1. IAEA International Atomic Energy Agency Technical Meeting on Regulatory Oversight of Human and Organizational Factors Vienna, Austria | 14-18 December 2015 Breakout sessions

2. IAEA Two breakout sessions To facilitate discussions and interaction among the participants in a smaller group: HOF concept and what areas need for oversight on HOF Content of a HOF regulatory oversight programme Every group will be requested to share their results and conclusions in plenum December 2015TM on Regulatory Oversight of HOF2

3. IAEA Content of a HOF regulatory oversight programme Scope of the discussion Regulatory strategies for the oversight of HOF Regulatory approaches and methods used to verify licensees effectively manages HOF in order for them to contribute positively to safety Other regulatory provisions to promote the positive contribution of HOF to safety and to mitigate possible adverse effects December 2015TM on Regulatory Oversight of HOF3

4. IAEA Content of a HOF regulatory oversight programme To develop the content of an effective oversight programme in considering, among others the followings: Strategy for RB to address HOF Different mechanisms to ensure effective management by the licensee: need to require the licensee to have an HOF improvement programme Regulation / oversight of organizational changes Key regulatory functions to be used in this area Use of Integrated Safety Assessment (See GSR Part 1 – Req. 25 / 26) Influence of the regulatory body to promote the licensee to work effectively in this area Use of performance indicators, etc. December 2015TM on Regulatory Oversight of HOF4 To identify recommendations / conclusions on a STRATEGY and an effective REGULATORY OVERSIGHT PROGRAMME

5. IAEA Group Composition Group 3 (MOE13) Amer Mahmood (Pakistan) Mari Nykanen (Finland) Viktor Szabó (Slovakia) Gladys Motlhabane (South Africa) Oleksandr Pecherytsia (Ukraine) Minh Le (Vietnam) December 2015TM on Regulatory Oversight of HOF5

6. IAEA REGULATORY STRATEGY RB can oversight HOF only based on exist requirements in own regulatory framework. RB need create this requirements for all documentation important for follow licensing processes (Sitting, Construction, Commissioning, Operation and Decommissioning). Main requirements need to add to documentation of integrated management system, as policy for elimination of negative aspects of HOF. December 2015TM on Regulatory Oversight of HOF6

7. IAEA REGULATORY STRATEGY Policy should includes: a written pledge by top management to preferentially achieve, maintain and constantly develop a high attention for identification and elimination of HOF with negative impact for nuclear safety, nuclear security, emergency preparedness and radiation protection, a policy including requirements for meeting and monitoring of HOF, a written pledge by all levels of management to identify and create the database of HOF, assess and continuously evaluate the HOF during the defined time period, system for using of corrective action for elimination of repetition of identified HOFs, December 2015TM on Regulatory Oversight of HOF7

8. IAEA Regulation / Oversight of organizational changes (1) Changes are the qualitative or quantitative changing of equipment or documentation with impact for nuclear safety, nuclear security or emergency planning. Changes must be justified in advance, carefully planned, and assessed following implementation. Changes shall be performed in accordance with principles and requirements applicable for the original facility or documentation. Changes to original design requirements or implementation of new requirements must be justified and relevant analyses must be performed to document their acceptability. December 2015TM on Regulatory Oversight of HOF8

9. IAEA Regulation / Oversight of organizational changes (2) The licensee applicant or a LH shall submit: a) an analysis of the causes of the proposed change, with justification of the goal of the change, b) an assessment of the impact of the change on nuclear safety, etc. c) proposed measures to eliminate possible negative effects of a new facility on existing facilities during its installation, inspection, tests, maintenance and operation, d) proposed measures to eliminate possible negative effects of the change, including its inclusion in quality management system documentation or employee vocational training, December 2015TM on Regulatory Oversight of HOF9

10. IAEA Regulation / Oversight of organizational changes (3) e) a record of the quality management system documentation that the change shall affect, and changed quality management system documentation if it is subject to RB approval, or if the RB requests it for examination, f) a safety assessment for the proposed change performed by an independent subject through risk analysis, g) an evaluation of the proposed change by the author of the original project, or another qualified individual. December 2015TM on Regulatory Oversight of HOF10

11. IAEA REGULATORY OVERSIGHT PROGRAMME Regulatory oversight program: Assess the LH`s policy including requirements for meeting and monitoring of HOF, Provide an inspection mechanism which has allow:  to supervise how adequate those requirements are fulfilled by LH,  to assess and continuously evaluate the HOF during the defined time period, Evaluate system of LH for using of corrective action for elimination of repetition of identified HOFs. Allocate adequate resources (human, knowledge, etc..) for effective implementation of mentioned activities. December 2015TM on Regulatory Oversight of HOF11

12. IAEA 12 j.jubin@iaea.org THANK YOU