1.1. BACKGROUND
The successful implementation of quality assurance (QA) and quality control (QC) is essential to providing confidence in the nuclear industry. A high degree of reliability and integrity is required of products and services, and the requirements are particularly stringent for assuring nuclear safety. Failure of structures, systems or components to perform their intended function, or their poor performance, could adversely affect the health and safety of workers and the public. Hundreds of years’ worth of safe operating performance by nuclear reactors have proven the value of quality assurance and quality control when properly executed.
Some management systems standards associated with the utilization of nuclear energy or generic activities no longer explicitly differentiate quality assurance and quality control activities from other processes necessary to achieve successful outcomes of an organization.
Only a few nuclear quality standards are published. Consequently, the important role played by quality assurance and quality control is not always recognised, and particularly newcomer countries in the nuclear field, and persons coming to it from other industrial sectors, may only have experience with generic quality management standards.
The concept of quality as underpinning safety and reliability has a long history. Industrial failures, often causing significant destruction of plant and loss of life, have led to the introduction of national standard bodies such as the American Society of Mechanical Engineers (ASME), the British Standards Institution (BSI) and the Deutsches Institut für Normung (DIN).
Quality assurance developed mainly from the rapid increase of global military production in World War II. This continued into aeronautics, space and civil nuclear sectors and involved contemporary development of reliability engineering. The USA developed standards for its nuclear weapons programme in 1954 and then for naval propulsion reactors in 1964, which resulted in the development of commercial nuclear power standards ANSI N45.21 [1] in 1971 and ASME NQA-1 [2] in 1979.
The USA, UK and France also introduced and adopted quality assurance requirements for Nuclear Power Plants (NPPs) during the 1980s. Expansion into general product and service sectors came with BS 5750, Quality Systems [3], which was subsequently developed into the ISO 9000 series of quality management system standards in the 1970s and 1980s.
These developments and new approaches were necessary for the development of high-risk technologies, materials having very unusual properties, requirements for high precision, and guaranteed conformance to strict requirements on the edge of current technology in large production quantities. Products with these attributes were intended to possess a high reliability thorough planning, checking, verification, and oversight. To eliminate human error in product realization, multiple independent confirmations of every aspect were used. The final products had to perform reliably throughout designed lifetimes.
1 This publication is superseded by ASME NQA-1
2
In 1978, the IAEA issued the Safety Series 50-C-QA, Quality Assurance for Nuclear Power Plants: A Code of Practice2 [4]. Separate Guides3 were published in the 1980s to support 50-C-QA (1978) [4]. They were all revised and incorporated into 50-C/SG-Q (1996)4 [5], Quality Assurance for Safety in Nuclear Power Plants and Other Nuclear Installations: Code and Safety Guides Q1-Q14. IAEA GS-R-3, The Management System for Facilities and Activities5 [6], was published in 2006. The safety guides GS-G-3.1 [7], GS-G-3.3 [8], GS-G-3.4 [9], GS-G-3.5 [10]
and TS-G-1.4 [11] present more detailed guidance about how to achieve compliance with the overarching management system requirements.
GS-R-3 [6] was then superseded in June 2016 by the publication of GSR Part 2, Leadership and Management for Safety [12]. GSR Part 2 presents the framework for management of nuclear facilities and activities. Figure 1 depicts the evolution of the level on which quality requirements have been presented in the IAEA Safety Standards. They currently represent high level requirements for a nuclear facility or activity.
FIG. 1. Evolution of the IAEA approach to quality, leadership and management showing the organizational management system and detailed quality requirements levels.
The IAEA NE Series publication NG-T-1.3 Development and Implementation of a Process Based Management System [13] and TECDOC-1740, Approach in the Application of the Management System Requirements for Facilities and Activities [14] are further examples of guidance publications. These publications do not frequently use the terms quality management, quality assurance and quality control. However, understanding how these quality concepts apply to all processes of the management system is crucial. This becomes very clear in the procurement of products and services where the supply chain normally uses quality
2 This publication is superseded by IAEA GSR Part 2
3 These safety guides were numbered 50-SG-QA N, where N was a sequential number.
4 This publication is superseded by IAEA GS-G-3.1 and GS-G-3.5
5 This publication is superseded by IAEA GSR Part 2
management or quality assurance related standards. Recent concerns with the reducing number of traditional nuclear suppliers and increases in the number of counterfeit products or certificates have made quality aspects more and more important.
The current IAEA approach to quality as a part of a management system, manifested in the references [7, 10, 12–14], describe all required elements as policy, processes, procedures and instructions that affect people, technology and the organization. An overarching requirement for all processes, as defined in the same references, is to determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective and efficient operation and control of these processes. This can be seen to represent quality assurance and quality control thinking applied to the processes of a management system.
Quality is a key element of a management system as defined in requirement 6 of GSR Part 2 [12]. The importance of quality assurance has also been highlighted in some other recently published IAEA documents e.g. the Safety Guide GSG-13 [15].
1.2. OBJECTIVES
The objectives of this TECDOC are to provide clarification of what is meant by quality assurance and quality control as a part of management system of nuclear facilities and activities, to provide practical examples of these activities, and to offer good practices and lessons learned from quality assurance and quality control in countries building, operating, and maintaining nuclear power plants.
This information is intended to:
Emphasize that quality assurance and quality control are essential and distinct activities that are particularly important to all activities of a management system;
Help in ensuring the safe and economic operation of nuclear facilities by ensuring all the activities, deliverables and services are based on well-specified requirements and acceptance criteria;
Provide a neutral technical basis for dialogue between government bodies, regulators, plant operators and suppliers when dealing with management system, quality assurance and quality control issues.
The focus of this publication is nuclear power plants, but the presented concepts are applicable to all nuclear facilities and activities.
1.3. SCOPE
This publication explains the basic concepts of quality assurance and quality control. It provides examples of good practices of their implementation as processes within nuclear facilities and describes how they are managed through interfaces with suppliers and subcontractors. This publication discusses the elements of a management system relevant for the quality assurance and quality control functions, such as the generation and retentionof documented information, sometimes called records. It does not present details of any framework or suggest that one approach would fit all; rather, the idea is to present the spectrum of tools and approaches for a reader for his/her choice.
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1.4. USERS
This publication is primarily intended for:
Senior management, who determine the business objectives and management system policies but also need to understand the role quality assurance and quality control play in delivering those objectives and policies;
Management and quality specialists who need to interpret the requirements of quality and management systems in nuclear power plants and manage those activities required to assure reliability, sustainability and safety;
Regulatory bodies;
Licensee personnel;
Project management organizations;
Technical support organizations;
Manufacturers of products and suppliers of services;
Newcomer Member States preparing to contract services (and items including the main plant contract); and
New personnel in operating and expanding Member States with responsibilities for quality in nuclear facilities and activities.
1.5. STRUCTURE
This publication consists of four (4) Sections, eight (8) Appendices and four (4) Annexes.
Section 1 is an introduction to the contents of this publication. Section 2 explains the concept of quality as a part of management systems in the field of nuclear energy. Section 3 deals with quality assurance and quality control activities. Section 4 discusses briefly quality assurance and quality control in different nuclear power plant life cycle phases.
The Appendices provide detail on the various elements and differing aspects of quality assurance and quality control at the different stages in the life of a nuclear facility as described in Sections 1–4.
The Annexes provide examples and lessons learned of actual circumstances where quality assurance and quality control practices play significant roles.