Training Course on Integrated Management System for Regulatory Body Module 5 (Development of IMS) (4) Graded approach

Objective The aim is to introduce the Application of grading Concept of graded approach when establishing the IMS Graded approach reflected in regulatory body activities IAEA Training Course on IMS Module 5.4

Content Defining graded approach Requirements Methods for grading Graded approach and activities P IAEA Training Course on IMS Module 5.4

Defining graded approach For a system of control, such as a regulatory system or a safety system, a process or method in which the stringency of the control measures and conditions to be applied is commensurate, to the extent practicable, with the likelihood and possible consequences of, and the level of risk associated with, a loss of control. IAEA-Tecdoc-1740 IAEA Training Course on IMS Module 5.4

Defining graded approach Grading is an approach to designing and applying requirements to an activity, item or service based on its importance, complexity, variability, and potential impact on safety, production, and cost. John Paciga and Germaine Watts IAEA Training Course on IMS Module 5.4

Graded approach (GSR Part 2) Requirement 7: Application of the graded approach to the management system. The management system shall be developed and implemented using a graded approach 4.15 The criteria used to grade the development and application of the management system shall be documented in the management system. IAEA Training Course on IMS Module 5.4

Graded approach (GSR Part 2) The following shall be taken into account: a) The safety significance and complexity of the organization, operation of the facility or conduct of the activity; b) The hazards and the magnitude of the potential impacts (risks) associated with the safety, health, environmental, security, quality and economic elements of each facility or activity [16, 24–26]; c) The possible consequences for safety if a failure or an unanticipated event occurs or if an activity is inadequately planned or improperly carried out. IAEA Training Course on IMS Module 5.4

Process-Based Management systems for high Reliability Organisations – Paciga and Watts IAEA Training Course on IMS Module 5.4

Risk management Implementation of a risk management model A risk process model ISO 31000 Risk management IAEA Training Course on IMS Module 5.4

Risk matrix Probability Consequence IAEA Training Course on IMS Module 5.4

Graded approach in GSR Part 1 GSR Part 1 provides requirements for introducing graded approach into the core processes: Requirement 24: Notification and Authorization Requirement 26: Graded approach to review and assessment of a facility or an activity; Requirement 29: Graded approach to inspections of facilities and activities; Requirement 31: Enforcement Requirement 34: Regulations and guides; Requirement 36: Communication and consultation with interested parties; IAEA Training Course on IMS Module 6 11

Risk management and IMS In developing the IMS Identification of the most critical processes The critical processes most elaborated and controlled Use of graded approach within a process for example supervision/oversight IAEA Training Course on IMS Module 5.4

Graded approach and activities A graded approach is needed in helping the regulator on focus on the most important areas and activities in order to achieve objectives IAEA Training Course on IMS Module 5.4

Summary The importance of a model for grading Risk assessment when identifying processes Graded approach when establishing the processes Using a graded approach when identifying for example supervision areas and activities e.g inspection program IAEA Training Course on IMS Module 5.4

References IAEA-TECDOC 1740 – Use of a Graded Approach in the Application of the Management System Requirements for Facilities and Activities Process-Based Management Systems for High Reliability Organisations – John Paciga and Germaine Watts IAEA Training Course on IMS Module 5.4