GSG-16 Leadership, Management and Culture for Safety in Radioactive Waste Management

Radioactive waste management activities will be conducted in compliance with the requirements.

Radioactive waste packages will be of appropriate and consistent quality.

The characteristics of radioactive waste packages will be sufficiently known.

Appropriate records will be kept that enable radioactive waste identification and decisions on whether radioactive waste packages and unpackaged waste⁵ conform to the waste acceptance criteria for radioactive waste management facilities.

The minimization of radioactive waste generation;

Processing, comprising pretreatment (e.g. collection, segregation, chemical adjustment, decontamination), treatment (e.g. volume reduction, removal of radionuclides from the waste, change of composition) and conditioning (e.g. immobilization, packaging, overpacking);

Storage;

Disposal (e.g. near surface disposal, geological disposal, borehole disposal).

Activities that generate waste containing naturally occurring radionuclides;

Activities in hospitals, laboratories and research and development facilities, and in industry;

Decontamination of facilities or parts thereof;

Decommissioning of facilities or parts thereof;

Remediation (e.g. of areas affected by past activities);

Activities to manage waste generated from incidents, including accidents, and from emergencies;

Activities to manage legacy waste.

Radioactive waste minimization;

Radioactive waste characterization (e.g. to determine the radiological and physicochemical properties of waste);

Clearance;

Design and manufacture of radioactive waste containers and waste packages;

Siting, design and construction of radioactive waste management facilities;

Safety case development and safety assessment of radioactive waste management facilities;

Authorization (e.g. licensing);

Commissioning of radioactive waste management facilities;

Operation of facilities for the predisposal management of radioactive waste;

Operation of radioactive waste disposal facilities (e.g. activities, which can extend over several decades, involving receipt of radioactive waste, waste emplacement in the disposal facility, backfilling and sealing, and any other operations in the period prior to closure);

Closure of radioactive waste disposal facilities;

Institutional control of radioactive waste disposal facilities, covering both active control (e.g. nuclear security, surveillance, monitoring) and passive control (e.g. preservation of records, restricted land use).

The provision of adequate human, financial and other resources for the safe management of radioactive waste. In accordance with the ‘polluter pays’ principle, an organization that generates radioactive waste is responsible for ensuring that funds are available for the waste to be managed properly.

Ownership of and responsibility for radioactive waste. The responsibility for radioactive waste can change during its management. There should be clarity at all times regarding both ownership of the waste and responsibility for safety. In some jurisdictions, ownership of and responsibility for radioactive waste is transferred when the waste moves from one organization to another; in others, ownership of and responsibility for radioactive waste always remains with the original generator of the waste. While the owner should retain overall responsibility for the waste, the licensee of the facility where the waste resides is responsible for its safety.

The possibility that national authorities or State organizations might need to take responsibility for radioactive waste because this responsibility cannot be discharged by the generator of the waste.

The timescales involved in radioactive waste management can span many human generations (see para. 3.7 of SF‑1 [2]); this raises issues for the provision of resources, particularly the provision of financial and human resources, not only for technical and safety related aspects but also for knowledge management and for culture for safety.

The need to ensure that radioactive waste generation is minimized (see para. 3.29 of SF‑1 [2]) and that waste packages and unpackaged waste conform to the waste acceptance criteria of the receiving organization (see Requirement 12 of GSR Part 5 [3]).

The views of interested parties on decisions on the management of radioactive waste.

The selection of permanent options (i.e. discharge, clearance or disposal) for the release of radioactive waste from regulatory control.

The need to ensure that, wherever possible, radioactive waste is in a passively safe condition.

International best⁷ practices and lessons from industry experience.

Maintaining the confidence of interested parties, including the public, that management supervision will be continuous over the period necessary;

Establishing confidence that the long term performance of a radioactive waste disposal facility will meet regulatory requirements;

Estimating costs and establishing the funding arrangements that will be necessary to continue to monitor and control the radioactive waste using the management system until active institutional control ceases;

Ensuring continuity of understanding, knowledge, resources and safety culture over long time periods.

Awareness and judgement;

A clear view of long term policies and strategies for radioactive waste management, and the ability to communicate these effectively;

The ability to distinguish strategically important issues;

An understanding of which aspects are important to the safety of radioactive waste management;

An understanding of the hazards and risks associated with the facilities and activities in their charge, and how these compare to other hazards and risks, so that they can oversee the development and application of the management system for radioactive waste management according to a graded approach;

An understanding of which aspects of radioactive waste management are important to the public and other interested parties;

The ability to explain and communicate the importance of safety and culture for safety in radioactive waste management.

Shall encourage and support all individuals in achieving safety goals and performing their tasks safely;

Shall engage all individuals in enhancing safety performance;

Shall communicate clearly the basis for decisions relevant to safety.”

International standards such as ISO 9001:2015 for quality management systems [22], ISO 14001:2015 for environmental management systems [23] and ISO 45001:2018 for occupational health and safety management systems [24];

The national legal framework, and regulatory requirements and guidance;

Best practices in the nuclear and radioactive waste management industries;

The organization’s responsibilities, short term and long term objectives, and strategic plans.

Coordinating the development and implementation of the management system and its assessment and continuous improvement;

Measuring and reporting on the performance of the management system, including its influence on safety and safety culture, and any need for improvement;

Resolving any potential conflicts between requirements on radioactive waste management and requirements on other fields of activity, such as mining safety and environmental protection (e.g. groundwater protection), and between different elements and processes of the management system.

Developing and documenting the process and maintaining the necessary supporting documentation;

Ensuring that there is effective interaction between process interfaces;

Ensuring that process documentation is consistent and appropriate for the waste management facilities and activities;

Ensuring that the records necessary for demonstrating that the process results have been achieved are specified in the process documentation;

Monitoring and reporting on the performance of the process;

Promoting improvement in the process;

Ensuring that the process and any changes subsequently adopted are aligned with the goals, strategies, plans and objectives of the organization and are consistent with the organization’s safety policy.

The ownership of radioactive waste and radioactive waste management facilities;

Management arrangements;

The regulatory body;

National and international legislation and standards;

Land use policies in relation to the institutional control of facilities.

A statement that safety will be given overriding priority, in ensuring that other relevant requirements and provisions (e.g. for nuclear security) are also met.

A statement that the safety policy will comply with applicable national, regional and international policies, strategies and regulations on radioactive waste management.

A statement that the safety policy will take into account the views, attitudes, concerns and expectations of the public and other interested parties, in relation to safety (and, where applicable, in relation to restrictions on the use of land and natural resources).

A statement that the safety policy will be appropriate to the objectives and the activities of the organization.

Statements on how societal and economic considerations are taken into account with regard to safety.

A commitment to comply with the management system and to seek continuous improvement.

A commitment to support the development of a strong culture for safety.

An appropriate framework for action and for establishing and reviewing goals and objectives at all levels. Where possible, safety goals and objectives should be measurable.

A commitment to periodic review to ensure continuing suitability and applicability.

A mechanism for the safety policy to be effectively communicated, understood and followed within the organization.

A commitment to minimizing the generation of radioactive waste, to safe storage and to safely disposing in a timely manner of radioactive waste that cannot otherwise be removed from regulatory control.

Changes in the legal and regulatory framework for radioactive waste management;

Changes in regulatory requirements for radioactive waste management;

International developments (e.g. new standards, conventions, agreements on information exchange);

Technological advances;

Learning from operating experience and from events;

Non‑conformances and corrective measures and preventive measures, and the results of safety assessments;

Results of national, regional and international reviews and assessments of radioactive waste management programmes and developments in radioactive waste management practices;

Results of internal and external audits, peer reviews and inspections of waste management facilities and activities;

Results of environmental monitoring and other types of monitoring and surveillance.

Appropriate means of communicating routinely and effectively with and informing interested parties with regard to radiation risks associated with the operation of facilities and the conduct of activities;

Appropriate means of timely and effective communication with interested parties in circumstances that have changed or that were unanticipated;

Appropriate means of dissemination to interested parties of necessary information relevant to safety;

Appropriate means of considering in decision making processes the concerns and expectations of interested parties in relation to safety.”

Legal aspects (e.g. the governmental, legal and regulatory framework and regulatory requirements relating to topics such as non‑radiation‑related safety, environmental protection, mining).

Restrictions on the transport of radioactive material and hazardous materials across borders and boundaries between different areas.

Nuclear security provisions that may be necessary, as appropriate, for nuclear material and other radioactive material.

Operational limitations, including those derived from agreements with the responsible national, regional and local authorities or organizations, or arising from operating logistics. For example, it may not be possible in practice to operate to the capacity authorized; voluntary agreements may have been reached with interested parties other than the regulatory body that have the effect of limiting operations in a way that goes beyond, or is different from, the limits and conditions contained in the authorization (e.g. stacking radioactive waste so that local residents cannot see it, running operations at only certain times of the day, organizing transport to avoid certain routes); logistical reasons might exist for not proceeding with certain waste management steps or not proceeding with them as fast as might be desired (e.g. the next facility in the waste management chain may not be ready to receive conditioned waste into its stores).

The needs, expectations and concerns of other organizations in the waste management chain.

Public attitudes, concerns and expectations about safety in relation to radioactive waste management (e.g. concerns about the consequences of discharges, the adequacy and reliability of long term organizational and financial arrangements, site selection and site characterization processes, the degree of confidence in safety during operations and in the long term, and the ability to respond to problems that might arise).

Public concerns and cultural expectations relating to restrictions on the use of land (e.g. historically significant sites, sacred sites) and resources (e.g. minerals, oil and gas, water).

Other concerns of interested parties (e.g. cultural expectations about working hours and the composition of the workforce, societal expectations regarding the distribution of risks and benefits, political choices about activities and sustainable development).

The safety case for radioactive waste management facilities and activities, the status of operations, and plans for the future;

The occurrence of any incidents, including accidents, the measures taken to respond to them and the actions taken to prevent a recurrence;

The safety, societal and economic impacts of the radioactive waste management activities;

Changes in management arrangements and the continuity of responsible management;

Maintenance of adequate financial resources to support the radioactive waste management activities;

Opportunities for, and results from, the involvement of interested parties in decision making;

Responses to questions and concerns from interested parties.

Bringing together in a coherent manner all the necessary elements for safely managing the organization and its activities;

Describing the arrangements made for management of the organization and its activities;

Describing the planned and systematic actions necessary to provide confidence that all requirements are met;

Ensuring that safety is taken into account in decision making and is not compromised by any decisions taken.”

Tentative specifications for waste and for waste packages, and criteria for their acceptance, should be developed when the sequence of waste management activities is first conceived. Once site specific and facility specific information is available, detailed waste package specifications and waste acceptance criteria should be developed based on safety assessment results and other data, as appropriate.

The level of safety provided by various combinations of waste, waste packages and alternative facility designs should be assessed.

The feasibility of implementing the possible designs should be evaluated.

The effect on safety of any potential design improvements to radioactive waste management facilities should be assessed.

Providing adequate (e.g. human, infrastructure, financial) resources (e.g. for site maintenance), taking account of the amounts and types of waste to be managed and the storage and disposal options that have been adopted. The adequacy of resources should be reviewed periodically, particularly for facility development and operational periods that may extend over decades.

Preserving technology and knowledge, and transferring knowledge to people joining the programme in the future.

Retaining or transferring ownership of waste and waste management facilities.

Succession planning for managers and personnel.

Continuing arrangements for interacting with interested parties.

The safety significance and complexity of the organization, operation of the facility or conduct of the activity;

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…;

The possible consequences for safety if a failure or an unanticipated event occurs or if an activity is inadequately planned or improperly carried out.”

The quantities of waste, the potential hazards associated with the waste, the necessary degree of isolation and the timescale over which isolation needs to function;

The potential dispersibility of the waste, the potential mobility of the waste and the necessary degree of waste containment;

The time period before disposal;

Experience with, and the maturity of, the technology used in radioactive waste management activities;

The reliability of equipment and its function in relation to safety;

The complexity and degree of standardization of the waste management activities;

The novelty and maturity of waste management activities, particularly for ‘first of a kind’ activities;

The size of the operating organization, the number and complexity of interfaces with other organizations in the radioactive waste management process, and the organization’s culture for safety;

Public perception of radiation hazards and the risks associated with the radioactive waste;

Government policy (e.g. on nuclear power generation and radioactive waste management);

Possible future human activities and realistic exposure scenarios;

External events and processes that could affect facilities, particularly long term events and processes such as ground settlement, erosion and climate change for facilities that will be operated for long periods;

The likelihood of incidents, including accidents, and provisions for mitigating their consequences if they were to occur.

The level of detail of work instructions and supporting documentation;

The level of qualification and training of personnel;

The quantity, level of detail and retention times of records;

The level of detail and frequency of testing, surveillance and inspection;

The equipment to be included in the configuration management at the facility;

Key performance indicators;

Equipment calibration;

The need to monitor the condition of equipment, waste and the facility;

The traceability of items, including radioactive waste;

The availability of storage, conditions of storage and control of associated records;

The level of reporting and the authority to act on non‑conformances and to implement corrective actions;

The maturity of the safety assessments and safety cases and how well they represent the current state of the facilities and activities, and the requirements for periodic safety assessment;

The scope, frequency and detail of safety audits of radioactive waste management facilities and activities;

The scope and detail of any environmental monitoring programme.

The origin of the waste and the processes by which it was generated;

The physical and chemical forms and properties of the waste (e.g. of the materials used in waste conditioning and their radionuclide retention properties);

The activity concentration and total activity of radionuclides in the waste;

The mass, activity concentration and total activity of fissile nuclides in the waste;

The type of waste package;

The radiation level at the surface of the waste package;

The level of surface contamination on the waste package;

The mass and weight of the waste or waste package;

The dates of waste processing;

The methods and instruments used to describe and characterize the waste.

Authorizations (e.g. licences, permits, amendments);

Commissioning records;

The safety case and safety assessments;

The environmental impact assessment;

Peer review reports;

Technical specifications and amendments;

Design options, concepts, documents, calculations and drawings;

Records of the facility actually constructed (‘as‑built’ records);

Approved design changes;

Procurement records for structures, systems and components;

Operating procedures;

Records of the implementation, review, updating and maintenance of emergency preparedness and response arrangements, including records of training, exercises, response to actual emergencies, lessons identified and corrective actions implemented;

Waste emplacement plans;

Records generated during facility operation, including records of emplaced waste packages;

Records of assessments, inspections and verifications of processes and activities;

Records of any non‑conformances and corrective actions;

Records of the training, experience and qualification of personnel;

Monitoring data;

Records of any incidents, including accidents, that have occurred;

Records of interactions between the operating organization and the regulatory body (e.g. meetings, inspections).

Modifications to equipment and materials;

The installation of new equipment;

Changes in procedures;

Changes in technologies for radioactive waste management;

Any tightening or relaxation of controls (e.g. on the number of waste packages that may be moved at any given time);

The introduction of additional controls;

Changes in the governmental, legal and regulatory framework;

Changes in regulatory requirements.

If the necessary funds cannot be obtained from the waste generator (e.g. as a result of bankruptcy, cessation of business, inadequate financial planning or the transfer of ownership of the waste to other parties), other means of applying the ‘polluter pays’ principle would need to be considered.

If funds are planned to come from public sources, other demands for such funding may make it difficult to gain access to adequate funds on a timely basis.

It may be difficult to make realistic estimates of costs for radioactive waste management activities that are still in the planning stage and for which little or no experience has been accumulated.

It may be difficult to estimate anticipated costs for activities that will only begin in the long term, because these costs will depend strongly on assumptions made about future inflation rates, bank interest rates and technological developments.

It may be difficult to incorporate appropriate risk and contingency factors into estimates of future costs, owing to the uncertainties associated with future changes in societal demands, political imperatives, public opinion and the nature of unplanned events.

Experience has shown that costs for large projects tend to increase compared with initial estimates (see e.g. Ref. [34]).

If several organizations are involved in the waste management process, the necessary financial arrangements could be complex and ensuring adequate continuity of funding could be problematic.

Research and development;

Commissioning, calibration and testing of new equipment;

Commissioning of new processes and activities;

Safety case development, including safety and performance assessments;

Facility design and optimization, and facility construction;

Environmental protection, environmental monitoring and surveillance;

Control of products (e.g. waste containers, waste packages);

Providing for traceability of waste;

Condition monitoring, particularly during any long term storage and when radioactive waste is in a disposal facility prior to the closure of that facility;

Retrieval of waste from waste management facilities;

Knowledge and information management, including the control, transfer and keeping of records;

Development of waste acceptance criteria, acceptance of waste and transfer of responsibility;

Radiation protection;

Ensuring legal compliance;

Risk management;

Applying a graded approach to the application of management system requirements;

Process management;

Decision making;

Communication with interested parties;

Human resources management;

Procurement;

Management of organizational change and resolution of conflicts;

Documentation of the management system and measurement, assessment and improvement of the management system;

Managing interactions between the management system processes;

Emergency preparedness and response;

Post‑closure institutional control and monitoring of a disposal facility.

The planning and implementation of a radiation protection programme¹⁴ for facility operation, including the use of protective clothing and shielded equipment and facilities;

The use of special handling equipment, tools and techniques for the emplacement of waste packages in, and their retrieval from, storage facilities;

Testing and assay requirements (e.g. equipment, methods, materials);

The design of non‑destructive systems and chemical analysis methods for waste characterization;

The need for waste pretreatment, treatment and conditioning;

The design of waste containers and waste packages on the basis of detailed specifications for materials, geometry, mechanical properties, sealing and containment capability, stability, robustness and durability (see IAEA Safety Standards Series Nos SSG‑40, Predisposal Management of Radioactive Waste from Nuclear Power Plants and Research Reactors [36], and SSG‑41, Predisposal Management of Radioactive Waste from Nuclear Fuel Cycle Facilities [37]);

The design of waste transport containers and waste storage facilities for use before development of a disposal facility, taking into account the uncertainty in the possible design of the disposal facility;

The length of time that waste is to be stored, taking into account the characteristics of the waste, the waste package and the store;

Events and processes that could lead to the degradation and possible failure of waste packages in storage;

The design of methods for examining waste packages that may have degraded while in storage;

The need to inspect, move, repair and/or re‑engineer waste packages in storage;

The need for equipment to be maintained and replaced during operations and the possible need for any specialized equipment in the future;

The need to maintain storage facility buildings, potentially over a very long lifetime.

Planning and implementation of site investigations while minimizing disruption to the integrity of the natural environment and the host geological formation;

Planning, use and sealing of site investigation boreholes that if not sealed might affect the safety of the disposal system;

Design and construction of facilities (e.g. near surface disposal vaults, the excavation of underground cavities) while minimizing damage to the natural environment and the host geological formation;

Planning and implementation of a radiation protection programme for facility operation, including the use of protective clothing and shielded equipment and facilities;

The use of special handling equipment, tools and techniques for the emplacement of waste in disposal facilities;

The installation of engineered barriers (e.g. buffers, backfills, seals, closure components);

Protection of waste packages from degradation (e.g. due to rock fall or corrosion) before the facility is closed;

Monitoring activities.

To provide assurance that it will be possible to quantify, either by direct measurement or by process control, the important waste parameters and characteristics (e.g. mass of fissile material, isotopic composition, chemical composition and physical state, decay heat) necessary to control the processes;

To determine the process variables that are important to the acceptability of the end product and the parameters that are potentially important to safety.

That the compositions of simulated waste are, as far as possible, representative of the actual waste to be processed;

That any anticipated conditions that might result in a significant reduction in the quality of waste packages are considered.

Support services;

Spare parts for equipment that might cease to be manufactured during the long operational period of the facility;

Equipment upgrades to meet new regulatory requirements or to make operational improvements;

Provisions to address the evolution and obsolescence of computer hardware and software.

Required tasks, inspections or tests are not inadvertently omitted;

Non‑conforming equipment is not installed, used or relied on;

Tools and items of test equipment that are possibly damaged, defective or out of calibration are not used;

Non‑conforming materials and items (e.g. waste, immobilizing agents, waste containers) are identified and segregated and are not processed further until the non‑conformance is resolved.

To ensure the continuity of control of the waste and waste management activities;

To maintain links and relationships between organizations, where more than one organization is involved;

To plan for the long duration of the waste management activities, where appropriate;

To ensure that safety will be maintained throughout the long lifetime of a disposal facility;

To ensure the retention of knowledge of the waste and of the waste management activities.

The output from the process depends strongly on the control of the process, the skill of the operating personnel or both;

It is not possible to fully confirm the conformity of the output with the specified acceptance criteria by inspection or testing after the process has been conducted (e.g. the welding of lids onto certain types of waste containers, the backfilling of a radioactive waste disposal facility).

The use of certain analytical methods and sampling protocols in waste characterization and process control;

Non‑destructive examination and testing of structures, systems and components (e.g. waste containers);

Welding;

Heat treatment;

Painting and coating of containers of waste that generate high radiation levels;

Non‑destructive examination and testing of waste (e.g. radiography in real time, gamma and neutron measurement techniques);

Corrective actions for waste containers and waste packages that do not comply with specified requirements (e.g. closure welding of lids on overpacks).

Processes involving remote handling methods (e.g. for controlled emplacement of waste packages and backfill materials in the presence of high radiation levels);

Certain waste emplacement activities (e.g. emplacement of large spent fuel containers);

The construction, installation, maintenance and monitoring of structures, systems and components (e.g. engineered barriers);

The retrieval, repair and relocation of waste packages if problems arise after they have been emplaced.

Use of empirical data to validate algorithms for measuring the activity of radionuclides;

In developing the method or in calibrating the equipment, use of reference materials that have the same attenuation properties and moderating properties as the radioactive items to be measured (e.g. waste or waste packages);

Quantification of the uncertainties associated with the analysis of the waste.

Inspection at source of items important to safety for which the quality is difficult to verify upon receipt;

Inspection and testing, as appropriate, on receipt of items important to safety (e.g. waste packages), including verification of related certification and documentation;

Inspection of installed items that are important to safety, including witnessing of equipment or system operational tests;

Appropriate acceptance inspections to validate structures, systems and components;

Inspection of radioactive waste treatment processes;

Inspection of processes (e.g. by non‑destructive analysis or real time radiography) used for determining whether waste forms are suitable and can be accepted;

Inspection of radioactive waste processing facilities and activities;

Final inspection of waste forms, waste containers and waste packages destined for storage;

Inspection of radioactive waste containers and waste packages that are designed to comply with the requirements established in SSR‑6 (Rev. 1) [8];

Periodic, non‑invasive inspection of the integrity and identification of radioactive waste in storage;

Inspection of the radioactive waste management facility construction processes;

Inspection of the facility before radioactive waste is accepted for receipt;

Inspection of radioactive waste emplacement and engineered barrier installation processes;

Inspection (e.g. by non‑destructive analysis or real time radiography) of radioactive waste destined for disposal (e.g. on receipt at the radioactive waste disposal facility, during storage awaiting disposal), including either comprehensive inspection or random sampling inspection;

Regular inspection to verify the operability of equipment or systems used for the prevention, detection or mitigation of accidents.

Identification of the process variables that should be controlled to ensure the adequacy of radioactive waste management activities;

Establishment of the limits or tolerances for the process variables;

Identification of adequate control methods for the process variables, including the frequency of sampling and testing of waste forms and packages.

For the production of waste packages: providing guidance and training to waste generators on the waste acceptance criteria at the relevant radioactive waste disposal facility as early as possible.

For site characterization: maximizing understanding of baseline conditions and knowledge drawn from non‑invasive investigations of a site, in addition to the use of selective and justified invasive methods such as borehole investigations.

For environmental impact assessment: minimizing disturbance of the environment.

For facility design: coordinating the interaction between the activities and teams involved in facility design, site characterization and safety case development.

For construction: selecting techniques and equipment that will minimize disturbance to the site, including the host geological formation, especially close to major discontinuities and zones of structural weakness.

For operation of storage facilities and disposal facilities: emplacing waste packages intact and without significant damage and in accordance with any waste emplacement strategy included in the safety case for the facility.

For operation and closure of a disposal facility: emplacing backfill and installing seals at the correct densities to achieve the intended hydraulic conductivities at the necessary locations in accordance with the design requirements; installing the cap over a near surface disposal facility so as to minimize the flow of water to the waste.

For the post‑closure period: arranging for archiving of relevant materials and information.

Timely identification, reporting and documentation of counterfeit or fraudulent items and other non‑conformities;

Segregation of non‑conforming items to prevent them from being used or transferred to another organization before the non‑conformance is resolved;

Clear identification of non‑conforming items and process equipment (e.g. tagging, labelling, stickers, marking);

Assessment of the condition of non‑conforming items, resolution of non‑conformances (e.g. rework, repair, reject), and determination of the causes for non‑conformances so that corrective actions can be taken to prevent the non‑conformances from recurring;

Appropriate follow up, as necessary, to evaluate the effectiveness of corrective actions.

Management system requirements;

Specifications for services, items and processes, as appropriate;

Validation and verification criteria;

Regulatory requirements;

Resource requirements and constraints.

The management system should ensure that the safety case has been appropriately prepared, reviewed and updated by suitably qualified and experienced personnel.

The management system should ensure that all relevant requirements relating to the safety case and the safety of the facility are met. Furthermore, the management system should provide confidence that the relevant requirements will continue to be met throughout all steps in the lifetime of the waste management facility.

The management system should include processes and procedures to ensure the quality of all activities associated with the safety case, such as data collection and safety assessment modelling. The safety case for a disposal facility may need to deal with particular uncertainties relating to the length of the assessment period (e.g. thousands of years) and the need to consider and model the behaviour of the natural system at the site and its evolution; where relevant, the management system should include specific processes and procedures for the management of such uncertainties.

The management system should identify the process for developing and applying waste package specifications and waste acceptance criteria consistent with, and derived from, the relevant safety cases (including, as appropriate, the safety case for the subsequent waste management facility), in accordance with Requirement 12 of GSR Part 5 [3] and Requirement 20 of SSR‑5 [4].

The management system should include processes and procedures for the periodic review and updating of the safety case (e.g. to take account of operational experience, new or revised standards and other newly available information).

The safety case should acknowledge the existence of unresolved issues and provide guidance for work to resolve these issues in future development stages. The management system should include processes and procedures for initiating and managing tasks aimed at addressing unresolved issues. The safety case should also enable the parties involved to judge the level of safety provided by the waste management facility throughout its development and as new information is obtained.

The management system should include processes and procedures to ensure that personnel involved in the development of the safety case are suitably qualified and experienced and that they have an understanding of the waste management system and its associated risks and of the process used for the review of the safety case.

The need for internal and external audits, as appropriate, of information and activities relating to the safety case, to determine the adequacy of the management system and its implementation;

The need to demonstrate the suitability of personnel involved in the preparation of the safety case (e.g. conducting safety assessments, undertaking safety case reviews) by documenting their qualifications and experience, and by providing further relevant training (e.g. through their participation in international projects);

The need to take into account the views of interested parties on the safety case;

The need to ensure consideration of applicable international safety standards in the development of the safety case;

The need for robust processes and procedures to ensure the quality of data, models, software and calculations used to underpin the safety case;

The need to develop and maintain competence with regard to the safety case, both within the operating organization and within the regulatory body, over the whole project time frame.

Generic (i.e. not site specific) studies;

Estimated values;

Extrapolated values;

Studies that were conducted for other purposes.

IAEA Safety Standards Series No. WS‑G‑6.1, Storage of Radioactive Waste [44];

IAEA Safety Standards Series No. SSG‑1, Borehole Disposal Facilities for Radioactive Waste [45];

IAEA Safety Standards Series No. SSG‑14, Geological Disposal Facilities for Radioactive Waste [46];

IAEA Safety Standards Series No. SSG‑29, Near Surface Disposal Facilities for Radioactive Waste [47].

Which field based activities could be conducted;

What the objectives and limits of the field based activities could be;

How decisions regarding the field based activities could be taken.

Development of a preliminary, conceptual design for the radioactive waste management facility;

Assessment of the level of safety that would be provided by the conceptual design for different combinations of waste, facility characteristics, site properties and assumed system performance (e.g. the behaviour of the host rocks for a geological disposal facility);

Evaluation of the robustness and reliability of the design using the results of the safety assessment and other safety case arguments;

Refinement, as necessary, and more detailed specification of the design in order to improve safety, environmental protection and the overall feasibility of the design;

Revision of the safety case using the revised design.

The operating organization of the disposal facility;

The generator of the waste;

The owner of the waste (where appropriate);

The operating organizations of predisposal management facilities;

The regulatory body.

The waste meets the waste acceptance criteria for the facility.

The waste is properly identified.

The required documentation and records are available and acceptable.

All necessary processes for waste processing have been undertaken and completed satisfactorily.

The waste and waste packages do not show signs of unacceptable deterioration.

If applicable, measures for criticality control are in place, are effective and are maintained.

The intended movements of waste within the storage facility can be performed safely, preclude inadvertent criticality and optimize occupational exposures.

Procedures are in place for the following:

Suitable locations and storage capacity exist within the facility.

Monitoring the integrity of waste packages;

Monitoring and controlling environmental conditions in the store (e.g. temperature, humidity, ventilation);

Surveillance of the store and of the status of equipment to facilitate maintenance and replacement, as needed, and surveillance for the detection of unintended events and accidents and mitigation of consequences;

Ensuring that waste can be readily identified, located and accessed for inspection and retrieval.

The waste meets the waste acceptance criteria for the facility.

The waste is properly identified.

The required documentation and records are available and acceptable.

All necessary processes for waste processing have been undertaken and completed satisfactorily.

The waste and waste packages do not show signs of unacceptable deterioration.

If applicable, measures for criticality control are in place, are effective and are maintained.

Intended movements of waste within the disposal facility can be performed safely, preclude inadvertent criticality and optimize occupational exposures.

Procedures are in place for the following:

Suitable locations and space exist within the facility for the waste. The management system for geological disposal facilities may also need to include a process and procedures to ensure the suitability of the host rock surrounding the disposal locations (see e.g. Ref. [57]). Such a process might, for example, seek to avoid locations in highly fractured or hydraulically conductive rock.

Monitoring the integrity of waste and waste packages;

Monitoring and controlling environmental conditions in the disposal facility (e.g. temperature, humidity, ventilation, rock fall, water inflow);

Surveillance of the disposal facility and of the status of equipment to facilitate maintenance and replacement, as needed, and surveillance for the detection of unintended events and accidents and mitigation of consequences;

Ensuring that waste can be readily identified, located and accessed for inspection.

Video surveillance of the waste management processes (e.g. waste immobilization by cementation or vitrification, testing of package closure welds);

Sample checks on activities critical to the quality of waste packages (e.g. production of metal used to fabricate metal containers, preparation of concrete for overpacks);

Remote measurement of radiation levels around packages and video surveillance checks of the external condition of packages;

Examination of the data recorded for each waste package.

Regulatory requirements;

The objectives of monitoring;

The views of interested parties;

The characteristics of the facility and the site and its surroundings;

The events and processes that may affect the facility (e.g. earthquakes, corrosion and other waste degradation processes);

The practicalities of monitoring and the available technologies.

A common understanding of safety and of safety culture, including: awareness of radiation risks and hazards relating to work and to the working environment; an understanding of the significance of radiation risks and hazards for safety; and a collective commitment to safety by teams and individuals;

Acceptance by individuals of personal accountability for their attitudes and conduct with regard to safety;

An organizational culture that supports and encourages trust, collaboration, consultation and communication;

The reporting of problems relating to technical, human and organizational factors and reporting of any deficiencies in structures, systems and components to avoid degradation of safety, including the timely acknowledgement of, and reporting back of, actions taken;

Measures to encourage a questioning and learning attitude at all levels in the organization and to discourage complacency with regard to safety;

The means by which the organization seeks to enhance safety and to foster and sustain a strong safety culture, and using a systemic approach (i.e. an approach relating to the system as a whole in which the interactions between technical, human and organizational factors are duly considered);

Safety oriented decision making in all activities;

The exchange of ideas between, and the combination of, safety culture and security culture.”

Management policy, objectives and strategy;

The management system documentation;

Assessments of the culture for safety;

Processes and procedures for conducting radioactive waste management activities;

Organizational changes;

The safety case for the facility and activities, the status of waste management activities, and plans for the future;

Technical and quality management issues (e.g. problems and their resolution, planned improvements and innovations);

Radiation protection issues (e.g. trends in occupational exposure and in releases to the environment, evaluation of incidents, including accidents);

Regulatory and statutory issues (e.g. the preparation of information to fulfil regulatory requirements and licence conditions, preparation for new laws and requirements on radiation protection and safety, on waste management and on environmental protection).

Individuals should not only consider immediate and short term safety, but should also consider the longer term safety implications of activities, which in some instances might not be manifested until several generations later; the management system should provide individuals with sufficient knowledge to do this. The management system should aim to engender and implement an enduring culture for safety, for example to ensure consistency in the production of high quality waste containers and waste packages, in the monitoring of waste and facility degradation, and in the keeping of records over the potentially very long period of time for which the radioactive waste will remain hazardous.

The waste hierarchy should be applied and the generation of radioactive waste should be minimized.

Where radioactive waste is transferred to other organizations, the safety implications of the actions undertaken at a facility might impact on the receiving organization.

Mistakes in radioactive waste management could lead to non‑conforming waste packages, which consequently may have no identified treatment or disposal route; although there might be no immediate safety consequence, a legacy could be left for subsequent generations to manage (see also paras 5.118–5.120).

Personnel, particularly at underground facilities, can sometimes be exposed to non‑radiological safety risks that are greater than those posed by radiological hazards. The operating organization should ensure that risks are considered in an integrated manner and that effective overall controls are put in place.

Personnel should use the safety case to determine an appropriate balance between operational safety and post‑closure safety at radioactive waste disposal facilities.

Lessons from experience gained and from events that have occurred, both within the organization and outside the organization, and lessons from identifying the causes of events;

Technical advances and results of research and development;

Lessons from identifying good practices.

Any changes in organizational structure or in the assignment of responsibilities and financial liabilities that could have an effect on radioactive waste management. This should include a consideration of relevant changes at the national level and, where appropriate, at the international level.

The continuation of assessments over long periods, where necessary, for radioactive waste storage and for the operation of a disposal facility as well as for the post‑closure period of institutional control.

Process variables and controls have not changed from those established in the original validated processes, as described in the safety case approved by the regulatory body.

Inspections and measurements are being performed in accordance with the management system, and the associated records are being maintained.

The ownership and characteristics of waste are traceable through any transfers of waste, and proper controls are implemented during storage.

The instrumentation used to monitor or control waste management activities has not degraded in service and has not been modified without proper change control.

Critical parameters associated with waste acceptance criteria or other specifications are being controlled within established limits.

Facilities are being operated in accordance with regulatory requirements.

Waste management activities are conducted in a manner that is consistent with the relevant safety assessments.

Waste packages and containers qualified by performance based testing are used within their qualification limits.

Regulatory requirements and conditions in authorizations that relate to waste specifications and waste acceptance criteria have been addressed and are being met.

During the site evaluation stage: Sufficient information is gathered about the nature of the site, including the geological formations, to establish baseline conditions before the site is disturbed by construction activities. All site characterization data can be traced to their origin, and associated uncertainties are adequately described and explained.

During the design stage: The understanding of the site, the design of the facility and the safety case (including the supporting safety assessments) are being developed concurrently in an integrated fashion, and the final descriptions are adequate and mutually consistent.

During the construction stage:

During the commissioning stage: Activities are being performed in accordance with documentation, appropriate data are being collected and records are being prepared and maintained, and interfaces between commissioning and operations activities are defined.

During the operational stage:

During the closure and post‑closure stages:

Sufficient information is being gathered about the disturbance of the site by construction activities, including the response of the geological formation and of the geochemical and geohydrological conditions to any perturbations induced by the construction activities.

Construction activities are being carried out in accordance with the safety case and the authorization issued by the regulatory body, and in a manner that facilitates the optimization of the actual facility layout (e.g. in relation to the host geological formation).

The construction materials are of the required quality.

Construction works meet the design requirements.

All prerequisites are being met before waste is emplaced (e.g. waste packages are being checked against and are satisfying the acceptance criteria).

Waste is being emplaced in accordance with the safety case and the authorization issued by the regulatory body.

Monitoring is being conducted in accordance with the monitoring programme and the associated records are being maintained, and monitoring instrumentation has not degraded in service and has not been modified without proper change control.

The safety case and safety assessments are being periodically reviewed in a systematic, planned manner and are being updated as necessary in the light of new data, and any necessary actions are being taken to ensure the continued safety of the facility and waste management activities.

Any backfilling, sealing and other activities are being carried out in accordance with the safety case and the authorization issued by the regulatory body.

Backfilling, sealing and other activities and closure of the facility are being carried out in accordance with the safety case and the authorization issued by the regulatory body.

Monitoring is being conducted in accordance with the monitoring programme and the associated records are being maintained, and monitoring instrumentation has not degraded in service and has not been modified without proper change control.

The safety case and safety assessments are being periodically reviewed in a systematic, planned manner and are being updated as necessary in the light of new data, and any necessary actions are being taken to ensure the continued safety of the facility and waste management activities.

Appropriate information on the condition of the radioactive waste disposal facility has been transferred if responsibility for the facility has been transferred.

An organizational unit within the organization itself, which is independent of cost pressure or production pressure, and is independent of the line management responsible for managing and implementing the process being assessed;

Other organizations in the waste management programme;

The regulatory body or other national or local authorities;

International organizations;

A suitably qualified and experienced external organization.

Changes in organizations;

Changes in the governmental, legal and regulatory framework;

Changes in waste management activities;

Significant non‑conformances detected;

The need to verify the adequacy of any corrective actions.

The specific radioactive waste management activities (e.g. pretreatment, treatment, conditioning, storage) under the control of the organization being assessed;

The safety case and safety assessments for these activities;

The quality of waste packages produced.

Site characterization and the disposal concept;

Facility design and safety case development;

Research and development projects and results;

The quality of waste packages and their performance in fulfilling their safety functions;

Specific activities such as excavation, waste emplacement and engineered barrier construction;

Performance of the disposal facility during operation;

Arrangements for closure of the facility and for institutional control;

The safety case;

The performance of the radioactive waste disposal facility as may be determined by monitoring of the disposal system.

The number of safety improvement proposals made, and the percentage of such proposals implemented;

The number of safety inspections conducted by senior management;

The number of safety audit recommendations implemented during a specific period.

A process for formally assigning to senior management responsibility for the management system and for its application to achieve the fundamental safety objective.

Descriptions of the structure of the organization and the responsibilities and authorities and decision making powers of individuals for processes.

Processes for ensuring that managers understand the concept of leadership for safety and possess and demonstrate appropriate leadership capabilities.

A process for establishing the management system.

Processes for defining goals, strategies, plans and objectives, consistent with the organization’s safety policy.

Processes and procedures for the identification of, interaction with and involvement of interested parties in decision making.

Processes and procedures to ensure that interdependencies between the steps in the radioactive waste management process are considered.

A process for integration of all elements of the management system so that safety is not compromised.

A process for applying and demonstrating the application of the graded approach to the management system commensurate with the risks associated with the facilities and activities being controlled.

Processes and procedures for documentation of the management system. This documentation includes the following:

Processes and procedures to ensure that the documents comprising the management system are controlled, usable, readable, clearly identified and readily available at the point of use.

Processes and procedures for the provision of resources (covering both financial and human resources) and their management, including for purchasing and management of the supply chain.

Processes and procedures for recruitment, training and continuing professional development of personnel and for succession planning.

Processes and procedures for the design, management, inspection, testing, verification and validation of processes.

Processes and procedures for the development, documentation, maintenance and use of the safety case for radioactive waste management facilities.

Processes and procedures to ensure the quality of all data, models and safety assessment results.

Processes for developing, promoting the understanding of, communicating and fostering a culture for safety among all personnel of the organization.

Processes and procedures for the steps in the management of radioactive waste (see para. A.4).

Processes and procedures for periodic safety review.

Processes and procedures for measurement, assessment and improvement of the management system.

Policy statements of the organization on values and behavioural expectations;

A statement of the fundamental safety objective;

A description of the organization and its structure;

A description of responsibilities and accountabilities;

The levels of authority, including all interactions of those managing, performing and assessing work, for all processes;

A description of how the management system complies with regulatory requirements;

A description of the interactions with external organizations and with interested parties.

The development and publication of documents;

Change control;

Communication;

Transparency;

Traceability;

Research and development;

Treatment of uncertainties;

Processes and procedures for establishing an integrated national radioactive waste management strategy and programme;

Optimization of the radioactive waste management system, of radioactive waste management facilities and activities, and of protection and safety;

Knowledge management;

Record keeping and archiving of relevant information.

Processes and procedures for establishing and maintaining the inventory of radioactive waste;

Processes and procedures for waste characterization and for the recording of relevant information;

Processes and procedures for the clearance of materials and classification of waste;

Processes and procedures for identifying appropriate predisposal management steps and disposal routes for radioactive waste;

Processes and procedures for the siting of facilities;

Processes and procedures for site selection and site characterization;

Procedures for the design of radioactive waste management processes;

Processes and procedures for the design of waste management facilities;

Processes and procedures for controlling the construction of radioactive waste management facilities;

Processes and procedures for the maintenance of facilities and equipment;

Processes and procedures for establishing arrangements for preparedness and response for a nuclear or radiological emergency;

Processes and procedures for controlling the commissioning of radioactive waste management facilities and activities;

Processes and procedures for controlling the operation of radioactive waste management facilities and activities, addressing issues such as facility housekeeping and cleanliness;

Processes and procedures for dealing with unexpected occurrences such as incidents, including accidents;

Processes and procedures for establishing waste package specifications for radioactive waste (e.g. covering waste containers and outputs from waste conditioning);

Processes and procedures for establishing waste acceptance criteria for radioactive waste management facilities;

Processes and procedures for waste acceptance at facilities, including compliance checking with the waste acceptance criteria;

Processes and procedures for dealing with non‑conformances, such as cases where waste acceptance criteria are not met;

Processes and procedures for waste storage, for the control of environmental conditions in storage facilities, for the identification and inspection of stored waste and for the retrieval of waste from storage;

Processes and procedures for waste emplacement and the installation of engineered barriers in disposal facilities in accordance with the safety case and authorization for the facility;

Processes and procedures for controlling the decommissioning and closure, as appropriate, of radioactive waste management facilities;

Processes and procedures for monitoring of radioactive waste management facilities and activities and for monitoring of the environment;¹⁶

Processes and procedures for identifying and prioritizing research and development needs and activities to fill gaps in knowledge that are important to safety;

Processes and procedures for ensuring compliance with regulatory requirements (see e.g. Ref. [61]).

Processes and procedures for the authorization of radioactive waste management facilities and activities;

Processes and procedures for the inspection of radioactive waste management facilities and activities;

Processes and procedures for the development of regulations and regulatory guidance on radioactive waste management;

Processes and procedures for review and assessment (e.g. of authorization applications, safety cases and safety assessments for radioactive waste management facilities and activities).

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