1. Regulatory review and assessment
Regulatory Control Training Workshop
Regulatory Cooperation Forum
Luis Lederman
7-11 November, 2016
IAEA, Vienna

2. Learning objectives
After going through this presentation the participants are expected to be familiar with:
Steps of the review and assessment process
The scope and depth of the regulatory review and assessment
Bases for the decisions and the review and assessment
Topics to be reviewed and assessed by the Regulatory Body
Main verification areas and verification of the submissions
Use of Reference/Generic NPP review and assessment data
Documentation prepared by the applicant and by the regulator body

3. Content The scope and depth of the regulatory review and assessment
Bases for the decisions and the review and assessment
Topics covered by review and assessment
Verification of the submissions
Reference/Generic NPP R&A
Documentation by the applicant and by the regulatory body
Steps of the review and assessment process

4. Purpose of the review and assessment
The purpose of the review and assessment of the information submitted by the operator is to enable the regulatory body to make a decision or a series of decisions on the safety of the facility and its associated activities
The general aim of the regulatory review of the safety analysis is to verify that the safety measures are sufficient to provide adequate assurance for each identified safety barrier.
The regulatory body perform a step by step process to determine whether the applicable safety objectives and requirements for each aspect or topic have been met. .
Decisions should be made by suitably qualified and experienced persons within the RB. They should be based on sound expertise and adequate information: they should be based on “guess work”.

5. Scope and depth of the review and assessment
The review and assessment is a critical appraisal of information submitted by the Applicant/Licensee to demonstrate the safety of the facility covering all the relevant aspects in accordance with the safety requirements and criteria. It should consider normal operation, abnormal condition, and accidents caused by systems failures, human errors, internal and external hazards.
The Regulatory Body as part of its responsibility verifies to determine whether the submissions of the licensee have provided a sufficiently complete, detailed and accurate demonstration of safety against safety requirements and applicable criteria.
The scope and depth of review and assessment will depend on several factors such as novelty, complexity, previous history, the experience of the operator and the associated risk.
During the review and assessment process, the RB is conducting a critical ………….
According to the safety guide GS-G-1.2, complementary inspection is a part of the review and assessment. it is essential that regulatory reviewers/assessors go to the site and see the facility and watch operations. This concept of checking applies to drawings and plans also!

6. Bases for review and assessment
Regulations and guides
Regulations (mandatory) should be developed on a generic basis or on the basis of facility type and should provide for more detailed requirements to be incorporated into individual authorizations.
Guides, of a non-mandatory nature, on how to comply with the regulations shall be prepared as necessary. These guides may also provide information on data and methods to be used in assessing the adequacy of the design and on analyses and documentation to be submitted to the regulatory body by the operator.
In some instance, the operator may propose an alternative approach to that suggested in a guide to achieving a safety objectives. → The operator should be required to demonstrate that its proposed approach will provide an equivalent level of safety.
To ensure clarity, regulations and guides should be developed by the RB.
……..
……………….
……………………
If they can apply to more than one type of facility or activity it should be made clear which regulations and guides refer to which activity or facility.

7. Safety objectives and requirements
The regulatory body may develop safety objectives and requirements, or it may adopt those issued by international organizations or by regulatory bodies in other States with a good understanding of their bases.
The safety objectives and requirements should cover:
Application of the principle of defence in depth;
Meeting the single failure criterion for safety systems;
Requirements for redundancy, diversity and separation;
Dose limits;
Emergency preparedness.

8. Topics covered by review and assessment
IAEA GS-G Appendix
Generic list of topics that should be considered in the review and assessment throughout the lifetime of a nuclear facility:
The physical nature of the facility and its environment;
Infrastructural aspects;
Safety analysis
The operating organization and the management system;
Operational procedures;
Equipment qualification;
Management of ageing;
Operator’s safety performance;
Experience from other facilities and research findings.

9. Use of a reference or generic NPP
When a reference design or generic information is submitted by the applicant for regulatory review and assessment :
the regulatory body cannot consider this information sufficient for review and assessment and for safety decisions,
even if the design has been authorized in another country, the regulatory body should still perform its own independent review and assessment considering factors related to the specific NPP site, managerial and operational aspects; differences in regulatory requirements, design changes and operating experience,
The regulatory body will need to establish close cooperation with the RB of the country that has previously performed the review and assessment in order to learn from the existing experience and to be able to perform its independent safety evaluation.
I also want to touch another important topic, particularly important for embarking countries, which is the use of reference or generic NPP safety assessment/evaluation data provided by the vendor or the applicant.

10. Documents produced by the Applicant/ Operating Organization
For a particular authorization, the operator should provide all
relevant information describing:
The approach to safety in order to demonstrate that
the facility will not present undue radiological risks to
workers, the public and the environment;
Proposed objectives, principles, criteria, standards and analyses in relation to nuclear safety for the stage of the authorization process;
Examples of documents to be submitted to the
regulatory body by the Applicant/Licensee (SSG-12)

11. Documents produced by the Regulatory Body
Safety evaluation report (SER) should typically, cover :
Reference to the documentation submitted by the operator;
The basis for the evaluation;
The evaluation performed;
Conformance with regulatory requirements, regulations and guides;
Comparison with another similar (reference) facility where appropriate;
Independent analysis performed by the regulatory body’s staff, or by consultants or dedicated support organizations on its behalf;
Conclusions with respect to safety;
Reason for the decision made;
Additional requirements to be fulfilled by the operator;
Management System Documentation
Refer to the safety evaluation report as a record.

12. Steps of the review and assessment process
1. Receipt of application for authorization of a facility
Internal and external resources, record and documentation…
Legal and regulatory requirements
Safety guides
2. Acceptance check/review for documentation of application
3. Planning and scheduling of review and assessment
This chart shows us a typical steps of the review and assessment process to be conducted by a regulatory body during an authorization.
There are five main steps: ……
………
………..
4. Performance of review and assessment
/ Regulatory inspections to complement review and assessment
5. Preparation of the Safety Evaluation Report
Regulatory decision

13. Steps of the review and assessment process
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;

14. Steps of the review and assessment process
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.

15. Steps of the review and assessment process
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;
In estimating the period of review and assessment process, several time consuming factors should be considered (acceptance review, possibility of safety issues, preparing additional information by the operator.)

16. Steps of the 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.
The scope and depth of the review and assessment should be graded particularly on the basis of its safety significance.

17. Scope of the regulatory review and assessment
Safety Assessment
Safety Analysis
Assessment of
engineering factors
important to safety
complementary
methods
In the safety assessment , there are two things, which are safety analysis and assessment of …
As you know, safety analysis consists of DSA and PSA.
Assessment of engineering factors important to safety will cover these things, proven engineering practice,…
I just focus on the assessment of … in this talk.
Deterministic
Safety Analysis
(DSA)
Probabilistic
Safety Analysis
(PSA)
Proven engineering practices
Defence in depth, multiple barriers
Single failure criterion
Redundancy, diversity
Physical separation
Fail-safe design
Safety classification
Equipment qualification
Protection against internal and external hazards
Combination of loads
Ageing
Human factors
Predicts the response to postulated events with predetermined assumptions; checks fulfilment of acceptance criteria
Combines the likelihood of initiating events, potential scenarios and their consequences into estimation of CFD, source term or overall risk

18. Steps of the review and assessment process
5. Regulatory inspection for review and assessment
Although a fundamental feature of the review and assessment process is the consideration of the safety documentation, the regulatory body should also verify claims made in the documentation and to supplement the information and data needed for review and assessment, as a necessary part of the process, by means of and inspections of the facility
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.
3.63 in GS-G-1.2,
Regulatory Inspection for Review and Assessment
Such verification should be carried out by specialists at all stages of the authorization process. These inspections will also allow the regulatory body to supplement the
information and data needed for review and assessment. Additionally, the regulatory body will be able to extend its practical understanding of managerial, engineering and operational aspects involved and foster links with specialists in the operating organization. Where the operator fulfils some central functions away from the facility, the regulatory body should also visit the relevant parts of the operating organization.
The staff of the regulatory body who carry out review and assessment shall 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. Such visits may provide a good opportunity to access the adequacy and effectiveness of the quality assurance systems of the operator, the manufacturers and the suppliers.
3.64. It may be useful for the operator to arrange for those preparing, or involved in, complex submissions to make presentation(s) to key regulatory assessors highlighting the main technical issues raised and the analytical techniques used in the submissions.

19. Steps of the review and assessment process
6. Preparation of the Safety Evaluation Report (SER)
A Safety Evaluation Report (SER) summarizes the R&A performed and presents results about the safety of the facility to be authorized and a conclusion on the acceptability of the safety based on:
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
I you will listen a specific presentation on this subject!

20. Steps of the review and assessment process
6. Preparation of the Safety Evaluation Report (SER) - 2
Typically the following topics should be covered by the SER:
Reference to the documentation submitted by the Applicant,
The bases for the evaluation,
The evaluation performed,
Comparison with requirements, regulations and guides,
Comparison with another similar (reference) facility,
Independent analysis performed by the regulatory body,
Conclusions with respect to safety,
Additional requirements to be fulfilled by the Applicant.

21. Outlook
The safety evaluation report prepared by the regulatory body staff is a cornerstone for the regulatory safety decisions.

22. Thank you