zation.
130
(b) Supplier’s production capability The Purchaser should ensure that Supplier documen-
(c) Supplier’s past performance tation is evaluated to determine the Supplier’s quality
(d) Supplier’s alternates and exceptions assurance program effectiveness.
500 PURCHASER/SUPPLIER COMMUNICATIONS 700 CONTROL OF CHANGES IN ITEMS OR

SERVICES
Depending on the complexity or scope of the item or
service, the Purchaser may initiate preaward and post- 701 Bid Evaluation Changes
award activities. These activities may take the form of Changes agreed upon by the Purchaser and Supplier
meetings or other communications to establish that the during the bid evaluation process should be incorpo-
Supplier understands the procurement requirements; rated into a revision of the appropriate procurement
the intent of the Purchaser in monitoring and evaluating documents.
the Supplier’s performance; and the planning and manu-
facturing techniques, tests, inspections, and processes 702 Control of Changes
to be employed by the Supplier in meeting procurement Changes to procurement documents should be subject
requirements. When Purchaser notification points, to the same level of controls utilized for their develop-
including hold and witness points, are required, they ment, except for editorial, price, delivery, or other minor
should be identified at this time. The depth and necessity changes that do not affect technical or quality require-
of preaward and postaward communication depend on ments.
the uniqueness, complexity, and frequency of procure-
ment with the same Supplier, and past Supplier perform- 703 In Process Control of Deviations
ance for the specific items or services covered by the Supplier-generated requests for deviations, changes,
procurement document. or exceptions to procurement documents should be con-
trolled in accordance with para. 702 of this Appendix.
(b07) 600 SUPPLIER PERFORMANCE EVALUATION The Purchaser should evaluate the need to maintain
agreement between the procurement documents, and
The Purchaser of items and services should establish approved Supplier and Purchaser changes.
measures to interface with the Supplier and to verify
Supplier’s performance as deemed necessary by the Pur-
chaser. The measures may include the following: 800 PRODUCT ACCEPTANCE
(a) establishing an understanding between Purchaser Among the methods used in the nuclear industry to
and Supplier of the provisions and specifications of the accept an item or service from a Supplier are source
procurement documents verification, receiving inspection, Supplier Certificate of
(b) requiring the Supplier to identify planning tech- Conformance, post-installation test at the nuclear power
niques and processes to be used in fulfilling procurement plant site, or a combination thereof.
document requirements
(c) reviewing Supplier documents that are generated 801 Source Verification
or processed during activities fulfilling procurement Acceptance by source verification may be most desir-
requirements able when the item or service is one of the following:
(d) identifying and processing necessary change (a) vital to plant safety
information (b) difficult to verify quality characteristics after
(e) establishing a method of document information delivery
exchange between Purchaser and Supplier (c) complex in design, manufacture, and test
(f) establishing the extent of source surveillance and Source verification may not be necessary when the
inspection activities quality of the item can be verified by review of test
These verification activities should be conducted as reports, inspections upon receipt, or other means.
early as practicable. The Purchaser’s verification activi- The source verification activities may include the fol-
ties, however, are not intended to relieve the Supplier of lowing checks.
the responsibility of verification of quality achievement.
801.1 Documentation has been submitted as
601 Records required and provides verification of approvals, mate-
rial, applicable inspections, and tests.
Activities performed to verify conformance to require-
ments of procurement documents shall be recorded. 801.2 Fabrication procedures and processes have
Source surveillances and inspections, audits, receiving been approved and complied with and the applicable
inspections, nonconformances, dispositions, waivers, qualifications, process records, and certifications are
and corrective actions should be documented. available.
137
801.3 Components and assemblies have been accept an item or service from a Supplier based on a
inspected, examined, and tested as required and applica- receiving inspection and a Supplier’s Certificate of Con-
ble inspection, test, and certification records are formance stating that the specified requirements have
available. been met. However, specific supplemental documenta-
801.4 Nonconformances have been dispositioned as tion, such as material certificates or reports of tests per-
required. formed, may be required by procurement documents.
Acceptance by this method is satisfactory when the item
801.5 Components and assemblies are cleaned, pre-
or service is of simple design and involves standard
served, packed, and identified in accordance with speci-
materials, processes, and tests. Such items may be fabri-
fied requirements.
cated subject to selected qualification, sample, or batch
802 Receiving Inspection testing to establish or maintain maximum quality.
Acceptance solely by receiving inspection should be
considered only when the items or services are as
follows: 804 Post-Installation Testing
(a) relatively simple or standard in design, manufac-
ture, and test Acceptance by post-installation test is satisfactory
(b) adaptable to standard or automated inspections when performed following the accomplishment of at
and/or tests of the end product to verify quality charac- least one of the preceding methods and when:
teristics after delivery (a) it is difficult to verify the quality characteristics
(c) such that receiving inspection does not require of the item without it being installed and in use; or
operations that could adversely affect the integrity, func- (b) the item requires an integrated system checkout
tion, or cleanness of the item or test with other items to verify its quality characteris-
803 Certificate of Conformance tics; or
In certain procurement actions that do not involve (c) the item cannot demonstrate its ability to perform
source verification by the Purchaser, the Purchaser may its intended function except when in use.
138
ASME NQA-1b–2007
NONMANDATORY APPENDIX 10A-1 (b07)
Guidance on Inspection
100 GENERAL Process monitoring may be advantageous when

acceptance inspection may introduce significant delays
This Appendix provides nonmandatory guidance on or process interruptions or inhibit effective material con-
the inspection, monitoring, and in-service inspection trol. When process monitoring is performed by person-
activities as specified in Requirement 10 of Part I. nel responsible for performing the process operation,
results of monitoring should be verified by sampling
inspection or surveillance.
200 INSPECTION AND PROCESS MONITORING
When inspection and process monitoring are used, 300 IN-SERVICE INSPECTION
they should be performed in a systematic manner to Inspection methods should be established and exe-
ensure that the specified requirements for control of the cuted to verify that the characteristics of an item con-
process and quality of the item are being achieved tinue to remain within specified limits. Inspection
throughout the duration of the process. methods should include evaluations of performance
Controls, where required, should be established and capability of essential emergency and safety systems
documented for the control and sequencing of these and equipment, verification of calibration and integrity
activities at established inspection points during succes- of instruments and instrument systems, and verification
sive stages of the conducted process or construction. of maintenance, as appropriate.
143
ASME NQA-1b–2007
(b07) NONMANDATORY APPENDIX 11A-1

Guidance on Test Control
100 GENERAL (a) required tests and test sequence

(b) required ranges of input parameters
This Appendix provides nonmandatory guidance on (c) identification of the stages at which testing is
test procedures and records. This Appendix may be used required
in conjunction with Requirement 11 of Part I. (d) criteria for establishing test cases
(e) requirements for testing logic branches
200 COMPUTER PROGRAM TEST PROCEDURES (f) requirements for hardware integration
(g) anticipated output values
Some factors to be considered in establishing com- (h) acceptance criteria
puter program test procedures may include the fol- (i) reports, records, standard formatting, and conven-
lowing: tions
144
Fig. 16A-1.1 Corrective Action Flow Chart
147
ASME NQA-1b–2007
NONMANDATORY APPENDIX 17A-1

Guidance on Quality Assurance Records
(a05) 100 GENERAL (a) a description of the storage facility

(b07) (b) the filing system to be used
records as specified in Requirement 17 of Part I, except (c) a method for verifying that the records received
for electronic records. Nonmandatory guidance for elec- are in agreement with the transmittal document and that
tronic records is contained in Nonmandatory Appendix the records are legible
17A-2. (d) a method of verifying that the records are those
designated
101 Generation of Records (e) the rules governing access to and control of the files
Documents that are designated to become records (f) a method for maintaining control of and account-
should be legible, accurate, and completed appropriate ability for records removed from the storage facility
to the work accomplished so that they can be read and (g) a method for filing supplemental information and
understood and be traceable to the associated items or disposing of superseded records
activities.
106 Preservation and Safekeeping
102 Authentication of Records To help ensure the preservation and safekeeping of
Statements of authenticity, handwritten signatures, records, the following should be considered:
electronic signatures, or any other means that ensures (a) placement of records in binders, folders, or enve-
traceability to a specific individual or organization of lopes for storage in steel file cabinets or on shelving
authentication and associated date are acceptable meth- (b) prevention of damage from environmental condi-
ods of authentication. If initials or codes are used for tions
identification, then a system should be established to (c) manufacturer’s recommendations on storage
ensure traceability to the authenticating individual or (d) measures to preclude the entry of unauthorized
organization. personnel into the records system or storage area for
The records system should provide methods for protection from larceny or vandalism may include access
authenticating copies of original records when the origi- lists, locked entry, attendant security, or a combination
nal record is contaminated or lost and a copy of the of these measures
original record is available. (e) measures for replacement restoration, or substitu-
tion of lost or damaged records
103 Indexing
(f) inspections of records to detect deterioration
Indexing can take many forms, including directories
or listings. Indices should identify summary informa- 107 Facilities and Containers
tion for the records, such as the associated item or activ- Current industry practices identify the use of two
ity, title or description, originating individual or methods of providing storage facilities, single or dual.
organization, retention period (lifetime or nonperma- (a) Single Facilities and Containers. NFPA-2321 provides
nent), location, and the media used for retention. For a set of methods that may be used for the storage of
nonpermanent records, the period of retention should records in vaults, file rooms, or records protection con-
be defined. tainers. Where file rooms are used, an exception to
NFPA-232 should be applied to permit forced air circula-
104 Corrected Information in Records
tion system to be used, provided it is dampered in accor-
When records are corrected, it is a good practice for dance with the room rating.
such corrections should include the date and identifica- (b) Dual Facilities. If storage at dual facilities for rec-
tion of the person authorized to issue such corrections. ords is provided, the establishment of sufficiently remote
storage facilities depends on the type of hazard, such
105 Storage
as earthquakes, fires, tornadoes, etc., and the probability
A written storage procedure should be prepared and for occurrence of these hazards.
responsibility assigned for the implementing procedure.
Storage procedures are suggested that include the fol- 1
National Fire Protection Association (NFPA), 1 Batterymarch
lowing: Park, Quincy, MA 02269-9101.
148
108 Retrieval (d) Eddy current examination final results

A key function of a records system is to ensure that (e) Electrical control verification test results
records are retrievable through their life cycle. (f) Ferrite test results
Records maintained at a Supplier’s facility or other (g) Heat treatment records
location should be accessible to the Purchaser or a desig- (h) Liquid penetrant examination final results
nated alternate. (i) Location of weld filler material
(j) Magnetic particle examination final results
109 Records Transfer to Owner or Purchaser (k) Major defect repair records
Records accumulated at various locations, prior to (l) Material properties records
transfer, should be made accessible to the Owner or (m) Nonconformance reports
Purchaser directly or through the procuring organiza- (n) Performance test procedure and results records
tion. For records transferred to the Owner or Purchaser, (o) Pipe and fitting location report
it is recommended that the Owner or Purchaser inven- (p) Pressure test results (hydrostatic or pneumatic)
tory the submittals, and acknowledge receipt. (q) Radiograph review records
Prior to transfer of the Supplier’s records, the Supplier (r) Ultrasonic examination final results
should consider the following: (s) Welding procedures
(a) ASME Boiler and Pressure Vessel Code require-
ments are met 204 Installation Construction Records (04)
(b) regulatory requirements are satisfied
204.1 Receiving and Storage: Nonconformance
(c) operational requirements are satisfied Reports
(d) warranty consideration is satisfied
(e) Purchaser’s requirements are satisfied 204.1.1 Civil
(a) Check-off sheets for tendon installation
(b) Concrete cylinder test reports and charts
200 LIST OF TYPICAL LIFETIME RECORDS (c) Concrete design mix reports
The following is a list of typical lifetime records con- (d) Concrete placement records
taining information meeting Requirement 17 of Part I. (e) Inspection reports for channel pressure tests
The nomenclature of these may vary. (f) Material property reports on containment liner
and accessories
201 Design Records (g) Material property reports on metal containment
(a) Applicable codes and standards used in design shell and accessories
(b) Computer programs or corresponding mathemat- (h) Material property reports on reinforcing steel
ical model (i) Material property reports on reinforcing steel
(c) Design drawings splice sleeve material
(d) Design calculations and record of checks (j) Material property reports on steel embedments in
(e) Approved design change requests concrete
(f) Design deviations (k) Material property reports on structural steel and
(g) Design reports bolting
(h) Design verification data (l) Material property reports on tendon fabrication
(i) Design specifications and amendments material
(j) Safety analysis report (m) Pile drive log
(k) Stress reports for code items (n) Pile loading test reports
(l) Systems descriptions (o) Procedure for containment vessel pressure proof
(m) Systems process and instrumentation diagrams test and leak rate tests and results
(n) Technical analysis, evaluations, and reports (p) Reports for periodic tendon inspection
(q) Reports of high strength bolt torque testing
202 Procurement Records (r) Soil compaction test reports
(a) Procurement specification 204.1.2 Welding
(b) Purchaser order (unpriced) including amend- (a) Ferrite test results
ments (b) Heat treatment records
(c) Liquid penetrant test final results
203 Manufacturing Records
(d) Material property records
(a) Applicable code data reports (e) Magnetic particle test final results
(b) As-built drawings and records (f) Major weld repair procedures and results
(c) Certificate of compliance (g) Radiograph review records
149
(h) Ultrasonic test final results (d) Initial heatup, hot functional, and cooldown pro-
(i) Weld location diagrams cedures and results
(j) Weld procedures (e) Initial plant loading data
(f) Initial reactor criticality test procedures and results
204.1.3 Mechanical
(g) Instrument AC system and inverter test proce-
(a) Cleaning procedures and results
dures and reports
(b) Code data reports
(h) Main and auxiliary power transformer test proce-
(c) Installed lifting and handling equipment proce-
dures and results
dures, inspection, and test data
(i) Off-site power source energizing procedures and
(d) Lubrication procedures
test reports
(e) Material properties records
(j) On-site emergency power source energizing proce-
(f) Pipe and fitting location reports dures and test reports
(g) Pipe hanger and restraint data (k) Plant load ramp change data
(h) Pressure test results (hydrostatic or pneumatic) (l) Plant load step change data
(i) Safety valve response test procedures (m) Power transmission substation test procedures
204.1.4 Electrical and I & C and results
(a) Cables pulling tension data (n) Preoperational test procedures and results
(b) Cable separation data (o) Primary and secondary auxiliary power test proce-
(c) Cable splicing procedures dures and results
(d) Cable terminating procedures (p) Reactor protection system tests and results
(e) Certified cable test reports (q) Start-up logs
(f) Relay test procedures (r) Start-up test procedures and results
(g) Voltage breakdown test results on liquid insu- (s) Station battery and DC power distribution test
lation procedures and reports
(t) Water chemistry report
204.1.5 General
(a) As-built drawings and records 206 Operation Records
(b) Final inspection reports and releases
(a) Records and drawing changes identifying facility
(c) Nonconformance reports design modifications made to systems and equipment
(d) Specifications and drawings described in the Final Safety Analysis Report
(b) New and irradiated fuel inventory, fuel transfers,
205 Preoperational and Start-Up Test Records
and assembly fuel-depletion history records
(a) Automatic emergency power source transfer pro- (c) Off-site environmental monitoring survey records
cedures and results (d) Spent fuel shipment records
(b) Final system adjustment data (e) Facility radiation and contamination survey
(c) Pressure test results (hydrostatic or pneumatic) results
150
year or at least once during the life of the activity, which- (d) when it is suspected that the quality of a product
ever is shorter. Internal audits of activities, conducted is in jeopardy due to deficiencies in the quality assurance
after placing the facility in operation, should be per- program
formed in such a manner as to assure that an audit of (e) when a systematic, independent evaluation of pro-
all applicable quality assurance programs elements is gram effectiveness is considered desirable
completed for each functional area1 within a period of (f ) when it is necessary to verify effectiveness of
2 years. required corrective action
Internal audit frequencies of well-established activi-
(g) when it is directed by management
ties, conducted after placing the facility in operation,
may be extended 1 year at a time beyond the above 2 year
interval based on the results of an annual evaluation of 205 Audit Equivalents
the applicable functional area and objective evidence
Audit equivalent activities such as independent
that the functional area activities are being satisfactorily
assessments and technical surveillances may be used to
accomplished. The evaluation should include a detailed
performance analysis of the functional area based upon satisfy part of all of an audit requirement provided
applicable internal and external source data and due (a) they each meet the requirements for a quality
consideration of the impact of any functional area assurance audit as defined in this Standard
changes in responsibility, resources, or management. (b) they are reviewed and approved for such use by
However, the internal audit frequency interval should the organization responsible for quality assurance audits
not exceed a maximum of 4 years. If an adverse trend
is identified in the applicable functional area, the exten- 206 Audit Schedule Compliance
sion of the internal audit frequency interval should be
rescinded and an audit scheduled as soon as practicable. A grace period of 90 days may be applied to the
203.2 Regularly Scheduled External Audits. External scheduled audit intervals but the periodicity of these
audits (e.g., Supplier audits) should be performed on a audits should be based on the original schedule. Upon
triennial basis and supplemented by annual evaluations completion of a regularly scheduled audit, supplemental
of the Supplier’s performance. A continuous or ongoing audit, or sanctioned audit equivalent activity that satis-
evaluation of the Supplier’s performance may be con- fies the audit requirement for all applicable quality
ducted in lieu of the annual evaluations, provided that assurance program elements, the time period for the
the results are reviewed in order to determine if correc- next required audit may be reset.
tive action is required.
If more than one Purchaser uses a Supplier, the Pur-
chaser may arrange for an audit of the Supplier on behalf 300 PREPARATION FOR AUDITING
of itself and the other Purchasers to reduce the number
of external Supplier audits. The scope of the audit should 301 Team Selection
address the needs of all Purchasers and the report should
be distributed to Purchasers for whom the audit was Prior to assigning personnel to perform audits, man-
conducted. Each Purchaser relying on the results of such agement should determine that the individuals have the
an audit remains individually responsible for the ade- experience or training commensurate with the scope,
quacy of the audit and for its use by their organization. complexity, or special nature of the activities to be
204 Supplemental Audits audited. The recommended practice is to include techni-
cal specialists who have directly related experience in
Regularly scheduled audits should be supplemented
the area to be audited as members of an audit team. For
by additional audits for any of the following conditions:
example, a design engineer, chemist, operator, etc., from
(a) to determine the capability of a Supplier’s quality
one unit or department may be used to audit the corres-
assurance program prior to awarding a contract or pur-
ponding activity of another unit or department.
chase order
In selecting personnel for audit assigments, consider-
(b) when, after award of a contract, sufficient time
has elapsed for implementing the Supplier’s quality ation should be given to special abilities, specialized
assurance program and it is appropriate to determine technical training, prior experience, personal character-
that the organization is adequately performing the func- istics, and education.
tions defined in the quality assurance program descrip-
tion, codes, standards, and other contract documents 302 Planning the Audit
(c) when significant changes are made in functional
areas of the quality assurance program, such as reorgani- 302.1 Team Familiarization. Prior to commencing the (b07)
zations, process control changes, mission or work scope audit, the Lead Auditor should ensure that the audit
changes, or procedure revisions team is prepared. Pertinent information, including
153
policies, procedures, standards, instructions, codes, reg- and available work process flowcharts. Checklists
ulatory requirements, and prior audit reports, should be should include a brief description of the investigative
made available for review by the auditors. During the method necessary to gather information related to the
planning phase of the audit, particular attention should performance criteria. Past and current performance
be directed toward an understanding of internal and results on items and work processes should be consid-
external organization contractual interfaces and respon- ered in developing audit checklists. Checklists are guid-
sibilities of the organization to be audited. ance and may be expanded or condensed during audit
performance as circumstances warrant.
302.2 Product Selection. In planning for an audit,
emphasis should be on the selection of the product to 303 Audit Notification
be evaluated and the performance criteria or metrics
Involved organizations should be notified of an audit
used to determine the capability and stability of the
a reasonable time before the audit is to be performed,
work processes that produce this product. Risk relative
except for unannounced audits. This notification should
to unavailability and unreliability of product applica-
be in writing and include such information as the scope
tions should prevail in the product selection. Product
and schedule of the audit and the names of the auditor,
selection is usually dependent on the following key
audit team leader and team members, if known. For
factors:
unannounced audits, prior agreements should be
(a) importance of intended function(s) of the product
reached by the parties involved.
(b) complexity of product attributes required to per-
form functions
(c) skill or complexity of work processes that impart 400 AUDIT PERFORMANCE
these attributes
401 Pre-Audit Conference
(d) capability of evaluating or inspecting work pro-
cesses A pre-audit conference should be conducted with the
management of the organization to be audited. The pur-
302.3 Product Experience. Organization or industry pose of the conference should be to confirm the audit
experience with a product’s performance should be con- scope and planned dates, meet counterparts, discuss the
sidered in selecting it for auditing. Information on past sequence and duration of the audit, set the time for the
performance may be obtained from various sources, post-audit conference, and establish channels of commu-
such as audit and assessment reports, plant operation nication. During the conference, there should be an
and maintenance records, trend data, equipment histo- agreed-to agenda for the audit.
ries, personal knowledge, and external information,
including regulatory agency notices. Nonconformance 402 Methods
reports, inspection results, customer complaints, and Audits should be performed in accordance with the
warranty claims are other sources of input. Product per- audit plan using the following methods:
formance information may be useful in determining (a) review of documentation, including procedures
which technical and quality requirements are most and work instructions, for completeness and adequacy
important to achieving satisfactory performance. (b) examination in work areas for evidence of imple-
302.4 Process Effectiveness. When auditing a pro- mentation of procedures and instructions
cess, flowcharts are valuable information sources. The (c) observation of processes for evidence of achieve-
selected processes, item characteristics, and perform- ment of specified results and evidence that performance
ance criteria should be discussed with those responsible criteria are being met
for the technical requirements. (d) examination of personnel training and qualifica-
tion records where special skills are required
302.5 Audit Plan. The audit plan should identify how (e) reexamination of selected work that has been
the audit will be performed and those key processes accepted, such as product, design calculations and draw-
and product characteristics that have the greatest influ- ings, and comparison of findings with applicable
ence on item performance. For example, the audit may requirements and the previous basis for acceptance
focus on product manufacturing processes, such as a (f) examination of process controls, and records to
critical assembly technique. Conversely, if a specific pro- determine conformance with specifications
cess is routinely inspected and has a stable performance
history, the process may not need to be evaluated during 403 Audit Implementation
the audit.
403.1 Evaluation. Audit team members or auditor
302.6 Checklists. Checklists should be used for eval- should review and evaluate product and process docu-
uating processes based on defined performance criteria mentation. Auditors should interview workers and
154
ASME NQA-1b–2007
NONMANDATORY APPENDIX 2.21 (b07)
Quality Assurance Guidelines for Decommissioning

Nuclear Facilities
100 GENERAL dismantlement: those actions required to disassemble and

remove sufficient radioactive material from a facility or
Appendix 2.21 provides quality assurance guidance site to permit release of the facility or site for
for decommissioning of nuclear facilities to permit unrestricted use.
unrestricted release of the facility or site. Decommis-
sioning consists of decontamination, dismantlement, or release criteria: the maximum radiation dose rate level
a combination of both. Safe storage and entombment and radioactive contamination level that are acceptable
are not addressed in this Appendix because neither will following decommissioning for unrestricted release of
lead to the release of a facility or site for unrestricted use. the facility or site being decommissioned.
Appendix 2.21 supplements Part I and should be used
in conjunction with its applicable sections when, and to 200 PREREQUISITES
the extent, specified by the organization invoking this
The following conditions should be confirmed as hav-
Appendix.
ing been met before the remainder of this document is
Guidance in this Appendix is intended to assist the applied:
user in developing and implementing a quality assur-
(a) Nuclear fuel and byproduct material have been
ance program for use in the decommissioning of a
removed from active use and safely stored on site or
nuclear facility or site. Unique terms applicable to this
moved off site.
Appendix are defined; activities are listed that should
(b) A physical and radiological characterization of the
be checked before specific tasks are started; checks that
facility has been performed and documented in accor-
should be performed before, during, and after each task
dance with American Society for Testing and Materials
are identified; and records that should be developed
(ASTM) E 1281, Standard Guide for Nuclear Facility Decom-
and retained are discussed. missioning Plans.
Quality assurance guidance specified in this Appen- (c) An assessment of appropriate radiological envi-
dix includes: ronmental issues has been performed to satisfy federal,
(a) support equipment used in decommissioning state, and local requirements.
(b) decommissioning (d) To substantiate para. 200(c) of this Appendix, the
following documents should be available for review:
101 Definitions (1) a listing of all applicable federal, state, and local
The following definitions are provided to ensure uni- radiological environmental requirements
form understanding of terms as used in this Appendix. (2) records to demonstrate compliance with all
listed radiological environmental requirements
byproduct material: any radioactive material (except spe- (e) A decommissioning project plan has been pre-
cial nuclear material) yielded in or made radioactive pared in accordance with applicable ASTM E 1281
by exposure to the radiation incident to the process of guidelines.
producing or utilizing special nuclear material. (f) To substantiate para. 200(e) of this Appendix, the
checks: the tests, measurements, verifications, or controls following documents relating to decommissioning
placed on an item or activity by means of investigations, should be available for review:
inspections, comparisons, or examinations to determine (1) the approved decommissioning project plan
satisfactory condition, accuracy, safety, or performance. (2) evidence that the decommissioning project plan
and changes thereto have been documented, reviewed,
decommission: to remove a nuclear facility or site safely
and approved
from service and reduce residual radioactivity to levels
(3) the latest applicable as-built facility drawings
that permit release of the facility or site for unrestricted
(4) records of applicable physical and radiological
use and termination of any applicable license.
characterization of the facility
decontamination: the reduction or removal of radioactive (g) Quality requirements have been identified and
contamination from a structure, area, object, or person. quality assurance activities have been planned to ensure
164.1
ASME NQA-1b–2007 PART III, NONMANDATORY APPENDIX 2.21
that activity and documentation requirements are met assurance requirements, and decommissioning require-
throughout the pre-decommissioning, decommis- ments applicable to each facility or site as specified in
sioning, and post-decommissioning phases of the work. the decommissioning project plan.
(h) Project, task, staffing, and equipment loading (c) Training Plan. Review to verify that a worker train-
schedules have been prepared to ensure that time and ing program has been developed to ensure performance
resources have been considered to accomplish the work of tasks specified in the decommissioning plan, imple-
in accordance with technical, cost, and schedule require- mentation plans, procedures, and work instructions.
ments. This review should also verify that radiological safety
(i) An as low as reasonably achievable (ALARA) pro- training was included. In addition, documentation of
gram has been prepared to ensure that worker radiation individual training and qualifications in compliance
exposure will be minimized. with federal, state, and local requirements should be
verified.
(d) When additional implementation plans such as
300 PRE-DECOMMISSIONING CHECKS work plans, security plans, emergency plans and envi-
ronmental, safety, and health plans are required by the
301 General decommissioning project plan, these additional imple-
Before the start of decommissioning, checks should mentation plans should be reviewed to verify that they
be completed to verify that decommissioning planning comply with the decommissioning project plan and fed-
and preparations conform to the requirements specified eral, state, and local requirements.
in the decommissioning project plan, implementing 302.3 Specifications. A review of the facility, struc-
plans, and procedures for a specific project. ture, system, and component specifications should be
The quality requirements and quality assurance performed to verify that decommissioning activities can
actions that are necessary during decommissioning be accomplished as described in the decommissioning
should be planned and reviewed. Performance of this project plan.
review should not be limited to quality assurance per-
302.4 Design and Qualification. Checks should be
sonnel.
performed to verify that systems, components, and
302 Plans, Specifications, and Procedures equipment required to initiate decommissioning have
been designed and qualified in accordance with applica-
302.1 Decommissioning Project Plan. The decommis- ble codes, standards, and specifications. Examples of
sioning project plan should be reviewed to verify that systems, components, and equipment required for
the plan meets federal, state, and local requirements and decommissioning are decontamination, ventilation, and
includes, as appropriate, standard industry guidance waste processing systems. Other examples are hoisting,
such as ASTM E 1281. The review should also verify rigging, and remotely operated cutting equipment.
that the decommissioning project plan states the project 302.5 Procedures. Consistent with the implementa-
objectives, specifies the major tasks that are to be per- tion plans, checks should be performed to verify that
formed, and identifies the implementation plans for procedures are ready when needed during the applicable
major tasks. phase of decommissioning. These checks should verify
302.2 Implementation Plans. Implementation plans the following:
should be reviewed to verify that they provide guidance (a) Engineering and operational limitations and
to accomplish decommissioning in a safe manner and requirements, as applicable, have been incorporated in
the procedures and instructions for the systems, compo-
to comply with the approved decommissioning project
nents, and equipment required to initiate decommis-
plan and federal, state, and local requirements. Where
sioning. These limitations and requirements should
implementation plans are required by the decommis-
include, as appropriate, storage and handling, installa-
sioning project plan, they should be reviewed using the
tion, testing (functional and periodic), maintenance, and
guidelines associated with each implementation plan
on-site processes such as cleaning, welding, nondestruc-
listed below.
tive examination, and parameters such as pressure, flow,
(a) Waste Management Plan. Review to confirm that speed, load limits (static and dynamic), travel limits,
the following activities, as applicable, are addressed: physical clearances, control and alarm settings, and envi-
(1) liquid radwaste processing, packaging, trans- ronmental and thermal limits, which are included in
portation, and disposal design specifications, manufacturer ’s data sheets,
(2) solid radwaste handling, packaging, transporta- instruction and maintenance manuals, and design
tion, and disposal reports.
(b) Quality Assurance Plan. Review to confirm that it (b) Procedures and instructions have been prepared
complies with applicable requirements of Part I, this and approved for each identified task and comply with
Appendix of Part III, applicable government quality applicable federal, state, and local requirements.
164.2
PART III, NONMANDATORY APPENDIX 2.21 ASME NQA-1b–2007
(c) Methods are provided to ensure that procedures operations or processes such as decommissioning activi-
and instructions will be revised as necessary to maintain ties conducted in radiation fields and remotely con-
current procedures and instructions that represent the trolled processes or operations.
status of the facility as the work progresses and provide (l) Systems, components, and equipment required for
guidance for safe and orderly work. decommissioning are available at the work location and
(d) Procedures and instructions address the following comply with specified requirements.
topics: (m) Warnings and safety notices, appropriate to the
(1) precautions and limitations to minimize radio- task being performed, are posted.
active material release to the environment (n) Approved inspection and test procedures for
(2) component and equipment protection require- ensuring that systems, components, and equipment
ments required for decommissioning perform in accordance
(3) prerequisites, including facility conditions, with their intended design requirements. Procedures
data, sequence of procedure execution, and related sys- shall include provisions for change control, revision,
tems status approval, and acceptance.
(4) test and inspection equipment, radiation instru-
mentation, and other equipment have been calibrated 303 Identification
and maintained in accordance with requirements for Checks should be made to verify that the identity
each equipment item of systems, components, and equipment required for
(5) sequence of activities to be followed and steps decommissioning has been maintained and is in accor-
within each activity dance with the latest approved-for-construction draw-
(6) qualification of personnel, including required ings, equipment lists, specifications, and established
training procedures. If these checks disclose an apparent loss of
(7) reporting requirements identification, the identity should be reaffirmed before
(8) hold points for technical or quality verifications release of systems, components, and equipment for use.
(9) approval and signature requirements Otherwise they shall be removed from service.
(10) data and report forms Checks should be made to verify that a control system
(11) interface requirements has been established for maintaining identification of
(e) Approved procedures and work instructions for systems, components, and equipment required for
performing decommissioning activities, as specified by decommissioning through the applicable phase of
the decommissioning project plan, have been prepared decommissioning, including provisions for control of
in accordance with applicable codes, standards, and substitution or exchange of systems, components, and
other requirements. equipment. The procedures for identification control
(f ) Approved procedures, drawings, manuals, or should provide traceability to drawings, specifications,
other work instructions have been provided to appro- or other records when identification or markings are
priate workers at their work locations. destroyed, hidden, or removed from an item.
(g) Special instructions and checklists required to
install and operate systems, components, and equip-
304 Physical Condition
ment required for decommissioning are available at the Checks, as appropriate, should be performed to verify
appropriate area or attached to the system, component, that systems, components, and equipment required for
and equipment. decommissioning meet specified requirements and that
(h) Approved procedures and instructions for tasks quality has been maintained. In addition, checks should
to be performed during decommissioning reflect latest be made to verify that the facility being decommissioned
facility radiological characterization, control of contami- meets specified requirements. These checks should ver-
nation spread, and adherence to ALARA principles. ify the following:
(i) Approved procedures and instructions for special (a) Materials have been selected and systems, compo-
processes such as coating, cutting, remotely controlled nents, and equipment required to initiate decommis-
processes, and decontamination are available at the sioning have been fabricated and assembled in
appropriate location. accordance with their design specifications and applica-
(j) Qualification of individuals, organizations, equip- ble published codes and standards. Conformance to
ment, and procedures has been completed in accordance requirements should have been demonstrated by the
with applicable requirements. responsible organization by using appropriate docu-
(k) Where applicable, personnel, procedures, and ments from the following list:
instructions should have been qualified through the (1) design specifications
preparation of workmanship standards, samples, or (2) latest approved drawings
mockups that simulate actual job conditions (except (3) system, component, or equipment specifica-
radiation fields). This is especially applicable for timed tions
164.3
ASME NQA-1b–2007 PART III, NONMANDATORY APPENDIX 2.21
(4) manufacturer’s installation instructions implementation of appropriate radiation exclusion

(5) installation procedures zones and area cleanliness requirements.
(6) evidence of compliance by manufacturer with (b) protection from inclement weather and other
purchase requirements, including quality assurance ambient conditions adverse to quality.
requirements (c) control of materials or conditions that may be dele-
(7) evidence that engineering and design changes terious to the systems, components, and equipment
are documented and approved before installation required during decommissioning.
(8) records of inspections and tests during on-site
receiving, storage, and handling of systems, compo-
nents, and equipment required for decommissioning 400 CONTROL DURING DECOMMISSIONING
(9) release of systems, components, and equipment
401 General
for installation or use
(10) records of functional testing completed before Actions should be planned and executed to ensure
placing systems, components, and equipment required conformance of decommissioning activities to require-
for decommissioning into service ments specified in the decommissioning project plan,
(11) evidence that nonconformances have been sat- implementation plans, and work procedures.
isfactorily resolved or controlled if unresolved In addition, checks of testing activities should be per-
(12) records of required calibration, testing, and formed during the installation and operation of systems,
maintenance of systems, components, and equipment components, and equipment required for decommis-
required for decommissioning sioning to verify that the required quality is being
(b) Protective measures and physical integrity during achieved in accordance with prescribed procedures.
storage have been maintained in conformance with spec- Checks should be performed in a systematic manner
ified requirements. throughout the decommissioning process. The coordina-
(c) Items required for decommissioning have been tion and sequencing of checks should be identified in
cleaned/decontaminated in accordance with specified the work procedures including hold points. When the
requirements. work procedures are properly executed, they will ensure
(d) When possible, items required for decommis- conformance of completed work to specified require-
sioning have been protected against possible contamina- ments and containment of radioactive materials during
tion in accordance with specified requirements. decommissioning as well as other requirements speci-
fied in plans and procedures.
(e) Installation of systems, components, and equip-
A method should be provided to ensure that engi-
ment required for decommissioning will not adversely
neering design and design changes implemented during
affect the subsequent installation or operation of other
systems, components, and equipment; repair or rework decommissioning are documented and controlled.
on any nonconforming items can be performed satisfac-
torily. 402 Processes and Procedures Control
(f) Approved temporary supports and mountings Checks should be made to verify that a system of
that will interface with the system, component, and controls has been established and is being maintained
equipment required during decommissioning have been at the decommissioning site to ensure that
properly installed. (a) applicable revisions of approved procedures,
(g) Servicing and maintenance of systems, compo- drawings, and instructions are being used
nents, and equipment have been performed. (b) qualified personnel are performing the work
(h) Deactivation of all active systems (i.e., gas, electri- (c) qualified and approved processes, materials, tools,
cal, air, and water) that are being dismantled has been and other equipment are being used
performed. (d) status of decommissioning activities is clearly
indicated or identified in appropriate documents
305 System Protection (e) specified sequence of decommissioning activities
Checks, as appropriate, should be performed to verify is being followed and documented
that conditions at the nuclear facility conform to speci- (f) nonconforming items are identified, appropriately
fied requirements, and that pre-decommissioning tasks segregated, and dispositioned before use
have been performed to prevent conditions that would (g) as-built information for systems, components, and
adversely affect the quality of systems, components, and equipment required for decommissioning is being pro-
equipment required to support decommissioning. These cessed and documented
checks should verify the following: (h) inspection and test reports for systems, compo-
(a) protection of specific areas from adjacent decom- nents, and equipment required for decommissioning are
missioning activities. This protection should include current, accurate, and complete
164.4
PART III, NONMANDATORY APPENDIX 2.21 ASME NQA-1b–2007
(i) inspection reports for special decommissioning (f ) timed operations in high-radiation fields to
processes, such as remote operations or timed activities include adequate personnel protective measures
in radiation fields, are current, accurate, and complete (g) removal, handling, and disposal of major systems
(j) procedures for radiological sampling and analyses or components
are followed and adequately address the need for radio- (h) removal, handling, and disposal of activated/con-
logical environmental monitoring taminated concrete
(k) procedures for decommissioning activities per- (i) removal, handling, and disposal of nonradioactive
formed in radiological conditions are followed and equipment and components
ensure ALARA exposures to personnel (j) demolition, removal, and disposal of structures
(k) excavation, removal, and disposal of contaminated
403 Checks of Systems, Components, and soil to satisfy release criteria
Equipment Required for Decommissioning (l) ongoing radiological environmental monitoring to
Checks of systems, components, and equipment assess effectiveness of contamination control
required for decommissioning should be performed to
verify the items will be located, installed, assembled, or
connected in compliance with the latest approved-for- 500 POST-DECOMMISSIONING CHECKS
construction drawings, manufacturer’s instructions, and Following the completion of decommissioning activi-
procedures. Checks should be performed to verify that ties, checks should be made on the results of the final
systems, components, and equipment have been cor- facility or site characterization to verify that the final
rectly installed and will function properly. condition conforms to the specified release criteria as
stated in the decommissioning project plan. Controls
404 Checks During Decommissioning should be provided for the identification, documenta-
Checks should be performed to verify that decommis- tion, and resolution of identified nonconformances.
sioning activities are being performed in compliance
with the latest approved procedures and work instruc-
tions. Checks should be performed, as appropriate, for 600 RECORDS
the following decommissioning activities: Record copies should be prepared and collected of the
(a) decontamination operations decommissioning plan, procedures, reports, personnel
(b) liquid radwaste processing and disposal qualification records, radiological site characterization
(c) removal of radioactively contaminated compo- records, dismantlement records, and inspection, surveil-
nents and equipment lance and adult records, and assessment records. These
(d) hoisting and rigging operations records should be retained with other project records
(e) solid radwaste handling, segregation, packaging, as required by code, standard, specification, or project
transportation, and disposal procedures.
164.5

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Addenda To ASME NQA-1-2004: Quality Assurance Requirements For Nuclear Facility Applications

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100 BASIC those verifying activities affecting quality have sufficient

100 BASIC 202 Training

100 BASIC Critical characteristics to be verified are those which

200 DESIGN INPUT 400 DESIGN ANALYSES

500 DESIGN VERIFICATION by addressing, where applicable, paras. 501.1(a) through

100 BASIC 205 Documentation Requirements

200 CONTENT OF THE PROCUREMENT 206 Nonconformances

204 Right of Access

(b07) 100 BASIC activity shall be described to a level of detail commensu-

100 BASIC (e) a method to ensure the correct documents are

100 BASIC 500 ACCEPTANCE OF ITEM OR SERVICE

100 BASIC 203 Special Requirements

100 BASIC qualified personnel or qualified automated means. Both

602 Inspection Requirements

300 INSPECTION HOLD POINTS 603 Modifications, Repairs, or Replacements

400 INSPECTION PLANNING

100 BASIC (1) calibrated instrumentation

(a) Test requirements and acceptance criteria shall be

100 BASIC as physical location and tags, markings, shop travelers,

100 BASIC 402 Responsibility and Authority

400 DISPOSITION 405 Reexamination (a05)

100 BASIC action taken to preclude recurrence. The identification,

100 BASIC 401 Lifetime Records

200 GENERATION OF RECORDS 401.2 Lifetime records are required to be maintained

300 AUTHENTICATION OF RECORDS

100 BASIC 400 PERFORMANCE

100 PURPOSE required to comply with the requirements of the defined

(b07) SUBPART 2.21

PART III: NONMANDATORY APPENDICES

(a05) Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114.1

2.20 Guidance on the Quality Assurance Requirements for Identification and

The following Appendices provide nonmandatory

NONMANDATORY APPENDIX 1A-1

100 GENERAL (b) characteristics to be verified and acceptance cri-

NONMANDATORY APPENDIX 3A-1 (b07)

Guidance on Design Control

100 GENERAL (1) ASME Codes and Standards

500 PURCHASER/SUPPLIER COMMUNICATIONS 700 CONTROL OF CHANGES IN ITEMS OR

NONMANDATORY APPENDIX 10A-1 (b07)

100 GENERAL Process monitoring may be advantageous when

(b07) NONMANDATORY APPENDIX 11A-1

100 GENERAL (a) required tests and test sequence

Fig. 16A-1.1 Corrective Action Flow Chart

NONMANDATORY APPENDIX 17A-1

(a05) 100 GENERAL (a) a description of the storage facility

108 Retrieval (d) Eddy current examination final results

NONMANDATORY APPENDIX 2.21 (b07)

Quality Assurance Guidelines for Decommissioning

100 GENERAL dismantlement: those actions required to disassemble and

(4) manufacturer’s installation instructions implementation of appropriate radiation exclusion

No reproduction may be made of this material without written consent of ASME.

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