Common Quality Standard for Nuclear Industry – WNA Symposium September 13 th, 2013 - p.1 Nuclear Quality Standard Association Ce document est la propriété

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

Nuclear Quality Standard Association

Ce document est la propriété de NQSA.Ce document est la propriété de NQSA.Il ne peut être utilisé, reproduit ou communiqué sans autorisation préalable. Il ne peut être utilisé, reproduit ou communiqué sans autorisation préalable.

General information about Quality management System in the nuclear industry

Which quality standard for the nuclear industry?

WNA Symposium, September 2013


Improve understanding of quality requirements 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


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

www.nqsa.org

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

http://www.nqsa.org/


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


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


The NSQ-100 story

Project Specifications



ISO 9001


n pr

ojects

Generic

Project

Specifications



n projects

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 system certification for the nuclear industry is addressed by NSQ-100

Su

b-C

on

tra

cto

rs

Before NSQ-100

Certification Process

Project Adaptation

Process

ISO 9001


Suppliers qualification process

Prequalification

SourcingQualification

Audit

Process

findings

Pre-

QualificationFinal Review AVL

Qualification Execution

Application

Apply for

approved

vendor

Certification

Audit

Application

ReviewAVL

Qualification Execution

Certified

TODAY’S PROCESS

NQSA PROCESS

Long interactions between customer and supplier

Certification bodiesShorter interactions/

allows a focus on the product compliances


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) : respectively NSQ-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 phase with 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


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

NQSA

Certification

Committee

(Industry Members

Only)

Qualification of

Certification Bodies

Audit Specification

Certificate issuance

Process

Certification Bodies

Issuance of

Certificate

SUPERVISION

Certification process


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 …


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 MANAGEMENT RISK

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 »


Main orientations of the new standard NSQ-100

Nuc

lear

Qua

lity

Project QualityN

uclear Safety

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?


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 chapters specific to nuclear context

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


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


8 Guidelines

Preamble

A : General

B : Safety Culture

C : Graded Approach

D : Planning

E : Design

F : Purchasing

G : Production & Inspection

H : Audits & NCR


Examples of Guidelines content

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


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


CLASSIFICATION / GRADED APPROACH 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).

Guideline C


Product RealisationDetermination of product requirements

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

Project Management

Risk Management

Design

Configuration Management

Purchasing

Production & Tests

Internal Audit

Verification by a person different than those who have participated to

the activity

Surveillance

Purchasing specs verification

Design verification

Inspection of product, items, activities

Surveillance of production

Auditor independent of the activity

List of IFS items or Activities

Guideline D


DESIGN & DEVELOPMENTExample of suggested follow-up table

Guideline E


Planning of inspection et surveillance

Guideline G


NON CONFORMANCE CONTROL : SUGGESTED SCHEME

Guideline H


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

Thank you

Documents

Common Quality Standard for Nuclear Industry – WNA Symposium September 13 th, 2013 - p.1 Nuclear Quality Standard Association Ce document est la propriété