1. Programme Performance Criteria

2. Regulatory Authority Objectives To identify criteria against which the status of each element of the regulatory programme can be assessed

3. Judgement of Effectiveness 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

4. Performance Criteria Laws/Regulations and Regulatory Authroity Is a Regulatory Authority  Established and empowered?  Resourced to fulfil its role?  Effectively independent? Are Regulations Promulgated? Do laws/regulations define scope & provide for exemption?

5. Performance Criteria Laws/Regulations and Regulatory Authroity Do regulations provide for safety & security of radiation sources? Are regulations revised and updated based on operational experience & international recommendations (eg. the BSS)? Does Regulatory Authority apply a systematic approach to the fulfillment of its responsibilities? Do regulations provide occupational, public and patient protection?

6. Performance Criteria Laws/Regulations and Regulatory Authroity Can Regulatory Authority access information on doses to workers & discharges to environment? Has Regulatory Authority established procures for quality assurance & analysis of programme data? Is Regulatory Authority self-sufficient in specialist expertise, or is it available through expert advisers/advisory committees?

7. Performance Criteria Notification During developmental phases, has Regulatory Authority  prioritised sources and practices?  identified and listed likely users?  informed users of notification requirement?  followed up non-responders?  followed up contradictory information?

8. Performance Criteria Notification During operational phase, does Regulatory Authority  document and log sources and users?  periodically update inventory?  check on accuracy of inventory ? (especially high risk sources or practices) Can Regulatory Authority identify and locate radiation sources?

9. Performance Criteria Authorization (licensing/registration) Does the Regulatory Authority have criteria for the level of authorization required for sources/practices? Are application forms and guidance available? Are priorities established for reviewing applications? Is guidance developed/adopted for assessment of applications? Is such guidance easily available?

10. Performance Criteria Authorization (licensing/registration) Does assessment of completed authorizations indicate:  guidance is being followed, inspection history reviewed and radiation protection/safety issues properly addressed?  clear indication of what is authorized and what requirements user must meet?  such requirements appropriate?  the process is adequately documented?  the assessment process is completed in a timely manner?

11. Performance Criteria Authorization (licensing/registration) Does the Regulatory Authority have a register of authorization, by category of practice? Does the Regulatory Authority request from users periodic radiation protection and safety reports? Has the Regulatory Authority established lines of communication with senior management of authorized users?

12. Performance Criteria Inspections Have inspection priorities, frequencies and schedules been established?  in relation to hazards  in consideration of past performance Are guidance documents available to inspectors and followed during inspections? Are inspections addressing correct issues? Are inspection reports clear and consistent with guidance?

13. Performance Criteria Inspections Do inspection reports adequately address radiation safety issues and non-compliance? 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)?

14. Performance Criteria Inspections Are inspections being performed within specified frequencies? 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?

15. Performance Criteria Enforcement Has enforcement policy/guidance been established? 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?

16. Performance Criteria Enforcement Are user corrective actions appropriately evaluated? Are (legal) challenges to enforcement actions successfully defended? Have criteria for the application of sanctions, if appropriate, been established?

17. Performance Criteria Emergency Response Are the roles and functions for emergency management defined and documented? Is there a national emergency plan?  defines roles of national and local organization Is Regulatory Authority’s plan integrated with national plan? Are there regulations/guidance on reporting of accidents and incidents?

18. Performance Criteria Emergency Response Are adequate procedures, training programmes, equipment, facilities and support available? 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?

19. Performance Criteria Investigation and follow-up Have dose investigation levels been established? Have procedures for investigation of accidents been established?  Documentation  follow-up procedures Is response to accidents timely, appropriate, in accordance with procedures? Is level of effort commensurate with health & safety significance?

20. Performance Criteria Investigation and follow-up Are findings documented? 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?

21. Performance Criteria Technical Services Dosimetry  external, internal, accredited Laboratory services Calibration services, traceable to standards Radioactive waste management facilities Training services Expert technical assistance

22. Performance Criteria Co-ordination and Co-operation Have areas where co-ordination and co- operation is needed been identified?  customs, emergencies, transport, public health 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?

23. Performance Criteria Staffing and training Are staff plans, qualification requirements and training plans:  in place?  appropriate?  funded ? Are there sufficient staff numbers? Is staff turnover rate adversely affected by  compensation?  lack of satisfaction?  management practices?

24. Performance Criteria Funding Is funding independent of income from authorizations, inspections and fines? Are resources adequate for Regulatory Authority to perform its functions? Are facilities and equipment adequate for required tasks?

25. Performance Criteria Information dissemination Are there procedures for  collection of important radiation safety information?  dissemination of such information to users, manufacturers, suppliers, international organizations? 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?

26. References IAEA-TECDOC 1217