1. Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Inspection Part II

2. Slide 2 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-7 Part II To provide an understanding of an inspection program and inspection procedure. Objective

3. Slide 3 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-7 Part II Objectives of inspections, including inspections prior to authorization and regular inspections. Establishing priorities and frequencies of inspection based on categorization of sources, complexity of practice, history of performance, etc. Contents

4. Slide 4 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-7 Part II Contents (cont) Announced and unannounced inspections. Pre-inspection preparation. Conduct of a inspection including the use of inspection check lists. Exit briefing of the legal person. Content of the inspection report with emphasis on items of non-compliance. Indicators of degraded performance.

5. Slide 5 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-7 Part II Pre-authorization inspection Prior to a practice starting work with radiation sources (to confirm structural shielding and other safety issues). Types of Inspection Final inspection Cessation of operations leading to termination of an authorization (e.g. to confirm a decontamination report; the removal of warning signs, etc).

6. Slide 6 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-7 Part II Announced inspections Regular inspections to identify changes which might require a review of safety and/or modification of the conditions of the authorization. Types of Inspection (cont) Unannounced inspections At varied intervals, particularly of potentially high risk practices where portable or mobile sources are being used (e.g. industrial radiography, well logging, etc.) Priorities and frequencies should be established in accordance with Regulatory Authority’s inspection program

7. Slide 7 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-7 Part II Additional inspections may be required:- in the event of abnormal events such as safety related incidents or accidents; Types of Inspection (cont) should there be significant changes in the practice (structural alterations, new radiation sources, changes in key personnel, etc); to investigate complaints by staff or the public.

8. Slide 8 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-7 Part II Advantages The practice is likely to be seen operating under its usual conditions. Unannounced Inspections Disadvantages Key personal might not be available to answer specific questions (eg RPO, responsible practitioners, etc); Some activities within the practice might not be in operation at the time. Appropriate timing of an unannounced inspection may require working knowledge of the practice’s operations.

9. Slide 9 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-7 Part II Inspection at short notice or without notice may be required if the Authority believes that an event warrants immediate investigation and action. Abnormal Events However, such inspections must not diminish the responsibility of the licensee to investigate relevant events immediately.

10. Slide 10 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-7 Part II The Regulatory Authority should establish an inspection program for each type of radiation practice detailing:- Inspection Program the frequency of regular inspections; the scope and depth of investigations; any exemptions from regular inspections. the types of inspections to be conducted;

11. Slide 11 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-7 Part II The frequency of regular inspections may be based on the:- potential for significant exposure (related to the categorization of radiation sources); Inspection Program (cont) complexity of the practice (complex work practices might increase the risk potential); past performance (history of compliance); resources of the Regulatory Authority.

12. Slide 12 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-7 Part II Provides a system for ranking of sources and practices in terms of their potential to cause harm to human health Can be used as a tool in planning the inspection frequency Categorization of Radioactive Sources Inspection Program (cont)

13. Slide 13 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-7 Part II Suggested inspection frequency related to source categorization Teletherapy sources Irradiators Industrial gamma radiography sources High/medium dose rate brachytherapy sources Industrial gauges with high activity sources Well logging gauges Low dose rate brachytherapy sources Industrial gauges with moderate/low activity sources X-ray fluorescence (XRF) devices Electron capture devices 1234512345 Frequency years Category 1 1-2 1-3 3-5 5 Inspection Program (cont)

14. Slide 14 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-7 Part II Suggested inspection frequency of health care practices Frequency years 1 1-2 2-3 3-5 5 Inspection Program (cont) Radiotherapy Nuclear medicine Diagnostic radiology - complex equipment (CT, interventional radiology, mammography etc.) Diagnostic radiology - conventional x-ray equipment Dental radiography

15. Slide 15 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-7 Part II The scope and depth of inspection depends on the:- potential for significant exposure; Inspection Program (cont) reliability (past performance) of the licensee; qualifications and competence of the RPO; qualifications and competence of the workers; inspection records; resources of the Regulatory Authority

16. Slide 16 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-7 Part II Some practices may be exempted from inspection e.g. very low safety risk sources (such as the use of fixed static eliminators, installation of smoke detectors, etc;) that have practically no potential for significant exposure Inspection Program (cont) The use of inspection exemptions should be considered part of the necessary prioritisation of the resources of the Regulatory Authority

17. Slide 17 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-7 Part II analyze the available information i.e. documents concerning the authorization including the safety assessment and history of the practices carried out. Pre-inspection Preparation review previous inspection reports i.e. noting previous non-compliance and any issues from past inspections that have not been resolved. In preparing for an inspection, officers should:-

18. Slide 18 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-7 Part II identify and prioritize potential problem areas; Pre-inspection Preparation (cont) select and/or prepare site or practice specific checklist(s); decide, from the Authority’s protocols or after consultation with their superiors, whether to perform an announced or unannounced inspection. In preparing for an inspection, officers should:- Example of practice specific inspection checklist

19. Slide 19 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-7 Part II survey instruments for measuring radiation and contamination levels (calibrated, with detectors appropriate to the radiation type); Pre-inspection Preparation (cont) In preparing for an inspection, officers should select equipment and instruments that might include:- personal protective equipment; personal dosimeters.

20. Slide 20 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-7 Part II Persons that might be involved at the entrance briefing include:- the radiation protection officer; a representative of the management; a representative of the workers. Entrance Briefing The Inspector should be prepared to discuss:- the purpose and scope of the inspection; the inspection plan (which may require adjustments based on findings and the concerns of workers).

21. Slide 21 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-7 Part II Inspections may involve:- general observations of work practices; Inspection Methodologies examination of records; examination of written guidance on working procedures; interviews with management and workers; independent measurements of radiation and contamination levels; routine checks of safety control systems.

22. Slide 22 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-7 Part II Inspection manuals and check-lists:- help identify items to be checked during the inspection; Inspection Methodologies (cont) are practice specific; provide the inspector with a resource on acceptable and unacceptable performance criteria; form part of the Authority’s quality/management system can enable less skilled or experienced staff to conduct inspections.

23. Slide 23 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-7 Part II Common performance indicators include:- a lack of management commitment to safety; Indicators of Degraded Performance a lack of RPO oversight (or too busy or inadequate authority) with other duties; too few (too busy) staff to conduct an effective radiation protection program; the radiation protection program not discussed by responsible individuals; the quality assurance program failing to detect radiation safety problems.

24. Slide 24 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-7 Part II The inspector should be prepared to discuss:- observations and conclusions from the inspection; further (or immediate) action that may be required. Exit Briefing Persons that might be involved at the exit briefing include:- the inspector; the radiation protection officer; a representative of the management; a representative of the workers.

25. Slide 25 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-7 Part II Analysis of information Pre-inspection preparation Plan for inspection Equipment and instruments Entrance briefing Observations, assessments Exit briefing Inspection Summary

26. Slide 26 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-7 Part II References Inspection of Radiation Sources and Enforcement IAEA Safety Report

27. Slide 27 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-7 Part II Choose an appropriate inspection interval for each practice 1-3 years; 3-5 years; 5-10 years; No inspections Exercise