common quality standard for nuclear industry – wna symposium september 13 th, 2013 - p.1 nuclear...
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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
Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.3
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
Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.4
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
Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.5
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.6
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.7
The NSQ-100 story
Project Specifications
Project Specifications
Project Specifications
ISO 9001
Project Specifications
n pr
ojects
Generic
Project
Specifications
Project Specifications
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
Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.8
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
Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.9
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
Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.10
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
Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.11
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.12
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 »
Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.13
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?
Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.14
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)
Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.15
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
Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - 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
Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.17
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
Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.18
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.19
CLASSIFICATION / GRADED APPROACH Guideline C
Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.20
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
Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.21
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
Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.22
DESIGN & DEVELOPMENTExample of suggested follow-up table
Guideline E
Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.23
Planning of inspection et surveillance
Guideline G
Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.24
NON CONFORMANCE CONTROL : SUGGESTED SCHEME
Guideline H
Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.25
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