Management systems play an important role in the nuclear industry. The industry has certain special requirements that the management systems need to meet, and above all, the management systems shall enable safe and high-quality operations.

The Finnish Nuclear Regulatory Guide YVL A.3 (Leadership and management for safety, 15.3.2019) presents the general requirements for safety and quality management that affect the content of management systems.

Safety shall take priority in all operations. (YVL A.3)

According to Guide YVL A.3, a party supplying products or services important to safety shall have a management system that has either been certified (e.g. standard ISO 9001 or ISO 19443) or has been independently assessed by a third party. The management system can be implemented through various operational processes.

Where applicable, the requirements of the Guide apply not only to licensees but also to engineering and expert organizations, equipment and material manufacturers and other suppliers important to safety. If the product or service relates to safety classes 1 or 2, the supplier’s management system shall meet the management system requirements of Guide YVL A.3.

One essential requirement is that the organisation must have an integrated management system in which issues receive the attention that is justified considering their safety significance. The management must demonstrate through its own actions the importance of safety in the organization and its commitment to its continuous improvement.

Safety culture is an important part of the management system of all organizations operating in the nuclear industry. The management system shall support the goal-oriented development of a good safety culture. Platom’s management emphasizes the importance of a safety culture in daily operations. Platom’s experts have also trained other companies in the field of safety culture. Safety has also been highlighted as one of the Platom’s values and it has been recognized that safety means more than just nuclear safety; social and economic security and the well-being of individuals, among others.

Project-specific audits

An integral part of management systems are audits (external/internal), in which Platom has diverse experience.

Typically, in the most demanding projects or plant modifications, the customer (licensee/applicant, subcontractor) carries out a separate supplier-specific audit with the aim of ensuring that nuclear and radiation safety requirements are met in the supplier’s operations. As a result of the audit, a need for improvement of the management system may emerge, which is familiar to an organization that has gone through the ISO 9001 certification process.

The auditor’s experience and competence play a role in determining what issues are examined and emphasized in audits, which means that observations may also vary between audits. For example, when auditing a manufacturer of equipment and/or materials, it is important to examine the process of handling material deviations, how the requirements set for the product are transferred to the product itself, how deviating products are directed in production, or how the conformity of the finished product is demonstrated.

Platom has several certified experts who have completed the Quality Management System Auditor/Lead Auditors qualification training (ISO 9001). Platom’s auditors have carried out various audits of suppliers and manufacturers operating in the nuclear industry both in Finland and abroad.

Platom’s Maria Nordlund and Toivo Kivirinta are certified Lead Auditors.

Continuous improvement of the management system

Continuous improvement of the management system and self-assessment (e.g. internal audits and management reviews) are essential parts of a management system. The organization’s desire to improve its performance and the personnel’s willingness to learn from experiences, including successes, play a key role in achieving peak performance. In addition, project-specific audits may require and, on the other hand, enable the development of a management system. For example, in the Fennovoima project, Platom was involved in training the suppliers participating in the project (e.g. safety culture training) and in developing their management systems to meet the requirements of the industry and customers.

In our experience, many established companies have their operating methods in order and the quality of operations is at a high level. Challenges may arise from the fact that the company is not familiar with the requirements of nuclear projects (e.g. YVL Guide requirements). It is important to understand the purpose behind the requirements and how the company’s management system and operating processes respond to the requirements of the project. The fulfilment of the requirements of the nuclear industry can be described in a project-specific quality plan without significant changes to the management system.

Platom has extensive experience in developing and drawing up quality plans for projects. Platom’s experts can help the customer understand what the requirements of the nuclear industry mean and how they should be met in order for the licensee/applicant and, ultimately, the authority to approve the supplier’s design and manufacturing process.

Requirements management

According to Guide YVL B.1, defined and appropriate processes shall be in place for requirements management. In practice, this means that the supplier must plan and describe the requirements management process in its management system. The YVL Guides do not directly state which information system or method should be chosen for requirements management but give the supplier the freedom to choose.

There are different ways to implement requirements management. The scope and implementation of requirements management should be taken into account when planning and implementing it. For example, spreadsheet-based follow-up may be sufficient for a project with a lower safety significance, whereas for safety-significant projects with a large number of requirements, an information system specializing in requirements management may be the best way to take care of requirements management.

Platom uses Polarion, which has been found to have a certain flexibility. Our experts also have experience in using the Doors system. Platom also has experience in spreadsheet-based requirements management. We are happy to advise our customers to choose the best implementation for their needs.

You can read more about developing requirements management procedures for a successful automation project in our blog post: Advanced requirement management – What is required? – Platom

The requirements of the YVL Guides can sometimes confuse, especially for a company that is new  in the nuclear industry. Based on their textual form, several requirements have been written primarily to apply to the licensee organizations of the nuclear facility. However, the requirements also extend to the supply chain and, for example, to companies supplying services or systems (also outside of  safety classes 1 and 2). The most common YVL Guides that concern projects are A.3, B.1 and the YVL E-series Guides related to the component or structure in question.

Experience makes thing easier when you need to understand the practical implications of the requirements. Platom’s experts have extensive experience in meeting the requirements of both nuclear and radiation safety in practice, which is valuable in demanding nuclear power projects.

In recent years, Platom has invested in the development of requirements management. As part of our multi-year development project, we have addressed the requirements of the YVL Guides by classifying them so that we can more easily identify which of them are relevant at any given time. At the same time, we have introduced a new requirements management system (Polarion) and we are creating a framework for how we implement systematic requirements management when operating in accordance with our own management system.

Summary

The goal of this series of articles is to increase the reader’s understanding of nuclear licensing, management systems and requirements management. The articles have dealt with various official materials and approvals from plant level to equipment level, not forgetting licensing planning. The series of articles progresses from the top level towards more detailed entities.

The first part is a general description of official materials and approvals in the field of nuclear energy in Finland. In Finland, the use of nuclear energy is strictly regulated: for example, more than six thousand detailed safety requirements have been set in the YVL Guides alone. For the successful execution of projects, it is essential to identify and plan the necessary approvals and the materials required for them at an early stage.

The second part describes the licensing process of a nuclear facility and the demonstration of safety at the plant level, what stages it involves and what kind of materials must be prepared at each stage. Perhaps the most important of these are the safety analysis report (PSAR and FSAR), conceptual plan (PES) and safety analyses. They are used to demonstrate and maintain information on how the nuclear power plant’s safety functions are realized in all situations on which the design is based.

The third part progresses from the nuclear facility level to the system level. The article highlights what kind of materials are prepared at the system level. At the system level, the summary document is called the pre-inspection documentation, the purpose of which is to describe and present the requirement compliance of the system.

The fourth article deals with equipment-level licensing and qualification data from the perspectives of mechanical equipment and structures as well as electrical and I&C equipment. These materials are prepared when individual components and structures are designed or replaced.

The fifth part provides an overview of licensing planning and the key issues of the licensing plan. At best, smart licensing planning saves significant amounts of experts’ working time.

This sixth part deals with matters essential for companies operating in the nuclear industry, such as management systems, supplier audits and requirements management.

We hope that the series of articles will be useful to a company operating in the nuclear industry. The theme is constantly evolving and profound, and some things can be open to interpretation – that’s why experience is useful. Platom is happy to advise companies already operating in or aspiring to enter the nuclear industry to develop their operations to meet the requirements, so don’t hesitate to contact us!