CSA N299.3-16 - QA Program Requirements For The Supply of Items and Services For Nuclear Power Plants Cat 3

N299.
3-16
Quality assurance program requirements

for the supply of items and services for
nuclear power plants, Category 3
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N299.3-16
Quality assurance program
requirements for the supply of items
and services for nuclear power
plants, Category 3
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Quality assurance program requirements for the supply of items
N299.3-16 and services for nuclear power plants, Category 3
Contents
Technical Committee on Management Systems for Nuclear Facilities 3
Subcommittee on Quality Assurance Program Requirements for Supply of Items and Services for Nuclear
Power Plants 6
Preface 8
0 Introduction 10
0.1 Background 10
0.2 Category series 10
1 Scope 13
2 Reference publications 14
3 Definitions 15
4 General requirements 19
4.1 Contractual requirements, resources, and schedule 19
4.2 Planning and descriptions 19
4.3 Items produced for inventory 19
4.4 Software 20
4.5 Customer’s responsibilities 20
4.6 Supplier’s responsibilities 21
4.7 Safety culture 21
5 QA program requirements 22
5.1 General 22
5.2 Management responsibilities 22
5.2.1 Management policies and organization 22
5.2.2 Management review 22
5.2.3 Management representative 23
5.2.4 Organizational authority 23
5.2.5 Independent inspection, witnessing, and monitoring 23
5.2.6 Indoctrination, training, and qualification 23
5.3 QA manual 24
5.3.1 General 24
5.3.2 Program application 24
5.3.3 Management responsibilities and organization 24
5.3.4 Descriptions 25
5.3.5 Manual review 25
5.4 QA program descriptions 25
5.5 QA program elements 26
5.5.1 Tender and contract review 26
5.5.2 Design 26
5.5.3 Documentation 28
5.5.4 Measuring and testing equipment 29
September 2016 © 2016 CSA Group 1
5.5.5 Procurement 30
5.5.6 Inspection and test planning 32
5.5.7 Inspection and testing 33
5.5.8 Inspection status 34
5.5.9 Identification and traceability 34
5.5.10 Handling and storage 35
5.5.11 Production 35
5.5.12 Special processes 36
5.5.13 Packaging and shipping 36
5.5.14 Quality records 36
5.5.15 Nonconformances 38
5.5.16 Corrective action 39
5.5.17 Use of experience 39
5.5.18 Customer-supplied items and services 39
5.5.19 Statistical techniques 40
5.5.20 Quality audits 40
Annex A (normative) — Category selection 43

Annex B (informative) — Guidance on QA program descriptions 51
Annex C (informative) — Guidance on design 54
Annex D (informative) — Guidance on measuring and test equipment 56
Annex E (informative) — Guidance on safety culture 59
Technical Committee on Management

Systems for Nuclear Facilities
R. Schewaga Areva Resources Canada Inc., Chair
Saskatoon, Saskatchewan
Category: Supplier/Fabricator/Contractor
R.K. Black TransCanada, Vice-Chair

Toronto, Ontario
Category: Service Industry
J. Brown GE-Hitachi Nuclear Energy Canada Inc., Vice-Chair

Peterborough, Ontario
P. Baquero TRIUMF,
Vancouver, British Columbia
Category: General Interest
R.W. Barnes ANRIC Enterprises Inc.,

Toronto, Ontario
K.D. Cassells AECON Energy,

Cambridge, Ontario
E. Clavel Clavel Quality Consulting,

Mississauga, Ontario
D. Constantinescu Bruce Power, Associate

Tiverton, Ontario
A. Coulas Canadian Nuclear Laboratories Limited (CNL),

Chalk River, Ontario
Category: Owner/Operator/Producer
D. Davis Bruce Power,

Tiverton, Ontario
C.F. Harris NB Power Corporation,

Lepreau, New Brunswick
S.D. Harris Ontario Power Generation,

Oshawa, Ontario
K. Heppell-Masys Canadian Nuclear Safety Commission (CNSC), Associate

Ottawa, Ontario
C. Ingalls Cameco Corporation Fuel Services Division,

Port Hope, Ontario
B. Johnston McMaster University,

Hamilton, Ontario
P. Jones TRIUMF, Associate

Vancouver, British Columbia
G. Kozak Bruce Power, Associate

Tiverton, Ontario
J. Krane Stuart Olson,

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

Ottawa, Ontario
Category: Government and/or Regulatory Authority
V. Raees Technical Standards and Safety Authority,

Ajax, Ontario
Category: Government and/or Regulatory Authority
P. Schultz Canadian Nuclear Safety Commission (CNSC), Associate

Ottawa, Ontario
C. Sellers Campbellcroft, Ontario Associate
J.R. Walker Vienna, Austria Associate
P. Young Scarborough, Ontario

M. Khan CSA Group, Project Manager

Toronto, Ontario
Subcommittee on Quality Assurance

Program Requirements for Supply of Items
and Services for Nuclear Power Plants
C. Sellers Campbellcroft, Ontario Chair
N. Boraso Hatch Limited,

J. Brown GE-Hitachi Nuclear Energy Canada Inc.,

Peterborough, Ontario
E. Clavel Clavel Quality Consulting,

A. Coulas Canadian Nuclear Laboratories Limited (CNL),

Chalk River, Ontario
S.D. Harris Ontario Power Generation,

Oshawa, Ontario
J. Lopez Bruce Power LP,

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

Pickering, Ontario
L. Payne NB Power,
Maces Bay, New Brunswick
M. Pletosu Ontario Power Generation Inc.,

Pickering, Ontario
K. Richardson Cambridge, Ontario
D. Sperling Burlington, Ontario
A. Wagland WAG QA Services Canada Inc.,

Waterloo, Ontario
G.B. Waterhouse GBW Technical Services,

Whitby, Ontario
P. Wong Canadian Nuclear Safety Commission (CNSC),

Ottawa, Ontario
M. Khan CSA Group, Project Manager

Toronto, Ontario
Preface
This is the first edition of CSA N299.3, Quality assurance program requirements for the supply of items
and services for nuclear power plants, Category 3.
The CSA N299 series of Standards defines a consistent set of quality assurance program requirements
for the provision of items and services for nuclear power plants.
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. The Canadian Nuclear Safety
Commission (CNSC) can therefore impose additional requirements to those specified in this Standard.
The CSA N-Series Standards provide an interlinked set of requirements for the management of nuclear
facilities and activities. CSA N286 provides overall direction to management to develop and implement
sound management practices and controls, while the other CSA Group nuclear Standards provide
technical requirements and guidance that support the management system. This Standard works in
harmony with CSA N286 and does not duplicate the generic requirements of CSA N286; however, it may
provide more specific direction for those requirements.
The following people made valuable contributions to the development of the seed documents for the
N299 series of Standards: G. Cairns; L. Colligan; A. Galati (COG); N. Gaudani (COG); S. Harris (Ontario
Power Generation); P. Karsten (Bruce Power); W. Kettle (Ontario Power Generation); J. Lopez (Bruce
Power); M. Pletosu (Ontario Power Generation); D. Rowland (Bruce Power); and M. Small (Ontario
Power Generation).
This Standard was prepared 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.
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illustrative sketch;
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N299.3-16
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 contained
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
for items and services. CSA Z299 was a commercial standard used broadly both nationally and
internationally, 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 generally
adopted by industry. CSA Z299 was no longer supported by the Technical Committee in charge of CSA
Z299, and it was eventually 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 fulfill this need, nuclear utilities have developed,
through a joint 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 N299 series of Standards, 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 third 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 this series of Standards and applicable
elements.
This Standard was developed in response to industry need for a quality assurance standard for items
and services supplied to nuclear power plants.
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.
Category 4 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 – Alternatives
• Document control • Tender and contract – Preliminary • Nonconformance
• Calibration review design (preventive
• Procurement • Program descriptions – Design analysis measures)
• Inspection and t ests • Design – Detailed design • Corrective action for
• Identification – Interfaces • Nonconformance potential
• Handling and stora ge – Design inputs cause analysis nonconformances
control – Software • Internal audits
• Production – Design outputs
• Identification – Design
• Packaging and verification
shipping – Design changes
• CFSI • Inspection and t est
• Quality records planning
• Nonconformance and • Identification and
Corrective action traceability
• Customer supplied • Production planning
items and services • Use of experience
• Statistical techniques • Special processes
• Extern al audits
Least comprehe nsive 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 requires suppliers to plan and establish a program for verifying the conformance of items
or services throughout the process. This Standard is suitable for items or services requiring few complex
processes, design changes, and design verification, and which might be high-volume services or mass-
produced items. Failure in service could result in some risk to safety or significant business risk.
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 appropriate 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
Comparison of N299 category requirements
(See Clause 0.2.)
Category Category Category Category

Matrix comparison of categories 1 2 3 4
1 Scope I II III IV
3 Definitions I I III IV
4 General requirements I I III IV
5 QA program requirements
5.1 General I I I I
5.2 Management responsibilities:
5.2.1 Management policies and organization I I III IV
5.2.2 Management review I II III IV
5.2.3 Management representative I I I IV
5.2.4 Organizational authority I I III IV
5.2.5 Independent inspection, witnessing, and monitoring I I I IV
5.2.6 Indoctrination, training, and qualification I I III IV
5.3 QA manual/program documentation I I I* IV
5.4 QA program procedures/descriptions I I III N/A

5.5 QA program elements:
5.5.1 Tender and contract review I I III IV
5.5.2 Design I II III N/A
5.5.3 Documentation I I I* IV
5.5.4 Measuring and testing equipment I I I IV
5.5.5 Procurement I I III IV
5.5.6 Inspection and test planning I I I N/A
5.5.7 Inspection and testing I I I IV
5.5.8 Inspection status I I I IV
5.5.9 Identification and traceability I I I IV
5.5.10 Handling and storage I I III IV
5.5.11 Production I I III IV
5.5.12 Special processes I II II N/A
5.5.13 Packaging and shipping I II III IV
5.5.14 Quality records I I I IV
5.5.15 Nonconformances I I III IV
5.5.16 Corrective action I II III III
(Continued)
Table 1 (Concluded)
Category Category Category Category

Matrix comparison of categories 1 2 3 4
5.5.17 Use of experience I I III N/A
5.5.18 Customer-supplied items and services I I I IV
5.5.19 Statistical techniques I I I* IV
5.5.20 Quality audits
5.5.20.1 Internal quality audits I I N/A N/A
5.5.20.2 External quality audits I I I N/A
Legend:
II =I Requirements equivalent with Category 1
III =I Requirements equivalent with Category 2
IIII =I Requirements equivalent with Category 3
IVI =I Requirements equivalent with Category 4
N/AI =I 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
referred to as “QA program”) for existing nuclear power plants — Category 3.
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 E).
2) This Standard may be used by other nuclear facilities.
1.1.2
The QA program is aimed primarily at verifying production processes, as well as planning inspection and
test verifications, and corrective actions that
a) ensure items or services conform to specified requirements; and
b) 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
1.3.1
The requirements of this Standard apply to the control of the use of software employed in the
operation of process, production, inspection, and test equipment.
1.3.2
This Standard does not apply to the design, use, development, or coding of analytical software.
Note: When a QA program is needed for these aspects, then a standard written specifically for them should be
used.
1.4
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 (R2013)
Measurement management systems — Requirements for measurement processes and measuring
equipment
CAN/CSA-ISO 19011:12
Guidelines for auditing management systems
N286-12
Management system requirements for nuclear facilities
ANSI/ASQ (American National Standard Institute/American Society for Quality)

ANSI/ASQ Z1.4-2003 (R2013)
Sampling Procedures and Tables for Inspection by Attributes
ASME (The American Society of Mechanical Engineers)

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

DIS-12-07 (2012)
Discussion Paper on Safety Culture for Nuclear Licensees
REGDOC 2.5.2 (2014)

Design of Reactor Facilities: Nuclear Power Plants
EPRI (Electric Power Research Institute)

EPRI 1019163 (2014)
Plant Support Engineering: Counterfeit and Fraudulent Items — Mitigating the Increasing Risk
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-1329 (2002)
Safety culture in nuclear installations — Guidance for use in the enhancement of safety culture
ISO/IEC (International Organization for Standardization/International Electrotechnical Commission)

17025:2005
General requirements for the competence of testing and calibration laboratories
U.S. DOD (United States Department of Defense)

MIL-STD-1916 (1996)
Department of Defense Test Method Standard: DOD Preferred Methods for Acceptance of Product
3 Definitions
The following definitions 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.
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 — comparing 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.
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 successfully
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 of the nonconformance 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 — important design, material, and performance characteristics of an item or

service that provides 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 survey and verify the quality of
the supplier’s work.
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 input — requirements and information specified by customers, AHJs, design group, or design
discipline, and needed as a reference base for design work.
Design output — requirements and information that document the configuration of the design.
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.
Inspection and test point — a location or stage in the production cycle where inspection and testing are
performed by personnel whose responsibility is to determine the acceptability of items or services and
to record inspection and test data.
Nonconformance — a deficiency in characteristic, documentation, or procedure that renders the quality

of an item or service unacceptable or indeterminable, 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]
Organizational function — a department within the supplier’s business providing a service such as
design, production, procurement, or quality assurance.
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 materials, 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.
Production — all activities involved in the fabrication, assembly, construction, and erection of items to
specified requirements.
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 nuclear 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 workers, 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 radiological and non-radiological effects.
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
radiological safety of the public or plant personnel.
Software — any set of machine-readable instructions (most often in the form of a computer program,
including programs that work closely together) that direct a computer's processor to perform specific
operations or tasks other than just running the computer 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 non-destructive 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 is

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, items, and services to ensure that requirements are met.
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]
Verification — the act of independently reviewing, checking, or inspecting to confirm that items and
services meet requirements.
Working knowledge — the understanding by experience in a specialty field 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 III]
4 General requirements
4.1 Contractual requirements, resources, and schedule
4.1.1
The supplier shall
a) document, implement, and maintain a QA program that assures all activities for quality are
integrated and executed effectively; and
b) conform to all customer requirements, including those for all outsourced processes, items, or
services.
4.1.2
The supplier shall review the contractual requirements, resources, and schedule required to assure item
or service quality prior to submission of a bid, and the review shall include
a) identifying, and providing or updating, the special process controls and requirements for delivery
and post-delivery activities;
b) the requirements of the AHJ applicable to the item or service;
c) equipment, including measuring and testing equipment; and
d) the personnel skills and qualifications.
4.2 Planning and descriptions

The supplier shall document, implement, and maintain plans and descriptions for specifying the
activities required, including those listed in Clause 5.4, to verify that items and services meet specified
requirements in accordance with this Standard.
4.3 Items produced for inventory

In cases where items are produced for inventory (i.e., for future sale to unidentified customers),
objective evidence shall be available to show compliance with this Standard, except for those
requirements where submittal of data is required before start of the work. This shall be resolved with
the customer before purchase.
4.4 Software
4.4.1
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.
4.4.2
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 Customer’s responsibilities

Customers shall
a) evaluate and select suppliers based on their ability to meet specified requirements by the time the
work starts, which shall include an evaluation of
i) the QA manual (or for Category 4, QA program description) and associated documentation;
ii) the QA program implementation (for CSA N299 Category 1, 2, 3, or equivalent);
iii) the ability to provide a technically adequate and economical item or service;
iv) the ability to respect delivery dates;
v) the supplier’s supply chain; and
vi) other required locations, plan(s), and resources;
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 standards 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) traceability in accordance with Clause 5.5.9;
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 5.5.17);
Note: Typically, these items are found in the tender and contract.
c) carry out surveillance and audits, as and when required, to ensure that the supplier and, where
applicable, the subsupplier(s), is conforming to this Standard;
d) ensure that customer-supplied items or services comply with specified requirements, and that they
are consistent with the quality requirements of the final 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, etc.) 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 relates to items produced 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.
4.6 Supplier’s responsibilities

Suppliers shall
a) satisfy the specified requirements and provide objective evidence that the requirements specified
have been met;
Note: Typically, customer requirements are found in the contract between the customer and the supplier.
b) forward contractual requirements to subsuppliers, as applicable;
c) document, implement, and maintain the QA program and communicate to personnel the
importance of meeting customer requirements and requirements of the AHJ;
d) submit the QA manual and the subsequent revisions to the customer;
Note: Revisions should be submitted to the customer when the QA manual is revised while the supplier is an
active approved supplier.
e) upon request, submit, update, and resubmit the QA program documents required by Clauses 5.4;
f) provide customer access to the applicable premises or working areas, including those of the
subsuppliers, for the purpose of surveillance, AHJ requirement verification, and audit;
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, quality 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 audit where
their QA program is not applicable, as long as this is not in contradiction with the information contained
in their QA manuals.
g) identify for the customer before the award of the contract which items will be supplied from
inventory and demonstrate that the QA program as specified was implemented for the items at the
time they were produced;
Note: The items to be identified are the contracted items agreed upon between the customer and supplier.
h) develop and implement a process for the detection and prevention of CFSIs to ensure that genuine
parts and services, duly tested and verified to meet specified requirements, are provided;
i) ensure that personnel involved in CFSI detection are provided with the necessary training to
perform these functions;
j) identify CFSIs, report those items to the customer, and process those items in accordance with
Clause 5.5.15; and
k) incorporate use of experience into the supply of the applicable item or service (see Clause 5.5.17).
4.7 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 workers to adherence to the QA program;
b) defining and implementing practices that contribute to excellence in worker performance;
c) providing the means by which the business supports workers in carrying out their tasks safely and
successfully, by taking into account the interactions between individuals, technology, and the
organization; and
d) monitoring to understand and improve the culture.
Note: See Annex E for additional details on safety culture.
5 QA program requirements
5.1 General
The supplier shall document, implement, and maintain a QA program in accordance with the
requirements of this Standard.
5.2 Management responsibilities
5.2.1 Management policies and organization
5.2.1.1
The supplier shall document top management’s commitment to the development and implementation
of the QA program.
5.2.1.2
The supplier shall
a) document, implement, and maintain management policies, objectives, and responsibilities for
quality;
b) define and document the responsibility and authority for quality of those organizational positions
that
i) manage and perform the work; and
ii) verify and audit conformance to specified requirements; and
c) describe the organizational structure of the supplier, including a multidivisional supplier, and show
the interrelationship of the positions mentioned in Item b) on organizational charts.
5.2.2 Management review

The supplier shall document, implement, and maintain a process for top management review to
demonstrate the suitability of the QA program in meeting the requirements of this Standard. 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. Upon completion
of the top management review, the results shall be documented. Actions resulting from management
review shall be verified.
Notes:
1) Management reviews are carried out by top management and not delegated to other staff.
2) Management reviews typically include, for example, subsupplier performance indicators, customer feedback,
process performance, and item and service conformity, as well as follow-up action from previous
management reviews.
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).
5.2.3 Management representative
5.2.3.1
Irrespective of the supplier structure, the supplier shall assign and document the authority and
responsibility of the representative for establishing, implementing, maintaining, and assuring the
effective execution of all portions of the QA program at any location where activities subject to this
Standard are being performed.
5.2.3.2
The supplier shall assign and document the appointment of a representative who has the authority and
responsibility to resolve quality matters and has direct access to top management to ensure that quality
matters are not subordinated to design, procurement, production, or delivery.
Note: The management representative should be the supplier's primary contact with customers on quality matters.
5.2.4 Organizational authority

The supplier shall define and document the responsibility and authority of personnel primarily
responsible for quality assurance to
a) identify and record nonconforming items or services;
b) initiate or recommend disposition of nonconforming items or services;
c) verify correction of nonconforming items and services; and
d) control further processing, delivery, or installation of a nonconforming item or service until a
disposition has been obtained internally or when required from the customer.
5.2.5 Independent inspection, witnessing, and monitoring

Unless otherwise agreed to in writing by the customer, the supplier shall assign personnel to perform
the inspection, witnessing, or monitoring of characteristics for acceptance. Such personnel shall be
other than those performing or directly supervising the work being accepted and shall not report
directly to immediate supervisors responsible for producing the work. However, additional in-process
inspections, as allowed by Clause 5.5.6.2 c), may be carried out by assigned personnel.
5.2.6 Indoctrination, training, and qualification
5.2.6.1 Indoctrination
Indoctrination shall be provided to ensure that personnel are aware of their general responsibilities in
the QA program. Personnel performing 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.
5.2.6.2 Training
Training shall ensure that personnel are aware of their specified responsibilities in the QA program and
their job function, are competent and capable of performing their work, and that their competency is
maintained.
Management shall
a) document, implement, and maintain training requirements;
b) evaluate trainees’ knowledge of the training objectives and requirements of applicable codes,
standards, specifications, and the commitments of the AHJ, when required; and
c) provide on-the-job training if direct hands-on applications or experience is needed.
5.2.6.3 Qualification
Management shall
a) document, implement, and maintain the necessary education, prerequisite skills, experience, and
proficiency required for those personnel whose activities/job functions require specialized
qualifications and competencies;
b) qualify personnel to the minimum defined qualification requirements prior to performing the
activity/job function; and
c) ensure competencies of personnel are maintained for their roles and responsibilities, taking into
account changes in technology, methods, or job responsibilities.
5.2.6.4 Records
Records shall be maintained as objective evidence of personnel competencies, indoctrination, training,
and qualifications in accordance with Clause 5.5.14.
Note: The supplier is advised to keep records of indoctrination and training separate from other personnel records.
5.3 QA manual
5.3.1 General
The supplier shall
a) prepare a QA manual approved and signed by a top management official before the contract is let;
Note: A supplier’s QA manual can include the following:
a) title page, name, location of the facility covered by the QA manual, and date or number of issue or
revision;
b) what QA program standards or specification it is intended to satisfy;
c) the item lines or services covered by the QA manual;
d) table of contents for easy location of information;
e) manual distribution and revision control;
f) the supplier's name or logo on each page; and
g) the page number on each page.
b) submit the currently implemented QA manual to the customer for evaluation, unless otherwise
agreed to in writing by the customer; and
c) include the items specified in Clauses 5.3.2 to 5.3.5 in the QA manual, as a minimum.
Note: If the supplier has prepared its QA manual to other QA standards, programs, or management systems,
then a compliance matrix to identify where the specification Category 3 requirements are met should be
developed.
5.3.2 Program application

The supplier shall identify in the QA manual
a) the business, facility, and items or services covered by the QA program; and
b) the process of how subsuppliers participate within the supplier’s QA program, together with the
designated functions assigned to these subsuppliers, when applicable.
5.3.3 Management responsibilities and organization

The supplier shall include in the QA manual
a) the requirements specified in Clause 5.2;
b) the responsibilities of, and interfaces between, each division involved with the item or service
within a multidivisional business; and
Note: For the purpose of this Standard, “division” is an organizational unit conducting an essentially
autonomous business. The head of the division has the responsibility for design, procurement, production,
accounting, quality assurance, etc.
c) document, implement, and maintain a process whenever the supplier intends 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 upon imposing the supplier’s own QA program, or part
thereof, on the subcontractor, the process for doing so is developed and implemented under the supplier’s QA
program.
5.3.4 Descriptions
The supplier shall cross-reference or include all descriptions specified in Clause 5.4 in the QA manual.
For any descriptions not cross-referenced or included, a rationale shall be provided for those
descriptions which are not applicable. Upon request, the supplier shall submit referenced descriptions
to the customer.
5.3.5 Manual review

The supplier shall include a statement in the QA manual for periodic review, updating, and controlling of
the QA manual.
5.4 QA program descriptions

The supplier shall
a) document, implement, and maintain systems and processes for planning and controlling the
following elements:
i) indoctrination, training, and qualification (Clause 5.2.6);
ii) tender and contract review (Clause 5.5.1);
iii) design (Clause 5.5.2);
iv) documentation (Clause 5.5.3);
v) measuring and testing equipment (Clause 5.5.4);
vi) procurement (Clause 5.5.5);
vii) inspection and test planning (Clause 5.5.6);
viii) inspection and testing (Clause 5.5.7);
ix) inspection status (Clause 5.5.8);
x) identification and traceability (Clause 5.5.9);
xi) handling and storage (Clause 5.5.10);
xii) production (Clause 5.5.11);
xiii) special processes (Clause 5.5.12);
xiv) packaging and shipping (Clause 5.5.13);
xv) quality records (Clause 5.5.14);
xvi) nonconformances (Clause 5.5.15);
xvii) corrective action (Clause 5.5.16);
xviii) customer-supplied items and services (Clause 5.5.18);
xix) statistical techniques (Clause 5.5.19); and
xx) quality audits (Clause 5.5.20);
b) document, as applicable, in each program description, such elements as
i) the purpose and scope of an activity;
ii) who is responsible for what; and

iii) the actions to be taken to fulfill the program requirements;
Note: The guidelines identified in Annex B 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) update QA program descriptions when necessary and make them available to the customer
representative, as requested.
5.5 QA program elements
5.5.1 Tender and contract review

The supplier shall
a) review the tender, contract, or purchase order before acceptance to detect and resolve differences
from the quote and obtain the concurrence of the applicable organizational functions. The
following shall be included in the review, as applicable:
i) verifying that the requirements are defined, including the requirements for delivery and post-
delivery activities, as applicable to the item or service;
ii) ensuring that the supplier’s, and subsupplier’s, resources and capability are adequate to meet
the requirements;
iii) confirming that any statistical techniques/sampling plans to be used are acceptable to the
customer; and
iv) documenting the results of the review of the contract documents;
Note: Tender and contract reviews should not be limited to design 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, and
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.
b) translate contract, technical, and quality requirements on work control documents after award of
contract, as applicable; and
Note: Examples of work control documents include, but are not limited to, the following: design documents,
production documents, and work tracking documents.
c) review and accept subsequent contract changes after award of 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.
Note: The supplier should ascertain the requirements for configuration management of items.
5.5.2 Design
Note: See Annex C for additional guidance on design.
5.5.2.1 Application
The design and associated verification activities shall be commensurate with the scope of work.
Category 3 designs include changes to an existing mature design that require a minimal degree of effort
and are of low complexity as specified in, but not limited to, Clauses 5.5.2.2 to 5.5.2.11 where design
controls are not required.
Category 3 designs are based on defined functional and performance requirements with no impact to
safety, are not a first of a kind design, and might include redesign of an item or use of a previously
accepted mature design for a new application.
5.5.2.2 Design planning

Design planning requirements are not applicable to a Category 3 QA program.
5.5.2.3 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.
5.5.2.4 Interfaces
Design interfaces requirements are not applicable to a Category 3 QA program.
5.5.2.5 Design inputs

The supplier shall identify, document, and review the performance functional requirements and critical
characteristics as applicable for change to the design of an item, and the use of experience, as
applicable (see Clause 5.5.17).
5.5.2.6 Preliminary design

Preliminary design requirements are not applicable to a Category 3 QA program.
5.5.2.7 Design analysis software

When software is used for design analysis of the item or service, the supplier shall
a) control the software and verify that the software is adequate for its intended use;
b) identify the computer, the computer program name and revision/version, and the method(s) used
for verification supporting the application of the computer program to the specific physical
problem; and
c) control and maintain the records in accordance with Clause 5.5.14.
Note: When a QA program is needed for these aspects, then a standard written specifically for them should be
used.
5.5.2.8 Detailed design

Detailed design requirements are not applicable to a Category 3 QA program.
5.5.2.9 Design output

The supplier shall ensure that final design documents
a) are traceable to the design inputs;
b) contain or reference all applicable criteria; and
c) are controlled in accordance with Clause 5.5.3.
5.5.2.10 Design verification

The supplier shall
a) document, implement, and maintain design verification points (including those of design inputs
and outputs), techniques, procedures, and characteristics to be verified that provide reasonable
assurance that once the change to the design is complete the item will perform its intended
function;
b) have personnel responsible for the design of the item or service arrange for appropriate
verification, which shall be performed in conjunction with knowledgeable personnel other than
those who performed the original design;
c) disposition design nonconformances in accordance with Clause 5.5.15;
d) control design documents in accordance with Clause 5.5.3; and

e) maintain design records in accordance with Clause 5.5.14.
5.5.2.11 Design changes

The supplier shall
a) ensure design changes are subjected to the same level of review, verification, and approvals 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, the item configuration has been
established, including materials to be used and associated QA program category, and critical
characteristics necessary for subsequent item acceptance have been identified and documented;
e) control changes in accordance with Clause 5.5.3;
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.
5.5.3 Documentation
Note: Documentation covers documents and data that can be read by people or machines.
The supplier shall
a) ensure that all essential documentation affecting item or service quality is reviewed for adequacy
and approved by authorized personnel before release. Such documentation includes as a
minimum, but is not limited to,
i) the QA manual required by Clause 5.3;
ii) QA program descriptions listed in Clause 5.4;
iii) engineering specifications, drawings, procedures or descriptions, and work instructions;
iv) the tender and contract review required by Clause 5.5.1;
v) measuring and testing equipment documentation required by Clause 5.5.4;
vi) procurement documentation required by Clause 5.5.5;
vii) inspection and test planning documentation required by Clause 5.5.6;
viii) traceability documentation required by Clause 5.5.9;
ix) handling and storage of documentation required by Clause 5.5.10;
x) production documentation required by Clause 5.5.11;
xi) special process procedures and documentation required by Clause 5.5.12; and
xii) audit documentation required by Clause 5.5.20;
b) ensure that the applicable revisions of the documentation described in Item a) is available in all
areas and at inspection and test points where they apply so that they are readily accessible;
c) ensure that incomplete, ambiguous, or conflicting documentation is identified, documented, and
withdrawn until resolved and accepted by the organizations responsible for generating the
requirements;
d) 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;
e) identify or remove obsolete documentation from all points of utilization to prevent unintended
use;
f) prepare and submit requests for changes to the customer’s documentation when required; and
g) review the application of external origin documents (e.g., codes, standards, and customer-
prescribed procedures) determined to be necessary for the planning and operation of the QA
program.
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 procedure.
5.5.4 Measuring and testing equipment

For all measuring and testing equipment used for item and service acceptance, the supplier shall
a) maintain a system for selecting, using, calibrating, and controlling measuring and testing
equipment, including physical standards and devices used for controlling and verifying item or
service quality. The supplier may subcontract the measurement and testing or calibration
functions, but shall not be relieved of the responsibility for meeting the requirements of this
Standard;
b) verify and document the ability of the software to satisfy the intended application for cases where
software is used in the actual calibration of the measuring and testing equipment prior to initial
use, and re-verify as necessary;
c) review the technical requirements for the item or service to ensure that applicable measuring and
testing equipment is available, and ensure that the equipment has measurement and testing
capability, stability, accuracy, tolerance, and range compatible with the intended application;
d) examine and verify newly acquired measuring and testing equipment, and calibrate it to the extent
necessary to ensure valid measurement before use;
e) establish a calibration interval for each piece of measuring and testing equipment so that
recalibration occurs before any anticipated significant change in measurement capability;
f) establish and maintain calibration procedures defining equipment description, identification
number, location, calibration interval, calibration method, acceptance criteria, and action to take
when results are unsatisfactory;
g) calibrate and use measuring and testing equipment in an environment controlled to the extent
necessary to ensure valid measurement, and give due consideration to temperature, rate of
change of temperature, humidity, lighting, vibration, cleanliness, and any other factor affecting
measurement;
h) calibrate measuring and testing equipment using reference standards whose calibration
i) is certified as being traceable to nationally recognized standards;
ii) has been derived from accepted values 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) label, code, or otherwise identify measuring and testing equipment, or its case when identification
cannot be applied directly to the measuring and testing equipment, to indicate its calibration status
and the scheduled date of its next calibration, and to identify it with its calibration record;
j) seal or otherwise safeguard access to adjustable devices on measuring and testing equipment,
which are fixed at the time of calibration, to deter tampering. The supplier shall not use equipment
with damaged seals or safeguards;
k) maintain a calibration record for each piece of measuring and testing equipment and record as-
found and as-left measurements;
l) maintain a system for handling and storing all measuring and testing equipment which prevents
mishandling, damage, or change in dimensional or functional characteristics;
m) provide for the immediate removal, or the conspicuous identification to prevent use, of measuring
and testing equipment that has failed in operation, is damaged, or is suspected of having deviated
from its established measurement capability or is past its calibration date; and
n) assess and record the validity of the previous measuring results when the measuring and testing
equipment is found not to conform to requirements, and take appropriate action on the measuring
and testing equipment and any item or services affected in accordance with Clause 5.5.15.
Note: See Annex D for additional guidance on measuring and testing equipment.
5.5.5 Procurement
5.5.5.1 Selection
The supplier shall 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 undertake the following:
a) select the applicable CSA Group or other QA program standard or specification for those
subcontracted items or services, and justify and document each selection; and
Note: See Annex A for the methods of selection.
b) select subsuppliers based on their ability to meet specified requirements by the time the work
starts. This includes
i) unless previously approved, performing an evaluation of the QA manual (or, for Category 4,
the QA program description);
ii) unless previously approved, performing an audit of the QA program implementation (for CSA
N299 Category 1, 2, 3, or equivalent), in accordance with Clause 5.5.20.2;
Note: Evidence of acceptance by a recognized authority to this Standard is considered to fulfill these
requirements or as otherwise agreed to by the customer.
iii) an evaluation of other required locations, plan(s), and resources;
iv) 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;
v) 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 contract and intends on using 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 utilize the selection process defined in this Clause
(and Annex A) to select the subsupplier QA program requirements for items, subassemblies,
components, and services utilized 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.
vi) verification of the validity of subsuppliers’ QA program certificates as specified in Item a); and
vii) establishing and maintaining a record of acceptable subsuppliers that includes approval status
and the scope of the approval.
5.5.5.2 Subcontract requirements

The supplier shall include specific customer requirements in subcontracts, 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;
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 inspection and test planning document(s) where the supplier’s customer
or 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 quality records;
k) documentation and instructions required when the items or services are shipped directly to a
consignee other than the supplier;
l) any traceability requirements specified in Clause 5.5.9;
m) requirements for the submittal of inspection and test procedures as specified by the customer and
supplier; and
n) requirements for prevention and detection of CFSIs, taking into consideration the complexity of the
supply chain.
5.5.5.3 Reviews
The supplier shall
a) review procurement documents for adequacy of specified requirements and ensure that
procurement documents contain the applicable provisions of Clause 5.5.5.2 before release. This
review shall be documented; and
b) make all subcontracts and associated reference data available for review by the customer
representative.
5.5.5.4 Inspection, surveillance, and audit of subsuppliers

The supplier shall
a) review subsupplier’s inspection and test planning document(s) when determined as necessary or
required by contract to ensure that specified requirements will be met;
b) evaluate all subcontracted items or services to determine the amount of inspection, surveillance,
and audit needed at subsupplier’s locations, taking into account the complexity of the item or
service;
c) carry out this inspection, surveillance, and audit;
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.
5.5.5.5 Amendments to subcontracts

The supplier shall process amendments to subcontracts in accordance with Clause 5.5.3 d).
5.5.6 Inspection and test planning
5.5.6.1
The supplier shall
a) plan the inspection and test activities for the constituent phases of the work from receipt through
delivery. During planning, the importance and complexity of the item or service, and the agents
and distributors that are involved, shall be taken into consideration when performing work
activities related to an item such as, but not limited to,
i) marking of an item;
ii) documentation control;
iii) assembling and creating records;
iv) handling, storage, preservation, and packaging; and
v) inspection and verification;
Note: Agents and distributors are types of suppliers or subsuppliers.
b) document and maintain the inspection and test planning document(s) which describe the
inspections, tests, and verifications for the item or service specified in the contract. Regardless of
who prepares the inspection and test planning document(s), they shall be approved by the
supplier’s representative who is primarily responsible for quality assurance;
c) ensure that the inspection and test planning document(s) format suits the supplier’s system and
meets, as a minimum, the requirements specified in Clause 5.5.6.2; 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 inspection and test planning document(s) to the customer for acceptance following
the award of the contract and before the applicable phase starts;
ii) update the inspection and test planning document(s) during the life of the contract to reflect
revisions, and resubmit for acceptance before the applicable phase starts; and
iii) submit referenced inspection and test procedures with the inspection and test planning
document(s).
5.5.6.2
The supplier shall identify the following in the inspection and test planning document(s):
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 inspection and test
planning document(s);
ii) inspection and test by the supplier at the subsupplier’s facility;
iii) surveillance by the supplier; and
iv) incoming inspection;
c) the location of each inspection and test point in the production cycle, including any inspection,
preservation of items, packaging, and on-site inspection and testing. If the supplier intends to
perform additional in-process inspections and tests for its own evaluation of quality, they shall be
indicated and the fact that they are not subject to customer representative acceptance shall also
be indicated;
d) what characteristics are to be inspected and tested at each point, and the inspection and test
procedures, sampling plans, and acceptance criteria to be used;
e) inspection and test points where a history of usage of measuring and testing equipment is
maintained so that assessments required by Clause 5.5.4 n) 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 5.5.12;
h) where statistical process control techniques will be used for item acceptance;
i) where lots or batches will be used;
j) what will be included in the review required by Clause 5.5.7 b); and
k) where software is used for 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.
5.5.7 Inspection and testing
5.5.7.1
The supplier shall
a) inspect and identify items or services at incoming, in-process, and final inspection, as required by
the inspection and test planning documents. The supplier shall
i) meet specified requirements;
Note: The specified requirements include both the customer requirements and 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. Items that are identified to be
counterfeit, fraudulent, or suspect shall be promptly reported to the customer, and shall be
processed in accordance with Clause 5.5.15;
iv) maintain the specified packaging and shipping requirements during shipping;
v) confirm that identification and markings are in accordance with applicable codes,
specifications, purchase orders, and drawings;
vi) confirm that protective covers and seals, coating and preservatives, inert gas blankets,
desiccants, etc., are performing as intended, and that there is no presence of foreign material;
vii) confirm that the item received was fabricated, tested, and inspected prior to shipment, in
accordance with the applicable code, specification, purchase order, or drawings;
viii) perform source inspection at the subsupplier’s facility, where required, in accordance with the
inspection and test planning documents. The results of the source inspection shall be
documented to provide evidence of acceptance and include, where applicable, results of
monitoring, inspection points performed and verified, examinations and tests, and acceptance
by the customer’s representative;
ix) meet the documentation requirements of the purchase order 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 items and services from receipt through final inspection to ensure that inspections have been
completed and accepted, and that the required quality records and certificates have been
reviewed and accepted, including records and documentation provided by subsuppliers;
c) initiate corrective action for subsupplier item or service nonconformances received that violate
contract requirements in accordance with the requirements of Clause 5.5.15;
d) disposition all nonconformances;
e) inspect the item or service at all points shown in the inspection and test planning document(s);
f) verify that requirements for inspection, markings, calibration, adjustments, protection from
damage, or other characteristics have been met, and that the item conforms to the specified
requirements and the quality records are complete;
g) obtain customer acceptance of the inspection points as identified in the inspection and test
planning document(s), including dispositions of nonconformances, when required;
h) make inspection and test 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
specified requirements.
5.5.7.2
The supplier may document, implement, and maintain a process for positive recall in conjunction with
Clause 5.5.15. Items or services may be released under this process; however, this shall not preclude
carrying out the inspections specified in the inspection and test planning document(s).
5.5.8 Inspection status

The supplier shall
a) provide means for ensuring that required inspections and tests are performed, and that the
acceptability of items or services with regard to inspections and tests performed is known
throughout production;
b) control items not having passed the required inspections and tests 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 or stamped impressions or other physical means on the
item or its container or on a service report that indicate final acceptance;
d) establish, control, and maintain a record of names and signatures of personnel authorized by the
supplier to review, approve, or accept a document, item, or service and, where applicable, control
the issue and removal of stamps to authorized quality assurance personnel;
e) show the supplier’s identity and that of the inspector on the inspection and test stamps used; and
f) control status indicators, including the authority for applying and removing tags, stamps, or other
physical means of indicating the inspection status.
5.5.9 Identification and traceability
5.5.9.1 Identification
The supplier shall
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 5.5.14; 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.
5.5.9.2 Traceability
The supplier shall
a) assign to each item or 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 5.5.14;
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.
5.5.10 Handling and storage

The supplier shall
a) adhere to the applicable customer and subsupplier handling and storage requirements;
b) establish and maintain a system for the cleaning, preservation, segregation, handling, and storage
of all items. The system shall address protective environments 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; and
c) periodically inspect critical, sensitive, perishable, or high-value items for condition and shelf life
expiry.
5.5.11 Production
5.5.11.1 Planning
The supplier shall
a) appoint qualified personnel to plan the work who are in possession of or have access to applicable
requirements (e.g., inspection and test criteria, process parameters, characteristics, contractual
requirements, codes, regulations, standards, specifications, drawings, project scope, and criteria for
services); and
b) identify and plan the production and service processes to ensure that the work is performed to
meet specified requirements.
5.5.11.2 Process descriptions

The supplier shall address production and service activities by appropriate documentation, such as
project execution plans, process descriptions, statistical process control descriptions, process sheets,
route cards, and drawings, including prevention, detection, and removal of foreign material, including
CFSIs, as applicable.
5.5.11.3 Process verification

The supplier shall, where applicable, verify production equipment, including all machines, jigs, fixtures,
tooling masters, templates, patterns, documentation, and computer programs used to automate and
control and monitor item realization processes before release for use in production or a service.
5.5.11.4 Work control

The supplier shall
a) produce the item or provide the service in accordance with the requirements resulting from
Clauses 5.5.11.1 to 5.5.11.3; and
b) correct the methods, procedures, and controls when shown to be unsuitable.
5.5.12 Special processes
5.5.12.1
The supplier shall
a) define the necessary qualifications of personnel (in accordance with Clause 5.2.6), process
procedures, documentation, and equipment for special processes not covered by existing codes or
standards, or where item or service quality requirements exceed the requirements of established
codes or standards; and
b) maintain qualification records for qualified personnel (in accordance with Clause 5.2.6), process
procedures, documentation, and equipment in accordance with the requirements of applicable
codes and standards.
5.5.12.2
The supplier shall
a) identify special production and special inspection processes, including those specified in the
contract by the customer; and
b) 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.
5.5.13 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) inspect to verify that the marking, labelling, final cleaning, preservation of item, environmental
protection, and adequacy of packaging and shipping processes meet the requirements;
c) 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
d) ensure that all shipping containers, packaging, and pallets are free of any harmful biological,
environmental, and combustible contamination, where specified in the contract.
5.5.14 Quality records
5.5.14.1 General requirements

Records shall be
a) legible;
b) complete
c) identifiable;
d) traceable to the related items and work;
e) retrievable;
f) preserved; and
g) retained, as specified.
5.5.14.2 General quality records

The supplier shall
a) retain, control, and maintain quality records consistent with applicable codes, standards or
specifications, and contract requirements in order to provide objective evidence that
i) the QA program complies with the requirements of this Standard;
ii) the item or service and documentation meet specified requirements;
iii) personnel, procedures, documentation, and equipment for special processes are qualified, as
required by Clause 5.5.12.2 b);
iv) selection, surveillance, and audit of subsuppliers are met, as required by Clauses 5.5.5.1,
5.5.5.2, and 5.5.5.4; and
v) corrective action has been taken and is effective as required by Clause 5.5.16; and
b) ensure the following:
i) identification, indexing, and filing of quality records for prompt retrieval are maintained up to
the time of customer acceptance of the item or service, unless the record retention period is
specified by contract or by requirements of the AHJ;
ii) records are traceable to associated items and activities and accurately reflect the work
accomplished or information required;
iii) records are stored for retrievability, maintained, and routinely inspected for compliance in
accordance with the specified requirements;
iv) suitable environmental conditions are maintained for the preservation, legibility, and
prevention of degradation, damage, and loss for all records, including electronic record media,
during the established retention period;
v) electronic record media remain retrievable and readable, notwithstanding changes in
hardware, software, and technology;
vi) access to the processing, storage, and retrieval of records is controlled and restricted to
authorized personnel; and
vii) quality records are made available to the customer representative for analysis and review.
Note: Quality records may be maintained electronically and may include electronic signatures, where used.
5.5.14.3 Specific quality records

The supplier shall
a) retain, control, and maintain the following 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) retain, control, and maintain records of management review and correction of deficiencies
required by Clause 5.2.2;
c) retain, control, and maintain the QA manual review records which identify all revisions required by
Clause 5.3.5; and
d) retain, control, and maintain records of verifications and item or service inspections and tests
which 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 [see Clause 5.5.15.1.2 h)];
vi) feedback or corrective action generated;
vii) dates of inspections or tests;
viii) verifiers or inspectors;
ix) data recording instruments as specified in the inspection and test planning documents;
x) that quality records are authenticated by authorized personnel; and
Note: Examples include, but are not limited to, stamps, signatures, initials, and dates).
xi) that electronic record authentication is provided on the record, within the media, or by linking
to the quality record itself.
5.5.15 Nonconformances
5.5.15.1 General nonconformance requirements
5.5.15.1.1
The supplier shall promptly disposition all nonconformances, including those of subsuppliers, that
violate contractual requirements. Final acceptance of nonconformances, including those of
subsuppliers, is at the prerogative of the customer.
5.5.15.1.2
The supplier shall
a) identify and define the responsibilities and authority of those assigned to the disposition of actual
nonconformances and corrective actions, including items and services;
b) identify and evaluate nonconformances;
c) record each nonconformance and corrective action, including the nature and extent of the
nonconformance;
d) perform a technical review that involves representatives from all pertinent functions, including the
quality assurance function;
e) develop a disposition with responsible parties and record the disposition and any subsequent
corrective actions to be taken, as applicable;
f) implement the accepted disposition and verify effectiveness of corrective actions;
g) for subsupplier nonconformances, where required by the contract [see Clause 5.5.5.2 d)], evaluate
and obtain agreement on the subsupplier’s proposed disposition;
h) maintain records of nonconformances and their corrective actions and dispositions, and objective
evidence of their implementation and effectiveness; and
i) review nonconformances to determine if they are systemic and identify appropriate corrective
actions, and report the analysis results to management for inclusion in the management review
process.
5.5.15.2 Nonconformance requirements for items and services

The supplier shall
a) provide holding areas or methods for segregating nonconforming items to prevent unauthorized
use, shipment, or mixing with conforming items. Where physical segregation is not practical,
tagging, marking, or other positive means of identification is acceptable;
b) if, during the investigation into an item nonconformance, additional item nonconformances are
suspected, appropriate action shall be taken to disposition the finding;
c) obtain concurrence of all responsible parties, including submission for acceptance to the customer,
as required, for “repair” and “use-as-is” dispositions;
d) verify 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;
e) when a nonconformance that might impact the design or functionality of an item or service is
detected after delivery, promptly notify the customer for resolution; and
f) verify that the item being dispositioned for scrap is conspicuously identified, controlled, and
rendered unusable, and that access is restricted to authorized personnel.
5.5.15.3 Other nonconformances and potential nonconformances

The additional other nonconfomances and potential nonconformances requirements are not applicable
to a Category 3 QA program.
5.5.16 Corrective action

The corrective action process shall be promptly implemented, as follows:
a) determine the need for any prompt actions and implement corrective action, as required;
b) initiate corrective action when notified by the customer’s representative of the existence of a
nonconformance, or an ineffective control;
c) plan, develop, and implement corrective actions;
d) verify that corrective actions taken are effective;
e) report to management periodically and, if requested, to the customer on the actions taken; and
f) document and maintain records of the corrective action taken in accordance with Clause 5.5.14.
5.5.17 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; and
c) implemented through action to prevent the recurrence of significant industry problems.
Experience within the supplier’s business should be made available to others based on its sensitivity.
Notes:
1) Use of experience can be employed to initiate improvement.
2) The supplier should identify and specify any areas of sensitivity that will be invoked. Where access to the
customer is to be denied based upon 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.
5.5.18 Customer-supplied items and services

The supplier shall control customer-supplied items and services, as follows:
a) maintain control and exercise care with customer-supplied property, items, and services, including
intellectual property and personal data, from receipt onwards in accordance with the requirements
of this Standard;
b) identify, verify, protect, and safeguard customer property provided for use or incorporation into
the item;
c) verify and accept the customer certification on the item supplied by the customer in accordance
with Clause 4.5 d);
d) verify and accept those items or services received indirectly from the customer through the
customer’s suppliers;
e) examine items, including those involving a service, on receipt for completeness and proper 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
f) promptly report in writing to the customer’s representative any customer-supplied property or
item that is lost, found damaged, nonconforming, or otherwise unsuitable or unnecessary for use
either on receipt or while in the supplier’s custody.
5.5.19 Statistical techniques

The supplier shall control and apply statistical techniques, as follows:
a) identify and classify item, process, and service characteristics for which statistical techniques and
sampling procedures will be used as a basis for the assurance and control of quality, and
acceptance or rejection of lots;
b) select appropriate statistical techniques or a recognized industry standard (e.g., U.S. DOD
MIL-STD-1916; ANSI/ASQ Z1.4) 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 inspection and test planning documents in
accordance with Clause 5.5.6.2 h);
d) identify to the customer the statistical techniques/sampling plans that will be used (see
Clause 5.5.1);
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 and maintain records of the results of statistical techniques/sampling plans used in
accordance with Clause 5.5.14.
5.5.20 Quality audits
5.5.20.1 Internal quality audits

Internal quality audit requirements are not applicable to a Category 3 QA program.
5.5.20.2 External quality audits

When the selection process (in accordance with Clause 5.5.5) determines that an audit of the
subsupplier is required, the supplier shall 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 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 auditor(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 5.2.6;
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) assign auditor(s) having experience and training commensurate with the scope, complexity, or
special nature of the activities to be audited;
i) 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 descriptions 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;
j) document the audit results in an audit report;
k) 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;
l) issue the audit report to the subsupplier, including the request for corrective actions, as required;
m) 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;
n) evaluate the acceptability of the subsupplier’s responses to the corrective actions issued;
o) re-audit deficient areas, as required, to verify that corrective actions taken by the subsupplier are
effective;
p) upon completion of the subsupplier audit, report and disposition of all the corrective actions
issued;
q) issue the report to the responsible personnel for determination of the qualification and
acceptability, in accordance with Clause 5.2.4;
r) include the qualified subsupplier in the active approved supplier list; and
s) include the audit plans, audit reports, written replies, and the evidence of completion of corrective
actions in the audit records, and maintain the audit records in accordance with Clause 5.5.14.
Note: CAN/CSA-ISO 19011, or equivalent, can assist in satisfying these requirements.
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 result 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 suppliers 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 for high-volume services designed to commercial
technical 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. Failure could result in
some business risk, or risk to safety, or both.
A.3 Selecting the appropriate category

A.3.1 General
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.
A.3.2 Responsibility for selection

Obtaining the basic information 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 quality 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 process
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 quality 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 maturity of the design; the complexity of the item and
of the production processes; and the business and safety consequences 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, item 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, tolerances, testing, operating environment, etc.) in the design or technical documentation.
Selecting the category does not replace the need to identify the required inspection, testing, and special
process requirements applicable to the item or service. It will only provide the means by which 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 the Category 4,
no QA program needs to be specified.
A.3.5 Quality assurance requirements

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 parameters, 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 the 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, storage, and/or handling;
h) the end use of the item and service; and
i) the potential for CFSIs 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, all available tools or inputs should
be considered, such as safety classification, code classification, results of safety analysis, and
documented engineering judgement.
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 desired
quality assurance. Qualitative 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
flowchart 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 this Annex should become thoroughly familiar with the contents of all categories.
1. Are there distinct pro perties o r attributes (quality o f the item or service) that can be described and measured to determine conformance
to specified requirements adequately identified in the technical specification/ description?
Return to authorized technical

YES NO
personnel/ requisitioner
2. Is the need for a QA program indicated by evaluation of the following factors:

(a) Business risk: Could failure of the item or service to meet its specified requirements have business impact?
(b) Safety: Could failure of the item or service to meet its specified requirements impact safety?
If both answers are NO,
If (a) or (b) 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 testing equipm ent?
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, o r suspect item s?
14. Provide quality 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 to 3 to 17 is YES, managem ent If answers 3 to 17 are all NO,
shall establish a QA program. Is it necessary to: no QA program required
18. Provide for a training and qualification program?

19. Produce a QA manual and descriptio ns?
20. Control design change verification activities that are not first of a kind, with 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 o f these item s will have minimal impact o n the safe o peratio n of the system/ component or business risk?
22. Implement and maintain inspection and test planning documents?
23. Provide for traceability?
24. Plan the pro duction?
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, If answers 18 to 27 are all NO,
is it necessary to: Specify Category 4
28. Produce QA program procedures?

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 who se application has limited safety impacts?
30. Perform nonconformance trend, cause and analysis activities?
31. Perform internal audits?

is it necessary to: Specify Category 3
32. Develop new designs, contro l conceptual design and design dev elopment, design change, and verification activities for first of a kind or
complex items that require significant design effort and whose application has significant safety impact?
33. Develop preventive measures to preclude po tential no nconformances?
34. Implement corrective actions for potential nonconformances?

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 failure. 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 electrical, 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 failures, 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 (0 to 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 Clause 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 risk 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 minimal 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 with minimal design changes or controls are required 1
Proven design for same application where significant design changes or controls are required 2
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
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
(Continued)
Table A.1 (Concluded)
Evaluation factor Value

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 significant number of critical and interrelated characteristics 3
Item or service has a large number of critical and interrelated characteristics 4
Business risk
Results in negligible business impact 0
Downgrades the operation of facilities to a limited extent and results in limited business impact 1
Significantly downgrades the operation of facilities and results in serious business impact 2
Seriously downgrades the operation of facilities 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 should 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 descriptions
Note: This Annex is not a mandatory part of this Standard.
B.1 General
QA program descriptions should be included or outlined in the QA manual in sufficient detail to cover
the control of the various applicable processes being performed; these descriptions also cover
processes for items and services procured from suppliers (design services, non-destructive examination
services, manufacturing of a component or a sub-assembly, etc.).
If the contract includes any requirement for configuration 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 descriptions.
Category 3 recognizes two categories of descriptions that control the QA program and work: QA
program descriptions (these refer to descriptions which are managerial in nature) and technical
descriptions.
B.2 QA program descriptions

B.2.1 Documentation
In Category 3, each QA program element should be documented in a description. QA program
descriptions should
a) state the scope and purpose of descriptions;
b) detail how to perform and control the QA program elements within the scope of the management
policies;
c) establish what needs to be done and by whom, and when it will be done;
d) include methods needed to plan, schedule, carry out, and complete required actions;
e) define (as applicable) what materials, equipment, documentation, and forms to use; and
f) be treated as a directive to staff, i.e., as a statement of the way in which management wants the
QA program carried out.
B.2.2 Example of applying the QA program description to special processes

The QA program description pertaining to special processes should define
a) who is responsible for preparing and maintaining process descriptions and process-monitoring
descriptions;
b) how the equipment is qualified, maintained, and controlled;
c) how processes are qualified for use in production;
d) how materials used are controlled;
e) what qualifications personnel who perform the process require [e.g., Canadian General Standards
Board (CGSB), American Society of Mechanical Engineers (ASME), Society for Nondestructive
Testing (SNT)], or internal training and testing;
f) who is responsible for coordinating training and qualification of personnel; and
g) the forms to be used and what records are kept.
B.3 Technical descriptions

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

a) Special process descriptions: These can be
i) descriptions for monitoring special processes, which define
1) who will monitor each special process, e.g., an independent analyst, inspector, or
specialist;
2) when processes will be monitored, e.g., frequency, checks per operator;
3) how processes will be monitored;
4) what will be monitored, e.g., a checklist covering such things as availability of correct
description, description being followed, calibrated equipment, correct settings,
acceptable personnel qualifications, right sequence, proper times; and
5) where and what monitoring records are kept; and
ii) special process descriptions 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) Inspection and test descriptions: 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 materials, equipment, documentation, forms, and statistical techniques are to be used.
c) Production descriptions: 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 descriptions: These describe the specific service being provided by the supplier; for
example, project management, construction management, design services, commissioning support,
quality oversight services, nuclear safety analyses/assessments, etc.
Annex C (informative)
Guidance on design
Note: Annex is not a mandatory part of this Standard.
C.1 Design
C.1.1 General
This Clause 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 5.5.15 on nonconformances in Category 3 might require involvement of the design function in
the disposition of nonconformances. Any involvement that is performed by a design function working to
Category 3 requires quality records to be generated and maintained in accordance with Clause 5.5.14.
For example, if manufacturing drawings are approved by an engineering department, records of that
approval are required to be retained by the supplier as part of its quality records.
C.1.2 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 necessary to complete the work within
the required time.
b) 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, environmental, 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 technical 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 verifications and reviews should be performed.
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 feasibility 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 technical interface data for various design activities and
design disciplines.
c) Design outputs: Outputs of the detailed design are the final technical documents used for
production or procurement, and inspection and testing. Final review of design outputs should
ensure that
i) they are traceable to design inputs and contain or reference all applicable criteria;
ii) they define, without ambiguity, the quality aspects of the item or the service;
iii) they contain acceptance criteria for the item or service; and
iv) all of the above-mentioned design documents are prepared, approved, issued, changed when
required, and controlled in accordance with Clause 5.5.3 on documentation.
Although personnel assigned to verification 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
errors are working 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 should be audited, and corrective action
should be taken when a nonconformance is found.
C.1.3 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 should 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
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 achieve
these objectives and to demonstrate with objective evidence the validity of measurements, suppliers
should 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 verified periodically to see that they are in good working
order and not worn. However, precision devices such as Pi Tape® are calibrated.
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 quality. 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
equipment;
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 protective chromate conversion film (iridite) on
aluminum and its alloys;
iii) welding equipment; and
iv) heat treating equipment;
i) electronic and electrical 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-measuring devices;
k) laboratory sample preparation and test equipment gauges; and
l) 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 to maintain a copy of the calibration procedure used by
subsuppliers, but the procedure should be identified and available for review by customers. Suppliers
should also perform surveys and audits to ensure that a subsupplier’s system for calibration conforms
to specified requirements (e.g., ISO/IEC 17025 and CAN/CSA-ISO 10012).
D.5 Calibration procedures

The QA program manual should reference calibration procedures. These should define
a) equipment descriptions;
b) identification numbers;
c) location (including environmental 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
procedure should be clearly defined by exact reference to the applicable sections.
Where calibration methods are defined by equipment manufacturers, such instructions may be
referenced as part of the calibration procedures. Calibrations are performed by comparing equipment
being calibrated with instruments or physical standards of authenticated accuracy.
D.6 Calibration environment

Environments for all measurement during calibration and inspection and test should be controlled to
the extent necessary to ensure continued measurements of required accuracy, due consideration being
given to temperature, humidity, vibration, cleanliness, and other factors affecting measurement.
Compensating corrections should be applied to calibration results obtained when the calibration
environment departs from standard conditions.
D.7 Calibration frequency

Periodic intervals should be established for calibrations based on equipment stability, purpose, and
degree of usage. Records should be kept of the as-found and as-left calibration findings for the
instruments, and the deviations and current interval between calibrations. 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 utilizing
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 should 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 recognized 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 3 or the subsupplier has been recognized by an accredited business
responsible for qualifying calibration facilities.
D.9 Calibration records

Category 3 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
should 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 calibration 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)
Guidance on safety culture
E.1 General
The requirements in Clause 4.7 are designed to support the fostering of a healthy safety culture
throughout a business. A healthy safety culture is a foundation that supports the continuing success of a
QA program. A successful QA program consists of a sound structure of documented processes coupled
with how workers implement these processes to achieve the business’s objectives. Worker attitudes
and behaviours drive the implementation of the QA program, and therefore it is important for the
business to have measures in place to foster a healthy safety culture. Essential aspects such as
commitment, self-reflection, and freedom to express ideas should be demonstrated by all workers. The
business should be focused on maintaining a questioning attitude to prevent mistakes, ensuring that
safety requirements are met, and facilitating continual improvement to the QA program.
E.2 Reference documents on safety culture

The following documents can be referenced for additional guidance on safety culture:
a) CNSC DIS-12-07;
b) IAEA INSAG-15;
c) IAEA Safety Guide No. GS-G-3.5; and
d) IAEA TECDOC-1329.

CSA N299.3-16 - QA Program Requirements For The Supply of Items and Services For Nuclear Power Plants Cat 3

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®A trademar k of the Canadian S tandards Association, operating as “CSA Group”

Published in September 2016 by CSA Group

© 2016 CSA Group

September 2016 © 2016 CSA Group 1

Annex A (normative) — Category selection 43

September 2016 © 2016 CSA Group 2

Technical Committee on Management

R.K. Black TransCanada, Vice-Chair

J. Brown GE-Hitachi Nuclear Energy Canada Inc., Vice-Chair

R.W. Barnes ANRIC Enterprises Inc.,

K.D. Cassells AECON Energy,

E. Clavel Clavel Quality Consulting,

D. Constantinescu Bruce Power, Associate

A. Coulas Canadian Nuclear Laboratories Limited (CNL),

D. Davis Bruce Power,

September 2016 © 2016 CSA Group 3

C.F. Harris NB Power Corporation,

S.D. Harris Ontario Power Generation,

K. Heppell-Masys Canadian Nuclear Safety Commission (CNSC), Associate

C. Ingalls Cameco Corporation Fuel Services Division,

B. Johnston McMaster University,

P. Jones TRIUMF, Associate

G. Kozak Bruce Power, Associate

J. Krane Stuart Olson,

P. Lahaie Canadian Nuclear Safety Commission (CNSC),

V. Raees Technical Standards and Safety Authority,

P. Schultz Canadian Nuclear Safety Commission (CNSC), Associate

C. Sellers Campbellcroft, Ontario Associate

J.R. Walker Vienna, Austria Associate

September 2016 © 2016 CSA Group 4

P. Young Scarborough, Ontario

M. Khan CSA Group, Project Manager

September 2016 © 2016 CSA Group 5

Subcommittee on Quality Assurance

N. Boraso Hatch Limited,

J. Brown GE-Hitachi Nuclear Energy Canada Inc.,

E. Clavel Clavel Quality Consulting,

A. Coulas Canadian Nuclear Laboratories Limited (CNL),

S.D. Harris Ontario Power Generation,

J. Lopez Bruce Power LP,

T. Mason Black & McDonald Ltd.,

M. Pletosu Ontario Power Generation Inc.,

K. Richardson Cambridge, Ontario

D. Sperling Burlington, Ontario

A. Wagland WAG QA Services Canada Inc.,

September 2016 © 2016 CSA Group 6

G.B. Waterhouse GBW Technical Services,

P. Wong Canadian Nuclear Safety Commission (CNSC),

M. Khan CSA Group, Project Manager

September 2016 © 2016 CSA Group 7

September 2016 © 2016 CSA Group 8

c) wording of the proposed change;

September 2016 © 2016 CSA Group 9

0.2 Category series

September 2016 © 2016 CSA Group 10

QA program QA program QA program QA program

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