Nuclear Quality Standard Association

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General information about Quality Management System in the nuclear industry

A relevant answer to a changing context

New needs identified by:

Buyers

Nuclear authorities

Suppliers

INCREASING DEMAND for safety and quality

NEWCOMERSincluding countries with poor nuclear

culture

TECHNICAL SUPPORTdevelopment support for their local

economies

CUSTOMER EXPECTATIONS for quality of products, services and

lead time

���� Long-term trend

NSQ-100 Quality Standard for Nuclear Industry – Marc h 2016 - p.2

An improved approach of Suppliers

� Evaluation of the supplier and its supply chain

Assessing capability to execute in compliance with the requirements

� Requirements based on « standards »

Capacity to understand and cascade the requirements

� Control of product execution

Performance of proficient Inspection

Integration of a new standard

« NSQ-100 »

« Inspection » Performance

To better manage risks related to the construction of the nuclear power plant all along the supply chain

* NQSA Nuclear Quality Standard Association

*

NSQ-100 Quality Standard for Nuclear Industry – Marc h 2016 - p.3

NSQ-100 Presentation

� NQSA (Nuclear Quality Standard Association)

A non profit association of major nuclear industry actors created to :

� Promote the application of a robust quality standar d (NSQ-100)

� Provide a framework for further evolutions of the s tandard

� Set a “nuclear oriented” supplier evaluation proces s to further prepare a new certification scheme

� Qualify certification bodies & NSQ-100 Auditors

www.nqsa.org

From the NQSA website, download with free access:

•NSQ-100 (in English, French, Russian & Spanish)

•Procedures Qualification of CBs & Auditors

•The correspondence matrices with: GS-R-3 (IAEA), RD 0034 (RSA), RPP-1 (AFCEN), 10 CFR 50 Appendix B (USA) and KTA 1401 (GER)

•8 Guidelines

NSQ-100 Quality Standard for Nuclear Industry – Marc h 2016 - p.5

An already long-lasting story

NSQ-100 v0 GuidelinesCorrespondence

matricesBV Certification

qualified by NQSA

2011 2012 2013 2014

•GS-R-3 (IAEA)•RD-0034 (SA)•RPP1 (Fr)•10 CFR 50 (USA)•KTA 1401 (GER)

NSQ-100 Quality Standard for Nuclear Industry – Marc h 2016 - p.6

Our results

� NQSA is a dynamic association, with already 9 full members (industry leaders)

� NSQ-100 is becoming a well-known standard (thousand s of downloads worldwide: utilities, suppliers, regulato ry bodies…)

� A popular website

� Productive discussions with ISO: NSQ-100 is set to be the new nuclear standard for quality management system

� Take part in the redaction of the Guidelines (shari ng experience and best practices)

� Development of the certification process

NSQ-100 Quality Standard for Nuclear Industry – Marc h 2016 - p.7

The method used to develop NSQ -100

� Based upon ISO 9001:2008 structure : an industry co nsensus quality standard ensuring the integration of Nuclea r QA requirements in well-known industrial quality pract ices

� Key elements integration of two major nuclear refer ence codes and experience� IAEA GS-R-3:2006 � ASME NQA-1-2008 (18 criteria)� Experience feedback from recent constructions

� Development process inspired by the approach follow ed in other industries, mainly Aircraft Industry (EN 9100 Quality Management Systems / Requirements for Aviation, Space and Defense Org.)� Similar context: strong safety requirements, high q uality and industrial

expectations combined with a product/process and lo w production volume orientation

� Integration of specific requirements into a largely deployed standard

NSQ-100 Quality Standard for Nuclear Industry – Marc h 2016 - p.8

The NSQ-100 story

Project Specifications

Project Specifications

Project Specifications

ISO 9001

Project Specifications

Generic Project

Specifications

Project Specifications

Project Specifications

InternationalTrans projectOver the time

NSQ-100Standard

based onISO 9001:2008

structureand on

IAEA GS-R-3:2006

ASME NQA-1:2008 2009 addenda principles

CorrespondenceMatrix

Specific Request(local regulation)

Buyers, Safety Authorities

90%*

* 90% of generic specifications of a management sys tem certification for the nuclear industry is addressed by NSQ-100

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Before NSQ-100

Certification Process

Project Adaptation

Process

ISO 9001

NSQ-100 Quality Standard for Nuclear Industry – Marc h 2016 - p.9

The quality of the certificate is guaranteed by:

� NQSA Industry Members oversight: periodic surveilla nce and witnessing audits

� The Impartiality Committee oversight, of the comple te NQSA process

NQSACertification Committee

(Industry Members Only)

Qualification of Certification

Bodies

Audit Specification

Certificate issuance Process

Certification Bodies

Issuance of Certificate

SUPERVISION

Certification process

NSQ-100 Quality Standard for Nuclear Industry – Marc h 2016 - p.10

NSQ-100 standard:

� includes detailed requirements for quality manageme nt, applicable to a supplier of goods or services used in the construction and maintenance of a nuclear installat ion,

� is not intended to substitute for regulatory or con tractual requirements, but is designed to help to answer the m.

Reminder : position of NSQ-100 standard versus Regu lations

NSQ-100 in details …

NSQ-100 Quality Standard for Nuclear Industry – Marc h 2016 - p.11

NSQ-100 - Main Requirements

� In addition to ISO 9001, NSQ-100 requirements mainly focus on:�Quality Management Program

�Safety Culture

�Graded approach

�Independence of verification

�Competences management

�Language / Translation

�Project Management

�Supplier Assessment

�Procurement control

GRADED APPLICATION OF

QUALITY REQUIREMENTS

PRODUCT CLASSIFICATION

TIME MANAGEMENTRISK MANAGEMENT

INTERNATIONAL ENVIRONMENT

MANAGEMENT OF COMPETENCIES

CONTROL OF PRODUCTION

PROCESSES AND NON-CONFORMING

PRODUCT

INDEPENDENCE OF REVIEW AND

SURVEILLANCE

NUCLEAR INDUSTRIAL PRACTICES

RELATIONS WITH NUCLEAR SAFETY

AUTHORITIES

« SAFETY CULTURE »

NSQ-100 Quality Standard for Nuclear Industry – Marc h 2016 - p.12

Main orientations of the new standard NSQ -100

Project Quality

� Independence of review and surveillance activities

� Control of non conforming product and production processes

� Management of competencies – qualification of personnel

� Safety culture� Grading and cascading

application of quality requirements

� Classification of product

� Time management : planning and time schedule

� Risk management and mitigation

� International environment -language

On what to focus for evaluation of Suppliers?

NSQ-100 Quality Standard for Nuclear Industry – Marc h 2016 - p.13

The contents of NSQ -100

5 MANAGEMENT RESPONSIBILITY5.1 Management Commitment5.2 Customer Focus5.3 Quality Policy5.4 Planning5.4.1 Quality Objectives5.4.2 Quality Management System Planning5.5 Responsibility, Authority and Communication5.5.1 Responsibility and Authority5.5.2 Management Representative5.5.3 Internal Communication 5.5.4 Communication with Regulatory Bodies5.6 Management Review5.6.1 General5.6.2 Review Input5.6.3 Review Output

6 RESOURCE MANAGEMENT6.1 Provision of Resources6.2 Human Resources6.2.1 General6.2.2 Competence, Qualification, Training and

Awareness6.3 Infrastructure6.4 Work Environment

Basics of ISO 9001:2008 dealing with quality system replicated as is

Slight adaptation to complement with nuclear specificities

Addition of chaptersspecific to nuclear context

In depth modificationto comply with nuclear specificities and standards (e.g. training to safety culture)

NSQ-100 Quality Standard for Nuclear Industry – Marc h 2016 - p.14

� The correspondence matrices to the following standa rds with NSQ-100, are available on the NQSA website:

�GS-R-3 (IAEA), � RD 0034 (RSA), � RPP-1 (FRANCE - AFCEN), � 10CFR 50 Appendix B (USA)� KTA 14001 (GER)

The Correspondence matrices with NSQ -100

These matrices show that NSQ-100 is fully in line w ith the requirements of GS-R-3 (IAEA) and 10 CFR 50 Appendi x B

NSQ-100 Quality Standard for Nuclear Industry – Marc h 2016 - p.15

A Win-Win Quality Standard

Benefits to Buyers

� Simplifies the process for assessment of Suppliers

� Relies on a panel of certified nuclear industry suppliers

� Gives to buyers the assurance of a standardized level of quality in products and services

� Provides charts for comparisons with country requirements

� Optimizes the buyer’s project schedule and improves productivity

Benefits to Suppliers

� Helps for acquiring a genuine safety culture

� Fills the gap between the nuclear requirements and common industrial requirements

� Eases implementation of the requirements through online guides and tools

� Leads for getting a certification of the nuclear Safety & Quality Management System

NSQ-100 Quality Standard for Nuclear Industry – Marc h 2016 - p.16

8 Guidelines

Preamble

� A : General

� B : Safety Culture

� C : Graded Approach

� D : Planning

� E : Design

� F : Purchasing

� G : Production & Inspection

� H : Audits & NCR

NSQ-100 Quality Standard for Nuclear Industry – Marc h 2016 - p.17

Looking forward

Our objectives

Topic Currently In the future

Promote good behaviorsSpread and share best practices through harmonized u nderstanding of

the requirements (Guidelines)

Share experience

Communication Promote NSQ-100 Promote ISO standard

Reduce cost of poor qualityIntroduce a culture of nuclear quality, of nuclear safety and of project

management, as early as possible in the value strea m

Certification process Define the process Oversight it s implementation

Nuclear safety authorities Coordinate initiative and activities

Process databaseDevelop and

maintain a list of:

-recognized Accreditation Bodies-accredited Certification Bodies-Qualified auditors-certified organizations

NSQ-100 Quality Standard for Nuclear Industry – Marc h 2016 - p.19

Our future model

EN

9100

Certification Bodies

AccreditationBodies

Training Bodies

Auditors

AEROSPACE COMPANIES

A model and method inspired by aircraft industrySimilar context:•strong safety requirements (risky industry)•high quality and industrial expectations•low production volume

Accreditation

Certification

NSQ

100

NSQ-100 Quality Standard for Nuclear Industry – Marc h 2016 - p.20

NUCLEAR SUPPLIERS

Our vision

2015 2016 2017 2018

Association ISO Certification process

Welcome newcomers

Objective:Publication of the international

standard ISO 19443 within2 years

• Qualify new CB• Qualify training bodies • Deliver certificates

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NSQ-100 Quality Standard for Nuclear Industry – Marc h 2016 - p.21

In conclusion� The management of the quality of the supply chain i s a major

challenge in the construction and maintenance of nu clear plants

Further DevelopmentWith ISO: The working group WG 4 has been created within ISO TC 85 (Nuclear), for:“Development of enhanced requirements for nuclear industry, with respect to ISO 9000/17000 series,

ISO/TC85/WG4 is currently developing the new projec t on quality management systems, on the basis of NSQ-100 :ISO 19443 “Specific requirements for the application of ISO 9001 and

IAEA GS-R, by organizations in the Supply Chain of t he Nuclear Energy sector”

With IAEA: One basis for updating:GSR- Part 2 guides for suppliers

NSQ-100 Quality Standard for Nuclear Industry – Marc h 2016 - p.22

Thank you