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? WNA Symposium, September 2013

The objectives of NSQ-100 standard 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 Suppliers work for many customers/manufacturers -> need to set in place a convergence between clients (DO) Increase the experience feedback by creating a shared platform Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.3

www.nqsa.org 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

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 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 ISO 9001 ISO 9001 International Trans project Over the time NSQ-100 Standard based on ISO 9001:2008 structure and on IAEA GS-R-3:2006 ASME NQA-1:2008 2009 addenda principles Implementation Guides Sub-Contractors 90%* Generic Project Specifications Project Specifications Project Specifications Project Specifications Project Specifications Certification Process n projects Project Specifications Project Specifications n projects Correspondence Matrix 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

Apply for approved vendor 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 ? 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.9

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 NQSA oversight 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 in details … 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. Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.11

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 NUCLEAR INDUSTRIAL PRACTICES RELATIONS WITH NUCLEAR SAFETY AUTHORITIES 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 On what to focus for evaluation of Suppliers? 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 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 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 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.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 Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.15

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

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.17

Concept of Safety Culture Guideline B 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 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 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). Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.20

Guideline D Product Realisation List of IFS items or Activities Determination of product requirements List of IFS items or Activities Identifying needs for monitoring (audits, inspections and tests, ...) and records required (methods of proof of compliance with requirements) Design Design verification Purchasing Purchasing specs verification Project Management Risk Management Production & Tests Inspection of product, items, activities Configuration Management Surveillance Surveillance of production Internal Audit Auditor independent of the activity 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 Guideline E DESIGN & DEVELOPMENT Example of suggested follow-up table Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.22

Planning of inspection et surveillance Guideline G Planning of inspection et surveillance Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.23

NON CONFORMANCE CONTROL : SUGGESTED SCHEME Guideline H NON CONFORMANCE CONTROL : SUGGESTED SCHEME Common Quality Standard for Nuclear Industry – WNA Symposium September 13th, 2013 - p.24

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

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