Joint KINS-IAEA Basic Professional Training Course on

Nuclear Safety, 15 to 26 Oct. 2018, Daejeon, Korea

Nuclear Quality Assurance

Oct. 2018

Jae Hun LEE

Korea Institute of Nuclear Safety

 Contents

I. Outline of Nuclear Quality Assurance

II. Regulatory Requirements on QA

III.QA Regulation in Korea

IV.QA Inspection Criteria

V. Concluding Remarks

2
I. Outline of Nuclear Quality Assurance (QA)
• Quality
• Overall feature and characteristics of the products and services related to the
capability to comply with the specified requirements
• Appropriateness of application (consumer's viewpoint)
• Conformity to the requirements or specifications (manufacturer's viewpoint)
• Nuclear QA
• Nuclear QA is the control system to satisfy the requirements necessary for
design, manufacturing, construction, operation and maintenance of NPP
• To achieve the safety and reliability of NPP
• Definition of Nuclear QA
• All those planned and systematic actions necessary to provide adequate confidence
that a structure, system, or component (SSC) will perform satisfactorily in service.
(USNRC 10 CFR 50 Appendix B, KEPIC QAP)

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I. Outline of Nuclear Quality Assurance (QA)
Comparison of the Quality Characteristics (Table 1)
Non-nuclear Industry Nuclear Industry

Characteristics of Items Light, Thin, Short, Small Heavy, Thick, Long, Bulky

Mass-production of various
Method of Fabrication Sole Items Small Quantity
Items
Duration of
By Hour Basis By Month/Year Basis
Production
Quality Verification Verified by manufacturer Verified by Third Party personnel
Methods of Quality
Product Quality Product Quality with Quality Records
Verification

Purpose of quality
Customer Satisfaction Safety & Reliability
Activity
Qualification Personnel, Equipment, Procedures,
None
Requirements Processes
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I. Outline of Nuclear Quality Assurance (QA)

• Characteristics of Nuclear QA
• Management Aspects
• Quality system and program shall be established in advance.
• Qualification required (personnel, process, procedures & equipment, etc.)
• Technical Aspects
• Regulatory, technical & contractual requirements are applied (design, purchase,
process, inspection and test, etc.)
• Involvement of regulatory body and third party inspection agency

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II. Regulatory Requirements on QA

• Nuclear Regulation
• Purpose
To prevent radiation disasters for the sake of public safety by
setting forth matters concerning safety management for research,
development, production, and use of nuclear energy.

• How safe is safe enough?

• Nuclear safety is not a matter of one country but an international
one.
• Internationally acceptable level of requirements within the
global nuclear safety regime. (Common rules based on state of
the art)
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II. Regulatory Requirements on QA
• Fig.1 Global Nuclear Safety Regime
International Conventions

International International
IAEA
Safety OECD/NEA Joint Research
Standards & Safety Reviews

National Nuclear Safety Infrastructure

Regulation Research/Education Operation
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II. Regulatory Requirements on QA

• Convention on Nuclear Safety (CNS)

• Objectives :
To establish and maintain effective defenses in nuclear installations
against potential radiological hazards in order to protect individuals,
society and the environment.

• General Safety Consideration :

Priority to safety, human factors, QA, assessment & verification of safety,
radiation protection, emergency preparedness.

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II. Regulatory Requirements on QA
• Table 1. Defense in Depth (from INSAG-3, TECDOC-986)
Objective
I Prevention of abnormal operation
and failure
II Control of abnormal operation and
detection of failure
III Control of accidents within the
design basis
IV Control of severe plant conditions
and mitigation of the consequences
of severe accident
V Mitigation of consequences of
releases of radioactive materials
Essential Means
Conservative design and high quality
in construction and operation
Control, limiting and protection
systems and other surveillance
feature
Engineering safety feature and EOP
Complementary measures and SAMP
Off-site emergency drill
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II. Regulatory Requirements on QA
• History of QA Standard
• 1963, US Department of Defense : MIL-Q-9858A, Military
Specification –Quality Program Requirements
• 1968, NATO : AQZP-1, Quality System Requirements
• 1970, US NRC : 10CFR 50 App. B (18 Criteria)
• 1975, IAEA : 50-C-QA
• 1983, ASME committee : ANSI/ASME NQA-1(1983)
• 2000, ISO : ISO-9001
• 2001, Korean Government : Regulations on Technical Standards
for Nuclear Reactor Facilities, Etc., Sec. 4, QA Requirements
• 2001, KEPIC : KEPIC/QAP was endorsed as QA Standard
• 2006, IAEA : GS-R-3, Management System
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II. Regulatory Requirements on QA
• Korean Legal System and IAEA Safety Standards

IAEA Korea U.S.A.

Safety Fundamentals Nuclear Safety Act (NSA) AEA, Policy Statements

Enforcement Decree and

Safety Requirements Enforcement Regulation 10 CFR 50
of the NSA

Regulatory Guides of the

Safety Guides, TECDOC KINS Regulatory Guides
USNRC

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II. Regulatory Requirements on QA
• Legal Basis on QA
Article 11/21 : Standards for CP & OL
4. The contents of a QA program shall
NSA conform to the standards as prescribed
by the regulation of NSSC.

Enforcement Enforcement Decree, Article 31 :

Decree & QA Inspection
Regulation of Regulation on Technical Standards for
NSSC Nuclear Reactor Facilities Etc., Article
67~85 (18 Criteria of QA)

Notice of Reactor.26(2016-13), Detail

NSSC Requirements for QA of Nuclear Reactor
Facilities (KEPIC/QAP)
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II. Regulatory Requirements on QA
• Legal Basis on QA (continued)
Nuclear
□ Notice of NSSC, Reactor.26 Safety Act

 For construction* : KEPIC/QAP (‘00 to Enforcement

Decree of the Act
‘11 Ed.) or ASME/NQA-1 (1994 to 2009
Ed.) were endorsed as detailed
requirements. Enforcement Regulation of
the Act :Technical Standards
 For operation : KEPIC/QAP
(ASME/NQA-1) + ANSI/ANS 3.2 (1994 Notices of NSSC
to 2009 Ed.)
Regulatory Standards
□ Application of other Code & Standards Regulatory Guides
Safety Review & Inspection Guides
 The addition and limitation of other
codes and standards are given in KINS
Industrial Codes and Standards
Regulatory Standards and Guides. (ASME, IEEE, ACI, KEPIC, etc.)
* Construction includes design, manufacturing
and assembling of the components 13
II. Regulatory Requirements on QA
• Regulatory Requirements
• Procedural Requirements
• Authorization Process with Standards for Permit including QA Program
• QA Inspection and Enforcement Policy

• Technical Requirements*
• QA Criteria regarding Construction and Operation of NPP
• Design Criteria regarding Location, SSC, Installation, and Performance of NPP

* Regulation on Technical Standards for Nuclear Reactor Facilities Etc.

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II. Regulatory Requirements on QA
• 18 Criteria of QA in Korea
1. Organization
2. QA program
3. Design Control
4. Procurement Document Control
5. Instructions, procedures and drawings
10. Inspection
11. Test control
12. Control of measuring and test
equipment
13. Handling, storage and shipping
14. Inspection, test and operation status

6. Document control 15. Control of non-conforming items

7. Control of purchased items and services 16. Corrective action

8. Identification of control of items 17. QA records

9. Control of special processes 18. Audit
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II. Regulatory Requirements on QA
• GS-R-3 Requirements
Section Title Contents
Section 1 Introduction Background, Objective, Scope, Structure

Section 2 Management System (MS) General Requirement, Safety Culture, Grading

Application, Documentation
Section 3 Management Responsibility Management Commitment, Satisfaction of interested
Parties, Organizational Policies, Planning,
Responsibility and Authority
Section 4 Resource Management Provision of Resources, Human Resources,
Infrastructure and working Environment
Section 5 Process Implementation Developing Process, Process Management, Generic
MS process
Section 6 Measurement, Assessment, Monitoring & Measurement, Self & Independent
Improvement Assessment, MS Review, Non-conformances &
corrective & preventive actions, Improvement
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III. QA Regulation in Korea
• Safety Assessment on QA Program

• Purposes
• To confirm the contents of QA Program satisfies the requirements in the
standards for permit or license and KEPIC/QAP
• To review the change of QA Program especially organization

• Objects
• NPP : 25 units in operation, 4 units under construction and 1 unit under
preparation for decommissioning
• Research Reactor : I in operation 1 under construction
• Fuel cycle facilities : 1 KNF and 1 Rad-waste storage facility
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III. QA Regulation in Korea
• QA Inspection

• Purposes
• To verify that QA program of objects are complying with applicable industry codes,
standards, and reg. requirements.
• To verify effective implementation of QA program.
• To verify identification of root cause of problems such as non-conformances, and
adequacy of corrective actions.
• To verify feed-back of problems arose in previous audits and/or inspections,
reflection of design modifications and results of those modifications.

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III. QA Regulation in Korea
• QA Inspection

• Objects
• Reactor Licensee : Perform construction & operation of NPP, procurement and/or
control activities of vendors (KHNP HQ, Site, Changwon, NY, and Paris Office)
• Designer : Supplies design service (KEPCO E&C)
• Manufacturers : Manufactures and supplies major components to reactor licensee
(Doosan, KNF)
• Vendors : Supplies components, or service to reactor licensee or manufacturer
(Samshin, Weir, Target Rock, Andritz, etc.)

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III. QA Regulation in Korea
• Regulatory Inspection

Category Construction Operation Type

QA Inspection

Planned Pre-operational Periodic Regular and

Inspection Inspection Inspection Announced
Inspection
Vendor Inspection
(QA/SAR)

Daily Inspection
(Site Office) Irregular and
Reactive Unannounced
Inspection
Special Inspection

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III. QA Regulation in Korea
• Nuclear Power Plant

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IV. QA Inspection Criteria
□ Organization (Criterion 1)
• Division of responsibility (DOR) of organizations

- Performing activities affecting quality (QAO) :

Siting / designing, purchasing, fabricating, handling, shipping / receiving, storing,

cleaning, erecting, installing, inspecting, testing / operating, maintaining, repairing,
refueling, modifying / and decommissioning

- Quality verification activities (QVO) : QA,QS, etc.

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IV. QA Inspection Criteria
□ Organization (Criterion 1 : Continued)
• Organizational freedom of QVO from cost and schedule

- to identify quality problems

- to initiate, recommend, or provide solutions

• Direct access to responsible levels of management

• Delegation of work to AE, NSSS, T/G, Nuclear Fuel, Construction, etc.

• Interface control

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IV. QA Inspection Criteria
Quality Regulation
□ QA Program (Criterion 2)
• Identification of SSC and activities to an extent consistent with their
importance to safety

• Establishment and implementation of documented QA program such as

procedures and instructions

• Control over Activities:

- Appropriate equipment

- Suitable environmental condition

- Prerequisites for the performance of activities

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IV. QA Inspection Criteria
Quality Regulation
□ QA Program (Criterion 2 : Continued)
• Regular assessment of QA program adequacy and/or effectiveness
• Education, training and personal qualification to assure that suitable proficiency
is achieved and maintained with records
- Inspection & test personnel
- NDE personnel
- Auditor and lead auditor
- Personnel education and training

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IV. QA Inspection Criteria

Fig. QA Program
Regulation 26
IV. QA Inspection Criteria
 QA Program (continued))
□ Appendices
• Appendix 1
- Organization Diagram (Headquarters)
- Personal Responsibility (Headquarters)
• Appendix 1-1
- Organization Diagram (Site Office)
- Personal Responsibility (Site Office)
• Appendix 2
- Application of Quality Class
• Appendix 3
- Terms and Definitions
27
IV. QA Inspection Criteria
Quality Regulation
 Quality Class of SSC in Korean Industry

- Q Class : Safety Related Items such as RCS(RCP, SG, Prz), ECCS, SCS, CVCS,
etc.
- AQ Class : Safety Impact Items such as Spent fuel handling facility, T/G, Trans
former, Condenser, etc.
- S Class : Industrial Standard Items

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IV. QA Inspection Criteria
□ Design Control (Criterion 3)
• Design plan to define & control the design of SSC
- DOR of design process : AE, SD and CD
- Expected output : design report, specification, drawing, etc.

• Design input to assure the translation of applicable regulatory requirements and the design
bases
- Identified, reviewed and approved

• Verification of design adequacy

- Design review, alternate calculation and qualification test

• Internal and external interface control

• Change control

• Software control
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IV. QA Inspection Criteria
 Design Plan

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IV. QA Inspection Criteria
 Design Verification Checklist

31
IV. QA Inspection Criteria
Quality Regulation
□ Procurement Document Control (Criterion 4)

• Preparation of procurement document

- Technical specification

- QA requirement

• Procurement document review

• Subsequent change procedure

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IV. QA Inspection Criteria
Quality Regulation
 Procurement Documents

QA Program
Requirements

Technical Requirements Document

(Dwg., Specification, Procurement Document (Records retention,
Test, Inspection & disposition)
Acceptance Criteria)

Others
(Right of Access
Inspection, Audit)

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IV. QA Inspection Criteria
Quality Regulation
□ Instructions, Procedures, and Drawings (Criterion 5)
• Organizational responsibility performing activities

• Acceptance criteria

• Change control

□ Document Control (Criterion 6)

• Documents to be controlled

• Preparation, review, approval, and release

• Change control
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IV. QA Inspection Criteria
Quality Regulation
□ Control of Purchased Items and Services (Criterion 7)
• Procurement planning

• Source evaluation and selection

- AVL (Authorized Vendor List)

• Verification of contractor QA program implementation

- Source inspection and audit

• Acceptance of items and services : Receiving inspection

35
IV. QA Inspection Criteria
Quality Regulation
□ Control of Purchased Items and Services (Criterion 7)
• Control of contractor’s non-conformances
• Control of submitted documents : Certificate of Conformance
(C of C)
• Commercial grade items (CGI)
- Identified in an approved design output document with critical
characteristics and acceptance criteria
- Identified in the purchase order
- Acceptance of CGI, combination of the following shall be utilized:
 specific testing, inspection or analysis
 survey for the Supplier's CGI
 source verification
 performance record of supplier/item
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IV. QA Inspection Criteria
Quality Regulation
□ Identification and Control of Items (Criterion 8)
• Identification methods
- Transfer when divided
• Control and verification of assembly
• Documentation

□ Process Control (Criterion 9)

• Special processes
• Approved and/or qualified work procedure
• Personnel qualification
• Process control by traveler, Quality Plan, etc.
37
IV. QAManufacture QA
Inspection CriterInspection
ia General

 Application of Special Process

Welding, NDE

Manufacturing Pre-operational
Inspection Maintenance

Assembling Periodic
& Erection Inspection Replacement

Construction Operation

38
IV. QAManufacture QA
Inspection CriterInspection
ia General
 Manufacturing & Construction Process

Design Specification

Procurement Doc. PWHT

Process Control Doc.

NDE
Materials Welding Prep.

Machining, Forming
Pressure Test

Data Reports

Welding

39
IV. QAManufacture QA
Inspection CriterInspection
ia General
 Manufacturing Process of Reactor Pressure Vessel

CLOSURE HEAD
DOME

CLOSURE HEAD CLOSURE HEAD CEDM NOZZLE

FLANGE INSTALLATION CLOSURE HEAD
ASSEMBLY

UPPER SHELL

UPPER VESSEL NOZZLE

INTERMEDIATE
SHELL INSTALLATION

RV FINAL
LOWER SHELL ASSEMBLY

VESSEL
ASSEMBLY
BOTTOM HEAD LOWER VESSEL
INSTRUMENT NOZZLE
INSTALLATION 40
Manufacture QA Inspection
V. QA Inspection General
Criteria
 General Manufacturing Process

41
IV. QA Inspection Criteria
Quality Regulation
□ Inspection (Criterion 10)
• Inspection Planning (Inspection and Test Plan : ITP)
- Hold points and witness points
• Inspection procedures & Inspector qualification
• In-process inspection and final inspection
• Inspection records

□ Test Control (Criterion 11)

• Test Planning (ITP)
• Procedures with requirements and methodology
• Evaluation of test result by authorized personnel
• Data analyses & test records
• Computer program testing
42
IV. QA Inspection Criteria
Quality Regulation
Inspection & Test Plan (ITP)

43
IV. QA Inspection Criteria
Quality Regulation
□ Control of Measuring and Test Equipment (Criterion 12)
• Identification of M&TE to be controlled
• Calibration program and records

□ Handling, Storage and Shipping (Criterion 13)

• Control Procedures for handling, storage, shipping, cleaning and preservation to
prevent damage or deterioration.
• Special equipment for handling
• Storage condition such as temp., humidity, test, etc.

□ Inspection, Test, and Operation Status (Criterion 14)

• Indication of status
• Authority for indication
44
IV. QA Inspection Criteria
Quality Regulation
 Transportation of RV

45
IV. QA Inspection Criteria
Quality Regulation
 Installation of RV

46
IV. QA Inspection Criteria
Quality Regulation
□ Control of Nonconforming Items (Criterion 15)
• Prevention of inadvertent installation or use
• Identification of nonconformance (Non-conformance Report : NCR)
• Documentation and notification
• Segregation
• Evaluation and disposition
- Technical justification of use-as-as and repair
• Records

47
IV. QA Inspection Criteria
Quality Regulation
□ Corrective Action (Criterion 16)
• Condition adverse to quality shall be identified promptly and corrected as soon as
practical to preclude recurrence.
• Significant conditions adverse to quality shall be reported to the regulatory body
• Documentation of cause analysis and corrective action (Corrective Action Report :
CAR)
• Follow-up action
• Trend analysis on a regular basis

48
IV. QA Inspection Criteria
Quality Regulation
□ QA Records (Criterion 17)
• Scope and classification of QA records
• Receipt control
• Retrieve-ability
• Storage, preservation and safekeeping

□ Audits (Criterion 18)

• Audit planning to verify the effectiveness of the QA Program
• Performing with written procedure or check list
• Trained personnel staffing, conducting and reporting
• Follow-up action
• Records
49
V. Concluding Remarks

• Safety in the operation of facilities and the use of radiation sources is of great
importance. The purpose of QA regulation is to secure safety and reliability of nuclear
system and to protect public and environment.

• Only strengthening of quality inspection does not provide an adequate confidence of

the quality, a preventive and programmatic QA system is needed.

• Regulatory Authority shall set up the rules and regulations related to QA system for
the nuclear industry.

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Always we keep watching
our Atomic Power

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