Safety Evaluation Report and RAI

Transcription

1 Safety Evaluation Report and RAI 2013

2 Learning Objectives After going through this presentation the participants are expected to be familiar with: When a SER is Needed Topics Covered in SER Typical Contents of SER Documents produced during Safety Evaluation Request for Additional Information Considerations for Writing RAI

3 References 1. Governmental, Legal and Regulatory Framework for Safety, GSR Part 1 2. The Management System for Facilities and Activities, GS-R-3 3. Review and Assessment of Nuclear Facilities by the Regulatory Body, GS-G Documentation for Use in Regulating Nuclear Facilities, GS-G-1.4

4 Contents IAEA Requirements and Guides When a SER is Needed Potential Readers of SER Topics Covered in SER General Process of Regulatory Review Typical Contents of SER Documents produced during Safety Evaluation Request for Additional Information Considerations for Writing RAI Examples

5 IAEA Requirements and Guides GSR Part 1 Requirement 25and 26 : Review and assessment of information relevant to safety (4.48) The regulatory body shall record the results and decisions deriving from the reviews and assessments, and shall take appropriate actions (including enforcement action) as necessary. The results of review and assessment shall be used as feedback information for the regulatory process.

6 IAEA Requirements and Guides GS-R-3 (Human Resources)(4.4) Individuals shall have received appropriate education and training, and shall have acquired suitable skills, knowledge and experience to ensure their competence.

7 IAEA Requirements and Guides GS-G-1.2(Review and Assessment of Nuclear Facilities by the Regulatory Body) The basis for the decision should be recorded and documented on an appropriated form. This documentation should summarize the review and assessment performed and should present a clear conclusion about the safety of the activity authorized. GS-G-1.4(Documentation for Use in Regulating Nuclear Facilities) Documentation produced by the regulatory body The topics that should be covered in the safety evaluation report (SER)

8 When a SER is Needed? A safety evaluation report (SER) documents the technical, safety, and legal basis for the regulatory body s disposition of the licensing applications The regulatory decision may approve, partially approve, or deny the application At several stages of the authorization process the basis should be recorded in the form of a report CP(Construction Permit) and OL(Operating License) Design Certification and Combined License Periodic Safety Review(PSR)/License Renewal /Continued Operation Amendments and Changes to the Operating License

9 Potential Readers of SER Technical staff and decision makers in the regulatory body Regulatory Advisory Committee Members (if applicable) Applicants (now) and Licensees (future) Interested members of the public External support organization Other governmental agencies

10 Topics Covered in SER Typically, the following topics should be covered(gs-g-1.4): Reference to the documentation submitted by the operator; The basis for the evaluation; The evaluation performed; Conformance with regulatory requirements and guides; Comparison with similar(reference) facility ; Independent analysis performed by the regulatory body s staff, or by dedicated support organization on its behalf; Conclusions with respect to nuclear safety; Any additional conditions to be fulfilled by the operator.

11 General Process of Regulatory Review 1. Review of documentation submitted by an applicant Confirming the adequacy of the scope, format and contents of documentation in light of legal requirements 2.Technical review of submitted documents Safety Analysis Report, Environmental Evaluation Report, Emergency Response Guide etc. ( Scope is dependent on national policy and requirements) Performing based on the national regulatory review guides as a reference 3. Making Request Additional Information (if Any) Requesting needed information to confirm the probable design deficiency 4.Evaluation Findings and Conclusions Dealing with significant deficiencies and issues raised during review Regulatory decision-making for design adequacy 5.Drafting Safety Evaluation Report Reviewer s self-explanatory work on how the subject of review is satisfied or not

12 Typical Contents of SER Chapter X.X.X : Subject Area of Review Introduction of the subject matter and the scope of review Summary of Application the applicant provided Review interfaces (could be a separate section) Regulatory Requirements Description of regulatory policies, requirements, guides, standards, and commitment for conducting the review Review Results Description of staff assessment about how the application meets (or does not meet) the regulatory basis Exchanged documents, RAIs, communications, etc. Conditional Acceptance and further actions (could be a separate section) Conclusions Summary of staff conclusions and findings (if any)

13 Documents Produced during SE The process of review and assessment is conducted by means of exchanges between the regulatory body and the operator. The records will concern mainly(gs-g-1.4): Requests for additional information by the regulatory body; Questions formulated by the regulatory body; Responses by the operator(including those provided by its contractors) Records of meeting between regulatory body staff and operator personnel

14 Documents Produced during SE These records should be kept in an organized way that permits retrieval according to different criteria such as subject, type, data or originator

15 Request for Additional Information A request for additional information(rai) is needed if: Information in the application is technically incomplete or unacceptable, unclear, ambiguous, or can be interpreted multiple ways and, One or more following purposes : to make a determination that there is a reasonable assurance of adequate protection of public health and safety to determine how the applicant meets the regulations. to complete a safety finding that is clearly tied to a regulation

16 Request for Additional Information Information in the RAI: A brief explanation of the regulatory requirements or acceptance criteria The type of information needed to complete technical review The section(s) of the application that contains the unclear or ambiguous information, if it is necessary for the applicant to address specific text in an application

17 Request for Additional Information The information that the applicant has omitted from its application but is needed for the staff to reach a conclusion about safety of the SSCs Differences of opinions in the use of engineering judgment, computer codes, analytical methods, calculations, code and standards, etc., between the staff and the applicant Identify whether the application needs to be revised to reflect the RAI response

18 Considerations for Writing RAI Staff should write RAIs only when information is needed to complete the technical review and there is missing or misleading information in the applications. RAIs must include concise statement(s) of information needed to complete technical review and must have clear and understandable regulatory basis (i.e., regulatory requirement or acceptance criteria). Do not use the term requirement when asking for information related to compliance with guidance (i.e. acceptable means of satisfying a regulation)

19 Considerations for Writing RAI Do not impose new regulatory requirements in RAIs. RAIs should not make determinations on the adequacy of the application Do not request reports unless the entire report is relevant to the review. Request relevant information in reports. State the facts; Take emotion (e.g., frustration) out of the question;

20 Summary When a SER is Needed Topics Covered in SER Typical Contents of SER Request for Additional Information Considerations for Writing RAI