Human Aspects of Nuclear Safety
2024

The Mutual Impactof Nuclear Regulatory
Bodies and License
Holders from a Safety
Culture Perspective

NE A

Human Aspects of Nuclear Safety

The Mutual Impact of Nuclear Regulatory Bodies
and License Holders from a Safety Culture Perspective© OECD 2024
NEA No. 7672
NUCLEAR ENERGY AGENCY
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NUCLEAR ENERGY AGENCYThe OECD Nuclear Energy Agency (NEA) was established on 1 February 1958. Current NEA membership consistsof 34 countries: Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Czechia, Denmark, Finland, France,
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Cover photos: Workers at the Flamanville Nuclear Power Plant, France (EDF); Inspectors at the Vogtle Unit 3 construction site (USNuclear Regulatory Commission/CC BY 2.0 DEED).

FOREWORD

Foreword
The NEA has vested considerable effort in recent years to improve theunderstanding of “human aspects of nuclear safety” – most particularly nuclear
safety culture. As highlighted by previous NEA work in this area, as well as a seriesof Country-Specific Safety Culture Fora held in various countries, safety culture,
while relatively simple in general concept, is a very complex matter that is
impacted by a wide range of factors – including history, culture, policy, leadershipand others that comprise the context in which regulatory staff and licensees
operate. Operating history shows clearly that the root cause of safety incidents isoften not technical nor the fault of a single individual, but rather originate
compromised safety culture – sometimes in both the operator and the regulator.
One of the most challenging aspects of safety culture is one that I find some regulatory
officials hesitate to consider – the impact the culture, approach and practices of the regulator
may have on operators. It is a precept of nuclear safety that responsibility for safety lay with
operators. Given that, it is then the job of regulators to provide the framework of expectations
and oversight on behalf of the public to assure that operators carry out their safety
responsibilities in an appropriate manner.
This is the general philosophy that has been espoused for decades. The reality is, often,
more complex. Regulators hold great power over licensees and how that power is wielded canhave great impact on how operators see their responsibilities. If an operator believes a newtechnology or methodology can improve safety and save costs, but finds it too difficult andexpensive to gain regulatory approval for its use, will the operator be more hesitant to suggest
improvements in the future? Is this a benefit to safety? Is it better for operators and regulators
to come to common understandings about safety matters or for operators to simply wait for
the regulator to decide what is best and then implement the orders without substantive
question? If licensees refrain from taking any actions before seeing decisions by regulators,
does that serve the cause of improved safety?
Understanding these interactions and influences is essential as we continue to strive
towards higher levels of nuclear safety around the world. This report, the result of
collaborative work conducted by safety culture experts in our member countries, presents amodel for how the safety culture of the regulator and the licensee mutually impact each other.
It substantiates with international, qualitative data the importance of responsive regulation andoutlines how to achieve this through an accountability-oriented, enabling regulatory approach.
The goal is for the regulator and licensee to advance towards higher safety culture maturity.
The data-backed insights contained in the following pages may also help countries withstakeholder engagement activities, specifically related to the effectiveness of dialogue- andlearning-based approaches over compliance-oriented regulation. Moving beyond prescription
to foster the licensee’s accountability for safety through a reciprocal, co-operative relationshipbetween the regulator and the licensee is in the ultimate public interest.
I thank and congratulate the expert group that developed, implemented and completed
this invaluable report. The work of regulators will only become more challenging as newtechnologies, new types of licensees and new operations approaches come into focus.
Optimising the relationship between the regulators and the regulated serves both nuclear
safety and broader public interests.
William D. Magwood, IV
Director-General
Nuclear Energy Agency

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ACKNOWLEDGEMENTS

Acknowledgements

The Nuclear Energy Agency (NEA) thanks the Committee on Nuclear Regulatory Activities (CNRA)
Working Group on Leadership and Safety Culture (WGLSC) Chair, Nobuhiko Ban (Commissioner,
Nuclear Regulation Authority [NRA], Japan) and the task group leader, Marc McBride (Office for
Nuclear Regulation [ONR], United Kingdom), as well as all the task group members for theirefforts and contributions to this report. Their respective leadership and participation in task
meetings, workshops and plenary meetings have made this report possible.
The qualitative data collection and analysis upon which this report is based would not havebeen possible without the significant efforts of many individuals. The contributions of Cornelia
Ryser (Swiss Federal Nuclear Safety Inspectorate [ENSI], Switzerland), Walter Glöckle (Ministry of
the Environment, Climate Protection and the Energy Sector Baden-Württemberg, Germany) andMarta Barrientos (Spanish Nuclear Safety Council [CSN], Spain) were particularly notable. Manyothers assisted by conducting interviews in their countries, translating and analysing the data,and providing support, including but not limited to Hiroko Takada (NRA, Japan), Su Jin Jung
(Korea Institute of Nuclear Safety [KINS], Korea), Anne Edland (Swedish Radiation Safety
Authority [SSM], Sweden) and Zoltánné Bódis (Hungarian Atomic Energy Authority [HAEA],
Hungary). Thanks are owed to these individuals and many more who participated over thethree-year initiative to bring this report to fruition.
WGLSC Secretariat Florence Maher guided the process from start to finish and her handtouched every page. Kosuke Tobe and Minori Kato from the NEA Secretariat provided significant
support for the Japanese interviews. Finally, the team would like to recognise Asli Bokesoy forher editorial support.
This publication was submitted to the CNRA via the written procedure and approved by
the committee on 7 December 2023.

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TABLE OF CONTENTS

Table of contents

List of abbreviations and acronyms .................................................................................................... 7
Executive summary ................................................................................................................................ 9
Key messages ..............................................................................................................................................9
Summary overview ....................................................................................................................................9
Chapter 1. Introduction ........................................................................................................................ 13
Chapter 2. Purpose and scope ............................................................................................................. 17
Chapter 3. Methodology ....................................................................................................................... 19
3.1. Summary of literature review .......................................................................................................19
3.2. Methodology for data collection and analysis............................................................................20
Chapter 4. Results of data analysis .................................................................................................... 23
4.1. Mechanisms of influence of the regulatory body on the safety culture of the licensee .....23
4.2. Mechanisms of influence of the licensee on the safety culture of the regulatory body .....33
4.3. Good practices and lessons learnt in the interactions between the regulatory
body and licensee ............................................................................................................................40
4.4. Challenges in effective interactions between the regulatory body and licensee.................41
4.5. Summary of findings ......................................................................................................................45
Chapter 5. Discussion ........................................................................................................................... 51
5.1. Factors and mechanisms of influence.........................................................................................51
5.2. The mutual nature of the impact of the regulatory body and licensee on eachother’s safety cultures and the need for a systemic view ........................................................52
5.3. The need to move towards an accountability-oriented, enabling regulatory approach ....53
5.4. The need for specific oversight methods to support accountability-oriented,
enabling regulation .........................................................................................................................54
5.5. The need to balance different regulatory goals and approaches while maintaining
the trust of the public .....................................................................................................................54
5.6. The need to adapt the regulatory approach based on the licensee’s performanceand safety culture maturity level .................................................................................................54
5.7. The need for a high level of safety culture maturity in the regulatory body ........................55
5.8. The need for responsive regulation .............................................................................................55
Chapter 6. Conclusions......................................................................................................................... 57
Glossary .................................................................................................................................................. 59
References .............................................................................................................................................. 61

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TABLE OF CONTENTS

List of annexes
A.
B.
C.

Literature review .............................................................................................................................65
Question set for semi-structured interviews..............................................................................69
Good practices and lessons learnt for effective interactions between the regulatory
body and licensee ............................................................................................................................71
Features of ineffective interactions between the regulatory body and licensee
leading to a downward spiral in safety culture..........................................................................75

D.

List of boxes
4.1. Accountability-oriented, enabling regulation (AER) ..................................................................49
List of figures
E1.
3.1.
3.2.
4.1.
4.2.
4.3.
4.4.

Model of effective interactions between the regulatory body and licensee: Howeach can positively influence the safety culture of the other (summarised version).............12
Research methodology ...................................................................................................................19
Methodology for data analysis ......................................................................................................21
Summary of the mechanisms of influence of the regulatory body on the safety
culture of the licensee ....................................................................................................................32
Summary of the mechanisms of influence of the licensee on the safety cultureof the regulatory body ....................................................................................................................39
The factors and mechanisms by which regulatory bodies and licensees influence
their respective safety cultures .....................................................................................................47
A model of effective interactions between the regulatory body and licensee:
How each can positively influence the safety culture of the other ........................................48

List of tables
1.1. Principles and attributes of a health safety culture in regulatory bodies .............................133.1. Interviews conducted by WGLSC members................................................................................20
4.1. Factors that determine the regulatory body’s influence on the safety
culture of the licensee ....................................................................................................................23
4.2. The factors which determine the licensee’s influence on the safety cultureof the regulatory body ....................................................................................................................33
C1. Good practices and lessons learnt for effective interactions between theregulatory body and licensee ........................................................................................................71

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LIST OF ABBREVIATIONS AND ACRONYMS

List of abbreviations and acronyms

AER

Accountability-oriented, enabling regulation

CNRA

Committee on Nuclear Regulatory Activities (NEA)

FAA

Federal Aviation Authority

HOF

Human and organisational factors

HRO

High Reliability Organisation

IAEA

International Atomic Energy Agency

NEA

Nuclear Energy Agency

OECD

Organisation for Economic Co-operation and Development

WGSC

Working Group on Safety Culture (NEA)

WGLSCWorking Group on Leadership and Safety Culture (NEA)

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EXECUTIVE SUMMARY

Executive summary

Key messages•

Regulatory bodies, by their nature, deeply influence the safety culture of nuclear site
licence holders. This influence is also mutual, from licensee to regulatory body.

•This study identifies the factors and mechanisms by which each party influences thesafety culture of the other, based on the insight of senior practitioners worldwide.

•

A clear picture emerges of the nature of interactions between the regulatory body andlicensee that leads to a positive mutual impact on safety culture. This picture is of areciprocal, co-operative style of interaction, characterised by respect, openness andtrust, with a shared focus on safety and learning.

•

Within this model, the regulatory body’s approach seeks to foster the licensee’s
accountability for safety, enabling continuous improvement and growth of thelicensee’s safety culture towards higher maturity levels. This approach has beentermed accountability-oriented, enabling regulation, which builds on the concept of
performance (or outcome) based regulation, but also includes a focus on risk (orhazard), processes, and self-assessment by licensee.

•

It is recognised that such an approach to regulation is not always achievable, norappropriate. Therefore, the regulatory body also needs to be agile in its approach,moving between accountability-oriented, enabling regulation and a more prescriptive
style according to the circumstances (responsive regulation).

•

Two main factors determine the extent to which the regulatory body is able to adopt an
accountability-oriented, enabling approach: the safety culture maturity of the licensee,
and the safety culture maturity of the regulatory body. In both cases, the more mature
the safety culture, the more an accountability-oriented, enabling regulatory approach islikely to succeed.

•

Regulatory bodies and licensees are encouraged to use the information contained inthis report to assess the health of their interactions and identify areas for improvement
and good practices to share.

•

Regulatory bodies should, where appropriate, consider how they might move theirapproach towards a more accountability-oriented, enabling style, developing theregulatory oversight methods and culture which support this.

Summary overview
This report presents NEA work to explore interactions between nuclear regulatory bodies andsite licence holders (licensees) and how each influences the safety culture of the other.
The specific objectives of the study were to:1.

Understand how regulatory bodies impact licensees (and vice versa) from a safety
culture perspective; and2.

Share good practice and learning on how regulatory bodies can ensure that this impact
is positive, avoid negative impacts, and support the achievement of safety objectives.

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EXECUTIVE SUMMARY

To explore this topic, nearly 50 interviews were carried out with experienced practitioners
and senior leaders in both regulatory bodies and licensees, representing 13 member countries,
to gather and analyse their insights and experience. The approach was based on wellestablished qualitative research techniques (Bell et al, 2019), to ensure a high standard of
methodological and ethical rigour.
The study identifies the principal factors which determine the influence of each party on
the safety culture of the other. These include the communications, relationships andbehaviours of staff at the interface between the regulatory body and licensee. In turn, these
are influenced by the regulatory regime, comprising the system of legislation and standards,
roles and responsibilities, regulatory approach, etc., and the capability, leadership andmanagement of each organisation. Finally, the ability of each party to learn from theirinteractions, and from others, determines whether the influence on safety culture has apositive (upward) or negative (downward) trend.
From the interview data, a consistent picture emerges of the nature of interactions
between the two organisations that leads to a positive mutual impact on safety culture,whether from a regulatory body or licensee perspective, and consistent despite differences innational context. This picture is of a reciprocal, co-operative style of interaction, characterised
by respect, openness and trust with a shared focus on safety and learning (as shown in
Figure E1). This type of interaction enhances the licensee’s ability to “self-regulate” throughincreased self-awareness and consequential improvement action. Such interaction drives a
focus on safe outcomes beyond mere compliance with regulations.
Within this model, the regulatory body’s approach seeks to foster the licensee’s
accountability for safety, enabling continuous improvement and growth of the licensee’s safety
culture towards higher maturity levels. This approach is termed “accountability-oriented,
enabling regulation”, which builds on the concept of performance (or outcome) based regulation,
but also includes a focus on risk (or hazard), processes, and self-assessment by licensee.
The need for an accountability-oriented, enabling approach is consistent with the increasing
focus on organisational resilience following the Fukushima Daiichi Nuclear Power Plant accident,
as well as “Safety-II” 1 thinking. These concepts place less emphasis on conventional regulatory
techniques, e.g. compliance inspections, and rather more emphasis on dialogue to understandthe normal functioning of organisations, including the day-to-day variability of performance andbehaviour (“work-as-done”) and its consistency with “work-as-imagined”.
It is recognised that an accountability-oriented, enabling approach to regulation is notalways achievable, nor even appropriate. Therefore, the regulatory body needs to be agile in its
approach, moving between accountability-oriented, enabling regulation and a moreprescriptive style according to the circumstances (“responsive regulation”). The present study
has identified two main factors which influence this:•The safety culture maturity of the licensee; and•The safety culture maturity of the regulatory body.

As regards the licensee’s safety culture, the more mature the safety culture, the more an
accountability-oriented, enabling regulatory approach is likely to succeed, fostering continued
innovation and growth of the licensee’s capability. However, for licensees with a less maturesafety culture, a prescriptive approach might be more appropriate, or even necessary, providing
the needed formality of requirements and supporting enforcement mechanisms. Even in thissituation, however, the regulatory body’s aim should always be to influence the licensee to movetowards a higher level of cultural maturity, in the long-term interests of safety.

1.

10

Safety-II is a condition where the number of successful outcomes is as high as possible. It is the ability
to succeed under varying conditions. Safety-II focuses on making sure that things go right, rather thanon preventing them from going wrong (Hollnagel, 2014).

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EXECUTIVE SUMMARY

The ability of the regulatory body to adopt an accountability-oriented, enabling approachalso depends on its own safety culture maturity. Such an approach places greater emphasis on
the technical and behavioural competence of inspectors to interpret regulatory requirements
in a particular setting and influence improvements.
Another factor which determines the extent to which the regulatory body is able to adopt an
accountability-oriented, enabling approach is the expectation of, and the level of trust it enjoys
from, the public 2. The more public trust in the regulatory body, the more it is able to adopt an
accountability-oriented, enabling approach with its greater emphasis on less formal styles ofinteraction, e.g. dialogue and influencing, as opposed to formal interactions, e.g. complianceinspections.
This report includes examples of good practices and lessons learnt which underpin themodel of regulatory body-licensee interactions described above. It also sets out the common
challenges for regulatory bodies and licensees identified by interviewees, including:•Establishing a clear and predictable regulatory framework;•

Maintaining trust and respect in the relationship between the regulatory body andlicensee; and•Understanding how the regulatory body can preserve its independence while also
maintaining open dialogue with the licensee.

The information contained in this report can be used by both regulatory bodies andlicensees to understand the health of their current working relationships, explore factors
which may be undermining a mutual positive impact on safety culture, and identify goodpractices which can be shared with others.
The present study points to the need for further work to explore how regulatory bodies
and licensees can move towards and sustain a more reciprocal, co-operative style ofinteraction, for example by:2.

•

Developing guidance and tools on how to create awareness of the impact regulatory
bodies and licensees have on their respective safety cultures;•

Deepening and substantiating the concepts of accountability-oriented, enabling
regulation and responsive regulation and the practical implications for the nuclear
industry;•

Developing guidance and tools, and exchanging experience on the development andapplication of accountability-oriented, enabling regulation and responsive regulation;•

Further exploring how the regulatory body achieves a balance in its regulatory
approach and interactions with the licensee and the wider interconnected system of
stakeholders; and•Communicating with the public on the concepts of accountability-oriented, enabling
regulation and responsive regulation, and their impact on safety and trust.

The topic of public trust is explored in the NEA publication The Characteristics of a Trusted Nuclear
Regulator (NEA, forthcoming) and complements ongoing NEA work by examining the regulatory bodypublic axis alongside the regulatory body-licensee axis explored here.

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Enablers

The regulatory body and licensee learn
from each other and from the experience of third
parties to continually improve

The licensee learns from its interactions with theregulatory body and continually improves

The regulatory body learns from its
interactions with the licensee andcontinually improves

Safety cultureof the licensee• The licensee has strong internal
assurance• The licensee has good structures and processes
for interacting with the regulatory body
• The licensee provides timely, high quality
information• Leaders demonstrate priority to safety in their
behaviours, actions and decisions• Licensee staff are competent

Learning and improvement• Behaviours demonstrate safety as a core value• Relationships are based on a shared goal of safety
and are characterised by respect, openness andtrust• There are regular, two-way, formal and less formal
communications at all levels

Interactions between theregulatory body and licensee:

The regulatory body and licensee identify and act onopportunities to collaborate with each other and withthird parties, e.g. on standards, research and training

Enablers• The licensee demonstrates accountability
for safety

Learning and improvement

Safety cultureof a regulatory body

• Management systems are aligned togood practice• Leaders create a shared focus on safety• The regulatory body is well-resourced andcompetent• Regulatory decisions are objective and transparent,with due priority to safety• The regulatory body has suitable enforcement
powers but balances “policing” and “coaching” roles• The regulatory body has political and technicalindependence, but is accountable to the public• There is a clear, predictable regulatory
framework, consistently applied, and weighted
towards an outcome-based approach

EXECUTIVE SUMMARY

Figure E1. Model of effective interactions between the regulatory body and licensee: How eachcan positively influence the safety culture of the other (summarised version)

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INTRODUCTION

Chapter 1. Introduction

The role of the regulatory body is to provide oversight of licensees, while the accountability forthe safe operation of a nuclear facility rests with the licensee. The safety culture of theregulatory body has a potentially significant impact on that of the licensee. Through its
regulatory strategy, the way it carries out its daily oversight work, the type of relationship it
cultivates with the licensee, the values it conveys and the importance this gives to safety (its“safety culture”), the regulatory body profoundly impacts the safety culture of the licensee andits sense of accountability for safety. This influence is also mutual, from licensee to regulatory
body, and by its nature it is pervasive and may be unseen.
The NEA report The Role of the Nuclear Regulator in Promoting and Evaluating Safety Culture (NEA,
1999) focuses on regulatory oversight of safety culture and discusses how the regulatory body
could recognise and respond to early signs of declining safety performance of licensees. The NEA
report also recognised that, in addition to enforcing safety regulations, the regulatory bodyshould make sure it has a positive effect on the operator’s safety culture. Another guidance
report, The Safety Culture of an Effective Nuclear Regulatory Body (NEA, 2016) (commonly andhereafter referred to as the “2016 NEA Green Booklet”), identifies and describes five principles
and their associated attributes (see Table 1.1) that underpin and support the safety culture of aneffective nuclear regulatory body. The 2016 NEA Green Booklet emphasises the importance ofthe regulatory body taking a holistic approach to safety by working in a systematic manner. The
human and organisational factors (HOF) analysis of the Fukushima Daiichi Nuclear Power Plant
accident also led to recognition of the need for a systemic approach that encompasses
interactions among all stakeholders involved in nuclear safety (IAEA, 2015).
Regulatory bodies oversee and regulate complex socio-technical systems that, together
with the regulatory body itself, form part of a larger system made up of many stakeholders,with competing as well as common interests. All the participants in this system influence andreact to each other, and there is a need for awareness and understanding of this mutual
influence. Past events in the nuclear sector and more recent events in other sectors, e.g. theBoeing 737 MAX accidents, continue to emphasise the role of the regulatory body as animportant component of the broader system ensuring the safety of workers and the public.

Table 1.1. Principles and attributes of a health safety culture in regulatory bodies
Principles

Attributes

Principle 1: Leadership for safety is to be
demonstrated at all levels in the regulatory body.

• “Safety first” is a guiding principle in the regulatory body.
• All leaders throughout the regulatory body demonstrate acommitment to safety in their decisions and behaviours.
• Leaders create an environment for positive development of thesafety culture.
• Leaders clearly define individual roles, responsibilities andauthority.
• Leaders ensure that the necessary resources are available to meetthe safety mission.

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INTRODUCTION

Table 1.1. Principles and attributes of a health safety culture in regulatory bodies (cont’d)Principles

Attributes

Principle 2: All staff of the regulatory body haveindividual responsibility and accountability for
exhibiting behaviours that set the standard forsafety.

• Personal commitment to and accountability for safety from every
staff member, at all levels of the organisation.
• A strong sense of collaboration and co-ordination of activities
across the organisation.
• The need for moral courage and agility in doing the right thing.

Principle 3: The culture of the regulatory bodypromotes safety and facilitates co-operation andopen communication.

• Openness and transparency.
• Clear organisational commitment to co-operation.
• A questioning attitude, and mechanisms to raise differing
opinions on regulatory decisions.
• Promotion of safety and associated knowledge.

Principle 4: Implementing a holistic approach tosafety is ensured by working in a systematicmanner.

• A healthy respect for the consequences of all actions anddecisions taken by the regulatory body.
• Clear awareness of roles and responsibilities in relation tolicensees.
• A clear regulatory framework.
• Proactivity, adaptability and a holistic approach.
• Recognition of the complexity of safety issues.

Principle 5: Continuous improvement, learningand self-assessment are encouraged at all levelsin the organisation.

• Safety culture self-assessment and peer reviews.
• Learning from experience, fostering exchanges and increasing
knowledge.
• Knowledge management to build a healthy safety culture.
• Continuous improvement as a clear value of the regulatory body.

Source: NEA (2016).

The NEA Working Group on Safety Culture (WGSC) was formed in 2017 to foster discussion
and exchange information and experience in practical approaches to developing andsustaining a healthy safety culture within the regulatory body and the wider interconnected
system. The first report published by the WGSC, Methods for Assessing and Strengthening the
Safety Culture of the Regulatory Body (NEA, 2021a) provides both an overview and practicalinformation regarding the methods and approaches performed by regulatory bodies to build
safety culture competence and awareness and to assess their own safety culture. The work
presented here is a follow-on to the 2021 report.
In 2021, WGSC members established subgroups to work on two main tasks. One task
addressed the impact of regulatory bodies on the organisations they oversee (and vice versa)
from a safety culture perspective. The other task identified effective characteristics,
competencies, values and how these are exhibited in the behaviour of leaders in a regulatory
body which has a healthy safety culture. Both tasks were in close alignment with thechallenges identified in the 2016 NEA Green Booklet.
Due to the important influence leadership has on the effectiveness of the regulatory body,the WGSC was subsequently restructured as the Working Group on Leadership and Safety
Culture (WGLSC) in January 2023. The aim of the WGLSC is to exchange information andexperiences at a senior regulatory level and to provide practical, innovative products to

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INTRODUCTION

support the leadership and safety culture of the regulatory body and wider interconnected
system. The WGLSC’s work is focused on leadership and safety culture as they relate toregulatory activities, while appreciating the mutual impact of the licensee and otherstakeholders within the wider interconnected system to ensure safety. The WGLSC collects
and analyses information to identify and capture best practices on how the leadership, humanaspects and safety culture of the regulatory body affects the regulated entity’s safety culture,and vice versa 1.
This document reports on the first task of the WGLSC (begun by the WGSC in 2021), toinvestigate interactions between the regulatory body and licensee and how each influences
the safety culture of the other. This report is intended to gather and analyse the knowledge
and experience of regulatory bodies and licensees on how regulatory strategies andapproaches, including relationships between regulatory bodies and licensees, influence safety
culture. The second report in the series, Practices for Enhancing Leadership for Safety in Nuclear
Regulatory Bodies (NEA, forthcoming), is a guidance document that identifies elements ofeffective leadership for safety characteristics, competencies and values. Specifically, the report
identifies how these are best exhibited in the behaviour of regulatory body leaders in order tomaintain a healthy safety culture.
This present document provides both an overview of mechanisms by which the regulatory
body and licensee influence their respective safety cultures, and associated good practices,lessons learnt and challenges. The remainder of this report is divided into five chapters.
Chapter 2 sets out the purpose and scope of the report. Chapter 3 provides a summary of theliterature review and the methodology for data collection and analysis. Chapter 4 thensummarises the data analysis results, including mechanisms of influence, good practices,lessons learnt and challenges. It also proposes a model for effective interactions between theregulatory body and licensee. The discussion and conclusions, along with recommendations
for future NEA work, are presented in Chapter 5. Annexes catalogue the literature reviewed(Annex A), the questions used in the data collection interviews (Annex B), examples of goodpractices and lessons learnt (Annex C), and features of ineffective interactions between theregulatory body and licensee (Annex D).

1.

Current information about the WGLSC’s work can be found at www.oecd-nea.org/WGLSC.

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PURPOSE AND SCOPE

Chapter 2. Purpose and scope

The regulatory body interacts with the licensee through its regulatory activities. The purposeof this study is to explore this interaction in more detail in the context of safety culture. This
will facilitate building and maintaining a healthy relationship between the two organisationsin the interests of safety.
Past events in the nuclear sector, e.g. the Fukushima Daiichi accident, and more recent
events in other sectors, e.g. the Boeing 737 MAX accidents, continue to emphasise the role of
the regulatory body as an important component of the broader system ensuring the safety ofworkers and the public. Prior to the Fukushima Daiichi Nuclear Power Plant accident, “…theregulatory bodies lacked an organisational culture that prioritised public safety over their own
institutional wellbeing, and the correct mindset necessary for governance and oversight”(National Diet of Japan, 2012: 44). Further, investigators into the Boeing 737 MAX accidents
noted that, “The [Federal Aviation Authority’s] waning safety culture stands as a significant
barrier to its capacity to learn lessons from the MAX tragedies and make fundamentalorganisational improvements” (U.S. House Committee on Transportation and Infrastructure,
2020: 234).
More specifically, the objectives of this study are to:•Understand how regulatory bodies impact licensees (and vice versa) from a safety
culture perspective; and•Share good practice and learning on how regulatory bodies can ensure that this impact
is positive, avoid negative impacts, and support the achievement of safety objectives.

Thus, the report will explore how regulatory bodies positively and negatively affect theorganisations they oversee (and vice versa) from a safety culture perspective. It gathers andanalyses the knowledge, insights and experience of regulatory bodies and licensees worldwide
in how regulatory strategies and approaches, including relationships between regulatory
bodies and licensees, influence the safety culture of each organisation.
This report focuses particularly on fourth principle of the 2016 NEA Green Booklet:“Implementing a holistic approach to safety is ensured by working in a systematic manner”(NEA, 2016) (see Table 1.1). The present report builds on the attributes of this principle, e.g. ahealthy respect for the consequences of all actions and decisions taken by the regulatory body,and a clear awareness of roles and responsibilities in relation to licensees.
This report also addresses three of the key challenges identified in the 2016 NEA Green
Booklet, namely:•

Maintaining the focus on safety by avoiding complacency and sustaining institutional
memory;•Addressing external pressures on the regulatory body by protecting against undue
influence and avoiding “regulatory capture”; and•Building, maintaining and adapting a regulatory system by evolving and adapting tochanges in government policy and the industry landscape to maintain a healthy safety
culture.

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PURPOSE AND SCOPE

Gaining a deeper awareness of these elements is important for regulatory bodies,considering their potential influence on the safety culture of licensees. Furthermore, it is also
important to be aware of how the licensees’ safety culture influences the regulatory body.
This report is intended primarily for staff in the regulatory body and their licensees. This
includes managers at all levels, and staff members who are responsible for, or involved in,regulatory strategies, activities and interactions to strengthen the safety culture of the regulatory
body as well as that of the licensee. However, it is also intended for staff in other functions,e.g. training, human resources, self-assessment and safety culture specialists. Furthermore,other potential readers might be interested stakeholders in the wider system, e.g. government,international bodies and the public. Widespread engagement of stakeholders in this report’s
findings provides an opportunity to develop awareness of the regulatory body and licensee’s
relative strengths and weaknesses and their impact on each other’s safety culture.
The report captures the knowledge and experience of 12 NEA member countries and theUnited Arab Emirates in regulatory strategy, practice and relationships, which serve to sustain
and enhance the safety culture and safety performance of the regulated organisations. While
there will inevitably be nuances in the regulatory approach taken by each country according to
the national culture and context, the report draws out insights and good practices from which
all countries can learn. This report also aims to contribute to nuclear safety by capturing key
success factors with the aim of avoiding repetition of past regulatory failure and promoting
good practice internationally.
The NEA encourages regulatory bodies and licensees to use this report as a reference forreviewing and improving their activities to foster and enhance a healthy safety culture. Thisaim is to help in raising awareness of the impact regulatory bodies and licensees have on eachother’s safety cultures. More specifically, this report can encourage regulatory bodies andlicensees to undertake self-reflection, self-assessment and improvement activities. Together
with the companion publication Practices for Enhancing Leadership for Safety in Nuclear Regulatory
Bodies (NEA, forthcoming), this report can be used to enhance training, development andguidance of staff.

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METHODOLOGY

Chapter 3. Methodology

The methodology used in this report was derived from well-established, qualitative researchtechniques (Bell et al., 2019). The main steps (Figure 3.1) comprised a literature review tounderstand the maturity of knowledge in the field of regulatory safety culture, followed by adata collection and analysis phase. The main method of data collection was semi-structured
interviews with senior practitioners in regulatory bodies and licensee organisations worldwide.
Section 3.1 summarises the outcome of the literature review. Section 3.2 then details theapproach to data collection and analysis.

Figure 3.1. Research methodology
Step 1:
Purpose andscope

Step 2:
Literature
review

Step 3:
Interview
designStep 4:
Conduct
interviews

Step 5:
Analysedata

Step 6:
Preparereport3.1. Summary of literature review
The literature review examined 24 items of literature ranging from academic publications, towork by international bodies, assessments of regulatory oversight culture, and authoritative
investigations and reviews of the role of the regulatory body in major accidents in the nuclear
and other sectors. The items of literature reviewed are listed in Annex A together with asummary of the main items considered relevant to the present study.
The main findings of the literature review were that:•

There have been no published, large-scale studies in the nuclear sector examining how
the regulatory body influences the safety culture of the licensee, and very little work on
the influence of the licensee on the regulatory body.

•

The studies that have been undertaken to explore the traits and attributes of healthy
regulatory safety culture have several common elements, e.g. leadership and continuous
improvement. These provide a useful reference point for the present study.

•

Investigations into the Fukushima Daiichi Nuclear Power Plant accident, as well asothers, have highlighted the crucial role of the regulatory body in providing competent,
independent, effective oversight of the industry, and the continuing challenges inachieving this.

•Studies in the nuclear and other sectors indicate that no single approach is optimal interms of the regulatory body delivering its purpose of assuring safety on behalf of the
public. Rather, a flexible approach is needed that depends on the safety culture
maturity of the duty holder as well as of the regulatory body itself. Nevertheless, theaim of any regulatory approach should be to foster the accountability of the regulatedorganisations and their growth towards higher cultural maturity levels.

The literature review was used to design the next phase of the study – specifically thedesign of the semi-structured interviews and the development of a set of categories or “codes”
around which to organise the data collected through the interviews.

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METHODOLOGY

3.2. Methodology for data collection and analysis
3.2.1. Data collection
The main method chosen for the data collection phase of the study was semi-structured
interviews with senior practitioners in regulatory bodies and licensee organisations worldwide.
The reason for choosing semi-structured interviews is that they allow rich discussion based ona core set of mandatory questions while allowing the interviewer to add further questions toseek clarification and further insights. The individuals interviewed were directors, managers,
inspectors and safety culture specialists within regulatory bodies and licensee organisations,
including recently retired staff, all with significant experience of working at the interface
between the regulatory body and licensee.
In total, 49 interviews, including focus group interviews, were conducted by members of
the WGLSC during 2022, encompassing 60 individuals in 13 member countries. Each interview
lasted approximately 90-120 minutes. An initial pilot of the interview and data analysis
process was undertaken to validate the approach and inform the remainder of the interviews.
The pilot phase comprised 17 of the 49 interviews.
Most of the interviews were recorded and transcribed, or extensive notes taken, to provide
the basis for detailed textual analysis while mitigating the introduction of unintentional bias.
The interviews were primarily conducted in the native language of the interviewee to ensure
clarity of communication, given the nature of the matters being discussed. Members of the
WGLSC also participated in each other’s interviews to promote learning and consistency ofapproach. Table 3.1 summarises the interviews conducted.

Table 3.1. Interviews conducted by WGLSC members
Country1.

20

Number of interviews
Regulatory body

Licensee

Total

Australia

2

13

Canada3

14

Finland2

02

Germany

1

2

3

Hungary

2

2

4

Japan

2

11 1

13

Korea

2

1

3

Slovak Republic

0

1

1

Spain

2

2

4

Switzerland

1

3

4

United Arab Emirates

1

0

1

United Kingdom

2

2

4

United States

2

1

3

Total

22

27

49

Interviews were conducted with all the licensees in Japan to provide an additional layer of protection
for the anonymity of the data. However, no additional weight was given to the views expressed inthese interviews compared to other countries.

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METHODOLOGY

The interviews were conducted in accordance with an ethical framework to protect theanonymity and confidentiality of the interviewees and the information provided. Participants
were provided with an information sheet in advance detailing the safeguarding provisions, thequestions to be asked and seeking their consent to participate in the study. Annex B lists thequestions forming the core of the semi-structured interviews, which align with the main
objectives of the study. Interviewers reported that the interviews were open and engaging, andthat participants provided high quality information and insights.

3.2.2. Data analysis
The method chosen for analysis of the data from the interviews was thematic data analysis(Bell et al., 2019). In this method a pre-specified coding template, drawing on existingknowledge, is used to organise the interview data, but the codes can be refined in the courseof the analysis. In this case, the literature review provided the source material for thedevelopment of the initial coding template. The codes were then modified in response to thethemes that arose from the interview data.

Figure 3.2. Methodology for data analysis

Define categories
for coding template

Read interview
transcripts andcode data

Develop anddeepen analysis

Make connections
and develop model

Each interviewer carried out the initial analysis of their interview data; the completed
coding templates were then translated into English. A core group of WGLSC members thenperformed the next level of data analysis to distil key themes and make comparisons andconnections in order to provide an explanation and interpretation of the data. Finally, theoutputs of this analysis were reviewed and refined in data analysis workshops in which all
WGLSC members participated.
The interview data provided rich information on:•

The mechanisms by which the regulatory body influences the safety culture of thelicensee (and vice versa); and•Good practices, lessons learnt and challenges in effective interactions between theregulatory body and licensee.

The information was used to develop a model for effective interactions between theregulatory body and licensee in which each party has a positive impact on the safety culture of
the other, as detailed in Chapter 4).

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Chapter 4. Results of data analysis

This chapter presents the results of the data analysis derived from the interviews with seniorpractitioners in regulatory bodies and licensee organisations on how each party influences thesafety culture of the other. Sections 4.1. and 4.2 of the chapter describe the mechanisms ofinfluence, with examples of positive and negative impacts. These sections also include
illustrative quotations from the interviews and present both a descriptive and normative
analysis, referring to the key items of literature in Section 3.1 and Annex A. Section 4.3 covers
good practices and lessons learnt for interactions between regulatory bodies and licensees.
Section 4.4 then analyses the challenges facing regulatory bodies and licensees in ensuringthat their interactions are effective and positively influence each other’s safety culture. Finally,
Section 4.5 discusses the main findings of the data analysis and presents a proposed model for
effective interactions between the regulatory body and licensee, drawing together the insights
provided by the interviews.
In analysing the interview data, consideration was given to whether there were any
significant differences in the opinions expressed by representatives of regulatory bodies
versus those of licensees, or among the different countries participating in the study. No suchdifferences were found and indeed the interview data gives a consistent picture of themechanisms of influence of each party on the safety culture of the other, and what constitutes
an effective interaction between a regulatory body and licensee. This may in part relate to thestrong international networks which exist in the nuclear sector.

4.1. Mechanisms of influence of the regulatory body on the safety culture of thelicensee
4.1.1. Overview
The literature review (Section 3.1 above and Annex A) identified a provisional set of factors
relevant to the influence that the regulatory body has on the safety culture of the licensee (andvice versa). The analysis of the interview data has provided significant additional insight into
these factors. In the case of the influence of the regulatory body on the safety culture of thelicensee, the following factors emerge from the interview data. These are presented inTable 4.1 below as the “main factors,” each of which has several “sub-elements”.

Table 4.1. Factors that determine the regulatory body’s influenceon the safety culture of the licensee
Main factors
1.

The regulatory
regimeSub-elements
1.1 The regulatory framework: its design, development and implementation
1.2 The roles, responsibilities, accountabilities and authorities allocated to the regulatory
body, licensee and other players
1.3 The regulatory body’s degree of independence
1.4 The regulatory body’s priorities
1.5 The regulatory body’s decision-making processes
1.6 The regulatory body’s methods and tools

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Table 4.1. Factors that determine the regulatory body’s influenceon the safety culture of the licensee (cont’d)Main factors

Sub-elements

2.

The capability of theregulatory body

2.1 The competence of staff in the regulatory body
2.2 The resourcing of the regulatory body
2.3 The ability of the regulatory body to access independent sources of technical expertise
2.4 The knowledge management practices of the regulatory body3.

The leadership andmanagement of theregulatory body

3.1 The capabilities and practice of leaders in the regulatory body
3.2 The regulatory body’s management system and practices

4.

The regulatory
body’scommunications

4.1 The structure and format of communications between the regulatory body and licensee
4.2 The content of communications between the regulatory body and licensee
4.3 The communications between the regulatory body and the public

5.

The regulatory
body’s relationships
with the licensee andother stakeholders

5.1 The characteristics of the relationship between the regulatory body and licensee
5.2 The development and maintenance of the relationship between the regulatory body andlicensee
5.3 The relationships between the regulatory body and other stakeholders

6.

The behaviour of thestaff of theregulatory body

6.1 The behaviour of the regulatory body’s staff in promoting safety
6.2 The visibility of the regulatory body’s staff in the licensee
6.3 The compliance of the regulatory body’s staff with the licensee’s safety arrangements

7.

The ability of theregulatory body tolearn and improve

7.1 The ability of the regulatory body to learn and improve from its own experience
7.2 The ability of the regulatory body to learn and improve from the experience of thelicensee
7.3 The ability of the regulatory body to learn and improve from the experience of others

The following sections describe how the above factors combine and influence the safety
culture of the licensee. These are the “mechanisms of influence” identified in this study.

4.1.2. Influence of the regulatory regime
The regulatory body influences the safety culture of the licensee, firstly, by the way in which
the regulatory framework (the system of legislation, standards and guidance) is designed,
developed and implemented. It is important that the regulatory framework is clear,comprehensive and predictable, aligned with regulatory objectives and values, and developedin consultation with licensees. It should then be consistently explained, interpreted andapplied. These sub-elements together will promote effective working relationships between
the regulatory body and licensee, generate mutual understanding and a motivation to comply.
By contrast, a regulatory framework that lacks clarity, or is inconsistently applied, can lead toconfusion, poor safety outcomes and wasted effort.
“Participation in the development of regulations, the possibility of considering both theregulatory body and licensee’s views, and full understanding of the meaning of the regulations,helps compliance and conviction on the need and benefits of the regulations. It sets the steps inbuilding a culture of improving, not merely fulfilling prescription.” – Interviewee“If the values and norms promoted by the regulatory body are inconsistent with the actual
regulations, it will be difficult to give a positive message to the operator no matter how theregulatory body emphasises safety culture.” – Interviewee
The insight provided by the interviewees indicates that the emphasis in the regulatory
regime should be towards an outcome-based or goal-setting approach (see Box 4.1 in
Section 4.5 for a definition) rather than a prescriptive approach. By focussing more on theoutcome, and less on the detail of how the outcome is to be achieved, the regulatory body24

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promotes the licensee’s sense of accountability for safety, allows flexibility for varying
circumstances, and supports innovation. Other important features of the design of theregulatory framework that were identified:•A holistic approach to safety, considering human, technology and organisation;•

A graded approach to safety, i.e. stringency of controls commensurate with level of risk;•

Systematic consideration of safety across national boundaries; and•The provision of a suitable range of regulatory enforcement powers.

Often there is more than one regulatory body involved in regulating related activities within
an operating organisation. A key lesson from past accidents (IAEA, 2015) is that regulatory bodies
co-ordinate their efforts to clarify expectations and promote optimal outcomes.
An important feature of the regulatory regime is the allocation of roles, responsibilities,
accountabilities and authorities to the regulatory body, licensee and other players. The
regulatory body should have authority to carry out its functions and clear accountability to the
public, while accountability for safety should rest with the licensee. An important influence on
the safety culture of the licensee is how the regulatory body interprets and exercises its role,e.g. as a “police officer” or “coach”. Too much of an emphasis on its policing role and formal
enforcement, for example, can diminish the licensee’s sense of accountability for safety. On
the other hand, too much of an emphasis on the coaching role can undermine theindependence and public accountability of the regulatory body. This is similar to the findingsof Reiman and Norros (2002), who identified three roles the regulatory body performs (“expert”,“authority” and “public”) and the trade-offs between them.
“My experience is that enforcement can sometimes be very positive for culture. It can also bevery difficult sometimes, in a formal interaction, when trying to understand the background andthe reasons for a particular course of action or decision. A blend between informal support,
early advice, that helps the licensee understand the direction of travel, before getting into therealms of enforcement, is really helpful.” – Interviewee
The independence of the regulatory body from both a technical and a politicalperspective is a key feature of the regulatory regime. However, this independence should not
be at the expense of the regulatory body becoming isolated from other stakeholders,e.g. licensees, government and other regulatory bodies, which may limit its ability to influence.
Many interviewees noted that the way in which the regulatory body prioritises its
activities has an important influence on the safety culture of the licensee. This can have apositive impact when the regulatory body prioritises its attention on key risks andperformance shortfalls. Conversely, it can have a negative impact when the regulatory body
focuses on irrelevant or insignificant matters.
“The regulatory approaches must pay attention to risks, operational performance and outcomes,
and the oversight activities should be targeted in the areas with the largest safety significance.
The regulatory approaches and activities must be justifiable and fair.” – Interviewee
Similarly, the regulatory body’s decision-making is an important manifestation of its
culture and can also have a positive or negative effect on the licensee. Decisions that are
objective, fair, predictable, transparent, suitably informed, and with due priority to safety,
foster trust and respect with the licensee. By contrast, decisions that are biased, ill-informed,
or unreasonable, create mistrust and can adversely influence the safety culture of the licensee.
Finally, the methods and tools used by the regulatory body are another way in which it
can influence the safety culture of the licensee. At the heart of this is the balance theregulatory body strikes between the use of formal methods, e.g. inspections and assessments,and less formal methods, e.g. dialogue. The former support the public accountability of theregulatory body, while the latter can generate a stronger, positive influence on safety culture
by promoting the licensee’s self-awareness and sense of accountability for safety. Other
important characteristics of the regulatory approach are the use of announced as well as

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RESULTS OF DATA ANALYSIS

unannounced inspections (to counteract undue “pre-positioning” by the licensee) and theintegration of regulatory intelligence to generate an overall view of the licensee’s safety
performance against regulatory standards. The latter can promote self-reflection andbenchmarking among licensees on respective strengths and weaknesses.
The mechanisms of influence identified above are consistent with those identified by the
NEA (2014 and 2016) and IAEA (2016a). They underline the importance of the regulatory regime
in promoting a healthy safety culture, within both the regulatory body and licensee, and positive
safety outcomes. They also reflect learning from past experience in the nuclear and othersectors, for example the Grenfell high-rise building fire in the United Kingdom (Hackitt, 2018) inwhich “…inadequate regulatory oversight and enforcement tools… had helped to create acultural issue across the sector, which can be described as a ‘race to the bottom…’” Theseelements can be considered, among other factors, as a self-reinforcing negative feedback loop.

4.1.3. Influence of the regulatory body’s capability
Staff in the regulatory body influence the licensee, firstly, by their technical ability, comprisingtechnical and regulatory knowledge, skills and experience. This supports good regulatory
decision-making and creates credibility and respect for the regulatory body in the eyes of thelicensee. By contrast, staff lacking technical competence can engender mistrust within thelicensee, and inexperienced staff may be unduly prescriptive or overzealous in their approach.
“The only chance to be taken seriously by the licensee is to be technically competent. It isineffective to act as a bureaucrat who only checks off formal aspects.” – Interviewee
The second important aspect of competence are the “soft skills” of regulatory staff,
e.g. communications skills and emotional intelligence. These enable professional, respectful
working relationships between staff in the regulatory body and licensee and support
resolution of difficult problems, enabling a positive influence on safety culture.
Other important aspects of staff competence in the regulatory body are their knowledge
and situational awareness of the context and challenges of the licensee, and theirunderstanding of the practical implications of implementing regulatory expectations. As
above, these can help build credibility and respect, and motivate the licensee to respondpositively to the regulatory body’s expectations.
“When you see what a regulatory requirement can trigger, that it can have massive
repercussions, then the regulatory body must be aware of its responsibility and ask itself ‘What
are we triggering in the plant?’ Every requirement costs money and binds resources, in theregulatory body as well as the licensee. You have to think about where to put the resources in
the interests of risk management.” – Interviewee
In addition to competence, the other dimension of capability is resources. It is importantthat there is alignment between the regulatory body’s priorities and the resources available toput them into effect. Furthermore, the regulatory body should balance reliance on its own
resources with access to independent sources of expertise. This ensures that the regulatory
body maintains its technical independence, while being open to new developments inknowledge. In turn, this means that the regulatory body can scrutinise the licensee’s proposals
authoritatively and efficiently.
The final aspect of capability that is important is the regulatory body’s knowledge
management practices. By sharing good practice and learning both internally and externally,
the regulatory body can maximise its ability to positively influence safety culture withinlicensees. Similarly, the regulatory body’s willingness to engage in collaborative research, at anational and international level, enhances both its own knowledge and that of the licensee.
The importance of regulatory capability is reflected in the work of Bradley (2017), who
identified a “commitment to technical excellence” as a cultural strength of regulatory bodies. It
also aligns with one of the key findings of the official investigation into the Macondo oil spill,
namely that the regulator’s “…ability to regulate safety is contingent upon adequate numbers of staff

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with multifaceted competencies in not only technical disciplines, but human and organisational factors,
communication and interpersonal skills such as negotiation, persuasion and advocacy” (U.S. Chemical
Safety and Hazard Investigation Board, 2016). The previous report in this series (NEA, 2021a)
identifies the methods by which regulatory bodies can build knowledge and awareness ofsafety culture – both as a matter of regulatory oversight and self-reflection.

4.1.4. Influence of the regulatory body’s leadership and management
Staff at all levels in the regulatory body influence the safety culture of the licensee not only bywhat they say, but by what they do, e.g. their decisions, actions, priorities and behaviours, andthe degree of alignment between the two. It is imperative that managers in the regulatory
body recognise the influence that the regulatory body has on the safety culture of the licensee
and set clear expectations for the regulatory approach and behaviours of staff. They should
lead by example, support staff, recognise good behaviour and correct poor behaviour whereappropriate. The prioritisation and timely resolution of issues raised by inspectors, following a
graded approach, is an important characteristic of managers in the regulatory body andsupports a positive safety culture. Underpinning their credibility, managers should becompetent in their role but also recognise the limits of their competence and when to draw on
expertise elsewhere in the organisation.
“Leaders in the regulatory body need to create a positive work environment with a clear, sharedfocus on safety, where there is trust, respect and open dialogue helping to enhance safety
culture. Dialogue must be maintained at all levels before decision-making, while understanding
each other’s role and the decision-making lines and responsibilities. This also creates aperception of trustworthiness in the regulatory body and impacts the licensee’s behaviour.
When the regulatory body is perceived as dysfunctional, the impact on the licensees can be
negative.” – Interviewee
The fundamental role that leaders play in creating and shaping culture was highlighted in
the official investigation into the Boeing 737 MAX crashes. That report noted a key takeaway
from a safety culture survey conducted by the U.S. Federal Aviation Authority (FAA) that “[FAA]
senior leadership’s response to and management of industry pressure is at the heart of theorganisation’s core safety culture challenges: lack of trust, inconsistent accountability, FAA role
confusion, and the perception that…[FAA] is moving further away from its safety mission” (U.S. House
Committee on Transportation and Infrastructure, 2020: 241) The NEA, in Practices for Enhancing
Leadership for Safety in Nuclear Regulatory Bodies (NEA, forthcoming) sets out in more detail thecharacteristics, competencies, values and behaviour of leaders in a regulatory body which has
a healthy safety culture (NEA, forthcoming).
Management systems and safety culture have a mutual dependence in any organisation(IAEA, 2016b; IAEA, 2019). Therefore, by following a systematic, graded approach to its
regulatory activities, aligned to relevant good practice, the regulatory body will enhance its
own safety culture and in turn have a positive impact on the safety culture of the licensee.
Conversely, a dysfunctional regulatory body sets a poor example and will have a negative
impact on the licensee. As part of its management arrangements, it is important that theregulatory body plans its work realistically, aligned to its regulatory strategy and priorities,
taking due account of uncertainties. This provides the basis for constructive engagement withlicensees, including managing expectations and mitigating undue time pressure on staff ineither organisation.
“It’s essential that the regulatory body has consistency in the implementation of its policies andpractices, and that it does things according to an integrated management system, which is the
backbone of its work.” – Interviewee“When the licensee asks the regulatory body ‘What do you do?’, the regulatory body has toshow that it is also making its own effort, e.g. by developing and implementing a mission
statement or a management system.” – Interviewee

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4.1.5. Influence of the regulatory body’s communications
The structure and format of communications between the regulatory body and licensee have an
important influence on safety culture (see also Section 4.1.8 concerning the regulatory body’s
ability to learn and improve). Regular, two-way communications at all levels between theregulatory body and licensee promote a consistent approach, allow expectations to be
promulgated by management and issues to be addressed at the most appropriate level (strategic
or technical). Lack of such a structure risks inconsistency, inefficiency, and ineffectiveness in therelationship between the regulatory body and licensee. Additionally, escalation of issues without
proper dialogue first between those accountable can create mistrust.
“I believe that one main element of a good safety culture influence from the regulatory body isthat the licensee trusts, respects, and understands the regulator. That’s why we need to havefrequent dialogue.” – Interviewee
Similar to the point made above (see Section 4.1.2, “Influence of the regulatory regime”), it
is important that the regulatory body strikes a balance in its approach between formal
communications with the licensee, e.g. meetings with the licensee that are open to the public,
formal reports, decisions and letters to the licensee that are publicly available etc., and lessformal communications, e.g. “closed door” meetings with the licensee (not open to the public)
and informal e-mail exchanges. Formal communications support the regulatory body’stransparency and accountability to the public, but do not necessarily encourage open andfrank exchange of information between the two organisations. This can lead to the gradualdistancing of relationships and “ratcheting” of regulatory action. This is particularly the casein some countries where discussions between the regulatory body and licensee are broadcast
live, which can impact psychological safety and the effectiveness of interactions. By contrast,
less formal communications allow issues to be aired by both parties, in turn generating better
understanding and a greater chance of the issues being resolved, ultimately leading to a moretrustful relationship. However, excessive use of such informal interactions risks undermining
the independence of the regulatory body and may cut across each organisation’s formal
processes.
“The most effective safety culture interaction is that informal conversation when the regulatory
body is not there to carry out a stated inspection against a particular standard. What I welcome
from our regulatory bodies is actually more frequent, less formal interactions. The formal
processes, great, but I think its impact on safety culture is actually less.” – Interviewee
Early engagement between the regulatory body and licensee is particularly beneficial inauthorisation activities, e.g. licensing and certification. Such engagement helps clarify regulatory
expectations and enables assumptions or misconceptions on both sides to be unravelled.
Aside from structure and format, the content of communications is equally important. By
consistently and regularly communicating its requirements, decisions, plans and priorities,
together with the supporting rationale (the “what” and “why”), the regulatory body promotes
understanding of its approach among licensees and other stakeholders and can address
queries and challenges. Without the “why” element in particular, the licensee may perceive
arbitrariness or irrationality in the regulatory body’s approach, making it more resistant toregulatory findings and weakening trust.
“If the regulatory body wants and requires something, it is important that it communicate
clearly. Open communication helps, with clear goals. If the licensee also understands it, theacceptance is there. ‘Because the regulator wants it’ is not a good explanation. The regulatory
body has to explain why it wants something.” – Interviewee
In addition to communications between the regulatory body and licensee, communications
between the regulatory body and the public are also relevant in this context. By publishing theoutcomes of its activities in a clear, accessible format, the regulatory body promotes
transparency and greater public understanding of its activities and decisions. Clarity is key, anda focus on only the technical rationale may generate misunderstanding or suspicion. Several
interviewees spoke of the benefits of the regulatory body engaging in broader communications
with the public on its activities and impacts in the industry. The licensee benefits from thepublic being assured of the independent scrutiny applied by the regulatory body.

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RESULTS OF DATA ANALYSIS“In the public and political sphere, having the supervisory authority also helps us. It gives us asafety net. We are not directly exposed to the wind. We can say we are monitored. It shields us
to some extent. It fosters trust, the knowledge that there is an independent supervisory
authority watching our backs.” – Interviewee
Open and candid communication between the regulatory body and industry, as well asother stakeholders, is among the attributes identified by Bradley (2017) as contributing to alearning culture between the respective organisations. The current findings are also mirroredin the study by Durbin (2013) that identifies the regulatory body’s communications as a factor
significantly impacting its effectiveness, irrespective of the particular regulatory approach
used (outcome-based, prescriptive, etc.).

4.1.6. Influence of the regulatory body’s relationships with the licensee and otherstakeholders
Interviewees explained that having a common understanding and shared goal on safety isfundamental to an effective working relationship between the regulatory body and licensees.
The interviewees were also consistent in identifying the main characteristics of an effective
working relationship between the regulatory body and licensee as follows:•

Trust;•

Professionalism;•

Fairness;•

Mutual respect;•

Openness, honesty and transparency;•

A questioning attitude; and•Self-reflection and learning.

Trust was described by interviewees as two-way. The licensee must be able to trust theregulatory body’s decision making, e.g. that it responds proportionately to a reported noncompliance. The regulatory body must in turn be able to trust that the licensee responds “inthe right way” to its expectations, i.e. in a way that is sustainable and strengthens safety
culture, not merely fulfilling requirements. However, too much trust can be problematic forthe regulatory body, which must retain its independence of view and questioning attitude tosatisfy its accountability to the public.
“It is important to trust each other. If a staff member of a regulatory agency thinks that a certain
person at a business is trustworthy, the discussion will be more active, and the conversation will
be more engaging. The question is how to build a relationship of trust.” – Interviewee
The characteristics set out above promote constructive, co-operative working relationships
between the regulatory body and licensee, enabling difficult issues to be addressed in theinterests of continuously improving safety culture and safety performance. By contrast,
suspicion, arrogance or defensiveness in the relationship have a detrimental impact. Positive
personal relationships between staff in each organisation are desirable but should not stray
into inappropriate fraternisation (“friendly but not friends”, as described by one interviewee).
“It’s about creating a respectful work environment, which includes trust in each other, as one is
not a ‘robber’ and the other not a ‘cop’, but professionals who can speak objectively about
technical issues.” – Interviewee“Regulators must respect that licensees are knowledgeable in their field … intimidation andtable-pounding are not good. It sets up an adversarial position. We are the regulator and need
to be independent, but we also need to be respectful.” – Interviewee
If relationships are important, then taking the time to build and maintain these
relationships is also important. Again, the regulatory body needs to strike a balance in its
approach. Inspectors in the regulatory body need time to build relationships before they

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RESULTS OF DATA ANALYSIS

become fully effective, but equally too long a time in a particular role can lead to “regulatory
capture,” in which the inspector begins to lose objectivity.
Alongside effective working relationships with licensees, the regulatory body needs tomaintain effective working relationships with a range of other stakeholders, e.g. unions andnon-governmental organisations. This demonstrates openness, invites challenge andultimately builds confidence in the regulatory approach.
The nature of the relationship between regulatory bodies and duty holders is a feature of
the literature reviewed for this study (Annex A). Black (2014) reviews several events in which
the regulatory body, in seeking a co-operative relationship with the duty holder, was“insufficiently interrogative of information”, “slow to take action,” and in one case “simply tootrusting”. The need for the regulatory body to balance its independence and openness towards
the licensee is identified as one of the challenges in the NEA’s ten-year report on the
Fukushima Daiichi Nuclear Power Plant accident, which proposes that…such [a] balance can and should be achieved through multilateral and bilateral,public and non-public engagement between the regulator and external stakeholders,
including nuclear industry representatives; care must be taken to conduct bilateralengagements with any stakeholder in a manner that avoids or minimises theperception of bias or compromise. (NEA, 2021b: 56)

4.1.7. Influence of the behaviour of the regulatory body’s staff
The behaviour of staff in the regulatory body represents one of the most direct means bywhich the regulatory body influences the safety culture of the licensee. Staff whose
behaviours consistently espouse the value of safety have a correspondingly positive effect on
the licensee. Likewise, staff who promote the licensee’s sense of self-awareness, e.g. by asking
about internal oversight and self-correction activities, promote the licensee’s sense ofaccountability for safety, in turn reinforcing its legal obligations and minimising dependence
on the regulatory body.
“It is foundational that licensees themselves find the minor event and its causes at the site andcorrect it by themselves. At the nuclear power plant, there were cases where the inspector
identified such events. When I exchanged opinions with the power plant manager, I was toldthat he was remorseful about why the licensees could not find such events themselves, and that
he would like to consider the cause and respond. I think that the awareness from inspectors,
and giving new awareness through such an approach, leads to improvement in a positive
direction.” – Interviewee
As discussed above (see Section 4.1.2, “Influence of the regulatory regime”), by focussing
more on outcomes and less on the detail of how the outcome is to be achieved, the regulatory
body enables innovation in the licensee and new paths to compliance. Conversely, seeking toimpose detailed requirements stifles innovation and may be unhelpful or ineffective.
Interviewees emphasised that a regulatory body that highlights good practices as well as
identifying deficiencies is likely to be more effective in positively influencing safety culture in
the licensee. Similarly, when shortfalls are found, a regulatory body that encourages thelicensee to address root causes and similar conditions elsewhere in its organisation, beyond
merely complying with the letter of the law, promotes a culture of “doing the right thing”.
“There is a positive impact of the regulatory body in reinforcing what the licensee does well,including innovation or going beyond the requirements. It even helps to understand andcontextualise the regulatory body’s role when identifying negative aspects.” – Interviewee
Interviewees highlighted that the mere existence of the regulatory body and its presence
on nuclear sites – in other words, what it says and does and what it does not say and do – hasan influence on the safety culture of the licensee. Regulatory staff who maintain visibility
throughout a licensee organisation (at a senior level and at the working levels), encouraging
safe behaviour as well as checking compliance, are more likely to have a positive impact.

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RESULTS OF DATA ANALYSIS“Regulatory body staff influence licensee staff by being in and around the station, e.g., by beingout and about, in meetings with licensee staff, and attending training with licensee staff. The
regulatory body’s presence can result in the licensee adjusting their ‘safety glasses’.” – Interviewee“The regulatory body should talk to the licensee in terms of safety, not in terms of regulations.
Dialogue should be based on observations or inspections that have a nexus to safety, not justthat you violated a regulation.” – Interviewee
Finally, a fundamental way for regulatory body staff to positively influence the licensee’ssafety culture is to take the time to understand and comply with the licensee’s own safety
arrangements – as well as those of the regulatory body – questioning and challenging where
necessary.

4.1.8. Influence of the regulatory body’s ability to learn and continuously improve
The final factor determining the regulatory body’s influence on the safety culture of thelicensee is its ability to learn from its own experience and that of the licensee and others andcontinuously improve. By implementing systematic arrangements within its own organisation
to identify and act on learning opportunities, and expecting the same of licensees, theregulatory body promotes a culture of continuous improvement in safety. It is important thatthe regulatory body regularly reflects on and assesses its own culture, including its impact on
the safety culture of the licensee and the regulatory body’s effectiveness in delivering its
objectives and priorities. In so doing, it should gather feedback from within its own
organisation as well as from licensees and other stakeholders in the system.
The methods by which the regulatory body can carry out safety culture self-reflection andself-assessment activities were the subject of the NEA’s 2021 report, which provides an
overview and practical examples of such methods (NEA, 2021a). These include key featuresand lessons learnt in their application. By cultivating an ability to learn, the regulatory bodycan detect signs where its influence on the safety culture of the licensee may be negative andtake appropriate corrective action.
“We need to have an ongoing discussion with licensees about how they see the effectiveness of
our oversight work – and what areas of our oversight work are viewed as the most effective.” –Interviewee“Getting examples out there of where the regulator has taken some learning from experienceand changed how it does things. It’s useful to get that out there to the license holders. The morethat the regulator can show that it’s receptive to challenge and, when there’s an opportunity tochange something because it’s the right thing to do, it does it. I think that’s a good thing to do.”– Interviewee
Interviewees identified that it is important for the regulatory body to have in placemethods by which anyone can raise concerns about safety, or the conduct of the regulatory
body, and for those concerns to be properly addressed. This is an essential feature of publicbodies in many countries and provides an important source of intelligence for the regulatory
body in carrying out its functions, including positively influencing safety culture in thelicensee, over and above the reporting systems that licensees themselves should have in place.
Finally, it is important that the regulatory body is open to learning through participation innational and international activities such as the development of standards, research,
benchmarking and peer review. This will enhance the safety practices of both the regulatory
body and licensee.
“What I experienced was the activity of a consultative body (a learning and research council). It
is used as a venue for active information exchange between the regulatory body and operator.
As a result, it can be said that it has a positive effect on safety culture by exchanging
information about safety issues actively and transparently.”

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RESULTS OF DATA ANALYSISThe ability of the regulatory body to learn and improve is a common feature of existing
frameworks for regulatory safety culture. For example, Bradley’s (2017) research indicates theneed for the regulatory body to both gather and leverage data and intelligence from external
stakeholders, e.g. industry members, associations and other regulators, and share data andintelligence with the same stakeholders.

4.1.9. Summary
This section has identified seven principal factors that determine the regulatory body’s
influence on the safety culture of the licensee. These factors are consistent with the traits andattributes of a healthy safety culture for the regulatory body (NEA, 2016) and for licensee
organisations (IAEA, 2006; IAEA, 2020) and extend further by explaining how the former
influences the latter, based on the experience of senior practitioners in nuclear regulatory
bodies and licensee organisations worldwide.
The interview data indicates that there is a relationship between the factors identified.
Factors 1, 2 and 3 (respectively, the regulatory regime; the regulatory body’s capability; and theleadership and management of the regulatory body) are enablers of factors 4, 5 and 6(respectively, the communications, relationships, and behaviours that characterise theinteractions between a regulatory body and licensee), while factor 7 (the regulatory body’s
ability to learn and improve), in affecting factors 1, 2 and 3, determines whether there is apositive (upward) or negative (downward) spiral in the influence that takes place. These
factors combine to influence the safety culture of the licensee. In particular, these factors
influence the licensee’s sense of accountability for and priority given to safety, and its
motivation to comply, learn and improve. This is summarised in Figure 4.1 below.

Figure 4.1. Summary of the mechanisms of influence of the regulatory
body on the safety culture of the licensee
The following factors (on the part of the regulatory body) …
Enablers:
1. Regulatory regime
2. Regulatory body’s
capability
3. Leadership andmanagementof the regulatory
body
Safetyculture of aregulatory
bodyInteractions withlicensee:
4. Communications
5. Relationships

Safetyculture of alicensee

6. Behaviours

7. Ability of regulatory
body to learn andimprove… determine the regulatory body’s influence on
the following elements of the licensee’s safety culture:
•
•
•
•
•
•
•
•

32

Sense of accountability for safety
Priority to safety
Motivation to comply, learn and improve
Willingness to “do the right thing”
Vigilance, self-monitoring and reporting
Willingness to challenge assumptions
Openness, honesty and transparency
Willingness to explore better (safer) alternatives

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4.2. Mechanisms of influence of the licensee on the safety culture of the regulatorybody
4.2.1. Overview
The nuclear regulatory body influences the safety of the installations and the licensee’s safety
culture. This is a matter of course, and the interviewees were able to illustrate this influencewith many examples. In contrast, the influence that the licensee exerts on the regulatory
body’s safety culture is not as obvious and presumably also more subtle. Nevertheless,investigations of major events like the Fukushima Daiichi and the Boing 737 MAX accidents
showed such influences.
The interviewees often stated that they had not thought in depth about how licensees
influence the safety culture of the regulatory body. Some interviewees from the licensee’s side
pointed out that they did not know the regulatory body and its organisational culture wellenough to be able to make a statement about it.
In addition, the regulatory body has the formal power to influence the licensee’s actions.
A licensee has no such formal power over the regulatory authority. Its influence is therefore
informal and stems more from its actions. Thus, a licensee mainly influences the regulatory
body’s safety culture by the way it communicates and reacts to the regulatory body’s actions.
The licensee often has a direct effect on the way that the regulatory body performs its
tasks like rulemaking, communication and oversight. The interviewees gave some examples ofthis. In contrast, they gave fewer examples of how licensees perceive their influence on theregulatory body’s safety culture. For them, it was easier and more tangible to talk about the
influence on action than about the influence on structures, values, or assumptions.
As shown in Section 4.1, analysis of the interview data has provided significant insight on
how the regulatory body influences the safety culture of the licensee, with an overview inTable 4.1. The main factors which determine the licensee’s influence on the safety culture of
the regulatory body are similar and are listed in Table 4.2. However, the identified subelements of those main factors are fewer in number and slightly different because of thereasons mentioned above.

Table 4.2. The factors which determine the licensee’s influenceon the safety culture of the regulatory body
Main factors

Sub-elements

1. The regulatory regime

1.1 The regulatory framework: its design, development and implementation
1.2 The roles, responsibilities, accountabilities and authorities allocated to theregulatory body and licensee
1.3 The impact on the independence of regulatory body

2. The licensee’s capability

2.1 The competence of the licensee’s staff

3. The licensee’s leadership andmanagement

3.1 The capabilities and practice of the licensee’s leaders

4. The licensee’s communications

4.1 The structure and format of the communications between the regulatory bodyand the licensee

3.2 The licensee’s structures and processes

4.2 The feedback provided by the licensee

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Table 4.2. The factors which determine the licensee’s influenceon the safety culture of the regulatory body (cont’d)Main factors

Sub-elements

5. The licensee’s relationship withthe regulatory body

5.1 The relationship building between the regulatory body and licensee
5.2 The characteristics of the relationship5.3 The collaboration between the licensee and the regulatory body

6. The behaviour of the licensee’s
staff
7. The ability of the licensee tolearn and improve

6.1 The behaviour of the licensee’s staff
6.2 The licensee’s response to the regulatory body’s oversight methods and tools
7.1 The ability of the licensee to learn and improve from its own experience
7.2 The ability of the licensee to improve its interaction with the regulatory body

The interviews highlighted how the above factors are related and how they influence thesafety culture of the regulatory body. These “mechanisms of influence” identified in this study
are described in the following Sections 4.2.1 to 4.2.8. In Section 4.2.9, the effects of the sevenfactors are summarised by emphasising in which respect the safety culture of the regulatory
body is affected.

4.2.2. Influence of the regulatory regime
The regulatory regime is established mainly by the regulatory body and as shown in
Section 4.1, it influences the safety culture of the licensee. An influence in the reverse
direction on the safety culture of the regulatory body is provided through joint development orcommenting on regulations. In this way, the licensee can contribute to a clear and predictable
regulatory regime.
The priorities of the regulatory body were also identified above as an influencing factor on
the licensee’s safety culture. Again, this is not one-way. The behaviour and safety
performance of the licensee also feed back into the prioritisation of the regulator. Furthermore,determining the right balance between a prescriptive and a goal-setting approach is
influenced by the behaviour of the licensee. The regulatory body adapts the regulatory regime
to the licensee’s behaviour and performance. Significant events may even lead the regulatory
body to fundamentally adjust the regulatory regime.
“In the case of the Fukushima Daiichi accident, for example, there were many aspects that thelicensee got wrong in decision making, design change, and response. It has influenced not only
Japan, but also the world, and has had a great influence on our country as well. Looking at it
like that, I think that licensees’ decisions and such things have a huge impact on the regulatoryorganisation of course.” – Interviewee
As stated above, the allocation of roles, responsibilities, accountabilities and authorities
between the regulatory body and the licensee is an important feature of the regulatory regime.
The accountability for safety should rest with the licensee. The interviews showed that thisfundamental distinction between accountability for safety on the side of the licensee and thetask to oversee if and how the accountability is discharged is well understood. However, inpractice licensees may seek to shift accountability, e.g. by saying that they do things in acertain way because the regulatory body required it. They may influence the role perception of
the regulatory body by discussing issues in order to get advice, or by adopting a reserved
attitude in order to receive strict instructions.
“We [the supervised organisations] can make life easier or harder for you [regulatory body]. We
could absolutely just always do the minimum and delegate the responsibility. That would cause
you to watch very closely. If the authority sees that we are proactive, trying to achieve higher
standards out of our own motivation, it is easier for the authority.” – Interviewee

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By knowing and accepting the different regulatory roles, a licensee can support thedischarging of them in a positive sense, e.g. supporting the public communication role byproviding adequate information in due time. On the other hand, unjustified reference toconfidentiality obligations can impair the communication role of the regulatory body. Theinterviewees gave several examples of how, in a given situation, the actions of a licensee andits interactions with the regulatory body trigger which roles the regulatory body considers
important and how it fulfils its responsibilities. By flexible adaptation to the licensee’s
behaviour, the regulatory body can adjust its oversight of each licensee. The different roles of
the regulatory body may cause ambiguities or misunderstandings, e.g. whether it
communicates advice or a requirement. Through knowledge and understanding of theregulatory body’s roles and responsibilities, a licensee can articulate ambiguities andconsequently create clarity on the side of the regulatory body. Thus, in sum, a licensee canpositively influence the regulatory body’s safety culture in the way that the regulatory body
adapts its regulation and ensures role clarity.
The independence of the regulatory body and its strict focus on safety is a centralcomponent of the regulatory body’s safety culture. Licensees benefit from having an
independent regulatory body. For example, this creates public confidence and protects thelicensees from unjustified accusations. However, licensees can also impair the regulatory
body’s independence in different ways. Emphasising financial conditions and economic goals
can distract the regulatory body from safety issues. Its decision-making can be put underpressure by unreasonable deadlines. Engagement in social activity between staff in thelicensee and the regulatory body may impair an independent evaluation of inspection findings.
A licensee may put pressure on the regulatory body’s staff by threating to complain to thegovernment that the regulatory body hinders business activities, thus causing politicalpressure on the regulatory body. The importance of the regulatory body’s independence,stability and reliability is reflected in the work of Bradley (2017). External pressure or relations
impairing these aspects may increase the politicised mission of the regulatory body, which is avulnerability for its safety culture.

4.2.3. Influence of the licensee’s capability
The licensee’s staff strongly influences the regulatory body through their knowledge andexperience. They can help the regulatory body to better understand the safety issues andinform its activities, priorities, or decision making. Licensees may help the regulatory body tounderstand new upcoming technologies. Inspectors taking training offered by the licensee
learn much about the technology of the nuclear plant and the plant-specific operatingprocedures.
“Resident inspectors take a lot of training offered by the licensee and understand their processes
and human performance tools and you learn a lot about safety from the licensee. And that rubs
off on how we do our own work.” – Interviewee
Additionally, a high level of competence on the part of the licensee generates appreciation,
respect, and trust on the part of the regulatory body. For example, documents fromorganisational units that are known as competent are more easily accepted by the regulatory
body. Thus, the depth and intensity of regulatory oversight is affected by the licensee’s
competence.
Interviewees from regulatory bodies acknowledged that licensee personnel naturally havemore plant-specific knowledge and experience. Nevertheless, they considered that theregulatory body should not merely trust, but should ask questions until fully understanding theissue. Overall, competently conveyed information from the licensee promotes the regulatory
body’s understanding and improves its capabilities and activities. It supports the common goal
to resolve conflicts on the basis of sound technical arguments and not in legal proceedings.
“We want to talk to each other directly and on a technical level, not via lawyers.” – Interviewee

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In sum, high competence on the part of the licensee can foster the regulatory body’s
technical excellence – a cultural strength according to Bradley (2017). However, it also brings
the risk of reducing the regulatory body’s critical questioning attitude.

4.2.4. Influence of the licensee’s leadership and management
Leadership behaviour and management processes are crucial to developing and sustaining ahealthy safety culture. Therefore, regulatory bodies include such aspects in the framework of
their oversight activities. In doing so, the regulatory body recognises good and negative
practices of the licensee and can transfer them to itself. Notably, the contacts between leadersfrom the regulatory body and licensee can influence their respective leadership behaviour andorganisational cultures.
Events in the nuclear industry as well as in other high-risk sectors (see Section 3.1) havedemonstrated the importance of safety-oriented structures and processes and of safety
culture. This has led to increased oversight in those areas. Regulatory bodies have increased
resources for oversight on safety management and safety culture, which has also enhanced
the self-reflection within their own organisation and the capability to improve their own
safety culture. In this way, the analysis of events and the oversight of the licensee’s leadershipand management feeds back to the regulatory body’s safety culture. The regulatory bodyrecognises the need to reflect its influence and to enhance its own safety culture.
“In order to conduct regulatory oversight on the safety culture of operators, it is necessary not
only to input the corresponding regulatory resources, but also to enhance the safety culture
within the regulatory body.” – Interviewee
In addition, good structures or processes in the licensee to interact with the regulatory
body support the regulatory body’s safety culture, e.g. a strong focus by the licensee on safety
causes inspectors to pay amplified attention to safety as well. The regulatory body’s
management and staff develop knowledge of different licensees and learn from examples ofgood processes for their own organisation.
Finally, strong safety assurance processes in the licensee affect the depth and intensity of
the regulatory body’s oversight and its regulatory approach, as is illustrated in the following
observation:“If licensees have really strong peer review processes, internal assurance processes, nuclear
safety committees etc. – internal governance is very safety focused, robust and you can see itworks well – this really does have an impact on us [the regulatory body] because it enables us
to almost step back a little in some areas.” – Interviewee

4.2.5. Influence of the licensee’s communications
Many interviewees pointed out the high importance of trustful communication between thelicensee and the regulatory body. All opportunities should be used for open exchange of
information and opinions. Discussions at different hierarchical levels are helpful. However,care should be taken to ensure that the information is also passed on within the respective
organisations.
“By talking with various inspectors, we can understand each other’s thoughts. It is important toexpress the operator’s thoughts to the regulator in this process.” – Interviewee“When they [the licensee] influence the regulatory body at the high-level management andbypass the staff of the regulatory body it can also influence the safety culture negatively in theregulatory body.” – Interviewee
An open dialogue helps to better understand and support the mutual perspectives, roles
and accountability of the regulatory body and licensee. The licensee recognises theinformation needs of the regulatory body and can provide appropriate data. Submitting plansand priority lists from the licensee helps the regulatory body with its workload and in its way

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of working. Exchange of expectations and boundary conditions help to avoid undue timepressure and a negative influence on safety. A mature, trustful relationship supports early andproactive provision of relevant background information (e.g. from licensee’s internal
discussions) and helps to cope with difficult developments, e.g. organisational changes inconnection with decommissioning and dismantling.
“The more the licensee talks openly and has open discussions with the regulator, it will have amore positive impact on the regulator’s understanding of safety culture as it pertains tooperating plants, and it just adds to a healthier relationship between the regulator and thelicensee.” – Interviewee
The licensee’s feedback concerning regulatory approaches and practices stimulates
improvements and fosters the regulatory body’s safety culture. Such feedback indicates whether
the messages of the regulatory body are understood, helps to adjust the oversight, and enables
effective regulation. In the same way that the regulatory body influences the safety culture of alicensee, a licensee can encourage the regulatory body’s learning and improvement by giving
feedback, asking questions, promoting good practices, and being an example.
“The best way they [licensees] can influence us [the regulatory body] is feedback on how they
have been regulated.” – Interviewee“It could have a positive impact on the regulatory body if the licensee asks questions […] eager
to understand [the decisions of] the regulator.” – Interviewee
The statements made in the interviews highlighted that frank discussion andcommunication promote understanding, familiarity and trust. An atmosphere of open
exchange enables the licensee to give constructive feedback to the regulator. Such feedback
helps the regulatory body to adapt and improve the regulatory regime and methods. In doing
so, the licensee can foster the learning culture of the regulatory body. By contrast,
inappropriate information or dominant and demanding communication by the licensee
impairs the openness and trust of the regulatory body. Such behaviour by a licensee may leadto a formal, compliance-oriented approach by the regulatory body.

4.2.6. Influence of the licensee’s relationships with the regulatory bodyThrough frequent contacts in meetings as well as during inspections, openness and trust cangrow between the people involved. Such relationship building needs time and space inmeetings or less formal conversation during inspections. Trust built between individuals
radiates out to their colleagues and organisations, and thus contributes to trustful
co-operation between the regulatory body and the licensee that even outlasts the individuals’
terms of service. However, caution and clarity are also necessary so that a good relationship is
not confused with fraternisation.
“Where there’s a good relationship between two people, one in the regulator and one in thelicence holder, you tend to find that there’s a more open and trustworthy dialogue happening.
And as a result of that, there is opportunity to work with each other and help shape outcomes.
But still doing it in a safe and secure way.” – Interviewee
Openness and trust on the side of the licensee leads to openness and trust on the side of
the regulatory body, and vice versa. On the other hand, an arrogant, criticising, oroverconfident attitude by the licensee causes rejecting or distancing behaviour on the part of
the regulator. A licensee withholding information or limiting it to what is explicitly requested
creates mistrust and an increasingly formalistic approach from the regulatory body. Thus,
both sides must pay attention to the relationship so that it is positively strengthened and does
not become a vicious circle of mistrust.
“For our safety culture, it is important that we have a trustful regulatory body that respects our
responsibility for safety. We can foster this trustful relationship by open and timely
communication and by believing in our strength, i.e. that we are good and have nothing to
disguise.” – Interviewee

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RESULTS OF DATA ANALYSIS

A special kind of relationship building is achieved through collaboration in joint efforts.
Interactions between regulatory body and licensee personnel in common activities liketraining events, symposia, committees for technical regulations or joint disaster drills increaseknowledge and promote mutual understanding. Thus, collaboration is a means by which thelicensee influences the regulatory body’s safety culture via improving the competence and thequality of its activities. Through questions and in-depth discussion, the regulatory body's staff
can expand their own knowledge while maintaining a detached, critical approach inaccordance with their oversight function.

4.2.7. Influence of the behaviour of the licensee’s staff
In Section 4.1, it was shown that the behaviour of the regulatory body’s staff exerts a major
influence on the safety culture of the licensee. Conversely, the behaviour of the licensee’s
staff also has an impact on the safety culture of the regulatory body. A questioning attitude,
focus on safety, learning from best practices, and conservative decision making by thelicensee impact the regulatory body’s response and attitudes towards the licensee. Free accessfor the inspector and the possibility to speak to everyone in the plant improvescommunication in a positive way. Openly presenting and not hiding issues and informing theregulatory body about internal discussions and processes increases the regulatory body’s
confidence and trust and allows it to reduce its oversight intensity.
By contrast, a licensee’s poor work and outcomes lead to unnecessary effort or time pressure
on staff in the regulatory body. A rude, obstructive, or aggressive attitude on the part of thelicensee’s staff may lead to a more prescriptive response. When licensee staff repeatedly
undercut requirements, the regulatory body loses faith in them and acts more strictly.
“Secrecy and hiding of problems on the licensee side promotes lack of confidence and suspicion
on the part of the regulatory body, leading to a more prescriptive approach, and creating in theregulatory body a culture of mistrust and antagonism between organisations.” – Interviewee
The way in which licensee staff respond to the regulatory body’s oversight methods andtools impacts directly on the regulatory body’s staff. It may increase trust and reduce theoversight intensity and approach, or it may cause the regulatory body to act more formallyand strictly. Thus, the licensee’s response provides feedback and learning potential for
improving regulatory practices. In reflecting on its regulation and oversight approach, theregulatory body should make sure that single negative cases are not overestimated. In the caseof poor licensee behaviour, the regulatory body may tend towards a more prescriptive
approach. This may cause licensee behaviour that itself is oriented towards solely fulfillingprescription instead of striving to improving safety. Therefore, a special challenge is to avoid
entering a prescriptive compliance spiral, but rather instead to enable the licensee to becomea learning organisation.

4.2.8. Influence of the licensee’s ability to learn and continuously improve
The ability to learn and continuously improve is a key characteristic of a healthy safety culture.
Developments and changes on the licensee’s side challenge and support learning in theregulatory body in order to stay up to date. The methods of self-reflection and self-assessment
to cultivate and improve a questioning attitude, focus on safety, learning from best practices,
conservative decision making, etc., of the licensee form a role model for the regulatory body.
Both the regulatory body and licensee can learn from the practices and experiences of eachother.
“If we create a system to praise and share each other’s good practices regarding safety culture, I
think it will contribute to the nuclear safety culture.” – Interviewee
With its arrangements to learn and continuously improve, the licensee uses insights fromits interactions with the regulatory body to improve its structures, capabilities and processes.
The licensee recognises ways in which to influence the regulatory body’s safety culture, e.g. by
giving feedback, asking questions, and promoting good practices.

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4.2.9. Summary
In this Section 4.2, the ways in which the licensee influences the safety culture of theregulatory body were described. The information from the interviews was structured
according to the same factors as in Section 4.1. The main influences identified were thecommunications, relationships and behaviours between the licensee and the regulatory body.
These have an immediate and direct effect on the regulatory body’s staff, and they affect theregulatory body’s safety culture as well. Of course, it is not only the effect of a single
interaction, but rather the totality of interactions with many individuals from various
licensees that exerts a formative influence on the regulatory body’s safety culture. The
licensee’s capability, its leadership and management, and its contributions to the regulatory
regime build the framework and support the licensee’s interactions with the regulatory body.
They act as enablers of effective and transparent communications, relationships andbehaviours between the licensee and regulatory body. Furthermore, the licensee’s ability tolearn from such interactions determines whether there is a spiral of continuous improvementin the way that it positively affects the safety culture of the regulatory body (Figure 4.2).

Figure 4.2. Summary of the mechanisms of influence of the licensee
on the safety culture of the regulatory body
The following factors (on the part of the licensee)…

Enablers:
1. Regulatory regime
2. Capability of thelicensee
3. Leadership andmanagement of thelicence

Safety cultureof a regulatory
bodyInteractions withregulatory body:
4. Communications
5. Relationships

Safetyculture of alicensee

6. Behaviours… determine the licensee’s influenceon the following elements of the regulatory
body’s safety culture:
•
•
•
•
•
•
•
•
•

Knowledge and understanding of the plant
Priority to safety
Openness, honesty and transparency
Willingness to self-reflect
Motivation to learn and improve
Independence in decision making
Clarity regarding its different roles
Oversight and enforcement methods
Regulatory approach

7. Ability of licensee
to learn and improve

The description of factors and sub-elements above showed how they affect the regulatory
body’s safety culture. These factors affect the depth of the regulatory body’s knowledge andunderstanding of the nuclear installation. Furthermore, they inform priority setting andassigning the necessary attention to safety. They determine the openness, honesty andtransparency of the regulatory body’s interactions and willingness to self-reflect. The
motivation of the regulatory body’s staff to assume accountability and to learn and improve isalso impacted by these factors. In addition, they affect the independence of the regulatory

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RESULTS OF DATA ANALYSIS

body and the clarity regarding its different roles. The influence of these factors on regulatory
oversight and enforcement actions, methods, and approaches is particularly important. This
influence affects how the regulatory body acts in specific situations, the choice of oversightmethods, and the general regulatory approach. The licensee’s influence on the safety cultureof the regulatory body should not be ignored, but instead recognised and addressed so that itenhances and does not degrade the safety culture of the regulatory body. Such a reflected
approach to the mutual influence is a significant component of a system of responsive
regulation that is elaborated in Chapter 5.

4.3. Good practices and lessons learnt in the interactions between the regulatory
body and licensee
As part of the interviews conducted with senior practitioners in regulatory bodies and licensee
organisations, interviewees identified good practices (existing or proposed) and lessons learnt
in effective interactions between their respective organisations. These provide practicalexamples and suggestions for how to conduct such interactions to have a positive mutual
influence on safety culture, and in turn to enhance the effectiveness of the regulatory bodyand the safety performance of the licensee.
Annex C presents these good practices and lessons learnt according to the themes below,
focussing on examples of how the regulatory body and licensee can work collaboratively, intheir mutual interest, while respecting each other’s duties and obligations:•

Regulatory regime;•

Capability;•

Leadership and management;•

Communications;•

Relationships;•

Behaviours; and•Learning and continuous improvement.

Specific examples of good practices and lessons learnt are as follows:
Lesson learnt – An enabling approach to regulation. At a fuel cycle facility, progress with legacy hazard
reduction had slowed, in part due a regulatory approach that was too bureaucratic and conservative. The
regulatory body changed to an “enabling” approach by:(i) Forming a group of senior stakeholder representatives to identify a common safety goal;(ii) Removing unnecessary bureaucracy and giving ownership of risk to the licensee; and(iii) Encouraging innovative, fit-for-purpose solutions to achieve the agreed goal.
The effect of the above was that tangible hazard reduction began at several facilities, with significantly
accelerated work programmes in others.

Good practice – Guidance and examples to promote understanding of regulations. The regulatory body
published a document providing commentary and examples to promote understanding of the safety
regulations. The document covers event reporting and disclosure rules in nuclear power and related facilities.
There are many differences of opinion on this subject, but through the commentary and examples provided,
the difference in understanding between the regulatory body and the operator has been reduced andresolved.

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RESULTS OF DATA ANALYSISGood practice – The role of the resident inspector. Resident inspectors have their own inspection modules
and required activities, but they observe a great deal simply by being on-site. This information can be very
valuable to the licensee’s leadership if the two parties take advantage of the proximity and talk to each other.
It is the daily, routine observation and full view of the station by the resident inspector that makes theirperspective particularly important.

Good practice – Dialogue between the regulatory body and licensee to reflect on their relationship.
The regulatory body and licensee engage in dialogue to reflect on their relationship: (i) regularly, as part offormal interactions, and (ii) sporadically, as part of project work or event follow-up. The regulatory body andlicensee can discuss for example:•

How each party deals with the other and their respective experiences of the relationship;•

How the relationship helps or how it hinders either party;•

What each party values about the other; and•What works well, or not so well, from the licensee’s perspective.

4.4. Challenges in effective interactions between the regulatory body and licensee
Regulatory body and licensee relationships are subject to a number of challenges that impact
their ability to effectively work together and interact in a way that supports safety culture inboth organisations and that guarantees a positive impact on one another, as discussed in theprevious sections. These challenges can derive from the regulatory regime itself; they might be
imposed from the surrounding environment; or they might relate to the regulatory body’s
ability to effectively achieve the right balance in its regulatory role and approach. The
particular challenge has been identified by such researchers as Reiman and Norros (2002),
Bradley (2017), and in the final report of the Ten-Year Investigation Commission on the
Fukushima Nuclear Accident (2021).
The interviews have identified challenges that have been grouped into the three categories
set out below. The first group relates to the characteristics of the regulatory system and theregulatory body and licensee themselves and their interaction (“internal”). The second groupof challenges derives from the external environment (“external”). A third group has been
added, referring to a special type of challenges related to the ability to reach a virtuousbalance between different approaches, forces, or roles (both internal or external) that aregulatory body faces and to which the solution is not always clear or unipolar (“Challenges ofbalance in the regulatory approach”).

4.4.1. Internal challenges
One of the main challenges to a successful interaction between the regulatory body and thelicensee is for the regulatory body to build a clear and predictable regulatory framework (thatwould include rulemaking, an enforcement and sanctions system, expectations, event
notification and reporting rules, among other aspects). The application of the regulatory
framework should take into account the risk and safety significance of issues, as
demonstrated in the regulatory body’s priorities and resource allocation.
The regulatory body’s public role implies a mediation with society on the desired level ofsafety. The regulatory body provides independent scrutiny, on behalf of the public, to ensurethat the industry achieves high standards of safety. To accomplish this, it needs to set therules by which such standards are fulfilled. In order to achieve this goal, the involvement oflicensees and their perspective in the rulemaking is crucial and will help ensure theachievability of the requirements and the willingness and accountability of the licensees tocomply with the rules.

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RESULTS OF DATA ANALYSIS“Regarding regulations, there are some matters that I believe are not clearly stated. Therefore,
the strength of the regulations can change depending on the interpretation of the person in
charge. As operators, we will not be able to trust them very much.” – Interviewee“There is a benefit in understanding the basis for regulatory body decisions and requirements,that helps compliance and willingness to comply. The prescriptive approach can be balancedwith the expert role.” – Interviewee
The relationship between the regulatory body and the licensees needs to be built on thefoundation of mutual trust and respect, enabling adequate communication and fostering thelicensee’s accountability and compliance through understanding and involvement. The
starting point to build such a relationship is a basic positive assumption of the counterpart’s
good intentions and accountability. Attention must be paid to the fact that trust takes time to
be built, but can be easily destroyed, impairing future communication.
“[The most significant challenge to effective interactions between regulatory bodies andlicensees] is having a relationship and establishing trust. When the relationships and trust
work well, amazing things can happen.” – Interviewee“Bad experiences and reputation are also easily preserved for a longer period of time because
the events of history stay alive and in the memories of people, and therefore trust can be lost or
weakened for a longer period of time.” – Interviewee
Interactions between the regulatory body and the licensees are challenged by the need tomaintain and differentiate each other’s role and to ensure independence in decision making,while also keeping open channels (in the exercise of the expert role, as stated by Reiman and
Norros [2002]). There is also the challenge for the regulatory body to understand the impactthat its chosen oversight methods and type of interactions have on licensees and thecapability to use these impacts as tools to strengthen desired behaviours and activities while
avoiding the negative impacts (as stated in previous sections) and encouraging accountability.
“If the oversight approach turns too prescriptive and intrusive, the licensee can diminish the
responsibility for safety that is part of its role, impacting culture: the licensee tries to merelycomply with requirements, and initiative (and even questioning attitude) is reduced.” –Interviewee
Leadership is recognised as a pillar in building culture in the organisation of the licensee
and the regulatory body, and as seen in the previous sections, is also key in the impact of eachorganisation in the safety culture of the other. Thus, building such leadership in eachorganisation is a significant challenge for both parties. This aspect is addressed in depth in the
NEA report Practices for Enhancing Leadership for Safety in Nuclear Regulatory Bodies (NEA,
forthcoming). Moreover, the regulatory body should be able to set the conditions for the licensee
to develop their own leadership for safety and to foster their own accountability for safety.

4.4.2. External challenges
One of the main challenges facing both the regulatory body and licensee is adapting to deal
with an uncertain and changing environment. Examples include announced nuclear power
plant shutdowns, electrical supply challenges, energy policies and priorities, new technologies,
increasing focus on waste management, decommissioning, or even challenges imposed by the
global COVID-19 pandemic and its effects. Thus, the common challenge is to build a resilient
environment to deal effectively with uncertainty and changes, and this may require new
regulatory approaches. Success will necessarily entail a space for collaboration and learningfrom each other.
“The regulatory body can support the development of a mutual understanding concerning
external challenges and changes (phase-out, decommissioning with differences in structures,persons, routines, and priorities) by demanding clear, timely actions, the submission of concepts(e.g. relocation of staff from operation to dismantling not too fast, counteracting the increasing
importance of non-safety-related goals), and by checking the plausibility of these concepts.” –Interviewee

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RESULTS OF DATA ANALYSIS“Where the licensees might be able to help too is technology foresight. So, as other technologies
are coming to the forefront, it might well be that there's more dialogue that can happen there interms of making sure that the regulator has the right level of understanding as to what thesetechnologies are and where some of the challenges could come in.” – Interviewee
Specifically, there is a need for both parties to prepare for and mitigate the impact of staff
turnover due to ageing workforces and changing interest in the nuclear field in somecountries in order to avoid the loss of knowledge and experience. In the process, generationalchange and associated cultural differences must be taken into account to maintaincompetence and effective work relationships. Also, it must be noted that recruitment andworkforce morale might be affected by the energy policy and phase-out decisions in somecountries, and measures to counteract this must be set in place.

4.4.3. Challenges of balance in the regulatory approach
Interactions between the regulatory body and licensee must balance opposing forces andtendencies in order to be effective. They must facilitate open communication and trust
building, even while independence is maintained and each other’s role is differentiated.
Ultimately, the interactions must ensure that the licensee has the chance to develop its
primary accountability for plant safety.
The issue of balancing opposed requirements or approaches is discussed in the literature
reviewed for this report. It is considered especially relevant in the work by Bradley (2017),
Reiman and Norros (2002), and in the report of the Ten-Year Investigation Commission on the
Fukushima Nuclear Accident (2021).
Some of the opposing forces and tendencies that interviewees mentioned are listed below:•

Prescriptive norms vs. licensee’s accountability
As stated above, the regulatory body’s selected methods and approaches to oversighthave an impact on the licensee response and set the basis for particular cultural traits
in the licensee. Safety requirements with a certain degree of prescriptiveness areneeded to lay the foundation and establish a stable framework with predictableconsequences, as stated in the Section 4.4.1. Rules must be clear and broad enough toground the framework, but at the same time allow room for the licensee to exert its
own role. They should avoid unnecessary burdens and unjustified conservatism.
In addition, an “intrusive” regulatory body that over-regulates or oversteps in its
technical decisions and makes decisions that would more properly belong to thelicensee can discourage the licensee’s sense of accountability for safety. Here again, theregulatory body should balance its authority role and expert role in order to be effective.
“If the oversight approach turns too prescriptive and intrusive, the licensee can diminish the
responsibility for safety that is part of its role, impacting culture: the licensee tries to merely comply
with requirements, and initiative (and even questioning attitude) is reduced.” – Interviewee•

Public transparency vs. open communication with the licensee
The transparency and public communication policy of the regulatory body must be set
in a way that does not jeopardise open communication with the licensee. It should
allow for a technical exchange of viewpoints, respect for confidential issues, and trust.
“Particular transparency laws that require disclosure of (almost) all findings and documents by
the regulatory body, although important for public trust building, can also be an obstacle foropen communication between the regulatory bodies and the licensees.” – Interviewee•

Open dialogue with the licensee vs. regulatory body independence
A balance must be sought to allow for an open dialogue between the regulatory bodyand the licensee, while maintaining independence and differentiating each other’s rolein safety. In this endeavour, attention must be paid to the channels used (including the

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level of formality), and the purposes and occasions when each one is used (as stated in
Section 4.1.2).
Creating an environment of trust and respect that enables effective communication
and relationships between the regulatory body and the licensee is a challenge itself, as
stated earlier. When doing so, it is necessary to avoid the risk of regulatory capture,
maintaining independence and a clear focus on each party’s role.
“From a regulator’s point of view, to have too cosy relationship with anybody is not perceived to
be a good thing. On the operator’s side, there’s a concern about, well, if I ask the question, do I
reveal that maybe I don't know as much as I should. How do we get to the situation where we
recognise that sharing knowledge and asking questions is a good thing?” – Interviewee“From the standpoint of regulatory independence, the social atmosphere is shifting toward
reducing the act of meeting with operators and/or stakeholders.” – Interviewee•

Independence from external forces vs. co-operation and co-ordination
The need to preserve the independence of the regulatory body and licensee from external
actors (political, commercial, etc.) should not prevent healthy interaction andcommunication with other stakeholders, facilitating adequate co-ordination and mutual
learning. Independence is a challenge regarding the many factors that can impact – orcreate the impression of impacting – the regulatory body’s independence. In any case, theregulatory body must seek an appropriate balance to maintain independence without
strangling communication channels with the various actors. It must avoid isolation andenable dialogue, thereby staying in contact with the frontline realities.

•

Notification of events vs. counting events
The notification of events and the goal of learning from operating experience should not
be jeopardised by a formalistic focus on event statistics. The emphasis should be onlearning from events rather than counting them. The latter approach could lead to atendency by the licensees to focus on statistics and to minimise the number of reported
events, rather than on continuous improvement and prevention of causal factors.
“Counting reportable events sometimes leads to unnecessary (counterproductive) measures on
the part of the licensee in order to avoid reportable events.” – Interviewee
As seen in the previous sections and in the above statements, each one of the “forces”
that a regulator needs to balance in its performance is interrelated and affected by theothers. Finding the right balance is therefore not a “two factor” equation. Instead, there
are multiple, interacting factors that must be addressed. When considering open
communication and collaboration, for example, it appears that the regulatory bodyneeds to engage the licensees in order to ensure a clear regulatory framework and toencourage accountability. At the same time, the regulatory body needs to maintain an
appropriate distance to differentiate roles, avoid interference in decision making andalso to ensure the licensee’s accountability for safety. In so doing, the regulatory bodymust be able to explain to the public that its independence is maintained, thus
avoiding a loss of trust on the part of the public.
When examining regulatory approaches, similar interrelations and balances arise.
Fewer prescriptive norms allow room for dialogue and licensee accountability in its
methods for achieving safety, but can also lead to an unclear framework. Overly
prescriptive frameworks, for their part, can reduce the licensee’s perception of theirown accountability. There is no rule of thumb for setting the level and appropriatebalance between the different factors and their impact. Each should be analysed caseby-case, taking into account each country’s unique context and culture; the safety
culture maturity of both the regulatory body and licensee; and the requirements
imposed by the legislative framework and the public. At the same time, the framework
should allow for open dialogue and collaboration.

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4.5. Summary of findings
4.5.1. Main findings – descriptive view
The preceding sections have identified the principal factors and mechanisms by which theregulatory body and licensee influence each other’s safety cultures. These form the“descriptive” view of this report’s findings – i.e. without a judgement on whether the influenceis a positive or negative one – and are presented in Figure 4.3. At the heart of this model are
the communications, relationships and behaviours that characterise the interactions between
the two entities. These provide the means by which each organisation influences the safety
culture of the other.
In turn, the interactions between the two entities are influenced by the regulatory regime(comprising the system of legislation and standards, roles and responsibilities, regulatory
approach etc.) and the capability, leadership and management of each organisation. Finally,
the ability of each organisation to learn and improve from their interactions acts as a “shaping”
factor, determining whether the influence on safety culture has a positive (upward) or
negative (downward) trend (the “normative” view as explained in Section 4.5.2). Figure 4.3
provides further detail about the elements that make up each of these factors.
The text boxes below illustrate some of the specific mechanisms of influence as anindication of the different “paths” through Figure 4.3:
The influence of the regulatory body’s decision making on the safety culture of the licensee
The objectivity, predictability, transparency, and timeliness of the regulatory body’s decision-making
influence the level of openness, trust, and respect of the licensee towards the regulatory body. This in turninfluences the licensee’s commitment to making safety improvements.

The influence of the regulatory framework, specifically the balance of outcome-based andprescriptive elements, on the safety culture of the licensee
The way in which the regulatory body balances the outcome-based and prescriptive elements of its
approach influences the nature of the dialogue between the two entities, the licensee’s sense ofaccountability for safety, and ultimately its safety culture. On the one hand, the regulatory body’s need toensure explicit requirements and a consistent approach lends itself towards a prescriptive approach. On theother hand, freedom for the licensee to explore alternative means of achieving the same, or higher, levels ofsafety would tend the regulatory body towards outcome-based approach.

The influence of the licensee’s capability on the safety culture of the regulatory body
The licensee’s level of knowledge and experience influences the regulatory body’s understanding of thelicensee’s technology and associated safety issues. This in turn influences the regulatory body’s activities,
priorities, and decision making. The licensee’s competence also influences the regulatory body’s level ofrespect and trust in the licensee and the depth and intensity of its oversight.

The influence of the licensee’s provision of information on the regulatory body’s safety culture
The quality and timeliness of the information provided by the licensee influences the regulatory body’s
workload, way of working, and the level of trust in the relationship. This may in turn influence the quality ofsafety decision making by the regulatory body and the ability of both entities to work through difficult
situations.

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4.5.2. Main findings – normative view
From the interviews conducted in this study, a consistent picture emerges of what constitutes
an effective interaction between the regulatory body and licensee and results in a positive
influence on each organisation’s safety culture. This forms the “normative” view of thisreport’s findings – i.e. “what good looks like” – and is shown in Figure 4.4 below. It reflects a
consistent view given by interviewees from both regulatory bodies and licensee organisations,and across the 13 participating countries.
The picture that emerges is of a reciprocal, co-operative style of interaction, characterised
by respect, openness, and trust, with a shared focus on safety and learning. This promotes thelicensee’s sense of accountability for safety and willingness to “self-regulate” throughenhanced self-awareness and corresponding improvement action. It drives a focus on safe
outcomes, e.g. safe operation, technical improvements, and staff competence, beyond merecompliance with regulations. Within this model, the regulatory body’s approach seeks tofoster the licensee’s accountability for safety, enabling continuous improvement and growthof the licensee’s safety culture towards higher maturity levels. This approach has been termed“accountability-oriented, enabling regulation” (AER). It builds on the concept of performance(or outcome) based regulation, but also includes a focus on risk (or hazard), processes, andself-assessment by the licensee (see Box 4.1 below). However, the regulatory body retains theability to adapt its approach towards a more prescriptive style according to the circumstances.
The interview data also points to approaches that clearly contribute to ineffective
interactions between the regulatory body and licensee. These are shown in an equivalent
figure in Annex D. Factors such as inadequate clarity or consistency in applying the regulatory
framework, or insufficient preparedness by the licensee for interactions with the regulatory
body can lead to mistrust and a lack of openness in the relationship. This may becompounded by the inability of each party to learn from their interactions and may lead to adownward spiral in the safety culture of both organisations.
Compared to studies carried out in other sectors (Bradley, 2017), the model (see Figure 4.3)
that emerges from this study has a stronger focus on the communications, relationships andbehaviours between the regulatory body and licensee. This is not surprising given the rigorous
licensing, inspection and authorisation regime that operates in the nuclear sector worldwide,
which necessitates a close working relationship between the regulatory body and licensee andnumerous contacts between their respective staff. In such circumstances, one organisation
will as a matter of course have an influence on the culture of the other.

4.5.3. Good practices and lessons learnt
The interview data highlighted several good practices and lessons learnt that underpin themodel set out in Figure 4.4. For instance, several examples were given of the means by which
regulatory bodies can collaborate with licensees in areas of mutual interest such as training,
standards, research, and emergency preparedness. These enhance the relationships and trust
between the two organisations, contributing to effective interactions on core regulatory
matters. Another example of a lesson learnt that emerged from one interview concerned theimplementation of an “enabling” approach to regulation. This places accountability firmly
with the licensee and focuses on fit-for-purpose solutions to deliver priority outcomes.

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responsibilities,
accountabilities andauthorities assigned to
the regulatory bodyand how they are
respected by thelicensee• The licensee’s prime
responsibility for safety
and how it isdischarged

The regulatory regime• The quality and timeliness of
information provided by thelicensee• The maturity of the licensee’sinternal assurance processes• The licensee’s structures andprocesses for interacting with theregulatory body

• The example set by leaders in thelicensee through their behaviours,
actions and decisions.

The leadership and management of
the licensee

7. The licensee’s ability tolearn and improve

7. The regulatory body’s
ability to learn andimprove

These factors determine the regulatory body’s
influence on the licensee’s safety culture, e.g.,
its: sense of accountability for safety; priority
to safety; motivation to comply and improve

Safety culture of a licensee

C. … and in turn are
shaped by:

6. The behaviours of staff and theextent to which they demonstrate
the value of safety

5. The quality of the relationship, e.g.
level of trust, respect and openness

4. The format, characteristics andcontent of communications

C. … and in turn are
shaped by:

These factors determine the licensee’s influenceon the regulatory body’s safety culture, e.g., its:
knowledge and understanding; regulatory
approach and priorities; openness to learningand improvement

3. The leadership and managementof the licensee

2. The capability of the licensee

2. The capability of the regulatorybody

3. The leadership and managementof the regulatory body

1. The regulatory regime

A. The following enablers …

• The competenceof staff in thelicensee (technical/regulatory/
behavioural)

The capability of
the licensee

1. The regulatory regime

B. … influence the nature ofinteractions between theregulatory body and licensee …

• The regulatory body’s
management system and theextent to which it drives asystematic, graded approach• The example set by leadersin the regulatory bodythrough their decisions,actions and behaviours

The leadership andmanagement of theregulatory body

A. The following enablers …

• The regulatory body’s
resources and how theyalign to its priorities• The competence of staff
in the regulatory body(technical/regulatory/
behavioural)

The capability of theregulatory body

Safety culture of a regulatory body

• The regulatory body’s
choice of oversightmethods and tools• The regulatory body’s
decision-making processes
and their application• The regulatory body’s
priorities and how they are set• The degree of
independence of theregulatory body(political/technical)• The roles, responsibilities,
accountabilities andauthorities assigned to theregulatory body and how
they are enacted• The regulatory framework its design, development andimplementation, including
the balance of prescriptive
and outcome-based elements

The regulatory regime

RESULTS OF DATA ANALYSIS

Figure 4.3. The factors and mechanisms by which regulatory bodies
and licensees influence their respective safety cultures

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• The regulatory balances
formal inspection andassessment with lessformal dialogue

Learning andimprovement

Safety cultureof a regulatory body

Leadership and managementof regulatory body

Capability of regulatory body

Regulatory regime

National/international bodies

The regulatory body and licensee learn fromtheir interactions and from the experience ofthird parties to continually improve

Interactions between theregulatory body and licensee:
There are regular, two-way, formal andless formal communications at all levels
covering: expectations and constraints; pointsof view and feedback; plans and priorities;
decisions and supporting rationale; business
context and background
Relationships are based on a shared goal ofsafety and are characterised by trust,
professionalism, fairness, respect, a questioning
attitude, openness and honesty
Behaviours demonstrate safety as a corevalue and respect the responsibilities
and accountabilities ofeach party

The regulatory body and licensee identify
and act on opportunities to collaborate witheach other and with third parties, e.g., onstandards, research and training• The licensee
supports theregulatory body’stasks and roles andaccepts its
independence• The licensee
demonstrates
ownership andaccountability forsafetyRegulatory regime• The regulatory body’s decision
making is objective, fair,transparent and informed with
due priority to safety• The regulatory bodymaintains a management
system aligned to goodpractice andimplemented following a
graded approach• Leaders in theregulatory body create apositive work
environment with ashared focus on safety

Leadership andmanagement of theregulatory body

National/international bodies
Enablers• The regulatory bodyis well-resourced withstaff who arecompetent(technical/regulatory/
behavioural)

Capability of regulatory
body• The regulatory body prioritises
its activities based on risk andperformance• The regulatory body has a suitable range
of enforcement powers but balances its“policing” role with a “coaching” role

• The regulatory body has clear
accountability to the public but is
independent (politically and technically)
and coordinates with other regulatory
bodies• The regulatory framework is clear,comprehensive and predictable,consistently interpreted and applied, andweighted towards an outcome-based
approach

The regulatory regime

Enablers• The licensee has strong internal
assurance and peer review processes• The licensee provides timely, highquality information• The licensee has clear structures andwell-established processes for interaction
with the regulatory body• Leaders in the licensee demonstrate
due priority to safety in their
behaviours, actions and decisions

Leadership and managementof the licensee

Learning andimprovement

Safety cultureof a licensee

Leadership and managementof licensee

Capability of licensee

Regulatory regime• The licensee’s
staff arecompetent(technical/
regulatory/
behavioural)

Capability oflicensee

RESULTS OF DATA ANALYSIS

Figure 4.4. A model of effective interactions between the regulatory body and licensee:
How each can positively influence the safety culture of the other

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4.5.4. Challenges
The interview data illuminated common challenges to achieving effective interactions
between the regulatory body and licensee. The regulatory body and licensee both face theissue of maintaining a relationship based on mutual trust and respect. Other challenges
include achieving a clear and predictable regulatory framework, and fulfilling short- and longterm term needs with existing scarce personnel resources. There are also specific issues forthe regulatory body to address. These include, for example, preserving its independence on
the one hand, while also maintaining openness with the licensee (and other stakeholders) on
the other and in balancing prescriptive and outcome-based approaches in its regulatory
framework. In sum, these challenges taken together highlight that there is further work to do
if regulatory bodies and licensees are to move towards and sustain a co-operative style ofinteraction, based on accountability-oriented, enabling regulation.

Box 4.1. Accountability-oriented, enabling regulation (AER)
An “accountability-oriented, enabling” regulatory approach (in contrast to a “prescriptive” approach) as
advocated in this report is an approach to regulation that respects the prime responsibility, or
accountability, 1 of the licensee. It aims to strengthen its motivation and ability to act and operate its nuclear
installations according to this accountability, thereby enabling continuous improvement and growth of thelicensee’s safety culture towards higher maturity levels (e.g. SM ICG, 2019). The term “accountability” is used
to make clear that it is not merely a matter of the licensee formally assuming its legal responsibility, but thatthe regulatory body acts in a way that enables the licensee to demonstrate its accountability for safety.
In the literature and in the policies and practices of some regulatory bodies, a “performance-based”
regulatory approach is often advocated when seeking ways that are better suited to foster the accountabilityof regulated organisations than a prescriptive approach (e.g. Wilpert, 2008). The term “performanceoriented/based” is usually used as a synonym for “goal” or “outcome” based. This means that the regulatory
body formulates its expectations and requirements in the form of goals or expected outcomes and assesses
the “performance” of the licensee in fulfilling them, leaving the approach and methods used to reach thegoals within the responsibility of the licensee (see IAEA, 2020a; Wilpert, 2008). In the taxonomy of regulatory
approaches found in two studies commissioned by the Swedish nuclear regulatory body (Melber & Durbin,
2005; Durbin, 2013; cf. also NEA, 2014), this understanding corresponds to the “outcome-based” strategy
that “(e)stablishes specific performance goals or outcomes for licensees to attain but does not specify how
they shall be attained. Licensees determine how they will conduct their work activities” (Durbin, 2013:127).
One difficulty of such an approach to oversight, however, is to define suitable goals and outcomes as well assuitable indicators to assess their achievement (see Melber et al., 2005; Durbin, 2013; Dandy, 2019). For
instance, it is important that the fulfilment of the goals is not only assessed in a reactive manner, waiting until
something (usually undesirable) has happened (see Melber et al., 2005) (using “lagging indicators”), but also
in a proactive way, identifying precursors and trends at an early stage as well as necessary capabilities andskills (using “leading indicators”). On the other hand, the fact that goals have been successfully achieved interms of outcomes does not necessarily imply that the way they have been achieved can be judged as safe
and as demonstrating a healthy safety culture on the part of the licensee. Often, flawed processes andpractices do not translate immediately into corresponding negative outcomes. For example, a deteriorationin training and qualifications of staff is not necessarily directly visible in terms of safety-related outcomes.
Instead, it can take a quite long time before the “safety performance” of the installation and the organisation
starts to decline and negative results become visible (see Melber et al., 2005).

1.

Prime responsibility for safety is the term often used in international standards, e.g. NEA (2016) and
IAEA (2016c). In this report, accountability is used as a synonym for prime responsibility, emphasisingthat the licensee is answerable for the desired outcome (safety), not just for compliance with the law.

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For this reason, in a regulatory approach oriented towards strengthening the accountability of the regulatedorganisations, outcome-based regulation needs to be complemented by “process-based” regulation,
defined in the Swedish study as a regulatory strategy that “identifies specific key processes that lead to safe
performance and requires licensees to establish and implement these processes effectively” (Durbin,
2013: 127). The term “performance” in its strictest sense primarily refers to the act of doing something or to
how well an activity is done (OED, 2005) rather than to the result of the activity. This means that theregulatory body in its oversight activities should also focus on how (well) the licensees manage safety, i.e. on
the processes they establish (including their implementation in daily practice, “work-as-done”) in order toensure the safe operation of their nuclear installations and to continuously improve safety and foster theirsafety culture. Yet in doing so, the regulatory body should avoid taking over the accountability from thelicensee by dictating the details of the processes and their implementation in a prescriptive manner. Rather,
the regulatory body should take care to maintain the spirit of the accountability-oriented, enabling approachin terms of supporting and fostering the licensee’s accountability by formulating its expectations andrequirements in a non-prescriptive manner.
A further regulatory approach identified by the Swedish studies (Melber et al, 2005; Durbin, 2013) is one
characterised by strengthening the licensee’s accountability for safety, namely the “self-assessment based”
approach that “identifies both good practices and problem areas needing improvement, internal reviews
and follow up. The regulator evaluates the licensee self-assessment programme, reviews the result of thelicensee assessments, and selectively inspects the licensees’ follow up on self-assessment results” (Durbin,
2013: 127). This approach appears to be well-aligned with an accountability-oriented, enabling regulatory
strategy.
Finally, an accountability-oriented, enabling regulatory approach also implies a focus on risks and hazards
and a risk consciousness by the regulatory body. This is in contract to the compliance or checklist mentality
associated with a primarily prescriptive approach (see Brandley, 2017). When directing its attention anddeploying its resources in oversight activities and requirements addressed to the licensee, the regulatory
body’s focus and priorities in turn directly impact the focus and deployment of resources on the side of thelicensee as well as its attitude towards risk management (Bradley, 2017). As an element of an accountabilityoriented, enabling regulatory approach, licensees need to “demonstrate an understanding of their risks andthe regulator should be investigating how they know this intelligence is accurate, how the (licensee) deals
with these risks, and how the (licensee) ensures those efforts are effective” (Bradley, 2017: 50). Therefore, the“risk/hazard-based approach” as described in the Swedish studies (Melber et al., 2005, Durbin, 2013) can beconsidered an element of an accountability-oriented, enabling approach. It is also important to remainsensitive to the danger that neither the licensee nor the regulatory body may pay enough attention to someissues if the focus is only on quantifiable risks. Therefore, “risks” should be considered as only one of several
important perspectives that inform oversight (Melber et al., 2005, Durbin, 2013).
In summary, an accountability-oriented, enabling regulatory approach can be defined as a combination ofvarious regulatory approaches. In the terminology of Melber et al. (2005), Durbin (2013), and the NEA (2014),
this combination includes the “outcome-based”, “process-based”, and “self-assessment-based” approaches.
AER also encompasses elements of the “risk/hazard-based” approach. It aims primarily at strengthening thelicensee’s accountability for safety and enabling the latter to continuously improve safety and to further
develop its safety culture according to its own initiative and motivation. The AER regulatory approach ischaracterised by a low degree of prescriptiveness in regulations and oversight activities. It is built on effective
relationships between the regulatory body and licensee, which are in turn based on constructive
co-operation, dialogue, and trust, as well as on mutual respect and acknowledgement of the respective roles
and responsibilities of each entity.

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Chapter 5. Discussion

The objective of the study discussed in this report is (1) to understand how regulatory bodies
impact the organisations they oversee (and vice versa) from a safety culture perspective; and(2) to share good practice and learning on how regulators can ensure that these impacts are
positive, avoid negative impacts, and support the achievement of safety objectives (See
Chapter 2). As is stated in The Safety Culture of an Effective Nuclear Regulatory Body (NEA, 2016)
and Methods for Assessing and Strengthening the Safety Culture of the Regulatory Body (NEA, 2021),
the regulatory bodies, by nature of their role, deeply influence the safety culture and the safetyof the organisations they regulate and oversee. Based on their regulatory strategy, the way
they carry out their daily oversight work, the type of relationship they cultivate with licensees,
the values they convey, and the importance they give to safety, regulatory bodies profoundly
impact the licensees’ safety culture, their sense of accountability for safety and, by extension,
the safety of their installations. Although this assumption might seem obvious and confirmedby the daily experience of the staff of regulatory bodies, not much literature and research areavailable addressing this topic in general, let alone in the nuclear industry (see Section 3.1).
Even less corroborated knowledge is available on the way the licensees for their part impact
the safety culture of the regulatory body.
The NEA, through its Working Group on Leadership and Safety Culture (WGLSC), therefore
decided to conduct a study to help fill this gap in order to better understand the nature of this
impact, i.e. through which mechanisms the regulatory body influences the safety culture of
the organisations it oversees and vice versa, and what the findings entail for the improvement
and further development of regulatory strategies and methods to ensure that the safety
culture of both licensees and regulatory bodies and hence the safety of nuclear installations
can be further improved. In the following sections, the findings of the study are discussed andconclusions are drawn.

5.1. Factors and mechanisms of influence
A very broad and differentiated set of factors and mechanisms of influence emerges from thestudy, showing that there is no easy and simple answer to the question of how the regulatory
bodies and licensees impact each other from a safety culture perspective. The following
mechanisms were identified (See Figure 4.3) by which the regulatory body and licensee influencesafety culture, comprising:•Enablers – the regulatory regime and the capability, leadership, and management ofeach party;

which influence•

the nature of interactions between the two organisations, i.e. the quality ofcommunications, relationships, and behaviours;

and in turn are shaped by•each party’s ability to learn and improve from their interactions.

By these means, the regulatory body influences, for example, the licensee’s sense ofaccountability for and priority placed on safety. In turn, the licensee influences, for example,
the regulatory body’s knowledge and understanding of the licensee’s activities and its
regulatory approach and priorities. The identified factors and mechanisms of influence were

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substantiated by the interviewees with concrete examples from their experience andunderstanding. Thus, the descriptive model (Figure 4.3) also resulted in a normative model of
effective interactions between the regulatory body and licensee, depicting how each canpositively influence the safety culture of the other (Figure 4.4).

5.2. The mutual nature of the impact of the regulatory body and licensee on eachother’s safety cultures and the need for a systemic view
While the factors and mechanisms by which the regulatory body influences the safety cultureof the licensees were relatively easily recognised and described by the interviewees, theidentification of the factors of influence of the licensees on the safety culture of the regulatory
body turned out to be more challenging. Nevertheless, a number of factors emerged from theinterviews that are based on the same basic mechanisms of influence identified for the
regulatory body (see Section 4.2). These show that the issue of the impact on safety culture isby no means unidirectional from the regulatory bodies to the licensees, but that a systemic
view considering the mutual impact of the regulatory body and the licensee must be applied.
The data from the study show that the influence of the licensee on the safety culture of
the regulatory body happens in both direct and indirect ways. This is one possible reason forthe difficulty experienced by the interviewees in identifying the factors and mechanisms ofinfluence by the licensees on the regulatory body. On the one hand, the licensees directly
influence the regulatory body in a relatively easily recognisable way as their performance
impacts the regulatory body’s oversight approach and its priorities. There is also a subtler andless visible influence, based on the “informal power” that the licensee can exert on theregulatory body. Examples include the licensee’s ability to control to some extent its degree of
openness and transparency and its proactive or restrictive information practice vis-à-vis theregulatory body.
On the other hand, the licensees can have an indirect impact on the safety culture of theregulatory body via third parties. Indeed, as is posited by Bradley (2017) and supported by thedata of the present study, the performance of the licensees also has an impact on external
stakeholders, e.g. governments, media, non-governmental organisations etc. These actors inturn can have an impact on the regulatory body, e.g. via funding, public or media pressure, etc.
Bradley (2017) concludes that…collectively, industry and other external parties affect the nature and character ofthe regulator by their actions (or inaction). The regulator seeks legitimacy andresourcing within this environment and adapts, as it deems appropriate, to maintaininstitutional credibility” (Bradley, 2017: 98).
She identified specific attributes of the regulatory body and its approach, such as theselected regulatory approach (prescriptive or performance-based), the type of oversight
instruments typically applied, the enforcement approach, the degree of political independence,the degree of technical competence, etc. “These aspects are in fact outputs of the broader
institutional environment and regulatory system, but they become regulatory inputs into theregulator’s safety (oversight) culture” (Bradley, 2017: 98). The data collected for the present
study supports these findings that not only the regulatory body impacts the licensees’ safety
culture, but also that its own safety culture is for its part impacted by the licensees and thewider interconnected system, as was postulated in The Safety Culture of an Effective Nuclear
Regulatory Body (NEA, 2016).
As a consequence, it is important that regulatory bodies are aware of this complex web ofinterrelationships and mutual impact in the wider interconnected system. Regulatory bodies
should therefore adapt their methods and regulatory approaches accordingly.

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5.3. The need to move towards an accountability-oriented, enabling regulatory
approach
As was explained above, a remarkable consensus can be seen in the views of the intervieweesfrom all over the world towards the need to develop regulatory approaches and interactions
that are more accountability-oriented, enabling, and co-operative (as opposed to prescriptive),or at least an integration of more accountability-oriented and enabling elements into theoverall regulatory approach. This implies a regulatory approach that aims to support thelicensee’s accountability and to enable the licensee to act and operate its nuclear installations
according to this accountability. This would thereby promote continuous improvement andgrowth of the licensee’s safety culture towards higher maturity levels (SM ICG, 2019) (seeBox 4.1). This need to develop further regulatory approaches towards accountability-oriented,
enabling approaches advocated by the interviewees is consistent with the shift that has been
observed in the last decades in the regulatory approaches in different industries (see Leistikow& Bal, 2020; Rorie, 2015) and on recent developments of new models of regulation that situate
co-operation between stakeholders at their core (e.g. outcome-based co-operative regulation,
see Hodges, 2022, 2023).
Similarly, in recent years increasing focus has been laid on the concept and principles of“high reliability organisations” (HRO) (e.g. Weick & Sutcliffe, 2015) and the need to foster
resilience in organisations that deal with high risks and hazards. For example, this entails
enhancing their ability to cope with and to (proactively) adapt to changing environments andboundary conditions as well as to respond flexibly and competently to occurring events while
maintaining control of the situation; or swiftly regaining temporarily reduced control byadjusting performance to the conditions as they arise and change (see e.g. Hollnagel, 2018).
The idea of organisational resilience itself has evolved over time as well, towards a more
integrative understanding of the concept. Resilience does not focus only on the “negative”,
i.e. on unwanted events and situations, but also includes the “positive”, i.e. the organisation’s
ability to seize and adapt to opportunities and allow for improvement and innovation(e.g. Macrae & Wiig, 2019). Such an encompassing concept of resilience is based on anunderstanding of safety that in the safety sciences is often referred to as “Safety-II”, as opposedto the traditional understanding of “Safety-I” (see Hollnagel, 2014; ENSI, 2021) 1. Accordingly,
regulatory bodies need oversight approaches that foster resilience and “Safety-II”-oriented
approaches to safety management in licensee organisations.
The literature on resilience and “Safety-II” (e.g. ENSI, 2021 for an overview) stresses theneed for regulatory approaches going beyond mere compliance-driven oversight to an
approach based on dialogue and trust. This also entails an understanding of the way thatlicensee organisations function on a day-to-day basis, and of the situational and contextual
factors that influence daily operations. In sum, the characteristics of a suitable regulatory
approach that fosters resilience and the “Safety-II” perspective that are discussed in theliterature are consistent with the accountability-oriented, enabling regulatory approach as
described in this report 2.

1.

Stated in simple terms, Safety-I focuses on things that go wrong and on “work-as-imagined”, i.e. on
assumptions and expectations about how work should be carried out as stated, for example, in work
plans, procedures and processes in the management system, and aims at strengthening compliance.
Safety-II, on the other hand, focuses also on things that go right and on “work-as-done”, i.e. on theway in which work is actually carried out under the conditions and circumstances of the realsituation, and aims at strengthening resilience (cf. Leistikow & Bal, 2020).

2.

Several further conceptualisations can be found in the literature. They all describe similar regulatory
approaches with similar aims and methodologies, albeit each with a somehow different focus andwording. For example, besides the above-mentioned organisational resilience and “Safety-II”, thesemight include complex systems and drift into failure, trustworthiness, and co-operation. These can beapplied to the conceptualisation of accountability-oriented, enabling regulation as discussed in thisreport (e.g. Bradley, 2017; Leistikow & Bal, 2020; Wiig, Aase & Bal, 2019; COFSOH, 2019; Dekker, 2011;
Hodges, 2022); for an overview on different conceptualisations also see ENSI (2021).

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5.4. The need for specific oversight methods to support accountability-oriented,
enabling regulation
Implementing an accountability-oriented, enabling regulatory approach that strengthens theaccountability and adaptability of the licensees calls for a co-operative relationship between
the regulatory body and the licensee organisations based on dialogue and trust. It requires
developing and using specific oversight methods that aim at both ascertaining that thelicensees are effectively upholding their accountability and at the same time at fostering theirsense of accountability. Such methods differ from traditional methods, such as formalised
inspections in which the regulatory body focuses on searching for deviations and noncompliances on the side of the licensee. Instead, accountability-oriented, enabling methods
concentrate on an open, respectful and trustful relationship and intensive dialogue between
the regulatory body and the licensee. They aim to foster self-reflection within the licensee
organisation. The licensees thereby need to demonstrate to the regulatory body that they “dothe right thing”, i.e. that they are “trustworthy” (Hodges, 2022).
Such an approach and the corresponding methods place high demands on the staff of theregulatory body. In particular, a high degree of technical and social competence and the ability
for self-reflection and learning on the side of regulatory staff are paramount (e.g. COFSOH, 2019).

5.5. The need to balance different regulatory goals and approaches while
maintaining the trust of the public
The present study clearly demonstrates the need for regulatory bodies to balance different goals
and approaches in their oversight of licensees and in their interactions with them as well aswith the other stakeholders towards whom they are accountable (e.g. the public). For example,
the regulatory body needs to strike a balance between prescriptive and accountability-oriented,
enabling regulation, between formal (e.g. inspection) and less formal (e.g. dialogue-based)
methods, between its different roles, e.g. the “policing” and the “coaching” role, and between
open dialogue with the licensee and maintaining independence of the regulatory body. Suchbalances are necessary for different reasons. On the one hand, the regulatory body not onlyinteracts with the licensees in its daily activities but is also accountable to the public in its“public” role. The results of the study suggest that many of the interviewees assume that the“policing role”, based on a prescriptive approach, can generate greater public trust in theregulatory body’s work due to the greater visibility of regulatory outputs and ultimately greaterpublic trust in the safety of nuclear installations.
On the other hand, the study supports the view that an accountability-oriented, enabling
approach produces better safety outcomes compared to a primarily prescriptive approach. In
particular, the former fosters the licensee’s accountability for the safety of its installations, while
the latter tends to transfer accountability to the regulatory body. The accountability-oriented,
enabling approach is also more suited to the complex environment that characterises thenuclear sector, i.e. complex combinations of technology, people, and organisations in a complex
environment where cause and effect are difficult to predict, and the development oforganisational resilience is imperative. It seems therefore of crucial importance for regulatory
bodies to engage in and find ways to explain to the public the benefits of such accountabilityoriented, enabling oversight approaches for safety and safety culture so that both public trustand safety can be enhanced. This would obviate the need for a prescriptive regulatory approachby the regulatory body to demonstrate its effectiveness towards the public.

5.6. The need to adapt the regulatory approach based on the licensee’s
performance and safety culture maturity level
The option to use prescriptive oversight methods and measures remains important for the
regulatory body despite a need and tendency to develop further their approaches towards
more accountability-oriented, enabling oversight. In fact, regulatory bodies need to be able to54

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adapt their oversight approach depending on the situation at hand (e.g. safety performance ofa licensee, incidents, developments in the markets, etc.). This may include using different
oversight approaches for different licensees. This would be based on the licensees’
demonstrated capability and willingness to effectively carry their accountability and to act in aself-reliant and trustworthy way to comply with the safety requirements, i.e. based on thematurity level of their safety culture (e.g. Hudson, 2007; SM ICG, 2019).
For example, a licensee might demonstrate a lower level of safety culture maturity by acting
only in a reactive manner to external inputs such as measures resulting from incidents, formal
requirements from the regulatory body, or the rules from the regulatory framework. In such acase, an accountability-oriented, enabling approach by the regulatory body requiring a highdegree of proactivity and a general sense of accountability by the licensee might not (yet) beappropriate. Instead, the situation might require a more prescriptive oversight approach. On thecontrary, if a licensee demonstrates a high level of cultural maturity and trustworthiness, thenan accountability-oriented, enabling approach is best suited and even necessary. In this case,prescriptive oversight may inhibit the licensee’s sense of accountability and impair its
motivation to further strive for continuous improvement (see SM ICG, 2019).

5.7. The need for a high level of safety culture maturity in the regulatory body
Notwithstanding the possibly different maturity levels of licensees, the aim of the regulatory
body should always be to foster the growth of the licensees towards higher cultural maturity
levels (SM ICG, 2019) that allow for continuous safety improvement in the nuclear industry.
This endeavour has in itself important implications for the regulatory bodies as well, as it
requires them to demonstrate high levels of cultural maturity themselves. A regulatory bodywith a low level of safety culture maturity will more likely practice a traditional, prescriptive
oversight approach, eventually hindering the further development of the safety culture in theentire nuclear industry of its country.
Therefore, the regulatory body must itself be highly reflexive (see Rutz, 2017). This means,for example, that it must be able to accept and deal with uncertainty and to adapt its oversightmethods accordingly. It must also be willing to continuously learn through a “…continuous
process of self-observation and self-critique” (Rutz, 2017: 151). In Reiman and Norros’ model ofbalancing the different roles of regulatory bodies, this requires a strong “expert role”, which ischaracterised by dialogue, co-operation, self-criticism. and reflectivity (Reiman & Norros, 2002).
In this “expert role”, the regulatory body sets high expectations concerning the technical andregulatory competence of its own staff.

5.8. The need for responsive regulation
The present study has identified the necessity for the regulatory body to advance its oversightapproaches towards a more accountability-oriented, enabling oversight while at the sametime preserving the option and ability to adapt its regulatory approach to unfolding situations
and to the safety culture level of licensees. This agility is at the core of the concept of“responsive regulation” (e.g. van der Heijden, 2020; Healy & Braithwaite, 2006). “Responsive
regulation” implies that there is no one specific approach to oversight that fits all licensees at
all times and in all situations, but rather that oversight needs to be adapted over timedepending on the performance and the culture of a specific licensee.
Responsive regulation is generally illustrated in the form of an escalation pyramid (often
called the “enforcement pyramid” or “regulation pyramid”) (e.g. Wood, et. al., 2010; Wood et al,2015; Ivec & Braithwaite, 2015). At the bottom of the pyramid is the oversight approach basedon self-regulation, persuasion, and voluntary compliance (i.e. an accountability-oriented,
enabling approach). The pyramid ladders upwards through different escalation levels. Strong
sanctions and a strictly prescriptive approach appear at the top of the pyramid as “ultima
ratio”, should all the milder and less intrusive regulatory actions in the lower levels of the

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escalation ladder be ineffective (Ivec & Braithwaite, 2015). Moreover, de-escalation down the
pyramid should be sought at first opportunity (Ivec & Braithwaite, 2015).
The concept of responsive regulation appears to be well suited to integrate the insights thatemerged from the present study and to serve as a foundation upon which to develop further the
nuclear industry’s oversight approaches. It seems therefore sensible to explore to a greater
extent if and how a responsive regulation pyramid could be developed for the nuclear industry.
Any such model should be accompanied by methods and tools for regulatory bodies to help
them advance their oversight towards more accountability-oriented, enabling approaches whileat the same time enabling them to find and sustain the right balance between different
requirements such as the safety performance or the cultural maturity level of licensees, thespecificities of different countries’ regulatory frameworks 3, the level of confidence and the
expectations of stakeholders in the regulatory body, as well as the national cultural context.

3.

56

E.g. the IAEA in Functions and Processes of the Regulatory Body for Safety argue that “The degree to which
the regulations are performance based or prescriptive, and the level of detail in the associatedguidance, will depend on the national approach; however, this should not reduce the authorised
party’s prime responsibility for safety” (IAEA, 2018: 11).

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CONCLUSIONS

Chapter 6. Conclusions

The current study explores interactions between the regulatory body and licensee andidentified the factors and mechanisms by which each organisation influences the safety
culture of the other. The main factors are the communications, relationships, and behavioursof staff at the interface between the two organisations. These influence on the one hand thelicensee’s sense of accountability for safety, and on the other the regulatory body’s approachand priorities. The communications, relationships, and behaviours of staff in the twoorganisations are in turn influenced by the regulatory regime, i.e. the regulatory framework,
roles and responsibilities, regulatory approach, etc., and the capability, leadership, andmanagement of each organisation. Finally, each organisation’s ability to learn from its
interactions and from others determines whether the influence on safety culture has apositive (upward) or negative (downward) trend.
A clear picture emerges from the study of the nature of the interaction between theregulatory body and licensee that produces a positive effect on each organisation’s safety culture.
This is a reciprocal, co-operative style of interaction, characterised by respect, openness, andtrust, with a shared focus on safety and learning. This promotes the licensee’s sense ofaccountability for safety and willingness to “self-regulate” through enhanced self-awareness andcorresponding improvement action. It drives a focus on safe outcomes, beyond mere compliancewith regulations. Within this model the regulatory body adopts an accountability-oriented,
enabling approach to regulation, but with the ability to adapt its approach towards a moreprescriptive style according to the circumstances (“responsive regulation”).
It is recognised that not all interactions between the regulatory body and licensee may
always achieve the characteristics set out above. Two main factors determine this: the safety
culture maturity of the licensee, and the safety culture maturity of the regulatory body. A low
safety culture maturity of the licensee may mean that it is more appropriate for the regulatory
body to adopt a prescriptive style of regulation. Similarly, the regulatory body’s ability to movetowards an accountability-oriented, enabling approach depends on its own safety culture
maturity; for example, the technical and behavioural competence of staff to interpret
regulatory requirements in a particular setting and influence improvements. The current
study therefore indicates the need for the regulatory body to be responsive in its regulatory
approach, although always with the goal of fostering the growth of the licensee towards
higher levels of safety culture maturity in the long-term interests of safety.
It is also apparent from the study that the ability of the regulatory body to follow an
accountability-oriented, enabling regulatory approach, with its increased emphasis on a lessformal, more dialogue-based style of interaction, depends on the expectations of – and thelevel of trust it enjoys from – the public. This important relationship is further explored in The
Characteristics of a Trusted Nuclear Regulator (NEA, forthcoming). It underlines the need for asystemic approach, considering the interactions between all stakeholders in the system –regulatory body, licensee, public and other stakeholders – and their mutual impact on safety
culture.
The current study builds on the five principles set out in The Safety Culture of an Effective
Nuclear Regulatory Body (2016). The NEA encourages regulatory bodies and licensees to use theinformation contained in this report to examine the health of their own interactions, and to
identify areas for improvement and good practices to share.

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CONCLUSIONS

Specifically, regulatory bodies are encouraged to:•

Recognise the systemic nature of the influence on safety culture, from regulatory bodyto licensee and vice versa, and extending to other stakeholders in the system;•

Consider how they can evolve their approach towards more accountability-oriented,
enabling regulation;•

Develop regulatory oversight methods based on dialogue and aimed at fostering selfreflection that support an accountability-oriented, enabling regulatory approach;•

Balance regulatory goals and approaches, e.g. balancing “policing” vs “coaching” styles
and formal vs less formal interactions, to maximise their influence on safety
improvements by the licensee, while maintaining the trust of the public;•

Adapt their regulatory approaches according to the performance and safety culture
maturity of the licensee;•

Enhance their own safety culture to support development towards accountabilityoriented, enabling regulation; and•Practice a responsive style of regulation, according to the cultural maturity of thelicensee, although always with the aim of promoting growth of the licensee’s safety
culture towards higher maturity levels.

To support regulatory bodies in implementing these recommendations, the NEA willcontinue to work on the insights gained and the challenges identified in this report. For
instance, it has identified the following further areas of potential investigation:

58•

Developing guidance and tools on how to create awareness of the mutual impact ofregulatory bodies and licensees based on the model of the factors and mechanisms ofimpact that resulted from the current study;•

Deepening and substantiating the concepts of accountability-oriented, enabling
regulation and responsive regulation and the practical implications for the nuclear
industry, including developing a responsive regulation “pyramid” for the nuclear sector
to understand the escalation / de-escalation mechanisms;•

Developing guidance and tools to help regulatory bodies to move towards moreaccountability-oriented, enabling regulatory approaches and towards responsive
regulation;•

Providing platforms and spaces for regulatory bodies to exchange experience with thedevelopment and implementation of accountability-oriented, enabling regulatory
approaches and responsive regulation;•

Further exploring how the regulatory body achieves a balance in its regulatory
approach and interactions with the licensee and the wider interconnected system of
stakeholders; and•Exploring ways to communicate with the public about regulatory approaches and theirimpact on safety and trust.

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GLOSSARY

Glossary

Accountabilityoriented,
enabling
regulation (AER)

A regulatory approach which seeks to foster the licensee’s accountability
for safety, enabling continuous improvement and growth of thelicensee’s safety culture towards higher maturity levels. This regulatory
approach is characterised by a low degree of prescriptiveness inregulations and oversight activities and is built on effective relationships
between the regulatory body and licensee, in turn based on constructive
co-operation, dialogue and trust, as well as mutual respect andacknowledgement of the respective roles and responsibilities of eachorganisation.

Accountable

Required or expected to justify actions or decisions. (OED, 2005)

Prescriptive
regulation

A regulatory approach which “establishes very detailed requirements
for technical solutions and conducting specific activities. Safety is
assured because the regulator has established that its requirements
provide for the safe conduct of these activities”. (Durbin, 2013)

Responsible

Having an obligation to do something, or having control over or care forsomeone, as part of one’s job or role. (OED, 2005)

Responsive
regulation

A regulatory concept which implies that there is not one specificapproach to oversight which fits all licensees at all times and in all
situations, but rather that oversight needs to be adapted over timedepending on the performance and the culture of a licensee. Responsive
regulation is generally illustrated in the form of a pyramid (“enforcement
pyramid”, “regulation pyramid”) which represents an escalation from anoversight approach based on self-regulation, persuasion, voluntarycompliance at the bottom of the pyramid, upwards through different
escalation levels, with strong sanctions and a strictly prescriptive
approach at the top of the pyramid as “ultima ratio”, should all the milder
and less intrusive regulatory actions in the lower levels of the escalation
ladder be ineffective. Moreover, de-escalation down the pyramid should
be sought at the first opportunity.

Safety cultureof a licensee

The assembly of characteristics and attitudes in organisations andindividuals which establishes that, as an overriding priority, protection
and safety issues receive the attention warranted by their significance.
(IAEA, 2022)

Safety culture ofa regulatory
body

The regulatory body’s strategy, the way it carries out its daily oversight 1
work, the type of relationship it cultivates with licensees, the values it
conveys and the importance it gives to safety. (NEA, 2016)

1.

In this report the term “oversight” is used to mean the specific activities the regulatory bodyundertakes to give effect to the regulations and ensure the compliance of licensees, e.g. inspection,assessment, authorisation, monitoring and dialogue, while the term “regulation” is used to mean all
the functions of the regulatory body, including rulemaking, stakeholder consultation.

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GLOSSARY

60

Safetyleadership

The use of an individual’s capabilities and competences to give
direction to individuals and groups and to influence their commitment
to achieving the fundamental safety objective and to applying thefundamental safety principles, by means of shared goals, values andbehaviour. (IAEA, 2016c)

Safetymanagement

A formal, authorised function for ensuring that an organisation operates
efficiently and that work is completed in accordance with requirements,
plans and resources. Managers at all levels need to be leaders for safety.
(IAEA, 2016c)

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LITERATURE REVIEW

Annex A. Literature review

A.1. List of literature reviewed
Bradley, C. (2017), Regulatory Safety (Oversight) Culture: How a Regulator’s Culture Influences Safety
Outcomes in High Hazard Industries, Doctoral dissertation, Fielding Graduate University.
Camargo, C.T.M, S.N. Choi, L. Gutierrez Ruiz and C. Ryser (2002), “Incorporating Safety Culturein the Regulatory Framework”, IAEA Consultancy Meeting, 11-15 November 2002.
CNSC (2018), “Regulatory Safety Oversight Culture Assessment”, Canadian Nuclear Safety
Commission,
https://cnsc.isilive.ca/2018-10-03_04/2018-10-04-7M.html(accessed
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February 2024).
CSB (2016), “Deepwater Horizon: Drilling Rig Explosion and Fire at The Macondo Well”, UnitedStates Chemical Safety Board. www.csb.gov/csb-board-approves-final-report-findingdeepwater-horizon-blowout-preventer-failed-due-to-unrecognized-pipe-bucklingphenomenon-during-emergency-well-control-efforts-on-april-20-2010-leading-toenvironmental-disaster-in-gulf-of-mexico.
Dekker, S. (2016), Just Culture – Restoring Trust and Accountability in Your Organisation, 3rd Edition,
Ashgate.
Dekker, S. (2011), Drift into Failure – From Hunting Broken Components to Understanding Complex
Systems, CRC Press.
Durbin, N. (2013), “Regulatory Approaches in Nuclear Power Supervision”, Swedish Radiation
Safety Authority, www.stralsakerhetsmyndigheten.se/en/publications/reports/safety-atnuclear-power-plants/2013/201329 (accessed 19 February 2024).
Fleming, M. and K. Bowers (2016), “Regulator Safety Culture: A Conceptual Framework for
Ensuring Safety in the Nuclear Industry, Human and Organizational Aspects of Assuring
Nuclear Safety – Exploring 30 Years of Safety Culture”, IAEA‐CN–237, www.iaea.org/
publications/11191/human-and-organizational-aspects-of-assuring-nuclear-safetyexploring-30-years-of-safety-culture (accessed 19 February 2024).
Hackitt, J. (2018), “A personal view from Dame Judith Hackitt”, in Grenfell: Building a Safer
Future, Independent Review of Building Regulations and Fire Safety: Final Report,
www.gov.uk/government/publications/independent-review-of-building-regulations-andfire-safety-final-report (accessed 16 February 2024).
House Committee on Transportation and Infrastructure (2020), “Boeing 737 MAX: Final
Committee Report, The Design, Development & Certification of the Boeing 737 MAX”,
https://democrats-transportation.house.gov/committee-activity/boeing-737-maxinvestigation (accessed 16 February 2024).
IAEA (2020c), Safety Culture Practices for the Regulatory Body, TECDOC-1895, IAEA Publications,
Vienna, www.iaea.org/publications/13586/safety-culture-practices-for-the-regulatory-body.
IAEA (2019), Safety Culture: A Report by the International Nuclear Safety Advisory Group, INSAG-4,
IAEA Publications, Vienna, www.iaea.org/publications/3753/safety-culture.
IAEA (2017), “Ensuring Robust National Nuclear Safety Systems — Institutional Strength in
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LITERATURE REVIEWIAEA (2015), The Fukushima Daiichi Accident, Report by the Director General, IAEA Publications,
Vienna, www.iaea.org/publications/10962/the-fukushima-daiichi-accident.
IAEA (2003), “The Role of Governments and Regulators in Fostering a Strong Nuclear Safety
Culture”, IAEA Technical Meeting.
Institute of Transport Economics (2018), “The relevance of safety culture as a regulatory
concept and management strategy in professional transport: Comparing the experiencesof regulators and companies from four sectors”, Norwegian Centre for Transport Research
www.toi.no/getfile.php?mmfileid=49658.
Ryser, C. (2019), “The regulatory body’s perspectives on safety culture”, in IAEA Human andOrganizational Aspects of Assuring Nuclear Safety – Exploring 30 Years of Safety Culture,
Proceedings of an International Conference, Proceedings Series, IAEA Publishing, Vienna,
Austria.
Safety Management International Collaboration Group (2019), “Organizational Culture SelfAssessment Tool and Guidance for Regulatory Authorities”, www.skybrary.aero/articles/organizational-culture-self-assessment-tool-regulators.
Schöbel, M. et al. (2017), “Digging deeper! Insights from a multi-method assessment of safety
culture in nuclear power plants based on Schein’s culture model”, Safety Science, Vol. 95,
pp. 38-49, https://doi.org/10.1016/j.ssci.2017.01.012.
Swiss Federal Nuclear Safety Inspectorate (ENSI) (2015), Oversight Culture: Report of Oversight
Practice, Swiss Federal Nuclear Safety Inspectorate, Brugg, www.ensi.ch/en/documents/
oversight-culture-2015-ensi-report-on-oversight-practice.
Weenink, J., I. Wallenburg, L. Hartman et al. (2022), “Role of the regulator in enabling a justculture: a qualitative study in mental health and hospital care”, BMJ Open 12:e061321,
https://doi.org/10.1136/bmjopen-2022-061321.

A.2. Summary of main items of literature relevant to the study•

Regulatory Culture: Balancing the Different Demands of Regulatory Practice in the Nuclear
Industry, Reiman and Norros (2002)
Reiman and Norros investigated the organisational culture of the Finnish nuclear
regulatory body and proposed a model for the core task of a nuclear inspector withthree, occasionally conflicting, roles: an authority role (leading to effectiveness), an
expert role (leading to competence) and a public role (leading to credibility).

•

Regulatory Safety (Oversight) Culture: How a Regulator’s Culture Influences Safety Outcomes inHigh Hazard Industries, Bradley (2017)
Bradley’s research in the oil and gas sector in Canada proposed a framework forregulatory safety culture and its influence on industry safety culture and performance.
The framework has six dimensions: leadership and political independence (vspoliticised mission); learning culture (vs punitive culture); innovation (vs bureaucratic
inertia); technical excellence (vs tolerance of inadequate capacity and competency);
risk consciousness (vs compliance mentality); and systems thinking (vs preoccupation
with active failures).

•

Regulator Safety Culture: A Conceptual Framework for Ensuring Safety in the Nuclear Industry,
Fleming and Bowers (2016)
Fleming and Bower’s study drew on interviews with experts across a range of industry
sectors to develop a framework for regulatory safety culture with five dimensions:leadership commitment to creating a positive safety culture; a proactive, risk informed
and flexible approach; continuous learning and self-improvement; unwavering ethicalstandards; and transparency through communication.

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Safety Culture Practices for the Regulatory Body, IAEA (2020)
The IAEA’s report identifies six practices that promote safety culture in the regulatory
body as well as regulatory oversight of the safety culture of licensees: leadership andcommitment; individuals’ awareness of safety culture, and their roles and responsibilities;
individual behaviours that place proper value on safety; decision making; continual
improvement and learning; and the management system.

•

Fukushima Daiichi Nuclear Power Plant Accident, Ten Years On: Progress, Lessons andChallenges (NEA, 2021) and the Ten-Year Investigation Commission on the Fukushima
Nuclear Accident, 2021)
These reviews have identified significant improvements that have been made in theregulatory approach in Japan since the Fukushima Daiichi accident, e.g. the technicalcapability and independence of the regulatory body. The reviews also identify
continuing challenges, e.g. balancing regulatory independence and openness withlicensees, and the regulatory approach (prescriptive vs goal setting).

•

Organisational Culture Self-Assessment Tool and Guidance for Regulatory Authorities, Safety
Management International Collaboration Group (2019)
This report explores how regulatory bodies in the aviation community impact duty
holders through their organisational culture. It suggests that regulatory bodies should
be flexible in their approach according to the safety culture maturity of the duty holder.
For duty holders at the less mature, reactive end of the spectrum, a regulatory
approach based on prescription and compliance might be appropriate, or evennecessary, although it entails the risk of hindering or hampering the development of
the duty holder towards higher levels of cultural maturity. However, for duty holders at
the more mature, proactive level, a performance-based approach should be applied. An
objective of the regulatory body should be to support the growth of the safety culture of
the duty holder towards more mature levels. The ability of the regulatory body tooperate in this flexible way depends on its own cultural maturity.

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QUESTION SET FOR SEMI-STRUCTURED INTERVIEWS

Annex B. Question set for semi-structured interviews

SectionMandatory questions in roman text.
Supplementary questions in italics.

1.

Introduction

Introduce purpose of interview and give opportunity to interviewee to ask any questions.

2.

Main questions

Q1. Based on your experience, how do the practices and behaviour of the regulatory bodyinfluence the safety culture of the licensee (positively or negatively)? What are the mostimportant mechanisms of influence?
-Can you give examples of positive and negative influences?

Q2. Based on your experience, how do the practices and behaviour of the licensee influence thesafety culture of the regulatory body (positively or negatively)? What are the most importantmechanisms of influence?
-Can you give examples of positive and negative influences?

Q3. (Refer to the most important mechanisms of influence identified by the interviewee in Q1
and Q2). How can regulatory bodies and licensees ensure that they have a positive influence oneach other’s safety cultures?
-

What good practices have you seen?

-

What are the conditions which enable this?

-What lessons have been learnt?

Q4. Based on your experience, what are the most significant challenges to effective interactions
between regulatory bodies and licensees and how can they be overcome?
3.

Closing question

Is there anything else that we have not covered so far that you would like to mention? Do you
have any questions for us?

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GOOD PRACTICES AND LESSONS LEARNT FOR EFFECTIVE INTERACTIONS BETWEEN THE REGULATORY BODY AND LICENSEE

Annex C. Good practices and lessons learnt for effective interactions
between the regulatory body and licensee
Table C1. Good practices and lessons learnt for effective interactions between theregulatory body and licensee(a) Regulatory regime
Good practices

Lessons learnt

Methods by which the regulatory body can promote the licensee’s
sense of accountability for safety

An enabling approach to regulation

The regulatory body can use its oversight methods to promote thelicensee’s sense of accountability for safety, in particular to strengthen:• The voice of those within the licensee who can bring forward
safety optimisations;• The value the licensee attaches to its own rules and processes (byevaluating compliance with these rules);• The licensee’s internal oversight and inspection methods, e.g. by
evaluating peer reviews and self-assessments;• The alignment of ‘work-as-done’ versus ‘work-as-imagined’, byrepeatedly inspecting actual working practice;• The licensee’s willingness to do more, beyond complianceactions, in the interests of safety; and• Mutual understanding of the impact of external challenges andchanges, e.g. plant life cycle changes.
Comprehensive inspections encompassing higher-level
management in the licensee

At a large fuel cycle facility, progress with legacy hazard
reduction had slowed, in part due a regulatory approach
which was too bureaucratic, and at times, overly conservativeand risk averse. The regulatory body changed to an “enabling”
approach by:• Forming a group of senior stakeholder representatives to
identify a common goal, the barriers to achieving hazard
reduction and how the barriers would be overcome;• Removing unnecessary bureaucracy in the regulation of
the facility and giving ownership of risk to the licensee;and• Encouraging innovative, fit for purpose and legallycompliant solutions, focused on the priority outcome.
The effect of the above was that tangible hazard reduction
began at several legacy facilities, with significantly accelerated
work programmes in others. The success of the enabling
approach depends on mature self-regulation by the licensee.

The regulatory body has found that comprehensive inspections
involving higher-level management in the licensee have a positive
impact on the safety culture because:• Lower-level staff can see that higher management are also
subject to inspection;• The inspections add value by stimulating thinking on safety
culture at senior management level; and• The inspections provide the opportunity to impart specialist
knowledge on safety culture to the licensee.
Guidance and examples to promote understanding of regulations
The regulatory body has published a document providing commentaryand examples to promote understanding of the safety regulations. The
document covers event reporting and disclosure rules in nuclear
power and related facilities. There are many differences of opinion on
this subject, but through the commentary and examples provided, thedifference in understanding between the regulatory body and theoperator has been reduced and resolved.
The role of the resident inspector
Resident inspectors have their different inspection modules and things
that they have to do, but they see a lot by acting as a ‘fly on the wall’.
This information can be very valuable to the licensee’s leadership ifthey just listen and talk to each other. It's the day in, day out, full viewof the station that comes from the resident inspector that makes them
particularly important.

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GOOD PRACTICES AND LESSONS LEARNT FOR EFFECTIVE INTERACTIONS BETWEEN THE REGULATORY BODY AND LICENSEE(b) Capability
Good practices

Lessons learnt

Use of staff secondments between the regulatory body andlicensee

Training of inspectors in soft skills

Use of staff secondments between the regulatory body and thelicensee has been found to enhance understanding of:•Each other’s role; and•What influences how the role is carried out.

It should not be assumed that all inspectors have the highlevel of communications skills needed to influence safety
culture and safety improvements in the licensee. They may
not be able to make themselves fully understood, or fully
understand the licensee’s staff. There is a need therefore fortraining of inspectors in communications skills to eliminate
variation in this competence.

(c) Leadership and management
Good practices

Lessons learnt

Targeted, holistic regulatory oversight programmes

Flexibility and agility in the application of the regulatory
regimeThe regulatory body has developed regulatory oversightprogrammes that support a targeted, holistic approach to safety, by:•

Utilising a range of regulatory tools – dialogue, inspection etc.;•

Covering all safety areas over a specific cycle;•

Providing a basic oversight programme to which further
activities can be added according to whether the licensee
takes responsibility and demonstrates their ability andcompetence;•

Developing and maintaining an overall picture of licensee
safety performance; and•Reflecting discussion with licensees on their view of theeffectiveness of regulatory oversight activities.

The accelerated approval of Covid-19 vaccines provides
useful learning for nuclear regulatory bodies in enabling
innovation while demonstrating leadership for safety. In one
country the accelerated time for the approval of the new
vaccines was attributed to:•adopting a regulatory process of “rolling review” ofdata on a vaccine’s safety, quality and effectiveness,considering data as and when it became available; and•the flexibility and agility of clinicians and scientists in
the regulatory body.

The above approach was underpinned by the existing
expertise, rigour and independence of the regulatory bodies.

Joint planning between regulatory body and licensee (proposed
good practice)
Agreement on a roadmap or long-term safety programme by thelicensee and regulatory body to support allocation of resources.

(d) Communications
Good practices

Lessons learnt

Regular communications between regulatory body and licensee
It is important to hold regular meetings and build up communication
as a way to achieve both transparency and frank discussions between
regulatory bodies and operators.
Use of different channels of communication between theregulatory body, licensee and public
The regulatory body uses various communication channels toengage the licensee, including:72•

Public meetings, held to give everyone access to informationand to provide open, honest discussion on working together;and•“Drop-ins” or private, closed-door meetings with managementof the regulatory body at which the licensee can discuss issues
privately. These are intended to be listening sessions, noapprovals of requests are given.

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GOOD PRACTICES AND LESSONS LEARNT FOR EFFECTIVE INTERACTIONS BETWEEN THE REGULATORY BODY AND LICENSEE(e) Relationships
Good practices

Lessons learnt

Development of regulatory body capability in advanced nuclear
technologies and early engagement with vendors
The regulatory body has established a capability to support andregulate advanced nuclear technologies. This includes:•

Familiarisation exercises and training to identify key safety
and security considerations, and close knowledge gaps;•

Engagement with industry via seminars and workshops toenhance the regulatory body’s understanding of design
developments and communicate its expectations;•

Engagement with other national nuclear regulators; and•Review and update of regulatory process and guidance toensure that they are fit for purpose.

(f) Behaviours
Good practices

Lessons learnt

Presence of regulatory body senior management on thelicensee’s site.

Monitoring the effectiveness of interactions between theregulatory body and licensee

The regulatory body has found that periodic visits by the regulatory
body’s senior management, in particular decision-makers, to thelicensee’s site is beneficial. It helps broaden the experience ofmanagers, generates better understanding of issues and leads tobetter decision making.

Senior management in the regulatory body were unawarethat relationships between the regulatory body and one
licensee had deteriorated. The regulatory body and industry
therefore agreed a set of values and behaviours which canbe used to monitor the health of their everyday interactions:••

The agreed values and behaviours fall under four
categories:-

Responsive, well-informed and innovative;-

Balanced and proportionate;-

Consistent and transparent; and-Timely.

At the end of a meeting or inspection, the regulatory
body and licensee take a few minutes to ask eachother whether:-

The objectives of the interaction were agreed;-

The objectives were met; and-There were any good practices or areas for
improvement against the agreed behaviours.

Any immediate actions are agreed and the feedback fromthe meetings is reviewed periodically for common themes.

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GOOD PRACTICES AND LESSONS LEARNT FOR EFFECTIVE INTERACTIONS BETWEEN THE REGULATORY BODY AND LICENSEE(g) Learning and continuous improvement
Good practices

Lessons learnt

Use of a professional association for employee concerns

Self-critical reflection by the regulatory body on its work
and impact

The regulatory body and licensees make use of a professional
association for employee concerns to talk about cases openly sothat they can learn from each other’s experiences without fear of
regulatory action.
Dialogue between the regulatory body and licensee toreflect on their relationship (proposed good practice)
The regulatory body and licensee engage in dialogue to reflect
on their relationship: (i) regularly, as part of formal interactions,and (ii) sporadically, as part of project work or event follow-up
The regulatory body and licensee discuss e.g.:•

How each party deals with the other and their respective
experiences of the relationship;•

How the relationship helps or how it hinders either party;•

What each party values about the other; and•What works well, or not so well, from the licensee’s
perspective.

The regulatory body should adopt a self-critical questioning
attitude to its work and make improvements, e.g. in the eventthat:•

Approval of a plant modification is delayed;•

The licensee implements requirements set by theregulatory body even though it doesn’t see any sense inthem, in order to avoid a conflict with the regulatory body;•Different disciplines within the regulatory body havedifferent opinions, attitudes or values on the meaning ofoversight work.

Learning for the nuclear regulatory body from otherindustry sectors
A regulatory body in the civil aviation sector was facing achallenge with the pace of technology advances coming
forward. Its response was to set up a dedicated Innovation Hub
with the purpose of:•

Making it easier for innovators to access regulatory body
expertise and viewpoints;•

Helping innovators maximise regulatory readiness for thedemonstration of their systems; and•Accelerating
regulations.

development

of

new

policiesand

The nuclear regulatory body in the same country has used theaviation regulator’s experience to develop its own approach toinnovation.

74

THE MUTUAL IMPACT OF NUCLEAR REGULATORY BODIES AND LICENSE HOLDERS FROM A SAFETY CULTURE PERSPECTIVE, NEA No. 7672, © OECD 2024• The regulatory body’s
decision-making is biased,
ill-informed or unreasonable• The regulatory body focusses on
irrelevant or insignificant matters• There is an imbalance in how theregulatory body exercises its “policing”
and “coaching” roles, or uses formal
methods (e.g., inspection) versus lessformal methods (e.g., dialogue)• The regulatory body’s independence
leads to isolationism• There is a lack of coordination between
regulatory bodies• There is misalignment between theregulatory framework and the valuesof the regulatory body

• The regulatory framework lacks clarity,
is inconsistently applied, or there is an
imbalance towards prescriptive as
opposed to outcome-based elements

The regulatory regime

Ability to learn
and improve

Safety cultureof a regulatory body

Leadership and managementof regulatory body

Capability of regulatory body

Regulatory regime

Enablers• There is a mismatch
between the prioritiesof the regulatory bodyand the resources todeliver them

• Staff in theregulatory body lackcompetence(technical/regulatory/
behavioural)

Capability of theregulatory body

• The licensee puts
external pressure on,
or interferes with theactivities of, theregulatory body

• The licensee
undermines theregulatory body’s
tasks• The licensee seeks
to shift responsibility
to the regulatory
body

Regulatory regime

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National/international bodies

The regulatory body and licensee fail tolearn from their interactions, or from third
parties

Behaviours focus unduly on bureaucratic or
administrative aspects, rather than safety,
or fail to recognise good as well as
poor performance

Relationships are characterised by mistrust,misunderstanding, suspicion, arrogance,
defensiveness, a lack of openness, or are too trusting

Communications are characterised by: lack oftimeliness or structure; information being withheld
or selectively passed on; an imbalance between
formal and less formal methods; or a failure tocommunicate the “why” as well as the “what”

Interactions between theregulatory body and licensee:

The regulatory body and licensee fail to
identify or act on opportunities to collaborate
with each other or with third parties, e.g., onstandards, research and training

National/international bodies• The regulatory body is
dysfunctional in its
management
arrangements• Leaders in theregulatory body fail torecognise their impact onsafety culture, or set apoor example

Leadership andmanagement of theregulatory body• Leaders in the licensee emphasise costor schedule goals over and above safety• Staff in thelicensee lackcompetence(technical/
regulatory/
behavioural)

Ability to learn
and improve

Safety cultureof a licensee

Leadership and managementof licensee

Capability of licensee

Regulatory regime

Enablers• The licensee has weak safety assurance
processes• The licensee’s submissions withhold
information or lack timeliness/quality• The licensee is ill-prepared forinteractions with the regulatory body

• The licensee puts undue time pressure
on the regulatory body

Leadership and managementof the licensee

Capability oflicenseeFEATURES OF INEFFECTIVE INTERACTIONS BETWEEN THE REGULATORY BODY AND LICENSEE LEADING TO A DOWNWARD SPIRAL IN SAFETY CULTURE

Annex D. Features of ineffective interactions between the regulatory
body and licensee leading to a downward spiral in safety culture

75

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The Mutual Impact of Nuclear

Regulatory Bodies and License Holders
from a Safety Culture Perspective
Most safety incidents are often not due to a technical fault or the actions of a single individual, but rather
originate in a compromised safety culture – the collection of the beliefs, perceptions and values that
employees share in relation to risks within an organisation, such as a workplace or a community.
Regulatory bodies, by their very nature, have a deep influence on the safety culture of nuclear site licenceholders. But this influence can also flow in the other direction, from licensee to regulatory body. Basedon the insights from senior practitioners worldwide, this report examines the factors and mechanisms
by which nuclear regulatory bodies and site license holders influence the safety culture of the other.
It presents a model, accountability-oriented, enabling regulation, for a regulatory body’s approach tofoster a licensee’s accountability for safety. This approach builds on the concept of performance (oroutcome) based regulation, but also includes a focus on risk (or hazard), processes, and licensee selfassessment. Two main factors determine the extent to which a regulatory body is able to adopt an
accountability-oriented, enabling approach: the maturity of the safety culture at the licensee and in theregulatory body. In both cases, the more mature the safety culture, the more an accountability-oriented,
enabling regulatory approach is likely to succeed.
Regulatory bodies and licensees are encouraged to use this report to assess the health of their interactions
and identify areas for improvement and good practices to share.

Nuclear Energy Agency (NEA)
46, quai Alphonse Le Gallo
92100 Boulogne-Billancourt, France
Tel.: +33 (0)1 73 21 28 19
nea@oecd-nea.org www.oecd-nea.org

NEA No. 7672