Nuclear Quality Standard Association - ASME · NSQ-100 Quality Standard for Nuclear Industry - July 2014 - p.‹#› In conclusion The management of the quality of the supply chain

NSQ-100 Quality Standard for Nuclear Industry - July 2014 - p.‹#›

Nuclear Quality Standard

Association

This document is the property of NQSA

Its copying, use or communication is subject to prior authorization

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

NEWCOMERS

including countries with poor nuclear

culture

TECHNICAL SUPPORT

development support for their local

economies

CUSTOMER EXPECTATIONS

for quality of products, services and

lead time

Long-term trend


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

Presentation


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

Qualify certification bodies

www.nqsa.org

From the NQSA website,

download with free access,

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

•Procedures Qualification of CBs & Auditors

•The correspondence matrices with: GS-R-3 (IAEA), RD 0034 (RSA), RPP-1 (AFCEN), and 10 CFR 50 Appendix B (To be posted soon)

•8 Guidelines

../Relation NEI/Pres_NEI 5th Annual Nuclear Supply Chain Conf_ May 2014/NQSA Accueil.pdf


An already long-lasting story

NSQ-100 v0 Guidelines

Correspondence

matrices

GS-R-3 (IAEA)

RD-0034 (SA)

RPP1 (Fr)

10 CFR 50 (USA)

BV Certification

qualified by NQSA

2011 2012 2013 2014


Our results

NQSA is a dynamic association, with already 9 full members

(industry leaders)

NSQ-100 is becoming a well-known standard (thousands of

downloads worldwide: utilities, suppliers, regulatory 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 (sharing experience

and best practices)

Development of the certification process


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 nuclear reference 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 followed in other industries, mainly Aircraft Industry (EN 9100 Quality Management Systems / Requirements for Aviation, Space and Defense Org.)

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


Generic

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

Imp

lem

en

tati

on

Gu

ide

s

Su

b-C

on

tracto

rs

Before NSQ-100

Certification Process

Project Adaptation

Process

ISO 9001


The quality of the certificate is guaranteed by:

NQSA Industry Members oversight: periodic surveillance and witnessing audits

The Impartiality Committee oversight, of the complete NQSA process

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 and maintenance 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 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 »


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?


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 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)


The correspondence matrices to the following standards with

NSQ-100, are available on the NQSA website:

GS-R-3 (IAEA), RD 0034 (RSA), RPP-1 (AFCEN),

And (To be posted soon on the website):

10 CFR 50 Appendix B

The Correspondence matrices with NSQ-100

These matrices show that NSQ-100 is fully in line with the

requirements of GS-R-3 (IAEA) and 10 CFR 50 Appendix B

Muguet.pdf

NSQ-160 Version 0 June 2014.pdf


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


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

../Relation%20NEI/Présentation%20NQSA_NSQ%20100/Safety%20Culture%20Leaflet-ENG.pdf

../Relation%20NEI/Présentation%20NQSA_NSQ%20100/Safety%20Culture%20Leaflet-ENG.pdf


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 Realisation

Determination 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


Looking forward


Our objectives

Topic Currently In the future

Promote good behaviorsSpread and share best practices through harmonized understanding 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 stream

Certification process Define the process Oversight its 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


Our future model

EN 9100

Certification

Bodies

Accreditation

Bodies

Training

Bodies

Auditors

AEROSPACE

COMPANIES

A model and method inspired by aircraft

industry

Similar context:

•strong safety requirements (risky industry)

•high quality and industrial expectations

•low production volume

Accreditation

Certification

NSQ

100

NUCLEAR

SUPPLIERS


Our vision

2014 2015 2016 2017

Association ISO Certification process

Welcome newcomers

Objective:

International standard within

2-3 years

• Qualify new CB

• Qualify training bodies

• Deliver certificates

Firs

t ce

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te

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f th

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an

da

rd

Ba

llot

Fin

al v

ersi

on

…

New

ISO

90

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New

ISO

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Sta

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(ISO

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pp

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In conclusion

The management of the quality of the supply chain is a major

challenge in the construction and maintenance of nuclear plants

Further Development

With 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, with the main objective

of conformity assessment guaranties in coherence with the

safety importance / classification”

With IAEA: One basis for updating:

GSR- Part 2 guides for suppliers


Thank you

Documents

Nuclear Quality Standard Association - ASME · NSQ-100 Quality Standard for Nuclear Industry - July 2014 - p.‹#› In conclusion The management of the quality of the supply chain