1. Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Program Performance Criteria

2. Slide 2 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 4-3 To identify criteria against which the status of each element of the regulatory program can be assessed Objective

3. Slide 3 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 4-3 Identifying the types of information and data that are relevant for the analysis including reports of incidents and accidents, inspection findings, trends in use of radiation technologies. Use of analysis including basis for adjustments of inspection frequency, the need for more in-depth authorisation procedure, the need for more prescriptive regulations or guidance for authorised users. Contents

4. Slide 4 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 4-3 Performance indicators provide qualitative or quantitative information that can be compared with performance criteria. Performance Criteria allow judgements to be made. Performance criteria should be established for each area of regulatory infrastructure. Judgement of Effectiveness

5. Slide 5 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 4-3 is a Regulatory Authority:- –established and empowered? –resourced to fulfil its role? –effectively independent? are regulations promulgated? do laws / regulations define the scope and provide for exemptions? Legislation

6. Slide 6 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 4-3 Do regulations provide for the safety and security of radiation sources? Are regulations revised and updated based on operational experience and international recommendations (eg. the BSS)? Does the Regulatory Authority apply a systematic approach to the fulfillment of its responsibilities? Do the regulations provide occupational, public and patient protection? Legislation (cont)

7. Slide 7 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 4-3 Can the Regulatory Authority access information on radiation doses to workers and on discharges to the environment? Has the Regulatory Authority established procedures for quality assurance and analysis of program data? Is the Regulatory Authority self-sufficient in specialist expertise, or is it available through expert advisers/advisory committees? Legislation (cont)

8. Slide 8 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 4-3 During its development phases, has Regulatory Authority:- prioritized sources and practices? Notifications identified and listed likely users? informed users of notification requirement? followed up non-responders? followed up contradictory information?

9. Slide 9 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 4-3 During the operational phase, does the Regulatory Authority:- –document and log sources and users? –periodically update the source inventory? –check on the accuracy of the inventory (especially high risk sources or practices)? Can the Regulatory Authority identify and locate radiation sources? Notifications (cont)

10. Slide 10 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 4-3 Does the Regulatory Authority have criteria for the level of authorization required for sources/practices? Authorization (licensing / registration) Are application forms and guidance documents available? Are priorities established for reviewing applications? Is guidance developed /adopted for the assessment of applications? Is such guidance easily available?

11. Slide 11 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 4-3 Does assessment of completed authorizations indicate: guidance is being followed, inspection history reviewed and radiation protection/safety issues properly addressed? Authorization (licensing / registration) cont clearly what is authorized and what requirements users must meet, and whether such requirements are appropriate? that the process is adequately documented? that the assessment process is completed in a timely manner?

12. Slide 12 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 4-3 Does the Regulatory Authority have a register of authorizations by category of practice? Authorization (licensing / registration) cont Does the Regulatory Authority request periodic radiation protection and safety reports from users? Has the Regulatory Authority established lines of communication with senior management of authorized users?

13. Slide 13 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 4-3 Have inspection priorities, frequencies and schedules been established? –in relation to hazards –in consideration of past performance Inspections Are guidance documents available to inspectors and followed during inspections? Are inspections addressing correct issues? Are inspection reports clear and consistent with guidance?

14. Slide 14 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 4-3 Do inspection reports adequately address radiation safety issues and non-compliance? Inspections (cont) Are the findings communicated to in user in a clear and timely manner? Are the findings communicated to in appropriate Regulatory Authority staff in a clear and timely manner? Is there documented follow-up to non-compliance (including follow-up inspections)?

15. Slide 15 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 4-3 Are inspections being performed within specified frequencies? Inspections (cont) Is there a database derived from inspection reports? –reviewed and analyzed? Is there a database on occupational exposures? –reviewed and analyzed? Are actions taken on the findings of such analysis?

16. Slide 16 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 4-3 Has enforcement policy/guidance been established? Enforcement Is there interaction between authorization and inspection staff regarding enforcement actions? Do inspection findings lead to timely enforcement actions? Are users required to provide details of corrective actions taken?

17. Slide 17 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 4-3 Are user corrective actions appropriately evaluated? Enforcement (cont) Are challenges (legal or otherwise) to enforcement actions successfully defended? Have criteria for the application of sanctions, if appropriate, been established?

18. Slide 18 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 4-3 Are the roles and functions for emergency management defined and documented? Emergency Response Is there a national emergency plan? –defining the roles of national and local organizations? Is the Regulatory Authority’s plan integrated with the national plan? Are there regulations/guidance on reporting of accidents and incidents?

19. Slide 19 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 4-3 Are adequate procedures, training programs, equipment, facilities and support available? Emergency Response (cont) Are actions levels established? For severe types of accidents, are emergency exercises conducted to –assess effectiveness of emergency plan? –ensure capabilities remain effective? Are emergency response plans modified in accordance with lessons learned following exercises?

20. Slide 20 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 4-3 Have dose investigation levels been established? Investigation and follow-up Have procedures for the investigation of accidents been established including:-?  documentation?  follow-up procedures? Is the response to accidents timely, appropriate, in accordance with procedures? Is the level of effort commensurate with the health and safety significance?

21. Slide 21 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 4-3 Are findings documented? Investigation and follow-up (cont) Is appropriate corrective and/or enforcement action taken? Is effectiveness of subsequent corrective and/or enforcement actions verified? Are accidents analyzed for ‘lessons learned’ and information disseminated? Is there participation in international reporting and dissemination?

22. Slide 22 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 4-3 Dosimetry –external, internal, accredited Technical Services Laboratory services Calibration services, traceable to standards Radioactive waste management facilities Training services Expert technical assistance

23. Slide 23 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 4-3 Have areas where co-ordination and co-operation is needed been identified? –customs, emergencies, transport, public health Co-ordination and co-operation Have appropriate procedures been adopted and implemented? Is there a specific arrangement with customs to prevent unauthorized import of sources? –does it work ? Are international co-ordination and co-operations agreements in place?

24. Slide 24 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 4-3 Are staff qualification requirements and training plans: –in place? –appropriate? –funded ? Staffing and Training Are there sufficient staff numbers? Is staff turnover rate adversely affected by:- –compensation? –lack of satisfaction? –management practices?

25. Slide 25 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 4-3 Is funding of the Regulatory Authority independent of income from authorizations, inspections and fines? Funding Are its resources adequate to properly perform its functions? Are the Authority’s facilities and equipment adequate for required tasks?

26. Slide 26 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 4-3 Are there procedures for –the collection of important radiation safety information? –dissemination of such information to users, manufacturers, suppliers, international organizations? Information Dissemination Are there procedures for rapid dissemination of information in the wake of an accident? Are there procedures for making information available to members of the public / media?

27. Slide 27 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 4-3 IAEA-TECDOC 1217 References