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IAEA International Atomic Energy Agency
INTEGRATION OF SAFETY CULTURE INTO REGULATORY
PRACTICES AND THE REGULATORY DECISION MAKING
PROCESS
IAEA perspective on Human and Organizational Factors
Technical Meeting
Adriana Nicic
Regulatory Activities Section, Division of Nuclear Installation Safety
6-8 October 2014,
Vienna, Austria
IAEA
Overview
• Human Factors (HF) Program
• Management System and Human Factors
Program related requirements
• HF in NPP life cycle
• Regulatory Oversight of HF Programmes
• Conclusions
IAEA
Human Factors Program
• There are many factors influencing Human
Performance in a complex system
• Human Factors – factors that influence human
performance as it relates to the safety of a nuclear
facility or activity throughout the lifecycle of the
facility
IAEA
Elements of Human Factors Program
• Requirements for Human Factors (HF) Program are defined by the regulatory body
• Establishment of HF program should be accompanied by adequate Human Performance programs
• IAEA Safety Standards do not prescribe the elements of such a program
• There is a general consensus regarding the elements of a HF program, but regulatory requirements are country specific
IAEA
Elements of Human Factors Program -
Example
• Human Factors Engineering Program
Management
• Operating Experience Review
• Functional Requirements Analysis and Function
Allocation
• Task Analysis
• Staffing and Qualifications
• Human Reliability Analysis
IAEA
Elements of Human Factors Program
Example
• Procedure Development
• Training program Development
• Human-System Interface Design
• Human Factors Verification and Validation
• Design Implementation
• Human performance Monitoring
IAEA
Management System and Elements of
Human Factors Program
• Quality Assurance and Management System
requirements contain many Human Factors
related elements:
• Organizational aspects, roles and
responsibilities
• Training, qualification, competence
• Operating Experience Review
IAEA
Management System and Elements of
Human Factors Program
• Safety Culture
• Human Performance
• Communication
• Management of organizational changes
IAEA
Human Factors - IAEA
• Consideration of Human Factors Program
elements are included in :
• Legally binding instruments (e.g. Convention on
Nuclear Safety)
• IAEA Safety Standards
• Other IAEA publications
• Requirements are specific to the stage of the
lifetime of the facility
IAEA
Human Factors - IAEA
IAEA Safety Glossary
• human factors engineering - engineering
in which factors that could influence human
performance are taken into account.
• No definition for human factors
IAEA
Human Factors – IAEA Safety Standards
Safety Fundamentals:
• “To prevent human and organizational failures,
human factors have to be taken into account
and good performance and good practices have
to be supported”
• How can we do this?
• Regulatory requirements for Human Factors
and Human Performance should exist
IAEA
Human Factors – IAEA Safety Standards
Safety Fundamentals:
• “where control measures or operator actions are
called on to maintain safety, an initial safety
assessment has to be carried out to
demonstrate that the arrangements are robust
and that they can be relied on”
IAEA
GSR Part 1
Requirement 25: Review and assessment of
information relevant to safety
In the process of its review and assessment of the facility or
activity, the regulatory body shall take into account such
considerations and factors as:
The basic design of the facility or the conduct of the activity
as relevant to safety
The applicable management system;
The competence and skills necessary for operating the
facility or conducting the activity.
Regulatory review of changes to safety related aspects
(including organizational changes)
IAEA
GSR Part 1
Requirement 27: Inspection of facilities and
activities
• In conducting inspections, the regulatory body
shall consider a number of aspects, including:
• Management systems;
• Operational activities and procedures;
• Liaison with contractors and other service
providers;
• Competence of staff;
• Safety culture.
IAEA
Safety Standards non-specific for
Regulatory Bodies
• Operating organizations, regulatory bodies
technical support organizations, consultants
and advisory bodies, including:
• GSR Part 4
• SSG - 25
• SSR - 2/1
• SSR - 2/2
IAEA
GSR Part 4
Safety Assessment for Facilities and
Activities, Requirement 11: • Human interactions with the facility or activity shall be
addressed in the safety assessment, and it shall be
determined whether the procedures and safety measures
that are provided for all normal operational activities, in
particular those that are necessary for implementation of
the operational limits and conditions, and those that are
required in response to anticipated operational occurrences
and accidents, ensure an adequate level of safety.
IAEA
SSG 25 - Periodic Safety Review for Nuclear
Power Plants
Safety factor 12: Human factors
In addition, re-assessment of safety contains several safety
factors related to Human Factors program elements
IAEA
SSR-2/1 Safety of Nuclear Power Plants:
Design
Requirement 6: Design for a nuclear power plant
• Design for NPP shall take into account human
capabilities and limitations, as well as factors
that could influence human performance.
Requirement 17: Internal and external hazards:
• All foreseeable hazards, including the potential for
human induced events shall be identified and
their effects assessed.
IAEA
SSR-2/1 Safety of Nuclear Power Plants:
Design
Human factors: Requirement 32: Design for optimal
operator performance):
• Systematic consideration of human factors (including
the human-machine interface)
• Specification of the minimum number of operating
personnel;
• Active involvement of operating personnel in design
process;
• Design shall support operating personnel in fulfilment of
responsibilities/tasks and shall limit effects of operating
errors on.
IAEA
SSR-2/1 Safety of Nuclear Power Plants:
Design
• Human-machine interface
• Necessary information provided to the operator
• Design shall promote the success of operator
actions
• Need for intervention by operator
• Protection and safety in MCR and SCR
• Application of ergonomic concepts
• Verification and validation
• Other Requirements, e.g. R36, R 37
IAEA
SSR-2/2 Safety of Nuclear Power Plants:
Commissioning and Operation
• Management and Organizational Structure
• Qualification and training
• Operating Instructions and Procedures
• Management of Modifications
• Periodic safety review
• Accident Management programme
• Feedback of operating experience
• Operation control room
• Maintenance and procurement
IAEA
Human Factors - CNS
Convention on Nuclear Safety (CNS):
• “Each Contracting Party shall take the
appropriate steps to ensure that the capabilities
and limitations of human performance are taken
into account throughout the life of a nuclear
installation.”
IAEA
Human Factors - CNS
• the design and construction of a nuclear
installation provides for several reliable levels
and methods of protection (defense in depth)…
• the design of a nuclear installation allows for
reliable, stable and easily manageable operation,
with specific consideration of human factors and
the man-machine interface
IAEA
Human Factors - CNS
• demonstration that the installation, as constructed, is consistent with design and safety requirements
• operation, maintenance, inspection and testing of a nuclear installation are conducted in accordance with approved procedures
• procedures are established …
• programmes to collect and analyse operating experience are established ….
IAEA
Regulatory Oversight of HF Programmes
• Regulatory activities related to HF
Programmes should include:
• Development of specific Human Factors and
Human Performance regulatory requirements
• Compliance activities
• Promotion
• Verification (review and assessment, inspection/
audit, assessment of performance indicators,
licensee’s events reports, etc.)
• Enforcement
IAEA
Regulatory Oversight of HF Programmes
• Different regulatory approaches (compliance-
based, performance-based, process-based) can
be used for conducting the regulatory oversight of
licensee’s HF Programme
• Regulatory body should identify HF specific
inspections elements and include them in the
overall regulatory inspection programme
• Management System audit/ inspections are
related to and contribute to ensuring an adequate
regulatory oversight of HF programmes
IAEA
Conclusions
• Various IAEA Safety Standards include Human
Factors related requirements and guidance, but they
are mainly directed to the operating organizations
• Regulatory body should develop requirements and
guidance for applicant’s/ licensee’s Human Factors
Programmes
• Regulatory oversight should include specific
verification activities aimed at ensuring that licensee’s
HF programmes are effectively implemented
IAEA
Conclusions
• Is additional guidance needed for regulatory oversight
of Human Factors programmes?
• Is harmonization of the elements of Human Factors
programmes needed?
• How should regulatory bodies share relevant
information from the oversight activities, in addition to
the existing methods (e.g. IRS, WGOF, etc)?