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.10 . Assessment of effectiveness of the regulatory programmes 10.1 Overview & Management System

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

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.

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.

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

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

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

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

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

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

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

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

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.

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

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

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

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

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)

Further information http://www-ns.iaea.org/default.asp IAEA Safety Requirements BSS GSR Part 3 (Interim) IAEA 2011 http://www-pub.iaea.org/MTCD/Publications/PDF/p1531_startpage.pdf 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- 1.4 IAEA 2001 IAEA Inspection of Radiation Sources and Regulatory Enforcement TECDOC 1526 (2007) IAEA-TECDOC- 1090 Quality assurance within regulatory bodies, IAEA, 1999