GSG-13 Functions and Processes of the Regulatory Body for Safety

The development and/or provision of regulations and guides;

Notification and authorization, including registration and licensing;

Regulatory review and assessment;

Regulatory inspection;

Enforcement;

Emergency preparedness and response;

Communication and consultation with interested parties.

Administrative support, including human resources, finance, management of relevant documents and records, equipment purchasing and control;

Legal assistance;

Research and development processes;

Arrangements for contracting external expert support, where needed;

Establishment of advisory committees;

Organization of international links and cooperation. These supporting functions and the associated processes are described in GSG-12 [4].

Regulations and guides “shall provide adequate coverage commensurate with the radiation risks associated with the facilities and activities, in accordance with a graded approach” (GSR Part 1 (Rev. 1) [2], para. 4.62).

For notification and authorization “[t]he extent of the regulatory control applied shall be commensurate with the radiation risks associated with facilities and activities, in accordance with a graded approach” (GSR Part 1 (Rev. 1) [2], para. 4.33).

“Review and assessment of a facility or an activity shall be commensurate with the radiation risks associated with the facility or activity, in accordance with a graded approach” (GSR Part 1 (Rev. 1) [2], Requirement 26).

“Inspections of facilities and activities shall be commensurate with the radiation risks associated with the facility or activity, in accordance with a graded approach” (GSR Part 1 (Rev. 1) [2], Requirement 29).

For enforcement, “[t]he response of the regulatory body to non-compliances with regulatory requirements or with any conditions specified in the authorization shall be commensurate with the significance for safety of the non-compliance, in accordance with a graded approach” (GSR Part 1 (Rev. 1) [2], para. 4.54).

For communication and consultation with interested parties, “[p]ublic information activities shall reflect the radiation risks associated with facilities and activities, in accordance with a graded approach” (GSR Part 1 (Rev. 1) [2], para. 4.69).

Provide the framework for regulatory requirements and conditions to be incorporated into individual authorizations or applications for authorization;

Establish principles, requirements and the criteria to be used for assessing compliance;

Are consistent and comprehensive;

Are commensurate with the radiation risks associated with the facilities and activities;

Involve consultations with interested parties;

Take into account internationally agreed standards and feedback gained from related experience;

Are made available to interested parties;

Are reviewed and revised as necessary and are kept up to date.

Emphasis on prevention of, rather than mitigation of, accidents;

Application of the concept of defence in depth;

Meeting the single failure criterion for safety systems;

Requirements for redundancy, diversity and separation;

Requirements for adequate safety demonstration of any passive systems that are used;

Criteria relating to human factors and the human–machine interface;

Dose limits and dose constraints (for both occupational exposure and public exposure), and limits on discharges to the environment;

Criteria for assessing radiation risks to workers and the public;

Minimization of waste and management of the waste generated, including waste from decommissioning;

Emergency preparedness.

Prepare and submit a comprehensive application to the regulatory body that demonstrates that highest priority is given to safety; this means that the level of safety is as high as reasonably achievable and that safety will be maintained for the entire lifetime of the facility or duration of the activity, until it is released from regulatory control by the regulatory body.

Have the capability within its own organization (either at the facility or activity or within the organization as a whole) to understand the design basis and safety analyses for the facility or activity, and the limits and conditions under which the facility is to be operated or the activity performed.

Exercise control over the work of contractors, understand the safety significance of their work (an ‘intelligent customer’ capability⁷ ) and take responsibility for the implementation of the work.

Submit a procedure or description of the process for dealing with modifications that may be subject to approval by the regulatory body.

Have a design capability and a formal and effective external relationship with the original design organization of the facility or equipment, or an acceptable alternative arrangement.

Assess safety in a systematic manner and on a regular basis.

Develop a safety assessment and submit it to the regulatory body as part of the application, depending on the magnitude of the possible radiation risks associated with the facility or activity (e.g. if there is a possibility for an exposure to be greater than a level specified by the regulatory body).

Have an appropriate prospective assessment made of radiological environmental impacts, commensurate with the radiation risks associated with the facility or activity (see GSR Part 3 [3], para. 3.9(e)).

For an application for authorization, demonstrate that it has and will continue to maintain:

• (i) Adequate financial resources for construction, operation and maintenance of the facility or activity as well as for the timely decommissioning (or closure) of the facility or termination of the activity and the management of radioactive waste and/or spent radiation sources, including disposal;

• (ii) Adequate human resources to safely construct, maintain, operate and decommission the facility or activity and deal with any radioactive material and waste and to ensure that regulatory requirements and safety standards are met and will continue to be met.

Notification and authorization; the regulations should provide clarity and transparency in the notification and authorization process.

Review and assessment of facilities and activities; the regulations should require a demonstration of the safety of the facility or activity that enables the regulatory body to make a decision or a series of decisions on the acceptability of the facility or activity in terms of safety.

Inspection of facilities and activities; the regulatory body should provide its inspectors with written guidelines in sufficient detail to ensure that facilities and activities are inspected to a common standard, based on a graded approach, and that there is a consistent level of safety.

Enforcement of regulatory requirements; the regulatory body should adopt clear administrative procedures and guidelines governing the use and implementation of enforcement actions.

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.

The name and location of the regulatory body;

The purpose of the regulations, their scope and their date of entry into force;

The powers of the regulatory body, such as powers of authorization, inspection and enforcement;

The relationship of a given set of regulations to other governmental regulations in force;

The criteria for exemption from some or all of the regulatory requirements;

Requirements for planned exposure situations, emergency exposure situations and existing exposure situations;

Requirements for occupational exposure, public exposure and medical exposure;

Requirements for construction, commissioning, operation and decommissioning (or closure) of facilities, management of radioactive waste and transport of radioactive material;

The financial arrangements for dealing with orphan sources and waste management (including decommissioning and waste disposal);

Acceptance criteria and performance criteria for any manufactured or constructed source, device, equipment or facility that when in use has implications for safety;

Criteria and methods for assessing the adequacy of the implementation of remediation following contamination;

Safety criteria and planning for radioactive waste management and discharge monitoring, as well as aspects of institutional controls at different stages of the authorized facility or activity’s lifetime, including removal from regulatory control.

Guidance on the format and content of the documents to be submitted by the applicant in support of an application for an authorization, including printed (or electronic) forms to be completed by authorized parties in a question and answer format, so that all relevant information is gathered. Guidance for nuclear power plants is provided in IAEA Safety Standards Series No. GS-G-4.1, Format and Content of the Safety Analysis Report for Nuclear Power Plants [14]; guidance for research reactors is provided in IAEA Safety Standards Series No. SSG-20, Safety Assessment for Research Reactors and Preparation of the Safety Analysis Report [15].

A list clearly stating the regulations and standards to be applied.

Advance information on the requirements for each major stage of authorization, in order to assist the authorized party in making sound plans and decisions with respect to safety in the siting, design, construction, commissioning, operation and decommissioning or closure of a facility or conduct and termination of an activity

Registers of sealed radioactive sources and radiation generators;¹⁰ Records of doses from occupational exposure;

Records relating to the safety of facilities and activities;

Records that might be necessary for the shutdown and decommissioning (or closure) of facilities;

Records of events, including non-routine releases of radioactive material to the environment;

Inventories of radioactive waste and of spent fuel.

Which activities and/or radiation sources are to be exempted from some or all of the legislative requirements, including the requirements for notification or authorization. The regulatory body is required to use as a basis for this determination the criteria for exemption specified in Schedule I of GSR Part 3 [3], or to specify any exemption levels on the basis of these criteria. The regulations should clearly state that exemption cannot be granted for activities deemed to be not justified (see paras 3.10 and 3.11 of GSR Part 3 [3]).

Which sources, including materials and objects, within notified or authorized activities may be cleared from further regulatory control. The regulatory body is required to use as the basis for this determination the criteria for clearance specified in Schedule I of GSR Part 3 [3], or to specify any clearance levels on the basis of these criteria. By means of these arrangements, the regulatory body is required to ensure that sources that have been cleared from regulatory control do not again become subject to the requirements for notification or authorization unless the regulatory body so specifies (see para. 3.12 of GSR Part 3 [3]).

Determining the need for the regulations or guide. This need may arise from the regulatory body’s activities and from the inventory of facilities and activities in the State. Alternatively, the need may be identified as a result of a request or enquiry by an authorized party, or an applicant for a new facility or activity. Additionally, the need for regulations may arise as a result of national debates or to meet international obligations.

Setting the priority for the development of the regulations or guide. The regulatory body should consider the advantages and disadvantages of the proposed regulations or guide, including such matters as: the risks associated with the facility or activity; the need for, and the costs associated with, improvements in safety; the number of authorized parties to be affected; the effects on the efficiency of the authorization process; and the feedback of information and experience from review and assessments, inspections, investigations and enforcement activities.

Determining the scope of the regulations or guide. This involves clear identification of the facilities and activities to which regulatory requirements or recommendations are to be applied, as well as the stage of the authorization process to be covered and the technical topic to be addressed.

Determining the resources necessary to develop the regulations or guide. The development of regulations and guides requires sufficient suitably qualified, competent and experienced people to be available, as well as adequate financial and other resources [4]. The need for the regulations or guide and the timescale required for its preparation and establishment will be a factor in determining the resources required.

Collection of information. The information necessary to prepare the proposed regulations or guide should be collected. In particular, the state of the art in technology should be taken into account.

Drafting of the regulations or guide. The staff of the regulatory body, assisted by technical support organizations, consultants, professional societies or advisory committees, drafts the initial version of the regulations or guide. Regulations and guides should be written in a style that is clear and easy to understand. Regulations and guides should be relevant, precise and unambiguous so as to be readily applicable and enforceable, as appropriate.

Review of the regulations or guide. Although practices differ widely, legal staff and special advisory committees, as appropriate, usually review the initial versions of proposed regulations or guides. In some States, authorized parties, professional societies or other organizations participate in these reviews. A draft version may also be published provisionally with an invitation for comment from the interested parties. Comments received as a result of the review should be analysed, evaluated and resolved, as appropriate. A review of the final draft for quality control should be carried out before formal approval. At this stage, consideration should also be given to the implications of the new regulations or guide for existing facilities and activities.

Establishing and issuing the regulations or guide. Regulations should be established and promulgated in a manner that makes them legally binding in accordance with the national legal system, thereby ensuring that their provisions can be enforced by the regulatory body. The procedure for issuing guides should follow steps similar to those for regulations, but a guide can be formally issued with a lower level of approval, since its contents are only advisory in nature.

Detailed or specific recommendations, concerning specific facilities, activities, equipment, operating procedures and protocols, and the qualification and training of personnel, that can be adopted by authorized parties as a means of meeting regulations;

Practical protection and safety manuals covering various activities and procedures that serve as aids for the training of workers and for management in setting up local rules;

Procedural guides, such as those pertaining to instrument calibration, individual monitoring, environmental surveys and radioactive waste management, for use by authorized parties and/or technical service providers;

Guidance relating to the safety of persons undergoing medical exposure;

Guidance on developing safety assessments that identifies areas that need to be evaluated or reviewed for the authorization;

Guidance on the safe transport of radioactive material;

Procedures for the conduct of investigations;

Guidance on the development of emergency plans and emergency procedures.

A facility or activity should be authorized only when the regulatory body has confirmed, by review and assessment of the submitted documentation, that the facility or activity is going to be used or conducted in a manner that does not pose an unacceptable radiation risk to people or the environment. This should include confirmation that the applicant has the organizational capability, the organizational structure, adequate resources, adequate competence of managers and staff, and appropriate management arrangements to comply with the safety requirements to become an authorized party.

The regulatory framework for dealing with requests for authorization should be clear, especially the process for applying for authorization.

The regulatory framework for the authorization process should be explicitly established by the regulatory body.

The authorization of a facility or activity should be based on a predefined list of documents that are to be submitted to the regulatory body by the person or organization responsible for the facility or activity. These documents should be reviewed by the regulatory body. Expenses associated with the authorization process and the person or organization that will be charged these expenses should be clearly specified.

A clear and explicit set of requirements, criteria and standards forming the basis for authorization should be defined.

A graded approach should be taken by the regulatory body when performing reviews, assessments or inspections throughout the authorization process.

Clear mechanisms should be established for public participation in the authorization process.

The authorization process should be transparent to the public, and authorizations should be published or made available to the public by other means, with account taken of the need for information security and protection of proprietary information.

The regulatory body should include conditions in the authorization, as appropriate.

The scope of the authorization (the site, the facility or activity, or parts of the facility or activity; or whether the authorization is one of a series of authorizations), its period of validity and any incorporated conditions should be clearly defined by the regulatory body.

Responsibility for safety may be transferred to a different authorized party, depending on national regulations; however, this may be done only with the agreement of the regulatory body, which may attach provisions and conditions to the new authorization (see para. 2.14 of GSR Part 1 (Rev. 1) [2]).

The applicant and the regulatory body should take into account good practices in other States, as appropriate, throughout the authorization process.

Regulatory review and assessment of reference or generic facilities and activities, and of similar facilities or activities in the State or other States, should be taken into account, if this would contribute to the authorization process.

The analysis approach to demonstrating safety should be clearly defined, including the use of deterministic and probabilistic methodologies and analytical tools, as appropriate.

Safety reviews should be carried out by the authorized party as required by the conditions in the authorization, and the results should be submitted to the regulatory body for review and assessment. Appropriate regulatory decisions may then follow.

The prime responsibility for safety is assigned to and assumed by the person or organization responsible for a facility or activity that gives rise to radiation risks. Compliance with regulations and requirements imposed by the regulatory body does not relieve the person or organization responsible for any facility or activity of the prime responsibility for safety (see Requirement 6 of GSR Part 1 (Rev. 1) [2]). The person or organization responsible for a facility or activity should demonstrate to the satisfaction of the regulatory body that this prime responsibility has been and will continue to be fulfilled.

The means of challenging or appealing against an authorization or part of an authorization should be made clear by the regulatory body and within the regulatory framework.

Clear identification of the applicant submitting the notification;

Information on the provisions for justification of the facility or activity;

The location(s) of the facility and, if applicable, where the radiation source(s) will be stored and used;

Specification of the management system for the facility or activity;

Clear specification of the equipment to be used in the facility or activity, including the radiation source(s) and associated equipment.

Legal information:

• (i) The formal name and address of the applicant and any additional contact information, such as the name of the individual(s) representing the applicant;

• (ii) Details of any relevant existing authorizations;

• (iii) Information on whether the facility or activity is fully or partly owned or controlled by a person from another State or by a foreign corporation, and, if so, details of the ownership structure.

Information on organizational matters:

• (i) The applicant’s organizational structure;

• (ii) Evidence that the applicant has and will continue to maintain adequate financial resources to cover the necessary costs associated with safety, such as regulatory fees, liability insurance and funding for decommissioning or radioactive waste management, as applicable, depending on national legislation and regulation;

• (iii) Evidence that the applicant has adequate human resources to ensure that regulatory requirements and safety standards are met and will continue to be met throughout the lifetime of the facility or activity.

Characteristics of the site and the facility or activity:

• (i) The nature of the facility or activity that is the subject of the application;

• (ii) A description of the relevant premises, including the layout of the facility, buildings and equipment;

• (iii) Where relevant, a description of the site in terms of geography, demography, topography, meteorology, hydrology, geology and seismology.

Staff qualification and training:

• (i) Identification of the necessary qualifications and training of staff who will have safety related responsibilities;

• (ii) For authorization of certain facilities or activities, the identification of persons by name may be required to be included in the application (e.g. the name of radiation protection officers or qualified experts);

• (iii) Details of qualifications and training in radiation protection of workers engaged in activities that involve or could involve occupational exposure;

• (iv) Evidence of trustworthiness of all staff who will be engaged in responsible or sensitive positions.

The management system:

• (i) For relevant safety systems of facilities or activities with significant risk, the operating procedures and maintenance procedures that will be followed;

• (ii) A description of the system for identification, traceability and preservation of documents and for control of records;

• (iii) The system for the development of procedures;

• (iv) Procedures for reporting on and learning from operating experience including accidents and other incidents;

• (v) Procedures for learning from good practices in the State and in other States;

• (vi) A description of the arrangements for establishing and sustaining leadership and management on the part of organizations and managers responsible for facilities and activities that give rise to radiation risks;

• (vii) A procedure or description of the process for dealing with modifications of the facility or activity that may be subject to approval by the regulatory body, depending on national legislation, regulations and practices if requirements for dealing with modifications are not established directly in the regulations;

• (viii) A description of the quality assurance arrangements established to ensure that all items to operate the facility or conduct the activity are designed, manufactured, constructed, assembled, tested, qualified, operated, maintained and replaced in compliance with the relevant safety requirements;

• (ix) A description of the arrangements for ensuring the technical quality of information provided to the applicant by external organizations (e.g. contractors) for use during the operation of the facility or the duration of the activity;

• (x) Quality assurance arrangements, including internal and external audits.

Safety activities:

• (i) Applicable safety regulations, guides and industrial standards.

• (ii) Safety assessments for exposures in normal operation and for potential exposures.

• (iii) An appropriate prospective assessment of radiological environmental impacts, commensurate with the radiation risks associated with the facility or activity, as required by the regulatory body (see para. 3.9(e) of GSR Part 3 [3]).

• (iv) The occupational radiation protection programme, including arrangements for designation of areas, local rules and procedures, monitoring of workers and the workplace, the health surveillance programme, and provision and maintenance of personal protective equipment.

• (v) Safety assessments and other design related documents that address the optimization of protection and safety, the design criteria and the design features relating to the assessment of exposure and potential exposure of members of the public.

• (vi) For activities involving medical exposure, information relating to the radiation protection of patients, including arrangements for the calibration of sources used for medical exposure and for clinical dosimetry and the description of the management system.

• (vii) For new, unusual or complex activities, or for the provision of consumer products, a demonstration that the principle of justification for engaging in the activity is fulfilled.

• (viii) Arrangements for ensuring safety, which will be maintained for all stages of the lifetime of the facility or the duration of the activity.

• (ix) The safety concepts and criteria used in the design of the facility or for carrying out the activity, including the classification of equipment, systems and components; the application of the concept of defence in depth; the use of multiple barriers to prevent radioactive releases; and the approach to issues relating to the human–machine interface.

• (x) A description of the items important to safety for operating the facility or conducting the activity (e.g. the facility’s structures, systems and components, including their design criteria, the processes involved in their design, and the modes of operation and testing).

• (xi) Arrangements for the management of radioactive waste generated throughout the lifetime of the facility or activity, including in decommissioning and for the management of disused sources (disused sources should either be managed in the State concerned or be returned to the supplier or manufacturer), and information on the financial arrangements for such activities.

• (xii) The results of an analysis of the normal operation of the facilities and activities, and, for a radioactive waste disposal facility, of the long term period after closure, to demonstrate the acceptability of the design, including a demonstration that radiation protection criteria, radioactive waste management requirements and effluent limits are met by the design.

• (xiii) The results of a safety analysis to demonstrate how the design and related operational procedures of the facility or activity will contribute to the prevention of accidents and to the mitigation of the consequences of accidents if they do occur. The analysis should describe and evaluate the predicted response of the facility or activity to events, both internal and external, which could lead to anticipated operational occurrences and accident conditions. The analysis should include relevant combinations of such disturbances, malfunctions, failures, errors and events. Consideration should be given to aspects, such as the initial conditions assumed, the physical or mathematical models used and their correlation with experiments, and the method of presenting the results.

• (xiv) A safety analysis that shows the extent to which the authorized party addresses precursors to events and anticipated operational occurrences and accident conditions. The limits and conditions for safe operation should be derived from this analysis. If any part of the analysis has been independently reviewed, the results of this review should also be presented. Additional recommendations and guidance on safety analysis for nuclear power plants are provided in IAEA Safety Standards Series Nos SSG-2 (Rev. 1), Deterministic Safety Analysis for Nuclear Power Plants [18]; SSG-3, Development and Application of Level 1 Probabilistic Safety Assessment for Nuclear Power Plants [19]; and SSG-4, Development and Application of Level 2 Probabilistic Safety Assessment for Nuclear Power Plants [20].

• (xv) Information on other plans and programmes established by the authorized party in support of its safety activities. This includes areas such as:

  • The environmental monitoring programme;

  • Fire protection;

  • Research and development in relation to the safe design, operation, decommissioning or closure of the facility or the activity;

  • Feedback of operating experience [21];

  • The decommissioning (or closure) strategy.

Emergency arrangements:

• (i) Emergency arrangements, including an emergency plan and financial arrangements for preparedness and response for a nuclear or radiological emergency, where appropriate, that address the general, functional and infrastructural requirements established in GSR Part 7 [7].

Interface with nuclear security:

• (i) In accordance with the national regulatory framework, relevant information on nuclear security needs to be provided to the competent nuclear security authority [10, 11].

For a specific time period (e.g. 10 years, 40 years) or for a specific stage in the lifetime of the facility (e.g. construction, operation) or for the duration of an activity. In such a case, a mechanism should be put in place to ensure that the authorized party responsible for the facility or activity retains the prime responsibility for safety and for the implementation of security measures at the facility or for the activity, even if the authorization has expired, unless the site has been removed from regulatory control.

For an indefinite period of time (a permanent authorization), under certain conditions and until the authorization is officially terminated by the regulatory body.

For a specific activity or a specific condition of the facility (e.g. the temporary storage of spent nuclear fuel).

Statutory authority. The authorization should have a unique identification and should explicitly refer to the laws and regulations on which it is based.

Issuing authority. The authorization should state the official designations of those who are empowered by law or regulation to issue the authorization, whose signature and/or stamp will appear on the authorization, and to whom the authorized party will be accountable under the terms of the authorization.

Fulfilment of requirements. The authorization should include a summary statement that all legal and technical requirements in respect of safety have been fulfilled and that the facilities can be operated and the activities can be conducted without unacceptable radiation risk to people or the environment.

Documentary basis. The authorization should identify the documents provided by the authorized party in support of the application, and those prepared by staff of the regulatory body in the review and assessment process, which together form the basis for issuing the authorization.

Relationship to other authorization(s). The authorization should indicate whether it is contingent upon a prior authorization or is a prerequisite for a future authorization.

The authorized party. The authorization should contain a precise identification of both the individual or organization legally responsible for the authorized facility or activity and the individual or organization responsible for the day to day control of the facility or the activity.

Period of authorization. The authorization should state an effective date of authorization. It may also include a termination date, which may be based on a fixed term. Alternatively, a period of validity may be stated over which the assumptions underlying the authorization decision will remain valid and at the end of which the basis for authorization will be re-examined.

Authorized activity. The authorization should clearly describe, in sufficient detail, the location of the facility or activity, including, as appropriate:

• (i) A clear depiction and description of the site boundaries;

• (ii) The facility design and its mode of operation and/or the conduct of activities;

• (iii) The allowed inventory of radioactive material or radiation sources;

• (iv) Other relevant information, as appropriate.

The authorized party’s responsibility for compliance. The authorization should contain:

• (i) An appropriate declaration that the authorized party has the responsibility for compliance with the legal requirements, regulations and conditions referenced or contained in the authorization or in other references, as applicable;

• (ii) A statement that establishes that the responsibility for safety may be transferred to a different authorized party, subject to the approval of the regulatory body.

Authorization conditions that set technical limits and thresholds, such as:

• (i) Any limits on operation and use, such as dose constraints or discharge limits;

• (ii) Action levels;

• (iii) Limits on the duration of the authorization.

Authorization conditions that specify procedures and modes of operation, such as:

• (i) The obligations of the authorized party in respect of its facility, equipment, radiation source(s), management and personnel;

• (ii) Requirements for minimization of the generation of radioactive waste;

• (iii) Criteria for conditioning of radioactive waste for existing or foreseen radioactive waste management facilities;

• (iv) Arrangements for emergency preparedness and response.

Authorization conditions pertaining to administrative matters, such as:

• (i) Requirements for notifying the regulatory body of any modifications in accordance with their safety significance;

• (ii) Any additional separate authorizations that the authorized party should obtain from the regulatory body, if necessary;

• (iii) The reports that the authorized party should make to the regulatory body;

• (iv) The means and procedures for changing any information stated in the authorization;

• (v) Procedures for, information about and identification of the legal framework for challenging the conditions in the authorization or part of it.

Authorization conditions relating to inspection and enforcement, such as:

• (i) The records that the authorized party should retain and the time periods for which they should be retained.

Authorization conditions pertaining to the response to abnormal conditions, such as:

• (i) The requirements for reporting of events and the procedures for taking suitable corrective actions.

Siting and site evaluation (which may include the environmental impact assessment);

Design;

Construction;

Commissioning;

Operation;

Decommissioning (or closure);

Release from regulatory control.

The regulatory requirements;

The nature and categorization of the associated hazards;

The site conditions and the operating environment;

The basic design of the facility or the conduct of the activity as relevant to safety;

The records provided by the authorized party or its suppliers;

Best practices;

The applicable management system;

The competence and skills necessary for operating the facility or conducting the activity;

Arrangements for protection (of workers, the public, patients and the environment) [see GSR Part 3 [3]];

Arrangements for preparedness for, and response to, emergencies;

Arrangements for nuclear security;

The system of accounting for, and control of, nuclear material;

The relevance of applying the concept of defence in depth to take into account inherent uncertainties (e.g. in the long term for the disposal of radioactive waste);

Arrangements for the management of radioactive sources, radioactive waste and spent fuel;

Relevant research and development plans or programmes relating to the demonstration of safety;

Feedback of operating experience, nationally and internationally, and especially of relevant operating experience from similar facilities and activities;

Information compiled in regulatory inspections;

Information from research findings;

Arrangements for the termination of operations.”

The available information demonstrates the safety of the facility or the proposed activity and the optimization of protection [see SF-1 [1] and GSR Part 3 [3]];

The information provided in the applicant’s submissions is accurate and is sufficient to permit confirmation of compliance with regulatory requirements;

Operational and technical provisions, and in particular any novel provision, have been proved or qualified by experience or testing, or both, and will enable the required level of safety to be achieved.”

To determine whether the authorized party has in place an appropriate management system that meets the regulatory body’s requirements;

To determine whether the authorized party has put in place the necessary arrangements for establishing, sustaining and continuously improving leadership and management for safety;

To determine whether the operational limits and conditions are consistent with the regulatory body’s requirements, the operational characteristics of the facility or activity, and up to date operational procedures and experience;

To determine whether an adequate level of safety is being maintained and improved;

To determine whether the authorized party’s personnel meet the regulatory requirements, in terms of number, qualification and competence;

To determine whether, regardless of the stage of the lifetime of a facility or activity, proposed modifications have been designed and their implementation planned so that safety is not compromised;

To evaluate safety reviews performed by the authorized party;

To determine whether the authorized party’s plans and commitments in respect of decommissioning meet the requirements of the regulatory body;

To determine whether the authorized party’s plans and commitments in respect of the closure and post-closure stages for a radioactive waste disposal facility meet the requirements of the regulatory body;

To evaluate the final radiological survey documentation;

To determine, if relevant, whether the performance indicators proposed by the authorized party are appropriate;

To determine whether the programme proposed by the authorized party for confirmation of performance is acceptable (particularly important for radioactive waste disposal facilities);

To determine whether any additional requirements (or authorization conditions) have been fulfilled by the authorized party.

During the authorization steps of siting and construction, reports on:

• The progress of site studies;

• The progress of construction activities;

• Results of the pre-operational environmental monitoring programme;

• Relevant events occurring during construction and manufacturing.

During the authorization steps of commissioning and operation, reports on:

• The results of commissioning tests;

• Data from operation, including data on the facility’s output and performance;

• Modifications;

• Results of the radiation protection programme;

• Results of the environmental monitoring programme;

• Radioactive waste management;

• Relevant operational safety and performance events occurring during commissioning and during operation.

For the release of any facility or site from regulatory control, or for institutional controls for the post-closure stage of a radioactive waste disposal facility, reports on:

• The types, amounts and destinations of radioactive waste resulting from the decontamination and dismantling programme;

• Levels of residual activity in the facility;

• Results of the radiation protection programme and environmental monitoring programme, including the final radiological survey, and other relevant confirmatory programmes;

• Restrictions and institutional controls in the case of restricted release from regulatory control.

Definition of the scope of the review and assessment process;

Specification of the purpose of and technical bases for the review and assessment process (these could be considered acceptance criteria for the review and assessment);

Identification of additional information, if necessary, for the review and assessment;

Performance of a step by step review and assessment procedure to determine whether the applicable safety objectives and regulatory requirements have been met for each aspect or topic;

Decisions⁸ on the acceptability of the authorized party’s safety arguments or the need for further submissions;

Reporting and documentation.

National laws and regulations;

Advice obtained from external experts including consultants, dedicated support organizations and advisory bodies associated with the regulatory body;

Standards and guidance on nuclear, radiation, transport and radioactive waste safety as well as information issued by national and international organizations;

Requirements applicable in and experience gained in other relevant industries;

Technical results and experience from research and development;

Expertise and requirements used by others involved in reviewing and assessing similar facilities or activities in respect of technologies or safety.

Requests for additional information and questions by the regulatory body;

Responses from the authorized party (including responses provided by its contractors);

Records of meetings between staff of the regulatory body and staff of the authorized party.

Experience relevant to safety that has been gained from the facility or activity, at similar facilities or activities or at other relevant nuclear and non-nuclear facilities or activities;

Information from relevant tests or from research and development programmes, and new knowledge of technical matters;

Proposed modifications to the facility or activity or to the way in which it is to be managed and operated;

Changes in the regulatory framework, regulations and guides;

A proposal to extend the lifetime of the facility or activity.

Identifying weaknesses, if any, in the safety case;

Estimating safety margins or the degree of conservatism in the safety case;

Performing sensitivity analyses and uncertainty analyses in order to verify the authorized party’s designation of the risk significance of various structures, systems and components;

Understanding complex process interactions between engineered features and natural features (this is particularly important for radioactive waste disposal facilities);

Verifying that the safety assessment is consistent with current data obtained from research and monitoring;

Gaining further confidence in its own decision making process;

Developing its in-house capacity for the resolution or further clarification of safety issues;

Extending the review and assessment process to include a quantitative evaluation of the design and operation of facilities and activities.

Engineering design;

Operational and management aspects;

Normal operation, anticipated operational occurrences and accident conditions.

Definition and categorization of the safety functions;

Identification and classification of structures, systems and components;

Ensuring the quality of engineered features as set out in the regulatory requirements or in terms of good engineering practice;

Demonstration of control of the facility or activity in normal operation, anticipated operational occurrences and accident conditions, with account taken of automatic systems, the human–machine interface and operating instructions;

Adequacy of the management system covering the structures, systems and components, and operational aspects, such as the training, qualification and experience of the authorized party’s personnel and quality assurance procedures.

Whether the authorized party’s safety policy has been established by and is promoted by senior management and shows commitment at a high level to meeting regulatory requirements and states the means by which these requirements will be met.

Whether the authorized party’s organization is such that it can achieve the aims and objectives in its safety policy. In particular, the following should be addressed:

• (i) Adequate control of activities at the facility;

• (ii) Fostering cooperation between staff members and between staff and managers;

• (iii) A satisfactory system for communication both up and down the management chain and between managers;

• (iv) Systems to ensure that staff are competent for the positions to which they are assigned.

Whether the authorized party has systems in place to ensure adequate planning of work and suitable performance standards so that staff and managers know what is expected of them in order to achieve the aims and objectives of the safety policy.

Whether the authorized party has systems in place to review and to audit periodically all the evidence on its performance, including consideration of operational events and other matters important to safety, in order to determine whether it is adequately achieving its aims and objectives, and to consider and make improvements where necessary.

Whether the authorized party has systems in place to ensure that it acquires and retains adequate capability within its organization to understand the nature, substance and detail of the advice given to it by contractors and is able to judge the soundness of that advice.

The development of operational limits and conditions;

The production and revision of safety documentation;

The planning and monitoring of maintenance, inspection and testing;

Control of contractors (see Appendix III for further details);

The procedures for the control and justification of changes to the authorized party’s management and organizational procedures and systems that could have an impact on safety;

Feedback of operating experience.

Reference to the documentation submitted by the authorized party;

The basis for the evaluation;

The evaluation performed;

Comparison with regulatory requirements, regulations and guides;

Comparison with another similar (reference) facility or activity, where appropriate;

Independent analysis performed by the regulatory body’s staff, or by consultants or dedicated support organizations on its behalf;

Conclusions with respect to safety;

Additional requirements to be met by the authorized party.

Structures, systems and components and materials important to safety;

Management systems;

Operational activities and procedures;

Records of operational activities and results of monitoring;

Liaison with contractors and other service providers;

Competence of staff;

Safety culture;

Liaison with the relevant organization for joint inspections, where necessary.

The authorized party is in compliance with applicable laws, regulations and authorization conditions and all relevant codes, guides, specifications and practices;

The authorized party has in place an effective management system, a strong safety culture, and self-assessment systems for ensuring the safety of the facility or activity and the protection of people and the environment;

The required quality and performance are achieved and maintained in the items and activities important to safety throughout the lifetime of the facility or activity;

Persons employed by the authorized party (including contractors) possess the necessary competence for the effective performance of their functions throughout the whole lifetime of the facility or activity;

Deficiencies and abnormal conditions are identified and promptly evaluated and remedied by the authorized party and duly reported to the regulatory body as required;

Any other safety issue that is neither specified in the authorization nor addressed in the regulations is identified and appropriately considered;

Any safety lessons learned are identified and disseminated to other authorized parties and suppliers and to the regulatory body as appropriate.

Conducting planned inspections, at relevant steps of the authorization process;

Carrying out reactive inspections, as appropriate, in response to events;

Identifying and recommending necessary changes to the requirements approved by the regulatory body, as specified in the authorization or contained in the regulations;

Preparing reports to document inspection activities and their findings;

Ensuring that the authorized party has adequate, comprehensive and up to date information on the status of the facility or activity and information for demonstrating safety, and a procedure for keeping such information up to date;

Detecting degraded performance and potential non-compliances;

Tracking recurrent problems and non-compliances;

Verifying that corrective actions have been undertaken by the authorized party to resolve safety issues identified previously;

Developing procedures and directives as necessary for the effective conduct and administration of the inspection programme;

Determining and recommending suitable enforcement actions when non-compliance with regulatory requirements or a violation of the conditions of an authorization is encountered.

To adjust the levels of attention given to particular inspection areas and to redeploy its human resources accordingly;

To alter the extent to which various inspection techniques and methods are employed;

To modify the rigour and frequency of the inspections.

A system of prioritizing inspections based on a graded approach;

On-site inspections⁹ ;

The investigation and follow-up of events and deviations from normal operation;

The submission of information on key operational safety parameters by authorized parties.

Housekeeping;

Financial stability;

Staffing, including turnover of staff;

Record keeping and retrieval systems;

Investigation levels set by the authorized party and the procedures to be followed in the event that investigation levels are exceeded;

Training, including arrangements for retraining of staff;

Occupational exposures for the type of facility or activity;

Recurring failures of structures, systems and components important to safety;

Unavailability of structures, systems and components;

Frequency of enforcement actions.

The results of previous inspections;

The safety analysis performed by the authorized party and the results of regulatory review and assessment;

The use of performance indicators or any other systematic method for assessment of the safety performance of the authorized party;

Operating experience and lessons learned from operating the facility or conducting the activity, and from similar facilities and activities in the State and in other States, as well as results of research and development;

Inspection programmes of the regulatory bodies in other States.

Determination of the reasons why the event occurred so as to take measures to prevent its recurrence;

Consideration of the legal aspects concerning liability for the event.

The determination of the root causes, the sequence of events and the contributory factors;

The assessment of the consequences;

The identification of preventive and corrective actions;

The identification and documentation of lessons to be learned;

The recommendations for measures to be taken for the prevention of similar events in the future, including changes in the regulatory programme, as well as any adjustments to the authorized party’s arrangements for safety;

The dissemination of the findings, lessons to be learned and recommendations to relevant authorized parties, manufacturers and suppliers, and other interested parties both in the State and in other States.

The type of facility or activity;

The safety significance of the technical area to be inspected;

The inspection methods and approaches used (e.g. the use of resident inspectors may influence the intervals and the scope and depth of inspections);

The performance record of the authorized party and the facility; for example, the number of non-compliances with regulatory requirements, violations of conditions in the authorization, deficiencies, events and the number of reactive inspections;

The results of regulatory review and assessment;

The personnel and other resources available to the regulatory body;

The results of previous inspections.

Policies of the regulatory body regarding inspections.

The legal basis for regulatory inspection and the scope of the inspector’s authority.

The use of regulatory requirements, regulations, guides and standards.

The development of an inspection programme.

The implementation of the inspection programme, including:

• (i) Facilities (or areas of the facility) or activities to be subject to inspection;

• (ii) Method of inspection to be used;

• (iii) Methods for selection of inspection samples;

• (iv) Use of relevant technical information;

• (v) Use of inspection questionnaires;

• (vi) Follow-up on inspection findings.

Reporting requirements and practices for inspectors.

Standards of conduct of inspectors.

The enforcement policy, procedures and practices.

Regulatory requirements relating to the authorized facility or activity, and conditions in the authorization issued to the authorized party;

Experience feedback relating to the inspection area;

Findings of previous inspections and enforcement actions relating to the inspection area, and any unresolved issues from previous inspections;

The analysis of accidents and other events in the past;

Past correspondence between the regulatory body and the authorized party relating to the inspection area;

The safety documentation and operational limits and conditions;

Documentation on operation and design for the facility or activity;

The authorized party’s management system.

Relevant inspection procedures, questionnaires and checklists as well as other relevant documents;

The accreditation of the inspector;

Personal dosimeters;

Appropriate survey meters or other necessary measuring equipment;

Safety equipment, such as high visibility clothing, safety shoes and hard hats;

A camera for documentation.

Monitoring and direct observation (such as of working practices and equipment);

Discussions and interviews with personnel of the authorized party and of the contractor, if necessary;

Examination of procedures, records and documentation;

Confirmatory tests and measurements.

Workplaces;

Transfer of jobs between persons;

Radiation protection arrangements including boundaries of controlled areas;

Items important to safety for the facility or activity;

Fire barriers;

Housekeeping;

The presence of management;

Internal and external interfaces and communications;

Arrangements for emergency preparedness and response.

Procedures and schedules for maintenance and testing;

Quality assurance records;

Test results and data;

Operational and maintenance records, and results of workplace monitoring;

Records of deficiencies and incidents;

Modification records, including records of modifications to management and operating procedures;

Training records;

Shift schedules;

Dose records.

The general administrative and legal structure in the State and the requirements established by the regulatory body;

The type of facility or activity and its steps of authorization;

The location of the inspection;

The type of inspection, whether planned or reactive, announced or unannounced, individual or team;

The purpose of the inspection (e.g. team inspection, special inspection, site visit by non-resident site inspectors, weekly inspection activities carried out by resident inspectors).

To record the results of all inspection activities relating to safety or of regulatory significance;

To document and record an assessment of the authorized party’s activities in relation to safety;

To record discussions held with authorized party’s staff, management and other concerned persons;

To provide a basis for informing the authorized party of the findings of the inspection and of any non-compliance with regulatory requirements, and to provide a record of any enforcement actions taken;

To record any findings or conclusions reached by inspectors;

To record any recommendations by inspectors for future actions by the authorized party or the regulatory body and to record progress on recommendations from previous inspections;

To inform other staff of the regulatory body of inspection results;

To contribute to maintaining an organizational memory.

Details of the authorized party inspected, the purpose and date of the inspection and the inspectors’ names;

The methods used in the inspection (interviews, observations, review of documents);

Reference to applicable requirements;

Criteria used in the assessment of safety performance;

Details of areas, activities, documents, processes, items, and qualification and training of personnel that have been inspected, assessed or reviewed;

A record of actual or potential problems relating to safety;

A record of the results of any checks for compliance with regulatory requirements and the conditions of the authorization;

A record of any deficiency or non-compliance with regulatory requirements or violation of conditions of the authorization found in regulatory inspections, including a record of which requirements or authorization conditions have been contravened;

A record of discussions held with the authorized party’s staff, managers and other persons, including a record of discussions with the authorized party’s managers about points of concern;

A record of the inspectors’ opinion about the response of the authorized party’s management to any matter of concern to which their attention was drawn after a regulatory inspection;

A record of any regulatory action taken by inspectors and any consequent action taken by the authorized party in the period covered by the report;

A record of the findings or conclusions of the inspectors, including corrective actions that should be taken;

A record of recommendations made by inspectors for future action, such as a need to advise other inspectors or authorized parties about particular problems, proposals for further inspections or proposals for enforcement actions.

A basis for future regulatory action;

A contribution to maintenance of the regulatory history by providing a record of inspections, discussions and associated findings and conclusions;

A basis for identifying major or generic issues that necessitate special inspections, changes to inspection plans or generic regulatory action;

Information to other staff of the regulatory body, for example those staff responsible for the development of regulations and guides, for review and assessment, and for the development of requirements for authorization;

A means of sharing information with other inspectors;

Information to regulatory staff responsible for the analysis of reportable events;

A basis for periodic reviews of inspection findings, including trends and root causes;

A means of passing information to interested parties or governmental bodies;

Self-assessment activities.

The safety significance of the non-compliance or of the violation and the complexity of the corrective action necessary;

Whether the non-compliance or violation is repeated;

Whether there has been a willful violation or a willful non-compliance;

Whether or not the authorized party identified and/or reported the non-compliance or the violation;

Whether the non-compliance or violation impacted the ability of the regulatory body to perform its regulatory oversight function;

The past safety performance of the authorized party and the performance trend;

The need for consistency and openness in the treatment of authorized parties.

Ensuring that on-site emergency arrangements are in place;

Ensuring coordination with off-site response organizations;

Establishing and maintaining internal arrangements for emergency preparedness and response;

Discharging its assigned responsibilities in emergency response.

Performing a hazard assessment;

Provisions for establishing and maintaining adequate infrastructure to support the performance of emergency response actions (e.g. plans, procedures, training and exercise programmes, staffing, equipment, tools, facilities, quality management programme and record keeping);

The timely notification of a nuclear or radiation emergency to the appropriate authorities;

The timely activation of the necessary emergency response actions on-site and, as relevant, off-site;

Provisions for obtaining off-site support and coordination with off-site authorities;

Provisions for protecting emergency workers (including health surveillance, medical follow-up, monitoring and control of exposure during the response);

Provisions for terminating the emergency;

Conducting a subsequent analysis of the emergency and the emergency response.

Are based on a hazard assessment that identifies all postulated nuclear or radiological emergencies that might occur in relation to the facility or activity, including those of very low probability;

Include arrangements for managing the on-site emergency response and for coordination with off-site response;

Address, as applicable, the operability and habitability of emergency response facilities (e.g. the emergency centre, technical support centre, operational support centre) under the range of postulated emergency conditions identified in the hazard assessment;

Include emergency procedures covering all postulated nuclear or radiological emergencies, including, where necessary, severe accident management guidelines [46], and which satisfactorily cover the necessary operator actions and functions in emergency response (including procedures for notification and activation of off-site emergency response);

Identify tools, instruments, supplies, equipment and communication systems necessary for response to a nuclear or radiological emergency that are adequate for the usage expected;

Include a specific training programme (which includes drills) and instructions for all staff of the authorized party on how to respond to a nuclear or radiological emergency and on the discharge of their expected duties;

Include sufficient suitably qualified staff to be available at all times to implement the emergency plans and procedures;

Include arrangements for obtaining support from off-site response organizations;

Describe the coordination with other plans, such as plans for nuclear security and plans for firefighting;

Include an exercise programme to ensure that all the emergency arrangements are tested satisfactorily within a specific period.

Send staff to appropriate locations during a nuclear or radiological emergency;

Collect data on the progress of the emergency either directly or remotely, which may require having access to the authorized party’s systems;

Analyse and draw conclusions on the likely progression of the emergency;

Advise the appropriate response organizations, which includes the authorized party, of its findings;

Ensure secure and reliable communication between its staff and other organizations.

A description of the consumer product, its intended uses and benefits, the radionuclide(s) incorporated and the function served by the radionuclide(s). Documentary evidence that the radioactive substance fulfils its function should also be provided.

The activity of the radionuclide(s) to be used in the consumer product.

Justification of the choice of radionuclide(s), particularly in relation to other radionuclide(s) that could be of lower risk to the public (e.g. radionuclides that emit less penetrating radiation and/or have a shorter half-life). The reason for choosing the radioactive substance in preference to a non-radioactive alternative should also be provided.

The chemical and physical forms of the radionuclide(s) contained in the consumer product.

Details of the construction and design of the consumer product, particularly with regard to the containment and shielding of the radionuclide in normal and abnormal conditions of use and disposal, and the degree of access to the radionuclide(s).

The quality assurance and verification procedures to be applied to radioactive sources, components and finished products to ensure that the maximum specified quantities of radionuclides or the maximum specified radiation levels are not exceeded, and to ensure that the consumer product is constructed in accordance with the design specifications.

A description of the prototype tests for demonstrating the integrity of the consumer product in normal use and in the event of possible misuse and accidental damage, and the results of these tests.

External radiation levels arising from the consumer product and the method of measurement.

Safety assessments, including estimates of individual doses and, if appropriate, collective doses arising from normal use, possible misuse and accidental damage and disposal and, if applicable, servicing, maintenance and repair.

The anticipated useful lifetime of the consumer product and the total numbers expected to be distributed and/or made available annually.

Information about any advice to be provided on the correct use, installation, maintenance, servicing and repair of the consumer product.

An analysis to demonstrate that the consumer product is inherently safe (i.e. it will not give rise to significant doses to individuals in the event of foreseeable accidents).

Information on how the consumer product is intended to be labelled.

The provisions foreseen for recycling or disposal of the consumer product at the end of its useful lifetime.

The facility should be designed and constructed in accordance with the relevant site parameters approved by the regulatory body.

The facility should be constructed in accordance with the design that has been justified in a safety case. The authorized party should not deviate from this design in any way that might affect safety without following a modification process that requires categorization of the modification according to safety significance. This modification process may require approval or agreement from the regulatory body depending upon the safety significance of the modification.

The authorized party should initiate a radiological study of the region, including an appropriate baseline survey, prior to the start of operation.

The authorized party should prepare reports during the stages of site evaluation and construction to keep the regulatory body informed of the progress of the project, covering the progress of site studies, the progress of construction and results of the pre-operational environmental monitoring programme.

The authorized party should keep records of site evaluation and construction of the facility (as appropriate), such as the results of site evaluation studies (geological, meteorological and hydrological data, as well as results of the pre-operational environmental monitoring programme), design records, manufacturing records (including results from quality control activities) and erection records (including quality control results and as-built design records). Such records may be useful later in the investigation of events or generic problems and in decommissioning.

Commissioning should be carried out in accordance with a programme approved by the regulatory body.

Completed structures, systems and components important to safety should be put into service only once they have been inspected, tested and approved as being in accordance with the terms of the authorization.

Commissioning records, including records of equipment and system tests, test procedures and test results should be kept to demonstrate to the regulatory body the continuing safety of the facility. Commissioning records should cover the following:

• The results of the commissioning tests and their evaluations;

• Operational data, including data on the facility’s output and performance;

• Modifications performed;

• Results of the radiation protection programme;

• Results of the environmental monitoring programme;

• Radioactive waste management.

The authorized party should provide approved storage facilities for nuclear or radioactive materials. The competent authority responsible for nuclear security may require that appropriate nuclear security measures be in effect before nuclear or other radioactive material is brought into the facility.

Fissile material or other radioactive material should not be brought onto the site without a regulatory authorization.

From the introduction of radioactive material into the facility, the authorized party should operate the facility only under the control and supervision of authorized personnel using written procedures, in accordance with the operational limits and conditions approved by the regulatory body. Any changes made to the operational limits and conditions should be approved by the regulatory body prior to their implementation.

The authorized party should have an approved emergency plan, coordinated with the other authorities involved in emergency preparedness and response.

The authorized party should not operate the facility or conduct the activity outside the limits authorized by the regulatory body.

The authorized party should have a procedure for modifications to be approved by the regulatory body in order to ensure that no part of the approved facility that is important to safety will be modified without the prior approval of the regulatory body.

The authorized party should ensure that the facility is subjected to in-service inspection and testing, to be carried out as specified for structures, systems and components important to safety, in accordance with a schedule approved by the regulatory body.

The authorized party should keep operational records to be used in the regulatory oversight for possible examination by the regulatory body. Operational records should cover:

• Operational data and performance records of the facility or activity;

• Operating log books;

• Inventories of fissile material and other radioactive material;

• Periodic calibration of equipment;

• Periodic testing of equipment and systems;

• Internal reviews or inspections;

• Preventive maintenance and repairs;

• Personnel training;

• Monitoring of occupational exposures;

• Records of workplace monitoring for the facility or activity;

• Radioactive waste management;

• Effluent discharges and the environmental monitoring programme;

• Anticipated operational occurrences and accidents.

The authorized party should ensure that the maintenance of equipment and systems important to safety is carried out in accordance with a schedule approved by the regulatory body.

Only changes given prior approval by the regulatory body should be made to the approved arrangements, schedules, procedures and rules.

The authorized party should ensure that the facility is operated or the activity is carried out only under the control and supervision of authorized personnel in adequate numbers that are acceptable to the regulatory body.

A detailed description of the facility or activity, supported by drawings of the layout, the systems and the equipment;

Information on the functional capability of the facility and the nature of the activity, its systems and major items of equipment (including radiation protection equipment and waste management systems and equipment);

The findings of tests that validate the functional capability of equipment and systems;

The results of inspections of components;

Maintenance records;

A description of the physical condition of structures, systems and components on the basis of inspections or tests;

A description of the support facilities available both on and off the site, including maintenance and repair workshops;

Geological, hydrogeological and meteorological conditions at the site;

A description of off-site characteristics, including population densities, land use, industrial structures and facilities (including pipelines) and transport arrangements (such as airports, roads and railways).

Are properly characterized and compatible with the anticipated nature and duration of storage pending disposal;

Can be subjected to regular surveillance;

Can be retrieved for further steps in radioactive waste management.

Specification of the safety standards and design codes used.

A compilation of the safety analyses and their assumptions.

Structures, systems and components important to safety.

Limits and permitted operational states.

Anticipated operational occurrences.

Postulated initiating events for the safety analyses:

• External hazards (e.g. external floods, earthquakes, aircraft crashes, transportation accidents, explosions, external fires and meteorological hazards);

• Internal failures (e.g. mechanical and electrical failures);

• Internal hazards (e.g. internal fires, internal floods and internally generated missiles).

Features, events and processes:

• A list of barriers with their relative contributions;

• A description of how requirements for defence in depth are met;

• Anticipated activities for confirmation of performance.

Analytical methods and computer codes used in the safety analyses and the verification and validation of such codes.

Radioactive releases and radiation exposures in normal operation, anticipated operational occurrences and accident conditions.

The authorized party’s safety criteria for analyses of authorized party actions, common cause failures, cross-link effects, the single failure criterion, redundancy, diversity and separation.

It will be in control of the facility or activity;

It has resources available to meet its obligations and liabilities in connection with an authorization.

Details of the organizational structure of the authorized party, showing that it has adequate control over the activities of its own staff and its contractors;

A demonstration of the adequacy of resources in terms of sufficient and appropriately trained and experienced staff, ensuring in-house expertise;

A demonstration of the adequacy of the procedures for controlling changes to the organizational structure and resources;

The specification and documentation of the duties of staff, demonstrating the integration of responsibilities for safety into their duties;

A demonstration of the provision of, or access to, a high level of expertise in safety to carry out safety and engineering analyses and to perform associated audit and review functions;

A demonstration of the adequacy of the provisions for financing of continuing liabilities for nuclear damage and of decommissioning;

Provisions for the use of contractors.

A mechanism for setting operating targets and safety targets;

A policy that states that the demands of safety take precedence over those of production;

Documented roles and responsibilities for individuals and groups;

Procedures for the control of modifications to the facility;

Procedures for the feedback of operating experience to staff, including experience relating to organizational and management aspects;

Mechanisms for maintaining the configuration of the facility and its documentation;

Formal arrangements for employing and controlling contractors;

Staff training facilities and programmes for initial, refresher and upgrade training, including the use of simulators, where appropriate;

A quality assurance programme and regular quality assurance audits with independent assessors;

A system for ensuring compliance with regulatory requirements;

Comprehensive, readily retrievable and auditable records of baseline information and operational and maintenance history;

Staffing levels for the operation of the facility or conduct of the activity that take account of absences, shift working and overtime restrictions;

Sufficient and qualified staff available and on duty at all times;

Systematic and validated methods for the selection of staff, including testing for aptitude, knowledge and skills;

A systematic approach to fostering leadership and management for safety, including training in safety culture, particularly for managers;

Guidelines on fitness for duty in relation to hours of work, health and use of drugs or alcohol;

Competence requirements for operating, maintenance and technical staff and managers;

A system for consideration of the human–machine interface and its design and for the analysis of information needs and task workload for operators in the control room and at other workstations.

Formal approval and documentation where required by regulatory body;

A formal system for modification of a procedure;

Understanding and acceptance of the procedures by management and staff;

Verification that the procedures are being followed;

Procedures that are adequate in comparison with international good practices;

Arrangements for regular review and, if necessary, revision of the procedures;

Clear procedures in which principles relating to human factors have been taken into account;

Procedures that comply with the assumptions and findings of the safety analysis and with experience from design and operation;

Adequate emergency operating procedures.

A list of equipment covered by the equipment qualification programme, including documentation of the analyses used to derive this list of equipment, and a list of control procedures;

A qualification report and other supporting documents (such as equipment qualification specifications and a qualification plan);

Verification that the installed equipment matches the qualification requirements;

Documentation of procedures to maintain qualification over the lifetime of the installed equipment;

Information on mechanisms for ensuring compliance with these procedures;

Documentation of a maintenance, testing and inspection programme and a procedure for providing feedback to ensure that ageing degradation of qualified equipment remains insignificant;

A list of appropriate corrective actions to maintain equipment qualification;

Information on the physical integrity and functionality of qualified equipment;

Records of all qualification measures taken over the installed lifetime of equipment.

Documented methods and criteria for identifying structures, systems and components covered by the ageing management programme;

A list of structures, systems and components covered by the ageing management programme and records that provide information for use in the management of ageing;

An evaluation of and documentation of potential ageing related degradation that may affect the safety functions of structures, systems and components;

Details of the extent of understanding of the dominant mechanisms of ageing for structures, systems and components;

Details of the programme for the timely detection and mitigation of ageing processes and/or ageing effects;

Acceptance criteria and required safety margins for structures, systems and components;

Awareness of the physical condition of structures, systems and components, including actual safety margins.

The system used for identifying and classifying safety related events.

The arrangements made for root cause analysis of events, the results and lessons learned and the follow-up measures taken.

Methods for selecting and recording safety related operational data, including data for maintenance, testing and inspection.

Trend analyses of safety related operational data.

Feedback of safety related operational data, including records and reports of incidents including accidents.

Records of radiation doses to persons on the site.

Records of off-site contamination and data from radiation monitoring on the site.

Records of quantities and relevant characteristics of radioactive waste generated and stored at the facility.

Records of the quantities of radioactive effluents discharged.

Analyses of safety performance indicators, such as:

• Frequency of unplanned shutdowns of operation;

• Frequency of selected safety system actuations and demands;

• Frequency of safety system failures;

• Unavailability of safety systems;

• Annual individual and collective occupational radiation doses;

• Trends in causes of failures (operator errors, equipment failures, administrative matters, control matters);

• Backlog of outstanding maintenance tasks;

• Extent of repeat maintenance;

• Extent of corrective maintenance, including repair and replacement;

• Frequency of unplanned operator actions in relation to safety and their success rate;

• Amounts of radioactive waste generated;

• Quantities of radioactive waste in storage.

Obtaining and assessing feedback of experience relevant to safety from similar facilities and activities and from other nuclear and non-nuclear facilities and activities, and taking action on the basis of this feedback;

Determining the need for research and development;

Obtaining and assessing the findings of relevant research programmes, and taking action on the basis of these findings.

Materials and structures, systems and components important to safety meet the requirements established by the regulatory body and conform to good practices;

Construction activities associated with manufacturing and installing structures, systems and components are conducted in accordance with regulatory requirements and in conformity with general safety objectives;

The as-built configuration of structures, systems and components is in conformity with the assumptions made in the regulatory review and assessment, any deviation is analysed and justified and the documentation is updated accordingly;

The authorized party’s system and procedures for quality assurance and inspection are adequate to ensure the conformance of equipment to the technical specifications.

Mixing and placement of concrete and its reinforcement, especially in:

• Foundations;

• Structures important to safety, particularly containment structures.

Construction of cooling intakes and discharge systems.

Installation of components important to safety, particularly:

• Containment and shielding boundaries;

• Internals of vessels that will contain fissile material and other radioactive material;

• Equipment to be used in radiation areas.

Installation of control, protection and power systems important to safety.

Areas of the facility that are inaccessible after construction is completed, particularly systems and components embedded in the foundations or the building structure.

Housekeeping in respect of structures, systems and components important to safety.

The management systems of the designer, manufacturer and constructor.

Testing before the introduction of fissile material and other radioactive material;

Initial introduction of fissile material and other radioactive material;

Testing of operations involving fissile material and other radioactive material;

Other commissioning activities.

Examination of documented procedures to verify that they are in accordance with the conclusions of the regulatory review and assessment;

Review of the implementation of these procedures;

Direct observation of the performance of certain key pre-operational tests;

Examination of the results of selected tests;

Confirmation of the integrity of any engineered barriers.

Structures, systems and components that prevent unsafe conditions or that mitigate the consequences of anticipated operational occurrences and accident conditions;

Structures, systems and components whose failure to operate properly will require action from one or more safety related structures, systems and components.

Tests of safety systems (such as instrumentation and control systems, shutdown systems and standby systems);

Tests of the integrity of the containment and shielding boundaries (such as hydraulic tests of pressurized structures), as appropriate;

Tests of the susceptibility of structures, systems and components to vibration or to other design loads;

Tests for secondary containment integrity (such as overpressure and leak rate tests), as appropriate;

Tests of emergency power systems, as appropriate;

Tests of communication capabilities;

Tests of ventilation systems;

Integrated cold and hot functional tests.

Tests of the main control room;

Access control and implementation of the radiation protection programme;

Arrangements for emergency preparedness and response and demonstration of the emergency plan;

Systems for monitoring radioactive releases and meteorological monitoring systems;

The distribution of fissile material and other radioactive material (such as the fuel loading pattern in a reactor) and process calculations and/or criticality calculations, as appropriate;

Systems involved in the handling or movement of radioactive or fissile material.

The facility is being operated in accordance with the descriptions given in the safety analysis report;

Systems respond to malfunctions in accordance with the claims made in the safety analysis report.

Any identified degraded equipment;

Discrepancies between installed components and/or system hardware and the facility drawings;

Controls for performing maintenance on equipment;

The quality of performance of the operations staff in log keeping and record keeping and in routine monitoring of equipment.

All types of maintenance performed on structures, systems and components and maintenance of the physical condition of the facility;

Testing, including the conduct of all surveillance testing activities, all in-service inspection and testing, calibration of instruments, equipment operability tests and other special tests.

Calibration of nuclear instrumentation systems;

Verification of containment integrity;

Testing of local leak rates for the containment;

Testing of piping support and restraint systems;

Tests for safety pumps, valve capacity and stroke timing;

Surveillance tests for breakers and transformers.