Establishment of a regulatory review and assessment process Group 2

Exercice 1 a) The main tasks of RaA processes to perform 1. Receipt of application for authorization of a facility Officially record all submissions related to the authorization process according to their level of classification (registration) Keeping all the information regarding the documents sent or received (title, date, name of sender or recipient) Keep access/distribution records 2. Acceptance check/review to confirm the completeness of submissions To confirm the completeness of submissions and identify of gross deficiencies all the documents have been prepared/verified by the applicant before the submission submissions are related to the specific facility or activity rather based on generic information, submissions are timely with reference to project schedule to enable appropriate review and assessment by the regulatory body. If the submission is complete, the RB will docket the submission and notify the acceptance of the application.

a) The main tasks of RaA processes to perform 3. Planning and scheduling the review and assessment The regulatory body should indicate to the operator the period of time considered necessary for review and assessment process; 4. Performance of the review and assessment The review and assessment is primarily based on the information submitted by the operator. For the thorough review and assessment of the operator's technical submission the regulatory body acquires an understanding of the design of the facility or equipment, the safety concept on which the design is based, and the operating principles proposed by the operator.

a) The main tasks of RaA processes to perform 5. Regulatory inspection for review and assessment The regulatory body should have the right to visit, or to designate others to visit on their behalf, the operator’s site and, if necessary, to visit contractors’ establishments with the knowledge of the operator. 6. Preparation of the Safety Evaluation Report (SER) Acceptability that the depth and detail of submissions are sufficient Extent to which the safety objectives and regulatory requirements have been met Confidence in the conclusions reached by the analysis

b) Processes of the RaA Review of application for authorization of facility Acceotance check/review for ducommentation for applicatin Planning and schedule of review and assessment Performance of review and assessment/egulatory inspection to complement review and assessment Preparation for evaluatuion of safety report

c) How to manage a regulatory body organization review and asssessment process we have to organize Designation of Team Leader Constitution of Review Team Scheduling of Submissions Planning and Scheduling of Review Conduct of Review Correspondence (Queries/Responses) Conduct of review meeting Preparation safety evaluation report

d) The mechanism for internal and external communications required during the implementation process Meeting Consultation with stakeholders Review and assess the licensees application Schedule of time frame for submission Submission of application by licensees Procedures and guidanace documents Records and documentations

e) Expected inputs and outputs of the process Submission of report by the operator Records and documentation Preliminary safety analysis report Inspections IAEA Standards and Guideline Outputs: Safety evaluation report Authorizations – deny or approval

Exercise 2