Core Questions (GSR Part 1 and GS-R-3) Primary Module ... - STUK

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The performance of regulatory activities is continuously evaluated by regular audits, self-assessments and management reviews (Guides STUK 6.1, Guide STUK 6.3, and STUK 6.4). These assessments include also identification of corrective actions and measures. The management system models include criteria against which our progress as a “quality organization” is assessed. The criteria cover areas like leadership, policy and strategy, processes, people, partnerships and resources. Internationally accepted criteria sets in assessing the adequacy and effectiveness of a regulatory infrastructure. In addition, results of external and evaluations are regularly used for identification for opportunities to improve regulatory activities, including safety culture. As an example of other assessments STUK has participated a national survey on safety culture in organisations in the field of safety or related to high risks (SAFEX). According the results STUK’s employees take safety into account in their work in a proper way. The results were also discussed with staff in order to seek opportunities to improve performance. QID SQID QTYPE References Primary Question Answer PA 6 Primary Safety Standards Series No. GS-R- 3;para 2.6 Does the regulatory body apply a graded approach in the performance of its regulatory activities? Yes No B x If ‘Yes’ go to: SQID 6.1 If ‘No’ go to: SQID 6.5 Otherwise go to: QID SQID QTYPE References True Subsidiary Question Next Question 6 6.1 Text Safety Standards Series No. GS-R- 3;para 2.6 Describe the bases for determining the graded approach with regard to the main areas of regulatory activity (e.g. issuance of regulatory requirements, review and assessment, inspection and enforcement). SQID 6.2 The nuclear energy and radiation legislation include the principle for graded approach. This is seen e.g. in licensing requirements for different type of facilities and activities. Accordingly this approach has been taken into account in regulatory activities. The basic approach for grading is presented in Guide STUK 1.1 as follows: the requirements contained in the decisions are proportional to the matter’s safety significance and increase actual quality and safety. A decision can be changed if new facts emerge after decision-making giving cause for this. Regulatory actions are documented in such a manner that procedures and grounds for decisions are traceable afterwards. The implementation of safety culture in STUK’s regulatory activities provides that safety significance of the matter or situation to be dealt with at the time is recognized (Guide STUK 2.1). Graded approach is applied to different STUK’s regulatory activities (Guide STUK 3.1) and the quality and process documents of STUK are prepared in consideration of the
graded approach required by the regulatory requirements. The requirements, orders and sanctions, which STUK as an authority directs to a responsible party under regulatory control, are in a correct and reasonable relationship with the concerning defect or non-compliance. In addition, the safety significance of the handled issues shall be recognised and the emphasis on ensuring safety shall be given in STUK’s regulatory activities. Thus the development and maintaining of proper safety culture is being promoted in all use of nuclear energy and radiation practice. As regards nuclear power plants and nuclear waste facilities the graded approach has specifically taken into account in the safety classification of the systems, structures and components (Guide YVL 2.1/ YVL B.2).Graded approach is also applied in regulation of nuclear energy activities. All regulatory requirements are based on safety significance and it is taken into account in regulatory processes. The systems, structures and components important to safety shall be designed, manufactured, installed and operated so that their quality level and the inspections and tests required to verify their quality level are adequate considering any item's safety significance. To comply with the above principles, the systems, structures and components of the nuclear facility are grouped into Safety Classes 1, 2, 3, 4 and Class EYT (classified nonnuclear). The items with the highest safety significance belong to Safety Class 1. Safety class determines what quality requirements apply to the facility’s systems, structures and components and to their quality assurance. The scope of the regulatory control of systems, structures and components is determined by safety class. The regulatory control of systems based on safety classification is described in Guide YVL 2.0, among others. The inspection and control practices for structures and components in Safety Classes 1, 2, 3, 4 and Class EYT are described in the respective YVL guides. Graded approach used in the regulatory control of radiation practices is described in Guide SKV 3.2 (Processing the application for a safety licence). In this approach, the radiation appliances and their use are divided into 3 categories based on the risk which these appliances and their use may pose on workers and members of the public. Category I is the lowest and Category III the highest category. In enforcement, the radiation and nuclear energy legislation give graded means to STUK. First, STUK can give orders, and if they are not obeyed, then STUK can use threats’ of fine and finally fines More specific guidance on enforcement procedures are given in internal guides (Guide STUK 3.1, Guide YTV 1.3, Guide SKV 3.7). QID SQID QTYPE References True Subsidiary Question Next Question 6 6.2 Text Safety Standards Series No. GS-R- 3;para 2.6 How is the graded approach applied in the scope and depth of regulatory reviews and inspection activities? SQID 6.3 Graded approach is applied to different STUK’s regulatory activities (Guide STUK 3.1) Safety significance of each issue to be handled shall be acknowledged and the regulatory operations are focused particularly on issues that have real safety
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Core Questions (GSR Part 1 and GS-R-3) Primary Module ... - STUK

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