15056716

IAEA-TECDOC-303
MANUAL ON THE SELECTION

OF APPROPRIATE
QUALITY ASSURANCE PROGRAMMES
FOR ITEMS AND SERVICES
OF A NUCLEAR POWER PLANT
A TECHNICAL DOCUMENT ISSUED BY THE

INTERNATIONAL ATOMIC ENERGY AGENCY, VIENNA, 1984
MANUAL ON THE SELECTION OF APPROPRIATE QUALITY ASSURANCE PROGRAMMES
FOR ITEMS AND SERVICES OF A NUCLEAR POWER PLANT
IAEA, VIENNA, 1984
IAEA-TECDOC-303
Printed by the IAEA in Austria

February 1984
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F O R E W O R D
The Agency's plans for establishing safety standards for nuclear

power plants referred to as the Programme NUSS, have been set out in IAEA
document GC(CXIII)/526/MOD.l. The objective of the programme as stated in
this document is to proceed with the development of three types of
documents:
1. Codes of Practice for thermal neutron nuclear power plants that

establish the objectives and minimum requirements which must be
fulfilled to provide adequate safety for these plants.
2. Safety Guides that provide additional requirements and recommend

procedures that should be followed to implement the Code of Practice.
3. User's Manuals, directed primarily to nuclear power plant operators,

that normally present one or several possible methods and techniques
to solve specific problems.
Work on Codes and Guides has been initiated in 1975 in five main
fields namely government organization, siting, design, operation and
quality assurance.
In the field of quality assurance the Code of Practice and ten Safety
Guides have by 1983 been developed and published in English, French,
Spanish and Russian. These documents are used now in a number of Member
States as quality assurance requirements for nuclear power plants. In
order to facilitate this use the Technical Review Committee on Quality
Assurance on a number of occasions has stressed the need and importance
to proceed with the development of User's Manuals. These documents should
provide Member States implementing the Code and the Safety Guides with
practical examples of procedures, practices and documents Illustrating
quality assurance methods and techniques, used in the organizations in
Member States having broad experience in quality assurance. The same
opinion has been expressed in the discussions during the International
Symposium on Quality Assurance for Nuclear Power Plants, Paris, May 1981.
A number of topics have been identified where Users Manuals could provide
additional information and facilitate correct implementation of the Code
and Guides in nuclear power plant project activités.
To implement these recommendations work has been initiated in the

Secretariat to develop those User's Manuals which are most needed in
Member States embarking on nuclear power programme and initiating quality
assurance activities. Having in mind the difference in the nature between
User's Manuals and Codes and Safety Guides, work on development of these
documents is undertaken outside of the NUSS programme and the established
procedures for development, review and approval of the documents used in
this programme. For User's Manuals it was decided to follow the standard
practices used in the development of Agency's publications such as
Guidebooks and Technical Reports. This procedure will reduce time and
cost for preparation of User's Manual, which are the lower level
documents in the hierarchy of NUSS programme documents and do not contain
requirements for which formulation a broad consensus of QA experts would .
be needed.
However, the full consistency of the Manuals with the Code and Safety
Guides will be ensured by information exchange between the Secretariat
and members of the Technical Review Committee on Quality Assurance and
the Senior Advisory Group of the NUSS programme. Also, members of these
two Committees in the capacity of consultants to the Agency and members
of Advisory Groups will be engaged in the development, review and
approval of the Manuals before these documents are recommended to the
Director General for publication.
The present Manuals on the Selection of Appropriate Quality Assurance

Programme for Items and Services of a Nuclear Power Plant, MAN-QA1,
contains supplementary material and illustrate examples for implementing
requirements for selective application of quality assurance programme
contained in the Code of Practice on Quality Assurance for Safety in
Nuclear Power Plants 50-C-QA Sect.2. and additional requirements and
recommendation presented in the Safety Guide on Establishing of the
Quality Assurance Programme for a Nuclear Power Project, SG-QA1.
During preparation and reviews of this Manual it was found out that
the methods and techniques for selective application of quality assurance
programme used at present in Member States vary considerably from
organization to organization. A number of these methods and techniques
are still under development and subject to changes and modifications. For
these reasons it was considered appropriate to publish this Manual as a
temporary publication for trial use. It is the intention of the
Secretariat to collect information from the use of this document in
nuclear power project activities and prepare a revision as soon as the
relevant methods and techniques obtain a broader support from quality
assurance organizations in nuclear power projects.
TABLE OF CONTENTS
1. INTRODUCTION .
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1.1 General .
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1.2 Scope .
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2. CLASSIFICATION OP ITEMS AND SERVICES .

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2.1 Identification of Items and Services .................................. 11
2.2 Classification Methods and Techniques ................................. 11
2.2.1 Classification by Function ...................................... 12
2.2.2 Classification by Safety and Operational Importance ............. 12
2.2.3 Classification by Item or Service Complexity .................... 13
2.2.4 Classification by Uniqueness, Maturity and Complexity of
QualityEffecting Work Activities . .............................. 13
3. GRADING OF QUALITY ASSURANCE ACTIVITIES .

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3.1 Basic Types of Quality Assurance Activities . ........
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3.2 Grading of Quality Assurance Programmatic Activities . .....
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3.2.1 Dividing and Organizing the Activities .**........*.........*.*.. 17
3.2.2 Specifying the Requirements for the Activities ................
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3.3 Grading of Quality Assurance Work-oriented Activities ..*........*..... 21
3*3.1 Organizing and Grading the Activities ........................... 21
3.3.2 Specifying the Requirements for the Activities ............
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4. CORRELATION OF APPLICABLE QUALITY ASSURANCE ACTIVITIES WITH ITEMS

AND SERVICES ...........
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5. CUSTOMIZING OF SELECTED QUALITY ASSURANCE ACTIVITIES .

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6. SPECIFYING OF APPLICABLE QUALITY ASSURANCE ACTIVITIES .

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7. SELECTIVE APPLICATIONS SYSTEMS .

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7.1 Selective Application System for a Nuclear Power Plant Project
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Using Standards of the CSA ..
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LIST OP ANNEXES
Annex I Typical Definitions for Basic Plant Units 29
Annex II Classification of Items and Services by Function 31
Annex III Classification of Items and Services by Importance of

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Annex IV Classification of Items and Services by Complexity of

Characteristics ..................................
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Annex V Classification of Items and Services by Uniqueness, Maturity

and Complexity of Quality-Affecting Work Activities ......... 39
Annex VI Principal Activities of a Quality Assurance Programme 47
Annex VII Organization of Quality Assurance Programme Activities 49
Annex VTII Grading of Quality Assurance Activities .

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Annex IX Correlation of Items and Services with Quality Assurance

Activities ....................................
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Annex X Typical Format for Quality Assurance Requirements Section of

a Specification for Items and Services ..................
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Annex XI Examples of a Selective Application System 63
LIST OP PARTICIPANTS .
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1. INTRODUCTION
1.1 General
The IAEA Code of Practice on Quality Assurance for Safety in

Nuclear Power Plants, hereafter referred to as the "Code", provides
the requirement that, "iteois, services and processes to which the
quality assurance programmes will apply shall be identified.
Appropriate methods or levels of control and verification shall be
assigned to those items, services and processes. All programmes
shall provide control and verification over activities affecting
the quality of the identified items to an extent consistent with
their importance to safety".
This requirement is further elaborated in the IAEA Safety

Guide on Establishing of the Quality Assurance Programme, SG-QA 1.
This Guide provides additional requirements and specific
recommendations on the selection and application of appropriate
quality assurance activities to items and services to implement tne
requirements of the Code.
However, neither the Code nor the Safety Guide provide

detailed information on how to accomplish the selective application
of quality assurance activities to items and services of a nuclear
power plant. This manual nas been prepared to supplement the
Safety Guide SG-QA 1 with appropriate information to illustrate
possible implementation of its requirements and its guidance on
selective application of quality assurance activities. The
illustrations presented are not intended to indicate a preferred
way of performing any aspect of tne selective application of
quality assurance activities but are intended to show methods and
techniques that organizations have used.
1.2 Scope and Purpose of tne Manual
This manual provides guidance and illustrative examples for

devising a system by waicn applicable quality assurance activities
may be selected and applied to items and services in conformance
«Tit n t ne requirements of the Code and the guidance of 33-QA 1. The
selective application system described nerein contains the
following elements:
(1) Classification of items and services
(2) Grading of quality assurance activities
(3) Correlation of applicable quality assurance activities witn
items and services
CO Adaptation of selected quality assurance activities to the
unique needs of tne items or services.
(5) Specifying of applicable quality assurance activities in bid
specifications or in a contract.
This selective application system is intended to be used by

plant systems designers in the classifying of items (structures,
components and materials) and related services; and by the
organizations designing, manufacturing, installing and operating
items or performing support services for such items in the
specifying of applicable quality assurance activities that are to
be implemented.
The parts of the system should be developed to the degree

and sophistication necessary for the particular needs of the
project or organization. There are many methods and techniques
that may De used effectively and those of one organization may not
suit the purposes of another organization. It is important that
the methodology of the system is developed with sufficient
instructions documented to guide its consistent -and disciplined
execution.
CLASSIFICATION OF ITEMS AND SERVICES
Trie first element in the selective application system is the

method of classifying itams and services. A uniform metnod should
oe devised to identify constituent items and services of a nuclear
power plant and Co classify eacn item or service with regard to:
(a) the importance of the item or service to tne safe operation

of tne plant
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(b) the importance of the item or service to tne reliable
operation and satisfactory performance of the plant
(c) other factors, as appropriate, including

complexity, uniqueness or novelty of tne item or
service
tne need for special controls, administrative methods
and inspection of processes, methods and equipment
tne degree to which functional compliance can be
demonstrated by inspection and test
tne quality history and degree of standardization of
tne item or service
the accessibility of the item after installation in
tne plant for maintenance, in-service inspection,
replacement and under post accident conditions.
2.1 Identification of Items and Services
Tne development of a meaningful method of classification

snould begin by dividing the plant into its major systems. Further
dividing and subdividing these systems into basic units should
follow such that each unit is at its lowest level of assembly and
can be identified as a discrete item (structure, component or
material) or service.
Typical definitions for basic units are shown in Annex I.
2.2 Classification Methods and Techniques
The method of classification should allow each item or

service to be characterized witn respect to:
its function in the plant

the importance of the function to the safe and satisfactory
operation of the plant
tne importance of tne function to the satisfactory plant
performance
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trie relative complexity of tne item or service
the uniqueness, maturity and complexity of work, activities
which affect item or service quality.
Numerous techniques have been devised for use in classifying

items and services. Several of these are identified and
illustrated hereafter to show how classification may be
accomplished.
2.2.1 Classification by Function
Items and services can be classified with regard to

their function in the plant. Principal considerations are
whether the item or service is used: in an application
related to an engineering discipline such as mechanical,
electrical, civil-structural, etc; as part of a system or
as an individual item; as part of a fluid boundary or
non-boundary; or is subject to pressure and temperature or
not.
A technique for classification by function is shown in

Annex II.
2.2.2 Classification by Safety and Operational Importance

the importance of the function each performs in the overall
safe and satisfactory operation of the nuclear power plant.
Typical techniques for classifying items and services in
relation to tnese considerations are as follows:
(a) Quality Group Classification

Classification techniques tnat have been developed to
grade quality have, for the most part, been defined in
terms of the application or end-use of the item or the
rales to be followed in producing the item. One such
technique is shown in Annex III a. Another is shown
in Annex III b.
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(b) Safety Classification
Items that are called upon to perform functions that
ara important to safety nave also been classified with
respect to the relative importance of tne safety
function to be performed. Techniques for safety
classification of items and services for various types
of nuclear power plants and examples of classification
criteria used by Member States, are shown in IAEA
Safety Guide No. 50-SG-D1 "Safety Functions and
Component Classification for 3WR, PWR and PTR".
(c) Seismic Classification

Items that are called upon to perform their safety
function following earthquakes have also been
classified based upon the capabilities which must be
retained after earthquakes of a given severity level.
A technique for seismic classification is shown in
Annex III c.
2.2.3 Classification by Item or Service Complexity
Items and services can be classified in accordance

with the complexity of their inherent characteristics, which
are, for example: the number of close tolerances; the
number of moving parts; and the requirements for leak
.tightness, strength, resistance to corrosion, physical and
metallurgical properties etc.
A technique for classification of items and services

by complexity of characteristics is described in Annex IV.
2.2.4 Classification by the Uniqueness, Maturity and Complexity of

Quality-Affecting Work Activities
Activities affecting quality have been identified in

the Code as including designing, purchasing, fabricating,
manufacturing, handling, shipping, storing, cleaning,
erecting, installing, inspecting, testing, commissioning,
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operating, maintaining, repairing, refuelling, modifying and
decommissioning. These are tne activities which must be
controlled and verified.
The following sub-sections describe examples of

classification of items and services oy tne uniqueness,
maturity and complexity of quality-affecting work, activities.
a. Designing

the relative difficulty and overall complexity of the
design process. Classification should consider
whether complex design activities such as performance
of safety, seismic and stress analyses, metallurgical
and environmental analyses, etc. need to be performed.
A further consideration in classifying items and

services is also the extent to which the design
process, although complex, is well established and
proven.
A technique for classifying items and services on the

basis of complexity and maturity of the design process
used by the item or service manufacturer is
illustrated in Annex V a.
b. Production of Items and Performance of Services
Items and services can be classified according to the

complexity and maturity of the production activities.
For example the production activities aiay be
classified according to complexity such as: the
number of different processes involved, tne degree of
difficulty associated witn each process and with
achieving and verifying item or service quality
cnaracteristics. Items and services may also be
classified in relation to the extent to which the
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production processes have been proven by previous
experience.
A general technique for classifying items and services

based on production process complexity and maturity is
illustrated in Annex V b.
A further technique for classifying items and services

based on design and production process complexity and
maturity is illustrated in Annex V c.
Handling, Storing, Cleaning
Items and services can be classified according to the

activities necessary to preserve quality
characteristics subsequent to production. For example
items and services can be classified with respect to
the need for: housekeeping for cleanness on the
construction site; protection during packaging,
shipping, receiving, storing and handling; and
cleanness during installation and testing.
Examples of criteria for classifying items and

services in these areas are illustrated in Annexes V
d, V e and V f.
3. GRADING OF QUALITY ASSURANCE ACTIVITIES
The second element in the selective application system is a

method of grading quality assurance activities. Subsequent parts
of this section provide guidance on the development of a method of
grading quality assurance activities and defining appropriate
requirements for these activities in a set of specifications.
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3.1 Sasic Types of Quality Assurance Activities
The applicable quality assurance activities for eacn item or

service »ill normally consist of two basic types. These have been
characterized as programmatic activities and work-oriented
activities.
The quality assurance programmatic activities encompass the

activities of an administrative or management nature that are
necessary for ensuring that an appropriate quality assurance
programme is established and effectively executed. Included are
activities associated with the establishment of the programme and
its management; and the control of quality-affecting work
activities during design, procurement, manufacture, construction
and operation. An example of a programmatic activity is a system
of document control.
The quality assurance work-oriented activities are technical

in nature and are normally covered by the procedures for carrying
out tne work (e.g. welding procedures) and the procedures for
verification of the quality of the work (e.g. NDE procedures).
However, it should be recognized that programmatic

activities and work oriented activities do not normally stay in
isolation of each other. For an item or service the proper
combination of progratnmatic and work oriented activities
constitutes the applicable quality assurance activities.
3.2 Grading of Quality Assurance Programmatic Activities
The development of a metnod for grading the quality

assurance programmatic activities begins with the assumption that
for each item or service tnere is a group of programmatic
activities that snould be delegated to the suppliers of items or
services for implementation. The scope of tnese activities snould
be identified, based upon the safety and otner characteristics of
tne item or service. Grading of quality assurance programmatic
activities consist mainly in identification and grouping of tnose
activities appropriate to the item or servies.
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3.2.1 Identifying of the Activities
The grading of quality assurance programmatic

activities should begin with the recognition that the
principal requirements of a quality assurance programme are
those defined in the Code and illustrated in Annex VI.
Hence any method of grading should start with a review of
these principal requirements, to consider first whether they
are applicaole to the specific item or service and then if a
selecting of these applicable would be appropriate to the
needs of tne nuclear power plant. For example establisnment
of a programme whicn deletes the requirements of Design
Control and/or Audits may be considered in manufacture of
those items which are of a standard design and which quality
can be verified by final inspection.
In the selection process, however, it must be

recognized that eacn principal requirement does not normally
stand in isolation of others, e.g. Design Control is related
to Document Control since both are usually needed for
adequate control and verification of designing.
As described above, the programmatic activities

include those which are necessary to ensure that an
appropriate quality assurance programme is established and
effectively executed, and those that are necessary for
control and verification of implementation of principal
programme requirements.
The method of grading snould reflect consideration of

each of these two types of programmatic activities and the
relationships between the principal requirements relevant to
eacn type.
Tae following relationships of programmatic activities

and principal programme requirements should be establisned.
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a. Programme management activities that are necessary to
ensure that trie appropriate quality assurance
programme is established and effectively executed
during design, procurement, manufacture, construction
and operation include:
(1) Quality assurance programme establishment and
documentation
(2) Organization structuring and assignment of
responsibilities
(3) Document control procedures preparation
(4) Non-conformance control procedures preparation
(5) Corrective action procedures preparation
(6) Records procedures preparation
(7) Audits procedures and schedules.
b. Control and verification activities that are necessary

for control and verification of activities of:
o Designing
(1) Document control
(2) Design control,
o Procuring
(1) Procurement control
(2) Material control
(3) Inspection and test control,
o Manufacturing
(3) Process control
(4) Inspection and test control
o Constructing
(3) Process control
(4) Inspection and test control,
o Operating
(1) Document control
(2) Design control
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(5) Process control
(3) Inspection and test control.
Having reviewed and selected the appropriate principal

quality assurance programme requirements and identified
respective programmatic activities, it may also be
advantageous to divide and sub-divide each activity into its
constituent detail parts and consider whether an
implementation of these parts or sub-activities would be
appropriate.
Annex VII is an illustration of the division and

sub-division of the principal programmatic activities
involved in both ensuring the establishment and effective
execution of a quality assurance programme, and in the
control and verification of programme requirements during
design, procurement, manufacture, construction and operation.
The next step in the grading of programmatic

activities is to structure a group of activities, consisting
of principal and detail parts, such that each group of
activities has a general application to a range of items and
services. The final objective should be to devise a set of
activity groups wnich will provide for relevant quality
assurance programmatic activities to be'applied, as a
minimum, to all items and services of the nuclear power
plant which are important to safety.
Some organizations have found that thi^ can be

accomplished witn as few as three groups of activities,
wnile others have found a need for up to nine or more. The
actual number is not as important as it is to have the set
divided sufficiently to meet the particular needs of the
project or organization making the selection such that for
each item or service it is readily perceivable which of the
groups of activities is generally applicable. It is
important to remember that the compliance of the supplier
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with the requirements for the group of activities specified
for his implementation will be verified through a process of
evaluation and audit. Since this process contains a large
element of subjectivity there should be measurable
differences between each grouping of activities.
3.2.2 specifying the Requirements for tne Activities
Having structured the programmatic activity groupings,

it is then useful to identify and specify the appropriate
specific requirements for the activities of each group or
type of programme. To accomplish this identification and
specification of requirements it may be advantageous to
réfère to national or international standards on quality
assurance. In some cases it may be appropriate to prepare a
company or project specification invoking none of the
available codes and standards or to use a combination of
techniques in order to provide the full range of programme
types that are needed.
Annex VIII a illustrates one set of activity groupings

or types of programmes that has been used to establish the
oaseline group of applicable quality assurance programme
activities for items and services of a nuclear power plant.
It provides six types of programmes that vary widely in
content from a programme having a very broad inclusive group
of programmatic activities to the opposite extreme of a
programme naving no programmatic activities.
Annexes VIII b and c illustrate other techniques that

have been used to identify the appropriate principal quality
assurance programmatic activities applicable to various
quality-affecting work activities.
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3.3 Grading of Quality Assurance Work-Oriented Activities
The development of a method for grading the quality

assurance work.-oriented activities also begins with the assumption
that for eacn item or service there is a group of work-oriented
activities that snoald oe implemented by the purchaser and the
supplier to control and verify the attainment of quality
objectives. The scope of tnese work-oriented activities should be
identified and will vary oased upon safety and other
characteristics of the item or service. Accordingly, a carefully
structured set of work-oriented activity groupings can be devised
such that one of the groups of activities defines the appropriate
level of control and verification effort that is generally
applicable to a range of items or services. Each group of
activities results in a particular level of control and
verification effort.
3.3.1 Organizing and Grading the Activities
Factors,to be considered in determining the

appropriate activities to be applied in each level of
control and verification effort have been defined in various
national and international standards. These factors include:
a. Amount and Content of Procedures and Instructions

Procedures and instructions should be prepared for the
activities to the extent necessary for correct
performance of the work. The content of these
documents should be such as to provide qualified
individuals with the information needed for
satisfactory performance of assigned tasks.
o. Metnods of Verification
Verification for tne purpose of acceptance of items
and services may consist of source verification;
shipping inspection; receiving inspection;
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supplier's certificate of conformance; inspection or
test daring and following fabrication, assembly,
installation or maintenance or any combination thereof,
c. Extent of Verification
Extent of verification may vary from a sampling
in-process inspection up to an elaborate system of
inspections.
d. Independent Verifications
The need f o r , and extent of, independent verifications
by third party organizations should be evaluated.
e. Quality Assurance Records

Tae need for records should be evaluated in order to
assure the availability of needed information and to
avoid over-documentation.
Annex VIII d illustrates one set of activity groupings

or levels of effort that has been used to establish tne
baseline group of applicaole quality assurance work-oriented
activities for items and services of a nuclear power plant.
It provides six levels of control and verification effort
that vary widely in content from a very comprehensive
interaction between the purchaser and the supplier, to the
opposite extreme where only an initial interaction between
the two organizations and a final inspection by the
purchaser of the completed item or service takes place.
3.3.2 Specifying the Requirements for the Activities
The applicable work-oriented activities in each level

of control and verification e f f o r t and the requirements for
tnose activities should be specific with regard to the
individual characteristics of tne item or service. They are
specified through the application of engineering standards
and competent engineering judgements.
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CORRELATION OF APPLICABLE QUALITY ASSURANCE ACTIVITIES WITH ITEMS
AND SERVICES
The third element of the selective application system is a

method of correlating items and services with applicable quality
assurance activities by bringing together the item or service
classification and the graded quality assurance activities. It
should properly relate a classified item or service with the
appropriate group of applicable quality assurance activities.
Several techniques can be used to establish this correlation.
One technique is illustrated in Annex IX a. In this

illustration the desired correlation is accomplisned through the
preparation of a set of taoles. Tue tables are constructed to
relate the item or service (by its basic unit) to its
classification in terms of function, importance of function to safe
and satisfactory operation, and its production category reflecting
the relative complexity of the item or service and the uniqueness,
maturity and complexity of work activities which affect the quality
of the item or service. At each line-column intersection,
representing an item or service and its potential classification,
is placed the identifying number for the appropriate group of
quality assurance programmatic activities or programme type and the
appropriate level of control and verification effort that is
generally applicable to such an item or service. The baseline
group of quality assurance activities that is generally applicable
to the item or service is the composite of the set of groups of
programmatic activities and the selected level of control and
verification effort.
Alternatively separate correlation tables can be constructed

to identify:
(a) the generally applicable group of quality assurance
programmatic activities and
(b) the generally applicable work-oriented activities
representing selected level of control and verifications
efforts.
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A composite of the activities obtained from each set of
tables defines the oaseline group of generally applicable quality
assurance activities.
A. set of correlation tables constructed as described may be

simple or complex depending upon the number of classifying
characteristics determined to be needed or desirable.
Another technique for preparing such a correlation is

illustrated in Annex IX b. In this illustration items are related
to quality assurance activities only on the basis of importance of
function to safe operation.
5. ADAPTATION OF SELECTED QUALITY ASSURANCE ACTIVITIES
The fourth element of tne selective application system is a

method of adapting the baseline group of quality assurance
activities, that has been selected, to the unique needs of the
items or services. The method of adaptation should reflect that
the baseline group of quality assurance activities is only the
beginning point for specifically defining the applicable quality
assurance requirements for an item or service. It may be
appropriate to select a more rigorous or less rigorous type of
programme or level of effort or other baseline group of activities
based on further consideration of characteristics identified during
classification of the item or service. In addition, other
considerations not ta&en into account during classification such as
unique or special features, intended function, or method of
acquisition may require that tne baseline group of quality
assurance activities are alterei, supplemented or completely
cnanged.
The method of adaptation should also reflect that under

certain conditions, the assignment of quality assurance activities
to some lower-tier programme participants may not be appropriate.
In such cases, it may be more effective for the purchaser of the
item or service to obtain the necessary level of confidence that
24
the requirements have been met by performing certain activities
himself. For instance, if the item being furnisned is a standard
mass-produced item, it may be more effective for the purchaser to
perform receiving inspection to screen out inferior items rather
than requiring the supplier to perform additional activities in his
shop. Eacn situation with regard to individual items and services
should be considered on its own merit and the applicable quality
assurance activities selected accordingly.
SPECIFYING OF APPLICABLE QUALITY ASSURANCE ACTIVITIES
The fifth element in the selective application system is a

method of specifying the applicable quality assurance activities
and requirements for those activities to be invoked in bid
specifications of a contract. The method should include
instructions as to the format and content of the requirements
specification.
Annex X illustrates a typical format for such a

specification. When using such a format, the requirements for
quality assurance programmatic activities are defined under the
neading, quality assurance programme, and should begin witn an
identification of the scope of application of the programme,
followed by a definition of the content of the programme in terms
of tne required activities and requirements for those activities.
This definition may be provided by invoking a reference document.
The requirements for quality assurance work-oriented

activities are defined under the neading, conformance control and
verification, and should address the specific actions that are to
be performed to control and verify that work activities have been
correctly performed and that quality objectives have been
attained. In specifying worn-oriented activities, care should be
exercised to clearly identify acceptance criteria for the required
reviews, inspections, examinations, or tests. The definition of
required work-oriented activities may also be provided by invoking
3. reference document.
25
The identification of actions to be performed by the
purchaser is optional, however, it may significantly enhance the
working relationship estaalished between the purchaser and tne
supplier. Actions by the purcnaser are described under the
heading, purchaser's actions. The supplier is ordinarily required
to notify the purchaser at a designated witness point. However,
the supplier is not prevented f r o m continuing in his work process
by tne purcnaser's actions. Tne supplier is also required to
n o t i f y tne purcnaser at a nold-point and the supplier may not
proceed beyond tne nold-point until specifically permitted to do so
by the purchaser.
When applicable quality assurance activities and

requirements for those activities are defined by invoking an
appropriate reference document, the reference to the document
should be complete and specific, including specific reference to
section, sub-section and paragraphs that apply. To the maximum
extent possible, the whole document, appropriate sections or
paragraphs should be invoked. The requirements should include
modifications, additions or deletions to the reference document as
appropriate.
When specifying standards, one must be aware that in some

cases the standard may leave the specification of certain
requirements to the purchaser. Therefore, additional details may
be required such as: access to supplier facilities; documentation
submittals and approvals; and transfer of requirements to
lower-tier suppliers.
7. SELECTIVE APPLICATION 3Y3TEMS
Earlier sections of this document have each provided

guidance and illustrations on oietnods and tecnniques that might be
useful to an organization or project in the development of the five
elements of a selective application system. However, to develop an
e f f e c t i v e system the five elements oiust be united to provide an
integrated system.
26
The following examples are provided to illustrate two such
systems:

Using Standards of the American National Standards Institute
Annex XI a illustrates an integrated selective application

system tnat nas been used for a nuclear power plant project. In
this illustration tne grading of quality assurance activities and
the specifying of requirements for tnose activities has been
accomplished by combining various parts of AN5I/ASME NQA-1 and the
uni re. or po rated daughter standards of ANSI/ASME NQA-2.

Using Standards of the Canadian Standards Association
Annex XI b illustrates another type of an integrated

selective application system that may be used for a nuclear power
plant project for identifying and specifying applicable quality
assurance activities for the manufacture of items and the
performance of related services. In this illustration the grading
of quality assurance activities and the specifying of requirements
for tnose activities has been accomplished by use of various
standards in tne CSA Z299 and N23o series.
27
ANNEX I
TYPICAL DEFINITIONS FOR BASIC PLANT UNITS
29
ANNEX l
TYPICAL DEFINITIONS FOR BASIC PLANT UNITS
STRUCTURE - Parts of the plant that are made up of systems, components, or

materials which are usually massive or static in nature, may
provide a supportive or load-bearing function, or may serve as
an enclosure. Examples of structures are building foundations,
radiation shields, and equipment supports and enclosures.
COMPONENT - An assembly of interconnected parts which constitute an identi-

fiable device, instrument, or piece of equipment. A component
can be removed and replaced as a unit. It has definable per-
formance characteristics which permit it to be tested as a unit.
Examples of components are pumps, valves, piping and vessels.
MATERIAL - A substance or combination of substances used in forming structures,

components, parts, and equipment. Examples of material are plate,
pipe, aggregate, bar, wire and conduit.
SERVICE - The performance by a supplier of activities such as design, fabri-

cation, inspection, nondestructive examination, repair, or installation
30
ANNEX II
BY FUNCTION
31
ANNEX II
an Example of
CLASSIFICATION OF ITEMS AND SERVICES BY FUNCTION
Engineering Discipline Application - Parts of the plant perform basic engineering

functions. These are characterized as mechanical, electrical, instrumentation and
control or civil-structural.
Plant Application - Parts of the plant may perform their functions as a system or
as a non-system. Mechanical functions are performed by fluid systems or by
non-fluid systems. Electrical, instrumentation and control functions are performed
by electrical, hydraulic or pneumatic systems "and civil-structural functions are
performed by soils, concrete and metal.
System Application - Plant systems are divided according to coolant or non-coolant

service. A coolant system is comprised of structures, components or materials that
come in direct contact with coolant, including those items which form an integral
part of structures, components, or materials which come in contact with coolant.
Pressure Application - Pressure applications are divided according to fluid

boundary or non-fluid boundary service. The fluid boundary is that portion of
structures, components and materials which contacts and confines fluid or by
which fluid passes.
Temperature Application - Temperature applications are divided according to

high and low temperature service.
32
ANNEX III
BY IMPORTANCE OF FUNCTION
33
ANNEX III a
an Example of
CLASSIFICATION OF ITEMS AND SERVICES BY IMPORTANCE OF FUNCTION
(Quality Grouping)
CATEGORY DESCRIPTION DEFINITION
I Permanent Plant-Safety Structures, systems and components that

Related prevent or mitigate the consequences of
postulated accidents that could cause
undue risk to the health and safety of
the p u b l i c (e.g., PHTS Components).
II Permanent Plant-Oper- Structures, systems and components not
ationally Significant covered in I above» but whose failure to
function at full design rating w i l l
effect the ability of the plant to func-
tion at its designed rating and which are
not essential for a safe shutdown or
shutdown heat removal. Failure of the
items in this category would not endanger
p u b l i c safety (e.g., Turbine Generator
and associated service equipment).
Ill Permanent Plant-Non- Structures, systems and components whose
Operationolly Related failure to function would not cause dam-
age to safety-class structures, systems
or components. This category covers
items used to support normal plant oper-
ations, but are not essential to the
a b i l i t y of the plant to function at its
designed rating; do not contain radio-
active material; or whose failure could
not result in the release of radioactive
material (e.g., A d m i n i s t r a t i v e b u i l d i n g ,
yard drains, parking lot).
IV Non-Permanent Plant Non-permanent plant structures, systems
and components required for plant con-
struction activities which do not become
part of the permanent plant. This cata-
gory includes site preparation and im-
provement a c t i v i t i e s (e.g., temporary
construction equipment and buildings).
34
ANNEX III b
an Example of
CLASSIFICATION OF ITEÜS AND SEKVICES BY IMPORTANCE OF FUNCTION
(Quality Grouping)
Quality Category Definitions

A The confinement barriers for radioactive materials
and their essential primary supporting services
which cannot be repaired, replaced, or shut down
to a safe mode in case of malfunction or failure
within the time required to prevent an undue risk
to the health and safety of plant personnel or the
public.
B The confinement barriers for radioactive materials

and their essential primary supporting services
which can be repaired, replaced, or shut down to a
safe mode in case of malfunction or failure within
.the time required to prevent ah undue risk to the
health and safety of plant personnel or the public.
C Those components» systems, and structures which

are not included in Category A or B; however,
because of design and fabrication complexity,
accessibility for repair and maintenance, SNM
Accounting, Security, or other considerations, the
owner elects to impose specific quality requirements.
D Those components., systems, and structures which

are not classified as A, B, or C above.
35
ANNEX 111 c
an Example of
CLASSIFICATION OF ITEMS AND SERVICES BY IMPORTANCE OF FUNCTION
(Seismic)
SEISMIC CATEGORY DEFINITION
Those structures, systems and components that are

important to safety that are to remain functional
in the event of a safe shutdown earthquake (SSE).
II Those structures, systems and components not in

Category I that are important to continued plant
operation and to protect plant investment in the
event of an operating basis earthquake (.OBP).
Ill Those structures, systems and components hot in

Category I or II that are important to maintain-
ing support of normal plant operations.
36
ANNEX IV
BY COMPLEXITY OF CHARACTERISTICS
37
ANNEX IV
an Example of
BY COMPLEXITY OF CHARACTERISTICS
Item or service has no tight or interrelated characteristics
Item or service has only a few tight or interrelated characteristics
Item or service has a few tight and interrelated characteristics
Item or service has a significant number of tight and interrelated

characteristics
Item or service has a large number of tight and interrelated

characteristics
38
ANNEX V
BY UNIQUENESS, MATURITY AND COMPLEXITY
OF QUALITY-AFFECTING WORK ACTIVITIES
39
ANNEX V a
an Example of
BY QUALITY-AFFECTING WORK ACTIVITIES
(Design for Manufacture)
Complexity of Design of Item or Service
Design effort is minimal and simple

Design effort is significant but simple
Design effort is significant and presents some complexity
Design effort is extensive or complex
Design effort is extensive and complex
Maturity of Design of Item or Service
Proven design available

Combination of proven design elements for same application
Modification of proven design for a different application
Redesign of existing item for a different application
New design from first principles of a complex item
40
ANNEX V b
an Example of
BY QUALITY-AFFECTING WORK ACTIVITIES
(Manufacturing)
Complexity of Manufacture of Item or Service
Few simple processes* required
Significant number of simple processes required
Few complex processes required
Significant number of complex processes required
Large number of complex processes required
*) Processes: manufacturing, inspecting, testing,

assembling, constructing or any other
applicable activity
41
ANNEX V c
an Example of
BY UNIQUENESS, MATURITY AND COMPLEXITY
OF QUALITY-AFFECTING WORK ACTIVITIES
(Design and Manufacturing)
Engineered Unit - An engineered unit is one that requires a significant amount

of design engineering to be performed in order to define and specify the charac-
teristics of the item and the methods or processes to be performed to produce
the item. Engineered units are usually complex in nature and are designed to
meet the performance requirements of a particular application or service.
Pre-Engineered Unit - A pre-ëngineered unit is one that is fabricated, manufac-

tured or assembled in accordance with existing drawings, specifications and
instructions for the item. Pre-engineered units are usually complex in nature
and have been designed to meet the performance requirements of a particular
application or service and is supplied when ordered-from the existing design.
Custom Unit - A custom unit is one that is manufactured and furnished when
ordered by a customer. It usually is furnished in accordance with the manufac-
turer's plans and specifications plus manufacturer-offered options to meet a
particular set of performance requirements. Requirements specified by the
customer are usually chosen from selected parameters within established ranges
designated by the manufacturer.
Standard Unit - A standard unit is one that is produced in mass quantity according
to plans and specifications of the manufacturer by a routine production process.
42
ANïîEX V c (oont.)
Standard units are usually produced in accordance with a standard specification

and may be identified by catalogue number or other standard designation. These
units are usually high volume production items, but may be produced through batch
or continuous production operation.
ANNEX V d
an Example of
BY QUALITY-RELATED WORK ACTIVITIES
(Housekeeping for Site Cleanliness Control)
ZONES
RESTRICTION LIST —
I II III IV V
CLOTHING CHANGE YES No No No No
CLEAN GLOVES, SHOE COVERS, YES YES No No No
HEAD COVERING
FILTERED AIR YES No No No No
MATERIAL PRECLEAMING YES No No No" No
MATERIAL ACCOUNTABILITY YES YES YES No No
PERSONNEL ACCOUNTABILITY YES YES YES No No
NO USE OF TOBACCO OR EATING YES YES YES YES No
43
ANNEX V e
an Example of
CLASSIFICATION OF ITEMS AND SERVICES BY QUALITY-RELATED WORK ACTIVITIES
(Protection during Packaging, Shipping, Receiving, Storage
and Handling)
EVEL DEFINITION EXAMPLFS

Level A items are those that are Level A items are:
exceptionally sensitive to environ- 1. Special electronic equipment and
mental contitions and require special instrumentation.
measures for protection from one or 2. Special materials, such as chemicals,
more of the following effects: tem- that are sensitive to environment.
peratures outside required limits, 3. Special nuclear material (fuel) and
sudden temperature changes, humidity sources. The requirements of the
and vapors, gravitational (g) forces, NRC fuel license and conditions
physical damage, and airborne contam- and other governmental agencies
ination (e.g., rain, snow, dust, salt shall be met.
spray, fumes).___________ __
Level 8 items are those that are sen- Level B items are:
sitive to environmental conditions 1. Instrumentation
and require measures for protection 2. Electrical penetrations
from the effects of temperature ex- 3. Batteries
tremes, humidity and vapors, acceler- 4. Welding electrode and wire
ation forces, physical damage, and 5. Control rod drives
airborne contamination and do not 6. Motor control centers, switchgear and
require special protection required control panels
for Level A items. 7. Motors and generators
8. Precision machined parts
9. Spares, such as gaskets, "o" rings
10. Air handling filters
11.. Computers__________________
Level C items are those that require Level C items are:
protection from exposure to the envi- 1. Pumps
ronment, airborne'contaminants, acceV 2. Valves
eration forces', and physical damage. 3. Fluid filters
Protection from water vapor and con- 4. Reactor internals
densation is not as important as that 5. Compressors
for Level B items. 6. Auxiliary turbines
7. Instrument cable
8. Refueling equipment
9. Thermal insulation
10. Fans and blowers
11. Cement_____ __
Level D items are those that are less Level D items are:
sensitive to the encironment than 1. Tanks
Level C. These items require protec- 2. Heat exchangers and parts
tion against the weather, accelera- 3. Accumulators
tion forces, airborne contamination, 4. Démineraiizers
and physical damage. 5. Reactor vessel
6. Evaporators
7. Steam generators
8. Pressurizer
9. Piping
10. Electrical cable
11. Structural itess
12. Reinforcing steel
13. Aggregates__________
44
ANNEX V f
an Example of
CLASSIFICATION OF ITEMS AND SERVICES E.Y QUALITY-RELATED WORK ACTIVITIES
(Cleanness)
CLASS DEFINITION EXAMPLE

A very high level of cleanness in which there is no evidence Class A cleanness applies to special items such
of contamination of a surface either under visual examina- as fuel elements, control rod drive mechanisms,
tion, with or without magnification, or v;ith the aid of delecate instruments, and other close tolerances
sensitive detection methods. or carefully controlled surfaces or assemblies.
Such items should receive their required level
of cleanness at the point of manufacture and
cleanness must be maintained at the construction
site.
A high level of cleanness in which: Class 0 cleanness applicable to reactor coolant
1. The surface shall appear "metal clean" when examined systems, components, and other items, such as
without magnification under a lighting level of 100 the reactor coolant purification system, which
foot candles. Scattered areas of rust are permissible, have similar cleanness requirements.
provided the aggregate area of rust does not exceed 2
square inches in any one square foot area.
2. The surface shall be free of particulate contaminants
such as sand, metal chips, weld slag, etc.
3. The surface shall be free of organic films and contam-
inants such as oils, paint, and preservatives.
An intermediate level of cleanness meeting the requirements Class C cleanness generally applicable to closed
of Class ß cleanness except: service-water systems that cool components con-
1. Thin uniform rust films are acceptable on carbon steel taining reactor coolant, engineered safety
surfaces. systems, and other high integrity systems.
2. Scattered areas of rust are permissible provided that
the area of rust docs not exceed 15 square inches in
any 1 square foot on corrosion resistant alloys.
A nominal degree of cleanness in which the following are Class D cleanness applicable to fire-protection,
acceptable: open service water, and similar systems.
1. Tightly adherent mill scale on carbon steel surfaces.
2. Paint or preservative coatings on carbon steel surfaces
that will not peel or flake when exposed to cold-water
flushing.
Rust films on carbon steel and stainless steel surfaces
that resist removal by scrubbing with a bristle brush.
ANNEX VI
PRINCIPAL ACTIVITIES OF A
QUALITY ASSURANCE PROGRAMME
47
ANNEX VI
PRINCIPAL ACTIVITIES OF A
AS DEFINED IN THE CODE (50-C-QA)
1. Quality Assurance Programme
2. Organization
3. Document Control
4. Design Control
5. Procurement Control
6. Material Control
7. Process Control
8. Inspection and Test Control
9. Non-Conformance Control
10. Corrective Actions
11. Records
12. Audits
48
ANNEX VII
ORGANIZATION OF QUALITY ASSURANCE
PROGRAMME ACTIVITIES
49
ANNEX VII
an Example of
ORGANIZATION OF QUALITY ASSURANCE PROGRAMME ACTIVITIES
OVER At L PROGRAMME
• OBJECTIVES
• RESPONSIBILITIES
• REQUIREMENTS
• CONTROL
PROGRAMME MANAGEMENT
> QUALITY ASSURANCE PROGRAMME • AUDITS AND REVIEWS • REPORTING

- PI ANHING AND DESIGNING - PROGRAMME AUDITS - QUALITY STATUS
- DEVELOPING - MANAGEMENT REVIEWS - PROGRAMME STATUS AND ADEQUACY
- DOCUMENTING
' ORGANIZATION • NON CONFORMANCE CONTROL • RECORDS
- STRUCTURING - IDENTIFICATION - RECORDS PREPARATION
DOCUMENTING - DOCUMENTATION - RECORDS MANAGEMENT
- STAFFING AND TRAINING - REVIEW AND DISPOSITION
' DOCUMENT CONTROL • CORRECTIVE ACTION
- PREPARATION REVIEW AND APPROVAL - REVIEW
- ISSUE AND DISTRIBUTION - TREND ANALYSIS
- CHANGE CONTROL - CORRECTION
•J AND\r •J ANot^
DESIGN PROCUREMENT MANUFACTURING CONSTRUCTION OPERATION
> DESIGN INPUT REQUIREMENTS PLANNING • MANUFACTURING PROCESS PLANNING AND • GENERAL ACTIVITIES • GENERAL ACTIVITIES
Cfi CHANGE CONTROL
• RESPONSIBILITIES AND REQUIREMENTS PROCUREMENT DOCUMENT PREPARATION - PLANNING - PLANNING
O
CHECK AND VERIFICATION REVIEW AND CHANGE CONTROL - IDENTIFICATION OF REQUIREMENTS - PROCEDURES PREPARATION - PROCEDURES PREPARATION
- IDENTIFICATION Of PROCESSES - HOUSEKEEPING - PERSONNEL TRAINING AND CERTIFICATION
• DESIGN PROCESS PLANNING AND CONTENT OF PROCUREMENT DOCUMENTS
- PROCESS QUALIFICATION - RECEIVING. STORAGE AND HANDLING • OPERATIONAL CONTROL
PERFORMANCE PROCUREMENT DOCUMENT CONTROL
- PERSONNEL QUALIFICATION - CLEANING AND CIEANESS CONTROL - OPERATION CONTROL
• DESIGN ANALYSIS SEI FCTION OF PROCUREMENT SOURCES
- PLANS AND PROCEDURES - CONTROL OF PROTECTIVE COATINGS - MAINTENANCE CONTROL
• DRAWINGS REVIEW OF PAST PERFORMANCE
- CHANGE CONTROL - MEASURING AND TEST EQUIPMENT - MODIFICATION CONTROL
• SPECIFICATIONS AND OTHER DOCUMENTS EVALUATION OF FACILITIES AND PERSONNEL
• DOCUMENT CONTROL CONTROL • MATFRIAL PROCUREMENT CONTROL
• DESIGN INTERFACES CONTROL EVALUATION OF QUALITY ASSURANCE
• PROCUREMENT CONTROL - QUALIFICATION AND CERTIFICATION OF - PHOCURFMENT
• DURING DESIGN PROCESS PROGRAMME
• ITEMS IDENTIFICATION CONTROL PERSONNEL
BID EVALUATION AND AWARD - REVIEWING
• DURING MANUFACTURING PHASE - CHANGE CONTROL
- BID REVIEW • INSPECTION AND TEST CONTROL ' - STORAGE
• DURING ERECTION AND TESTING • INSTALLATION. INSPECTION AND TESTING
- SUPPLIER SELECTION - PROCEDURES AND INSTRUCTIONS • INSPECTION AND TESTING
> DESIGN VERIFICATION OF CONCRETE AND STRUCTURAL STEEL
- CONTRACT AWARD - INSPECTION - PLANNING AND SCHEDULING
DESIGN REVIEWS - PRECONSTRUCTION VERIFICATION
PURCHASER EVALUATION OF SUPPLIER - TESTING - IN PROCESS INSPECTION AND TESTING OF - INSPECTION
ALTERNATE CALCULATIONS PERFORMANCE - RESULTS EVALUATION AND REPORTING - TESTING
CONCRETE
• auA.uricA.Ttou TESTING - PURCHASER AND SUPPLIER COORDINATION • MEASURING AN» TEST EQUIPMENT - INSPECTION OF STEEL CONSTRUCTION - INSTRUMENT CALIBRATION
' DESIGN CHANGES CONTROL - CONTROL OF SUPPLIER GENERATED CALIBRATION AND CONTROL - INSPECTION AND TEST EQUIPMENT
• INSTALLATION. INSPECTION AND TESTING
• DESIGN CHANGES DOCUMENTS • MANUFACTURING EQUIPMENT CONTROL OF MECHANICAL EQUIPMENT AND SYSTEMS CALIBRATION
• SHOP AND FIELD CHANGES - CONTROL OF CHANGES TO ITEMS OR • HANDLING. STORAGE AND SHIPPING - PRE INSTALLATION VERIFICATION - RESULTS EVALUATION AND REPORTING
• OPERATIONAL CHANGES SERVICES - HANDLING - INSTALLATION PROCESS CONTROL • NON CONFORMANCE CONTROL
VERIFICATION ACTIVITIES BY PURCHASER - STORAGE - INSTALLED SYSTEMS INSPECTIONS AND - IDENTIFICATION AND DOCUMENTATION
- PLANNING - SHIPPING TESTS - REVIEW AND DISPOSITION
- SOURCE VERIFICATION RECEIVING • NON-CONFORMANCE CONTROL • INSTALLATION, INSPECTION AND TESTING
INSPECTION • REVIEWS
- IDENTIFICATION AND DOCUMENTATION OF INSTRUMENTATION AND ELECTRICAL
- RtPORTING EQUIPMENT - MANAGEMENT REVIEWS
- SEGREGATION - INDEPENDENT REVIEWS
NON CONFORMANCE CONTROL AND - PRE INSTALLATION VERIFICATION
CORRECTIVE ACTION - REVIEW AND DISPOSITION
. - INSTALLATION PROCESS CONTROL
- NON CONFORMANCE CONTROL AND - INSTALLED SYSTEMS INSPECTIONS AND
DISPOSITION TESTS
- CORRECTIVE ACTION • INSPECTION AND TEST DATA ANALYSIS
ACCEPTANCE OF ITEMS AND SERVICES AND EVALUATION
- ACCEPTANCE BY SOURCE VERIFICATION • NON CONFOHMANCE CONTROL
ACCEPTANCE BY RECEIVING INSPECTION - IDENTIFICATION AND DOCUMENTATION
- ACCEPTANT BY SUPPLIER CERllFICATiON - SEGREGATION
- ACCEPTANCE BY POST INSTALLATION - REVIEW AND DISPOSITION
TESTS.
- ACCEPT, AN« or- stnvtcss ONLV
ANNEX VIII
GRADING OF QUALITY ASSURANCE ACTIVITIES
51
ANNEX VIII a
an Example of
(Programmatic by Programme Type)
IXPJL Scope of Activities

1 - Programme in accordance with ANSI/ASME NQA-1 Basic Requirements and Supplements, and ANSI M5. 2 Supporting
5ij\aclanl5.. This means any combination of programme requirements selected and specified by invoking all or part
of ANSI/ASME NQA-1 Basic Requirements and Supplements, plus suporting standards selected from the N'15.2 seried
(e.g., ANSI N'15.2.1, M5.2.2, N'15.2. 3, M5.2A, M5.2.5, M5.2.8, and N15.2.20). This also includes any com-
bination of selective application of N'15.2 supporting standards without the application 'of ANSI/ASME NQA-1 or
ANSI M5.2 itself (e.g., ANSI NM5.2.5 or N45.2.8 for inspection, examination or testing).
2 - Programme in accordance with ANSI/ ASHE^NQA-1 'BasAouRepJUinements, and Supplements. This means any combination of
programme requirements selected and specified by invoking all or part of ANSI/ASME NQA-1 (e.g., ANSI/ASME NQA-1
Basic Requirements 1, 2, 3, 4, 5, 6, 15, 16, 17, and 18, and Supplements S-1 , 1S-1, 2S-3, 3S-1 , 'IS-1 , 6S-1 ,
17S-1, and 18S-1 for Design Activities).
3 - Programme in accordance with ANSI/ASjjE NQA-1 JBgsjLC^ReAUiEemejita . This means any combination of programme
requirements selected and specified by invoking all or part of ANSI/ASME NQA-1 Basic Requirements (e.g.,
ANSI/ASI1E NQA-1 Basic Requirements 1, 2, 3, 4, 5, 6, 15, 16, 17, and 16 for Design, Activities).
4 - Programme in accordance with Project or Company Specification. This means any combination of programme
requirements specified through the invoking of a standard company specification, or written directly into the
equipment specification or other scope of work statement,
5 - Progranme in accordance with Hanjjfactut er1 s Standard .Practice. This means a control programme is required, but
the purchaser does not choose to define specific requirements. Usually, documentation defining or describing
the programme is required to be submitted to the purchaser for approval, for information, or for record
purposes. Included are programmes in which there are no special programmatic requirements, but there are
specific work-oriented requirements for inspections, examinations, or tests.
6 - Programme in which there are No„ Purchaser.^ Requirements. This means the manufacturer or performer has a
standard product or service which is produced or provided under its own quality assurance practices, and the
purchaser is willing to accept that product or service with no additional actions required of the supplier.
ANNEX VIII b
an Example of
(Programmacic)
3
Design/ rocure- Fabrication/ Operations Decannissioning
Engineering ment Construction
\ X. ACTIVITY
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BASIC REQUIREMENTS^ u <£ CD u a 3
0. CO Q t. Bf eu Û.H OHDioi STO
1. Organization X X X X X X - X X X X
2. Program X X X X X X - X X X X
3. Design Control X X X X X
1 X
1 - X X
4. Procurement
Document Control X X X X X X - - X X
5. Instructions,
Proc. & Drawings X X X X X X - X X X X
6. Document Control X X X X X X X X X X X
7. Control of Pur-
chased M a t l s . ,
2 2 2
etc. X X X — X X X — - X X
8. Identification &
Control of M a t l s . . , 1
Parts, etc. - X
1 X
~ X X X - X X
9. Control of Spec.
Processes - X
1 X
1 - X X X - - X X
10. Inspection - X
1 X
1 - X X X X X X X
11. Test Control - X

1 X
1 - X X - X X X X
12. Control of Meas.

& Test Equipment - X
1 X
1 - X X X X X X X
13. Hand ling, S t or age

& Shipping X
1 X
1 - X X X - X X X
14. Inspection Test &

Operation Status - - - - X X - X X X X
15. Nonconforming
M a t l s . , P a r t s , etc. - - - - X X X X X X X
16. Corrective Action X X X X X X X X X X X
17. Records X X X X X X - X X X X
18. A u d i t s X X X X X X - X X X X
NOTES :
1. Specific requirements to be implemented by others.
2. For procurement of design services.
53
AKÏ7SX VIII c
an Example of
(Programmatic by P rogramme Type)

Requirement Z-299-1 Z-293.2 Z-299-3 Z-299.*
Quality Program Assurance Control Verification Inspection
Organization 1 2 3 *
Quality Audits (Internal) 1
Quality Program Documents

Manual QA QC QV
inspection and Test Plan/Checklist 1 I 3
P rocedures/Desc r i pt i ons I 1 3
Records
- Inspection and Test 1 1 1 t

• Disposition of Non -Con form ing Items 1 1 1 4
* Feedback or Corrective Action 1 1 1
- Qualification of special processes, personnel, etc 1 1
- Audit and Analysts of Audit Data 1
System Functions
Contract Review 1
Design Assurance 1
Document Control 1 1 3
* Engineering Control 2 3 t-
Measuring and Testing Equipment 1 J 3 *
Purchasing ! I 3
Incoming Inspection (Including Test as appropriate) ! 1 3
In Process Inspection (including Test as appropriate) 1 1 1
Final Inspection (including Test as appropriate) 1 1 3 *
Inspection Status (including Test as appropriate) t 1 l
Identification and Traceability of Items 1 l 1
Handling and Storage 1 1
Manufacturing and Construction 1 1
Special Processes 1 1 1
Preservation, Packaging and Shipping 1 1 1
Quality Records 1 2 3 *
Non-Conforming Items 1 1 3 *
Customer Supplied Items 1 1 1 <t
Corrective Action 1
'
Verification of Quality by Customer
I n i t i a l Evaluation for Quality Program Capability QA QC QV

Inspection and Test Plan/Checklist Review and X X X
Acceptance
Continuing Evaluation and Verification X X X
Corrective Action (right to demand) X X X X
Access - audit X X X X
- survei 1 lance X X X X
legend: ' 'As required by CSA 2-299.1 4 - As required by CSA Z-23S.lt

2 - As required by CSA Z-299.J X - As appropriate
3 - As required by CSA Z-29J.J
Not presently required in Z 29 9 series

54
ANNEX VIII d
an Example of
(Work-Oriented by Level of Control and Verification Effort)
Scope of Activities
Joint review of requirements.
Review and approval of instructions, procedures, and drawings.
Review and approval of change proposals.
Review and approval of deviation proposals.
Monitor all production activities with resident representative.
Perform or witness all inspections, examinations, and tests.
Review and approve all inspection, examination, and test results.
Final inspection of completed item.
Review and approval of instructions, procedures, and drawings.
Monitor production activities with itinerate representative.
Perform or witness all inspections,- examinations, and tests.
Final inspection of completed units.
Review and approval of. instructions, procedures, and drawings.
Witness selected production activities at designated hold points.
Perform or witness selected inspections, examinations, and tests.
Final inspection of completed item.
Review and approve selected instructions, procedures, and
drawings.
Review and approval of selected change proposals.
Review and approval of selected deviation proposals.
Final inspection of completed unit.
Review and approve selected instructions, procedures, and
drawings.
Review and approve selected inspection, examination, and test
results.
55
ANNEX IX
CORRELATION OF ITEMS AND SERVICES
WITH QUALITY ASSURANCE ACTIVITIES
57
ANNEX IX a
an Example of
CORRELATION OF ITEMS AND SERVICES WITH QUALITY ASSURANCE ACTIVITIES
\ Disciplina Mochanicul
\ Application Fluid Systems
\ Sub Coolant System
\ Sub Fluid Boundary Non-Fluid Boundary
Sub
A High Température Low Temperature High Temperature Low Temperature
^\Sub Safety Non-Safety Safety Non-Safety Safety Non-Safety Safety. Non-Safety
TD
•f\ Prod. m
Cfl
oo
•ACot.
\
TJ
n>
a:c TJ
\
\ s;r u>
c
LU
E
o
*-*
ra
u
\ ut c
'o ô> D
m
^
1_
Plant Unit \^ Ul CL O C/)
NSSS
Strucluros 1 1 2 4
Compononts 1 1 2 4
Matorinls 1 1 2 4
Sorvicos 1 1 2 4
BOP
Structures 1 1 2 4
Components 0
1 1 2 4
Motorlols 1 1 2 4
Sorvicoo 1 1 2 4
NOTE: Numborn in Table rofor to quality assurance programme type and level of control and verification effort.
v
, ,, , , , , , , 2 Z2
1
O
Category I"
Seismic
- - - - - - - „ = —
jnntruction
.anda rds Ie)

rodes and
'rincipAl
X X x .
H I U l x . i t l l U) x , | IIU t U x, M
U
r* U w -4 •-• M. M U *r »^ M MU M U «r < »- <
y ">
XT)
W— tn i/: v.
4) t/t Z Z 2
k. V) fN fM ^ IN r« M f* fM •-* Z ZZ
tr> ^
o
fication ' c '
Quality
Classi-
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< H^
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ü ä * j « a a ^ T J
« a u « n c t i E E - ^c
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O 4 i x i t « j « - * « « e
ew o > .— u 4 « 4 t r > o« t1-*
u «—
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—
A J _ C J ^ « 4 B
« f - o .
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V ^ U i i c ^ ^ o t l ^ C b C V 4 J < ^ 0 ) ^ J J U )
T3-«wfi n*'*- r - * c c e u *j a.ß.-*u «-Ê ifa u. ^ (~u.

« —Œ « C— OU W C &. > 0,-w — 0. U.
» O 0 3
e 0 t) u.
fa. U E —
59
ANNEX X
TYPICAL FORMAT FOR QUALITY ASSURANCE
REQUIREMENTS SECTION OF A
SPECIFICATION FOR ITEMS AND SERVICES
61
ANNEX X
TYPICAL FORMAT FOR QUALITY ASSURANCE
REQUIREMENTS SECTION OF A
SPECIFICATION FOR ITEMS AND SERVICES
0. QUALITY ASSURANCE REQUIREMENTS
1. Quality Assurance Programme
1.1 Quality Assurance Programme for Safety Related

Components
1.2 Quality Assurance Programme for Non-Safety

Related Components
2. Conformance Control and Verification
2.1 Configuration Control and Verification
2.2 Inspections, Examinations and Tests
3. Purchaser's Actions
3.1 Witness Points
3.2 Hold-Points
62
ANNEX XI
EXAMPLES OF A SELECTIVE APPLICATION SYSTEM
63
AKNEX XI a
EXAnPLE OF A SELECTIVE APPLICATION SYSTEh

(Guidelines for Selecting
Quality Assurance Activities and
Specifying Quality Assurance Requirements for
Plant Items and Services)
1.0 INTRODUCTION
These guidelines are to be used in selection of appropriate quality
assurance activities and the specification of requirements for those activi-
ties to be delegated for implementation to the suppliers of plant items or
to the performer of project services. The guidelines are intended to provide
a uniform method of classifying plant items and services in their lowest
level of unit assembly and using that classification in the selection of
applicable quality assurance activities and the specification of appropriate
requirements for those activities.
It is to be used by project organizations preparing detailed specifica-

tions for the design, manufacture, installation and testing of plant items or
for the pa; fc.'mance of support services. The st-lective application process
covered by these guidelines begins with the identification of the desired
basic unit of the plant and progresses according to the steps shown in
Illustration 1.
2.0 CLASSIFICATION OF PLANT ITEMS AND SERVICES

The basic unit of the plant is characterized with regard to its function
in the plant and its importance to the successful operation of the plant.
The development of a meaningful characterization includes several steps in
which the unir, is classified according to various factors.
64
2.1 Classification as to Unit Type
The first step is to classify the plant unit as to unit type.
The first consideration is whether the unit is in the nuclear portion
of the plant (nuclear systems - NSSS) or in the balance of plant (BOP).
The second consideration is whether the unit is a structure, component,
material, or service. These basic unit types are defined as follows:
2.1.1 Structure
Parts of the plant that are made-up of systems, components,
or materials which are usually massive or static in nature, may
provide a supportive or load-bearing function, or may serve as
an enclosure. Examples of structures are building fourdations,
radiation shields, and equipment supports and enclosures.
2.1.2 Component
An assembly of interconnected parts which constitute an
identifiable device, instrument, or piece of equipment. A com-
ponent can bî removed and replaced as a unit, it has aefi nable
performance characteristics which permit it to be tested as a
unit. Examples of components are pumps, valves, piping, and
vessels.
2.1.3 Material
A substance or combination of substances used in forming
structures, components, parts, and equipment. Examples of
material are plate, pipe, aggrigate, bar, wire, and conduit.
2.1.4 Service
The performance by a supplier of activities such as design,
fabrication, inspection, nondestructive examination, repair,
installation, or erection.
65
2.2 Classification as to Service Function
The second step is to classify the unit with regard to its service
function in the plant. Principle considerations are whether a unit is
used in an application: related to an engineering discipline such as
mechanical, electrical, civil-structural, etc.; as part of a system or
a non-system; as part of a system boundary or non-boundary; that is
sensitive to pressure and temperature; or in which it performs a safety
function. The basic service functions are defined as follows:
2.2.1 Engineering Discipline Application

Parts of the plant perform basic engineering functions. Those
are characterized as mechanical, electrical, instrumentation and
control, or civil-structural.
2.2.2 Plant Application

Parts of the plant may perform their functions as a system or
as a non-system. Mechanical functions are performed by fluid systems
or by non-fluid systems. Electrical, instrumentation, and control
functions are performed by electrical, hydraulic, or pneumatic systems;
and civi.l-structural functions are performed by soils, concrete, and
metal.
2.2.3 System Application

Plant systems are divided according to coolant or non-coolant
service. A coolant system is comprised of structures, components,
or materials that corae in direct contact with coolant, including
those items which form an integral part of structures, components,
or materials which come in contact with coolant.
66
2.2.4 Pressure Application
Pressure applications are divided according to fluid boundary
or non-fluid boundary service. The fluid boundary is that portion
of structures, components, and materials which contacts and confines
fluid or by which fluid passes.
2.2.5 Temperature Application

Temperature applications are divided according to high and low
temperature service.
2.2.6 Safety Applications

Plant units may or may not perform functions that are essential
for safe operation. Units that are essential for safe operation
include those structures, components, and materials that are neces-
sary:
* To prevent accidents that cou^d adversely affect the health
and safety of the public, or,
* To mitigate the consequence of such accidents if they were
to occur.
It should be pointed out that consideration of safety appli-

cation can and should be given much more attention than just the
determination that an item does or does not perform a significant
safety function. An'alternative to the either/or safety-related
classification is to divide the plant items and services into
four categories as follows:
2.2.6.1 Category I, Permanent Plant Safety Related

Structures, systems, and components that prevent or
mitigate the consequences of postulated accidents that could
67
cause undue risk to the health and safety of the public (e.g.,
Primary Heat Transport System [PHTS] Components).
To provide more definitive classification for the safety-related

applications, Category I can be further divided into three safety
classes as follows:
a. Safety Class 1 (SC-1) - Those components:

• Which comprise part of the reactor coolant boundary;
• Which are used to perform scram functions under any plant
condition; and
• Which maintain core geometry or provide core support and
whose failure could initiate a core disruptive accident.
b. Safety Class 2 (SC-2) - Those components not in SC-1:

' Which are required to maintain an adequate reactor coolant
inventory following a reactor coolant boundary leak;
• Which are a part or extension of the reactor containment
boundary;
• Which are required to remove residual heat from the reactor
core or from the spent fuel storage and whose single failure
following any plant condition constitutes a loss-of-safety
function, or which are not normally operating or cannot be
tested adequately during normal power operation; and
• That could experience single failure that could cause a
loss-of-safety function of other SC-2 components.
68
c. Safety Class 3 (SC-3) - Those components not in SC-1 or SC-2:
* Which are required to remove residual heat from the reactor
core or from spent fuel storage;
* That could fail and the failure could result in the
loss-of-safety function of another component (e.g., loss
of Cuoling to components which require cooling for accomplish-
ments of their safety function);
* Which are extensions of the reactor coolant boundary and are
capable of being isolated from that boundary'during all modes
of normal reactor operation by two valves, each of which is
either normally closed or capable of remote closure; and
* That could fail and the failure could result in the release to
the environment of radioactivity and would result in calculated
potential exposures at the site boundary in excess of 0.5 rem -
whole body (or its equivalent).
2.2.6.2, Category II, Permanent Plant Operationally Significant

Structures, systems and components not covered in Category I,
but whose failure to function at full design rating will effect
the ability of the plant to function at its designated rati'ng
and which are not essential for a safe shutdown or shutdown
heat removal. Failure of the items in this category would
not endanger public safety (e.g., turbine generator and asso-
ciated service equipment).
2.2.6.3 Category III, Permanent Plant Non-Operationally Related
Structures, systems and components whose failure to function

would not cause damage to safety-class structures, systems, or
components. This category covers items used to support normal
69
plant opérations, but are not essential to the ability of the
plant to function at its designed rating; do not contain

radioactive material; or v/hose failure cound not result in
the release of radioactive material (e.g., administrative
building, yard drains, parking lot).
2.2.6.4 Category IV, Non-Permanent Plant

Non-permanent plant structures, systems and components
required for plant construction activities which do not
become part of the permanent plant. This category includes
site preparation and improvement activities (e.g., temporary
construction equipment and buildings).
2.3 Classification as to Production Category

The third and final step is to classify the unit with regard to its
production category. To be considered in this step is whether the unit
is available only as a specially designed and manufactured product,
commonly referred to as an engineered unit, or is available in a less
specialized form as a pre-engineered, custom, or standard unit. These
production categories are-defined as follows:
2.3.1 Engineered Unit

An engineered unit is one that requires a significant amount
of design engineering to be performed in order to define and specify
the characteristics of the item, and the methods or processes to be
performed to produce the item. Engineered units are usually complex
in nature and are designed to meet the performance requirements of
a particular application or service.
70
2.3.2 Pre-Engineered Unit
A pre-engineered unit is one that is fabricated, manufactured,
or assembled in accordance with existing drawings, specifications
and instructions for the item. Pre-engineered units are usually
complex in nature and have been designed to meet the performance
requirements of a particular application or service.and are supplied
when ordered from the existing design.
2.3.3 Custom Unit

A custom unit is one that is manufactured and furnished when
ordered by a customer. It usually is furnished in accordance with
the manufacturer's plans and specifications, plus manufacturer-offsred
options to meet a particular set of performance requirements. Require-
ments specified by the customer are usually chosen from selected
parameters within established ranges designated by the manufacturer.
2.3.4 Standard Unit

A standard unit is one that is produced in mass quantity
according to plans and specifications of the manufacturer by a
routine production process. Standard units are usually produced
in accordance with a standard specification and may be identified
by catalogue number or other standard designation. These units
are usually high volume production items, but may be produced
through batch or continuous production operation.
3.0 SELECTION OF APPLICABLE QUALITY ASSURANCE ACTIVITIES

The next step is to select the generally applicable quality assurance
activities that should be implemented by the organization supplying the unit
to the plant. These activities will include programmatic activities and
71
work-oriented activities. Each grojp of activities are to be selected as
described hereafter.
3.1 Selection of Programmatic Activities

lv
Tables * through provide an identification of the programmatic
activity groupings or program types. Using the results from the preceding
classification steps, enter the appropriate table and find the intersec-
tion between, the line listing the plant unit type and the column listing
the service function and production category. At the line-column inter-
section will be a number from 1 through 6. That number identifies the
quality assurance program type that is applicable to the unit.
The activities contained in the program type selected, and the

requirements for those activities are as follows:
3.1.1 Type 1 Program - In accordance with ANSI/ASME NQA-1 Basic

Requirements and Supplements, and ANSI N45.2 Supporting Standards.
This means any combination of program requirements selected and
specified by invoking all or part of ANSI/ASME NQA-1 Basic Require-
ments ar,d Supplements, plus supporting standards selected from the
N45.2 series Ce.g., ANSI N45.2.1, N45.2.2, N45.2.3, N45.2.4, N45.2.5,
N45.2.8, and N45.2.20). This also includes any combination of
selective application of N45.2 supporting standards without the
application of ANSI/ASME NQA-1 or ANSI N45.2 itself (e.g., ANSI
N45.2.5 or N45.2.8 for inspection, examination or testing).

Requirements and Supplements. This means any combination of program
requirements selected and specified by invoking all or part of
72
ANSI/ASME NQA-1 Ce.g., ANSI/ASME NQA-1 Basic Requirements 1, 2, 3,
4, 5, 6, 15, 16, 17, and 18, and Supplements S-l, 1S-1,2S-3, 3S-1,
4S-1, 6S-1, 17S-1, and 18S-1 for Design Activities).

Requirements. This means any combination of program requirements
selected and specified by invoking all or part of ANSI/ASME NQA-1
Basic Requirements (e.g., ANSI/ASME NQA-1 Basic Requirements 1, 2,
3, 4, 5, 6, 15, 16, 17, and 18 for Design Activities).
3.1.4 "ype 4 Program - In accordance with Project or Company

Specification. This means any combination of program requirements
specified through the invoking of a standard company specification,
or written directly into the equipment specification or other
scope of work statement.
3.1.5 Type 5 Program - In accordance with Manufacturer's Standard

Practice. This means a control program is required, but the pur-
chaser does not choose to define specific requirements. Usually,
documentation defining or describing the program is required to be
submitted to the purchaser for approval, for information, or for
record purposes. Included are programs in which there are no special
programmatic requirements, but there are specific work-oriented
requirements for inspections, examinations, or tests.
3.1.6 Type 6 Program - In which there are No Purchaser Requirements.

This means the manufacturer or performer has a standard product or
service which is produced or provided under its own quality assurance
73
practices, and the purchaser is willing to accept that product or
service with no additional actions required of the supplier.
3,2 Selection of Work-Oriented Activities

Using the number found in the preceding step from Tables I through
iv to also represent the level of control and verification effort, the
work-oriented activities are identified as follows:
3.2.1 Level 1. Effort includes:

* Joint review of requirements;
* Review and approval of instructions, procedures, and
drawings;
* Review and approval of change proposals;
* Review and approval of deviation proposals;
* Monitor all production activities with resident
representatives;
* Perform or-witness all inspections, examinations, and
tests;
* Review and approve all inspection, examination, and
test results; and
' Final inspection of completed item.
3.2.2 Level 2 Effort includes:

v
Joint review of requirements;
* Review and approval of instructions, procedures, and
drawings;
* Review and approval of deviation proposals;
74
' Mnrntor production activities with itinerate repre-
sentative;
* Ptrform or witness all inspections, examinations,
and tests;
* Review and approve all inspections, examinations, and
test results; and
* Fi.nal inspection of completed units.
3.2.3 Ievel 3 Effort includes:

" Joint review of requirements;
*" Review and approval of instructions, procedures, and
drawings;
** Review and approval of deviation proposals;
* Witness selected production activities at designated
hold points;
" Perform or witness selected inspections, examinations,
and tests;-
' Review and approve all inspection, examination, and
test results; and
' Final inspection of completed item.
3.2.4 Level 4 Effort includes

* Joint review of requirements;
" Review and approve selected instructions, procedures,
and drawings;
' Review and approval of selected change proposals;
* Review and approval of selected deviation proposals;
75
* Perform or witness selected inspections, examinations,
and tests;
* Review and approve all inspection, examination, and
test results; and
' Final inspection of completed unit.
3.2.5 Level 5 Effort includes:

' Joint review of requirements;
* Review and approve selected instructions, procedures,
and .drawings;
>
Perform or witness selected inspections, examinations,
and tests;
* Review and approve selected inspection, examination,
and test results; and
" Final inspection of completed unit.
3.2.6 Level 6 Effort Includes:

* Joint review of requirements, and
* Final inspection of completed unit.
4.0 CUSTOMIZING THE SELECTED QUALITY ASSURANCE ACTIVITIES

The quality assurance activities selected by the techniques described,
are to be recognized as only the beginning point for specifically defining
the applicable quality assurance requirements. Other considerations unique
to the plant unit are to now enter the selection process. It may be appro-
priate to select a more rigorous type of program or level of effort based on
considerations for safety, reliability, availability, or maintainability, or it
may be appropriate to select a less rigorous type of program or level of effort
76
based on previous performance history or specific service function details.
In addition, there may be unique or special features about the unit or its
intended service which dictate that specific quality assurance activities be
added, altered or deleted altogether from the group of applicable activities.
5.0 SPECIFYING OF APPLICABLE QUALITY ASSURANCE ACTIVITIES

After all considerations have been factored into the selecting and
customizing of applicable quality assurance activities, the activities to be
implemented by the purchaser are to be defined in the purchaser's work plans
and schedules, and the activities and the requirements for those activities
to be delegated to the supplier for implementation are to be defined in the
appropriate specification for the unit. Illustration 2 provides a standard format
for the quality assurance requirements section of these specifications.
5.1 Specifying Applicable Programmatic Activities

The requirements for quality assurance programmatic activities are
to be defined in the specification under the heading of "Quality Assur-
ance Program." The statement should begin with an identification of the
scope of application of the program followed fay a definition of the
content of the program in terms of the required activities and require-
ments for those activities. If this definition is provided by an
invoking of a reference document, the specification should clearly
identify the document and its applicable parts. Typical program
requirements specifications are as follows:
5.1.1 A Type 1 Program Statement:

"Quality Assurance Program. Supplier shall implement and
maintain a documented quality assurance program to assure that the
(state name of component) , including subcontracted items,
77
are designed, manufactured, inspected, tested, documented, and
delivered in accordance with the requirements of this detailed
specification and supplier's documented instructions and proce-
dures. A description of the program shall be submitted for
purchaser's approval and copies of implementing procedures shall
accompany the program description for information. Supplier
shan notify purchaser in writing of any intended changes to its
program that would affect the quality of the delivered item and
such changes shall be approved prior to implementation. Supplier's
quality assurance programme shall conform to the requirements
and provide the actions specified in Section I, Section II Basic
Requirements (list requirements numbers) and Section III
Supplements .(list supplement numbers) of ANSI/ASME NQA-1
(and '.hose supporting ANSI N45.2 series standards referred to
in this detailed specification) ."

maintain a documented quality assurance program to assure that
the (state name of component) , including subcontracted
items, are designed, manufactured, inspected, tested, documented
and delivered in accordance with the requirements of this detailed
specification and supplier's documented instructions and pro-
cedures. A description of the program shall be submitted for
purchaser's approval and copies of implementing procedures shall
accompany the program description for information. Supplier shall
notify purchaser in writing of any intended changes to its program
that would affect the quality of the delivered item and such
78
changes shall be approved prior to implementation. Supplier's
quality assurance program shall conform to the requirements and'
provide the actions specified in Section I, Section II Basic
Requirements (list requirement numbers) , and Section III
Supplements (list supplement numbers) of ANSI/ASME NQA-1."

are designed, manufactured, inspected, tested, documented, and
specification and supplier's documented instructions and procedures.
A description of the program shall be submitted for purchaser's
approval and copies of implementing procedures shall accompany the
program description for information. Supplier shall notify purchaser
in writing of any intended changes to its program that would affect
the quality of the delivered item and such changes shall be
approved prior to implementation. Supplier's quality assurance
program shall conform to the requirements and provide the actions
specified in Section-I and Section II Basic Requirements (list
requirements numbers) of ANSI/ASME NQA-1."

"Quality Assurance Prograjn. Supplier shall implement and
are designed, manufactured, inspected, tested, documented and
79
specification and supplier's documented instructions and procedures.
A description of the program shall be submitted for purchaser's
approval and copies of implementing procedures shall accompany the
program description for information. Supplier shall notify pur-
chaser in writing of any intended change to its program that would
affect the quality of the delivered items and such changes shall be
approved prior to implementation. Supplier's quality assurance
program shall include, but not be limited to the following elements:
a. Documented methods for defining, controlling and verifying the

design. Design interfaces between supplier and its subcontrac-
tors shall be identified and controlled. Design changes,
including shop changes, shall be controlled by measures commen-
surate with those applied to the original design (see Note 1).
b. Controlled issuance of engineering documents and changes to

manufacturing and inspection stations and subcontractor's
facilities to assure that the latest authorized documents
are used at workstations.
c. Identity of items from receipt through fabrication, inspec-

tion and shipment by means of shop orders, travelers or
other documented control procedures.
d. Inspections, examinations, and tests performed in accordance

with documented instructions and procedures which prescribe
acceptance criteria. Current instructions and procedures
shall be maintained at each point of use.
80
e. Results from inspections, examinations, and tests are docu-
mented and maintained readily available to demonstrate compliance
with requirements.
f. Nonconforming items are identified, documented and controlled to

prevent misuse. Provisions shall be made for purchaser approval
for disposition of nonconforming items as required by contract
documents.
g. An inspection staff sufficiently independent of production

pressures to permit verification of conformance to established
requirements and to control further processing or shipment of
nonconforming items until proper disposition is obtained.
h. Documented system for the Calibration and control of inspection

and test equipment used in acceptance or rejection of items.
Supplier's quality assurance program shall also conform to the

ASME Boiler and Pressure Vessel Code, Section VIII, Division 1,
Appendix X for those portions of the equipment that are required
to be in accordance with the Code (see Note 2).
Notes: 1 - To be used when an engineered unit is required.

2 - Code statement is used when unit includes a Code
covered component."

"Quality Assurance Program. Supplier shall implement its
standard quality assurance program to assure that the (state
name of component)__, including subcontracted items, are designed,
81
manufactured, inspected, tested, documented and delivered in accor-
dance with the requirements of this detailed specification and
supplier's instructions and procedures. A description of the
program and implementing procedures shall be submitted to purchaser
for information. Supplier shall notify purchaser in writing of any
intended changes to its program that would affect the quality of
the delivered items."

"Quality Assurance Program. No requirement.
Note: In these cases the specification will contain no
statement of quality assurance program requirements.
5.2 Specifying Applicable Work-Oriented Activities

The requirements for quality assurance work-oriented activities
are defined under the heading, "Conformance Control and Verification,"
and should address the specific actions that are to be performed to
control and verify that work activities have been correctly performed
and that quality objectives have been attained. In specifying work-
oriented activities, care should be exercised to clearly identify
acceptance criteria for the required reviews, inspections, examinations,
or tests. The definition of required work-oriented activities may also
be provided by an invoking of a reference document.
5.2.1 Conformance Control and Verification

A typical statement for the Conformance control and verification
requirements specification is as follows:
82
"a. Configuration Verification. Supplier shall prepare a data
package which demonstrates that the product configuration
selected conforms to the quantitative requirements of this
specification. When this data includes calculations, they
shall be independently checked by qualified personnel. Data
shall be reviewed and approved by the supplier and available
for review by the purchaser prior to submittal of required
documents based on or using the data. The data shall be
identifiable and shall provide applicable references, assump-
tions, conclusions and other information required to permit
positive correlation with specification requirements.
b. Inspections, Examinations and Tests.

Note: To be prepared for each unit as necessary to
meet need."
5.3 Specifying Purchaser's Actions

The identification of actions by the purchaser is optional, however,
it may significantly enhance the working relationship established between
the purchaser and the supplier. Actions by the purchaser are described
under the heading, "Purchaser's Actions." The supplier is ordinarily
required to notify the purchaser at a designated witness point. However,
the supplier is not restrained in his work process by the purchaser's
actions. The supplier is also required to notify the purchaser at a hold
point and the supplier may not proceed beyond the hold point in his work
process until specifically released by the purchaser. A typical statement
for the ourchaser's actions is as follows:
83
"Purchaser's Actions. Supplier implementation of its quality assur-
ance program will be verified through surveillance by the purchaser. In
addition, the following activities or events are purchaser witness or hold
points and are subject to revision, addition, or deletion at the descre-
tion of the purchaser:
Witness points are:

Note: To be prepared for each unit as necessary'to meet need.
Hold Points are:

Note: To be prepared for each unit as necessary to meet need."
5.4 Other Considerations

When applicable quality assurance activities and requirements for
those activities are defined by an invoking of an appropriate reference
document, the reference to the document should be complete and specific
including specific reference to section, subsection, and paragraphs
that apply. To the maximum extent possible, the whole document, appro-
priate sections, or paragraphs should be invoked. The requirements
should include modifications, additions, or deletions to the referenced
document as appropriate.
When specifying standards, one must be aware that in some cases the
standard may leave the specification of certain requirements to the pur-
chaser. Therefore, additional details may be required such as; (1) access
to supplier facilities; (2) approval of documents; (3) documentation
submittal; and (4) transfer of requirements to lower-tier suppliers.
In specifying work-oriented activities, care should be exercised to

clearly identify acceptance criteria for the required inspection, examin-
ation or test.
84
ILLUSTRATION 1
CLASSIFICATION OF PLANT ITEMS AND SERVICES
BY ENGINEERING
NSSS-NUCLEAR SYSTEMS AS A APPLICATION
BOP-BALANCE OF PLANT STRUCTURE
BY PLANT
APPLICATION
AS A
COMPONENT CLASSIFY THE BY SYSTEM
UNIT AS TO SERVICE APPLICATION
APPLICATION
BY PRESSURE
AS A APPLICATION
MATERIAL
BY TEMPERATURE
APPLICATION
ASA
BY SAFETY
SERVICE
APPLICATION
H ENGINEERED UNIT
CLASSIFY THE UNIT
AS TO PRODUCTION
-> PRE-cNGlNEERED UNIT CLASSIFIED
CATEGORY -*-
PLANT UNIT
CUSTOM UNIT J-
STANDARD UNIT —'
ILLUSTRATION 1 (continued 1 )
CORRELATION OF ACTIVITIES WITH PLANT UNITS
TYPE 1 PROGRAMME
TYPE 2 PROGRAMME
SELECT- BASELINE
T Y P E S PROGRAMME
PROGRAMME TYPE ACTIVITIES
*- TYPE 4 PROGRAMME
TYPES PROGRAMME
TYPE 6 PROGRAMME
85
Illustration 2
STANDARD FORMAT
for
Quality Assurance Requirements Section
of a
Detailed Specification
,0 QUALITY ASSURANCE REQUIREMENTS
.1 Quality Assurance Programme

.1.1 Quality Assurance Programme for Safety Related
Components
.1.2 Quality Assurance Programme for Non-Safety
Related Components
.2 Conformance Verification
.2.1 Configuration Verification
.2.2 Inspections, Examinations and Tests
3 Purchaser's Actions
.3.1 Witness Points
.3.2 Hold Points
86
TABLE I
CORRELATION OF QUALITY ASaURAHCS ACTIVITIES AND'PLANT UNIT BASED UPON
CLASSIFICATION CHARACTERISTICS
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\ Dlnr.lpl Ino llcclmnlcnt . . . . ' . ... • ' ... ,„,..,,.

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HOTE :
Numbers in Table 1 refetf to Quality Assurance Programme Type and Level of Control and VerificaLidu E f f o r t .
TABLE II
CORRELATION OF QUALITY ASSURANCE ACTIVITIES AND PLANT UNIT BASED UPON
^•^ nil«c»pHn« tlectrict i — f&C

"~"\ Application tlectrica bvstem
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IIOTE :
ll
Numbers In Tnfclc" refer to Quality Anourance'Programme Type and Level of C o n t r o l and V e r i f i c a t i o n E f f o r t .
TABLE III
CORRELATION OF QUALITY ASSURANCE ACTIVITIES AND PLANT UNIT BASED UPON
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NOTE :
Nuuilxira In Tnblc III refer Lo Quality Asournnce Proßrnmmb Type and Level of. Control and V e r i f i c a t i o n E f f o r t .
TA3LZ IV
CORRELATION OF QUALITY ASSU5ANCS ACTIVITISS AND PLANT UNIT 3ASED 'JPOK
CLASSLTÏCATION CHARACTERISTICS
v^ Discipline Civil / S truc rural

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•^ U ±J et
s- u i^ u u U
Plant Unit ^N^ S

e* w
K ^
en
Ü
c. M
ü
*•* W
£ CO •^ "**
^
NSSS— S tructures 1 1 2
* 2 2 5 ô 1 1 2 It 2 2 5 5 1 1 2 (t 2 2 5 5
NSSS— Conponents 1 1 2
* 2 2 5 6 1 1 2 "
2 2 5 6 1 1 2 «r 2 2 5 5
2 it
* 5 1 1 2 2 2 5 e 1 1 2 2 2 5 S
KSSS—Material » it 5 5 it It
NSSS — Services 2 i*
» it
* 5 6 S 1 I 2 It 2 2 5 6 1 1 2 «t. 2 2 5 5
1 1 I 1 1 1 1 1 1 i
1
BO? — S tructures 1 1 2 if it 5 5 6 1 1 2 1+ IL 5 6 5 1 1 2 If
^
ï 5 ç
i+ 6 1 1 2 5 S 6 1 1 2 it 5 5 5
BOP- — Components 1 1 2
* 5 6
» «f »t
BOP— Materials 2 it
* Jt !f 5 5 6 1 1 2 IT
" 5 5 £ 1 1 2
*
L 5 5
30P — Services - * M. U
* 5 5 5 1 1 2 U If 5 5 5 1 1 2 4 U - 5 S
NOTE: Numbers in Table A.7 refer to Quality Assurance Programme Type. For description
of type, see Table A.8.
90
ANNEX XI b
EXAMPLE OF A SELECTIVE APPLICATION SYSTEli

Guidelines for Selecting Quality Assurance
Programmes for the Supply of Items and_
Services Important to Safety in Nuclear Power Plants
1. General
1.1 Introduction
These guidelines, which are based on Canadian practice, describe a method

which may be used to select suitable quality assurance programmes for items and
services important to safety in nuclear power plants. The method employs two
separate series of quality assurance standards used in conjunction with each
other: one series is single-tier and is implemented by the responsible
organization and its delegated participants; the other series is multi-tier and
is specified by the responsible organization for implementation by suppliers.
1.2 Basic principles
(a) All aspects pertaining to public and operator safety are considered
and are included in the technical specification for the item. To ensure
that an item will perform in a safe manner the performance requirements
must be correctly and adequately defined in the technical specification.
An item which successfully meets these requirements is said to possess the
required quality.
(b) The preparation and verification of technical specifications and other

activities which are part of the design process are controlled by a quality
assurance programme.
(c) All items and services important to safety are subject to quality
assurance in some form for design, procurement and production.
(d) All participants contributing to the supply of items important to

safety have quality assurance programmes to ensure that their contributions
comply fully with the specified requirements.
91
(e) The detailed Quality Assurance Programme requirements varies directly
in accordance with the controls which must be applied to provide the
required level of confidence that the item or service meets the specified
quality requirements.
2. Methodology
2.1 Basic Approach
The Canadian approach makes use of two sets of quality assurance standards.
The first set , which is single-tier, relates to major design and procurement
activities which are usually performed by the responsible organization,-
o
architect-engineers and major consultants. The second set* which is
multi-tier, relates to non-major design and procurement activities and
production and related activities which are performed by equipment suppliers.
2.2 Establishing the Quality Requirements
In the approach, the essential safety-related quality requirements are

incorporated in technical specifications and other documents by system and
equipment designers during the design phase. In large measure, the assurance of
quality related to safety for each item and service is achieved by requiring
that the complete design process, including the preparation of the technical
specifications, is carried out in accordance with a formal quality assurance
programme. This programme is under the control of the responsible organization
and the single-tier design standard applies. The multi-tier series of standards
is imposed on the supplier. In the multi-tier series the top level document,
unlike the remaining standards in the series, contains detailed requirements for
design quality assurance. Where a supplier is required directly to undertake
complex design work he is required to comply with this top level standard. If,
on the other hand, a supplier is required to carry out design work which is not
complex or difficult he may very well be required to comply with a lower level
document in the multi-tier series. Under these latter circumstances the
responsible organization makes provision for the verification and approval of
1. CSA N286 series (comparable to IAEA 50-SG-QA series)

2. CSA Z299 series
92
the design work undertaken by the supplier. This could be done completely and
directly by the responsible organization in which case it would cover the design
and the engineering by the supplier associated with the translation of specified
requirements into practical manufacturing information e.g. detailed drawings,
bills of material, engineering specifications, purchasing data, identification
requirements, packaging, preservation, handling and shipping requirements.
Alternatively the responsible organization might undertake directly only the
verification and approval of the design in which case it would require that the
supplier's quality assurance programme control the detailed pre-manufacturing
process. The capability of the supplier to produce equipment which fully
satisfies the pre-defined safety-related quality requirements clearly also forms
part of item safety-related quality assurance. This consideration is included
in the procurement quality assurance requirements contained in both the single
and multi-tier standards.
2.3 Programme Selection
Having established the safety-related quality requirements and assured that

these are correct and adequate, and that suppliers are competent to satisfy
these requirements, the ensuing production is carried out in accordance with a
formal quality assurance programme based on a standard selected from the multi-
tier series. This selection is not based on item safety significance as such,
since safety considerations have been previously catered for by implementing
design and procurement quality assurance programmes. Instead it results from
consideration of such aspects as the nature of the item, the activities that the
manufacturer must perform to produce the item and the degree of difficulty in
controlling these activities. This rationally permits a supplier producing an
item or service important to safety, where the activities he performs are quite
basic, to provide the required assurance of quality by implementing a relatively
simple quality assurance programme. On the other hand, the approach leads to
the application of more extensive quality assurance programmes for other items
and services important to safety where this is warranted. In this fashion it is
ensured that the previously established safety-related quality requirements have
been achieved.
Suppliers of items and services important to safety are subject to

surveillance by their purchasers during the production process as part of the
procurement quality assurance programme in order to ensure that production
93
quality assurance is indeed being applied effectively and thus that
safety-related quality requirements are being achieved.
2.4 Pre-produced Safety-related Items
Many items and services important to safety are pre-produced and available
commercially. In such cases, it may not be either possible or practicable to
implement a quality assurance programme for their design and production. In
these cases, however, the applicability of standard or previously proven designs
is verified for each application by the purchasing organization or some other
responsible design authority. The purchaser's procurement quality assurance
programme then provides for verification by the appropriate organization that
the standard or previously approved design is applicable and that production is
being controlled in an adequate fashion.
This may lead to the purchaser performing supplementary in-plant inspections

and/or receiving inspection to assure conformance to safety requirements.
The above methodology is adaptable to permit design and procurement quality

assurance activities to be performed by the responsible organization and his
architect-engineer and/or by individual item and service suppliers who in turn
deal with sub-contractors as appropriate. In this way the responsible
organization ensures that the assurance of quality for items and services
important to safety may be obtained as the result of the collective
contributions of all the individual participants concerned.
3. Selection Process for Supplier Quality Assurance

3.1 General
The method used by the responsible organization or its delegated

participant for selecting the appropriate quality assurance programme standard
to be implemented by the supplier of items and services involves a two-step
approach. The purpose of these two steps is that each is intended to act as a
check against the possible mis-application of the other.
The first step examines the item or service relative to the maturity and
complexity of its design and production processes and its inherent
characteristics. Evaluation factors for these criteria are listed and rated in
94
Clause 3.2. Each rating should provide an estimate of the significance of the
factor. Thus the summation of the four ratings provides an estimate for
determining the standard required.
The second step examines the need for the requirements of the quality
assurance standards and what they are intended to do. The analysis of the
evaluation factors in the first step will assist the user in selecting the
appropriate quality assurance programme features in the second step. The
features are compared with the possible nonconformances that could occur when
they are performed with respect to the item or service. This analysis indicates
the appropriate quality assurance programme standard needed to give adequate
confidence that the specified requirement will be met.
The final selection of the appropriate standard, as described in Section

3.4, is made by summing the results of the evaluation factors as per Table 1 and
comparing this with the results obtained in step 2.
3.2 Item or Service Evaluation Factors - First Step
Analysing and evaluating the following four factors are considered

fundamental in the first step. The evaluation team should consist of the
designer and a person(s) knowledgeable in the production process and associated
quality assurance programmes. They should review the technical specification
and other design and contract documents to become familiar with the
characteristics of the item or service and the intended application to clearly
establish that the technical requirements are adequate and verifiable.
If all pertinent information needed to evaluate a factor correctly is not

available, the missing information should be obtained from the appropriate
source.
Each of the four factors is rated from zero to six. Zero is the minimal or
simplest situation and six is the most significant or complex.
(a) Design Process Complexity
This factor deals with the complexity of the design process (including
engineering control involving the preparation of manufacturing drawings and
specifications) when it is undertaken by a supplier and accounts for the
95
difficulty likely to be encountered in implementing the process
effectively. The factor should also be considered where a supplier must
carry out essential and extensive review of a design by others prior to its
production. This kind of review is often complex and is closely related to
the design process. The factor reflects the difficulty and overall
complexity of performing the design and complying with the technical
specification and not the complexity of the item or service, or their
function. The evaluation should consider the requirements for safety,
seismic and stress analysis, metallurgical and environmental analysis, etc.
Rate the Design Process Complexity as zero if the effort is minimal and
simple and up to six depending on how extensive and complex it is.
Design Process Complexity Rating 0 to 6
(b) Design and Production Process Maturity
This factor is based on the availability of proven design and established

production processes. Based on information arising from field experience
as well as performance testing an assessment is made of the extent to which
the total design is known and proven. In the same manner, a similar
judgement is made with respect to the production processes.
Rate the Design and Production Process Maturity as zero if a proven design
is available and the production process is well established, and rate this
factor as six for a new design or where new production processes are
required. Intermediate rating will depend on the modification or redesign
of an existing item for the same or different application with related
changes to the production processes.
Design and Production Process Maturity Rating 0-6
(c) Production Process Complexity
This factor is based on an assessment of the complexity of producing the

item or service. The assessment should evaluate, for example, the number
of different processes* involved, the degree of difficulty associated with
* The term processes includes manufacturing, inspection, testing, assembly,

construction, services or any other production activity.
96
each process and with achieving and verifying specified item or service
quality characteristics. Also to be considered are the prospective
supplier's process experience and capability.
Rate the Production Process Complexity as zero for a few simple processes
and up to six depending on their number and complexity.
Production Process Complexity 0 to 6
(d) Item or Service Characteristics
This factor accounts for the inherent complexity of the item or service.
Considered are such things as the number of close tolerances and
interrelated characteristics; the importance of each characteristic to
performance; the number of moving parts; the requirements for
leak-tightness, for strength, for resistance to corrosion, abrasion and
creep; electrical, electronic, chemical, physical, metallurgical, and other
service characteristics.
Rate the Item or Service Characteristics as zero if there are no tight

tolerances or other complex characteristics and up to six depending on
the number and complexity of the characteristics.
Item or Service Characteristic Rating 0 to 6
3.3 Quality Assurance Programme Function Evaluation - Second Step
After evaluating the item or service factors of the previous clause proceed
with step 2 and determine the need for specific program requirements.
Evaluators should be familiar with all the requirements of each multi-tier
standard before proceeding to evaluate the item or service requirements against
the coverage provided by each standard. The following checklist, which is not
exhaustive, may be used to perform this review.
97
After studying and rating the item or service evaluation factors, complete
the following for the second step.
(a) Is there a need for any of the following? YES NO

i) Measuring and testing equipment are to be in a known state
of calibration?
ii) Inspection records as evidence that the item or service

meets specified requirements?
iii) Disposition (means use as-is, repair, rework, scrap)

records of all nonconforming items and services?
iv) Control of customer-supplied items?
v) A checklist that indicates each inspection and test point

and its relative location in the production cycle?
vi) A review for adequacy of all essential documents affecting

quality and approval for their release by authorized
personnel?
vii) Document change control?
viii) Selection and surveillance of sub-contractors for the

purchase of items and services?
ix) Incoming, in-process as well as final inspection, and

inspection status?
x) Procedures and qualification of personnel for special

processes?
xi) Inspection of preservation, packaging and shipping

operations?
98
xii) Description of the above activities that state their
purpose and scope, who is responsible and what has to be
done to complete them?
If all the answers to questions i) to xii) above are "no",

a level 4 programme should be applicable. If any answer is
"yes", proceed to the next series of questions.
(b) Is there a need for any of the following? YES NO
i) A plan for inspection and testing with procedures which

define: what is to be inspected and tested, when, where,
and how they will be performed, who will perform them and
the acceptance criteria?
ii) A plan for production with procedures which define the

control and sequence of work methods, type of equipment
used and special working environments?
iii) A system for preserving, segregating and handling all

items from time of receipt through the entire production
process and subsequent storage, to prevent abuse, misuse,
damage, deterioration and loss?
iv) A system for investigating the cause of nonconformance, and

corrective action required to prevent recurrence?
v) Procedures for the above activities which in addition to

stating their purpose and scope, who is responsible and
what has to be done to complete them, also detail how to
perform, accomplish and control them?
If all the answers to questions i) to v) above are "no", a level

3 Programme should be applicable. If any are "yes", proceed to
the next series of questions.
99
(d) Is there a need for any of the following? YES NO
i) Review of the contract to ensure the requirements are the

same as those in the tender and to resolve those which are
not. Also, to ensure the necessary resources, facilities
and personnel will be available to fulfill contract
requirements?
ii) Verifying that safety and performance objectives, design

input criteria and engineering analyses have been properly
identified and fulfilled and that design outputs have been
correctly translated into drawings, specifications and
work instructions?
iii) Periodic audits that verify compliance with the quality

assurance programme procedures and specified requirements
and that evaluate the programme's effectiveness.
If all the answers to questions i) to iii) above are "no", a

level 2 programme should be applicable. If any answer is "yes",
a level 1 programme should be applicable.
3.4 Final Selection of the Quality Assurance Program Standard
Sum all values obtained in step 1 (Clause 3.2), and select a

quality assurance programme level from Table 1.
100
TABLE 1 *
Quality Assurance Program

Level Selection
Value Range Quality Program Standard
18-24 Level 1
13-17 Level 2
8-12 Level 3
1-7 Level 4
The results arrived at in both steps should be compared. If they both

indicate the same quality assurance programme standard then it is a fair
estimate of what is required for the item or service. If the two steps
disagree, further analysis of each step is required.
If doubt remains or there is contention, the detailed requirements of the

standard should be re-examined in the light of the characteristics of the item
or service and the consequences of nonconformances before a final choice is
made. In such a situation it may be advisable to consult the IAEA who can
assist the user to obtain advice from experienced users of the standards.
Table 2 is offered as an example of the means by which the quality

assurance programme features required of an item can be satisfied by examining
the detailed requirements of a set of tiered standards.
While the value ranges in the Annex and in Guideline "B" of 2299.1 - 1978
appear to correspond they are arrived at using different methods. The
method embodied in this text results from addressing only quality assurance
for safety for nuclear power plant items. The method described in
Guideline "B" on the other hand, is intended for more general application.
101
The matrix shown in Table 2 compares the requirements of the Canadian
Standards Association's set of four quality assurance standards. The Z299
series of standards provides a graded approach to fulfilling quality assurance
requirements and though the documents are generic in nature they are used by the
Canadian nuclear industry. Numbers in the columns indicate which clauses of
each standard have the same requirements and where there are differences. For
example, requirements for controlling purchasing are identical in Z299.2 and
Z299.1. Purchasing requirements in Z299.3 are different. The blank space
opposite purchasing under Z299.4 indicates that there is no provision for
controlling purchasing in that standard, which would be unsuitable when control
of purchasing is desired to provide assurance of conformance.
102
Table 2
Matrix Comparison of CSA Quality Assurance Standards
ftequtrement Z-299.Ï 2-299.2 Z-299.3 2-299.*»
Qua I i ty Program Assurance Control Ver]fie«t ion Inspect(on
Organization
Quality Audits (internat)
Quality Program Documents
Manual QA QC QV
Inspection and Test Plan/Checklist 1 1 3
Procedures/Descriptions 1 1 3
Records
- Inspection and Test 1 1 1 4

- Disposition of Non-Conforming Items 1 1 1 It
- feedback or Corrective Action 1 1 1
- Qualification of special processes, personnel, etc 1 1
- Audit and Analysis of Audit Data 1
System Functions
Contract Review 1
Design Assurance t
Document Control 1 1 Î
* Engineering Control 2 3 L
Measuring and Testing Equipment 1 1 3 k
Purchasing 1 1 3
Incoming Inspection (including Test as appropriate) I 1 3
In Process Inspection (including Test as appropriate) 1 1 1
Final Inspection (including Test as appropriate) 1 1 4
1
Inspection Status (including Test as appropriate) t 1 1
Identification and Traceability of Items 1 1 1
Handling and Storage 1 1
Manufacturing and Construction 1 1
Special Processes 1 1 1
Preservation, Packaging and Shipping 1 1 1
Qual i ty Records 1 2 3 J.
Non-Conforming Items 1 1 3 4
Customer Supplied Items 1 1 1 4
Corrective Action 1 1
Verification of Quality by Customer
I n i t i a l Evaluation for Quality Program Capability QA QC QV

Inspection and Test Plan/Checklist Review and X X X
Acceptance
Continuing Evaluation and Verification X X X
Corrective Action (right to demand) X X X X
Access - audit X X X X
- survei 1 lance X X X X
Legend: ' 'As required by CSA 2-299.1 k - As required by CSA 2-299.'i

2 - As required by CSA Z-299.2 X - As appropriate
3 - As required by CSA Z-293.3
* Not presently required in Z299 series

103
(a) Design Process Complexity (DPC)
0. Design effort is minima) and simple.
1. Design effort is significant but simple.
2. Design effort is significant and presents some complexity.
3- Design effort is extensive or complex.
4. Design effort is extensive and complex.
(b) Design Maturity (DM)
0. Proven design available*
1. Combination of proven design elements for same application.
2. Modification of proven design for a different application.
3. Redesign of existing item for a different application.
*t. New design from first principles of a complex item.
(c) Item or Service Characteristics (1C)
0. Item or service has no tight or interrelated characteristics.
1. Item or service has only a few tight or interrelated characteristics.
2. Item or service has a few tight and interrelated characteristics.
3. Item or service has a significant number of tight and interrelated characteristics.
4. Item or service has a large number of tight and interrelated characteristics.
(d) Manufacturing Complexity (MC)
0. Few simple processes» required.
1. Significant number of simple processes required.
2. Few complex processes required.
3. Significant number of complex processes required.
4. Large number of complex processes required.
(3) Safety (S)
0. No risk to the health and safety of operating personnel.
1. Results in limited risk to the health and safety of operating personnel.
2. Results in significant risk to the health and safety of operating personnel.
J. Re'sults in undue risk to the health and safety of operating personnel and/or limited risk to
the public.
4. Results in undue risk to the health and safety of operating personnel and co the public,
(f) Economics (E)
0. Results in negligible inconvenience and/or cost.
1. Downgrades the service of a facility to a limited extent and results In limited cost.
2. Significantly downgrades the service of a facility and results in significant cost.
3. Seriously downgrades the service of a facility and results In serious cost.
4. Results in total loss of service of a facility and extreme cost.
Selection Formula
Select the applicable value from 0 to k for each of the above factors and sum all values.
Read the suggested 2*293 Quality Program Standard requirement from the following table**:
Quality Program Standard Selection
Value Range Quality Program Standard
18 - 21» CSA Z-299.1

13 - 17 Z-299-2
8-12 2-299.3
* -7 2-293.4
0 -3
* processes: manufacturing, Inspection, testing, assembly, construction or any other activity.

** This table can be adjusted to suit the industry concerned.
104
LIST OF PARTICIPANTS
The meetings held in Vienna with the purpose of assisting the

IAEA in the preparation of this Manual were:
Consultants' Meeting: 14 - 18 June 1982

Advisory Group Meeting:11 - 15 October 1982
The participants at these meetings were:

CANADA J.V. Mullan (C)*
R.A. Thomas (A)
CZECHOSLOVAKIA J. Koutsky (A)
FRANCE C. Carrier (0
J.A. Vaujour (A)
ITALY D. Maniori (A)

P. Petronzi (A)
UK G.F. Churchill (C) (A)
USA J.W. Anderson (C)
IAEA N. Raisic (Scientific Secretary)
*/ (C) and (A) after name dénotâtes participation in the

Consultants' and Advisory Group Meeting, respectively.
105

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IAEA-TECDOC-303

MANUAL ON THE SELECTION

A TECHNICAL DOCUMENT ISSUED BY THE

Printed by the IAEA in Austria

Orders should be accompanied by prepayment of Austrian Schillings 80.00

The Agency's plans for establishing safety standards for nuclear

1. Codes of Practice for thermal neutron nuclear power plants that

2. Safety Guides that provide additional requirements and recommend

3. User's Manuals, directed primarily to nuclear power plant operators,

To implement these recommendations work has been initiated in the

The present Manuals on the Selection of Appropriate Quality Assurance

2. CLASSIFICATION OP ITEMS AND SERVICES .

3. GRADING OF QUALITY ASSURANCE ACTIVITIES .

4. CORRELATION OF APPLICABLE QUALITY ASSURANCE ACTIVITIES WITH ITEMS

5. CUSTOMIZING OF SELECTED QUALITY ASSURANCE ACTIVITIES .

6. SPECIFYING OF APPLICABLE QUALITY ASSURANCE ACTIVITIES .

7. SELECTIVE APPLICATIONS SYSTEMS .

Annex I Typical Definitions for Basic Plant Units 29

Annex II Classification of Items and Services by Function 31

Annex III Classification of Items and Services by Importance of

Annex IV Classification of Items and Services by Complexity of

Annex V Classification of Items and Services by Uniqueness, Maturity

Annex VI Principal Activities of a Quality Assurance Programme 47

Annex VII Organization of Quality Assurance Programme Activities 49

Annex VTII Grading of Quality Assurance Activities .

Annex IX Correlation of Items and Services with Quality Assurance

Annex X Typical Format for Quality Assurance Requirements Section of

Annex XI Examples of a Selective Application System 63

The IAEA Code of Practice on Quality Assurance for Safety in

This requirement is further elaborated in the IAEA Safety

However, neither the Code nor the Safety Guide provide

1.2 Scope and Purpose of tne Manual

This manual provides guidance and illustrative examples for

This selective application system is intended to be used by

The parts of the system should be developed to the degree

CLASSIFICATION OF ITEMS AND SERVICES

Trie first element in the selective application system is the

(a) the importance of the item or service to tne safe operation

(c) other factors, as appropriate, including

2.1 Identification of Items and Services

Tne development of a meaningful method of classification

Typical definitions for basic units are shown in Annex I.

2.2 Classification Methods and Techniques

The method of classification should allow each item or

its function in the plant

Numerous techniques have been devised for use in classifying

2.2.1 Classification by Function

Items and services can be classified with regard to

A technique for classification by function is shown in

2.2.2 Classification by Safety and Operational Importance

Items and services can be classified with regard to

(a) Quality Group Classification

(c) Seismic Classification

2.2.3 Classification by Item or Service Complexity

Items and services can be classified in accordance

A technique for classification of items and services

2.2.4 Classification by the Uniqueness, Maturity and Complexity of

Activities affecting quality have been identified in

The following sub-sections describe examples of

Items and services can be classified with regard to

A further consideration in classifying items and

A technique for classifying items and services on the

b. Production of Items and Performance of Services

Items and services can be classified according to the