Presentation on theme: "Postgraduate Educational Course in radiation protection and the Safety of Radiation sources PGEC Part IV The International System of Radiation Protection."— Presentation transcript:
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 FrameworkModule IV Assessment of effectivenessof the regulatory programmes10.1 Overview & Management System
2 Overview of Module IV.10This module will discuss the following aspects:10.1 Management and assessment of the effectiveness of the Regulatory Programme, Management system10.2 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 resourcesThe 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 SystemRequirement 3: Responsibilities of the regulatory bodyThe 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 systemThe 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:LegalityEqualityObjectivityEfficiencyOpenness (and thus confidence in)of regulatory processes
9 Regulatory processes Legality Equality Legislation and regulations need to be complied with in all regulatory processesEqualityAll “customers” are treated in equal mannerSimilar 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 incompetenceEfficiencyStandardised processes streamline the conducting the programmeOpennessRegulatory control procedures are transparent and “tolerate” outside criticism
11 Management system Management system = Quality system Designation of responsibilities and interaction within the organizationDocumentation of policies, functions and proceduresMaintenance of records of regulatory Body functionsMaintenance of information and dataAssessment of programme efficiencyFeedback 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 organizationQuality 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 proceduresManuals on department-specific functions and proceduresWork instructions, laboratory handbooks, etc.
14 Quality policy Basic values and vision for Overall mission of the organizationConduction of workPersonnel policyManagementPublic communicationetc.Developed and signed by senior management
15 Organization level functions Examples of Quality Manual topicsQuality systemDesignation of responsibilities and interaction within the organizationRules of administration and financeMain and supportive functionsPersonnel administrationQuality assessment
16 Department level functions Examples of Quality Manual topicsDesignation of responsibilitiesProcedures for main functionsReview of license applicationsConduction of inspectionsPractice-specific procedures for controlProcedures to be followed in case of an accident/incidentPreparation of guidesInformation collection and dissemination
17 Assessment of operations Self AssessmentContinuous assessment should be part of management functionsMore formal assessemnt may be done annually, feedback to strategic planningShould cover all activitiesResults assessed by senior managementQuality Award Criteria or other similar criteria can be used
18 Assessment of operations Internal auditsInternal audit programmeManagement reviews on auditsAnnuallyOrganization levelDepartment levelExternal assessment of operationsE.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) IAEAIAEA Safety Requirements: Governmental, Legal and Regulatory Framework for Safety. GSR Part 1 IAEA 2010IAEA 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 2001IAEA Inspection of Radiation Sources and Regulatory Enforcement TECDOC (2007)IAEA-TECDOC Quality assurance within regulatory bodies, IAEA, 1999