1. Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Staffing and Training

2. Slide 2 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-12 To understand approaches to the development of strategies and policies for staffing of a Regulatory Authority including recruitment and training Objective

3. Slide 3 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-12 Identification of the types of skills needed by Regulatory Authority staff on a day to day basis and the kinds of skills needed occasionally. The use of consultants and advisory committees. Development and use of a staffing plan. Contents

4. Slide 4 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-12 The Regulatory Authority should have:- Requirements staffing plans staff qualification requirements individual training plans funding for staff training

5. Slide 5 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-12 Staffing levels will depend on:- the size, scope and complexity of practices; Staffing Levels the degree to which standardized sources, facilities and equipment suitable for generic assessment are in use; the nature of the regulations (prescriptive/performance); the extent to which practice specific guidance documents and standard assessment plans are used; the status of the regulatory program i.e. organization, implementation or operational phase.

6. Slide 6 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-12 A Suggested Structure for a Regulatory Authority DIRECTOR TECHNICAL SERVICES INSPECTIONSAUTHORIZATIONS ADMINISTRATIVE LEGAL & ENFORCEMENT Could be part of Administrative, or external

7. Slide 7 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-12 Budget and staff recruitment; Responsibilities of the Director of the Authority Regular reviews of the program's effectiveness. e.g. number of applications received and processed; number of notifications; registrations and licences; inspections performed; accident / incident reports and follow-up; etc. Supervise regulation amendments; Dissemination of Information to the public and authorities.

8. Slide 8 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-12 maintain the budget; Responsibilities of the Administrative Section prepare job descriptions; administer recruitment and personnel matters; maintain coordinated staffing and training plans; arrange training; perform housekeeping tasks; maintain and co-ordinate emergency response;

9. Slide 9 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-12 development of regulations* Responsibilities of the Administrative Section (cont) *could be the responsibility of a separate legal and enforcement section maintain source inventory; prepare policies and procedures*; analyze program data for quality management system; disseminate information.

10. Slide 10 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-12 maintain radiation monitoring equipment operate or identify analytical laboratory/equipment Responsibilities of the Technical Section

11. Slide 11 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-12 establish safety assessment review procedures; Responsibilities of the Authorization Section establish schedules for submission of applications and safety assessments; review notifications and authorization applications; initiate detailed safety assessments when indicated by inspections.

12. Slide 12 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-12 initiate inspections based on requirements of new regulations and in accordance with established inspection priorities and schedules; Responsibilities of the Inspection Section initiate enforcement action as appropriate; investigate the potential for abandoned, orphan sources; follow up on status of potential users that have not submitted appropriate notifications.

13. Slide 13 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-12 Authorizations Regulations and codes development Inspections RADIOTHERAPY DIAGNOSTIC X-RAYS INDUSTRIAL Input from Regulatory Staff

14. Slide 14 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-12 Regulatory sections require:- professional staff with appropriate qualifications and experience in radiation safety; and Regulatory Authority Staff clerical support; The regulatory control of medical diagnosis and radiotherapy generally requires special expertise. Technical skills needed by Regulatory Authority staff are normally acquired through education, training and on the job training

15. Slide 15 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-12 knowledge of a radiation safety regulatory program (legislation and regulations); knowledge of the safety of radiation sources that are subject to regulatory control; operational and regulatory experience to effectively verify that regulations are being implemented and complied with. Regulatory sections require:- a broad knowledge of radiation protection; Regulatory Authority Staff

16. Slide 16 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-12 Staffing analysis (inspectors) Assume that 600 inspections are carried out annually. Estimating Staffing Needs Required Inspection Staff Based on experience, assume that it takes an average of 20 [2-20] hours/per inspection. Therefore, the total inspection hours are 600 x 20 = 12,000 hours. Assume also that each inspector works 1,600 hours per year. Therefore, 7.5 full equivalent (FTE) persons are required.

17. Slide 17 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-12 New licence application hours = 30 x 40 hours / licence Total hours (new) = 1,200 hours Staffing analysis (licensing) New applications: Assume 30 new licence applications per year Amendment, renewals, cancellations of licence. Assume 600 per year Amendment licence hours = 600 x 10 hrs / licence, etc Total hours (amendment, etc) = 6,000 hours Estimating Staffing Needs (cont)

18. Slide 18 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-12 Total Licensing hours = 7,200 hours Assume that each licensing officer works 1,600 hours per year Therefore, 4.5 full equivalent (FTE) persons are required Staffing analysis (licensing; cont) Estimating Staffing Needs (cont)

19. Slide 19 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-12 Recommended staff value: 1 FTE for every 100 licensees Staffing analysis (licensing; cont) Estimating Staffing Needs (cont)

20. Slide 20 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-12 to ensure that the proper skills are acquired and that adequate levels of competence are achieved and maintained; Objectives of a Staff Training Program to ensure that staff are aware of technological developments and new safety principles and concepts.

21. Slide 21 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-12 legislation and regulations the authorization process procedures and guidance for authorization assessment procedures and guidance for inspections the enforcement policy emergency response procedures, etc Contents of a Staff Training Program (cont)