1. Regulatory Oversight of HOF in Finland
Technical Meeting on Regulatory Oversight of Human and Organizational Factors
14-18 December 2015, Vienna
Mari Nykänen

2. Content Finnish Legislation - Requirements
Finnish Regulatory Body, Oversight Process and Practices

3. YVL Guides issued by STUK
Government Decree on the Safety of Nuclear Power Plants 717/2013
Nuclear Energy Act
Nuclear Energy Decree
Government Decrees
YVL Guides issued by STUK
Codes and Standards
§ 6 Management of human factors
§ 24 Operational experience feedback and safety research
§ 28 Safety Culture
§ 29 Safety and Quality Management
§ 30 Lines of Management, responsibilities and expertise

4. § 6 Management of human factors

5. § 24 Operational experience feedback and safety research

6. § 28 Safety Culture

7. § 29 Safety and Quality Management

8. § 30 Lines of management, responsibilities and expertise

9. Regulatory requirements: Structure of YVL Guides

10. Regulatory requirements: Guide YVL A.1
Regulatory oversight of safety in the use of nuclear energy
430. Operational events at a nuclear facility may consist of single transients or observations as well as recurring or common cause failures, human errors and omissions. Based of the reports provided by the operating organisation and its own observations made during inspections, STUK may appoint an investigation team as appropriate to assess a specific event. The specific duty of such a team is to determine the root causes of the event and define objectives for corrective measures.

11. Regulatory requirements: Guide YVL A.3
Management system for a nuclear facility
Management of human and organisational factors
319. The interaction between man, technology, and organisation affects safety. Systematic methods shall be incorporated in the management system in order to identify and manage human and organisational factors affecting safety.
320. Human and organisational factors shall be handled together with technical matters.
321. The personnel´s individual competence shall be developed as regads the identification and management of human factors and potential errors.

12. Regulatory requirements: Guide YVL A.3
Management system for a nuclear facility
Developing and managing the processes of the management system
603. Written instructions shall be provided for process-related procedures and the manner of carrying out the activities. The possibility of human error in work performances shall be taken into account when defining the processes and the activities contained in them. The processes shall be planned so as to identify and disclose potential errors as early in the process as possible.

13. Regulatory requirements: Guide YVL A.4
Organisation and personnel of nuclear facility
303. The licensee shall demonstrate that the organisation of the nuclear facility will ensure the safe, reliable and appropriate operation of the facility under all conditions […] The structure and ways of working of the organisation shall contribute to the management of human errors.

14. Regulatory requirements: Guide YVL A.6
Conduct of operations at a nuclear power plant
418. When planning the tasks of the shift teams, care shall be taken to ensure that the workload, participation in training, and the human factors related to the duration of the shifts, shift rotation, and rest periods do not affect the teams´ability to perform safety-related work.
717. The procedures and guidelines shall be systematically validated and verified. Validation shall address the role of human factors in the procedures. The validation of the procedures and guidelines shall be based on simulations or other suitable methods, primarily by using a training simulator.

15. Regulatory requirements: Guide YVL A.7
Probabilistic risk assessment and risk management of a nuclear power plant
401. In the PRA, the following shall be analysed as initiating events: the plant´s internal failures, disturbances and human errors […] as well as external factors caused by human activities.
403. The PRA shall utilise operating experience feedback collected from similar plants or corresponding applications. The licensee shall maintain a database of the reliability of safety-related components as well as initating events and human errors.

16. Regulatory requirements: Guide YVL A.10
Operating experience feedback of a nuclear facility
602. The licensee shall carry out a generic investigation of multiple events when similarities can be seen with regard to their underlying technical causes, organisational or human factors, or other recurrence problems.

17. Regulatory requirements: Guide YVL B.1
Safety design of a nuclear power plant 1/2
461. The presentation of the infromation needed for performing maintenance work – as well as the related instructions and the tools used – shall be designed with the objective of preventing human error during system maintenance. Due attention shall also be paid to the physical work environment and the accessibility of components.
5302. Due consideration shall be given to human factors and organisational circumstances right from the outset when plans are prepared for control room operations or changes affecting the control room.

18. Regulatory requirements: Guide YVL B.1
Safety design of a nuclear power plant 2/2
Final Safety Analysis Report
618. The following information concerning the overall plant design shall be provided:
[…]
5. A description of how the following safety issues have been taken into account in the overall plant design of the safety-classified systems:
f. the principles related to the avoidance of human errors

19. Organization Oversight Process and Practices

20. NRR organization

21. Oversight Process Oversight findings Analysis and decision on action
Requirement letter
Management meeting with licensee
Independent evaluation
Investigation
Follow up and evaluation of effects

22. STUK´s oversight activities
Inspection activities on site and off-site
e.g. Periodic inspection programme
Observation and surveillance of licensee performance at the site
Review and assessment of documents
Operating experience, reporting
Oversight of the implementation of projects, modifications, outages
Interactions with the licensee (meetings, audits, training…)
Collecting oversight findings in HAKE-database (Polarion)
External independent evaluations to support STUK oversight activities

23. About HAKE Database
The use of HAKE aims at integrating different observations from licensee organization and operations in a systemic way
Process management
Communication
Handling of Non Conformances and incidents
Management and leadership
Quality Management
Resource planning and competences
Project management
Automation
Waste management
Chemistry
Operations
Commissioning
Mechanics
Construction
Risk management
Electricity
Radiaton protection
Data security
Security and physical protection
Emergency
Nuclear safety and process systems
Organization