1. Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Management Systems Part I

2. Slide 2 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 4-1 Part I To understand the importance of a management system to ensure effectiveness of a regulatory program and its upgrading Objective

3. Slide 3 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 4-1 Part I Establishment of a management system that includes clear designation of responsibilities and internal interactions among organizational units of a regulatory authority. Documentation of internal policies and procedures and their continuous updating. Maintenance of records of the Regulatory Authority’s functions Maintenance of information and data. Contents

4. Slide 4 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 4-1 Part I Preparation of regulations and guides Authorization Inspection Enforcement Core Functions of the Regulatory Authority Competent work requires clear allocation of responsibilities, and structured and systematic processes

5. Slide 5 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 4-1 Part I Structured and systematic written procedures facilitate:- objectivity; efficiency; legality; equality; openness (and thus confidence in) the regulatory processes. Management System

6. Slide 6 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 4-1 Part I Legality Legislation and regulations need to be complied with in all regulatory processes Regulatory Processes Equality All “customers” are treated in equal manner Similar matters are solved in the same way

7. Slide 7 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 4-1 Part I Objectivity Rules for transferring the treatment of a matter to an other officer in case of legal incompetence Regulatory Processes (cont) Efficiency Standardised processes streamline the conduction of the program Openness Regulatory control procedures are transparent and “tolerate” outside criticism

8. Slide 8 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 4-1 Part I Management system = Quality system designation of responsibilities and interaction within the organization; Management System documentation of policies, functions and procedures; maintenance of records of regulatory authority functions; maintenance of information and data; assessment of program efficiency; feedback to improve the program.

9. Slide 9 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 4-1 Part I General The structure and content of a quality system is organization dependent. Quality System It cannot be transferred but shall be created based on the needs of each organization. A quality system describes existing functions and procedures and establishes a system for their systematic improvement.

10. Slide 10 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 4-1 Part I a quality policy (a statement on quality); Quality System (cont) A quality system includes the preparation of:- manuals on the organization, levels, functions and procedures; manuals on section specific functions and procedures; work instructions, laboratory manuals, etc.

11. Slide 11 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 4-1 Part I the overall purpose and aims of the organization; Quality Policy A quality system provides basic values and vision for:- The policy should be developed and acknowledged (signed) by senior management the conduct of work; personnel policy; management; public communication. etc.

12. Slide 12 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 4-1 Part I Examples of Quality Manual topics Quality system; Organization Level Functions Designation of responsibilities and interaction within the organization; Rules of administration and finance; Main and supportive functions; Personnel administration; Quality assessment.

13. Slide 13 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 4-1 Part I Examples of Quality Manual topics (cont) Department Level Functions Procedures for main functions –review of licence applications; –conduct of inspections; –practice specific procedures for control; –procedures to be followed in case of an accident or incident. Preparation of guides; Information collection and dissemination.

14. Slide 14 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 4-1 Part I Self Assessment usually annually with feedback to strategic planning; Assessment of Operations should cover all activities; results should be assessed by senior management; quality award criteria or other similar criteria can be used.

15. Slide 15 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 4-1 Part I Internal audits Internal audit program Assessment of Operations (cont) Management reviews on audits Annually Organization level Department level External assessment of operations e.g. IAEA International Regulatory Review Team (IRRT)

16. Slide 16 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 4-1 Part I Personal dosimetry; Accreditation of Technical Services Measurement and analytical services used for dose monitoring should have a formal accreditation. Gamma measurements; Analyses of different radionuclides (e.g. 3 H, 89 Sr, 90 Sr, 238 Pu, 239 Pu, 240 Pu, 241 Pu, 241 Am, 242 Cm, 243 Cm, 244 Cm, 222 Rn, 234 U, 238 U, etc.); Whole body counting.

17. Slide 17 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 4-1 Part I IAEA-TECDOC- 1090 Quality assurance within regulatory bodies, IAEA, 1999 References

18. Slide 18 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 4-1 Part I What would be the most important topics for internal guidance (a Quality Manual) for a new Regulatory Authority being established? Exercise