Nuclear Quality Standard Association

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1 Nuclear Quality Standard Association General information about Quality Management System in the nuclear industry This document is the property of NQSA Its copying, use or communication is subject to prior authorization

2 A relevant answer to a changing context Buyers New needs identified by: 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

3 An improved approach of Suppliers Evaluation of the supplier and its supply chain Assessing capability to execute in compliance with the requirements Integration of a new standard «NSQ-100» Requirements based on «standards» Capacity to understand and cascade the requirements * Control of product execution Performance of proficient Inspection «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

4 NSQ-100 Presentation

5 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 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

6 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

7 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

8 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 (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

9 Implementation Guides Sub-Contractors The NSQ-100 story ISO 9001 Project Specifications Project Specifications Project Specifications Project Specifications ISO 9001 Generic Project Specifications Project Specifications Specifications 90%* 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: addenda principles Correspondence Matrix Specific Request (local regulation) Certification Process Project Adaptation Process Before NSQ-100 Buyers, Safety Authorities * 90% of generic specifications of a management system certification for the nuclear industry is addressed by NSQ-100

10 Certification process NQSA Certification Committee (Industry Members Only) Qualification of Certification Bodies Audit Specification Certificate issuance Process SUPERVISION Certification Bodies Issuance of Certificate 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

11 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 and maintenance of a nuclear installation, is not intended to substitute for regulatory or contractual requirements, but is designed to help to answer them.

12 NSQ 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 MANAGEMENT OF COMPETENCIES INDEPENDENCE OF REVIEW AND SURVEILLANCE CONTROL OF PRODUCTION PROCESSES AND NON-CONFORMING PRODUCT NUCLEAR INDUSTRIAL PRACTICES TIME MANAGEMENT RELATIONS WITH NUCLEAR SAFETY AUTHORITIES RISK MANAGEMENT PRODUCT CLASSIFICATION GRADED APPLICATION OF QUALITY REQUIREMENTS INTERNATIONAL ENVIRONMENT «SAFETY CULTURE»

13 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 Project Quality Time management : planning and time schedule Risk management and mitigation International environment - language

14 The contents of NSQ MANAGEMENT RESPONSIBILITY 5.1 Management Commitment 5.2 Customer Focus 5.3 Quality Policy 5.4 Planning Quality Objectives Quality Management System Planning 5.5 Responsibility, Authority and Communication Responsibility and Authority Management Representative Internal Communication Communication with Regulatory Bodies 5.6 Management Review General Review Input Review Output 6 RESOURCE MANAGEMENT 6.1 Provision of Resources 6.2 Human Resources General 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 In depth modification to comply with nuclear specificities and standards (e.g. training to safety culture)

15 The Correspondence matrices with NSQ-100 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 These matrices show that NSQ-100 is fully in line with the requirements of GS-R-3 (IAEA) and 10 CFR 50 Appendix B

16 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

17 8 Guidelines Preamble A : General B : Safety Culture C : Graded Approach D : Planning E : Design F : Purchasing G : Production & Inspection H : Audits & NCR

18 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

19 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

20 Guideline C CLASSIFICATION / GRADED APPROACH

21 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 standard (Risk management Risk assessment techniques).

22 Guideline D Product Realisation Determination of product requirements Identifying needs for monitoring (audits, inspections and tests,...) and records required (methods of proof of compliance with requirements) List of IFS items or Activities Design Design verification Project Management Risk Management Purchasing Production & Tests Purchasing specs verification 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

23 Looking forward

24 Our objectives Topic Currently In the future Promote good behaviors Share experience Spread and share best practices through harmonized understanding of the requirements (Guidelines) Communication Promote NSQ-100 Promote ISO standard Reduce cost of poor quality Introduce 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 database Develop and maintain a list of: -recognized Accreditation Bodies -accredited Certification Bodies -Qualified auditors -certified organizations

25 Our future model A model and method inspired by aircraft industry Similar context: strong safety requirements (risky industry) high quality and industrial expectations low production volume Accreditation Bodies Accreditation NSQ EN Certification Bodies Certification Training Bodies Auditors AEROSPACE NUCLEAR COMPANIES SUPPLIERS

26 First certificate issuance CD version of the standard Ballot New ISO 9001 Final version New ISO Nucl. Standard for CBs (ISO Appx) Our vision Association ISO Certification process Welcome newcomers Objective: International standard within 2-3 years Qualify new CB Qualify training bodies Deliver certificates

27 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

28 Thank you

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