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
NSQ-100 Quality Standard for Nuclear Industry - July 2014 - p.‹#›
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
NSQ-100 Quality Standard for Nuclear Industry - July 2014 - p.‹#›
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 - July 2014 - p.‹#›
NSQ-100
Presentation
NSQ-100 Quality Standard for Nuclear Industry - July 2014 - p.‹#›
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
NSQ-100 Quality Standard for Nuclear Industry - July 2014 - p.‹#›
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
NSQ-100 Quality Standard for Nuclear Industry - July 2014 - p.‹#›
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
NSQ-100 Quality Standard for Nuclear Industry - July 2014 - p.‹#›
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
NSQ-100 Quality Standard for Nuclear Industry - July 2014 - p.‹#›
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 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
NSQ-100 Quality Standard for Nuclear Industry - July 2014 - p.‹#›
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 Quality Standard for Nuclear Industry - July 2014 - p.‹#›
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 Quality Standard for Nuclear Industry - July 2014 - p.‹#›
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 - July 2014 - p.‹#›
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 - July 2014 - p.‹#›
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)
NSQ-100 Quality Standard for Nuclear Industry - July 2014 - p.‹#›
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
NSQ-100 Quality Standard for Nuclear Industry - July 2014 - p.‹#›
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 - July 2014 - p.‹#›
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 - July 2014 - p.‹#›
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
NSQ-100 Quality Standard for Nuclear Industry - July 2014 - p.‹#›
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
NSQ-100 Quality Standard for Nuclear Industry - July 2014 - p.‹#›
CLASSIFICATION / GRADED APPROACH
Guideline C
NSQ-100 Quality Standard for Nuclear Industry - July 2014 - p.‹#›
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
NSQ-100 Quality Standard for Nuclear Industry - July 2014 - p.‹#›
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
NSQ-100 Quality Standard for Nuclear Industry - July 2014 - p.‹#›
Looking forward
NSQ-100 Quality Standard for Nuclear Industry - July 2014 - p.‹#›
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
NSQ-100 Quality Standard for Nuclear Industry - July 2014 - p.‹#›
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
NSQ-100 Quality Standard for Nuclear Industry - July 2014 - p.‹#›
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
rtif
ica
te
issu
an
ce
CD
ver
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f th
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an
da
rd
Ba
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Fin
al v
ersi
on
…
New
ISO
90
01
New
ISO
Nu
cl.
Sta
nd
ard
fo
r C
Bs
(ISO
17
02
1 A
pp
x)
NSQ-100 Quality Standard for Nuclear Industry - July 2014 - p.‹#›
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
NSQ-100 Quality Standard for Nuclear Industry - July 2014 - p.‹#›
Thank you