1. IAEA International Atomic Energy Agency ESTABLISHING THE SAFETY INFRASTRUCTURE FOR A NUCLEAR POWER PROGRAMME IAEA WORKSHOP ON LEADERSHIP AND MANAGEMENT SYSTEM FOR REGULATORY BODY (WS-8) CORE SET – Topic 3.2 Processes

2. IAEA Learning objectives The aim of this lecture is about the regulatory body’s process implementation in an integrated manner This presentation provides information to assist implementation of SSG-16 Actions 75 (2) and 79 (3) January 2014WS8 - Core Set2

3. IAEA Content 1. Introduction 2. Process implementation 3. Core processes of the regulatory body 4. Support processes of the regulatory body 2014Integrated Management System3

4. IAEA 1. Introduction Developing processes The processes of the IMS that are needed to achieve the goals, provide the means to meet all requirements and deliver the “products” of the regulatory body shall be identified, and their development shall be planned, implemented, assessed and continually improved The sequence and interactions of the processes shall be determined [From GS-R-3 |5.1, 5.2, 5.3, 5.4, 5.5; GS-G-3.1 |5.1, 5.9] 2014Integrated Management System4

5. IAEA 1. Introduction The need for processes The operational framework within a RB is made up of processes. Processes should be identified, their development planned, implemented, assessed and continually improved. No single ‘process catalogue’ can apply to every organisation Organizations have found beneficial to structure processes as follows : Core processes, for the actual execution of the core regulatory functions Supporting processes, to provide the infrastructure necessary for the core processes Management processes, to ensure the operation of the entire management system Processes have interfaces across the organisation: their sequence and interactions should be determined 2014Integrated Management System5

6. IAEA 1. Introduction No single ‘process catalogue’ can apply to every organization Processes need to be developed to conduct the key regulatory functions in a stable, systematic, and consistent manner. The management system should maintain and improve the performance of the regulatory body by means of the planning, control and supervision of its safety related activities Each RB should determine which processes are to be documented, on the basis of its requirements, and the nature of its activities and overall strategy [From GSR Part 1| Req. 19, 22] 2014Integrated Management System6

7. IAEA 1. Introduction The development of processes necessary for the management system needs to consider: Planning Grading of the application of management system requirements Process management and interactions between them The approach to decision making The expectations of interested parties Management of organizational change and resolution of conflicts Communication Knowledge management, Human resources Infrastructure and the working environment Control of products, Purchasing Control of records and documentation of the management system Measurement, assessment and improvement 2014Integrated Management System7

8. IAEA 2. Process implementation For each process, the following activities should be performed Selecting a process team: the team leader, normally the process owner, representatives from the relevant departments, and a facilitator Identifying the major inputs and outputs and the interested parties Determining the risks and hazards, together with any necessary control measures and mitigatory actions Identifying interactions with interfacing processes Establishing process measurement criteria Identifying additional expectations from the process so as to be able to control performance 2014Integrated Management System8

9. IAEA 2. Process implementation Developing a process description that identifies: Governing documents, definitions and key requirements, e.g., applicable regulatory, statutory, legal, safety, health, environmental, security, quality and economic requirements Key process responsibilities and descriptions of activities Supporting documentation and requirements for records How the process is or has been validated where necessary Procedures for the approval and distribution of the process documents 2014Integrated Management System9

10. IAEA 2. Process implementation For each process, a flow chart may be use for description purpose 2014Integrated Management System10

11. IAEA 2. Process implementation Processes Management For each process a designated individual is given the authority and responsibility for: developing and maintaining the necessary supporting documentation ensuring effective interaction between interfacing processes ensuring that the records required exist monitoring and reporting on the performance of the process ensuring periodic reviewing and promoting improvement in the process The process owner has the authority to assess, monitor and propose changes to the process Process ownership is not regarded as a status issue. Process owners is not selected on the basis of their position in the management structure. [From GS-R 3|5.6, 5.9, 5.10; GS-G 3.1|5.14, 5.15, 5.16] 2014Integrated Management System11

12. IAEA 3. Core processes of the regulatory body Drafting, adopting, reviewing and revising Regulations and Guides The RB issues regulations and guides upon which its judgments, decisions and actions are based, specifying the documentation and procedures necessary in the various steps of the bidding process, site evaluation, licensing process and inspections A general procedure includes the details of general format and style of language to be used in developing the regulations and guides The periodic review of regulations and guides is established to keep these up to date Too frequent changes need to be avoided as they can affect the stability of the regulatory system, induce detrimental effects on the industry and investors, and reduce public confidence [From SSG-16|Action 30, 31, 161, 174] 2014Integrated Management System12

13. IAEA 3. Core processes of the regulatory body The procedure, to be adapted to Member States’ legal systems and practices, may include the following steps Determination of the need Setting the priorities Determination of the scope of the proposed regulations Determination of the resources to be employed Collection of information Drafting of the proposed regulations Review of the proposed regulations Establishing and issuing the regulations 2014Integrated Management System13

14. IAEA 3. Core processes of the regulatory body Review and Assessment The RB carries out comprehensive reviews and independent verifications of reports, such as site evaluation report, safety analysis report, submitted by the operating organization in order to verify compliance with the regulatory requirements Before granting an authorization or a licence for the construction of a nuclear installation, the RB reviews, assesses and inspects inter alia: the management system of the applicant documentation relating to demonstration of compliance with requirements of the selected design organizational and financial arrangements [From SSG-16|Action 120, 164] 2014Integrated Management System14

15. IAEA 3. Core processes of the regulatory body Licensing The RB specifies practical arrangements including what documents are required for a licence application, as well as the depth of review for each document submitted in support of a licence application in such a way that applicants are aware of the requirements Separate hold points are specified for certain steps in design, manufacturing, construction and commissioning, for the purpose of verifying the results of work and the preparedness to proceed The involvement of the public and interested parties, including public hearings, and resolution of the issues expressed in those hearings, is part of the licensing process [From SSG-16|2.68, 2.90] 2014Integrated Management System15

16. IAEA 3. Core processes of the regulatory body Inspection and Enforcement Regulatory inspections should cover all areas of responsibility of the RB RB should have the authority to carry out independent inspections The manner, extent and frequency of inspections shall be in accordance with a graded approach Regulatory enforcement actions may include recorded verbal notification, written notification, and imposition of additional regulatory requirements and conditions, written warnings, penalties and, ultimately, revocation of the authorization Regulatory enforcement may also entail prosecution. [From GS-R Part 1|4.52, 4.55] 2014Integrated Management System16

17. IAEA 4. Support processes of the regulatory body Control of documents A document control process needs to be established to provide for their preparation, review, approval, issuing, distribution, revision and validation (where appropriate) The types of document to be controlled includes: documents that define the management system; safety requirements; work instructions; assessment reports; drawings; data files; specifications; computer codes; purchase orders and related documents; supplier documents The documentation of the IMS should accommodate the feedback of experience from implementation and from internal and external lessons learned. [From GS-G 3.1|5.24, 5.26, 5.28; GS-G 3.1|2.46, 2.52] 2014Integrated Management System17

18. IAEA 4. Support processes of the regulatory body Control of products For Regulatory Body activity, “product” includes items, services or deliverables such as regulatory documents, licences, inspection reports, information provided to stakeholders… Specifications and requirements for products, including any subsequent changes, shall be in accordance with established standards and shall incorporate applicable requirements Administrative controls and performance indicators should be developed for each process [From GS-R 3|5.14, 5.16 ; GS-G 3.1|5.31, 5.32] 2014Integrated Management System18

19. IAEA 4. Support processes of the regulatory body Control of records The RB shall make provision for establishing, maintaining and retrieving adequate records relating to the safety of facilities and activities Storage facilities for records should be maintained to prevent damage from causes such as fire, water, air, rodents, insects, earthquakes and the actions of visitors without admission rights From GS-R.1 |Req. 35; GS-G 3.1|5.40, 5.46] 2014Integrated Management System19

20. IAEA 4. Support processes of the regulatory body Purchasing Purchasing requirements shall be developed and specified in procurement documents Evidence that products meet these requirements shall be available to the RB before the product is used [From GS-R 3|5.24] 2014Integrated Management System20

21. IAEA 4. Support processes of the regulatory body Communication and consultation with interested parties The RB is responsible to: promote the establishment of appropriate means of discussion that involve professional and constructive interactions with relevant parties inform and consult interested parties and the public about the possible radiation risks associated with facilities and activities, and about the processes and its decisions make arrangements to identify lessons learned from operating experience and regulatory experience, including in other States begin establishing a suitable working relationship with the operating organization and with international organizations [ From GS-R Part 1|Req. 36, 4.66, 4.67; GS-R Part 2 - Draft (2011)| 2.36; GS-R Part 1|Req. 14, 15 ; SSG16|Action 32] 2014Integrated Management System21

22. IAEA 4. Support processes of the regulatory body Managing organizational change Organizational changes should be evaluated and classified according to their importance to safety and each change be justified The implementation of such changes shall be planned, controlled, communicated, monitored, tracked and recorded to ensure that safety is not compromised [From GS-R 3 |5.28, 5.29] 2014Integrated Management System22

23. IAEA 4. Support processes of the regulatory body Interfaces with other issues such as environment protection, emergency and security The RB and relevant parties should ensure that programmes for environmental monitoring, for emergency preparedness and response are made available All the relevant organizations should coordinate safety and security aspects from the early stages of development. There should be mechanisms to communicate to the public appropriate information regarding safety and nuclear security Where the responsibilities of the regulatory body and other organizations interact or have an interface, formal agreements should be established [From GSR Part 3 Interim | Req. 32, 43; GS-R.1 Req. 8; SSG16|Action 138; SSG16|Action 194, 195, 196; GS-G-1.1|3.36, 3.38] 2014Integrated Management System23

24. IAEA 4. Support processes of the regulatory body SSG-16 Action 76: The regulatory body (and the operating organization) need to develop competences in managing the growth of and change in the organization Careful consideration of the interactions between different changes The process for managing change to identify and evaluate the risks to the objectives of the organization, including safety, health, environmental, security, quality and economic risks, and ensure that there is no degradation in the safety culture of the regulatory body Careful consideration of the total workload imposed on the organization to implement the changes in parallel with continued operational activities [From GS-G 3.1|5.61, 5.62, 5.66, 5.67, 5.59] 2014Integrated Management System24

25. IAEA THANK YOU 2014LMSRB | Safety Culture25