Training Course on Integrated Management System for Regulatory Body Module 7 Measurement, Assessment, Evaluation and Improvement of IMS (1) Continual Improvement

Objective To acquaint the participants with: The importance of introducing the continual improvement process into the regulatory body; The continual improvement process. IAEA Training Course on IMS Module 7

Content Introduction IAEA requirements Inputs for improvements Improvement process Non-conformances, corrective and preventive actions Summary References P IAEA Training Course on IMS Module 7

Introduction - 1 The main objective of continual improvements of regulatory body management system is to continually improve safety. Continual improvement is recurring activity to increase the ability to fulfill the requirements. (Definition from ISO 9000:2005). The organization should continually improve the effectiveness and efficiency of the management system and its processes. (ISO 9000:2005). Improvements can range from small improvements to strategic improvement projects. P IAEA Training Course on IMS Module 7 4

Introduction - 2 The continual improvement of the management system and its processes should be a strategic objective of each organisation. Organization should have a process in place how to identify and manage the improvements. P Source: 9.12.2015https://www.google.si/search?q=continual+improvements+photo&biw=828&bih=349&tbm=isch&tbo=u&source=univ&sa=X&ved=0ahUKEwjdy8m71s_JAhXK_HIKHWW1AMYQ7AkILw#imgrc=zUEBOQ9M4KcikM%3A IAEA Training Course on IMS Module 7 5

IAEA requirements - 1 Some examples of requirements: The management system of the regulatory body shall be continuously assessed and improved. Senior management shall establish, implement and continuously improve an effective integrated management system that ensures safety. Senior managers and managers at all levels in the organization shall demonstrate commitment to the establishment, implementation, assessment and continual improvement of the management system. Leaders at all levels shall demonstrate commitment to continual improvement of safety. P IAEA Training Course on IMS Module 7 6

IAEA requirements – 2 Managers at all levels shall foster and encourage the involvement of all individuals in the implementation and continual improvement of the management system. The effectiveness of the management system shall be monitored and measured in order to identify opportunities for improvement. Opportunities for improvements in safety and in the management system shall be identified. Continual improvement of safety culture shall be ensured. P IAEA Training Course on IMS Module 7 7

Inputs for improvements - 1 Management should create an organizational culture where employees are actively involved in seeking opportunities for improvement of processes, products and activities. Finding the opportunities for improvements is a continual process through the use of: Audit findings; Audit conclusions; Management reviews; Self-assessments; Analysis of data. P IAEA Training Course on IMS Module 7 8

Inputs for improvements - 2 In addition, the introduction of the improvements can be based on: Gathered feedback; Lessons learned from other organizations; Experience of comparable regulatory bodies abroad; Technological innovations in the field of nuclear and radiation safety; Propositions made by the employees. P IAEA Training Course on IMS Module 7 9

Deming cycle – basis for improvement - 1 (ISO/TC 176/SC 2/N 544 R) Maintenance and continual improvement can be achieved by PDCA concept at all levels in organisation PDCA ("Plan-Do-Check-Act") is a four-step problem-solving process typically used in quality management. It is also known as the Deming Cycle, Deming Wheel. W. Edwards Deming 1900-1993 Picture taken from http://en.wikipedia.org/wiki/W._Edwards_Deming IAEA Training Course on IMS Module 7

Deming cycle – basis for improvement - 2 Learning organisation Structure, way of doing work etc PDCA Plan – Identify and analyze problems, develop solutions and plan implementation Do – Implement solutions Check – Review results Act – Correct deviations and standardize solutions IAEA Training Course for Regulators on Enforcement Module 5.2 11

Deming cycle – basis for improvement - 3 Deming cycle (ISO/TC 176/SC 2/N 544 R) - Requirements of stakeholders 1.PLAN Establish objectives and make plans (analyze your organization's situation, establish your overall objectives and set your interim targets, and develop plans to achieve them). 4. ACT Correct and improve your plans and how you put them into practice (correct and learn from your mistakes to improve your plans in order to achieve better results next time). Defining objectives and processes Continuous improvements of processes Define the method for implementing processes 3. CHECK Measure your results (measure/monitor how far your actual achievements meet your planned objectives). 2. DO Implement your plans (do what you planned to). Training the personnel and ensuring the resources Measurement and monitoring of the processes Implementing the processes IAEA Training Course on IMS Module 7

Improvement process - 1 The need for improvement may occur: At the working level; At the process level; At the organizational level. IAEA Training Course on IMS Module 7 13

Improvement process - 2 Example: How to use PDCA cycle in processes Preparation of legislation: - Requirements of stakeholders 1. PLAN Harmonization of regulation with IAEA standards. -Define process and process owner with interim targets. Prepare plan with deadlines 4. ACT On the basis of findings and suggestions the improvements are introduced into the process. Defining objectives and processes Continuous improvements of processes Define the method for implementing processes 2. DO The process owner implements the process according to: defined process; plan. 3. CHECK The process should be constantly checked against: defined procedure; in advance specified requirements plan Training the personnel and ensuring the resources Measurement and monitoring of the processes Implementing the processes IAEA Training Course on IMS Module 7 14

Non-conformances, Corrective and Preventive Actions - 1 Non-conformances should be regarded as opportunities for improvement, The cause s of non-conformances should be managed and mitigated through corrective and preventive actions Errors made during every day work which are corrected in time without consequences are not identified as non-conformities. The responsibility for the implementation of corrective measures lies with the causer of the non-conformance. IAEA Training Course on IMS Module 7 15 15

Non-conformances, Corrective and Preventive Actions -2 Corrective and preventive actions can be used as a tool for improvements . Corrections are activities performed in order to eliminate a detected non-conformity (i.e. rework). Corrective actions are activities for eliminating the causes of non – conformances and introducing improvements. Preventive actions are activities for eliminating the causes of potential non-conformances or for introducing improvements. IAEA Training Course on IMS Module 7 16 16

Non-conformances, Corrective and Preventive Actions - 3 Preventive actions may consist of the following activities: Implementation of the management system; Audits; Training and dissemination of knowledge; Assessment and comparison to similar regulatory bodies abroad; Following best foreign practices and the introduction of good practices into the RB; Regularly informing employees about the activates; Following changes in domestic and foreign legislation; Actively following and promoting the development of the profession. IAEA Training Course on IMS Module 7 17 17

Summary A continual improvement process is an ongoing effort to improve products, services or processes. Improvements can be based on many small changes rather than the radical changes that might introduce research and development project. For implementing the improvements the regulatory body should have improvement process in place. Corrective actions should be designed in away to prevent the recurrence of non-conformances. IAEA Training Course on IMS Module 7 18

References IAEA Safety Standard GSR Part 1 Governmental, Legal and Regulatory Framework for Safety, IAEA, Vienna (2010) IAEA Safety Standards Series No. GS-R-3, The Management System for Facilities and Activities, IAEA, Vienna (2006) IAEA Safety Standards DS456, Leadership and Management for Safety, IAEA July 2014 ISO, Quality Management Systems — Requirements, ISO 9001:2008, ISO, Geneva (2008) ISO Quality Management Systems –Fundamentals and vocabulary (ISO 900:2005) ISO/TC 176/SC 2/N 544 R ISO 9000 Introduction and Support Package: Guidance on the Concept and Use of the Process Approach for management systems IAEA Training Course on IMS Module 7 19