1. Module 1.11 Management System Requirements Phil Metcalf Regional Training Course on Drafting Regulations on Waste Management and Public Exposure Including Decommissioning 12 November - 7 December 2012, IAEA, Vienna

2. 2 Overview  Concept evolution  International standards  Specific aspects  Predisposal  Disposal  Lessons learned  Summary

3. 3 Concept Evolution Quality Control Quality Assurance (Total) Quality Management (Integrated) Management Systems Time Safety & Performance 50-C-QA (1985-88) 50-C-Q (1996) GS-R-3 (2006)

4. 4 Concept Evolution (cont.) Quality Control (QC) Part of quality assurance intended to verify that systems and components correspond to predetermined requirements (e.g. waste package control) Quality Assurance (QA) All planned and systematic actions necessary to provide adequate confidence that a system, structure or component will perform satisfactorily in service (e.g. waste conditioning)

5. 5 Concept Evolution (cont.) Quality Management Management of processes QA programme Instead of implementing a separate QA programme, introduce an (Integrated) Management System (MS)

6. 6 Concept Evolution (cont.) Management System (MS) A single coherent management system Integrating safety, quality, environment, health, security in the day to day business −Personnel, equipment, culture, documented policies and processes −Organizational structure and resources

7. 7 International Standards on MS (IAEA) ISO 14001 1996 Environmental Management Systems 2004 (revision) 50-C-Q 1996 Code Quality Assurance 50-C/Q ISO 9001 2000 Quality Management System – Requirements 2008 (revision) GS-R-3 2006 The Management System for Facilities and Activities 2011 (planned update) Basis for the Safety Requirements GS-R-3

8. 8 International Standards on MS (IAEA, cont.)

9. 9 Fundamentals SF-1 Principle 3: Leadership and management for safety Effective leadership and management for safety must be established and sustained in organizations concerned with, and facilities and activities that give rise to, radiation risks. -Effective management system -Integration of all aspects - safety, security, quality -Recognition of entire range of interactions - people, technology, organisations -Safety culture, regular performance assessment and lessons learned

10. 10 International Standards on MS (IAEA, cont.) Safety Requirements GS-R-3 PlanningImplementationSupervision - Operators - Regulators - Suppliers of services Normal conditions Transient conditions Emergency conditions

11. 11 International Standards on MS (IAEA, cont.) Safety Requirements GS-R-3 Replaces Safety Series 50-C-Q In line with ISO 9001:2000 and includes additionally: −Safety Culture −Grading of requirements −Independent assessment −Human resources and knowledge management −Emergency preparedness −Self-assessment Specifically focused on the nuclear industry

12. 12 International Standards on MS (IAEA, cont.) Safety Requirements GS-R-3 (cont.) Resource management Process implementa tion Measurement, assessment and improvement Manageme nt system Management responsibility

13. International Standards on MS (IAEA, cont.) 13 MANAGEMENT SYSTEM (MS) Cover all RAW management activities, e.g.: - Waste generation to disposal/clearance - Secondary waste management Provide assurance of compliance with all requirements, limits, controls and conditions (LCCs) Include measures if non-conformity occurs (e.g. RAW packages) Adequate for as long as needed (RAW programme, emergency drills) Accommodate future technological development

14. International Standards on MS (IAEA, cont.) 14 Safety Culture Implement and enhance safety culture at all levels Awareness of safety and environment protection Application of best practice Learning and questioning attitude Means for continuous improvement Documentation of the MS Documents for control of work processes are relevant, up-to-date, understandable and available to the organizations Graded Approach Level of detail; instructions, inspection, assessment, training, etc. Not be used as a reason for non-compliance with requirements

15. International Standards on MS (IAEA, cont.) 15 LLW and ILW disposal facility, Hungary HLW storage facility, Netherlands

16. International Standards on MS (IAEA, cont.) 16 MANAGEMENT RESPONSIBILITY Management commitment Development, implementation and improvement of MS Satisfaction of expectations of interested parties, e.g. Operators, regulators, local and national governments, public Organizational policies Management shall develop the policy statements of the organization Planning (long term considerations) −Plan, goals and objectives of organisation −Ownership transfer of waste Responsibility and authority for MS At the level of top management

17. International Standards on MS (IAEA, cont.) 17 RESOURCE MANAGEMENT Financial −To perform activities of the organization and to maintain MS −Long term storage and disposal (of concern) Human and individual competence −The competence requirements for personnel −Regular training (newcomers, medium level and senior staff) Infrastructure and working environment −Buildings, facilities, equipment, supporting services, etc. necessary for work to be carried out in a safe manner −Long term – future requirements, maintenance/upgrade of equipment, software, etc.

18. International Standards on MS (IAEA, cont.) 18 PROCESS IMPLEMENTATION Developing processes All management and work processes needed to achieve the goals and objectives shall be identified, developed, implemented, maintained, and improved: - continuity, relationship and long term duration Process management and control of products −Processes shall be developed, documented, performed, evaluated and controlled. −Every process shall have a person who has the authority, responsibility and accountability for managing the process Control of documents Periodical review and update, e.g. legislation, long term cultural and educational change

19. International Standards on MS (IAEA, cont.) 19 PROCESS IMPLEMENTATION (CONT.) Control of records −Preservation of knowledge and experience −Content, duration, media, transfer between organisations Purchasing −Equipment to be evaluated on the basis of adequacy, availability, quality and meeting criteria −Timeframes (long term storage, disposal) Communication Appropriate internal and external communication processes shall be established within the organization Managing organizational change A process shall be developed to manage organizational change – ownership, organisational structure, etc.

20. International Standards on MS (IAEA, cont.) 20 MEASUREMENT, ASSESSMENT AND IMPROVEMENT Measurement and monitoring −Measurement and monitoring of the effectiveness of the MS shall be carried out at all steps of RAW management −During the whole duration of activities Self-assessment Self assessment shall be carried out by top management and at all other levels in the organization: - Work processes and their management Independent assessment Independent assessment shall be regularly conducted on behalf of top management, e.g.: - Unit within organisation - Waste generator, national authorities, international organisation(s), etc.

21. International Standards on MS (IAEA, cont.) 21 MEASUREMENT, ASSESSMENT AND IMPROVEMENT Management system review At planned intervals and as appropriate, e.g.: −Significant organisational changes or new regulatory requirements −Changes to RAW management activities Non-conformances and preventive actions Products and processes that do not conform to specified requirements shall be identified, reported and evaluated (e.g. preventive and corrective actions) Improvement −Improvement possibilities for the MS shall be identified and the actions shall be selected, planned and monitored −Incidents/accidents, benchmarking, peer reviews

22. 22 Specific Aspects Predisposal/Disposal All elements of management system applied to waste management Unique aspects for waste management include: -Management of radioactive waste may extend over a very long period (long-term nature) -Waste management includes a broad range of activities and possibly a series of organizations (diverse nature) -Waste management knowledge evolves as implementation proceeds (evolving nature) Disposal High dependency on natural geological systems for safety of disposal

23. 23 Specific Aspects (cont.) Long Term Nature Confidence that long term performance will meet requirements (incl. public confidence) Plans for provision of resources including finance, infrastructure, equipment and personnel for the long term should be established. Consideration should be given to whether packages may have to be designed ahead of the final disposal plan. Arrangements should be made to ensure the maintenance of records for long periods (hundreds of years) Preservation and transfer of knowledge to the future responsible persons (training, retraining) The frequency of assessment (audit) can be decreased, especially in the extended storage and post-closure phases according to a plan and needs.

24. 24 Specific Aspects (cont.) Diverse Nature Waste may be controlled under a series of different management systems and organizations; that presents challenges to maintaining continuous active oversight of the waste and proper transfer of necessary data between organizations Grading of the application of requirements based on the type of waste, facility and activity is important since these are highly variable (e.g. LLW versus HLW) MS should consider public attitudes, concerns, and expectations about the safety of waste disposal activities in the long term (e.g., selection of site, reliability of organizational and financial arrangements, and safety during closure and post-closure phase)

25. 25 Specific Aspects (cont.) Evolving Nature Understanding and knowledge will continue to grow and must be continuously managed. Technological advances over time, which could impact the waste management programme, should be accommodated. Organizations should be structured to ensure continuity in managing the waste management activities, and should be able to cope with possible changes in policy, regulations, ownership, roles and responsibility. There should be continued application of management reviews to meet the needs of future generations who were not the original customers and/or stakeholders. Implementation of monitoring programmes

26. 26 Specific Aspects (cont.) High Dependency on Geological Systems Natural barriers and long timescales (natural events and processes) Passive safety (in particular in post-closure phase) Uncertainties inherent in the data relating to natural geological systems should be clearly documented so that they will be recognized during the later decision-making process. Non-conformance control for characterization activities performance assessment of geological systems should be identified and documented. Safety assessment is an iterative process also involving the estimation of the behavior of natural geological systems, selection of design features, and requires rigid input/output controls and recording.

27. 27 Lessons Learned Waste – could be given inadequate attention Develop a MS prior activity startup –Scope (clearance, retrievability, site release, etc.) –Requirements (legal, regulatory, WAC, etc.) –Parties involved (in particular regulatory authorities) Implement consistently and at all levels –Operator –Subcontractors, etc. Communication between all interested parties Review periodically and update (lessons learned)

28. 28 Summary Common sense and recognition of safety Integration of MS in practice Importance of: –Clear scope of work (RAW types, activities, facilities, parties involved, timescales, etc). –Clear understanding of regulatory and legal framework and boundaries –Responsibilities, timescales and resources –Interdependences and quality of waste product –Procedures for control, communication, review and improvement –Capturing lessons learned and improvement