CSA N299.3:19

Quality assurance program requirements for the supply of items and services for nuclear power plants, Category 3

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  CSA N299.3:19

  December 2019

  
  

  Title: Quality assurance program requirements for the supply of items and services for nuclear power plants, Category 3

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CSA N299.3:19

Quality assurance program requirements for the supply of items and services for nuclear power plants, Category 3

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CSA N299.3:19

Quality assurance program requirements for the supply of items and services for nuclear power plants, Category 3

Contents

Technical Committee on Management Systems for Nuclear Facilities 4

Subcommittee on Quality Assurance Program Requirements for Supply of Items and Services for Nuclear Power Plants 6

Preface 8

0 Introduction 9

1. Background 9

2. Category series 9

1. Scope 12

   
   

2. Reference publications 13

   
   

3. Definitions 15

   
   

4. General requirements 19

   1. General 19

   2. Customer’s responsibilities 20

   3. Management responsibilities 20

      1. Top management 20

      2. Management representative 21

   4. Independent verification 21

   5. Software 21

      1. Software employed in work methods or tools 21

      2. Embedded software 21

      3. Design analysis software 21

   6. Safety culture 22

   7. Use of experience 22

   8. Counterfeit, fraudulent, and suspect items (CFSIs) 22

      
      

5. QA manual 23

   1. General 23

   2. QA manual contents 23

      
      

6. QA program descriptions 23

   
   

7. QA program elements 24

   1. Management review 24

   2. Indoctrination, training, and qualification 24

      1. Indoctrination 24

      2. Training 24

      3. Qualification 24

   3. Tender and contract review 25

      1. Review of tendering requirements 25

      2. Review of contractual requirements 25

         
         

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         CSA N299.3:19

         Quality assurance program requirements for the supply of items and services for nuclear power plants, Category 3

         
         

   4. Design 25

      1. Application 26

      2. Design planning 26

      3. Work assignment 26

      4. Interfaces 26

      5. Design inputs 26

      6. Preliminary design 26

      7. Design analysis software 26

      8. Detailed design 26

      9. Design output 26

      10. Design verification 26

      11. Design changes 27

   5. Documentation 27

   6. Procurement 28

      1. Selection 28

      2. Use of customer’s approved suppliers 29

      3. Subcontract requirements 29

      4. Reviews 30

      5. Inspection, surveillance, and audit of subsuppliers 30

      6. Amendments to subcontracts 30

   7. Verification planning 30

   8. Verification activities 32

   9. Verification status 33

      1. Verification status for items 33

      2. Verification status for services 33

   10. Measuring and testing equipment (M&TE) 34

   11. Identification and traceability 35

       1. Identification 35

       2. Traceability 35

   12. Handling and storage 35

   13. Production 35

       1. Planning 35

       2. Process descriptions 36

       3. Process verification 36

       4. Work control 36

   14. Special processes 36

   15. Packaging and shipping 36

   16. Records 37

       1. General requirements 37

       2. Generation of records 37

       3. Authentication of records 37

       4. Maintenance and storage of records 37

       5. Record retention periods 38

   17. Nonconformances 38

       1. General nonconformance requirements 38

       2. Specific nonconformance requirements for items and services 39

   18. Corrective action 39

   19. Customer-supplied items and services 40

   20. Statistical techniques 40

       
       

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       CSA N299.3:19

       Quality assurance program requirements for the supply of items and services for nuclear power plants, Category 3

       
       

       7.21	Quality audits 40
       7.21.1	Internal quality audits	40
       7.21.2	External quality audits	41

8. CSA N299 dedication requirements 41

   1. Application 42

   2. Dedication eligibility 43

   3. Planning 43

   4. Work assignment 43

   5. Identification and maintaining traceability 43

   6. Design evaluation 43

   7. Acceptance 44

      1. Acceptance criteria and control areas 44

      2. Control Area 1: QA program augmentation 45

      3. Control Area 2: Verification activities 45

      4. Control Area 3: Supplier performance 47

   8. Conduct acceptance activities 47

   9. Dedication outputs 48

   10. Dedication changes 48

Annex A (normative) — Category selection 49

Annex B (informative) — Guidance on QA program descriptions 58

Annex C (informative) — Guidance on design 61

Annex D (informative) — Guidance on measuring and test equipment 63 Annex E (informative) — Counterfeit, fraudulent, and suspect items (CFSIs) 66 Annex F (informative) — Risk evaluation 68

Annex G (informative) — Records 69

December 2019 © 2019 Canadian Standards Association 3

CSA N299.3:19

Quality assurance program requirements for the supply of items and services for nuclear power plants, Category 3

Preface

This is the second edition of CSA N299.3, Quality assurance program requirements for the supply of items and services for nuclear power plants, Category 3. It supersedes the previous edition published in 2016.

The CSA N299 series of Standards defines quality assurance program requirements for the provision of items and services for nuclear power plants when specified in the contract between the customer and the supplier.

The most significant updates to this edition include

1. the addition of requirements on dedication in Clause 8;

2. the revision of Annex E to provide guidance on counterfeit, fraudulent, and suspect items (CFSIs);

3. the addition of Annex F to provide guidance on risk evaluation; and

4. the addition of Annex G to provide guidance on records.

   This Standard has also been restructured and reordered for better readability.

   Users of this Standard are reminded that civilian nuclear facilities in Canada are subject to the provisions of the Nuclear Safety and Control Act and its Regulations.

   
   

   This Standard was 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.

   4. To submit a request for interpretation of this Standard, please send the following information to inquiries@csagroup.org and include “Request for interpretation” in the subject line:

      1. define the problem, making reference to the specific clause, and, where appropriate, include an illustrative sketch;

      2. provide an explanation of circumstances surrounding the actual field condition; and

      3. where possible, phrase the request in such a way that a specific “yes” or “no” answer will address the issue.

         Committee interpretations are processed in accordance with the CSA Directives and guidelines governing standardization and are available on the Current Standards Activities page at standardsactivities.csa.ca.

   5. This Standard is subject to review within five years from the date of publication. Suggestions for its improvement will be referred to the appropriate committee. To submit a proposal for change, please send the following information to inquiries@csagroup.org and include “Proposal for change” in the subject line:

      1. Standard designation (number);

      2. relevant clause, table, and/or figure number;

      3. wording of the proposed change; and

      4. rationale for the change.

December 2019 © 2019 Canadian Standards Association 8

CSA N299.3:19

Quality assurance program requirements for the supply of items and services for nuclear power plants, Category 3

CSA N299.3:19

Quality assurance program requirements for the supply of items and services for nuclear power plants, Category 3

0 Introduction

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 CANDU Owners Group (COG) project, a set of graded standards that align with the withdrawn CSA Z299 series so that the impact to the design basis and content transition to the new standards is minimized. These graded standards were used as the seed documents for the new

   CSA N299 series of Standards, which incorporates operating experience and current best practices and harmonizes, to the extent possible, with other standards (both national and international).

   
   

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’s need for a quality assurance standard for items and services supplied to nuclear power plants.

December 2019 © 2019 Canadian Standards Association 9