International Atomic Energy Agency V. Nys Definition and practical application of demonstration of...

International Atomic Energy Agency

Considerations in the safety case for the construction and commissioning of RW

management facilities

V. Nys

Definition and practical application of demonstration of operational and long-term safety for predisposal RWM facilities

Vienna28 sept – 2 Oct 2015


Flying Carpet

Safety Concept

Sept 2015

FIRST IDEA

Sept 2015

MORE REALISTIC


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Sept 2015

DESIGN

Sept 2015

SITE SELECTION

Sept 2015

CONSTRUCTION

Sept 2015

WITHOUT COMMISSIONING


Outline of the Presentation

• Definition • GSR Part 5

• Safety Case• Management System• Construction• Commissioning

• Example• Evolution of the Safety Case arguments

15


Definition


Commissioning (IAEA Glossary)

The process by means of which systems and components of facilities and activities, having been constructed, are made operational and verified to be in accordance with the design and to have met the required performance criteria.

• Commissioning may include both non-nuclear and/or non-radioactive and nuclear and/or radioactive testing.


GSR Part 5


GSR Part 5 - Requirements

Requirement 18: Construction and commissioning of the facilities

Predisposal radioactive waste management facilities shall be constructed in accordance with the design as described in the safety case and approved by the regulatory body.

Commissioning of the facility shall be carried out to verify that the equipment, structures, systems and components, and the facility as a whole, perform as planned.


GSR Part 5

• Responsibility of the operator to construct facilities in accordance with the approved design

• Responsibility of the regulatory body to oversight of these activities for construction and verification.

• Commissioning may be carried out in several stages that are subject to the review and approval of the regulatory body. • completion of construction and inspection, • installation and testing of equipment, • demonstration of performance, • non-active commissioning (i.e. without radioactive waste) • active commissioning(i.e. with radioactive waste).


GSR Part 5

• A final commissioning report is usually produced by the operator.

• Document the as-built status of the facility providing information to facilitate operation and the tests performed;

• Provide evidence of the successful completion of testing and of any modifications made to the facility or to procedures in commissioning;

• Provide assurance that all the conditions of authorization have been satisfied;

• Be a reference document when considering possible future modifications to the facility and its shutdown and decommissioning.


GSR Part 5

• Any modification of a facility with significant safety implications that requires a revision of the safety case has to be subject to the same regulatory controls and approvals as are applicable for the new facility.


Safety Case


Safety Case

• The safety case is the collection of scientific, technical, administrative and managerial arguments and evidence in support of the safety of a waste management facility or activity,

• The safety case covers the suitability of the site and location and the design, construction and operation of the facility, the assessment of radiation risks and assurance of the adequacy and quality of all of the safety related work associated with the facility or activity.

• The safety case provides the basis for safety decisions with respect to siting and location, design, construction, operation and decommissioning of a facility, including for the justification of changes with a significant impact on safety.


Safety Case

• The safety case should also address the feasibility of construction and reliability

• The operator should be explained how the safety case for the commissioning stage has progressed from the safety case for the construction stage, and how this will justify the operation of the facility once commissioning is complete.


Management System


GSR Part 5

Requirement 7: Management systems

• To ensure the fulfilment of waste acceptance criteria, management systems are to be applied to all steps of the lifecycle of the facility and to all aspects of processing, handling and storage of waste.

• Management systems shall be applied for all steps and elements of the predisposal management of radioactive waste.


Management System

The requirements on the management system influence the development of the safety case.

• The description of the management system that applies to the various stages of facility development should represent an important element of the safety case, contributing to the confidence that the relevant requirements and criteria for construction are met.

• Programmes should be set up to ensure the quality of all activities associated with the safety case and safety assessment, such as data collection and modelling.


Management System• The safety case should provide updated information about

the management system, with particular emphasis on:

• The organization and procedures that will be put in place to ensure the quality of the work performed;

• The keeping of records on the basis of decisions made during construction or commissioning;

• Design basis information, including information on design modifications;

• The expertise available to construct and carry out tests.

• Example: Personnel should carry out their assigned work competently and with a clear understanding of the consequences for safety and environmental protection of their tasks


Construction


Construction

At the stage of construction, the safety case should be further developed, so that it can be demonstrated whether the following conditions are met:

• The adopted design will meet all safety requirements;

• The facility can be safely constructed or the activity can be safely carried out.

The safety case should provide a mature assessment of the engineering aspects and of the impact of the facility or activity.

What’s the output of the Safety Case ? The output of the safety case at this stage is justification that the facility or activity, as designed, can be safely constructed and operated.


Commissioning


Commissioning

Specific attention should be paid to the performance of structures, systems and components important to safety.

The safety case should be capable of demonstrating that the as-built facility meets the safety requirements specified in the final design.

This should include the impact of any modifications to the design that have been implemented during the construction period.

Schedule should be prepared for commissioning that details the tests to be undertaken and the expected results, to ensure that all aspects of the facility important to safety are adequately tested.


• It is possible that separate safety cases and commissioning schedules will be required for inactive commissioning and active commissioning.

What’s the role of the inactive (cold) commissioning? Safety case for inactive (cold) commissioning is to justify the decision that the as-built facility is safe to operate.

What’s the role of the active (hot) commissioning ? Safety case for active commissioning is to justify the decision that the facility can accept radioactive material safely.


Example


Example

MPF Facility – Monolith Production Facility where the waste is encapsulated into monoliths

Context• In relation with the disposal process of the category A waste• The waste is placed in concrete caissons (boxes) and subsequently

encapsulated with mortar to form a monolith. • The monoliths stop radioactive radiation and immobilize radioactive

substances, thus constituting a key safety element. • The monoliths containing the waste are placed in modules: concrete

bunkers with thick reinforced walls.


Example

MPF belongs to class 1 facility.


Example

Requirements (few example) for pre-disposal facility

• The licensee operates his installation(s) in a safe manner, in compliance with the legal and regulatory requirements, and with the conditions laid down in the construction and operating licence.

• On the basis of a detailed analysis of the nuclear safety related tasks and activities to be performed, appropriate requirements on the staffing, their qualifications and continuous training at the different levels of the organisation shall be determined and documented in a systematic manner.


ExampleRequirements (cont.)

• The adequacy of these requirements to ensure safe operation of the installation shall be verified and documented on a regular basis.

• The licensee shall develop a systematic and documented programme for the management of human resources related to long-term objectives in order to anticipate future staffing requirements.

• An integrated management system, giving the required priority to the nuclear safety, shall be established, implemented, assessed and improved on a continuous basis. This management system shall deal with all provisions related to the organisation, the responsibilities, resources, processes and quality assurance.



• The documentation of the management system shall include namely the following: • The licensee’s policy declarations. • A description of the management system. • A description of the organisational structure of the licensee. • A description of the functional responsibilities, hierarchy levels and

interactions between those who manage, carry out and assess the tasks. • A description of the interactions with the relevant external organisations. • An identification of the interactions with the other requirements to be met

by the licensee, especially as regards the wellbeing of the workers at their work.

• A description of the processes and related information explaining how the tasks are to be prepared, reviewed, performed, recorded, assessed and improved.


Evolution of the Safety Case arguments


GSR Part 5 requirement

Requirement 13: Preparation of the safety case and supporting safety assessment

• The operator shall prepare a safety case and a supporting safety assessment. In the case of a step by step development, or in the event of modification of the facility or activity, the safety case and its supporting safety assessment shall be reviewed and updated as necessary.


GSR Part 5 Requirement

Requirement 15: Documentation of the safety case and supporting safety assessment

• The safety case and its supporting safety assessment shall be documented at a level of detail and to a quality sufficient to demonstrate safety, to support the decision at each stage and to allow for the independent review and approval of the safety case and safety assessment. The documentation shall be clearly written and shall include arguments justifying the approaches taken in the safety case on the basis of information that is traceable.


• Questions

1. Which “decision step” are concerns by the requirement 14? 2. Who are the decision-makers?

3. What are the relevant safety case argument in relation with the decision step?

Example from PRISM – IAEA project for Near Surface Disposal Facility

International Atomic Energy Agency47


NEED FOR ACTION:

Decision:

- Go for disposal


DISPOSAL CONCEPT

Decide on the site disposal conceptand on safety strategy in a given environment


CONSTRUCTION

Decision - For construction

- Authorization and/or license for construction


OPERATION Decision - For operate

- Authorization and license for operation


CLOSURE

Decision for closeand to initiate the active

institutional control period


PASSIVE INSTITUTIONAL CONTROL PERIOD

Decide to initiate the passiveinstitutional control period


License Termination ?

Decide or not to release the regulatory control


Task 1

Task 2

Task 3Task 4


PRISM - Safety ArgumentsSafety Case Arguments could be gathered in the following themes:

Safety Case Context

Safety Strategy

Management system

System Description

Safety Assessment

Limits, Control & Conditions

Surveillance

Management of uncertainties

Iteration and design optimization

Integration of safety arguments


Link between the Safety Case argument and the Decision Steps

For each safety case argument, a prioritisation has been performed taking into account the decision step These estimation have been summarized for each main topic and are illustrated in the above table

Main decision-making steps: NEED FOR ACTION DISPOSAL CONCEPT SITE SELECTION AND

ENGINEERING DESIGN

CLOSURE PASSIVE INSTITUTIONAL

CONTROL PERIOD

POST-LICENSING

- Decision: Go for disposal or/and Decision for

reassessment of an existing facility

- Decide on the disposal concept and the Safety Strategy in a given

environment (conditions)

- Decision: choose the site and

associated design

- Decision for construction

(operator)

Decision: Authorization and/or license for

construction (authorities)

Decision to operate (operator)

Decision: Authorization and license for operation

(authorities)

- Decision to close - Decide to initiate the passive

institutional control period

Decide or not to release the regulatory

control Safety Case Context 2 3 3 2 3 2 3 3 2 2

Management 1 2 3 3 3 3 3 3 3 3Stakeholder & Regulatory Process 1 2 3 3 3 3 3 3 3 3

Optimisation 0 2 3 2 3 2 3 3 0 0Uncertainties 2 3 3 2 3 3 3 3 2 2

Safety Strategy 1 3 3 2 3 2 3 3 1 1System Description 1 3 3 3 3 1 3 3 1 2Safety assessment 1 2 3 3 3 3 3 3 1 1

Integration of Safety Arguments 2 2 2 2 2 2 2 2 1 1

Limits, Control & Conditions 1 1 3 3 3 3 3 3 3 0

==> not relevant to the decision at hand==> of value but is not significant==> significant==> mandatory

CONSTRUCTION OPERATION


Masc Matrix

• In the PRISM project it was recognized that, during the implementation of a disposal facility program, safety case components may have different levels of relative importance at different stages in the facility life cycle.

• A tool has been developed that addresses the development of the Safety Case components throughout the facility’s life cycle. This tool has been designated as the Matrix of key Arguments in the Safety Case, also referred to as the "MASC Matrix".

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Masc Matrix

• In the PRISM project it was recognized that, during the implementation of a disposal facility program, safety case components may have different levels of relative importance at different stages in the facility life cycle.

• A tool has been developed that addresses the development of the Safety Case components throughout the facility’s life cycle. This tool has been designated as the Matrix of key Arguments in the Safety Case, also referred to as the "MASC Matrix".

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Masc Matrix

• During the PRISM project, it was recognized that the MASC Matrix could serve the following important purposes:

• To serve as a useful tool for programmatic risk assessment and to evaluate possible implications of incomplete or inadequately addressed components of the Safety Case on subsequent repository development.

• To serve as a check-list to make sure that all relevant Safety Case components have been addressed throughout the life cycle of a facility.

• To assess the relative importance of Safety Case arguments at all the stages throughout the life cycle of the disposal facility.

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0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

Rel

ativ

e Im

port

ance

Safety Case Context Management & Stakeholder Regulatory Process

Safety Strategy System Description Safety assessment

Surveillance Integration of Safety Arguments Limits, Control & Conditions

Relative importance of the Safety Case components

Sept 2015

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Question?

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SAFETY CASE ARGUMENTS


Safety Arguments

Safety Case Context includes amongst other

NATIONAL STRATEGY

REGULATIONS

INTERNATIONAL GUIDANCE AND DUTIES/COMMITMENTS

FINANCIAL CONSIDERATIONS

…

Financial considerations over the guaranties that the financial resources for conceive, construct, operate, close and monitor the facility, will be available when needed.Finance for R&D activities are included.

Includes - the description of the

responsibilities at the national level;

- the national waste management plan;

- ..


Safety Arguments

Safety Strategy includes amongst others, considerations on how the following topics will taken into account :

Graded approach

Optimization

Robustness

Demonstrability

Multiple Safety Functions

Passive Safety

Good engineering/scientific practices

Management of uncertainties

…

The safety strategy is defined as the high-level integrated approach adopted for achieving safe disposal.


Safety Arguments

Management and Stakeholders includes amongst other

INVOLVMENT OF STAKEHOLDERS

MANAGEMENT SYSTEM• Organization• Staff competence• Q/A• record keeping / traceability

REGULATORY PROCESS• Management system• Licensing process• Early and continuous involvement

…

Management systems have to provide for assurance of the quality of all safety related activities, systems and components throughout all steps of the development, operation and closure of a disposal facility.


Safety ArgumentsSystem Description includes amongst others, considerations on how the following topics will be taken into account :

WASTE CHARACERISTICS

SITE CHARACTERISTICS

DESIGN

Identification of the safety functions, theirs allocation to the system components and their evolution

…

System description should be considered as an internal process (intern iterative loop) of the safety case. Its outcomes is the safety concept.

The safety concept should provide the need information arguing why the disposal system could be considered as safe. It’s included the description of the waste to be disposed of, the engineered and natural components, their respective role in the safety and their evolution. Argumentation of the robustness of the disposal system could also be presented at this stage.

System description is based on the level of knowledge available at the considered stage.

- Radionuclide inventory, - Physical and chemical form, - Volume, - Content of chemical substances such as complexing agents, hazardous substances etc.;


Safety ArgumentsSafety Assessments includes amongst others:

ENVIRONMENTAL IMPACTS ASSESSMENT

RADIOLOGICAL IMPACT AND PERFORMANCE ASSESSMENT

OPERATIONAL SAFETY

…

Safety Assessment (SSG-21): The safety assessment, a systematic assessment of radiation hazards, is an important component of the safety case. It involves the quantification of radiation dose and risk that may arise from the disposal facility for comparison with dose and risk criteria, and provides an understanding of the behaviour of the disposal facility under normal and disruptive conditions, considering the timeframes over which the radioactive waste remains hazardous.

It addresses the non-radiological hazards generated by the facility through its different lifecycle


Safety Arguments

Limits, Controls & Conditions includes amongst others:

Limits: dose/risk limits; activity limits per waste package; per disposal unit and for the site

Controls: active and passive institutional controls; control for waste acceptance; conformity control; compliance with design criteria and with operational procedures, etc.

Conditions: quality management, format and nature of facility description, licensing conditions for operation, closure, etc.

…

The fundamental bases for such limits, controls and conditions are the safety requirements and on the licensed conditions. They generally are derived from formalized safety assessment, both operational and post-closure. Limits, Controls and Conditions contribute to the demonstration of the overall safety.


Safety Arguments

Surveillance includes amongst others:

MONITORING

SECURITY

…

Surveillance and monitoring programmes should be developed and implemented to provide evidence for a certain period of time that the disposal facility will be performing as predicted and that components have the required level of performance (safety function).


Safety Arguments

Management of Uncertainties addresses almost of the safety case argument. In particular,

Safety Assessment

System Description

Integration of Safety arguments

…

Uncertainty and sensitivity analysis shall be performed and taken into account in the results of the safety analysis and the conclusions drawn from it. Uncertainties that may have implications for the outcome of the safety analysis and for decisions made on that basis are to be addressed in uncertainty and sensitivity analyses


Safety Arguments

Iteration and design optimisationA safety case is multi-faceted in that several varied and sometimes competing arguments have to be brought together and reconciled to reach a decision.Iteration could address:

Safety case Context

Safety strategy could be revised

System description (new data)

…

It should be demonstrated that the selected design option has been chosen by means of a well defined, rational procedure. Confidence in the selected design option may be increased if alternative design options are presented in the safety case with an assessment of their advantages and disadvantages, and a justification is provided for the preferred option


Safety Arguments

Integration of safety arguments includes amongst others:

ARGUE (Multiple lines of reasoning)• the robustness• the defence in depth, • the system understanding, • the monitoring, etc.

COMPARISON OF OPTIONS• Comparison between different sites for new disposal facilities;• Comparison of different disposal facility types, design,..; • Comparison of different risk management and remediation options for existing facilities

ADDITIONAL MEASURES TO INCREASE CONFIDENCE• Independent review; • Complementary Safety indicators; • Multiples lines of reasoning

R&DAny R&D activities that are needed in order to support the knowledge and the understanding of the phenomenology and also plans for addressing unresolved issues

…


Management System/ Different Organizations in the Development of RWM

Facilities


Layout

1. Introduction

2. Perspectives

3. Management System

1. Requirements

2. Organisations


Management System

Aims at

• “To improve the safety performance of the organization through the planning, control and supervision of safety related activities in normal, transient and emergency situations;

• “To foster and support a strong safety culture through the development and reinforcement of good safety attitudes and behaviour in individuals and teams so as to allow them to carry out their tasks safely.”


Terminology (IAEA Glossary)

Management system

• A set of interrelated or interacting elements (system) for establishing policies and objectives and enabling the objectives to be achieved in an efficient and effective manner.

Integrated management system (for facilities and activities)

• A single coherent management system in which all the component parts of an organization are integrated to enable the organization’s objectives to be achieved.


Terminology

• These component parts include the organizational structure, resources and organizational processes.

• Personnel, equipment and organizational culture, as well as the documented policies and processes, form parts of the management system.

• The organizational processes have to address the totality of the requirements on the organization, as established by or in, for example, interested parties, IAEA safety standards and other international codes

and standards.


Remarks

• The term management system has been adopted in the revised standards (IAEA glossary 2007) instead of the terms quality assurance and quality assurance programme

• Management is defined (in ISO 9000) as coordinated activities to direct and control an organization.

IAEA documentation

This Safety Guide covers the management systems for the pretreatment (collection, segregation, chemical adjustment and decontamination), treatment (volume reduction, removal of radioactive material and change of composition), conditioning (immobilization, packaging and overpacking) and storage of radioactive waste.


Layout

1. Introduction

2. Perspectives


1. Requirements

2. Organisations


Perspectives

• Radioactive waste must be managed in such a way as to avoid imposing an undue burden on future generations; that is, the generations that produce the waste have to seek and apply safe, practicable and environmentally acceptable solutions for its long term management” [1].

Why highlight “Management System” in Waste Management System?


Perspectives

• An appropriate management system that integrates quality assurance programmes will contribute to confidence that the relevant requirements and criteria for site selection and evaluation, design, construction, operation, closure and safety after closure are met.

• The level of attention assigned to each aspect has to be commensurate with its importance to safety.

• Management systems play an important role in applying such solutions, and should be implemented for all stages of waste management, from waste generation to waste disposal


Perspectives

• Managing radioactive waste involves a variety of technical and managerial activities and may extend over a very long period of time

• While the host environment of a disposal facility is important to safety, it cannot be designed or manufactured, but only characterized, and that to only a limited extent.


Perspectives

The following aspects warrant particular consideration in developing a management system for programmes for waste management facilities and activities:

• By definition, waste is material for which no further use is foreseen. Special attention has to be given to provision of funds and the organizational arrangements to manage waste.

• Waste can be managed safely on an interim basis, in many cases for extended periods. Selection and implementation of definitive solutions may be postponed by a series of short term deferrals.


Perspectives

The following aspects warrant particular consideration in developing a management system for programmes for waste management facilities and activities (con’t)

• If definite end points for waste have not been selected, it may be difficult to define the preferable form of the waste material to be produced and held during storage, and the acceptable form for final disposition. Attention on treatment and packaging of wastes:

- Avoid to waste form unsuitable for disposal and difficult to convert to a form that is suitable for disposal.

- Uncertainty about the end point should not be used as a rationale for not taking steps to ensure that the waste is managed in a safe and environmentally acceptable manner pending disposal.


Perspectives


• Responsibility for waste for which the generator can no longer reasonably be held responsible commonly reverts to governmental authorities.

• Waste may be managed by a series of organizations that carry out the sequence of required processing steps


Perspectives


• The long term nature of waste management operations means that particular attention should be paid to:

- Maintaining public confidence that management supervision will be continuous;

- Establishing confidence that the performance of the waste management facilities and activities will meet the requirements;

- Estimating costs and establishing the funding arrangements that will be necessary to manage the waste in the long term.


Perspectives

• The management system for a disposal facility has to provide for the preparation and retention of documentary evidence to illustrate

• that the necessary quality of data has been achieved; • that components have been supplied and used in accordance

with the relevant specifications; • that the waste packages and unpackaged waste comply with

established requirements and criteria; • that they have been properly emplaced in the disposal facility.


Perspectives

• The management system also has to ensure the collation of all the information that is important to safety and that is recorded at all steps of the development and operation of the facility, and the preservation of that information.

This information is important for any reassessment of the facility in the future.


Layout

1. Introduction

2. Perspectives


1. Requirements

2. Organisations


Requirements

• A management system shall be established, implemented, assessed and continually improved. It shall be aligned with the goals of the organization and shall contribute to their achievement.

• The main aim of the management system shall be to achieve and enhance safety by:• Bringing together in a coherent manner all the requirements for

managing the organization;• Describing the planned and systematic actions necessary to provide

adequate confidence that all these requirements are satisfied;• Ensuring that health, environmental, security, quality and economic

requirements are not considered separately from safety requirements, to help preclude their possible negative impact on safety.


Requirements

Safety shall be paramount within the management system, overriding all other demands

• The organization shall be able to demonstrate the effective fulfilment of its management system requirements.


Requirements – safety culture

• The management system shall be used to promote and support a strong safety culture by:• Ensuring a common understanding of the key aspects of

safety culture within the organization;• Providing the means by which the organization supports

individuals and teams in carrying out their tasks safely and successfully, taking into account the interaction between individuals, technology and the organization;

• Reinforcing a learning and questioning attitude at all levels of the organization;

• Providing the means by which the organization continually seeks to develop and improve its safety culture.


Requirements – Graded approach

• The application of management system requirements shall be graded so as to deploy appropriate resources, on the basis of the consideration of:

• The significance and complexity of each product or activity;

• The hazards and the magnitude of the potential impact (risks) associated with the safety, health, environmental, security, quality and economic elements of each product or activity;

• The possible consequences if a product fails or an activity is carried out incorrectly.


Requirements - Documentation

• The documentation of the management system shall include the following:

• The policy statements of the organization;

• A description of the management system;

• A description of the structure of the organization;

• A description of the functional responsibilities, accountabilities, levels of authority and interactions of those managing, performing and assessing work;

• A description of the processes and supporting information that explain how work is to be prepared, reviewed, carried out, recorded, assessed and improved.


Layout

1. Introduction

2. Perspectives


1. Requirements

2. Organisations


Fundamentals

• Principle 3: Leadership and management for safety

Effective leadership and management for safety must be established and sustained in organizations concerned with, and facilities and activities that give rise to, radiation risks.

An important factor in a management system is the recognition of the entire range of interactions of individuals at all levels with technology and with organizations. To prevent human and organizational failures, human factors have to be taken into account and good performance and good practices have to be supported


OrganisationRegulatory Body

Importance of Management System is such that in the GSR Part 1 “Governmental, legal and regulatory framework for safety” we could find at least two direct recommendations addressing the management system

• Requirement 18: Staffing and competence of the regulatory body

• Requirement 19: The management system of the regulatory body


Management SystemWaste management organization

• Requirement 7: Management Systems

• Management systems shall be applied for all steps and elements of the predisposal management of RW;

• Features that are important to safe operation, and that are considered in the management system, are to be identified on the basis of the safety case and the assessment of environmental impacts.

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OrganisationAll concerned parties

Requirement 25: Management systems

Management systems to provide for the assurance of quality shall be applied to all safety related activities, systems and components throughout all the steps of the development and operation of a disposal facility. The level of assurance for each element shall be commensurate with its importance to safety.


Example

Requirements (cont.)

• All structures, systems and components important to safety, including Instrumentation & Control software, shall be identified and classified according to their importance for safety.

• The periodic safety review shall cover all of the safety aspects of a facility. In this context, the facility is considered as the whole set of installations (systems, structures and components) covered by the construction and operating licence.



• A safety report shall be prepared by the licensee in to the frame of the licensing process described in the General Regulations. It represents a major part of the licencing basis of the nuclear installation and the base for the safe operation of the installation.

• The safety report shall contain sufficiently detailed information on the installation and its operating conditions so that the regulatory body can assess the nuclear safety of the installation.

• The licensee ensure that the installation, the activities that are carried out, the equipment, the organisation, the qualification and training of the personnel, the quality assurance programme, and the safety systems and instructions comply with the safety report.

• The licensee shall also use the safety report as a basis to assess the impact of modifications to the installation or to operating practices on the nuclear safety.

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