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Nuclear Quality Standard Association. General information about Quality management System in the nuclear industry. Ce document est la propriété de NQSA. Il ne peut être utilisé, reproduit ou communiqué sans autorisation préalable. Which quality standard for the nuclear industry?.

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Nuclear quality standard association

Nuclear Quality Standard Association

General information about Quality management System in the nuclear industry

Ce document est la propriété de NQSA.

Il ne peut être utilisé, reproduit ou communiqué sans autorisation préalable.

Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.1


Which quality standard for the nuclear industry

Which quality standard for the nuclear industry?

WNA Symposium, September 2013


The objectives of nsq 100 standard

Improve understanding of qualityrequirements by the suppliers

Helps increasing the safety culture

Translating very general requirements and providing guidance for implementation

Standardize the requirements

Is a way to capitalize on industrial practices already well understood and applied in other industries while strengthening the integration of the nuclear requirements

Promote all major nuclear industry players to work in the same direction with their suppliers

Help suppliers through a unique and shared quality platform

Represents a greater attractiveness for suppliers as an international and recognized standard, trans project and over the time cost reduction, quality enhancement

Creates a capitalization of know-how and competence of supply chain create a high quality platform of nuclear suppliers

The objectives of NSQ-100 standard

Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.3


Nuclear quality standard association

  • NQSA (Nuclear Quality Standard Association)

    A non profit association of Major Nuclear Industry Actors created to :

    • Promote the application of a robust quality standard (NSQ-100)

    • Provide a framework for further evolutions of the standard

    • Set a “nuclear oriented” supplier evaluation process to further prepare a new certification scheme

    • Accredit certification bodies

From the NQSA website,

download with free access,

  • NSQ 100 (in English and French versions)

  • The correspondence matrices with: GS-R-3 (IAEA), RD 0034 (RSA), RPP-1 (AFCEN)

  • 8 Guidelines

www.nqsa.org

Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.4


Nuclear quality standard association

A joint work open to partners

  • NQSA members :

    • And with an observer status

    • Discussions under progress with:Eskom, MHI, EDF, WNA

  • But non exclusive and designed to be open to all major nuclear procurement organizations: utilities, engineering, major vendors as well as other certification bodies: e.g.HSB

  • NSQ-100 standard is the property of NQSA

Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.5


The method used to develop nsq 100

The method used to develop NSQ-100

Based upon ISO 9001:2008 structure : an industry consensus quality standard ensuring the integration of Nuclear QA requirements in well-known industrial quality practices

Key elements integration of two major reference nuclear codes

IAEA GS-R-3:2006

ASME NQA-1-2008

Development process inspired by the approach followed in other industries, mainly Aircraft Industry (EN 9100 Quality management systems / Requirements for Aviation, Space and Defense Organizations)

Similar context: strong safety requirements, high quality and industrial expectations combined with a product/process and low production volume orientation

Integration of specific requirements into a largely deployed standard

Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.6


The nsq 100 story

The NSQ-100 story

InternationalTrans projectOver the time

NSQ-100Standardbased onISO 9001:2008 structureand onIAEA GS-R-3:2006

ASME NQA-1:20082009 addenda principles

Implementation Guides

ISO 9001

ISO 9001

Sub-Contractors

90%*

Generic

Project

Specifications

Project Specifications

Project Specifications

Project Specifications

Project Specifications

Certification Process

Project Specifications

n projects

Project Specifications

n projects

CorrespondenceMatrix

Project Adaptation Process

Specific Request(local regulation)

Before NSQ-100

Buyers, Safety Authorities

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

Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.7


Nuclear quality standard association

Suppliers qualification process

TODAY’S PROCESS

Prequalification

Qualification

Execution

Sourcing

Pre-Qualification

Qualification Audit

Process findings

Final Review

AVL

Long interactions between customer and supplier

NQSA PROCESS

Qualification

Execution

Application

Certification Audit

Apply for approved vendor

Application Review

Certified

AVL

Shorter interactions/

allows a focus on the product compliances

Certification bodies

Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.8


Progress status where are we today

Progress status: Where are we today ?

Standard= QA specification

Version 0 of NSQ-100 standard has been developed and can be downloaded on NQSA website: Reference in English and French translation available

Guidelines= provide additional explanations and proposal of implementation methods

8 Guidelines available on NQSA website, to be downloaded

Correspondence matrixes= formalize correspondence between NSQ-100 and major nuclear QA standards

Done for GS-R-3 (IAEA) , RD-0034 (RSA), RPP-1 (AFCEN): respectivelyNSQ-110, NSQ-140 & NSQ-150, available on NQSA website, to be downloaded

in progress for : NQA-1 (USA), KTA 1401 (Germany)

Procedures available on NQSA website, to be downloaded for Certification Body candidates

Qualification process for Certification Bodies

Qualification of auditor and lead auditor

Pilot phasewith some selected suppliers

Has given confidence on adequacy of the requirements to nuclear safety objectives

Next step :

Qualification of Certification Bodies and auditors

2nd semester 2013: Launching the NSQ-100 certification process for companies

Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.9


Nuclear quality standard association

Certification process

Qualification of Certification Bodies

SUPERVISION

NQSA

Certification Committee

(Industry Members Only)

Audit Specification

Certification Bodies

Certificate issuance

Process

Issuance of Certificate

  • The quality of the certificate is guaranteed by the Industry Members through NQSAoversight by performing periodic surveillance and witness audits

Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.10


Reminder position of nsq 100 standard versus regulations

NSQ-100 standard:

includes detailed requirements for quality management, applicable to a supplier of goods or services used in the construction of a nuclear installation,

is not intended to substitute for regulatory or contractual requirements, but is designed to help to answer them.

Reminder : position of NSQ-100 standard versus Regulations

NSQ-100 in details …

Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.11


Nsq 100 main requirements

NSQ-100 - Main Requirements

RELATIONS WITH NUCLEAR SAFETY AUTHORITIES

NUCLEAR INDUSTRIAL PRACTICES

  • 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

MANAGEMENT OF COMPETENCIES

PRODUCT CLASSIFICATION

INDEPENDENCE OF REVIEW AND SURVEILLANCE

GRADED APPLICATION OF QUALITY REQUIREMENTS

CONTROL OF PRODUCTION PROCESSES AND NON-CONFORMING PRODUCT

TIME MANAGEMENT

RISK MANAGEMENT

INTERNATIONAL ENVIRONMENT

« SAFETY CULTURE »

Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.12


Main orientations of the new standard nsq 100

Main orientations of the new standard NSQ-100

Independence of review and surveillance activities

Control of non conforming product and production processes

Management of competencies – qualification of personnel

On what to focus for evaluation of Suppliers?

  • Safety culture

  • Grading and cascading application of quality requirements

  • Classification of product

Nuclear Quality

Nuclear Safety

Project Quality

  • Time management : planning and time schedule

  • Risk management and mitigation

  • International environment - language

Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.13


The contents of nsq 100

The contents of NSQ-100

5 MANAGEMENT RESPONSIBILITY

5.1 Management Commitment

5.2 Customer Focus

5.3 Quality Policy

5.4 Planning

5.4.1 Quality Objectives

5.4.2 Quality Management System Planning

5.5 Responsibility, Authority and Communication

5.5.1 Responsibility and Authority

5.5.2 Management Representative

5.5.3 Internal Communication

5.5.4 Communication with Regulatory Bodies

5.6 Management Review

5.6.1 General

5.6.2 Review Input

5.6.3 Review Output

6 RESOURCE MANAGEMENT

6.1 Provision of Resources

6.2 Human Resources

6.2.1 General

6.2.2 Competence, Qualification, Training and Awareness

6.3 Infrastructure

6.4 Work Environment

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

Slight adaptationto complement with nuclear specificities

Addition of chapters specific to nuclear context

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

Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.14


A win win quality standard

Benefits to Buyers

Simplifies the buyer’s assessment of Suppliers

Provides charts for comparisons with country requirements

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

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 nuclear quality label

A Win-Win Quality Standard

Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.15


8 guidelines

8 Guidelines

Preamble

  • A : General

  • B : Safety Culture

  • C : Graded Approach

  • D : Planning

  • E : Design

  • F : Purchasing

  • G : Production & Inspection

  • H : Audits & NCR

Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.16


Nuclear quality standard association

Examples of Guidelines contentObjective of the guidelines is to answer question that the supplier may have for a correct implementation of the NSQ-100 Standard requirements

Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.17


Concept of safety culture

Concept of Safety Culture

Safety Culture Definition : Overall characteristics and attitudes in organizations and individuals which establishes that, as an overriding priority, protection and nuclear safety issues receive the attention warranted by their significance

NSQ-100 Guideline – Section B : Safety Culture

Guideline B

Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.18


Classification graded approach

Guideline C

CLASSIFICATION / GRADED APPROACH

Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.19


Classification graded approach1

Guideline C

CLASSIFICATION / GRADED APPROACH

  • The “PRODUCT” has to be the subject to an analysis by the manufacturer in order to determine the importance of:

    • Each item on the product safety function or the product final quality,

    • Each activity (during design, development, manufacturing, erection, commissioning and related services), which may affect the product safety function or the product final quality.

  • To perform this analysis, it may be useful to refer to one or more of the different type of methods as listed in EN 31010 standard (Risk management – Risk assessment techniques).

Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.20


Product realisation

Product Realisation

Guideline D

Determination of product requirements

List of IFSitems or Activities

Identifying needs for monitoring (audits, inspections and tests, ...) and records required (methods of proof of compliance with requirements)

Design verification

Design

Purchasing specs verification

Purchasing

Project Management

Inspection of product, items, activities

Production & Tests

Risk Management

Configuration Management

Surveillance of production

Surveillance

Auditor independent of the activity

Internal Audit

Verification by a person different than those who have participated to the activity

Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.21


Design development example of suggested follow up table

DESIGN & DEVELOPMENTExample of suggested follow-up table

Guideline E

Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.22


Planning of inspection et surveillance

Planning of inspection et surveillance

Guideline G

Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.23


Non conformance control suggested scheme

NON CONFORMANCE CONTROL : SUGGESTED SCHEME

Guideline H

Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.24


Further development within iso

Further Development within ISO

  • A new working group is being created within ISO TC 85, for “development of enhanced requirements for nuclear industry, with respect to ISO 9000/17000 series, with the main objective of conformity assessment guaranties in coherence with the safety importance / classification”

  • Proposed basis for this development is NSQ-100 and its associated procedures

Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.25


Nuclear quality standard association

Thank you


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