Development, functions and management system of the regulatory body

4.1.2 Developing the structure of the organization

The regulatory body is structured and organized in order to fulfil its respon­sibilities and to perform its functions effectively and efficiently. There are key elements to consider in the organization of the regulatory body.

Primarily the regulatory organization needs to take into account its regu­latory functions: licensing; review and assessment; inspection; enforcement; and the development of regulations and guides. The objective of these regu­latory functions is the verification and assessment of safety in compliance with regulatory requirements.

The national legal arrangements, regulatory infrastructure and policy direction given by the State represent one key element of the organization.

National legal arrangements and structure have a significant influence on the regulatory body, including the need to consider the requirements of regulatory bodies in other areas of industry (IAEA, 2010a).

The regulatory body will need to decide whether or not to utilize techni­cal or other expert professional advice or services to assist it in discharging its responsibilities; this decision will influence the body’s own organizational structure. The professional advice or services could be provided by advisory bodies, dedicated technical support organizations, consultants, other regula­tory bodies or national and international agencies. However, the regulatory body should ensure that its organization has sufficient resources with the necessary competence to allow it to make effective decisions.

The regulatory body’s organizational structure will also be affected by whether its staff are all located in a single central headquarters or whether some staff are regionally located. In considering whether to locate staff regionally there are a number of factors that need to be taken into account, including the type and geographical spread of the nuclear power plants, the number of inspectors and the amount of time they need to spend on site to fulfil their duties.

The scope of the regulatory activities in relation to safety, security and safeguards may be comprehensive or may be distributed in different regula­tory organizations; this latter approach may be necessary because of the wide range of the activities covered by the regulatory oversight of planning, licensing and operation, i. e. construction, manufacturing of components, training and qualification, technical specifications, maintenance, surveil­lance testing, management of modifications, fire protection, radiation pro­tection, emergency preparedness, and the management system of both the operating organization and the various suppliers.

As a case in point, licensing activities essential to the development of a nuclear facility site may be carried out either by very few or by a larger number of governmental authorities, depending on the structure and func­tions of the regulatory body as established by law. In some States, it is the practice for the regulatory body to approve the various suppliers involved, following audits and inspections of their management systems. Once the regulatory body issues the construction licence, construction starts, includ­ing the manufacture of important safety (and safety-related) systems and components. The construction should proceed in a manner that ensures quality and safe operation. In this phase, the operating organizations, and the regulatory body as applicable, should monitor continuously the con­struction of safety-related structures, systems and components, both at the site and at manufacturing facilities, to ensure that the construction is in accordance with the approved design.

In a regulatory organization, each of its functions may be assigned to an organizational unit with its own specialists. However, it is often practical and efficient to group the specialists in a matrix such that each organiza­tional unit that is assigned responsibility for a particular function can draw on the necessary specialist skills. There is a particular need for interaction and integration between assessment and inspection functions.

The nuclear power planning programme needs to consider the number and type of nuclear power plants to be regulated in a timeframe. This needs to be considered sufficiently in advance in order to formulate a comprehen­sive regulatory plan in terms of regulatory resources so that effective regu­latory oversight can be provided at all times to all nuclear plants.

In general, in the early stages, a new regulatory body should review the experience from regulatory bodies and appropriate organizations within the State (e. g. national research organization) and from other States (includ­ing international organizations) and use this to inform its initial organiza­tional development including the minimum core organization and staffing needs. The use of an advisory body made up of experienced national and international experts should be considered to assist this process.

The regulatory body should regularly review its organization and make adjustments as necessary to take account of its operational experience, to address regulatory changes, and to address other changes in the regulatory environment or processes. Other factors to be considered include staffing and funding issues and the outcome of both internal and external audits, evaluations and peer reviews. Lessons learned from nuclear and non­nuclear experiences are elements to consider when the organization is reviewed.