CSA N299.1-2019 (En) - Quality Assurance Program Requirements For The Supply of Items and Services For Nuclear Power Plants - Category 1

CSA N299.
1:19
CSA
GROUP™
Quality assurance program requirements

for the supply of items and services for
nuclear power plants, Category 1
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CSA N299.1:19
Quality assurance program
requirements for the supply of items
and services for nuclear power
plants, Category 1
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Quality assurance program requirements fo r the supply of items
CSA N299.1:19 and services fo r nuclear power plants, Category 1
Contents
Technical Committee on Management Systems for Nuclear Facilities 4
Subcommittee on Quality Assurance Program Requirements for Supply of Items and Services for Nuclear
Power Plants 6
Preface 8
0 Introduction 9
0.1 Background 9
0.2 Category series 9
1 Scope 12
2 Reference publications 13
3 Definitions 15
4 General requirements 19
4.1 General 19
4.2 Customer's responsibilities 20
4.3 Management responsibilities 21
4.3 .1 Top management 21
4.3.2 Management representative 21
4.4 Independent verification 21
4.5 Software 22
4.5.1 Softwa re employed in work methods or tools 22
4.5.2 Embedded software 22
4.5 .3 Design analysis software 22
4.6 Safety culture 22
4.7 Use of experience 22
4.8 Counterfeit, fraudulent, and suspect items (CFSls) 23
5 QA manual 23
5.1 General 23
5.2 QA manual contents 23
6 QA program procedures 24
7 QA program elements 24
7.1 Management review 24
7.2 Indoctrination, training, and qualification 25
7.2 .1 Indoctrination 25
7.2.2 Training 25
7.2.3 Qualification 25
7.3 Tender and contract review 26
7.3 .1 Review of tendering requirements 26
7.3.2 Review of contractua l requirements 26
December 2019 © 2019 Canadian Standards Association 1

Quality assurance program requirements for the supply of items
CSA N299.1:19 and services for nuclear power plants, Category 1
7.4 Design 27
7.4.1 Application 27
7.4.2 Design planning 27
7.4.3 Work assignment 27
7.4.4 Interfaces 27
7.4.5 Design inputs 27
7.4 .6 Preliminary design 28
7.4.7 Design analysis software 28
7.4.8 Detailed design 28
7.4.9 Design output 28
7.4.10 Design verification 28
7.4.11 Design changes 30
7.5 Documentation 30
7.6 Procurement 31
7.6.1 Selection 31
7.6.2 Use of customer's approved suppliers 32
7.6.3 Subcontract requirements 32
7.6.4 Reviews 33
7.6.5 Inspection, surveillance, and audit of subsuppliers 33
7.6.6 Amendments to subcontracts 33
7.7 Verification p lanning 33
7.8 Verification activities 35
7.9 Verification status 36
7.9.1 Verification status for items 36
7.9.2 Verification status for services 36
7.10 Measuring and testing equipment {M&TE) 36
7.11 Identification and traceability 38
7.11.1 Identification 38
7.11.2 Traceability 38
7.12 Handling and storage 38
7.13 Production 39
7.13.1 Plann ing 39
7.13.2 Process procedures 39
7.13 .3 Process verification 39
7.13.4 Work control 40
7.14 Special processes 40
7.15 Packaging and shipping 40
7.16 Records 40
7.16.1 General requirements 41
7.16.2 Generation of records 41
7.16.3 Authentication of records 41
7.16.4 Maintenance and storage of records 41
7.16.5 Record retention periods 42
7.17 Nonconformances 42
7.17.1 General nonconformance requirements 42
7.17.2 Specific nonconformance requirements for items and services 43
7.18 Corrective action 43
7.19 Customer-supplied items and services 44
7.20 Statistical techniques 44

7.21 Quality audits 44

7.21.1 Internal quality audits 44
7.21.2 External quality audits 45
8 CSA N299 dedication requirements 46

8.1 Application 47
8.2 Dedication eligibility 48
8.3 Planning 48
8.4 Work assignment 48
8.5 Identification and maintaining traceability 48
8.6 Design evaluation 48
8.7 Acceptance 49
8.7.1 Acceptance criteria and control areas 49
8.7.2 Control Area 1: QA program augmentation 50
8.7.3 Control Area 2: Verification activities 50
8.7.4 Control Area 3: Supplier performance 52
8.8 Conduct acceptance activities 52
8.9 Dedication outputs 53
8.10 Dedication changes 53
Annex A (normative) - Category selection 54

Annex B (informative) - Guidance on QA program procedures 63
Annex C (informative) - Guidance on design 66
Annex D (informative) - Guidance on measuring and test equipment 70
Annex E (informative) - Counterfeit, fraudulent, and suspect items {CFSls) 73
Annex F (informative) - Risk evaluation 75
Annex G (informative) - Records 76

Technical Committee on Management

Systems for Nuclear Facilities
J. Brown BWXT Nuclear Energy Canada Inc., Chair
Peterborough, Ontario, Canada
Category: Supplier/Fabricator/Contractor
A. Coulas Canadian Nuclear Laboratories Limited (CNL), Vice-Chair

Chalk River, Ontario, Canada
Category: Owner/Operator/Producer
S. D. Harris Ontario Power Generation, Vice-Chair

Oshawa, Ontario, Canada
R. W. Barnes ANRIC Enterprises Inc.,

Toronto, Ontario, Canada
Category: Service Industry
E. Clavel Clavel Quality Consulting,

Mississauga, Ontario, Canada
D. Constantinescu Bruce Power,

Tiverton, Ontario, Canada
C. M. Daniel AECOM,
Richmond Hill, Ontario, Canada
R. Grismer Cameco Corporation,

Saskatoon, Saskatchewan, Canada
B. Johnston McMaster University,

Hamilton, Ontario, Canada
Category: General Interest
P. Jones TRIUMF,
Vancouver, British Columbia, Canada

J. Krane Stuart Olson,

Port Elgin, Ontario, Canada
P. Lahaie Canadian Nuclear Safety Commission (CNSC),

Ottawa, Ontario, Canada
Category: Government and/or Regulatory Authority
G. Lamarre Canadian Nuclear Safety Commission (CNSC), Non -voting

V. Raees Technical Standards and Safety Authority,

Ajax, Ontario, Canada
Category: Government and/or Regulatory Authority
R. Schewaga Orano Canada,

M . Schnell Canadian Light Source Inc.,

P. Schultz Canadian Nuclear Safety Commission, Non-voting

C. Sellers Campbellcroft, Ontario, Canada Non -voting
P. L. Wiggins NB Power Corporation,

Lepreau, New Brunswick, Canada
P. Young Scarborough, Ontario, Canada

M . Khan CSA Group, Project Manager


CSA N299.1 :19 and services for nuclear power plants, Category 1
Subcommittee on Quality Assurance

Program Requirements for Supply of Items
and Services for Nuclear Power Plants
C. Sellers Campbellcroft , Ontario, Ca nada Chair
N. Boraso CANDU Owners Group Inc.,

J. Brown BWXT Nuclear Energy Canada Inc.,

Peterborough, Ontario, Canada
R. Burns Kinectrics Inc.,

M . Cagnetta Framatome,
Kincardine, Onta r io, Canada
S. Ciobanu Framatome,
Pickering, Ontario, Canada
E. Clavel Clavel Quality Consulting,

Mississauga, Ontario, Canada
S. Demeter Kinectrics Inc.,

S. Guj ral Tetra Tech,

S. D. Harris Ontario Power Generation,

Oshawa, Ontario, Canada
P. Karsten Karsten Nuclear Quality Services Inc.,

Kincardine, Ontario, Canada
J. Lopez Bruce Power LP,

Tiverton, Ontario, Canada
T. Mason Black & McDonald Ltd .,


L. Payne Energie NB Power,

Maces Bay, New Brunswick, Canada
M . Pletosu Ontario Power Generation Inc.,

Pickering, Ontar io, Canada
D. Sperling Sperling Quality and Project Services,

Burlington, Ontario, Canada
A. Wagland WAG QA Services Canada Inc.,

Waterloo, Ontario, Canada
G. B. Waterhouse Vermeer Engineering,

Whitby, Onta r io, Canada
P. Wong Canadian Nuclear Safety Commission (CNSC),

M . Khan CSA Group, Project Manager


Preface
This is the second edition of CSA N299.1, Quality assurance program requirements for the supply of
items and services for nuclear power plants, Category 1. It supersedes the previous edition published in
2016.
The CSA N299 series of Standards defines quality assurance program requirements for the provision of
items and services for nuclear power plants when specified in the contract between the customer and
the supplier.
The most significant updates to this edition include

a) the addition of requirements on dedication in Clause 8;
b) the revision of Annex E to provide guidance on counterfeit, fraudulent, and suspect items (CFSls);
c) the addition of Annex F to provide guidance on risk evaluation; and
d) the addition of Annex G to provide guidance on records.
This Standard has also been restructured and reordered for better readability.
Users of this Standard are reminded that civilian nuclear facilities in Canada are subject to the
provisions of the Nuclear Safety and Control Act and its Regulations.
This Standard was p repared by the Subcommittee on Quality Assurance Program Requirements for
Supply of Items and Services for Nuclear Power Plants, under the jurisdiction of the Technical
Committee on Management Systems for Nuclear Facilities and the Strategic Steering Committee on
Nuclear Standards, and has been formally approved by the Technical Committee.
Notes:
1) Use of the singular does not exclude the plural (and vice versa) when the sense allows.
2) Although the intended primary application of this Standard is stated in its Scope, it is important to note that it
remains the responsibility of the users of the Standard to judge its suitability for their particular purpose.
3) This Standard was developed by consensus, which is defined by CSA Policy governing standardization - Code
of good practice for standardization as "substantial agreement. Consensus implies much more than a simple
majority, but not necessarily unanimity". It is consistent with this definition that a member may be included in
the Technical Committee list and yet not be in full agreement with all clauses of this Standard.
4) To submit a request for interpretation of this Standard, please send the following information to
inquiries@csaqroup.org and include "Request for interpretation" in the subject line:
a) define the problem, making reference to the specific clause, and, where appropriate, include an
illustrative sketch;
b) provide an explanation of circumstances surrounding the actual field condition; and
c) where possible, phrase the request in such a way that a specific "yes" or "no" answer will address the
issue.
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a) Standard designation (number);
b) relevant clause, table, and/or figure number;
c) wording of the proposed change; and
d) rationale for the change.

CSA N299.1:19
Quality assurance program requirements
for the supply of items and services for
0 Introduction
0.1 Background
The CSA Z299 series of Standards (referred to collectively as "CSA Z299") was selected by Ontario Hydro
and AECL in the 1970s as the quality assurance standard for the procurement of items and services for
their nuclear facilities. As a result, the CSA Z299 Standards were embedded in the design bases of all
nuclear power stations and some utility-owned nuclear facilities licensed in Canada, and continue to be
used. These Standards were initially developed from Ontario Hydro quality standards and conta ined
many of the requirements that were in force at that time. When the CSA N286 series of Standards were
developed in the late 1970s, they referenced CSA Z299 as the recommended quality assurance standard
fo r items and services. CSA Z299 was a commercial standard used broadly both nationally and
internationa lly, and it was the pre-cursor to development of the ISO 9000 series of Standards. With the
development of ISO 9001 in 1994, ISO 9001 became the commercial quality standard that was general ly
adopted by industry. CSA Z299 was no longer supported by the Technical Committee in charge of
CSA Z299, and it was eventual ly withdrawn .
Internationally, there have been mixed approaches to creating industry-specific QA standards, such as
augmenting ISO 9001 or creating completely new standards. CSA Z299 has not been issued since 1985
and needed to be updated to reflect current needs. To fu lfill this need, nuclear utilities have developed,
through a joint CAN DU Owners Group (COG) project, a set of graded standards that align with the
withdrawn CSA Z299 series so that the impact to the design basis and content transition to the new
standards is minimized . These graded standards were used as the seed documents for the new
CSA N299 series of Standa rds, which incorporates operating experience and current best practices and
harmonizes, to the extent possible, with other standards (both national and international).
0.2 Category series

This is the first in a series of four Standards for the four quality assurance program categories
(Category 1 to Category 4) . See Figure 1 for a summary of th is series of Standards and applicable
elements.
This Standard was developed in response to industry's need for a qualit y assurance standard for items
and services supplied to nuclear power plants.

CSA N299.1 :19 and services fo r nuclear power plants, Category 1
Figure 1
Summary of standards and applicable elements
(See Clauses 0.2 and A.2.1 .)
Category 1
Category 2 Note: Category 1 includes
Category 3 Note: Category 2 includes Category 2, 3, and 4
Note: Category 3 includes Category 3 and 4 requirements.
Category4 Category 4 requirements. requirements.
QA program QA program QA program QA program

• Training • Training and • Program procedures • Process review
requirements qualification program • Design • Design
• Contract review • QA manual - Planning - Alternat ives
• Document control • Tender and contract - Preliminary • Nonconformance
review
• Calibration design (preventive
• Program descriptions
• Procurement - Design analysis measures)
• Design
• Verification activities - Detailed design • Corrective action for
- Interfaces
• Identification • Nonconformance pot ential
- Design inputs
• Handling and storage cause analysis nonconform an ces
- Software
control • Internal audits
- Design outputs
• Production
- Design
• Packaging and verification
shipping
- Design changes
• CFSls
• Verification planning
• Records • Identification and
• Nonconformance and traceability
corrective action • Production planning
• Customer-supplied • Use of experience
items and services • Special processes
• Statistica l t echniqu es • External audits
• Dedication
Least comprehens ive Most comprehensive
Category 4 is the least comprehensive, with each category in the series being more comprehensive as
the category numbers decrease, and with Category 1 being the most comprehensive. The matrix
comparison shows the increasing requirements by clause (see Table 1). The matrix will assist users
when cross-referencing or upgrading from one category to another. When contractually required to
produce an item or provide a service to one of the categories, suppliers may implement applicable
additional requirements of a higher category quality assurance program.
This Standard aims at preventing the occurrence of nonconform ing items or services. This is ach ieved by
thorough planning and controls that extend to identifying and correcting weaknesses in the qual ity
assurance program. This Standard is suitable for custom-designed, first of a kind, high-technology items
and services, which tend to require many complex processes and extensive design effort by either
customers or suppliers, or both. Failure in service could result in undue risk to safety or the business.
The selection of any one category does not change the contractual requirements to produce an item or
provide a service of the required quality. For selection of the most appropri ate category, the use of
Annex A within each CSA N299 series Standard is required. Selection of the appropriate category should
be made by considering the parameters that are inherent to the item or service.

Table 1
Information comparison of CSA N299 category requirements
(See Clause 0.2 .)
Matrix comparison of categories Category 1 Category 2 Category 3 Category 4

1 Scope I II 111 IV
3 Definitions I I 111 IV
4 General requirements I I 111 IV
4.1 General I I I IV
4.2 Customer's responsibilities I I I IV
4.3 Management responsibilities
4.3.1 Top management I I 111 IV

4.3.2 Management representative I I I IV
4.4 Independent verification I I I IV
4.5 Software I I I IV
4.6 Safety culture I I I N/A
4.7 Use of experience I I 111 N/A
4.8 Counterfeit, fraudulent, and
I I I I
suspect items (CFSls)
5 QA manual/program documentation I I I* IV
6 QA program procedures/descriptions I I 111 N/A

7 QA program elements
7.1 Management review I II 111 IV
7.2 Indoctrination, training, and

I I 111 IV
qualification
7.3 Tender and contract review I I 111 IV

7.4 Design I II 111 N/A
7.5 Documentation I I I* IV
7.6 Procurement I I 111 IV
7.7 Verification planning I I I* N/A
7 .8 Verification activities I I I IV
7 .9 Verification status I I I IV
7.10 Measuring and testing
equipment (M&TE) I I I* I*
7.11 Identification and traceability I I I IV
(Continued)

Table 1 (Concluded)
Matrix comparison of categories Category 1 Category 2 Category 3 Category 4

7.12 Handling and storage I I 111 IV
7.13 Production I I 111 IV

7 .14 Special processes I I I N/A
7.15 Packaging and shipping I I 111 IV
7 .16 Records I I I IV
7.17 Nonconformances I I 111 IV
7 .18 Corrective action I II 111 111
7.19 Customer-supplied items and
. I I I I
services
7.20 Statistical techn iques I I I* IV
7 .21 Quality audits
7.21.1 Internal quality audits I I 111 N/A

7.21.2 External quality audits I I 111 N/A
8 CSA N299 dedication requirements I II 111 N/A
Note: Table 1 is provided to show the differences between the standard categories.
Legend:
I - Requirements equivalent with Category 1
11 -- Requirements equivalent with Category 2
111 - Requirements equivalent with Category 3
IV - Requirements equivalent with Category 4
N/A - Specific clause is not applicable to the specified category
* Descriptions rather than quality assurance procedures.
1 Scope
1.1
1.1.1
This Standard defines minimum requirements for a supplier's quality assurance program (hereafter
referre d to as "QA program") fo r the supply of items and services to nuclear power plants -
Category 1.
Notes:
1) This Standard does not include a separate implementation guide; instead, relevant guidance is found
throughout the Standard as notes, or within the relevant annex (see Annexes B through §).
2) The requirements in this Standard do not restrict or specify the form that suppliers' programs should take; nor
do they specify how to establish such programs. The requirements only specify what these programs cover;
they allow suppliers to determine how their programs should be structured in order to suit their own

situations and objectives. The onus is on suppliers to develop programs in a consistent and systematic way
that allows customers, recognized qualifying authorities, or regulatory authorities to survey and audit the
programs.
3) This Standard may provide guidance for nuclear facilities other than nuclear power plants. The operators of
these facilities may determine the applicability and suitability of this Standard.
1.1.2
The QA program is aimed primarily at preventing nonconforming conditions by controlling design,
production, and verification processes, and by developing corrective actions that
a) ensure items or services conform to specified requirements;
b) maintain control of, and confirm compliance to, quality and customer requirements; and
Note: Typically, customer requirements are found in the contract between the customer and the supplier.
c) readily detect and control the disposition of nonconformances and prevent their recurrence.
1.2
This Standard applies to suppliers and subsuppliers when specified by the customer.
Note: Other QA program standards or management system standards may be used provided that the requirements
of this Standard are met.
1.3
In this Standard, "shall" is used to express a requirement, i.e., a provision that the user is obliged to
satisfy in order to comply with the Standard; "should" is used to express a recommendation or that
which is advised but not required; and "may" is used to express an option or that which is permissible
within the limits of the Standard.
Notes accompanying clauses do not include requirements or alternative requirements; the purpose of a
note accompanying a clause is to separate from the text explanatory or informative material.
Notes to tables and figures are considered part of the table or figure and may be written as
requirements.
Annexes are designated normative (mandatory) or informative (non-mandatory) to define their

application.
2 Reference publications
This Standard refers to the following publications, and where such reference is made, it shall be to the
edition listed below.
CSA Group
CAN/CSA-ISO 10012:03 (R2018)
Measurement management systems - Requirements for measurement processes and measuring
equipment
CAN/CSA-ISO/TR 10017:03 (R2018)

Guidance on statistical techniques for ISO 9001:2000
CAN/CSA-ISO 19011:12 (R2017)

Guidelines for auditing management systems

ASME (The American Society of Mechanical Engineers)

Boiler and Pressure Vessel Code, 2015 edition
Section Ill - Rules for Construction of Nuclear Facility Components
NQA-1- 2015
Quality Assurance Requirements for Nuclear Facility Applications
CNSC (Canadian Nuclear Safety Commission)

REGDOC-2.1 .2 {2018)
Safety Culture
REGDOC-2.5.2 {2014)
Design of Reactor Facilities: Nuclear Power Plants
REGDOC-3.6 {2018)
Glossary of CNSC Terminology
EPRI {Electric Power Research Institute)

EPRI 1019163(2014)
Plant Support Engineering: Counterfeit and Fraudulent Items - Mitigating the Increasing Risk
EPRI NP-5652 (2014)

Plant Engineering: Guideline for the Acceptance of Commercial-Grade Items in Nuclear Safety-Related
Applications
IAEA (International Atomic Energy Agency)

INSAG-15 (2002)
Key Practical Issues in Strengthening Safety Culture
Safety Guide No. GS-G-3.5 (2009)

The Management System for Nuclear Installations
TECDOC-1169 (2000)
Managing suspect and counterfeit items in the nuclear industry
TECDOC-1329 (2002)
Safety culture in nuclear installations - Guidance for use in the enhancement of safety culture
INPO {Institute of Nuclear Power Operations)

12-012 (2013)
Traits of a Healthy Nuclear Safety Culture
ISO {International Organization for Standardization)

9001:2015
Quality management systems - Requirements
ISO/IEC (International Organization for Standardization/International Electrotechnical Commission)

17025:2017
General requirements for the competence of testing and calibration laboratories

SAE International
AS6496 (2014)
Fraudulent/Counterfeit Electronic Parts: Avoidance, Detection, Mitigation, and Disposition -
Authorized/Franchised Distribution
3 Definitions
The following defin itions shall apply in this Standard:
Authority having jurisdiction (AHJ) - the organization having jurisdiction over the design,
procurement, fabrication, installation, testing, operation, inspection, maintenance, and
decommissioning of a nuclear facility.
Authorized distributor - a distributor authorized by a manufacturer to conduct transactions and

distribute an item within the terms of a distribution agreement.
Note: Other distributor(s) are considered unauthorized distributors/brokers.
[Source: Adapted from SAE AS6496)
Batch (or volume or lot) - an identifiable collection of items, or quantity of material, of a single type,
grade, class, size, or composition produced in the same facility under essentially the same conditions
and at essentially the same time.
Business - an organizational entity with accountability to implement some or all of the requirements
of this Standard.
Calibration - compa ri ng two instruments, measuring devices, or standards, one of which is of known
accuracy.
Note: It is done to detect, correlate, report, or eliminate by adjustment any variation in accuracy of the instrument
or measuring device of unknown accuracy.
Characteristic - any distinct property or attribute of an item, process, or service that can be described
and measured to determine conformance and nonconformance to specified requirements.
Configuration management - a process that

a) establishes consistency between design requirements, physical and operational configuration, and
documentation and records;
b) maintains configuration management element consistency from initial conception to cessation of
operations;
c) maintains alignment of safety and design analysis with item configuration;
d) facilitates safe operations; and
e) supports changes .
Contract - the written covenant and other documents agreed to and legally binding between the
customer and supplier, which specify requirements and conditions that are to be met to successfu lly
complete the work.
Corrective action - any measure taken to rectify a nonconformance or other undesirable situation and,
where necessary, the measures taken to rectify the cause(s) to preclude recurrence.
Counterfeit, fraudulent, or suspect item (CFSI) - an item that has been intentionally produced to
a) replicate another item without obtaining legal permission to do so;
b) defraud by posing the false copy as genuine or original; or

c) misrepresent the original with intent to deceive, whether provided with incorrect identification or
falsified or inadequate certification .
[Source: Adapted from EPRI 1019163]
Critical characteristics - applicable QA program elements, design, material, and performance

characteristics of an item or service that provide reasonable assurance that the item or service will
perform its intended end-use function.
[Source: Adapted from ASME NQA-1]
Customer - the party or its representative issuing a contract for procuring items or services.
Note: When suppliers subcontract part of the work to subsuppliers, suppliers become customers as referred to in
the CSA N299 series of Standards.
Customer representative - the person appointed by the customer to verify the quality of the supplier's
work.
Dedication - an acceptance process undertaken to provide reasonable assurance that

a) an item or service procured from a supplier whose QA program does not meet the requirements
specified in this Standard will perform its intended function; and
b) the item or service specified in Item a) is deemed equivalent to an item designed and
manufactured under a QA program as described by this Standard.
Dedication entity - the entity contracted to perform the dedication activities; this may be the
customer, the supplier, or a third party.
Description - a document stating the purpose and scope of an activity and who is responsible for
what, and the action to be taken to fulfill the QA program requirements.
Design - activities that lead to the specification and technical description of a structure, system, or
component.
Design change - any change or modification, either physical or on paper, to design inputs, outputs, or
controls in support of item or service development, implementation, use, and maintenance.
Design input - requirements and information specified by customers, AHJs, design groups, or design
discipline, and needed as a reference base for design work.
Design output - requirements and information that document the configuration of the design.
Design review - a systematic and disciplined review of selected systems and equipment by qualified
personnel familiar with aspects like design, such that an appropriately broad engineering knowledge is
applied to the process.
Note: Such a process is intended to verify that the design is achieving its specified requirements and to provide
assurance to the business that the design outputs meet those requirements. Design review is a verification task.
The objectives of the design review are to
a) verify that the specified design requirements are correct and complete;
b) verify that the design meets the specific system, component, and/or project requirements;
c) verify that appropriate design methods were used, that design inputs were correctly selected, and that the
required features are incorporated into the design;
d) identify problems (nonconformances) in design and bring them to the attention of those responsible for their
resolution;
e) provide a means for ensuring that system interface elements are compatible; and

f) promote mature designs by utilizing past experience, proven techniques, and collective knowledge of
competent individuals.
Electronic record authentication - the process of establishing user identities electronically associated
with information stored in a database, document management system, or other electronic information
repository.
Notes:
1) The establishment of user identities refers to determining whether someone or something is, in fact, who or
what it is declared to be.
2) Information can be in the form of a single record or assembled data (e.g., metadata; collection of data or
data elements).
First of a kind - a design that is new and is not based on a mature or standard design practice. It can
also be a complex design that has not been performed for a significant amount of time.
Foreign material - any substance or object not belonging naturally in the place where found and not
part of the design.
Indoctrination - providing personnel with instruction regarding certain fundamental ideas and core
values.
Inspection - the examination, measurement, and testing of the characteristics of items or services to
determine acceptability and to record inspection data.
Nonconformance - a deficiency in characteristic, documentation, process, or procedure/description

that renders the quality of an it em or service unacceptable or indeterm inate, or not according to
specified requirements.
Note: Examples of nonconformances are physical defects, test failures, inadequate documentation, and deviations
from prescribed processing or from any other part of the QA program.
Nuclear power plant - any fission reactor installation constructed to generate electricity on a
commercial scale.
[Source: Adapted from CNSC REGDOC-2.5.2)
Objective evidence - information, records, or statements of fact, based on observation, measurement,

or assessment, that demonstrate the implementation of requirements and can be verified.
Organizational function - a department within the supplier's business providing a service such as
design, production, procurement, or quality assurance.
Personnel - anyone who performs an occupational task, including top management.
Positive recall - a method whereby an item can be released so that further work can proceed,
provided that the item is identified as being subject to recall and can be removed, repaired, or
reworked at a later stage if found unacceptable.
Procedure - a document that specifies, as applicable,

a) the purpose and scope of an activity;
b) what is required to be done and by whom;
c) when, where, and how it is required to be done;
d) what materia ls, equipment, and documentation are required to be used; and
e) how it is required to be controlled.

Process monitoring methods - methods used to carry out independent, periodic verification of
processes to confirm that all the parameters of those processes are maintained within the specifications
defined by the process procedures/descriptions.
Production - all activities involved in the fabrication, assembly, construction, and erection of items to
Qualification (personnel) - the characteristics or abilities gained through education, training, or

experience, as measured against established requirements such as standards or tests, that qualify an
individual to perform a required function.
Quality - the ability to meet specified requirements.
Quality assurance (QA) - a planned and systematic pattern of means and actions that is designed to
provide confidence that items or services will meet specified requirements and perform satisfactorily in
service.
Quality audit - a documented activity aimed at verifying by independent examination and evaluation
that the applicable elements of the QA program have been established, documented, and implemented
effectively in accordance with specified requirements.
Recognized authority - the nuclear utility, or a business accepted by the nuclea r utility, that is
authorized to evaluate conformance of a QA program to this Standard.
Repair - processing nonconforming items so that they can function reliably and safely even though the
items still do not conform to the originally specified requirement.
Review - the formal examination of an output to confirm its adequacy.
Rework - reprocessing items to conform to the originally specified requirement.
Safety - a business's objective directed at preserving and protecting personnel, the public, the
environment, and assets against harm resulting from known conditions, natural occurrences, malicious
acts, accidents, and risks at a nuclear facility that causes radiologica l and non-radiological effects.
Safety culture - the characteristics of a work environment, such as values, rules, and common
understandings, that influence employee perceptions and attitudes about the importance that the
organizat ion places on safety.
[Source: CNSC REGDOC-3 .6]
Safety-related - a category of applications and systems and their related components and supports
that, by failing to perform in accordance with the design intent, has the potential to impact the
radiologica l safety of the public or plant personnel.
Software - all or part of the programs, procedures/descriptions, rules, and associated documentation
of an information processing system .
Special inspection process - an inspection requiring either specialized inspector skills or inspection
techniques, or both.
Note: An example of a special inspection process is nondestructive testing.

Special production process - a production process where conformance is ensured by using evidence
generated during the process and when subsequent inspections required to establish conformance are
either impossible or undesirable.
Note: Examples of special production processes include welding, soldering, heat treating, or special surface
coatings.
Subcontract - a contract between a supplier and a subsupplier.
Supplier - the party responsible for the performance of the work specified in the contract issued by
the customer.
Supplier evaluation - an assessment to determine the extent to which a supplier's QA program and
business resources are capable of meeting specified requirements, producing a quality item or service,
and generating evidence that supports decisions of acceptability.
Surveillance - the continuing evaluation, analysis, and verification of a supplier's records, methods,
procedures/descriptions, items, and services to ensure that requirements are met.
Survey - a limited-scope qua lity audit to assess the implementation of specific QA program elements
as a part of the dedication p rocess.
Top management - the person or group of people who directs and controls the business at the highest
level.
[Source: ISO 9001)
Traceability - the ability to trace the history, application, or location of an item and like items or
activities by means of recorded identification .
[Source: ASME NQA-1)
Validate - determine the degree to which performance requirements are met, using functional tests or
an equivalent method.
Verification - the act of reviewing, checking, or inspecting to confirm that work meets requirements.
Working knowledge - the understanding by experience in a specialty fie ld of the standard

requirements and of the principles on which the standard rules are based, to the extent that the
qualified personnel can apply or direct others in the application of the requirements.
[Source: Adapted from ASME Boiler and Pressure Vessel Code, Section Ill]
4 General requirements
4.1 General
The supplier sha ll
a) document, implement, and maintain a QA program in accordance with the requ irements of this
Standard;
b) inform the customer as early as reasonably possible of any significant it em or service perfor mance
ri sks, or changes to the QA program or the organizational structure that could impact the
conditions under which the supplier acceptance was granted {see Annex F on risk evaluation for
changes and impacts); and

c) provide customer access to the applicable premises or working areas, including those of the
subsuppliers, for the purpose of surveillance, AHJ requirement verification, and aud it .
Notes:
1) Customer representatives may perform evaluations, surveillance, and audits at buildings or premises where
the customer's work is being performed. This right of access may extend to all subsuppliers in the supply
chain such as agents, distributors, item manufacturers, and assembly and test facilities.
2) The right of access includes the right to review items and services, documents, records, and procedures
pertaining to the customer's work. However, suppliers have the right to refuse access to unrelated work being
done for other customers, and to refuse access to items, services, or audits where their QA program is not
applicable, as long as this is not in contradiction with the information contained in their QA manuals.
4.2 Customer's responsibilities

Customers shall
a) evaluate and select suppliers based on their abi lity to meet specified requirements by the time the
work starts, which shall include an evaluation of
i) the QA manual (or fo r Category 4, QA program description) and associated documentation;
ii) the QA program implementation (for CSA N299 Category 1, 2, 3, or equivalent), including the
supplier' s procurement process;
iii) the ability to provide a technically adequate and economical item or servi ce;
iv) the ability to respect delivery dates;
v) other required locations, plan(s), and resources; and
vi) the supply performance history;
Notes:
1) Evidence of conformance to this Standard by a recognized authority should be considered to fulfill this
responsibility.
2) The frequency of the supplier evaluations depends on the results of previous supplier monitoring activity,
the effectiveness of QA programs, and the response received to requests for corrective action. This can
be determined by evaluating QA program performance, item or service conformance, and the accuracy
of records generated by the QA programs.
b) specify the following items:
i) the scope of and requirements for the work;
ii) the QA program standa rds and specifications the supplier is required to meet, as well as any
specific ones to be included in subcontracts;
iii) the QA program standards and specifications that apply to customer-supplied items or
services;
iv) traceabi lity in accordance with Clause 7.11;
v) the requirements of the AHJ that apply to the items or services;
vi) documentation to be delivered to the customer and retained by the supplier, as well as the
applicable retention period; and
vii) experience applicable to the item or service (see Clause 4. 7);
Note: Typically, these items are found in the tender and contract.
c) carry out surveill ance and audits, when required, to ensure that the supplier and, where applicable,
the subsupplier(s) are conforming to this Standard;
d) ensure that customer-supplied items or services comply with specified requirements, and that they
are consistent with the qua lity requirements of the fina l items or services, or advise the supplier
that nonconformances have been suitably dispositioned; and
Note: Items used for manufacturing or assembly purposes (e.g., fixtures, jigs) that are not being incorporated
into the final item or service are not subject to the requirement in Item d).

e) evaluate the supplier's QA program as it r elates to items p roduced for inventory (stock) and
resolve with the supplier, at the time of the initial evaluation, those standard requirements where
document submittal is required before the start of the work.
Note: When a recognized authority has accepted a QA program for items produced for inventory, submittal
requirements to customers before the work starts might not have been addressed during the verification of the
original scope of the QA program. The customer should resolve this with the supplier.
4.3 Management responsibilities
4.3.1 Top management
4.3.1.1
The supplier shall document top management's commitment to t he development and implementation
of t he QA program and to continually improving its effectiveness.
4.3.1.2
Top ma nagement shall ensure adherence of management and personnel to the requirements of the
QA program and shall be responsible for determining, providing, and ma intaining the resources and
wor k environment needed to achieve conformity to item or service requirement s.
Note: The term "work environment" relates to those conditions under which work is performed, including physical,
environmental, and other factors (including, but not limited to, noise, temperature, humidity, lighting, or weather).
4.3.2 Management re presentative
4.3.2.1
The supplier shall
a) appoint a representative who reports to top management at a level which ensures that quality
assurance requirements are not subordinated to procurement, production, or delivery; and
b) define the representative's authorit y and responsibility to resolve qua lity matters.
Note: The management representative should be the supplier's primary contact with customers on quality matters.
4.3.2.2
When conditions adverse to quality are identified, the management representative is responsible for
ensuring that
a) solutions are initiated, recommended, or p rovided through designated channels;
b) dispositions are implemented; and
c) further processing, delivery, or installation of a nonconforming item or service is controlled until a
disposition has been obtained internally or when required from the customer.
4.4 Independent verification

Unless otherwise agreed to in w riting by the customer, the supplier sha ll assign personnel to perform
independent verification of character istics for acceptance. Such personnel shall meet the following
req uirements:
a) did not perform the work to be verified; and
b) did not supervise directly t he work to be verified.

Verification of design activities shall be performed in accordance with Clause 7.4.10.

Note: Personnel that do not meet the requirements of this Clause may perform additional checks (e.g., machine
set-up, intermediate measurements).
4.5 Software
4.5.1 Software employed in work methods or tools

Software employed in work methods or tools shall be
a) documented and approved;
b) placed under configuration control; and
c) verified or validated, as appropriate.
4.5.2 Embedded software

Software that forms part of or is incorporated into items or services shall be subject to performance
testing and final acceptance in accordance with this Standard. When known, the customer shall be
promptly notified that an item to be supplied includes embedded software.
4.5.3 Design analysis software

When software is used for design analysis of the item or service, the supplier shall
a) control the software and validate that the software is adequate for its intended use; and
b) identify and document the computer, the computer program name and revision/version, and the
method(s) used fo r verification supporting the application of the computer program to the specific
physical problem.
Note: When a QA program is needed for these aspects, then a Standard written specifically for them should be
used.
4.6 Safety culture

Management of the supplier 's business shall use the QA program to understand and promote a safety
culture by
a) issuing a statement committing personnel to adherence to the QA program;
b) providing the means by which the business supports personnel in carrying out their tasks safely
and successfu lly, by taking into account the interactions between individuals, technology, and the
organization;
c) monitoring to understand and improve the culture; and
d) driving the organization to understand the customer requirements and the importance of safety of
the items and services offered.
Note: See the following documents for additional guidance on safety culture:
a) CNSC REGDOC-2.1.2;
b) IAEA INSAG-15;
c) IAEA Safety Guide No. GS-G-3.5;
d) IAEA TECDOC-1329; and
e) INPO 12-012.
4.7 Use of experience

Experience gained within the supplier's business, by other suppliers, and by customers shall be
a) identified and collected;
b) reviewed for relevance and significance;
c) implemented through action to prevent the recurrence of relevant industry problems; and

d) used to initiate improvement.
Experience within the supplier's business shou ld be made available to others based on its sensitivity.
Note: The supplier should identify and specify any areas of sensitivity that will be invoked. Where the customer's
access is to be denied based on sensitivity, the specifics should be included during the contract review process and
acceptance by the customer should be obtained in writing before the contract is let.
4.8 Counterfeit, fraudulent, and suspect items (CFSis)

The supplier sha ll develop and implement a process for the detection and prevention of CFSls to ensure
that genuine parts and services, du ly tested and verified to meet specified requirements, are provided.
The process shall include the
a) abi lity to identify the origin of the primary source of the item(s), when specified by the customer;
and
b) identification of CFSls. Items identified as CFSls shall be reported to the customer, and then
processed in accordance with Clause 7.17.
Note: For additional guidance on CFSls, see Annex E.
5 QA manual
5.1 General
The supplier shall
a) prepare a QA manual approved by top management; and
b) submit the QA manual and the subsequent revisions to the customer fo r evaluation, unless
otherwise agreed to in writing by the customer.
5.2 QA manual contents

A supplier's QA manual shall address the requirements of this Standard and include as a minimum, but
not limited to, the following:
a) the business name, facility location(s), scope of the items or services covered by the QA program,
and revision date;
b) what QA program standards or specifications it is intended to satisfy;
c) the revision history;
d) a table of contents for easy location of information;
e) the supplier's identification on each page;
f) the page number on each page;
g) a statement describing the periodic review, updating, and controlling of the QA manual in
accordance with Clause 7.5;
h) the organizational structure of the supplier, including a multidivisional supplier, and show the
interrelationship and responsibilities of the roles mentioned on organizational charts with those
groups involved with the item or service;
i) a process that addresses whenever the supplier intends a subsupplier to participate within the
supplier 's QA program, or to delegate to others (e.g., subsuppliers, agents, or consultants) the
execution of any part of the scope of work under the supplier's QA program. The supplier shall at
all times retain overall responsibility;
Note: Where a supplier in the course of its operations intends to use others, such as contractors, agents, or
consultants, to supply items and services, and intends to impose its own QA program, or part thereof, on the
subsupplier, the process for doing so is developed and implemented under the supplier's QA program.
j) a cross-reference to all applicable procedures that make up the QA program; and

k) a rationale for any exemptions to the elements within this Standard.
6 QA program procedures
The supplier sha ll have QA procedures that
a) document, implement, and maintain systems and processes for planning and controlling the
QA program;
b) document for each QA program element the following, as applicable:
i) the purpose and scope;
ii) who is responsible for what;
iii) how, when, and where all steps are performed;
iv) what materials, equipment, and documentation will be used; and
v) how each element is controlled;
Note: The guidelines identified in Annex §. provide examples and explanations and suggest means for
satisfying the requirements of this Clause.
c) maintain, control, and reference the forms used in the QA program; and
d) are updated when necessary and made available to the customer representative, as requested.
7 QA program elements
7 .1 Management review
7.1.1
The supplier shall document, implement, and maintain a process for top management review. Top
management shall perform management reviews with sufficient frequency to ensure their continuing
suitability and effectiveness in meeting the requirements of the QA program. The process used to
review the status and adequacy of the QA program shall be stated in the QA manual. The review shall
analyze appropriat e data to demonstrate the suitability and effectiveness of the QA program in meeting
the requ irements of this Standard, with the objective of continually improving the QA program. The top
management review process shall specify actions required and assignment of personnel to implement
and confirm the effectiveness of the actions taken. Upon completion of the top management review,
the results shall be documented.
Notes:
1) The internal audit function is not a substitute for a management review.
2) Management reviews are carried out by top management and not delegated to other personnel.
3) Typically reviews are performed annually; however, companies may choose a higher frequency to avoid
missed opportunities for identifying and correcting adverse quality trends (e.g., customer complaints,
internal/external audits, internal nonconforming items, and rework).
7.1.2
The management review shall include, as applicable, but not be limited to,
a) results of interna l and external audits;
b) subsupplier performance indicators, including item rejections and returns, nonconformance reports
raised at receiving, nonconforming items dispositioned as "accept as is" or "repair", and on-
schedule delivery;
c) an evaluation that the subsuppliers delegated to execute work under the supplier's QA program
are implementing the QA program effectively;

d) customer feedback;
e) process performance and item and service conformity;
f) status of corrective actions;
g) follow-up actions from previous management reviews;
h) recommendations for improvement;
i) the need for changes to the QA program itself, including its scope and principles; and
j) the results of the trend analysis reported in accordance with Clause 7.17.1 .
7 .2 Indoctrination, training, and qualification
7.2.1 Indoctrination
Indoctrination shall be provided to ensure that personnel are aware of their general responsibilities in
the QA program. Personnel perfo rming or managing activities affecting quality shall receive
indoctrination in their job responsibilities, authority, and safety culture with respect to their roles in the
QA program, and in company policies and procedures. The supplier shall communicate to personnel the
importance of meeting customer requirements and the requirements of the AHJ.
7.2.2 Training
Training shall ensure that personnel are aware of their specified responsibilities in the QA program and
their job functions, are competent and capable of performing their work, and that their competency is
maintained.
The supplier sha ll

a) document, implement, and maintain the required training program and ensure effectiveness of the
training program;
b) document the process and the methods that will be used, and provide the required training
commensurate with the scope, complexity, and importance of the activities;
c) evaluate trainees' knowledge of the training objectives and requirements of applicable codes,
Standards, and specifications; and
d) provide on-the-job training if direct hands-on applications or experience is needed to achieve and
maintain proficiency by confirming trainee performance against expectations.
7.2.3 Qualification
The supplier sha ll
a) develop and document job descriptions or equivalent documents showing the necessary education,
prerequisite skills, experience, and proficiency required for those personnel who affect the
performance and effectiveness of the QA program;
b) qualify personnel who are developing the training needs analysis, expectations, and programs, and
qualify those delivering the training;
c) define and document activities/job functions that require specialized qualifications and
competencies (e.g., engineers, cause analysis personnel, CFSI detection personnel, nondestructive
examination technicians, welders, software programmers, verification personnel, and auditors),
and their minimum qualification and requalification requirements;
d) take into consideration the necessary education, experience, and proficiency (skills and abilities) of
the activity/job function when determining qualification requirements;
e) qualify personnel to the minimum defined qua lification requirements prior to performing the
activity/job function;
f) ensure that competencies of personnel are maintained for their roles and responsibilities, taking
into account changes in technology, methods, or job responsibilities; and

g) conduct reviews at predetermined intervals to verify continued competence, and document the
reviews and actions initiated to correct competence deficiencies found .
7.3 Tender and contract review
7.3.1 Review of tendering requirements

The supplier sha ll
a) review the tendering documents befor e bidding to
i) det ermine that t he requirements are defined, including the requ irement s for delivery and
post-delivery activities, as applicable to the item or service;
ii) determine where the supplier requi res additiona l information to be stipulated in the
specifications for the item or service, and identify and confirm this in writing to the customer
as part of the bid process;
iii) confirm that the supplier's, and subsupplier' s, resources and capability ar e adequate to meet
the requirements;
iv) confirm that any statistical techniques/sampling plans to be used are acceptable to the
customer; and
v) det ermine wh ich items will be supplied from invent ory and demonstrate that the QA program,
as specified, was implemented for t he items at t he time they were produced;
b) record the resu lts of the review of the tender and contract documents; and
c) involve and obtain concurrence of t he applicable organizational functions within the supplier 's
business during t he review of the tender and contract documents.
Notes:
1) The items to be identified are the contracted items agreed upon between the customer and the supplier.
2) Tender and contract reviews should not be limited to design changes and technical aspects. Suppliers need to
establish whether they have the necessary resources to meet schedules and costs, as difficulties regarding
these aspects are likely to affect quality. Requirements for delivery and post-delivery activities, requirements
of the AHJ applicable to the item or service, and any additional requirements that the supplier considers
necessary should be included in the review.
3) During the bidding process, the supplier should ascertain whether the contract or tender documents include
any requirement for configuration management of items or services to be supplied, to what extent, and for
how long a period.
7.3.2 Review of contractual requirements

The supplier shall
a) review t he contract before acceptance to detect differences in the contract from the tender (or
proposal), and resolve those differences with the customer;
b) review t he contr actual requirements, resou rces, and schedule requir ed to ensu re item o r service
qualit y. The review shall include
i) an identification of special p rocess controls;
ii) the requirements of the AHJ applicable to the item or service;
iii) equipment , including measuring and testing equipment (M&TE);
iv) personnel skills and qualifications;
v) requirements for delivery and post-delivery activities; and
vi) any additional r equirements considered necessary by the supplie r;
c) translate contract, t echnical, and quality requirements on work cont rol documents after award of
the contract, as applicable; and
Note: Examples of work control documents include, but are not limited to, design documents, production
documents, and work tracking documents.

d) review and accept subsequent contract changes after award of the contract by the applicable
organizational functions. Personnel impacted by the changes shall be made aware of the changes,
and applicable documents and work-in-progress shall be reconciled.
7.4 Design
Note: See Annex C for additional guidance on design.
7.4.1 Application
The design and associated verification activities shall be commensurate with the scope of work.
Category 1 designs include
a) those with a significant impact to safety, extensive effort, and complexity;
b) first of a kind designs; or
c) those that consist of changes to existing designs as specified in, but not limited to, Clauses 7.4.2 to
7.4.11 where design controls are required to the full extent.
7 .4.2 Design planning

The supplier sha ll
a) identify design and verification work and divide them into discrete activities;
b) plan the sequential or parallel order of the activities;
c) identify resources to work on activities in accordance with Clause 7.4.3;
d) identify interfaces in accordance with Clause 7.4.4;
e) describe or reference the activities in a plan(s) and, when specified in the contract, submit the
plan(s) to the customer prior to the applicable work activity; and
f) update the plan(s) to include additional activities and verification points as the design evolves and,
when specified per Item e}, resubmit to the customer prior to the applicable work activity.
Note: Designs should be sufficiently practical to ensure that production, verification, and maintenance are
technically feasible and consider business risk.
7.4.3 Work assignment

The supplier shall assign the responsibility for each design activity to designated, qualified personnel
who have access to adequate information and resources to complete the work.
7 .4.4 Interfaces
The supplier sha ll
a) identify, define, and document internal and external technical interfaces and obtain agreement for
the following:
i) assignment of design activities in multidisciplinary or multi-organizational design teams;
ii) communication methods across interfaces; and
iii) documented transmitta l of technical information; and
b) resolve inadequate or ambiguous requirements with individuals in the business responsible for
generating the requirements.
7 .4.5 Design inputs

The supplier sha ll identify, document, and review design inputs for adequacy. They include at a
minimum, but are not limited to,
a) performance and functiona l requirements;
b) results of conceptual studies;
c) environmental conditions;

d) requirements of the AHJ;

e) applicable codes, Standards, and specifications; and
f) use of experience, as applicable (see Clause 4. 7).
7 .4.6 Preliminary design

The supplier sha ll
a) identify, define, control, and document the following:
i) assumptions;
ii) altern atives, as applicable;
iii) differences between the present and a proven design;
iv) development and associated testing, including test parameters;
v) conceptual and feasibility studies and analyses;
vi) design requirements consisting of performance and functional requirements, and critical
characteristics; and
vii) design acceptance criteria; and
b) plan and document verification activities, work assignments, analyses, and decisions needed fo r
the detailed design.
Note: One or more conceptual studies may be undertaken to initiate the development of a design. The resulting
design concepts should be evaluated, and the preferred concept should be defined.
7 .4. 7 Design analysis software

When software is used for design analysis of the item or service, it shall be used in accordance with
Clause 4.5.3.
7 .4.8 Detailed design

The supplier shall
a) prepare design documentation, including the identification and revision status of any design tools
(e.g., analytical software) used and the decisions made, and ensure that the characteristics of the
item are specified, including details for the operation, maintenance, preservation, and delivery of
the item, as applicable;
b) where test procedures are developed and implemented as part of design qualification or for
compliance with the requirements of the AHJ for design registration, ensure that the tests are
carried out, monitored, and verified, and that the results are documented and maintained in
accordance with the requirements of this Standard;
c) translate the design outputs into documents required for procurement, production, inspection, and
test that will ensure the quality of the item or service; and
d) specify QA program requirements required for the item or service.
7.4.9 Design output

The supplier shall ensure that design output documents
a) are traceable to the design inputs;
b) contain or reference all applicable criteria; and
c) are controlled in accordance with Clause 7.5.
7.4.10 Design verification

The supplier sha ll
a) document, implement, and maintain design verification activities (including those of design inputs
and outputs), techniques, procedures, and characteristics to be verified that provide reasonable

assurance that the item will perform its intended function as specified, taking into consideration, at
a minimum, the following:
i) the importance to safety;
ii) the complexity of the design;
iii) the degree of standardization;
iv) the maturity of the design; and
v) the similarity to previously proven designs;
b) document, implement, and maintain design verifications to confirm that the design requirements
are met. Criteria for verification technique selection shall be defined. Verification shall consist of
one or more of the following techniques, as applicable:
i) design reviews;
ii) alternative or simplified calculations or analyses;
iii) qualification tests or demonstrations. Where a test program is used to verify the adequacy of
specific design features in lieu of other verifying or checking processes, it sha ll include suitable
qualification testing of a prototype unit under the most adverse design conditions. The test
equipment shall be verified for adequacy in creating and maintaining the desired test
conditions; and
iv) evaluation of differences between the present and a proven design. The supplier shall
compare the original design and associated verification documentation records in the
subsequent application to the present design and confirm that the ana lysis is still valid and the
application is still correct;
c) document, implement, and maintain the qualification tests that are necessary for verification to
ensure and prove the following:
i) that the test plans or specifications
1) identify the item being tested and the resources being used;
2) define test objectives, test conditions, and the parameters to be recorded; and
3) define the relevant acceptance criteria;
ii) that the test procedures describe the method of operation, the performance of the test, and
the recording of the resu lts;
iii) that the correct configuration of the item is submitted for the test; and
iv) that the requirements of the test plan and the test procedures are observed;
d) have personnel responsible for the design of the item or service arrange for appropriate
verification, which shall be planned and performed in conjunction with knowledgeable personnel
other than those who performed the original design;
Note: Verification by design review may be performed by peer or multidisciplinary design review; however,
the responsibility for the adequacy of the design remains with those who manage and prepare the design.
e) indicate evidence of verification by date, and signatures or stamps, on documents;
f) have the design reviewed by the applicable functions to ensure that items or services can be
purchased, produced, and verified in accordance with specified requirements. Other design
organizations may be designated as verifiers, provided that the designated organizations have
access to pertinent background information, have demonstrated competence in the specific design
area of interest, and have an adequate understanding of the requirements and the intent of
original design;
g) review the design before release to ensure that the design has been verified at all verification
points and that the verification records are complete;
h) disposition design nonconformances in accordance with Clause 7.17;
i) control design documents in accordance with Clause 7.5; and

j) maintain design records in accordance with Clause 7.16.

Note: Depending on the specified requirements, statistical techniques can be used to support design verification
(e.g., reliability, maintainability, and safety).
7.4.11 Design changes

The supplier sha ll
a) ensure that design changes are subjected to the same level of review, verification, and approval as
the original documents;
b) evaluate design and development changes, and include in the evaluation the effect of the changes
on constituent parts and items already delivered, including interfacing designs;
c) document the assessment of the impact of the design changes on all existing test results being
used to demonstrate compliance with the requirements. If the design changes invalidate any of the
critical testing characteristics, testing shall be repeated;
d) demonstrate that the design inputs have been addressed, that the item configuration has been
established (including materials to be used and the associated QA program category), and that
critical characteristics necessary for subsequent item acceptance have been identified and
documented;
e) control changed documents in accordance with Clause 7.5;
f) control design configuration of the item using unique identifiers;
g) maintain tracking control of all design changes that affect form, fit, or function to enable future
identification of changes between the original and replacement or reorders of the item; and
h) advise the customer of those changes.
Note: Previously approved designs can be included in design upgrades or in new applications, provided that these
have been verified for applicability and analyses/calculations are still valid.
7.5 Documentation
Note: Documentation covers documents and data that can be read by people or machines.
The supplier shall
a) document all activities related to the QA program;
b) review the documentation for adequacy and obtain approval by authorized personnel before
release;
c) ensure that the applicable revisions of the documentation are available in all areas and at
verification points where they apply so that they are readily accessible;
d) ensure that incomplete, ambiguous, or conflicting documentation is identified, documented, and
withdrawn until resolved and accepted by the organizations responsible for generating the
requirements;
e) document, implement, and maintain a process to control changes to documentation, and ensure
that changes to documentation receive the same level of review and approval as the originals;
f) identify or remove obsolete documentation from all points of utilization to prevent unintended
use·I
g) prepare and submit requests for changes to the customer's documentation when required; and
h) review the application of external origin documents determined to be necessary for the planning
and operation of the QA program, and maintain customer-supplied documents required for
execution of work.
Note: Some documentation cannot be signed in the literal sense of the word; for example, when the information is
stored on electronic media, one of the more common forms of revision is the access code method. This allows a
computer program to be revised only by those having "writing" access to the program. When several approvals are
required, this can also be achieved by having several access codes in order to revise any one computer program or

instruction to the program. However, other techniques exist that will provide the same kind of control. These
should be specified in the appropriate documentation.
7 .6 Procurement
7.6.1 Selection
7.6.1.1 Selection of QA program

The supplier sha ll review all subcontracted items or services and determine which ones require a
QA program, except for those specific critical items or services identified in the contract for which the
customer has already specified a QA program standard or specification, and shall justify and document
those which do not. Where such a QA program is required, the supplier shall select the applicable CSA
Group Standard, other QA program standard, or specification for those subcontracted items or services
in accordance with Annex ~ and justify and document each selection.
Note: See Annex A for the methods of selection. The QA program is established prior to supplier selection.
7.6.1.2 Evaluation and selection of suppliers

Prior to the work starting, the supplier shall select subsuppliers based on their ability to meet specified
requirements. Th is includes
a) unless previously approved, performing an evaluation of the QA manual (or, for Category 4, the
QA program description);
b) unless previously approved, performing an audit of the QA program implementation (for CSA N299
Category 1, 2, 3, 4, or equivalent), in accordance with Clause 7.21.2 . Evidence of acceptance by a
recognized authority to this Standard may be used to fulfill these requirem ents;
c) in lieu of performing an audit of a Category 4 supplier, evaluation may be conducted by a review of
the QA program documentation in conjunction with evidence of registration by a recognized
certification body;
d) an evaluation of other required locations, plan(s), and resources;
e) consideration of the subsupplier's history of providing an identical or similar item or service that
meets requirements. The subsupplier's history shall reflect current capability;
f) where the supplier intends to award all or part of the contract to a subsupplier who will not be
implementing the QA program specified in the customer contract for that item or service, and
intends to prescribe an alternate QA program for procurement, the supplier shall obtain prior
written acceptance of the alternate QA program from the customer;
Note: When the supplier applies its own QA program as the manufacturer, or assumes the contract
responsibilities of a manufacturer, the supplier should use the selection process defined in this Clause (and
Annex ~ to select the subsupplier QA program requirements for items, subassemblies, components, and
services used in assembling, manufacturing, or otherwise fulfilling the customer's item or service
requirements. Justification for this determination needs to be documented and maintained. Such QA program
assignments do not require the customer's written acceptance prior to procurement, unless the customer
contract includes a specific QA standard for the respective subassemblies, components, and services. Where
items and services are not available from suppliers with the selected QA program, dedication is an alternative
acceptance method. See Clause §..
g) confir mation of the validity and scope of subsuppliers' QA program certificates as specified in
Item b); and
h) establishing and maintaining a record of acceptable subsuppliers that includes approval status,
address, method of evaluation, and the scope of the approva l.
Note: The scope of approval can include restrictions and special instructions identified as a result of the
supplier's evaluation.

7.6.2 Use of customer's approved suppliers

Suppliers and subsuppliers audited and accepted by the customer may be used when authorized by the
customer in writing. The customer shall provide approval for the supplier to use customer-approved
suppliers together with access to the necessary information and documentation (e.g., approved supplier
list, scope of qualification, any known restrictions, applicable QA program, expiration date).
When the customer's approved supplier is used, the supplier shall document this process within their
QA program, which shall include, as a minimum, the following:
a) a formal review and acceptance of the customer-supplied information and documented conclusion
that the information provided is sufficient and meets the specified QA program and the applicable
codes and Standards requirements;
b) any additional actions that might be required for accepting the subsupplier's QA program (e.g.,
visiting the subsupplier's facility, accessing subsupplier's supporting QA program documents);
c) confirming that the subsupplier has the technical and quality assurance capability for the scope of
work and the ability to provide the required items or services before award of the contract;
d) a process to confirm that the subsupplier's QA program that has been reviewed and accepted by
the customer is effectively implemented before the contract is let; and
e) a process to confirm that if the customer's approved supplier list is used as the basis of
determining the acceptability of a subsupplier, the supplier shall ensure that the subsupplier's
scope of acceptability is valid throughout the execution of the contract.
The suppliers shall use subsuppliers audited and accepted by the customer only for the contract and
scope specified by the customer.
7.6.3 Subcontract requirements

The supplier shall include specific customer requirements in subcontracts (see Clause 4.2), and the
following, as applicable:
a) a description of the items or services ordered, including specifications, requirements of the AHJ,
drawings, verification requirements, and other relevant technical data by title or other positive
identification and applicable issue;
b) the title, number, and issue of the QA program standard or specification to be applied to the items
or services, as specified in Clause 7.6.1;
c) requirements for approval or qualification of documentation, items or services, procedures,
processes, equipment, and personnel;
d) requirements for the submittal for acceptance of the disposition of nonconformances;
e) identification requirements for the items or services;
f) requirements for preservation, packaging, and shipping;
g) the right of the supplier's customer, the supplier, and the authorized inspection agency, in
conjunction with or through the supplier, to
i) review the subsupplier's documentation required by the applicable QA program standard or
specification; and
ii) have access to the subsupplier's premises or working area to facilitate audits and surveys, and
verify that the supplier is conforming to specified requirements;
h) points in the subsupplier's design p lan or the verification planning documentation where the
supplier's customer or the supplier will verify conformance to contract requirements;
i) references as required by contract;
j) requirements for the submission, approval, control, or qualification of documentation, including
distribution, retention, maintenance, and disposition of documentation and records;

k) documentation and instructions required when the items or services are shipped directly to a
consignee other than the supplier;
I) any traceability requirements specified in Clause 7.11;
m) requirements for the submittal of verification procedures as specified by the customer and the
supplier;
n) requirements for prevention and detection of CFSls, taking into consideration the complexity of the
supply chain;
o) requirements for prevention, detection, and removal of foreign materials; and
p) the use of experience related to the item or service (see Clause 4.7).
7 .6.4 Reviews
The supplier sha ll
a) independently review procurement documents fo r adequacy of specified requirements before
release. Technical and quality content of procurement documents shall be reviewed by qualified
personnel. This review shall be documented; and
b) verify that subsuppliers have been selected in accordance with the requirements of Clause 7.6.1,
Clause 7.6.2, or both, and that procurement documents contain the provisions of Clause 7.6.3 . All
subcontracts and associated reference data shall be available for review by the customer
representative.
7 .6.5 Inspection, surveillance, and audit of subsuppliers

The supplier sha ll
a) review the subsupplier's verification planning documentation when determined as necessa ry or
required by contract to ensure that specified requirements w ill be met;
b) evaluate all subcontracted items or services to determine the amount of inspection, surveillance,
and audit needed at the subsupplier's locations, taking into account the complexity of the item or
service;
c) perform source verification at the subsupplier's facility, where required, in accordance with the
verification planning documents. The results of the source verification shall be documented to
provide evidence of acceptance and include, where applicable, results of monitoring, verification
activities, and acceptance by the customer's representative;
d) where nonconformances are identified, notify the subsupplier and ensure that corrective action is
taken; and
e) evaluate for effectiveness the disposition of all reported nonconformances and corrective actions
taken.
7.6.6 Amendments to subcontracts

The supplier shall process amendments to subcontracts in accordance with Clauses 7.5 d), 7.6.3, and
7.6.4.
7.7 Verification planning

Note: Verification planning was formerly known as "inspection and test planning". The term "verification" (see the
definition in Clause ~ includes both inspection and testing, along with other verification methods.
7.7.1
Item or service verification shall demonstrate that characteristics of the item or service are met as
specified. Verification of specified characteristics is achieved by a combination of the following :
a) visual verification of items;

b) observation of critical process steps and monitoring of process parameters; and

c) measurement, testing, or otherwise confirming that measurable characteristics are achieved as
specified.
7.7.2
The supplier sha ll
a) plan the verification activities by taking into consideration the following:
i) complexity of the item or service;
ii) access to concealed items;
iii) importance of the item or service for the end use;
iv) complexity and risk of the supply chain;
v) necessary degree of standardization, skills, and qualifications, equipment needed, and work
conditions necessa ry for the methods chosen to verify the characteristics of the item or
service, and the availability of these; and
vi) special conditions necessary to maintain quality;
b) document and maintain the verification planning documentation which describe the inspections,
tests, and any other verification method for the item or service specified in the contract.
Regardless of who prepares the verification planning documentation, they shall be approved by the
supplier's representative who is primarily responsible for quality assurance;
c) control verification planning documentation under the supplier's document control system and
meet, as a minimum, the requirements specified in Clause 7.7.3; and
Note: A separate planning document format may be developed for each of the phases specified in Item a), or
the phases may be combined in one document.
d) unless otherwise agreed to in writing by the customer,
i) submit the verification planning documentation to the customer for acceptance following the
award of the contract and before the applicable phase starts;
ii) update the verification planning documentation during the life of the contract to reflect
revisions, and resubmit for acceptance before the applicable phase starts; and
iii) submit referenced verification procedures with the verification planning documentation.
7.7.3
The supplier shall identify the following in the verification planning documentation:
a) the items or services to be subcontracted, specifying the QA programs to be applied;
b) how the supplier will verify the subsupplier's conformance to specified requirements by one or
more of the following methods:
i) inspection and test by the subsupplier as defined in the subsupplier's verification planning
documentation;
ii) inspection and test by the supplier at the subsupplier's facility;
iii) surveillance by the supplier;
iv) incoming inspection; and
v) verification of services;
c) the identification and sequence of the verification activities in the item or service realization;
Notes:
1) Verification activities can be defined in the supplier's QA program in alignment with other Standards
(e.g., ASME Boiler and Pressure Ve ssel Code, Section Ill NCA 9000 or ASME NQA-1) for use in the
verification plan.
2) Verification activities in the production cycle can include inspection, test, verification of records,
preservation of items, packaging, and verification at the customer site.

d) the characteristics to be verified at each point, acceptance criteria, the verification procedures,
sampling plans, methods of verification, and equipment to be used;
Note: Acceptance criteria can be referenced rather than stated in the verification plan.
e) verification points where a history of usage of M&TE is maintained so that assessments required by
Clause 7.10 o) can be met;
f) the location of customer-established witness or verification points for selected characteristics of an
item or service, beyond which the work shall not proceed;
g) where and how item acceptance to special production process procedures will be accomplished
and documented, as specified in Clause 7.14;
h) statistica l process control techniques used for acceptance;
i) verification activities needed before concealed items become inaccessible;
j) lots or batches used;
k) if software is used fo r verifying item or service quality, that verification of the ability of software to
satisfy the intended application has been performed and documented prior to initial use; and
I) the aspects to be included in the final verification prior to delivery to the customer.
7.8 Verification activities
7.8.1
The supplier sha ll
a) inspect and identify items or services at incoming, in-process, and final verification, as required by
the verification planning documents. The supplier shall
i) meet specified requirements;
Note: The specified requirements include both the customer requirements and the requirements of the
AHJ.
ii) confirm that the item received is free from physical damage;
iii) confirm that items are not counterfeit, fraudulent, or suspect;
iv) maintain the specified packaging and shipping requirements during shipping;
v) confirm that identification and markings (including their transfer) are in accordance with
applicable codes, specifications, customer requirements, and drawings;
vi) confirm that preservation methods such as protective covers and seals, coating and
preservatives, inert gas blankets, desiccants, etc., are performing as intended;
vii) confirm that there is no presence of fo reign materia l;
viii) confirm that the item received was fabricated, tested, and inspected prior to shipment, in
accordance with the applicable code, specifications, customer requirements, or drawings;
ix) meet the customer's documentation requirements for the item and, where required, qualified
personnel shall review the documentation received from the subsupplier to confirm that the
requirements of the item have been met; and
x) confirm that monitoring has been performed by qualified personnel or qualified automated
means for cases where special process monitoring methods are required. The supplier shall
provide for both inspection and process monitoring methods when control is inadequate
without both means;
b) hold an item or service from receipt through final inspection until inspections have been completed
and accepted, and that the required records and certificates have been reviewed and accepted,
including records and documentation provided by subsuppliers;
c) disposition all nonconformances;
d) inspect the item or service at all points shown in the verification planning documentation;

e) verify that requirements for inspection, markings, calibration, adjustments, protection from
damage, or other characteristics have been met, that the item conforms to the specified
requirements, and that the records are complete;
f) obtain written confirmation from the customer if customer hold or witness points are waived;
g) obtain customer acceptance of the inspection points as identified in the verification planning
documentation, including dispositions of nonconformances, when required;
h) make verification records available to the customer representative before submitting items or
services for acceptance; and
i) submit to the customer representative for acceptance only those items or services which meet
7.8.2
Where applicable, the supplier shall document, implement, and maintain a process for positive recall in
conjunction with Clause 7.17. The release of items or services under this process shall not preclude
carrying out the inspections specified in the verification planning documentation.
The positive recall process shall specify the ultimate point in processing to which the item or service
may proceed before the recorded nonconformance shall be corrected. The positive recall process shall
specify who is responsible for the corrective action.
7.9 Verification status
7.9.1 Verification status for items

The supplier shall
a) provide means for ensuring that required verification activities are performed, and that the
acceptability of items with regard to verification activities performed is known throughout
production;
b) control items not having passed the required verification activities from being inadvertently
installed or used, by utilizing indicators such as tags, markings, shop travellers, stamps, inspection
records, or other suitable means, including using a separate physical location where necessary;
c) establish and maintain a system for tags, stamped impressions, or other means on the item, its
container, or on a medium (e.g., report, record, stamp, metadata) that indicates acceptance. The
medium shall include the supplier's identity, the authorized personnel's identity, and the date;
d) establish, control, and record the names and signatures of personnel authorized by the supplier to
review, approve, or accept a document or item and, where applicable, control the issue and
removal of stamps to authorized personnel; and
e) control status indicators, including the authority for applying and removing tags, stamps, or other
means of indicating the verification status.
7.9.2 Verification status for services

The supplier shall identify and document the status in accordance with planned verification activities.
7.10 Measuring and testing equipment (M&TE)

For all measuring and testing equipment (M& TE) used for item and service acceptance, the supplier
shall
a) document, implement, and maintain a process for selection, use, calibration, and control of M&TE,
including physical standards and devices used for controlling and confirming item or service quality;

b) verify and document the ability of the software to satisfy the intended application for cases where
software is used in the actua l calibration of the M&TE prior to initial use, and re-verify when
changes to the software are implemented;
c) review the technical requirements for the item or service to ensure that applicable M&TE is
available, and ensure that the equipment has measu rement and testing capability, stability,
accuracy, tolerance, and range compatible with the intended application;
d) examine newly acquired M&TE, and calibrate it to the extent necessary to ensure valid
measurement before use;
e) establish calibration intervals such that the M&TE remains within accepted tolerances;
f) document, implement, and maintain calibration procedures defining equipment description,
identification number, location, calibration interval, ca libration method, acceptance criteria, and
action to take when results are unsatisfactory;
g) calibrate and use M&TE in an environment controlled to the extent necessary to ensure valid
measurement;
h) calibrate M&TE using reference standards whose calibration
i) is certified as being traceable to nationally recognized standards;
ii) has been derived from accepted va lues of natural physical constants; or
iii) has been derived from the ratio type of self-calibrating techniques.
Where Sub-items i) to iii) do not apply, the supplier shall demonstrate and document the basis for
calibration;
i) ensure that M&TE is uniquely identified and traceable to its application and use;
j) ensure that M&TE is suitably marked, tagged, labelled, or otherwise identified to indicate
calibration status and the scheduled date of its next calibration, and then establish traceability to
calibration records;
k) sea l or otherwise safeguard access to adjustable devices on M&TE, which are affixed at the time of
calibration, to deter tampering. The supplier shall not use equipment with damaged seals or
safeguards;
I) maintain a calibration record for each piece of M&TE and record as-found and as-left
measurements;
m) maintain a system for handling and storing all M&TE which prevents mishandling, damage, or
change in dimensional or functional characteristics;
n) identify and remove from service M&TE that has failed in operation, is damaged, or is suspected of
having deviated from its established measurement capability or is past its calibration date;
o) document, implement, and maintain a process to assess and record the validity of the previous
measur ing results when the M&TE is found not to conform to requirements, and take appropriate
action on the M&TE and any items or services affected in accordance with Clause 7.17; and
p) ensure that automated equipment used to verify items is controlled as M&TE.
Notes:
1) Calibration and control measures are not required for non-precision equipment (e.g., rulers, tape measures,
levels) if such equipment provides the required accuracy. Acceptable accuracy should be established by the
supplier responsible for the respective measurement. Exclusion of non-precision equipment should be
identified in the supplier's QA program.
2) See Annex 0 for additional guidance on measuring and testing equipment.

7.11 Identification and traceability
7.11.1 Identification
The supplier sha ll
a) maintain identification from receipt through delivery, either on the item or on records for
materials, parts, and components, including partially fabricated assemblies, in accordance with the
contract requirements. These identification and control measures shall be designed to prevent the
use of incorrect or defective materials, parts, components, and assemblies. This identification shall
be recorded on all process, inspection, and test records in accordance with Clause 7.16; and
b) identify each item (batch, lot, component, or part) or service to the applicable drawing,
specification, or other technical document, from receipt through delivery. Where identification
marking is employed, the marking shall be clear, unambiguous, and indelible and shall be applied in
such a manner as to not affect the function of the item.
7 .11.2 Traceability
The supplier sha ll
a) assign to each item, service, or batch a unique identification (e.g., by heat number, serial number,
or project number) where traceability is required by the contract, regulation, or specifications. This
identification shall be recorded on all process, inspection, and test records in accordance with
Clause 7.16;
b) transfer the markings to each part of the item, and ensure that the markings are not obliterated or
hidden by surface treatment or coatings, unless other means of traceable identification are
maintained, when an item is subdivided; and
c) transfer markings to each part prior to division of the item, when identification marking is
employed.
7.12 Handling and storage

The supplier sha ll
a) adhere to the applicable customer and subsupplier handling and storage requirements;
b) maintain control fo r the cleaning, preservation, segregation, handling, and storage of items. This
shall address protective environments such as, but not limited to, inert gas atmosphere, specific
moisture content levels, electrostatic discharge, and protection from ultraviolet light from the time
of receipt through the entire production, storage, and subsequent delivery, and shall be designed
to prevent mishandling, damage, deterioration, loss, or introduction of foreign material;
c) periodically inspect critical, sensitive, perishable, or high-value items for condition and shelf life
expiry;
d) establish a schedule and maintain items identified as requiring in-storage maintenance;
e) provide, inspect, test, and maintain handling tools and equipment at specific times to ensure safety
and ensure that tools and equipment will not damage the item;
f) periodically inspect any special storage and protective environments to ensure that they are
continually maintained and monitored; and
g) record the results of the inspections in accordance with Clause 7.16.

7.13 Production
7.1 3.1 Planning

The supplier sha ll
a) define the requirements fo r production of an item or service (e.g., verification criteria, process
parameters, characteristics, contractual requ irements, codes, regulations, Standards, specifications,
drawings, project scope, and criteria for services);
b) identify and p lan the production and service processes to ensure that the work is performed to
meet specified requirements;
c) identify those processes and workmanship standards required, including those that are new or
have significant differences from proven processes;
d) arrange for the review of new processes and wor kmanship standa rds by personnel other than
those w ho performed the original planning;
e) include in the review personnel from other applicable functions to ensure that the items or
services can be produced, inspected, and tested to specified requirements; and
f) indicate evidence of reviews and approvals by signatures or st amps on applicable documents.
7.13.2 Process procedures

The supplier sha ll define all production and service activities by appropriate documentation including,
as applicable,
a) sequence of operations;
b) types of eq uipment;
c) working environments;
d) personnel qualifications;
e) work methods;
f) materials;
g) batches and lots;
h) characteristics and tolerances to be met ;
i) inspection, test, and control points;
j) workmanship specifications or standards;
Note: Workmanship specifications and standards define measures on craftsmanship that affect the quality of
the item or service.
k) packaging and shipping; and
I) prevention, detection, and remova l of foreign material, and CFSls.
Note: Documentation that describes production and service activities can include project execution plans, process
procedures, work instructions, process sheets, route cards, and drawings.
7.13.3 Process verification

The supplier sha ll
a) verify production equipment, including all machines, jigs, fixtures, tooling masters, t emplates,
patterns, documentation, and computer programs used to automate and t o control and monitor
item realization processes before release for use in production or a service;
b) periodically, and when changes occur, check t he items listed in Item a) to ensure that they are
capable of producing t he req uired resu lts; and
c) define the extent and frequency of checking.

7.13.4 Work control

The supplier sha ll
a) produce the item or provide the service in accordance with the requirements resulting from
Clauses 7.13.1 to 7.13.3;
b) include provisions for the prevention, detection, and remova l of foreign material during the
process;
c) control the documentation to ensure that it remains current during the life of the contract in
accordance with Clause 7.5; and
d) correct the methods, procedures, and controls when shown to be unsuitable.
7.14 Special processes
7.14.1
The supplier shall
a) define the necessary qualifications of personnel (in accordance with Clause 7.2), process
procedures, documentation, and equipment for specia l p ro cesses; and
b) record personnel qua lification information (in accordance with Clause 7.16), process procedures,
documentation, and equipment in accordance with the requirements of applicable codes and
Standards.
7.14.2
The supplier shall
a) identify special production and special inspection processes, including those specified in the
contract by the customer;
b) perform special production and special inspection processes under controlled conditions by
qualified personnel using qualified process procedures, documentation, and equipment in
accordance with specified requirements and established criteria; and
c) document and maintain evidence generated during each special production and special inspection
process indicating that control of the process has been achieved and that the requirements have
been met.
7.15 Packaging and shipping

The packaging and shipping process shall prevent mishandling, damage, deterioration, loss, or
introduction of foreign material during packaging and shipment to the customer. The supplier shall
a) package and ship in accordance with the specified customer requirements;
b) protect item openings to prevent any ingress or contamination by foreign material;
c) inspect to confirm that the marking, labelling, final cleaning and preservation of the item,
environmental protection, and adequacy of packaging and shipping processes meet the
requirements;
d) provide all documents required to accompany the item, and ensure that the documents are made
available to the customer at time of shipment, as specified in the contract; and
e) ensure that all shipping containers, packaging, and pallets are free of any harmful biological,
environmental, and combustible contamination, where specified in the contract.
7.16 Records
Note: See Annex G for guidance on records.

7.16.1 General requirements

The supplier shall identify and control the following:
a) records that are essential to provide evidence that items and services meet specified requirements;
b) records that demonstrate the QA program has been effectively implemented;
c) records that satisfy the requirements of this Standard and other applicable codes, Standards,
specifications, and regulations; and
d) records that are specified by the customer.
Records shall be made available to the customer representative for analysis and review upon request.
Note: The supplier is advised to keep records of indoctrination and training separate from other personnel records.
7.16.2 Generation of records

The supplier shall establish a record system to ensure that records are
a) generated in accordance with the requirements of the QA program, procedures, instructions,
product specifications, procurement specifications and documentation, and protocols;
b) legible;
c) complete;
d) identified, indexed, and filed for prompt retrieval;
e) preserved and maintained for the period of time determined in accordance with Clause 7.16.5, by
contract or by the requirements of the AHJ; and
f) traceable to associated items and activities and accurately reflect the work accomplished or
information required.
7.16.3 Authentication of records

Records shall be authenticated by authorized personnel. Stamps, initials, signatures, and dates, or other
approved methods/media used, shall identify the personnel who authenticated the recorded
information .
Note: Electronic record authentication is provided on the record, within the media, or by linking to the record itself
7.16.4 Maintenance and storage of records
7.16.4.1 General
Records shall
a) be retrievable, maintained, and routinely inspected to ensure that they are in good condition;
b) be stored in suitably maintained environmental conditions during the established retention period
for the preservation, legibility, and prevention of degradation, damage, and loss of all records,
including electronic record media. Activities detrimental to the records shall be prohibited in the
records storage areas;
c) for electronic record media, remain retrievable and readable, notwithstanding changes in
hardware, software, and technology;
Note: This includes records retained in the business information systems.
d) be controlled and restricted to authorized personnel when processing, storing, and retrieving
records;
e) be dispositioned upon reaching their retention period; and
f) be changed in accordance with a documented process.

7.16.4.2 Transferring records

Provisions shall be established to ensure the following when records are duplicated or transferred to
the same media or to different media for the purposes of maintenance or storage:
a) duplication or transfer is appropriately authorized; and
b) content completeness, legibility, and retrievability.
7.16.5 Record retention periods

Record retention periods shall be documented. Records shall be retained for their retention per iod.
Records identified in Clause 7.16.1 sha ll be retained for a minimum of 6 years, or as specified by the
contract, or in accordance with other applicable codes or Standards, whichever is most restrictive.
7.17 Nonconformances
7.17.1 General nonconformance requirements
7.17.1.1
The supplier sha ll p romptly identify, disposition, review, and analyze all nonconformances and then
a) correct the nonconformance;
b) analyze the cause of nonconformances and initiate corrective action (see Clause 7.18), as required;
c) identify recurring and similar nonconformances, including subsupplier nonconformances, to
determine if they are systemic, and identify required corrective actions; and
d) report the analysis resu lts to management for inclusion in the management review.
The supplier shall determine acceptability of the subsupplier nonconformance dispositions that impact
contract requirements. Final acceptance of the supplier's nonconformance dispositions is at the
prerogative of the customer as required by contract [see Clause 7.6.3 d)] .
Physica l items affected by nonconforming services shall be processed in accordance with

Clauses 7.17.1.2 and 7.17.2.
Processes used to deliver nonconforming services shall be treated as nonconforming and processed
(i.e., documented, investigated, analyzed, and corrected) in accordance with the applicable
requirements of Clauses 7.17.1.2 and 7.17.2 .
Corrective actions necessary to eli minate causes of nonconforming services shall be taken in accordance
with Clause 7.18.
QA program processes determined nonconforming shall be addressed in accordance with the applicable
requirements of Clause 7.17, and corrective actions shall be taken in accordance with Clause 7.18.
7.17.1.2
The supplier sha ll
a) identify and define the responsibilities and authority of those assigned to the disposition of
nonconformances, including identification of any required actions necessary to correct their causes
(see Clause 7.18);
b) identify, record, and evaluate nonconformances (including their nature and extent);
c) determine actions necessary to correct the causes of nonconformances (see Clause 7.18) by
i) performing a technical review that involves representatives from all pertinent functions,
including qua lity assurance;

ii) developing and recording a disposition to correct the nonconfor mance in conjunction with
responsible parties. The supplier shall determine the need for any prompt actions to mitigate
risk;
iii) implementing necessary actions to correct the nonconformances and their causes, as
required. Nonconforming items shall be dispositioned and corrected before shipment to t he
customer, unless otherwise agreed to by the customer;
iv) determining and classifying the significance of the actua l or potential nonconformance and
the extent of cause analysis requi red; and
v) identifying, recording, and implementing any subsequent actions to be ta ken, as applicable, to
1) correct the cause of nonconformances in accordance with Clause 7.18; and
2) correct the items revealed through analyzing the extent of condition; and
d) ma intain records of nonconformances, their corrective actions and dispositions, and objective
evidence of their implementation and effectiveness.
7.17.2 Specific nonconformance require ments for items and services

The supplier shall
a) provide holding areas or methods for segregating nonconforming items or services to prevent
unauthorized use, sh ipment, or m ixing with conforming items or services. Where physical
segregation is not practical, tagging, ma r king, or other positive means of identification is
acceptable;
b) obtain concurrence of all responsible parties, includ ing submission for acceptance to the customer,
as required, for " repair" and "use-as-is" dispositions;
c) confirm that reworked and repaired items are re-inspected and retested in accordance with
specified requirements or to requirements developed as part of the nonconforming item
disposition;
d) confirm that reworked services are re -verified in accordance w ith the specified requirements or to
requirements developed as part of the nonconforming service disposition;
e) when a nonconformance that might impact the design or functionality of an item or service is
detected after delivery, p romptly notify the customer for resolution; and
f) confirm that the item being dispositioned for scrap is conspicuously identified and controlled to
prevent inadvertent installation or use .
7.18 Corrective action

The supplier sha ll
a) identify, p lan, develop, and promptly implement corrective actions to
i) address the actual or potential causes of t he nonconformances; and
ii) preclude recurrence and prevent potent ial occurrence of nonconformances or undesirable
situations;
b) init iate corrective action when notified by the customer's representative of the existence of a
potential or actual nonconformance, or an ineffective control;
c) assess and confirm that corrective actions taken are effective, and fo llow up to ensure continued
effectiveness;
d) report regularly to appropriate levels of management fo r inclusion in management review and, if
requested, to the customer on the causes of the nonconformances and the corrective action taken;
and
e) document the corrective action records taken.

7.19 Customer-supplied items and services

The supplier sha ll control customer-supplied items and services, as follows:
a) ma intain control and exercise care with customer-supplied items and services, including intellectua l
property and personal data, from receipt onwards in accordance with the requirement s of this
Standard;
b) verify and accept the customer certification on the item suppl ied by the customer in accordance
with Clause 4.2 d);
c) verify and accept those items or services received indirectly from the customer through the
customer's suppliers;
d) examine items, including t hose involving a service, upon receipt for completeness and p roper type
and to detect transit damage. Further incoming inspection and tests are not required unless the
supplier needs actual characteristics for subsequent work or unless specified in the contract .
Examination may be deferred until further processing is scheduled if items are in sealed containers
or have special preservation or packaging; and
e) promptly report, in writing, to the customer's representative any customer-supplied item or service
that is lost, found damaged, nonconforming, or otherwise unsuitable or u nnecessary for use either
upon receipt or w hile in the supplier's custody.
7.20 Statistical techniques

The supplier shall control and apply statistical tech niques, as follows:
a) identify and classify item, process, and service characteristics for w hich statistical techniques and
sampling p lans w ill be used as a basis for the assurance and control of qua lity, and acceptance or
rejection of lots;
b) select appropriate statistical techniques or a recognized industry Standard (e .g.,
CAN/CSA-ISO/TR 10017) to provide adequate confidence levels for process control and
item acceptance and justify the basis for the selection;
c) include or reference the selected statistical techniques and special process monitoring to be used
for item or service acceptance, and identify these in the verification plann ing documents in
accordance with Clause 7.7.3 h);
d) identify t o the customer the statistical techniques/sampling plans that will be used (see Clause 7.3);
e) apply the statistical techniques selected, monitor their application, and verify that they are
adequate to ensure that specified requirements are met; and
f) document the r esults of stat istical techniques/sampling plans used as records in accordance with
Clause 7.16.
7.21 Quality audits
7 .21.1 Internal quality audits

The supplier sha ll perform internal aud its in accordance with this Standard to verify compliance to the
QA requirements. The supplier sha ll
a) evaluate and verify by quality aud it t hat
i) all aspects of the QA program and specified requirements are being met;
ii) the QA program is effective;
iii) nonconformances and their causes are identified; and
iv) cor rective actions are implemented and effective;
b) develop a quality audit schedule in a manner t o provide coverage and coordination w it h ongoing
activities, taking into account the status and importance of the activity;

c) assign auditor(s) having experience and training commensurate with the scope, complexity, or
special nature of the activities to be audited;
d) document and maintain auditor qualification in accordance with Clause 7.2;
e) perform supplemental audits of specific elements or areas of concern when necessary;
f) ensure that the quality audit p lanning includes
i) what is to be audited, including the audit scope, requirements, and activities to be audited;
ii) assignments of those performing quality audits; and
iii) applicable documents and written procedures and checklists;
g) perform quality audits on areas, activities, processes, and items or services being produced, as
follows:
i) assign auditing personnel who are not directly responsible for the area being audited to
perform the qua lity audits in accordance with audit p rocedures, using checklists that identify
the essential characteristics to be verified;
ii) evaluate elements selected for aud it against specified requirements using written procedures
and audit checklists;
iii) examine and record objective evidence to the depth necessary to determine whether these
elements are being implemented effectively;
iv) report immediately to management any conditions requiring p rompt corrective action;
v) where any of the scheduled audits are not performed, document the reasons and report to
the person who originated the audit request; and
vi) follow up where indicated to resolve the findings;
h) document and record the results in an aud it report;
i) include in the audit report
i) the audit scope;
ii) the auditors and persons contacted;
iii) a summary of the audit results, including a statement on the effectiveness of the elements
aud ited;
iv) each reported adverse audit finding; and
v) the corrective action requests;
j) issue the aud it report to the assigned personnel re sponsible for ma intaining the QA program;
k) investigate audit findings documented in the audit report, and take appropriate corrective action
to confirm compliance and effectiveness, including measures to prevent recurrence;
I) ensure that deficient areas are re-audited as required, to confirm compliance and effectiveness;
and
m) include audit plans, audit reports, w ritten replies, and the evidence of completion of corrective
actions as records in accordance with Clause 7.16.
Not e: CAN/CSA -ISO 19011, or equivalent, can assist in satisfying these requirements.
7.21.2 External quality audits

When the selection p rocess (in accordance with Clause 7.6) determines that an audit of the subsupplier
is required, the supplier sha ll perform external audits on subsuppliers to verify compliance to the QA
requirements, and shall
a) evaluate and verify by quality audit that
i) all aspects of the subsupplier' s QA program and specified requirements are being met;
ii) the subsupplier's QA program is effective;
iii) nonconformances and their causes are identified; and
iv) corrective actions are implemented and effective;
b) develop a quality audit schedule in a manner to provide coverage and coordination with ongoing
activities, taking into account the status and importance of the activity;

c) document and report where any planned audits are not performed, stating the reasons why the
audit was not performed, evaluating the impact on the supplier approval qualification, and
identifying any follow-up actions required;
d) assign audit or(s) having experience and training commensurate with the scope, complexity, or
special nature of the activities to be audited;
e) document and maintain auditor qualification in accordance with Clause 7.2;
f) define supplemental audits of specific elements or areas of concern, when necessary;
g) develop an audit plan that defines
i) what is to be audited, including the audit scope, requirements, and activities to be audited;
ii) assignments of those performing quality audits;
iii) the applicable documents and written procedures or checklists;
iv) the method of reporting findings and recommendations;
v) the person(s) to whom the findings and recommendations are to be reported; and
vi) the means for having corrective actions decided, implemented, and verified;
h) perform quality audits on the subsupplier activities, processes, and items or services, as follows:
i) evaluate elements selected for audit against specified requirements using written procedures
and audit checklists;
ii) examine and record objective evidence to the depth necessary to determine whether these
elements are being implemented effectively;
iii) assess the subsupplier's QA program procedures and instructions for acceptability and
compliance with the requirements;
iv) report immediately to the subsupplier's management any conditions requiring prompt
corrective action; and
v) provide the subsupplier with a draft copy of any findings discovered during the audit;
i) document the audit results in an audit report;
j) include in the audit report
i) the audit scope;
ii) the auditors and persons contacted;
iii) a summary of the audit results, including a statement on the effectiveness of the elements
audited;
iv) each reported adverse audit finding; and
v) the corrective action requests;
k) issue the documented audit results to the subsupplier, including the request for corrective actions,
as required;
I) follow up with the subsupplier, where indicated, to resolve the findings revealed in the subsupplier
audit results, and issue appropriate corrective action to the subsupplier;
m) evaluate proposed corrective action responses from the subsupplier to determine acceptability;
n) take follow-up action to confirm that corrective actions taken by the subsupplier are effective;
o) include the qualified subsupplier in the active approved supplier list; and
p) include the audit plans, audit reports, written replies, and the evidence of completion of corrective
actions as records, in accordance with Clause 7.16.
Note: CAN/CSA-ISO 19011, or equivalent, can assist in satisfying these requirements.
8 CSA N299 dedication requirements

Note: The requirements included in this Clause do not apply to other upgrade practices established by applicable
codes and Standards (for example, material upgrades in the ASME Boiler and Pressure Vessel Code, Section Ill
NCA 3800).

8.1 Application
8.1.1
In some cases, it is not possible to procure an item or service that is entirely controlled (designed and
manufactured) under the specified CSA N299 program category.
In the absence of design and manufacture under the specified CSA N299 program category, it might still
be possible to demonstrate that the item or service is suitable for its intended application. Dedication is
a process whereby items not designed and manufactured under the specified CSA N299 program
category, or in the absence of a nuclear QA program, can be demonstrated to be suitable and accepted
for use in the intended application.
8.1.2
Dedication and associated verification activities shall be commensurate with the scope of work.
Dedication may be performed by the customer, the supplier, or a third party, who shall be defined as
the dedication entity. The dedication entity is responsible for identifying and evaluating
nonconformances, reporting defects and failures to comply for the dedicated item, and controlling and
maintaining the records of the dedication process in accordance with Clause 7.16.
Evidence of conformance to the ASME NQA-1 program for dedication, in accordance with EPRI NP-5652,
provided by a recognized authority, may be considered as fulfilling the requirement to be defined as a
dedication entity.
Notes:
1) A third party is the dedication entity that is neither the customer nor the manufacturer.
2) In cases where the customer is not the dedicating authority, the responsibilities of dedicating authority may
be shared between the customer and the supplier or a third party in accordance with the contractual
agreement between the parties.
8.1.3
A dedication entity shall have a QA program meeting the requirements of this Standard (i .e., that meets
the requ irements of CSA N299.l). Dedication activities shall be invoked when the supplier's QA program
does not meet all of the required program elements of the selected standard category. The dedication
entity shall evaluate the supplier's program and apply reasonable measures using their own QA
program to ensure the acceptability of the item or service.
Notes:
1) Dedication involves two key aspects. The first aspect is the design evaluation, which ensures that the item or
service requirements are identified and defined. The design evaluations are typically performed to determine
the applicable QA program elements and design requirements for purchased items or services. The second
aspect is the acceptance process, which provides reasonable assurance that the item procured meets the
specified QA program elements and design requirements and is therefore capable of performing its intended
function(s).
2) The objective of the process is to maximize the usage of the supplier's existing QA program elements by
integration or applied controls from the customer. Dedication outcomes rely on
a) strong collaboration between the customer and the supplier;
b) development of clear and unambiguous controls by the customer to mitigate gaps in the supplier's
QA programs; and
c) development of clear and unambiguous criteria for acceptance.
3) Dedication is not a central tenet of quality assurance; it is an alternate acceptance method in the absence of
specific elements of a supplier's QA program that provides reasonable assurance that the item or service

conforms to the specified QA program and design requirements, and will perform its intended function.
Where an item or service with the specified QA program is available, dedication should not be used.
8.2 Dedication eligibility

The dedication entity shall determine if the item or service is a candidate for dedication and is in
accordance with contractual requirements.
Notes:
1) Identification of a candidate item or service for procurement as dedicated items or services typically involves a
search to determine if the item or service can be provided by a supplier with an approved QA program that
meets the requirements of the appropriate CSA N299 Standard. If the supplier cannot be accepted in
accordance with Clause 7.6.1.2, and an item or service with a required QA program is intended for use in a
nuclear facility, it becomes a candidate item or service for procurement as a dedicated item.
2) This step involves identifying what is being considered as a candidate for procurement as a dedicated item or
service. The candidate item or service will have QA program requirements and specific design requirements
and is intended for use in a nuclear facility. This step might occur during the customer's review of new
purchase requests or reorder requests. There are many reasons for a supplier's QA program requirements not
meeting the customer-specified requirements for design and evaluation (e.g., the supplier will not allow
access for audit) for proper evaluation. Typically, these will be the smaller specialized suppliers or those that
produce items or services to a larger customer base than the nuclear industry and do not wish to participate
in a managed system specifically for the nuclear industry.
8.3 Planning
The dedication entity shall
a) identify dedication evaluation and acceptance work and divide them into discrete activities;
b) plan the sequential or parallel order of the activities;
c) document and describe or reference the work activities in a plan{s} and, when specified in the
contract, submit the plan(s} to the customer prior to t he applicable work activit y; and
d) update the plan(s} to include additional work activities and verification points as the dedication
activities are executed and, when specified per Item c}, resubmit prior to the applicable work
activity.
8.4 Work ass ignment

The dedication entity shall assign the responsibility for each dedication activity to designated, qualified
personnel who have access to adequate information and resources to complete the work.
8.5 Identification and maintaining traceability

The dedication entity shall identify and maint ain traceability of the item or service being ded icated.
8.6 Design evaluation

a) assess the QA program and design requirements for the item or service requested to determine an
end-use application(s}, function(s}, and the corresponding QA program and design requirements
that form the basis for the it em or service;
Note: Information on QA program and design requirements is typically included in design outputs (see
Clause 7.4.9) and procurement specifications.
b} identify t he item's or service's credible failu re modes in it s operating environment and the effects
of t hese failure modes as they relate to the parent component's function(s}, and document them
in the design evaluation;

c) perform an evaluation of the specified requirements in Item a) and identify and document any
shortfalls or gaps in the supplier's QA program for the item or service to be procured;
d) identify critical characteristics of the item or service. The end uses and requirements on which the
evaluation and acceptance plan are based shall be clearly documented;
Notes:
1) Critical characteristics are bounded by the intended function of the item or service, QA program
elements, and the design function.
2) As an alternative, critical characteristics may be identified using the design requirements, if they are
available. For example, when the dedication entity does not know the end-use applications for the item
and does not establish specific boundaries for the dedication, all of the original design requirements and
allowable tolerances are critical characteristics that must be verified. For this reason, it is advantageous
to first establish a scope of use and perform an evaluation of failure modes based on the scope of use so
that the determined bounding conditions are justified. The basic premise in this case is as follows: if the
suitability of the item's design was previously established through design and qualification activities, and
the items are verified as meeting all of the original design requirements, then the item will be capable of
performing the design functions for which the suitability of its design was originally established.
e) of the characteristics identified in Item d), determine the QA program elements that need to be
augmented and the characteristics that need to be verified in order to provide adequate assurance
of quality and performance of the item or service;
Note: The characteristics necessary to meet its intended function, QA program, or design requirements
(including those that preclude failure) are determined. A set of critical characteristics to be verified is
identified. The set of critical characteristics identified is reviewed to ensure that they are adequate to provide
reasonable assurance that the item being dedicated will be able to perform each intended function. If it is
not, additional critical characteristics should be identified. The critical characteristics selected are clearly
documented in the evaluation along with the basis for their selection and associated acceptance criteria.
f) perform an evaluation of the prospective supplier's QA program; and
Note: Typically the supplier of the item or service will have some level of QA program, as defined by the
categories in this Standard. If it does not, the use of the supplier's item or service should be done with careful
consideration. In the event that there is no QA program, then verification Control Area 2 (see Clause 8. 7.3)
becomes the only viable option for acceptance criteria in the dedication process.
g) evaluate the supplier's QA program against the identified QA program requirements in Item a).
A gap analysis identifying the missing elements between the two sha ll be documented . The gaps
shall be reviewed to determine actions required to achieve reasonable assurance that the critical
characteristics of the item or service are met. The QA program elements relevant to the critical
characteristics that need mitigation or augmentation shall be identified and documented.
8. 7 Acceptance
8.7.1 Acceptance criteria and control areas

The dedication entity shall identify acceptance criteria and control areas to achieve them. The
acceptance criteria are established for each of the critical characteristics and are defined and
documented to support the outcomes in the design evaluation. Implementation of these criteria can be
defined by three primary control areas, as follows:
a) Control Area 1: QA program augmentation (see Clause 8.7.2 );
b) Control Area 2: verification activities (see Clause 8.7.3); and
c) Control Area 3: supplier performance (see Clause 8.7.4).
These control areas should be used in conjunction with each other to validate all the critical
characteristics. Control Area 1 may be used alone or in conjunction with Control Area 2, Control Area 3,
or in conjunction with both. In the absence of any supplier with an acceptable QA program, Control
Area 2 may be used in conjunction with Control Area 3; however, ca reful consideration should be taken

when using Control Area 2 alone. Use of an alternate supplier with an acceptable QA program would be
preferred. Control Area 3 shall only be used in conjunction with another control area method.
8.7.2 Control Area 1: QA program augmentation

QA program augmentation is used to establish whether the item or service meets the critical
characteristics (specifically those related to the QA program) identified by the design evaluation . This is
the primary control area used if t he supplier has a QA program .

a) define the critical characteristic for QA program elements required to augment the QA program
identified in the gap analysis conducted in the design evaluation. Defined QA program controls
should provide reasonable assurance that the item will perform its intended function taking into
consideration, at a minimum, the following:
i) the importance to safety;
ii) the complexity of the activity;
iii) the degree of sta ndardization;
iv) first of a kind activity;
v) first in a wh ile (FIAW) activity;
vi) the maturity of the control; and
vii) the similarity to previously proven applications of controls;
b) plan, document, and implement QA augmentation controls in accordance with Clause 7.16;
Note: Plans may include other control area activities, as applicable, to support acceptance of the item or
service.
c) justify and document the specific QA program controls selection; and
d) perform a survey of the suppl ier's QA program to determine if the supplier of the item or service
has documented controls in place that adequately control the critical characteristics that have been
determined to be applicable. It should also dete rmine whether those controls are being
implemented effectively. This survey sha ll be performance-based and witness the execution of
activities to ensure that the item's or service's critical characteristics are consistently achieved. If
suppliers (not a dedication entity) have a program that has been evaluated in accordance with
Clause 7.6.1.2 to have met a less-comprehensive category level than required by the design
evaluation, then the supplier eval uation (see Clause 7.6.1.2) is used to validate implementation of
the existing program. When there is no evaluation, then a review of the QA program
documentat ion and evidence of registration by a recognized authority may be used . The evidence
provided will validate the implementation of t he supplier's QA program for dedication activities.
Note: Evidence of re gistration by a recognized authority may be used for any category.
8.7.3 Control Area 2: Verification activities
8.7.3.1 Ge ne ral
8.7.3.1.1
Verification activities such as testing, inspections, and source verification are used to establish t hat the
item or service meets the critical characteristics identified by t he design evaluation . The verification
activities shall be planned, implement ed, and documented in accordance with Clause 7.7. The results of
the verification activities shal l be evaluated against the acceptance criteria for the critical characteristics
of the item or service as ident ified by the design evaluation .

8.7.3.1.2
Verification activities shall be controlled to provide reasonable assurance that the item will perform its
intended function . The verification activities shall be specified, taking into consideration, at a minimum,
the following:
a) the importance to safety;
b) the complexity of the activity or characteristic being verified;
c) the degree of standardization of the verification technique;
d) first of a kind activity;
e) first in a while (FIAW) activity;
f) the maturity of the verification technique; and
g) the similarity to previously proven verification techniques.
8.7.3.1.3
Although used in very rare instances where specialized testing can only be performed at the nuclear
facility, veri fication activities may include
a) specialized inspection and testing after receipt of the item; and
b) post-installation activities that occur after the item has been installed in its intended end-use
application at the nuclear faci lity.
8.7.3.2 Testing
Testing sha ll
a) confir m the critical characteristic defined in the design evaluation, and be developed such that it
verifies the item performs as identified to the critical characteristic(s) being tested;
b) be defined, implemented, and documented in accordance with Clauses 7.5 and 7.16; and
c) have established sampling p lans, as applicable, in accordance with Clause 7.20.
8.7.3.3 Inspection
Inspection shall
a) confir m the critical characteristic defined in the design evaluation, and be developed such that it
verifies the item performs as identified to the critical characteristic(s) being tested;
Note: Inspection is used to confirm form and fit of the item, and is typically tied to its configuration.
Inspection is used to verify critical characteristics (e.g., dimensions, markings, documentation, workmanship,
traceability).
b) be defined, implemented, and documented in accordance with Clauses 7.5 and 7.16; and
c) have established sampling p lans, as applicable, in accordance with Clause 7.20.
8.7.3.4 Source verification

Source verification shall
a) confirm the critical characteristic(s) defined in the design evaluation; and
b) be defined, implemented, and documented in accordance with Clauses 7.5 and 7.16.
Note: Source verification is an examination of the items at the supplier's facility by the dedication entity that
occurs prior to shipment. Source verification can be used to provide oversight at various points in the
manufacturing process, witness inspections, witness testing, examine technical work, and so forth . Source
verification activities should be identified in the verification planning document. Source verification is a verification
activity that may be used in conjunction with Control Areas 1 and 3. Source verification is typically appropriate in
the following situations:
a) The supplier is providing a new item or an item fabricated to unique or custom specifications, as opposed to
an off-the-shelf item.

b) Where it is important to minimize the risk that items will be rejected after delivery, or at a later point that
could have a severe impact on the schedule.
c) Operating experience, performance, or quality problems in the past indicate that exposure to manufacturing
processes might help better understand and resolve issues and prevent them in the future.
d) Fabrication, testing, or adjustment of the item is complex, requires specialized equipment and skills, or both.
e) The only opportunity for the dedication entity to verify certain characteristics is during the manufacturing
process or execution of service.
f) The equipment or qualified personnel required to perform necessary verifications is only available at the
supplier's facility.
8.7.4 Control Area 3: Supplier performance
8.7.4.1
Supplier performance assessments shall be planned, implemented, and documented in accordance with
Clauses 7.5 and 7.16. The results of the assessments shall be evaluated against the acceptance criteria
for the critical characteristics of the item or service as identified by the design evaluation.
Supplier performance assessment includes a documented record of h istorical evidence indicating

acceptable results as a basis for accepting a supplier. Control Area 3 is used in combination with another
control area to reduce the sample size or frequency of oversight activities. Control Area 3 shall not be
used by itself to dedicate an item or service.
Note: Using Control Area 3 is typically appropriate in the fallowing situations:
a) Documented indication of the supplier's past performance can be used as a basis for selecting an appropriate
sampling plan.
b) Documented indication of an item's or service's past performance can be used as a basis for selecting an
appropriate sampling plan.
c) Broad industry or ather industry feedback is available to develop a documented basis for accepting certain
characteristics based on successful performance in the past.
d) The dedication entity is not able to obtain rights of access to the supplier's facilities.
8.7.4.2
Supplier performance reviews shou ld consider
a) schedule performance;
b) past quality of performance of the items or services, including a review of historical and current
nonconformances, corrective actions, and safety culture, as applicable;
c) use of experience in accordance with Clause 4.7; and
d) capacity and capability of business, organization functions, and personnel.
8.8 Conduct acceptance activities

a) implement acceptance activities specified in the dedication plan;
Note: Acceptance activities are performed in accordance with the acceptance plan and the dedication entity's
applicable procedures and processes.
b) document and reject an item or service when it fails to meet acceptance criteria. This
nonconformance shall be documented and dispositioned in accordance with Clause 7.17;
c) document the cause of the failure and evaluate for extent of condition;
Notes:
1) As part of the nonconformance disposition, the design evaluation should be revisited to determine
further controls required to meet the acceptance criteria. This is even more critical for dedication of
services.

2) Failures of items or services during the acceptance process should be tracked and trended to determine
if other controls are necessary in the acceptance process or to performance history for suppliers.
d) develop, implement, and maintain procedures for controlling, tracking, and evaluating failed items
and services; and
e) notify the customer, and forward a copy of the documented results, nonconformance,
nonconformance dispositions, and corrective actions to the customer.
8. 9 Dedication outputs
The dedication entity shall ensure that final documents
a) are traceable to the design and QA p rogram requirements;
b) contain or reference all applicable criteria; and
c) are controlled in accordance with Clause 7.5 and Clause 7.16.
8.10 Dedication changes

a) ensure that dedication changes are subjected to the same level of review, verification, and
approva ls as the original documents;
b) evaluate and accept dedication cha nges, and include in the eva luation the effect of the changes on
constituent parts;
c) document the assessment of the impact of the changes on al l existing test results being used to
demonstrate compliance with the requirements. If the changes invalidate any of the critical testing
characteristics, testing shall be repeated;
d) demonstrate that the design and QA program requirements have been addressed, that the item
configu ration has been established (including materials to be used and the associated QA p rogram
category), and that critical characteristics necessary for subsequent item acceptance have been
identified and documented;
e) control design changes in accordance with Clause 7.4.11; and
f) advise the customer of those changes.

Annex A (normative)
Category selection
Note: This Annex is a mandatory part of this Standard.
A.1 General
This Annex applies to Categories 1, 2, 3, and 4.
This Annex defines a systematic approach to selecting a category appropriate to the design,
procurement, and production of items or services. This Annex leads users through the careful
consideration of fundamental aspects that can affect the category selection. Before selecting a category,
users of this Annex should become thoroughly familiar with the content of all categories.
A.2 Scope of the series categories

A.2.1 General
The categories contain requirements concerning
a) suppliers' internal QA programs; and
b) interfaces with customers, such as specific recordkeeping, document submittal, approvals, and
right of access. These should be considered when establishing bids.
Notes:
1) When suppliers subcontract part of the work to subsuppliers, suppliers become customers as referred to in the
CSA N299 series of Standards.
2) The supplier retains responsibility for all subcontracted work.
Clauses A.2.2 to A.2.5 describe what each category (see Figure 1) is designed to do and where it is
appropriately applied.
A.2.2 Category 1
Category 1 aims at preventing the occurrence of nonconforming items or services. This is achieved by
thorough planning and controls, which extend to identifying and correcting weaknesses in the QA
program before nonconformances occur. This should identify and eliminate causes for potential
nonconformances.
Note: The following are examples of tools used to identify potential nonconformances: failure modes and effects
analyses, error proofing, alternative designs and analyses, and evaluation of services to determine if the failure or
improper performance of the service could have an adverse impact on the correct function of equipment and
materials or on the ability to operate.
Category 1 is suitable for custom-designed, first of a kind, high-technology items and services that tend
to require many complex processes and extensive design effort by either customers or suppliers, or
both. Failure in service could resu lt in undue risk to the business, undue risk to safety, or both.
A.2.3 Category 2
Category 2 aims at reacting to nonconforming items or services to prevent their recurrence. This is
achieved by developing a robust nonconformance detection and corrective action program to eliminate
causes of nonconformances to preclude their recurrence.

Category 2 is suitable for relatively high-technology items or services that tend to require design
activities, design verification, and production planning, and have a significant number of complex
processes. Failure in service could result in serious business risk or significant risk to safety, or both.
A.2.4 Category 3
Category 3 requires suppl iers to plan and establish a program for verifying the conformance of items or
services throughout the process.
Category 3 is suitable for items or services requiring some complex processes. They might be high-
volume services or mass-produced items and might include design changes and associated verification
and production activities. Failure in service could result in significant business risk or some risk to safety,
or both.
A.2.5 Category 4
Category 4 requires suppliers to plan and establish a quality control program for sorting conforming and
nonconforming items and services. There are no design elements associated with a Category 4 QA
program.
Category 4 is suitable for mass-produced items or fo r high-volume services designed to commercial

technica l standards or for simple processes such as custom machining and assembly. Designs are usually
mature and established, and the production and interfaces are not complex. Failu re could result in
some business risk, or risk to safety, or both.
A.3 Selecting the appropriate category

Note: When justified and documented, an industry QA standard may be used in addition to or in lieu of a CSA N299
category Standard, provided that customer approval is obtained.
A.3.1 Gene ral

The appropriate category shall be selected by considering item or service parameters (e.g., design,
production activities, and end use). The selection shall not change the contractual requirements to
produce items or provide services of the required quality. It is important to ensure that the selection is
centred around the most restrictive or critica l element of the item or service development. For
example, production might be simple and the item might be mass produced, but it might also have a
critica l function (e.g., safety) and require complex testing that requires more robust controls. In this
case, the more stringent controls would feature predominantly in the section of the appropriate
category.
A.3.2 Responsibility for selection

Obtaining the basic infor mation needed to evaluate and select the appropriate category primarily rests
with authorized technical personnel, or the organizational function appointed to perform this function.
The evaluation should, at a minimum, consider the following: reliability and maintainability, safety,
engineering, and qua lity assurance.
Personnel who are performing category selection shall obtain training on and a working knowledge of
the CSA N299 series of Standards.

A.3.3 Selection proce ss
A.3.3.1
An important step in using the CSA N299 series of Standards is the selection of the appropriate category
for a supplier's internal QA program for procuring items and services.
A.3.3.2
The following methods shall be used for selecting the appropriate category:
a) Analytical method : This is based on evaluating the impact on business and safety attributes of the
item or service. Then, by answering a sequence of questions related to the management controls
needed to obtain the desired qualit y assurance and a summing-up of answered questions, the
most appropriate category is identified (see Figure A.1).
b) Factor rating method: This is based on assigning numerical ratings based on criteria outlined in
Table A.1 (e.g., the extent, complexity, and matu rity of the design; the complexity of the item and
of t he production processes; and the business and safety conseq uences of failure). Summation of
the ratings (see Table A.2) indicates which category to use.
A.3.3.3
The higher quality level result shall be used.
A.3.4 Basic considerations

Before selecting an appropriate category to use, it em and service characteristics have to be clearly
defined in technical specifications, drawings, procedures, and instructions for procurement and
production. The selected category shall be compatible with the level of confidence necessary to ensure
that specified requirements will be met.
Specifying a category is not an alternative to identifying and specifying the quality characteristics
(reliability, t olerances, testing, operating environment, et c.) in the design or technical documentation.
Selecting t he category does not replace the need to identify the requ ired inspection, testing, and special
process requirements applicable to the it em or service. It will only provide the means by w hich one can
be assured that the specified requirements and activities are accomplished in a planned, systematic,
and documented manner.
Selecting the appropriate category provides customers and suppliers with greater assurance, backed by
documentary evidence, that the quality requirements are met, provided that the suppliers' QA
programs are implemented and effective . Where the need is less than the provisions of Category 4, no
QA program needs to be specified.
A.3.5 Quality assurance require me nts

Design and technical specifications prepared by authorized technical personnel define the technical
requirements that items and services shall meet. Properly documented, implemented, and maintained
QA programs should provide appropriate assurance that these requirements will be met . The extent of
quality assurance requirements to be applied depends on several paramet ers, as applicable:
a) the consequences of failure that the item or service could have in terms of business risk and safety
impact to operating personnel or the public;
b) the complexity and maturity of the design;
c) the inherent parameters related to t he design and production processes, and the QA program
elements needed to control the work;
d) the applicability of requirements of the AHJ;

e) the nature, number, and intricacies of the production process(es);

f) the complexity of the item or service characteristics;
g) the need for inspection, testing, traceability, and storage and handling;
h) the end use of the item and service; and
i) the potential for CFSls to be introduced into the item or service.
If none of these parameters is present, a formal supplier's QA program might not be necessary (i.e.,
standard commercial practices might be satisfactory). A category is specified in contracts when it is
determined that there is a need for some assurance of quality.
A.3.6 Safety and business risks

Taking into account the safety and business risks should lead to the choosing of an optimum category.
The risk to the safety of operating personnel and the public associated with failures of a service or
component while in operation will vary with the end-use application. All failure modes, their
consequences, and probability of failures should be considered, as follows:
a) Safety: Failures in terms of safety might require a more comprehensive category than business risk
considerations alone would warrant. When considering safety, al l available tools or inputs should
be considered, such as safety classification, code classification, results of safety analysis, and
documented engineering judgment.
Note: It is important to remember the definition for "safety" is all-encompassing, including such attributes as
nuclear, environmental, and conventional safety.
b) Business risk: Impact to the customers or suppliers due to item or service failures should be
considered, as follows:
i) consequential impacts to customers include removal and replacement considerations,
shutdown and start-up considerations of systems containing defective items, out-of-service
consequences, and consequences related to delays in schedule; and
ii) resulting impacts to suppliers include those due to rework, repair, replacement, loss of
production, and resulting damage, and potential loss of reputation, loss of market share,
claims, and lawsuits.
A.4 Selection methods

A.4.1 QA program analytical selection method
This method employs a decision flowchart (see Figure A.1 ) to determine an appropriate category. It
provides a sequence of questions related to the management controls necessary to obtain the desi red
quality assurance. Qua litative input based on knowledge of the item or service is required to answer
these questions, but answers are limited to "yes" or "no".
Periodically throughout this process, a summing-up of points is specified; these summing-up points have
been selected to allow the decisions which flow out of the process to indicate which of the categories is
most appropriate.
Using Figure A.1 requires knowledge and understanding of the four categories, the technical
characteristics of the end item or service, the techniques used to produce the item or service, and the
environment in which the item or service will be operating. Once these parameters are understood, the
flowcha rt questions are answered in sequence, with periodic summing-up where indicated on the chart,
until a decision on the appropriate category is reached.

Figure A.1
QA program element selection method flowchart
(See Clauses A.3.3.2 and A.4.1.)
Instructions:
1. All steps shall be completed before making a final decision.
2. Before selecting a category, the user of t his Annex shou ld become thoroughly familiar w ith the content of all categories.
1. Are there distinct properties or attributes (quality of the item or service) that can be described and measured t o determine conformance
to specified requirements adequat ely identified in the technical specification/description?
I Return to authorized technical

YES f NO
personnel/requisitioner
2. Is the need for a QA program indicated by evalu ation of t he following factors:

a) Business risk : Could failure of the item or service to meet its specified requirements have business impact?
b) Safety: Could fail ure of the item or service t o meet its specified requirement s impact safety?
I If both answers are NO,

If a) orb) is YES, is it necessary to: no QA program required
3. Provide for training requirements?

4. Perform a review of tender or contract documents?
5. Provide for document control?
6. Calibrate measuring and t esting equipment?
7. Control procurement?
8. Perform inspections and tests?
9. Provide for identification ?
10. Provide handling and storage control?
11. Control production?
12. Control packaging and shipping of items?
13. Identify counterfeit, fraudulent, or suspect items?
14. Provide records?
15. Control item and service nonconformances and implement corrective action?
16. Control items and services supplied by the customer?
17. Control statistical techniques?
If any of the answers t o 3 to 17 is YES, management I If answers 3 to 17 are all NO,

shall establish a QA program. Is it necessary to:
18. Provide for a training and qualification program?
+ no QA program required
19. Produce a QA manual and descriptions?

20. Control design change and verification activities for designs that are not first of a kind, w ith low complexity, that require significant effort
and whose application has minimal safety impacts?
21. Control designs that involve a minimal degree of effort and are of low complexity or consist of changes to existing mature designs,
where the failures of these item s w ill have minimal impact on the safe operation of the system/component or business risk?
22. Implement and maintain verification planning documentation?
23 . Provide for traceability?
24. Plan the production of items or provision of services?
25. Control special processes?
26. Perform supplier audits?
27. Perform nonconformance cause and analysis activities?
If any of the answers to 18 to 27 is YES, I If answers 18 to 27 are all NO,

is it necessary to: Specify category 4
28. Provide QA program procedures beyond the QA program descriptions required in CSA N299.3?
29. Control design development, detail design, design change, and verification activities that are not first of a kind or are complex,
require significant effort, and whose application has limited safety impacts?
30. Perform nonconformance trend, cause and analysis activities?
31. Perform internal audits?
If any of the answers t o 28 t o 31 is YES, I If answers 28 to 31 are all NO,

is it necessary to : Specify category 3
32. Develop new designs, control conceptual design and design development, design change, and verification activities for first of a kind or
complex items that require significant design eff ort and whose application has significant safety impact?
33. Develop preventive measures t o precl ude pot ential nonconformances?
34. Implement corrective actions for pot ential nonconformances?
If any of the answers to 32 to 34 is YES, I If answers 32 to 34 are all NO,

.
Specify Category 1 Specify category 2

A.4.2 Factor rating selection method
A.4.2.1 General
The factor rating selection method consists of assigning numerical values to each of the six evaluation
factors defined in Clause A.4.2.2, summing the total, and comparing it to a value range associated with
a given category (see Table A.2).
Note: Compliance with the requirements of each category is required regardless of score. For example, design
activities cannot be performed under a Category 4 QA program, and safety-related equipment requires a QA
program to be assigned.
A.4.2.2 Evaluation factors

The following six evaluation factors are considered fundamental for determining an appropriate
category for items or services:
a) Safety: This factor should be considered in terms of the probability that failure will occur and the
consequence of that fa ilure. In assessing the dangers arising from a failure, the characteristics of
one's own industry should be compared to other industries. The safety impact of item or service
failures has to be considered both for operating personnel and the public.
b) Design process complexity: This factor essentially deals with defining the difficulty of performing
the design, and the overall complexity of carrying out design, analysis, and development, rather
than the complexity of the parts or the function of the items or services. It includes, for example,
design reviews, stress, and seismic analysis, and is not limited to new designs.
c) Design maturity: This factor defines the availability of proven designs, i.e., what percentage of the
total design is known and proven, either by performance testing or field experience. The analysis
should consider market availability and the capability of prospective suppliers and subsuppliers.
d) Production process complexity: This factor addresses the complexity of production, i.e., the
number of different processes involved and the difficulty of each process. It is tied to the difficulty
of achieving and verifying item or service characteristics defined in the specifications and the
general state of the art in the field. The capability of prospective suppliers and subsuppliers should
be considered.
e) Item or service characteristics: This factor considers the inherent complexity of items or services,
such as the number of tight tolerances and interrelated characteristics, criticality of each
characteristic for performance, number of moving parts, leak-tightness, strength, resistance to
corrosion, abrasion, creep, and electrica l, electronic, chemical, physical, metallurgical
characteristics, installation, commissioning, and operational complexity.
f) Business risk: This factor should be considered in terms of the probability that failure will occur
and the consequences of that failure. In assessing the business risk arising from a failure, the
characteristics of one's own industry should be compared to other industries. An effort should be
made to assess the impact of fai lures, as follows:
i) to suppliers - impacts on business due to loss of production, rework, repair, replacement,
resulting damage, potential loss of reputation, potential loss of market share and warranties,
claims, and lawsuits due to liability; and
ii ) to customers - impacts on business due to item removal and replacement, field repairs,
shutdown and start-up of systems containing defective items, being out-of-service, and delays
in schedule .
A.4.2.3 Assigning value ratings to evaluation factors

Each of the six evaluation factors generates a value rating (from 0 to 4). These ratings are added to
obtain the value range for selecting the appropriate category. Table A.1 is used for rating the evaluation
factors.

Selection of the appropriate category primarily rests with authorized technical personnel, or the
organizational function appointed to perform this function. The evaluation should, at a minimum,
consider the following: reliability and maintainability, safety, engineering, and quality assurance.
For each evaluation factor, users should select the value rating by comparing the rating descriptions and
selecting the value of the rating (Oto 4) closest to the actual situation (see Table A.1).
For each evaluation factor, users should justify the selection of each value rating based on the
requirements identified in Clause A.4.2.2 .
Table A.1
Evaluation factor value assignment table
(See Clauses A.3.3.2, A.4.2.3, and A.4.2.4 .)
Evaluation factor Value
Safety
No risk to safety 0
Minimal risk to safety (not safety-related) 1
Results in limited ri sk to safety (not safety-related) 2
Results in significant risk to safety (safety-related) 3

Results in undue risk to safety (safety-related) 4
Design process complexity
No design effort 0
Design effort is min imal 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 maturity
Proven design, no design changes or controls are required 0

Proven design for same application where minimal design changes or controls are required 1
Proven design for same application where significant design changes or controls are
2
required
Proven design for a different application where design changes or controls are required 3
First of a kind design where design controls are required 4
Production process complexity
Few simple processes* are required 0

Significant numbers of simple processes* are required 1
{Continued)

Table A.1 (Concluded)
Evaluation factor Value

Few complex or special processes* are required 2
Significant numbers of complex or special processes* are required 3
Large numbers of complex or special processes* are required or are first of a kind 4
Item or service characteristics

Item or service has no critical or interrelated characteristics 0
Item or service has only a few critical or interrelated characteristics 1
Item or service has some critical and interrelated characteristics 2
Item or service has a sign ificant number of critical and interrelated character istics 3
Item or service has a large number of critical and interrelated characteristics 4
Business risk
Result s in negligible business impact 0
Downgrades the operation of facilities to a limited extent and results in limited business
1
impact
Significantly downgrades the operation of facilities and results in serious business impact 2
Seriously downgrades the operation of faci lities and results in serious business impact 3
Results in the total loss of operation of facilities and extreme business impact 4
* Processes include production, inspection, testing, assembly, construction, or services.
A.4.2.4 Selection of the category

Users shou ld select the applicable value from 0 to 4 for each of the factors described in Table A.1 and
sum all values, then compare the sum of all values to the value range in Table A.2 to select the
appropriate category.
Table A.2
QA program factor rating selection method
(See Clauses A.3.3.2, A.4.2.1, and A.4.2.4 .)
Value range Category

18-24 Category 1
13-17 Category 2
8-12 Category 3
4-7 Category 4*
0-3 None required
* Design activities are not applicable to a Category 4 QA program.

A.5 Final selection of the category

The user is cautioned that there might be cases where the required category has already been
established by the customer. One should always determine whether this is the case before finalizing
category selection.
Note: The user may always select a more comprehensive category.

Annex B (informative)
Guidance on QA program procedures
Note: This Annex is not a mandatory part of this Standard.
B.1 General
QA program procedures should be included or outlined in the QA manual in sufficient detail to cover
the control of the various applicable processes being performed; these procedures also cover processes
for items and services procured from suppliers (design services, nondestructive examination services,
manufacturing of a component or a sub-assembly, etc.).
If the contract includes any requirement for configu ration management of items to be supplied, the
supplier develops, implements, and documents a process to accommodate configuration management
and includes it in their QA program procedures.
Category 1 recognizes two categories of procedures that control the QA program and work: QA program
procedures (these refer to procedures which are manageria l in nature) and technica l procedures.
B.2 QA program procedures

B.2.1 Procedure documentation
In Category 1, each QA program element should be documented in a p ro cedure. QA program
procedur es should
a) state t he scope and purpose of procedures;
b) detail how to perform and control the QA program elements within the scope of the management
policies;
c) establish w hat needs to be done and by w hom, and when it w ill be done;
d) include methods needed to plan, schedule, carry out, and complete required actions;
e) define (as applicable) what materia ls, equipment, documentation, and forms to use; and
f) be treated as a directive to person nel, i.e., as a statement of the way in which management wants
the QA program ca r ried out.
B.2.2 Example of applying the QA program procedure to special processes

The QA program procedure pertaining to special p ro cesses should define
a) who is responsible for prepar ing and maintaining process p rocedures and process-monitoring
procedures;
b) how the eq uipment is qualified, maintained, and controlled;
c) how processes are qualified fo r use in production;
d) how materials used are controlled;
e) what qualifications personnel who perform t he process requir e [e.g., Canadian General St anda rds
Board (CGSB}, American Societ y of Mechanical Engineers (ASME), Societ y for Nondestructive
Testing (SNT)], or internal training and testing;
f) who is responsible for coordinat ing training and qualification of personnel; and
g) t he forms to be used and what records are kept.

B.3 Technical procedures

Technical activities carried out within the scope of the QA program should be planned and, when
required, should be documented in technical procedures. Technical procedures describe activities
required to produce or verify the item or service.
Technical procedures are seldom included in the QA manual, but procedures for mon itoring special
processes usually are. If there is only occasional application of a particular process, a standard
monitoring procedure might not be necessary. In that case, an individual monitoring procedure could be
developed for specific verification planning documents. Some suppliers elect to put detailed verification
planning procedures in their QA p rogram procedures (e.g., incoming, in-process, or final inspection).
Technical procedures can be document ed in four different categories, as follows:

a) Special process procedu res: These can be
i) procedures for monitoring special processes, which define
1) who will monitor each special process, e.g., an independent analyst, inspector, or
specia Iist;
2) when processes will be monitored, e.g., frequency, checks per operator;
3) how processes will be monitored;
4) what will be monit ored, e.g., a checklist covering such things as availability of correct
procedure, procedure being followed, calibrated equipment, correct settings, acceptable
personnel qualifications, right sequence, and proper times; and
S) where and what monitoring records are kept; and
ii) specia l p rocess procedures themselves, which define
1) process parameters;
2) how processes are performed, in detail;
3) what equipment and materials are used; and
4) who performs the work, including the required qualifications.
b) Verification procedures: These define
i) what is to be inspected and tested;
ii) when the inspection or test is to be done;
iii) where the inspection or test is to be done;
iv) who does the inspection or test;
v) how the inspection or test is to be done;
vi) acceptance criteria;
vii) how the inspection or test is to be controlled; and
viii) what materi als, equipment, documentation, forms, and statistical techniques are to be used .
c) Production procedures: These define how production operations are to be performed and
controlled, and should include, but not be limited to,
i) sequence of operations;
ii ) types of equipment used;
iii) special working environments;
iv) work methods;
v) materials;
vi) batches and lots;
vii) characteristics and tolerances to be met;
viii) inspection, test, and control points;
ix) workmanship standards in the form of written instructions or samples, or both; and
x) packaging and shipping instructions.

d) Service procedures: These describe the specific service being provided by the supplier; for example,
project management, construction management, design services, comm issioning support, quality
oversight services, nuclear safety analyses/assessments, etc.

Annex C (informative)
Guidance on design
C.1 General
This Annex applies to design by suppliers or their agents for items or services they produce or procure.
For adequate assurance of quality, items or services should be designed so that they will meet
performance requirements and operate safely and reliably throughout their life.
Clause 7.17 on nonconformances in Category 1 might require involvement of the design function in the
disposition of nonconformances. Any involvement that is performed by a design function working to
Category 1 requires records to be generated and maintained in accordance with Clause 7.16. For
example, if manufacturing drawings are approved by an engineering department, records of that
approval are required to be retained by the supplier as pa rt of its records.
Note: For general context when reading the word "design", the user is reminded to review the definition as
specified in Clause 3. Design, in the context of this Standard, encompasses all technical work activities in the
development, production, maintenance, and use of an item or service.
C.2 Design
C.2.1 Design planning
Category 1 divides design and verification activities into discrete design activities which are planned and
controlled throughout the design process. When specified in contracts, design plans, including any
requirement for configu ration management, are prepared and submitted to customers.
Category 1 does not specify that design plans require customer acceptance or approva l. Contracts,
therefore, shou ld specify what customer approvals would apply. Design plans should include the
sequential or parallel schedule of work, including all design verification points as required.
C.2.2 Design process

Design documents are produced at several milestones during the design process. These milestones
include the following:
a) Work assignment: Responsibilities for each design activity are assigned to designated, qualified
personnel who have received indoctrination advising them of their responsibilities in the QA
program and who have access to information and resources necessa ry to complete the work within
the required time.
b) Interfaces: Technical interfaces between design activities shou ld be identified and relevant design
parameters documented. The means for transmitting technica l information between internal and
external design groups and other organizations should be established and documented.
c) Design inputs: One of the first major design documents established identifies and records design
input criteria that will satisfy both a customer's objectives and applicable requirements of the AHJ.
All pertinent design inputs, such as performance, functional, environmenta l, and safety
requirements, should be identified, reviewed, and documented. Such a document might be
referred to as the reference design, design proposal, design specification, or design description.
This document should quantify all technica l requirements to the greatest possible extent. This
document will be referred to henceforth as the "design description" .

The design description lays the foundation for a unified approach to the design. It should record
agreements reached at meetings between customers and suppliers on how customer requirements
and requirements of the AHJ will be met. It should identify design aspects, materials, and processes
requiring development and analysis, including prototype testing to verify their adequacy. It should
also identify when design veri fications and reviews should be perfor med.
The design description should be maintained, and periodically updated, to include new design
inputs as they are generated during the following preliminary and detailed design stages. It should
only contain established design information, and data and references supporting documentation
such as feasibil ity studies, computer programs, engineering analysis, specifications, drawings, etc.
The design description becomes the definitive up-to-date reference document as the design
progresses to completion. It provides technica l interface data for various design activities and
design disciplines:
i) Preliminary design: This includes identifying, controlling, and documenting assumptions used
and alternatives considered, as well as any development, feasibility studies, design acceptance
criteria, etc., needed. Other important documents prepared during the preliminary design
stage are engineering studies, computer programs, reports which record the results of
development, test programs, and engineering analyses.
These documents establish whether design criteria for performance and safety objectives can
be met, and whether the design is economically feasible and can be accomplished with known
and available technology. These documents can cover safety and stress analysis, thermal,
hydraulic, metallurgical, and environmental analysis, reliability and maintainability analysis,
and other considerations.
ii) Detailed design: The requirements resulting from the preliminary design are translated into
drawings, specifications, instructions, and bills of material, which document the configuration
of an item or service. This is often refer red to as the "design" or "design package" . The QA
program, standards, and specifications are specified for items or services to be procured.
These documents are referenced in the design description.
iii) Design outputs: Outputs of the detailed design are the final technica l documents used for
production or procurement, and verification activities. Final review of design outputs should
ensure that
1) they are traceable to design inputs and contain or reference all applicable criteria;
2) they define, without ambigu ity, the quality aspects of the item or the service;
3) they contain acceptance criteria for the item or service; and
4) all of the above-mentioned design documents are prepared, approved, issued, changed
when required, and controlled in accordance with Clause 7.5 on documentation.
C.2.3 Design verification

Design verification is the independent, systematic process of ensuring that all technical requirements
have been incorporated into the final design, and that the item wil l perform all its functions under the
specified conditions and loads. Design verification is p lanned to systematically demonstrate that all
requirem ents are met, and the plan identifies which of the various verification techniques (e.g.,
alternate analysis, qualification testing, design reviews) is most suitable for verifying that a specific
requirement or set of requirements is met.
Design verification includes design reviews and may include a combination of the techniques as
specified in Clause 7.4.10 b).
Design reviews should be carried out and reported on as called for in approved design requirements
documents (design description). Independent reviews of design documents are often the primary

means for confirming the adequacy of designs. Participants in design reviews should be qualified to
examine designs and their ramifications. The reviewers may be drawn from suppliers' businesses or
from outside businesses.
The following questions deal with some major areas which should be confirmed during design reviews:
a) Do designs satisfy all specified requirements?
b) Are safety considerations covered?
c) Do designs meet functional and operational requirements (e.g., performance, reliability, and
maintainabi lity objectives)?
d) Have appropriate materials been selected?
e) Have interfacing and compatibility of materials and components been covered?
f) Is the design satisfactory for all anticipated environmenta l and load conditions?
g) Are parts standardized, and do they p rovide fo r interchangeability?
h) Is production, procurement, inspection, and testing technically and economically feasible?
i) Can specified tolerances be achieved and the necessary inspections and tests accomplished?
j) Are the categories selected for subsuppliers appropriate?
k) Are assumptions valid?
Suppliers, when considering the above-mentioned factors, should also consider such interrelated factors
as business r isk, materials availability, production, verification activity equipment availability and
capability, delivery, and production schedules.
Category 1 does not allow independent design reviewers to modify, change, or override a designer's
design choices or decisions; rather, it is intended to support and reinforce the design choices and
decisions made.
Although Category 1 requires that participants in design reviews be knowledgeable, it is not anticipated
that they will base thei r approva ls of original design decisions solely on their own expertise or on
information uniquely available to them. It is anticipated that they will use their knowledge and
experience to ensure that all pertin ent design inputs were known to and considered by designers. In
addition, they will expect to find evidence of compliance with written procedures set up to ensure this.
Design reviewers will question the designer's level of confidence in the decisions that the designer has
made and examine evidence that supports that confidence. If, for example, design reviewers feel that
there are insufficient test data to support an adequate level of confidence in an original or new feature
of design, they might recommend additional testing and withhold approval until tests are satisfactorily
carried out. The reviewers should not attempt to impose alternative decisions, although they may
recommend them.
Design reviews also have to be performed for repeat contracts. However, such reviews might be limited
to verification and affirmation that designs on repeat contracts are identical in all respects to those
which resulted from final design reviews of original items. Design reviews should verify that production
experience, field experience, current state of the art, and specification revisions have been duly
considered and do not warrant additiona l changes in designs.
Although personnel assigned to verification or review of design documents and calculations will flag
errors if they encounter them, they will not assume prime responsibility for detecting them . Rather,
they will devote their attention to ensuring that the design element procedures set up to detect and
eliminate such er rors are wor king effectively. Decisions as to the adequacy of designs always remain
with those who perform and manage the designs.

The application and performance of the design procedures and design reviews shou ld be audited, and
corrective action should be taken when a nonconformance is found.
C.2.4 Design changes

The supplier controls and documents deviations and deletions from, and additions or changes to, an
item design and related design documents. The design changes should be subjected to the same extent
and rigor of verification and approvals as the original design.
The supplier controls item configuration of all design changes that affect form, fit, or function.
Configuration control is required to enable identification of changes between the original and
replacement or reorders of the item. The supplier shou ld use unique identifiers, maintain tracking
control of items, and advise the customer of those changes during the contract review process.

Annex D (informative)
Guidance on measuring and test equipment
Not e: This Annex is not a mandatory part of this Standard.
D.1 General
To supply items whose characteristics are within specified limits of accuracy, suppliers should use
measuring and testing equipment capable of providing results within the stated limits. Measurement
standards should have the accuracy, stability, and range needed for their intended uses. To ach ieve
these objectives and to demonstrate with objective evidence the validity of measurements, suppliers
shou ld establish and maintain a calibration control system which detects deficiencies and provides
timely and positive corrective action.
A calibration system is required for all measuring and testing equipment, including production
equipment used for controlling processes and verifying item quality.
D.2 Types of measuring and testing equipment

Examples of measuring and testing equipment include the following types of equipment:
a) business and employee-owned measuring equipment (verniers, micrometers, scales, etc.) used in
production and control;
b) measuring and testing equipment lent to subsuppliers;
c) all devices that control special production processes, such as the meters on arc welding and spot
welding machines; and
d) certain non-precision, transfer, and measuring devices, such as common measuring tapes, precision
dividers, paint colour chips, visual roughness comparators, logic probes, and Variacs (variable
transformers). These devices need only be confirmed periodica lly to see that they are in good
working order and not worn. However, precision devices such as Pi Tape® are ca li brated.
D.3 Requirements for calibration

Calibration and control of measuring equipment are not restricted to precision equipment associated
with machining, but encompass all measuring and testing equipment used to monitor qualit y. For
measuring and testing equipment lent by customers to suppliers, or by suppliers to subsuppliers, it is
the responsibility of suppliers to ensure that gauges are calibrated.
The following is a partial list of types of equipment requiring calibration:

a) dimensional measuring equipment such as gauge blocks, verniers, surface plates, angle blocks,
micrometers, indicators, measuring wires, and parallels;
b) nondestructive examination equipment such as radiographic penetrometers, magnetic particle
equipment meters, ultrasonic search units, and calibration blocks;
c) destructive testing equipment such as tensile, drop weight, impact, and hardness testing
equ ipment;
d) welding equipment such as ammeters, voltmeters, and electrode baking and holding ovens;
e) heat-treating furnaces such as temperature recorders, pyrometers, and thermocouples;
f) thermometers;
g) pressure gauges;
h) control instrumentation on special production and special inspection process equipment, such as
i) plating equipment, cadmium, nickel plating, etc.;

ii) chemical coating equipment, anodizing, and pr otective chromate conversion fi lm (iridite) on
aluminum and its alloys;
iii) welding equipment; and
iv) heat treating equipment;
i) electronic and electr ical measuring equipment such as oscilloscopes, power supplies, signal
generators, multimeters, frequency counters, spectrum analyzers, impedance bridges, distortion
analyzers, decade resistors, current probes, and chart recorders (X-Y and circular plotters);
j) time-measur ing devices;
k) laboratory sample preparation and test equipment gauges; and
I) environmental testing equipment such as temperature/humidity chambers, vibration tables, salt
spray chambers, and altitude chambers.
D.4 Use of subsuppliers for calibration

Suppliers may use the services of subsuppliers to calibrate measuring and testing equipment, in which
case the totality of suppliers' and subsuppliers' calibration systems should meet requirements of this
Standard. For example, suppliers do not have t o maintain a copy of t he calib ration procedure used by
subsuppliers, b ut the procedure should be identified and ava ilable for review by customers. Suppliers
shou ld also perform audit s to ensure t hat a subsupplier 's system for calibration conforms to specified
requirements. For suppliers of calibration and testing services, cert ification to the current edition of
ISO/IEC 17025 is acceptable when obtained from a registrar under an accredited certification body.
D.5 Calibration procedures

The QA program manual should reference calibration procedures. These should define
a) equ ipment descriptions;
b) identification numbers;
c) location (includ ing environmenta l conditions);
d) calibration intervals;
e) calibration methods; and
f) acceptance criteria and action to be taken when results are unsatisfactory.
CAN/CSA-ISO 10012, ISO/IEC 17025, or equivalent specifications should be used as guides to methods
for performing actual equipment calibration . Simple reference to a given standard is not sufficient. The
procedur e should be clearly defined by exact reference to the appl icable sections.
Where calibration met hods are defined by equipment manufacturers, such instructions may be
referenced as part of the ca libration p rocedures. Calibrations are performed by com paring equipment
being calibrated w ith instruments or physical standards of authenticated accuracy.
D.6 Calibration environment

Environments for all measurement during calibration and inspection and test shou ld be controlled to
the extent necessary to ensu re continued measurements of required accuracy, due consideration being
given to temperature, humidity, vibration, clean liness, and other factors affecting measurement.
Compensating corrections should be applied to calibration results obtained when the ca libration
environment departs from st anda rd conditions.
D. 7 Calibration frequency
Period ic intervals should be established for ca librations based on equipment stability, purpose, and
degree of usage. Records should be kept of the as-found and as-left ca libration findings for the

instruments, and the deviations and current interval between ca librations. Based on these records,
intervals should be shortened when results of preceding calibrations indicate that a shorter period is
needed to ensure the required level of accuracy. The calibration periods may be lengthened, provided
that previous calibration records indicate that this will not adversely affect measurement capability of
the equipment.
D.8 Traceability
Measuring and testing equipment may be calibrated by either suppliers or commercial facilities using
reference standards whose calibration is certified as being traceable to nationally recognized standards
or has been derived from accepted values of natural physical constants. In Canada, the majority of
nationally recognized standards are published by the National Research Council in Ottawa. All reference
standards used by suppliers or subsuppliers shou ld be supported by certificates, reports, or data sheets
attesting to the date, accuracy, and conditions under which the results furnished were obtained.
For calibration services procured from other countries, suppliers should ensure that the calibrations are
traceable to that country's national reference standard.
The requirement for calibration being traceable to nationally recogn ized standards is satisfied when a
subsupplier submits a covering certificate identifying the equipment that it has calibrated, and either
the subsupplier's calibration system has been audited and approved by the supplier to the
requirements of Category 1 or the subsupplier has been recognized by an accredited business
responsible for qualifying calibration facilities.
D. 9 Calibration records
Category 1 requires maintaining calibration records for each piece of measuring and testing equipment.
These records provide a continuing statement of the accuracy of the equipment and the necessary
adjustments. To do this, the records should show the equipment identification number, the date of
calibration, reference to procedures used, and results obtained .
As-found and as-left measurements should be recorded for control purposes. The intent is that the
history thus provided is needed to afford the necessary measurement accuracy and allows assessing an
appropriate period between calibrations. This requirement might not apply to all measuring and testing
equipment.
D.10 Calibration status indicators

Labels and codes are used to indicate calibration status and schedule the date of the next calibration of
measuring and testing equipment, as well as identifying it to its calibration record . These indicators
shou ld be on the instrument itself or on the carrying case (provided that the carrying case is traceable
to the actual measuring device) so that the user can readily determine the ca libration status.
In addition to the calibration status indicator, suppliers should have a system which ensures that
measuring and testing equipment is removed from use when it is due for recalibration.

Annex E (informative)
Counterfeit, fraudulent, and suspect items (CFSis)
Not es:
1) This Annex is not a mandatory part of this Standard.
2) For additional information on CFS/s, refer to IAEA TECDOC-1169 and EPRI 1019163.
E.1 General
The supplier should
a) clearly specify critical characteristics of items purchased and establish methods to ensure that
these are met. Such methods might involve witnessing inspections and tests where these
characteristics are verified, requesting access to verification records, or auditing a supplier's QA
program;
b) have access to sources of informat ion (through externa l feedback mechanisms) that provide up-to-
date counterfeit experience for the types of products purchased;
c) provide awareness to personnel of risks associated with CFSls. Training of personnel involved in
specifying item characteristics, procuring, inspecting, testing, and fabricating items should include,
but not be limited to,
i) appearance of purchased item including colour, markings, symbols, and other methods of
identification applied on the item. This information should be made available to the personnel
inspecting the item and updated periodically;
ii) item certifications including symbols of accreditation bodies;
iii) verification that certificates were issued by a recognized authority, and that these include
cor rect item or service characteristics; and
iv) any other industry-specific measures that detect or prevent CFSls;
d) procure items by adopting anti-counterfeit methods such as
i) purchasing from the OEM or OEM-authorized distributors, ensuring traceability of the item's
origin is maintained;
ii) controlling of the supply chain by following the requirements of Clause 7.6 or using equivalent
controls;
iii) sourcing from suppliers adopting zero-tolerance policies fo r CFSls. The supplier should include
specification of anti-CFSI requirements in purchasing requirements. These anti-CFSI
requirements should be provided to subsuppliers;
iv) using advanced non-reproducible technologies for the process of uniquely marking items; and
v) avoiding procurement at risk practices where traceabil ity of the item's origin is lost;
e) examine procured items to ensure that
i) physical, performance, and control characteristics are met;
ii) components not accessible to inspection by a customer upon receipt have been confirmed/
tested before concealing. Test reports should be available to demonstrate that such testing
was performed, critical characteristics were met, and nonconformances were eliminated
before concealing; and
iii) item certification is valid. If required by the customer or by risk evaluation, the supplier may
confirm certification of materials or services used for critical items (i.e., items having a safety
function, being difficult to replace in operation, or having limited access) by
1) performing additional testing and verifications in-house or by third parties;
2) comparing certification received with the original provider's certification (e.g., based on
records); and

3) confirming with the OEM the source of material and associated testing; and
Note: Alternate verifications to confirm that certification is valid might be employed in accordance
with item type and type of certification verified.
f) take all measures necessa ry to ensure that scrap items have been destroyed and will not re-enter
the supply chain. In addition to legal requirements, counterfeit items should be reported to the
customer and the OEM.
E.2 Distributors
E.2.1
In cases when items are purchased f rom OEM-authorized distributors, the customer should verify that
the supplier's QA program controls the following aspects:
a) traceability of items to the OEM is available, including associated valid and unaltered certifications;
b) items are adequately handled and stored;
c) identification markings are intact. Methods used to transfer markings are approved by the
customer, the OEM, or both; and
d) a CFSl-detection and prevention program is in place.
E.2.2
In cases when items are purchased from distributors not authorized by the OEM, the requirements of
Clause E.2.1 apply with the following additional requirements:
a) Suppliers should transfer all of the customer's purchasing requirements to the subsuppliers,
including the QA program requirements.
b) Suppliers should evaluate and select subsuppliers in accordance with Clause 7.6.1.
c) Suppliers should only use approved and controlled production activities that affect the item's
characteristics. Alterations to item characteristics should be approved by the OEM, communicated,
and sent to the customer for acceptance.
d) Suppliers should fully inspect and thoroughly examine returned items for the potential addition of
CFSls. Quantities greater than purchased should not be accepted.

Annex F (informative)
Risk evaluation
F.1
The supplier should consider the risk to the customer for
a) changes in its own business operat ion; and
b) consequences of fai lure for supplied items and services.
F.2
The supplier should inform the cust omer at the ea rliest possible time of changes in its own business
that will affect the conditions under which the approved supplier status was granted.
F.3
The customer should inform the supplier if the items present a risk for plant operation, safety, or
maintenance. In these cases, the supplier should
a) review the processes for item realization, including associated verifications, and determine if
addit ional controls are necessa ry; and
b) review p urchasing p ractices and determine if additional controls are necessary for purchased
materials.

Annex G [informative)
Records
G.1
The supplier should identify those records that need to be retained, controlled, and maintained to
demonstrate that the QA program has been implemented as defined. These records should be
consistent with applicable codes, Standards, or specifications. The following list should be used in
conjunction with those records identified in the body of this Standard as required to be retained:
a) quality audit records:
i) audit plans, audit checklists identifying the QA manual(s) procedures, processes, items, and
services audited;
ii) audit reports identifying the results obtained, including nonconformances; and
iii) analyses of audit data and corrective action(s) taken;
b) records of management review and correction of deficiencies;
c) records to demonstrate that personnel, procedures, documentation, and equipment for special
processes are qualified;
d) records to demonstrate that selection, surveillance, and audit of subsuppliers have been
performed, and that related corrective actions taken are effective; and
e) records of verifications and item or service inspections and tests that identify, where applicable,
i) either the reference document number and revision or the part number of the item or service;
ii) that as-built conditions of items are controlled and maintained in accordance with
requirements of the AHJ and customer specifications;
Note: Typically, customer specifications are found in the contract between the customer and the
supplier.
iii) contract or specification requirements;
iv) specific verifications, inspections, and tests performed and results obtained. If measurements
are not required, the basis of acceptance should be included;
v) nonconformance reports;
vi) feedback or corrective action generated;
vii) dates of inspections or tests;
viii) identity of verifiers or inspectors; and
ix) data recording instruments as specified in the inspection and test planning documents.
G.2
Records should be authenticated by authorized personnel.
Note: Examples of authentication include, but are not limited to, stamps, signatures, initials, and dates.

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CSA N299.1-2019 (En) - Quality Assurance Program Requirements For The Supply of Items and Services For Nuclear Power Plants - Category 1

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®A trademark of the Canadian Standards Association, operating as "CSA Group"

Published in December 2019 by CSA Group

© 2019 Canadian Standards Association

December 2019 © 2019 Canadian Standards Association 1

December 2019 © 2019 Canadian Standards Association 2

7.21 Quality audits 44

8 CSA N299 dedication requirements 46

Annex A (normative) - Category selection 54

December 2019 © 2019 Canadian Standards Association 3

Technical Committee on Management

A. Coulas Canadian Nuclear Laboratories Limited (CNL), Vice-Chair

S. D. Harris Ontario Power Generation, Vice-Chair

R. W. Barnes ANRIC Enterprises Inc.,

E. Clavel Clavel Quality Consulting,

D. Constantinescu Bruce Power,

R. Grismer Cameco Corporation,

B. Johnston McMaster University,

December 2019 © 2019 Canadian Standards Association 4

J. Krane Stuart Olson,

P. Lahaie Canadian Nuclear Safety Commission (CNSC),

G. Lamarre Canadian Nuclear Safety Commission (CNSC), Non -voting

V. Raees Technical Standards and Safety Authority,

R. Schewaga Orano Canada,

M . Schnell Canadian Light Source Inc.,

P. Schultz Canadian Nuclear Safety Commission, Non-voting

C. Sellers Campbellcroft, Ontario, Canada Non -voting

P. L. Wiggins NB Power Corporation,

P. Young Scarborough, Ontario, Canada

M . Khan CSA Group, Project Manager

December 2019 © 2019 Canadian Standards Association 5

Subcommittee on Quality Assurance

N. Boraso CANDU Owners Group Inc.,

J. Brown BWXT Nuclear Energy Canada Inc.,

R. Burns Kinectrics Inc.,

E. Clavel Clavel Quality Consulting,

S. Demeter Kinectrics Inc.,

S. Guj ral Tetra Tech,

S. D. Harris Ontario Power Generation,

P. Karsten Karsten Nuclear Quality Services Inc.,

J. Lopez Bruce Power LP,

T. Mason Black & McDonald Ltd .,

December 2019 © 2019 Canadian Standards Association 6

L. Payne Energie NB Power,

M . Pletosu Ontario Power Generation Inc.,

D. Sperling Sperling Quality and Project Services,

A. Wagland WAG QA Services Canada Inc.,

G. B. Waterhouse Vermeer Engineering,

P. Wong Canadian Nuclear Safety Commission (CNSC),

M . Khan CSA Group, Project Manager

December 2019 © 2019 Canadian Standards Association 7

The most significant updates to this edition include

December 2019 © 2019 Canadian Standards Association 8

0.2 Category series

December 2019 © 2019 Canadian Standards Association 9

QA program QA program QA program QA program

Least comprehens ive Most comprehensive

December 2019 © 2019 Canadian Standards Association 10