Nuclear Quality Standard Association General information about Quality Management System in the nuclear industry

Transcription

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 NSQ-100 Quality Standard for Nuclear Industry March p.2

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 NSQ-100 Quality Standard for Nuclear Industry March p.3

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 & NSQ-100 Auditors From the NQSA website, download with free access: NSQ-100 (in English, French, Russian & Spanish) Procedures Qualification of CBs & Auditors The correspondence matrices with: GS-R-3 (IAEA), RD 0034 (RSA), RPP-1 (AFCEN), 10 CFR 50 Appendix B (USA) and KTA 1401 (GER) 8 Guidelines NSQ-100 Quality Standard for Nuclear Industry March p.5

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) KTA 1401 (GER) BV Certification qualified by NQSA NSQ-100 Quality Standard for Nuclear Industry March p.6

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 NSQ-100 Quality Standard for Nuclear Industry March p.7

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 NSQ-100 Quality Standard for Nuclear Industry March p.8

9 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) Implementation Guides Sub-Contractors 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 NSQ-100 Quality Standard for Nuclear Industry March p.9

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 NSQ-100 Quality Standard for Nuclear Industry March p.10

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. NSQ-100 Quality Standard for Nuclear Industry March p.11

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 MANAGEMENT OF COMPETENCIES INDEPENDENCE OF REVIEW AND SURVEILLANCE CONTROL OF PRODUCTION PROCESSES AND NON-CONFORMING PRODUCT NUCLEAR INDUSTRIAL PRACTICES RELATIONS WITH NUCLEAR SAFETY AUTHORITIES PRODUCT CLASSIFICATION GRADED APPLICATION OF QUALITY REQUIREMENTS Procurement control TIME MANAGEMENT RISK MANAGEMENT INTERNATIONAL ENVIRONMENT «SAFETY CULTURE» NSQ-100 Quality Standard for Nuclear Industry March p.12

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 NSQ-100 Quality Standard for Nuclear Industry March p.13

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) NSQ-100 Quality Standard for Nuclear Industry March p.14

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 (FRANCE - AFCEN), 10CFR 50 Appendix B (USA) KTA (GER) 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 March p.15

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 NSQ-100 Quality Standard for Nuclear Industry March p.16

17 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 March p.17

18 Looking forward

19 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 NSQ-100 Quality Standard for Nuclear Industry March p.19

20 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 NSQ-100 Quality Standard for Nuclear Industry March p.20

21 Our vision Association ISO Certification process Welcome newcomers Objective: Publication of the international standard ISO within 2 years Qualify new CB Qualify training bodies Deliver certificates First certificate issuance New ISO 9001 CD version of the standard Ballot Final version New ISO Nucl. Standard for CBs (ISO Appx) NSQ-100 Quality Standard for Nuclear Industry March p.21

22 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, ISO/TC85/WG4 is currently developing the new project on quality management systems, on the basis of NSQ-100: ISO Specific requirements for the application of ISO 9001 and IAEA GS-R, by organizations in the Supply Chain of the Nuclear Energy sector With IAEA: One basis for updating: GSR- Part 2 guides for suppliers NSQ-100 Quality Standard for Nuclear Industry March p.22

23 Thank you