1. Postgraduate Educational Course in radiation protection and the Safety of Radiation sources
PGEC Part IV The International System of Radiation Protection and the Regulatory Framework
Module IV Assessment of effectiveness
of the regulatory programmes
10.1 Overview & Management System

2. Overview of Module IV.10
This module will discuss the following aspects:
10.1 Management and assessment of the effectiveness of the Regulatory Programme, Management system
10.2 Collection and analysis of program data, Programme performance indicators, peer review, conducting an assessment, performance criteria

3. Effectiveness of the Regulatory Program
Requirement 16: Organizational structure of the regulatory body and allocation of resources
The regulatory body shall structure its organization and manage its resources so as to discharge its responsibilities and perform its functions effectively; this shall be accomplished in a manner commensurate with the radiation risks associated with facilities and activities.

4. Effective Regulatory Body
Given the necessary authority and resources as prerequisites, the regulatory body is effective when it:
Ensures that an acceptable level of safety is being maintained by the regulated operating organisations.
Develops and maintains an adequate level of competence.
Takes appropriate actions to prevent degradation of safety and to promote safety improvements.
Performs its regulatory functions in a timely and cost-effective manner as well as in a manner that ensures the confidence of the operating organisations, the general public, and the government.
Strives for continuous improvements in its performance.

5. Management System
Requirement 3: Responsibilities of the regulatory body
The regulatory body shall establish or adopt regulations and guides for protection and safety and shall establish a system to ensure their implementation.
The regulatory body shall establish, implement, assess and strive to continually improve a management system that is aligned with the goals of the regulatory body and that contributes to the achievement of those goals

6. Management system
The regulatory body needs a management system, and this is important element of ensuring effectiveness of a regulatory programme, and achieving the goals of the regulatory body

7. Management system Core functions of the Regulatory Body
Notification and authorization;
Review and assessment of facilities and activities;
Inspection of facilities and activities;
Enforcement of regulatory requirements;
The regulatory functions relevant to emergency exposure situations and existing exposure situations;
Provision of information to, and consultation with, parties affected by its decisions and, as appropriate, the public and other interested parties.
To be effective requires clear allocation of responsibilities for all functions, and structured and systematic processes

8. Management system of regulatory processes
Structured and systematic written procedures facilitate:
Legality
Equality
Objectivity
Efficiency
Openness (and thus confidence in)
of regulatory processes

9. Regulatory processes Legality Equality
Legislation and regulations need to be complied with in all regulatory processes
Equality
All “customers” are treated in equal manner
Similar matters are solved in the same way

10. Regulatory processes Objectivity Efficiency Openness
Rules for transferring the treatment of a matter to an other officer in case of legal incompetence
Efficiency
Standardised processes streamline the conducting the programme
Openness
Regulatory control procedures are transparent and “tolerate” outside criticism

11. Management system Management system = Quality system
Designation of responsibilities and interaction within the organization
Documentation of policies, functions and procedures
Maintenance of records of regulatory Body functions
Maintenance of information and data
Assessment of programme efficiency
Feedback to improve the programme

12. Quality system General Structure and content is organization dependent
Quality system can not be transferred, it shall be created from the needs of each organization
Quality system describes existing functions and procedures and establishes a system for their systematic improvement

13. Quality system Quality policy; Statement on quality
Manuals on organization level functions and procedures
Manuals on department-specific functions and procedures
Work instructions, laboratory handbooks, etc.

14. Quality policy Basic values and vision for
Overall mission of the organization
Conduction of work
Personnel policy
Management
Public communication
etc.
Developed and signed by senior management

15. Organization level functions
Examples of Quality Manual topics
Quality system
Designation of responsibilities and interaction within the organization
Rules of administration and finance
Main and supportive functions
Personnel administration
Quality assessment

16. Department level functions
Examples of Quality Manual topics
Designation of responsibilities
Procedures for main functions
Review of license applications
Conduction of inspections
Practice-specific procedures for control
Procedures to be followed in case of an accident/incident
Preparation of guides
Information collection and dissemination

17. Assessment of operations
Self Assessment
Continuous assessment should be part of management functions
More formal assessemnt may be done annually, feedback to strategic planning
Should cover all activities
Results assessed by senior management
Quality Award Criteria or other similar criteria can be used

18. Assessment of operations
Internal audits
Internal audit programme
Management reviews on audits
Annually
Organization level
Department level
External assessment of operations
E.g. IAEA International Regulatory Review Team (IRRT)

19. Further information http://www-ns.iaea.org/default.asp
IAEA Safety Requirements BSS GSR Part 3 (Interim) IAEA
IAEA Safety Requirements: Governmental, Legal and Regulatory Framework for Safety. GSR Part 1 IAEA 2010
IAEA Safety Requirements: The Management System for Facilities and Activities; IAEA Safety Standards Series No. GS-R-3 : IAEA 2006.
IAEA, Organization and Implementation of a National Regulatory Infrastructure… , IAEA-TECDOC-1067, Vienna (1999).
IAEA, Assessment by Peer Review of the effectiveness of a regulatory programme for radiation safety IAEA- TECDOC-1217 (2001).
IAEA Safety Guide: Building Competence in Radiation Protection and the Safe Use of Radiation Sources RS-G IAEA 2001
IAEA Inspection of Radiation Sources and Regulatory Enforcement TECDOC (2007)
IAEA-TECDOC Quality assurance within regulatory bodies, IAEA, 1999