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

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Overview

• Human Factors (HF) Program

• Management System and Human Factors

Program related requirements

• HF in NPP life cycle

• Regulatory Oversight of HF Programmes

• Conclusions

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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

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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

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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

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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

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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

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Management System and Elements of

Human Factors Program

• Safety Culture

• Human Performance

• Communication

• Management of organizational changes

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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

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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

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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

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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”

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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)

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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.

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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

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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.

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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

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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.

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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.

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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

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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

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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.”

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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

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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 ….

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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

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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

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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

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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)?