analysis of irrs missions, 2006-2017 · 2018. 12. 10. · this report provides an analysis of the...

ANALYSIS OF IRRS MISSIONS, 2006-2017

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Executive summary This report provides an analysis of the Integrated Regulatory Review Service (IRRS) missions

conducted from 2006 to 2017. During this period, the Agency conducted 69 initial missions and 26

follow-up missions. This is the first report to analyze all of the IRRS missions conducted to date.

IRRS missions vary substantially in their scope, based both on the nuclear and radiological activities

taking place in the Member State and the decision by the Member State on what activities to include in

the scope of the mission. Nevertheless, the 95 IRRS missions include sufficient information to draw

meaningful conclusions on general characteristics and trends.

The observations arising from an IRRS mission are categorized as:

• Recommendations: which reflect non-compliance with a requirement from the IAEA

Safety Standards;

• Suggestions: which identify opportunities for improvement: and,

• Good Practices: which identify regulatory practices superior to those observed elsewhere.

Almost half of the references for Recommendations and Suggestions are to GSR Part 1 (Rev. 1):

Governmental, Legal and Regulatory Infrastructure for Safety. GSR Part 3: Radiation Protection and

Safety of Radiation Sources: International Basic Safety Standards accounts for 15% of the references

with GSR Part 2: Leadership and Management for Safety, GSR Part 7: Preparedness and Response

for a Nuclear or Radiological Emergency each accounting for about 10% of the references.

The most frequently referenced GSR Part 1 (Rev. 1) requirements for Recommendations and

Suggestions were:

• Requirement 2: Establishment of a framework for safety;

• Requirement 24: Demonstration of safety for the authorization of facilities and activities;

• Requirement 32: Regulations and guides;

• Requirement 18: Staffing and competence of the regulatory body;

• Requirement 4: Independence of the regulatory body;

• Requirement 29: Graded approach to inspections of facilities and activities.

The most frequently referenced GSR Part 2 requirements for Recommendations and Suggestions

were:

• Requirement 10: Management of processes and activities;

• Requirement 8: Documentation of the management system;

• Requirement 13: Measurement, assessment and improvement of the management system;

• Requirement 6: Integration of the management system;

• Requirement 4: Goals, strategies, plans and objectives.


were:

• Requirement 2: Establishment of a legal and regulatory framework;

• Requirement 34: Responsibilities of the government specific to medical exposure;

• Requirement 38: Optimization of protection and safety (for medical exposure);

• Requirement 32: Monitoring and reporting (public exposure);

• Requirement 47: Responsibilities of the government specific to existing exposure

situations;

• Requirement 3: Responsibilities of the regulatory body.

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were:

• Requirement 2: Roles and responsibilities in emergency preparedness and response;

• Requirement 7: Identifying and notifying a nuclear or radiological emergency and

activating an emergency response;

• Requirement 25: Training, drills and exercises for emergency preparedness and response;

• Requirement 4: Hazard assessment;

• Requirement 23: Plans and procedures for emergency response.

For Good Practices, GSR Part 1 accounted for the most references. However, many IRRS missions

identified at least one Good Practice related to GSR Part 2, GSR Part 3 and GSR Part 7 requirements.

The most frequently referenced requirements all come from GSR Part 1, namely:


• Requirement 36: Communication and consultation with interested parties;

• Requirement 27: Inspection of facilities and activities;

• Requirement 14: International obligations and arrangements for international cooperation

and assistance;

• Requirement 24: Demonstration of safety for the authorization of facilities and activities.

Another way of categorizing IRRS observations is according to subject. In the analysis, each

observation was placed into one of 73 subject groups. The highest number of observations for

Recommendations and Suggestions were in the following subject groups:

• Basic safety requirements;

• Specific topics for regulations and guides;

• National policies and strategies for safety;

• Authorization procedures and guides;

• Providing / using the legal framework.

Regarding the topic of processes, procedures and guidance, these observations were broken out in the

various modules for management system, authorization, review and assessment, inspection,

enforcement and emergency preparedness and response. Taken together, however, they account for

289 Recommendations and 230 Suggestions, making the topic of procedures and guidance the most

frequent observation.

Not all Member States have requested a follow-up mission, where peer reviewers determine if

Recommendations and Suggestions can be closed or remain open. For those Member States that have

hosted a follow-up mission, the closure rate for Recommendations and Suggestions directed to

Member State governments is 73%, while the closure rate for Recommendations and Suggestions

directed to the regulatory body is 84%.

New observations are also normally included in follow-up missions, with more than 40% of these new

observations referencing a requirement in GSR Part 1. GSR Part 7, GSR Part 3 and Other

Requirements documents each account for around 14% of the references, while various Safety Guides

are referenced in about 10% of the observations. GSR Part 2 is referenced in about 5% of the

observations.

The requirements most frequently referenced in new Recommendations or Suggestions in follow-up

missions are all from GSR Part 1:


• Requirement 7: Coordination with different authorities;

• Requirement 33: Review of regulations and guides.

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• Requirement 16: Organizational structure of the regulatory body and allocation of

resources;

• Requirement 20: Liaison with advisory bodies and support organizations.

The report also noted in the outlook section that in some Member States some regulatory issues

require actions that are still work underway. The level of completion of actions associated with these

issues varies among different countries. For illustration, some highlights are presented here:

• The effective separation between the functions of the regulatory body and those of any

other body or organization concerned with the promotion or utilization of nuclear energy

is essential to ensure that the regulatory body is free from any undue pressure from

interested parties;

• The development of the regulatory body integrated management system is a key issue for

regulatory effectiveness;

• International cooperation for information exchange among regulatory bodies is essential

for enhancing nuclear and radiation safety worldwide;

• Processes, procedures and guidance are required for the regulatory body to conduct its

functions in a consistent manner;

• Sharing of IRRS recommendations, suggestions and good practices is of utmost

importance;

• Transparency and openness in the regulatory process is significantly improving as part of

new communication practices and consultations with the public and other interested

parties;

• There is an increasing harmonization between national safety standards and the IAEA

Safety Standards.

Finally, there is general consensus about the benefits of self-assessment and peer review processes and

the knowledge and experience exchange associated with the IRRS.

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Contents

Executive summary ................................................................................... i

1 Introduction ......................................................................................... 1

1.1 The Integrated Regulatory Review Service ............................................................. 1

1.2 Objective and scope ................................................................................................ 1

1.3 Structure of the report ............................................................................................ 1

2 Background.......................................................................................... 1

2.1 Structure of the IRRS ............................................................................................... 1

2.2 Relationship between IRRS and the IAEA Safety Standards ................................... 2

2.3 GSR Part 1 (Rev. 1) versus GS-R-1 ........................................................................... 3

2.4 GSR Part 2 versus GS-R-3 ......................................................................................... 4

2.5 GSR Part 7 versus GS-R-2 ......................................................................................... 4

2.6 Missions analyzed .................................................................................................... 4

2.7 Limitations and assumptions of the analysis .......................................................... 4

2.8 Basis for the analysis of findings to the IAEA Safety Standards .............................. 5

3 Analysis of Recommendation and Suggestion references to the IAEA Safety Standards ....................................................... 6

3.1 General references to IAEA Safety Standards ......................................................... 6

3.2 References to GSR Part 1: Governmental, Legal and Regulatory Infrastructure for Safety ....................................................................................................................... 7

3.3 References to GSR Part 3: Protection and Safety of Radiation Sources: International Basic Safety Standards ...................................................................... 8

3.4 References to GSR Part 2: Leadership and Management for Safety ...................... 9

3.5 References to GSR Part 7: Preparedness and Response for a Nuclear or Radiological Emergency......................................................................................... 11

4 Analysis of Good Practice references to the IAEA Safety Standards ........................................................................................... 12

4.1 Overall references to Good Practices .................................................................... 12

4.2 Good Practice references to GSR Part 1 ................................................................ 13



4.5 Good practice references to GSR Part 7 ................................................................ 17

5 Analysis of observations by subject groups ......................... 18

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5.1 Introduction ........................................................................................................... 18

5.2 Module 1: Responsibilities and functions of the government .............................. 19 5.2.1 Highlights of observations ............................................................................................... 20

5.3 Module 2: Global Nuclear Safety Regime ............................................................. 22 5.3.1 Highlights of observations ............................................................................................... 22

5.4 Module 3: Responsibilities and functions of the regulatory body ........................ 23 5.4.1 Highlights of observations ............................................................................................... 24

5.5 Module 4: Management system of the regulatory body ...................................... 25 5.5.1 Highlights of observations ............................................................................................... 26

5.6 Module 5: Authorization ....................................................................................... 27 5.6.1 Highlights of observations ............................................................................................... 27

5.7 Module 6: Review and assessment ....................................................................... 28 5.7.1 Highlights of observations ............................................................................................... 29

5.8 Module 7: Inspection............................................................................................. 30 5.8.1 Highlights of observations ............................................................................................... 31

5.9 Module 8: Enforcement ........................................................................................ 32 5.9.1 Highlights of observations ............................................................................................... 32

5.10 Module 9: Regulations and guides ........................................................................ 33 5.10.1 Highlights of observations ............................................................................................... 33

5.11 Module 10: Emergency preparedness and response (regulatory aspects) .......... 34 5.11.1 Highlights of observations ............................................................................................... 35

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5.12 Overall analysis of subject groups ......................................................................... 36

6 Follow-up missions ........................................................................ 39

6.1 Closure rates for Recommendations and Suggestions ......................................... 39

6.2 New observations resulting in Recommendations and Suggestions in follow-up missions ................................................................................................................. 39

7 Analysis of IRRS missions related to the regulation of operating nuclear power plants (NPPs) ............................... 42

7.1 Introduction ........................................................................................................... 42

7.2 Reference to IAEA Safety Standards ..................................................................... 42

7.3 Reference by subject group .................................................................................. 44

8 Analysis of IRRS missions related to the regulation of radioactive sources ........................................................................ 46

8.1 Introduction ........................................................................................................... 46

8.2 Reference to IAEA Safety Standards ..................................................................... 46

8.3 Reference by subject group .................................................................................. 49

9 Outlook ................................................................................................ 50

Appendix 1: Mapping of GS-R-1 to GSR Part 1 ........................... 51

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1 Introduction

1.1 The Integrated Regulatory Review Service

In 2006, the Agency introduced the Integrated Regulatory Review Service (IRRS), which replaced its

IRRT, RaSSIA and TranSAS services, as well as the regulatory aspects of its EPREV service. To the

end of 2017, the Agency had conducted 95 IRRS missions (including both initial and follow-up

missions) to 65 Member States.

1.2 Objective and scope

This report summarizes the analysis of the IRRS missions conducted from 2006 to 2017. Although all

IRRS review missions cover key aspects of the regulatory programme in a Member State, the modular

nature of the IRRS service allows Member States to specify the scope of the review. In many cases,

the Member State requests a review of the entire regulatory programme, while in some cases, the

Member State requested that the IRRS review focus on a limited number of facilities and activities.

The result is that the scope of the various missions varies considerably in terms of size and

complexity.

1.3 Structure of the report

Chapter 2 provides the background to the IRRS and the nature of the analysis. Chapter 3 is the

analysis of the Recommendations and Suggestions references to the IAEA Safety Standards. Chapter 4

is the analysis of the Good Practices references to the IAEA Safety Standards. Chapter 5 is the

analysis of the observations by subject group and Chapter 6 is the analysis of information from follow-

up missions. Chapter 7 provides some details on IRRS observations regarding the regulation of

operating nuclear power plants. Chapter 8 provides some details on IRRS observations regarding the

regulation of radioactive sources. Chapter 9 provides an outlook for future work needed by Member

State governments and regulatory bodies to further enhance regulatory effectiveness.

2 Background

2.1 Structure of the IRRS

The Agency established the IRRS to strengthen and enhance the effectiveness of national regulatory

infrastructures for nuclear, radiation, radioactive waste and transport safety and the security of

radioactive sources while recognizing the ultimate responsibility of each Member State to ensure

safety. Using the IAEA Safety Standards, the IRRS considers both regulatory technical and regulatory

policy issues.

As Figure 1 shows, the IRRS has a modular structure designed to be tailored to both generic and

Member State specific needs and to facilitate the review of circumstances where the scope of

regulatory responsibility may be changing.

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Figure 1 Modular structure of the IRRS

The observations arising from an IRRS mission are categorized as:

• Recommendations: which reflect non-compliance with a requirement from the IAEA

Safety Standards;

• Suggestions: which identify opportunities for improvement;

• Good Practices: which identify regulatory practices superior to those observed

elsewhere.

To review the progress in the implementation of the Recommendations and Suggestions from the

IRRS mission, the Agency recommends that a follow-up mission takes place two to four years after

the initial mission. The follow-up mission will rate each Recommendation and Suggestion as either

closed or open. The follow-up mission will typically also identify further observations, resulting in

new Recommendations, Suggestions or Good Practices.

2.2 Relationship between IRRS and the IAEA Safety Standards

The IAEA Safety Standards provide the basis for all of the Agency’s safety related services, including

the IRRS. For the IRRS, the main safety standards used for the 2006 to 2017 missions are:

• GSR Part 1 (Rev. 1): Governmental, Legal and Regulatory Framework for Safety;

• GSR Part 2: Leadership and Management for Safety;

• GSR Part 3: Radiation Protection and Safety of Radiation Sources: International Basic

Safety Standards;

• GSR Part 7: Preparedness and Response for a Nuclear or Radiological Emergency.

In addition to these four main IAEA Safety Standards, IRRS missions frequently reference other

IAEA Safety Standards.

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GSR Part 1 (Rev. 1) comprises 36 overarching requirements on the governmental, legal and regulatory

framework for safety. The 36 requirements form the basis for the IRRS as shown in Table 1.

Table 1 Modules and the associated safety requirements of the IRRS

2.3 GSR Part 1 (Rev. 1) versus GS-R-1

The IRRS missions between 2006 and early 2010 were based on IAEA Safety Standard GS-R-1: Legal

and Governmental Infrastructure for Nuclear, Radiation, Radioactive Waste and Transport Safety,

published in 2000. This was superseded in 2010 by GSR Part 1, which was updated to GSR Part 1

(Rev.1) in 2016. GSR Part 1 (Rev.1) did not introduce any new requirements. Although the main

principles and requirements of GS-R-1 and GSR Part 1 (Rev. 1) are the same, they differ both in

structure and format. To be able to make valid statements on the references and observations of all

missions, references from GS-R-1 were converted to their equivalent in GSR Part 1 (Rev. 1) 1.

1 For the remainder of this document, (Rev. 1) is to be implied when references are made to GSR Part 1

Module No GSR Part 1 (Rev. 1) Overarching Requirement

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R1: National policy and strategy

R2: Establishment of a framework for safety

R3: Establishment of a regulatory body

R4: Independence of the regulatory body

R5: Prime responsibility for safety

R6: Compliance with regulations and responsibility for safety

R7: Coordination of different authorities with responsibilities for safety within the regulatory framework for safety

R9: System for protective actions to reduce existing or unregulated radiation risks

R10: Provision for the decommissioning of facilities and the management of radioactive waste and of spent fuel

R11: Competence for safety

R13: Provision of technical services

2 R14: International obligations and arrangements for international cooperation

R15: Sharing of operating experience and regulatory experience

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R16: Organizational structure of the regulatory body and allocation of resources

R17: Effective independence in the performance of regulatory functions

R18: Staffing and competence of the regulatory body

R20: Liaison with advisory bodies and support organizations

R21: Liaison between the regulatory body and authorized parties

R22: Stability and consistency of regulatory control

R35: Safety related records

R36: Communication and consultation with interested parties

4 R19: The management system of the regulatory body

5 R23: Authorization of facilities and activities by the regulatory body

R24: Demonstration of safety for the authorization of facilities and activities

6 R25: Review and assessment of information relevant to safety

R26: Graded approach to review and assessment of a facility or an activity

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R27: Inspection of facilities and activities

R28: Types of inspection of facilities and activities

R29: Graded approach to inspections of facilities and activities

8 R30: Establishment of an enforcement policy

R31: Requiring of corrective action by authorized parties

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R32: Regulations and guides

R33: Review of regulations and guides

R34: Promotion of regulations and guides to interested parties

10 R8: Emergency preparedness and response

11 Observations from Module 11 are reallocated to Modules 1-10 as appropriate

12 R12: Interfaces of safety with nuclear security and with the State system of accounting for, and control of, nuclear material

4

2.4 GSR Part 2 versus GS-R-3

The IRRS missions before 2016 were based on IAEA Safety Standard GS-R-3: The Management

System for Facilities and Activities, published in 2006. This was superseded in 2016 by GSR Part 2:

Leadership and Management for Safety. To be able to make valid statements on the references and

observations of all missions, references to GS-R-3 were converted to their equivalent in GSR Part 2.

2.5 GSR Part 7 versus GS-R-2

The IRRS missions before 2016 were based on IAEA Safety Standard GS-R-2: Preparedness and

Response for a Nuclear or Radiological Emergency, published in 2002. This was superseded in 2015

by GSR Part 7: Preparedness and Response for a Nuclear or Radiological Emergency. Although the

main principles and requirements of the two documents are the same, they differ both in structure and

format. To be able to make valid statements on the references and observations of all missions,

references to GS-R-2 were converted to their equivalent in GSR Part 7.

Moreover the content of the module 10 was revised in 2017 to ensure more adequate focus on the

regulatory aspects of emergency preparedness and response. This revision has been reflected in the

report template used from the second half of 2017. Therefore direct comparison might not be easily to

conduct. This has been taken into account in producing this report.

2.6 Missions analyzed

This analysis covers 69 initial and 26 follow-up IRRS missions to 65 Member States. Figure 2 shows

the year and location of the IRRS missions conducted. Follow-up missions are denoted by (f), the UK

part 2 mission was a mixture of follow-up and initial mission, all other missions were initial missions.

Belgium (f)

Tanzania

Botswana

Ireland

Cyprus

Republic of

Korea (f) Indonesia

South Africa

Czech Rep (f)

Niger

UAE

France Finland (f) Italy Ethiopia

Mexico Germany

Canada (f)

Zimbabwe Croatia Belarus France (f)

Mauritius Ukraine Russia

Switzerland

Netherlands Hungary Estonia Greece (f)

Cameroon

Sierra Leone

UK (part 2)

Australia (f)

Belgium Cameroon Armenia Kenya Guatemala

Kenya Namibia Vietnam

Slovenia

Czech Rep

Vietnam (f) Switzerland

(f) China (f) Jordan (f)

Uganda Madagascar Lebanon

Ukraine (f)

Germany (f)

Finland Russia

(f) Slovenia (f) Malta

Sweden (f)

FYR of Macedonia

France Gabon Botswana Canada USA Republic of

Korea Greece UK (f) Jordan India Lithuania Nigeria

UK Australia Spain Peru China Spain (f) Slovakia Bulgaria Pakistan Slovakia (f) Bulgaria

(f) Poland (f)

Romania Japan Cote

d’Ivoire France

(f) Iran Romania Sweden Poland USA (f) UAE (f) Japan

Romania (f)

2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017

Figure 2 IRRS Missions from 2006 to 2017

2.7 Limitations and assumptions of the analysis

IRRS missions vary substantially in their scope, based both on the nuclear and radiological facilities

and activities in the Member State and the decision by the Member State on what facilities and

activities to include in the scope. This analysis includes data from 95 IRRS missions, which is

sufficient to draw meaningful conclusions on general characteristics and trends. However, individual

mission data vary substantially, due to:

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• Scope and size of the mission;

• Composition, expertise and size of the team;

• Working methods of the team leader and members;

• Nuclear and radiological activities in the Member State;

• Evolution of the IRRS process over time.

2.8 Basis for the analysis of findings to the IAEA Safety Standards

The purpose of the IRRS is to assess the host Member State national regulatory infrastructure against

the relevant IAEA Safety Standards through a peer review. Thus, the Recommendations, Suggestions

and Good Practices identified during a mission are based on IAEA Safety Standards that are clearly

documented in the mission report. Any requirement in any IAEA Safety Standard may form the basis

for a Recommendation, Suggestion or Good Practice. Figure 3 shows how the IRRS mission report

identifies the basis for Recommendations, Suggestions and Good Practices.

Figure 3 Examples of IAEA Safety Standard requirements as bases for observations

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Each time a particular requirement from an IAEA Safety Standard was used as a basis for a

Recommendation or Suggestion was counted as a reference to that requirement. If two separate

requirements from the same IAEA Safety Standard were cited as the basis for a particular

Recommendation or Suggestion, then that would count as two references to that IAEA Safety

Standard. However, if a requirement was cited more than once for the same Recommendation or

Suggestion, then that would count as a single reference.

3 Analysis of Recommendation and Suggestion references to the IAEA Safety Standards

3.1 General references to IAEA Safety Standards

As Figure 4 shows, almost half of the references are to GSR Part 1. GSR Part 3 accounts for 15% of

the references, with GSR Part 2, GSR Part 7 and various IAEA Safety Guides accounting for around

10% each.

Figure 4 References to IAEA Safety Standards

Referring again to Figure 4, for the requirements documents (GSR Part 1, GSR Part 2, GSR Part 3 and

GSR Part 7), the references are predominantly related to Recommendations, while for the Safety

Guides, the references are predominantly related to Suggestions. This is as expected, since

Recommendations are only issued where there is non-compliance with a safety requirement. Guidance

documents identify approaches for achieving the safety requirements but do not introduce new safety

requirements. In every case where an IAEA Safety Guide is used as a basis for a Recommendation,

there is also an IAEA Safety Requirements document as a basis.

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3.2 References to GSR Part 1: Governmental, Legal and Regulatory Infrastructure for Safety

Figure 5 References to GSR Part 1 (sorted by Requirement number)

As Figure 5 shows, every requirement in GSR Part 1 was referenced by at least one Recommendation

and one Suggestion during the reporting period, with the references for Recommendations usually

outnumbering the references for Suggestions for a given requirement.

Figure 6 presents the same data sorted from most frequent to least.

Figure 6 References to GSR Part 1 (sorted by frequency)

Figure 6 shows that the following requirements are referenced most frequently:




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• Requirement 4: Independence of the regulatory body;

• Requirement 29: Graded approach to inspections of facilities and activities.

The least frequently referenced requirements are:

• Requirement 12: Interfaces of safety with nuclear security and with the State system of

accounting for, and control of, nuclear material;

• Requirement 21: Liaison between the regulatory body and authorized parties;

• Requirement 6: Compliance with regulations and responsibility for safety;

• Requirement 8: Emergency preparedness and response;

• Requirement 13: Provision of technical services.

3.3 References to GSR Part 3: Protection and Safety of Radiation Sources: International Basic Safety Standards

The second most frequently referenced requirements document was GSR Part 3. As Figure 7 shows,

almost three quarters of the references to GSR Part 3 were for Recommendations.

Figure 7 References to GSR Part 3 (sorted by frequency)

Figure 7 shows that the following GSR Part 3 requirements are referenced most frequently:






situations;

• Requirement 3: Responsibilities of the regulatory body.

The following GSR Part 3 requirements are not referenced in any IRRS mission:

• Requirement 5: Management for protection and safety;

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2 34 38 32 47 3 8 36 31 37 35 11 41 24 25 21 29 42 49 7 20 13 40 14 27 39 50 52 48 51 19 22 33 30 26 6 10 23 28 12 45 1 44 9 43 4 17 46 18 5 15 16

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• Requirement 15: Prevention and mitigation of accidents;

• Requirement 16: Investigations and feedback of information on operating experience.

Of the GSR Part 3 requirements that are referenced in an IRRS mission, the least frequently

referenced requirements are:

• Requirement 18: Human imaging using radiation for purposes other than medical

diagnosis, medical treatment or biomedical research;

• Requirement 46: Arrangements for the transition from an emergency exposure situation

to an existing exposure situation;

• Requirement17: Radiation generators and radioactive sources;

• Requirement 4: Responsibilities for protection and safety;

• Requirement 43: Emergency management system;

• Requirement 9: Responsibilities of registrants and licensees in planned exposure

situations;

• Requirement 44: Preparedness and response for an emergency;

• Requirement 1: Application of the principles of radiation protection.

3.4 References to GSR Part 2: Leadership and Management for Safety

Figure 8 References to GSR Part 2

As shown in Figure 8, the five most common GSR Part 2 requirements referenced are:

• Management of processes and activities (Requirement 10);

• Documentation of the management system (Requirement 8);

• Measurement, assessment and improvement of the management system (Requirement

13);

• Integration of the management system (Requirement 6);

• Goals, strategies, plans and objectives (Requirement 4).

Figure 8 also shows that three GSR Part 2 requirements received fewer than 10 references:

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• Management of the supply chain (Requirement 11);

• Achieving the fundamental safety objective (Requirement 1);

• Interaction with interested parties (Requirement 5).

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3.5 References to GSR Part 7: Preparedness and Response for a Nuclear or Radiological Emergency

Another frequently referenced standard in IRRS mission Recommendations and Suggestions was GSR

Part 7.

Figure 9 References to GSR Part 7

As shown in Figure 9, the top five requirements referenced are:

• Roles and responsibilities in emergency preparedness and response (Requirement 2);

• Identifying and notifying a nuclear or radiological emergency and activating an

emergency response (Requirement 7);

• Training, drills and exercises for emergency preparedness and response (Requirement

25);

• Hazard assessment (Requirement 4);

• Plans and procedures for emergency response (Requirement 23).

Figure 9 also shows that the following requirements were not referenced in any IRRS mission:

• Mitigating non-radiological consequences of a nuclear or radiological emergency and of

an emergency response (Requirement 16);

• Requesting, providing and receiving international assistance for emergency preparedness

and response (Requirement 17).

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4 Analysis of Good Practice references to the IAEA Safety Standards

4.1 Overall references to Good Practices

Another objective of the IRRS is to share Good Practices among regulatory bodies. Many IRRS initial

missions identified at least one Good Practice. Figure 10 shows the references related to Good

Practices.

Figure 10 Overall references to Good Practices

GSR Part 1 accounted for 65% of the references. However, IRRS missions identified Good Practices

related to GSR Part 2, GSR Part 3 and GSR Part 7 requirements. For GSR Part 1, the ratio of Good

Practices to Recommendations and Suggestions was 1:7, while for GSR Part 2 and GSR Part 7, the

ratio was around 1:10, and for GSR Part 3, the ratio was around 1:30.

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GSR Part 1 Safety Guides GSR Part 7 GSR Part 2 GSR Part 3 OtherRequirements

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4.2 Good Practice references to GSR Part 1

Figure 11 Good Practice references to GSR Part 1 (sorted by frequency)

Figure 11 shows that every GSR Part 1 requirement except Requirements 6 and 13 were referenced in

at least one IRRS mission.

The top five requirements referenced with respect to a Good Practice are:



• Requirement 27: Inspection of facilities and activities;


and assistance;

• Requirement 24: Demonstration of safety for the authorization of facilities and activities.

The least referenced requirements with respect to a Good Practice are:

• Requirement 13: Provision of technical services;


• Requirement 30: Establishment of a compliance policy;


accounting for and control of nuclear material;

• Requirement 5: Prime responsibility for safety.

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Figure 12 Recommendation & Suggestion vs Good Practice references to GSR Part 1

Figure 12 shows that, with three exceptions, the number of references to a requirement for Good

Practices is a small fraction of those references for Recommendations and Suggestions combined.

The three exceptions are for:

• Requirement 14: International obligations and arrangements for international cooperation;


• Requirement 36: Communication and consultation with interested parties.

In these cases, the number of references to Good Practices is more than 40% of the number of

Recommendations and Suggestions combined.


Figure 13 Good practices references to GSR Part 2

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2 24 32 18 4 29 27 7 23 33 22 19 16 26 25 30 1 20 31 10 36 11 28 17 15 3 14 34 35 9 5 13 8 6 21 12

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Figure 13 shows that the GSR Part 2 requirements receiving the highest number of references for

Good Practices are:

• Provision of resources (Requirement 9);

• Management of processes and activities (Requirement 10);

• Foster a culture for safety (Requirement 12);

• Measurement, assessment and improvement of the management system.

Four requirements did not receive a reference for a Good Practice:

• Management of the supply chain (Requirement 11);

• Application of the graded approach (Requirement 7);

• Interaction with interested parties (Requirement 5);

• Achieving the fundamental safety objective (Requirement 1).


Referring to Figure 14, it is seen that for the number of references to a Good Practice is a fraction of

the number of references to a Recommendation or Suggestion.

Note that Requirement 11: Management of the supply chain, was never referenced in an IRRS

mission.

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Figure 15 Good Practice references to GSR Part 3

Figure 15 shows that only 18 GSR Part 3 requirements were referenced for a Good Practice. The GSR

Part 3 requirements receiving more than one reference for a Good Practice are:


• Requirement 30: Responsibilities of relevant parties specific to public exposure;

• Requirement 31: Radioactive waste and discharges;


• Requirement 37: Justification of medical exposures;

• Requirement 41: Unintended and accidental medical exposures;

• Requirement 49: Responsibilities for remediation of areas with residual radioactive

material.


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Good Practices

17

Referring to Figure 16, it is seen that the number of references to a Good Practice is a small fraction of

the number of references to a Recommendation or Suggestion.

Three GSR Part 3 requirements, namely:

• Requirement 5: Management and protection for safety;

• Requirement 15: Prevention and mitigation of accidents;

• Requirement 16: Investigations and feedback of information on operating experience,

have never been referenced in an IRRS mission. The essential elements of these three requirements are

covered by requirements in other IAEA Safety Standards.

4.5 Good practice references to GSR Part 7

Figure 17 Good Practice references to GSR Part 7

As Figure 17 shows, 17 GSR Part 7 requirements were referenced for a Good Practice. The GSR Part

7 requirements receiving more than two references are:

• Roles and responsibilities in emergency preparedness and response (Requirement 2);

• Logistical support and facilities for emergency response (Requirement 24);

• Managing operations in an emergency response (Requirement 6);

• Training, drills and exercises for emergency preparedness and response (Requirement

25);

• Identifying and notifying a nuclear or radiological emergency and activating an

emergency response (Requirement 7);

• Communicating with the public throughout a nuclear or radiological emergency

(Requirement 13);

• Plans and procedures for emergency response (Requirement 23).

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Referring to Figure 18, it is seen that, with three exceptions, the number of references to a Good

Practice is typically a small fraction of the number of references to a Recommendation or Suggestion.

For two of the exceptions, namely:

• Logistical support and facilities (Requirement 24);

• Emergency management system (Requirement 1),

the number of Good Practice references is around half of the Recommendation and Good Practice

references.

One requirement—Requirement 16: Mitigating the non-radiological consequences of a nuclear or

radiological emergency— is only referenced for a Good Practice.

Finally, one requirement—Requirement 17: Requesting, providing and receiving international

assistance for emergency preparedness and response—was not referenced in any IRRS mission.

5 Analysis of observations by subject groups

Another way of categorizing the observations from IRRS missions is to sort them according to the

subject. The subjects that more frequently result in Recommendations and Suggestions should receive

further consideration, as this indicates that a number of Member States may face the similar

challenges.

5.1 Introduction

The subject groups do not have exact definitions; rather they comprise sufficient numbers of

observations sharing the same or similar characteristics. Consequently, although a mission report may

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19

place a Recommendation in a particular module, for the purpose of this analysis, observations may be

allocated to another, more appropriate subject group in another module.

In the following sections, the number of observations (Recommendations, Suggestions and Good

Practices) for each module are tabulated, with those subject groups with the most observations

highlighted.

Observations from Module 11 2 of IRRS missions have been reallocated to Modules 1 to 10 as

appropriate. Every observation from the IRRS missions is included in the analysis by subject groups.

In the following sections, the number of observations (Recommendations, Suggestions and Good

Practices) for each module is tabulated, with those subject groups with the most observations

highlighted.

5.2 Module 1: Responsibilities and functions of the government

There are eight subject groups associated with the responsibilities and functions of the government:

a) Cooperation/interaction among organizations, bodies: Role of the regulatory body in various

fields and cooperation amongst the respective authorities; coordination with other

governmental organizations; common use of databases; memoranda of understanding.

b) National policies and strategies for safety: National safety policy and strategy; training

policy and strategy; competence/human resources building strategy.

c) Providing resources to the regulatory body: Provision of financial and human resources by

the government; resources for international cooperation; adjusting funding to workload.

d) Providing/using legal framework for regulatory activities: Revision of regulations to provide

authority; reflecting independence of the regulatory body; issuance of decrees and orders;

relieving time constraints on decision making.

e) Transparency, public involvement: Determining the role of the public in the regulatory

process; stakeholder engagement; establishing communication strategy; informing the public;

meeting with residents; public consultations; impact of transparency on safety.

f) Prime responsibility for safety: Clarifying the responsibilities of the regulatory body;

declaration by law; declaration by the regulatory body.

g) Building competence in safety: Recommending training for other organizations; qualification

and registration of experts; establishment of international school; capacity building

programme for students.

x) Other: Any other government responsibilities and functions subject not included above.

As Table 2 shows, a total of 825 observations were related to the responsibilities and functions of the

government, the largest number of any module. Four subject groups accounted for most of these

observations, namely:

• Cooperation / interaction among organizations, bodies;

• National policies and strategies for safety;

• Providing / using the legal framework for regulatory activities;

• Independence of the regulatory body.

Table 1 Number of observations by subject group for government responsibilities and functions

Subject group R S GP

2 Such as: transport; control of medical exposures, occupational radiation protection; control of radioactive

discharges and materials for clearance; environmental monitoring associated with authorized practices for public

radiation protection purposes; control of chronic exposures and remediation

20

a Cooperation/interaction among organizations, bodies 62 55 16

b National policies and strategies for safety 136 51 15

c Providing resources to the regulatory body 43 6 0

d Providing/using legal framework for regulatory activities 138 31 12

e Transparency, public involvement 17 26 27

f Prime responsibility for safety 20 16 2

g Building competence in safety 34 23 12

h Independence of the regulatory body 58 19 5

x Other 1 0 0

Σ Sum of observations 509 227 89

5.2.1 Highlights of observations

5.2.1.1 Cooperation / interaction among organizations, bodies

Arrangements should be made for the effective coordination of the authorities having regulatory

responsibilities for nuclear and radiation safety, as well as those responsible for the regulation of the

transport of radioactive material. Consideration should be given to assigning one organization the

responsibility for coordinating the nuclear and radiological safety infrastructure.

Formal agreements and memoranda of understanding should be used to clarify the relationships

between organizations.

Consideration should be given to conducting joint activities, such as review and assessment and

inspections.

5.2.1.2 National policies and strategies for safety

A national policy and strategy for safety should be established. The policy and strategy should include

all nuclear and radiological facilities and activities in the Member State, including decommissioning,

waste management and the transport of radioactive material.

The national strategy should include mechanisms for the funding of the decommissioning of nuclear

and radiological facilities.

Time limits prescribed for the completion of a safety review prior to the granting of an authorization

for a facility or activity should be flexible enough to ensure safety is not compromised.

Organizations taking actions to recover and manage orphan sources should have access to adequate

funding and resources.

Action should be taken to bring all unlicensed nuclear and radiological facilities under regulatory

control.

An action plan for controlling public exposure due to radon should be established and implemented.

5.2.1.3 Providing resources to the regulatory body

The regulatory body should have sufficient human and financial resources to completely fulfil its

statutory regulatory obligations.

21

5.2.1.4 Providing / using the legal framework for regulatory activities

The legal framework should extend to include all nuclear and radiological facilities and activities in

the Member State, including the regulation of patient protection, transport of radioactive material,

waste management and disposal of radioactive material.

The legal framework should clearly delineate the roles, responsibilities and authorities of the various

entities in the Member States and should include a requirement that a positive decision from the

regulatory body is a prerequisite to issuing an authorization.

The legal framework should empower the regulatory body to establish requirements for authorization.

The legal framework should include provisions for an applicant or authorized party to appeal a

decision of the regulatory body.

The legal framework should explicitly address the interface between safety and security, including

oversight and enforcement.

5.2.1.5 Transparency, public involvement

Interested parties including the public should be informed and consulted regarding possible radiation

risks associated with facilities and activities, and about the processes and decisions of the regulatory

body. Specific provisions should be in place to foster consultation of interested parties in regulatory

body processes.

5.2.1.6 Prime responsibility for safety

Legislation should explicitly assign primary responsibility for safety to the persons or organizations

responsible for facilities and activities.

5.2.1.7 Building competence in safety

Provisions should be in place to ensure the competence of all parties having responsibilities for the

safety of facilities and activities.

Appropriate qualification requirements should be established and training arrangements should be

made to ensure a reliable supply of competent radiation specialists (i.e., Radiation Protection Officers,

medical radiation technologists, radiopharmacists and radiochemists).

A process for the formal recognition of medical physicists and qualified experts for radiation

protection should be established.

Provisions should be in place for research and development programmes to support nuclear and

radiological safety.

5.2.1.8 Independence of the regulatory body

Provisions should be in place to ensure that the regulatory body is effectively separate from entities

having responsibilities or interests that could unduly influence its decision-making.

The regulatory body should have the authority to assign its resources and reorganize or restructure to

enable it to discharge its assigned responsibilities.

22

With regard to the national policy and strategy, the regulatory body should limit its advice to nuclear

and radiological safety issues. In addition, the regulatory body should avoid assuming responsibilities

that conflict with its statutory regulatory responsibilities.

5.2.1.9 Good Practices

• A statutory requirement to comply with IAEA Safety Standards.

• Cooperation between the regulatory body and police and customs services supports an

integrated approach to safety and security of radiation sources.

• The national radon control strategy uses a “top down” approach driven by Government,

ensuring all stakeholders work together.

• The Member State system of radiation protection education and training is exemplary.

• The promotion of public education on national television and the engagement of the

regulatory body to provide technical expertise.

• Routine workshops and training for news media to inform them of the safety of facilities

and activities, and about the processes and decisions of the regulatory body.

5.3 Module 2: Global Nuclear Safety Regime

There are three subject groups associated with the Global Nuclear Safety Regime:

a) Operating and regulatory experience exchange with international community: Operating

and regulatory experience feedback in line with the international recommendations; exchange

with the international community; publication of research results and experience; action plan

based on review missions; use of IAEA Safety Standards.

b) Relationship with international organizations: Resources for international cooperation; role

of national coordinator; inviting IRRS missions; participation in international conventions.

c) Relationship with other countries’ regulatory bodies: Establishing liaison and cooperation

with neighbouring countries, countries with similar technology and countries supplying

technology or equipment.

x) Other: Any other Global Nuclear Safety Regime subject not included above.

Table 3 shows that 103 observations were related to the Global Nuclear Safety Regime, the fewest

number of any module. This module was unique in that the number of Good Practices was almost the

same as the number of Recommendations.

Table 2 Number of observations by subject group for Global Nuclear Safety Regime


a Operating and regulatory experience exchange with international community 8 8 9

b Relationship with international organizations 15 20 9

c Relationships with other countries’ regulatory bodies 8 14 12

x Other 0 0 0



5.3.1.1 Operating and regulatory experience exchange with international community

Arrangements for operating and regulatory experience feedback should include radiation safety and

radiation protection. The operating and regulatory experience feedback should be disseminated to

authorized parties, the regulatory body and other relevant authorities.

23

5.3.1.2 Relationship with international organizations

Resources should be provided to enable active participation in international cooperation activities for

safety, such as sharing of regulatory experience and participation in IAEA safety review missions.

5.3.1.3 Relationships with other countries’ regulatory bodies

Neighbouring countries should be included in the public consultation process for nuclear facilities that

could affect those countries.

Countries should liaise with, and establish arrangements with, regulatory bodies of other countries

using similar technology.


• Active engagement in international cooperation including international arrangements,

peer reviews and international support programmes.

• Use of state-of-the-art safety standards from foreign regulatory bodies to cover gaps in

the national framework.

5.4 Module 3: Responsibilities and functions of the regulatory body

There are nine subject groups associated with the responsibilities and functions of the regulatory body:

a) Staffing of the regulatory body: Staffing needs; recruitment programme; rotation of positions;

exchange of staff with technical support organizations; retention, hiring, motivation of staff;

filling vacancies; recruitment of successors.

b) Competence of the regulatory body: Necessary/adequate qualifications and expertise;

competence requirements; continuity of actions and consistency of priorities following staff

changes; capability of performing tasks; procedure and control of staff qualification needs.

c) Resources of the regulatory body: Determining/planning/reviewing resource needs for given

tasks; managing available resources; financing external support; salaries; charging fees for

regulatory activities; resources for research activities.

d) Organization of the regulatory body: Evaluating task assessments; integration of inspector

tasks; reviewing the organization to increase effectiveness; internal cooperation.

e) Developing documents for regulatory activities and cooperation: Research and development

programme; cooperation documents; document management.

f) External involvement in the regulatory process: Advisory committees; involvement of other

organizations in nuclear safety matters; technical support organizations; policy for seeking

external expert advice; relationship with licensees.

g) Training of regulatory body personnel: Establishment of a systematic training programme;

specific contents of training; training requirements of staff; mentoring programme.

h) Decision-making process, content of decisions: Developing/reviewing the decision-making

process; communicating the bases of decisions; diverse decision formats.

x) Other: Any other regulatory body responsibilities and functions subject not included above.

As seen in Table 4, there were 292 observations related to the responsibilities and functions of the

regulatory body, the third highest number of observations for a module. The subject groups most

frequently identified were:

• Staffing of the regulatory body;

• Competence of the regulatory body;

• Training of the regulatory body.

24

Also note the large number of Good Practices identified for training of the regulatory body.

Table 3 Number of observations by subject group for Regulatory Body Responsibilities and Functions


a Staffing of the regulatory body 30 24 8

b Competence of the regulatory body 21 31 9

c Resources of the regulatory body 10 10 2

d Organization of the regulatory body 5 12 1

e Developing documents for regulatory activities and cooperation 8 6 1

f External involvement in the regulatory process 7 13 3

g Training of the regulatory body 30 19 13

h Decision making process, contents of decisions 13 5 3

x Other 0 4 4



5.4.1.1 Staffing of the regulatory body

A long term human resources plan to ensure the availability and competence of staff involved in

regulatory functions should be developed and maintained.

Procedures should be developed so that personnel are selected and trained so they have the requisite

knowledge, skills and abilities for the position.

5.4.1.2 Competence of the regulatory body

The regulatory body should have access to technical capabilities to review and assess safety

submissions. The regulatory body should have sufficient expertise in radiation safety.

5.4.1.3 External involvement in the regulatory process

The regulatory body should consult and communicate with interested parties, including the public, on

regulatory judgements and decisions.

5.4.1.4 Training of the regulatory body

Comprehensive training plans should be created and implemented to improve knowledge, skills and

abilities to perform all the functions and responsibilities.

The regulatory body should establish a process for developing and maintaining the necessary

competences and skills of its staff.

5.4.1.5 Decision-making process, contents of decisions

The regulatory body should record the results and decisions arising from review and assessment of

applications.

25


• A system, implemented annually, for establishing and addressing the competence and

training needs among its staff aimed at improving their contribution to achievement of

organizational goals;

• Employees are included in systematic planning and follow-up of training. The

dissemination of information of the lessons learned in international courses and seminars,

and the self-assessment of the usefulness of received training is an integral part of the

management of training.

5.5 Module 4: Management system of the regulatory body

There are seven subject groups associated with the management system of the regulatory body:

a) Developing an integrated management system, general: Commitment to establish a

management system; person responsible for developing the management system; improving

the management system; managers to be involved in the development; communicating the

management system to staff; process map.

b) Details of, and documenting the management system: Development of processes and

procedures, updating documentation.

c) Management system review and audits: Self assessments, independent assessments, audits,

review methodology.

d) Safety culture: Formalization; common understanding; assessment; survey; promotion by

management.

e) Knowledge management and information technology tools: Intranet applications;

implementation of a knowledge management system; document management; records

management; tracking regulatory actions.

f) Managing organizational changes: Develop process; include in the management system.

x) Other: Any other regulatory body management system subject not included above.

Table 5 shows that there were 317 observations associated with the management system of the

regulatory body, with the most common subject groups being the development of the integrated

management system and knowledge management and information technology tools.

Table 4 Number of observations by subject group for Management System


a Developing an (integrated) management system, general 75 23 11

b Details of and documenting the management system 24 24 2

c Management system review and audits 11 22 5

d Safety culture 12 20 7

e Knowledge management and information technology tools 20 35 18

f Managing organizational changes 3 5 0

x Other 0 0 0


26


5.5.1.1 Developing an integrated management system, general

The regulatory body should establish and implement an integrated management system, based on GSR

Part 2.

An individual should be appointed with the authority to coordinate and develop the integrated

management system and to raise issues relating to the management system to senior management.

The regulatory body should identify, develop and document all key processes contributing to safety.

5.5.1.2 Details of and documenting the management system

All the key elements of the management system should be documented and staff should have ready

access to this documentation.

5.5.1.3 Management system reviews and audits

A system for self-assessment and independent assessment of leadership for safety and of safety culture

in the organization should be developed.

5.5.1.4 Safety culture

The management system of the regulatory body should be developed so as to foster a strong safety

culture and provide structure and direction in a way that permits and promotes the development of

such a culture.

5.5.1.5 Knowledge management and information technology tools

A records management policy should be developed to ensure that the regulatory body maintains all the

records necessary to account for the safe operation of facilities and the safe conduct of activities.

A national register of radiation sources should be established. This national register should also

include records of the occupational exposure history of each worker.

Provisions should be in place for a national system of records covering all the data gathered before,

during and after remediation.


• A documented system provides a link between the legislation mandating the organization

and individual contribution to delivery of goals, including corporate values and

behavioural expectations.

• Annually, senior management visits all functional units of the regulatory body and

discusses the goals and topical issues of the organization directly with employees.

• Legislation requires the regulatory body to periodically conduct a self-assessment and

invite an international peer review.

• Safety culture self-assessment.

• A regulatory framework web-portal with links between different levels of requirements

and guides.

• Web-based systems for new licence applications and for renewals and amendments of

existing licences and for collection of transport of radioactive material information.

27

5.6 Module 5: Authorization

There are seven subject groups associated with authorization:

a) Authorization of modifications and backfitting: Safety classifications; accounting for state of

the art in other Member States; basis for decision; approval of organizational changes; safety

assessment.

b) Authorization of new facilities and activities: Preparations; authorization process; pre-

certification; updating licensing criteria.

c) Licensee authorizations permitted by the regulator, graded approach: Collecting experience;

adopting graded approach.

d) Procedures and guidance: Steps for licence issuance; categorization of modifications; format

and content of applications; consistency of provisions; risk information; use of IAEA Safety

Standards.

e) Authorization of personnel, confirming competence: Direct evidence of qualifications;

positions to be included; qualification requirements; consistent and graded approaches;

adequate training.

f) Licence duration and hold points: Hold point for integrated review; hold points for operation;

authorization before licence expiry; licence renewal; time limits for licences.

g) Scope of authorizations: The range of activities covered by the activities of the regulatory

body; gaps, omissions and overlaps in authorizations

h) Radioactive source registry: Establishment and maintenance of a comprehensive radioactive

source inventory in the country

x) Other: Any other authorization subject not included above.

The authorization module was just behind inspection for the highest number of observations, at 415.

However, it had the highest number of observations resulting in Recommendations and Suggestions.

Table 6 shows that procedures and guidance accounted for the most authorization observations. Also

note that IRRS reviewers also identified ten Good Practices for that same subject group.

Table 5 Number of observations by subject group for Authorization


a Authorization of modifications and back-fittings 8 4 4

b Authorization of new facilities and activities 19 10 5

c Authorization by licensee / graded approach 43 29 2

d Procedures and guidance 111 73 16

e Authorization of personnel, confirming competence 22 13 6

f License validity time and hold points 2 6 0

g Scope of authorizations 3 3 1

h Radioactive source registry 14 7 6

x Other 7 0 1



5.6.1.1 Authorization of new facilities and activities

A process should be established, in accordance with a graded approach, for the authorization of

facilities and activities as required by GSR Part 1 and GSR Part 3. The requirements for authorization

28

should include the detailed specification of all radiation sources/devices associated with the facility or

activity.

The regulatory body should approve transport packages or validate the approval certificates of

transport packages in accordance with SSR-6.

5.6.1.2 Graded approach

The regulatory body should establish guidance for staff on the implementation of the graded approach

in all its regulatory processes.

The regulatory system for protection and safety should include a process for notification, with criteria

for when notification only is sufficient.

The principle of a graded approach should be included the nuclear and radiological safety law.

5.6.1.3 Procedures and guidance

The regulatory framework should include the arrangements and responsibilities for justification and

optimization of practices and only justified practices should be authorized.

Existing exposure situations should be evaluated to determine which occupational exposures and

public exposures are of concern.

There should be objective and clear criteria and procedures for issuing, amending, renewing,

suspending and revoking an authorization. The authorization process for facilities should proceed in

distinct steps (e.g. facility design, construction, operation, closure). Where appropriate, inspection

findings, regulatory actions and feedback from operational performance should be taken into account

in authorization decisions. The authorization process should include provisions for the appeal of a

decision.

The authorization process for facilities should include a requirement for a decommissioning plan.

5.6.1.4 Competence of qualified experts and staff, including authorization

A process should be in place regarding the formal recognition of qualified experts for radiation

protection and for medical physicists.

There should be a requirement for authorized parties to designate a radiation protection officer and to

provide radiation protection training to all employees.

5.6.1.5 Good Practice

• For Category 1 safety modifications, a condition is added to the authorization amendment

requiring the authorized party to notify the regulatory body of the installation and testing

dates of the modification and to submit test data. The regulatory body uses this

information to plan subsequent inspections and independently validate the

appropriateness of facility modifications.

5.7 Module 6: Review and assessment

There are ten subject groups associated with review and assessment:

a) Developing the review and assessment process: Human factors and organizational aspects;

graded approach; safety analysis report; commissioning programme.

29

b) Procedures and guidance: Review and assessment process of nuclear facilities; periodic

verifications/safety review; acceptance of external experts; licensee safety performance.

c) Technical support: Identification of available support; ensuring availability; financing;

competence.

d) Independent verification by the licensee: Requiring; independence.

e) Operational experience feedback: Identification, sharing lessons learned; strengthening the

process; event reporting and analysis; collecting events from other facilities.

f) Periodic Safety Review, updating the Safety Analysis Report: Need for periodic safety

review, process for review of periodic safety review, regular updating of safety analysis

report.

g) Probabilistic Safety Analysis (PSA): Review of the PSA model; considering probabilistic

insight; assessing operator performance; severe accident management; risk-informed decision

making; use of PSA as a regulatory tool.

h) Ageing management: Consistency of assessment methods; guidance; extension to newer

NPPs.

i) Safety performance: Safety performance indicators; assessing operator performance.

x) Other: Any other review and assessment subject not included above.

Table 7 shows that 224 observations were related to review and assessment. procedures and guidance

were the subject most frequently identified in review and assessment. IRRS missions also identified 22

Good Practices related to review and assessment procedures and guidance, the most of any subject

group in any module. IRRS reviewers identified more Good Practices (57) in review and assessment

than in any other module.

Table 6 Number of observations for Review and Assessment


a Developing the review and assessment process 5 3 6

b Procedures and guidance 36 29 9

c Technical support 1 3 0

d Independent verification by the licensee 10 4 0

e Operational experience feedback 13 18 12

f Periodic Safety Review, updating Safety Analysis Report 17 19 4

g Probabilistic safety analysis 0 10 4

h Ageing management 3 3 2

i Safety performance 5 3 5

x Other 0 0 0




Requirements should be established for the safety assessment to be submitted by applicants.

Procedures should be developed for the review and assessment of these submissions and for the

recording of the results.

Procedures and instructions should ensure sufficient information is gathered, reviewed and assessed in

order to verify the continued safety of transport packages that do not require specific regulatory body

approval in the country of origin.

30

Existing exposure situations should be identified comprehensively and systematically evaluated in

order to control public exposures.

5.7.1.2 Operational experience feedback

A formal process should exist for reviewing events. The process should include events at both in the

Member State and internationally.

The operating experience feedback process should be reviewed periodically to confirm that the criteria

require the reporting of all safety significant events, that lessoned are learned from these events and

that appropriate and timely measures are taken to prevent recurrence.

5.7.1.3 Periodic safety review, updating safety analysis report

There should be a requirement for authorized parties to periodically update their safety assessments.


• Requirement for periodic safety review for Category I, II and III sources;

• Established performance indicators to monitor research reactor performance;

• Scoring table for NPPs to aide in the determination of appropriate post event

investigations and oversight of corrective actions.

• Software developed by regulatory body to independently and quickly assess licensee

submissions.

• Requirement for ageing management programme for research reactors.

• Requirement for full scope level 1 and level 2 PSA for research reactors.

5.8 Module 7: Inspection

There are ten subject groups associated with inspection:

a) Developing the inspection programme: Preparations for inspections, development of

inspection plans; assessment, review, expansion of the programme; balance of resources for

specific inspections; inspections outside working hours; unannounced inspections; inspection

of all facilities; access to the sites.

b) Use of previous results: Use of periodic safety review and operating experience results in

inspection programme; use of performance information; use of licensee assessment reports;

optimizing objectivity of inspectors; inspection of specific activities.

c) Procedures and guidance: Inspection in general, inspection of human and organizational

issues; to enhance consistency; for reactive inspection; for follow-up; on recording issues;

checklists for inspection.

d) Follow-up of inspections: Need for; compilation of and access to a database; evaluation of

effectiveness of inspections; presentation of results, drawing conclusions; sharing lessons

learned from manufacturing; summarizing, analyzing and publishing inspection results;

tracking compliance.

e) Preparation of inspection reports: Standardization of the report format; inclusion of

references to requirements; timing of reporting.

f) Site inspectors: Objectivity and independence; rotation.

g) Inspection team composition: Removing the limitations, conflicts; diversity of team

members.

h) Graded approach: for inspection programme; for procedures; for inspection frequency; for

daily inspections.

31

i) Inspector training and qualification: Systematic process for training inspectors, formal

qualification or designation as inspector.

x) Other: Any other inspection subject not included above.

With 299 observations, inspection had the largest number of observations for a module. Table 8 shows

that the development of the inspection programme and its associated procedures and guidance were

the most common subject group in Module 7. There was also a high number of Suggestions related to

inspector training and qualification.

Table 7 Number of observations by subject group for Inspection


a Developing the inspection programme/system 65 46 13

b Use of previous results 1 9 1

c Procedures and guidance 24 47 11

d Follow-up of inspections (monitor, evaluate, share) 2 6 5

e Preparation of inspection reports 3 4 0

f Site inspectors 0 4 5

g Inspector team composition 0 0 0

h Graded approach 10 5 3

i Inspector training and qualification 9 17 9

x Other 0 0 0



5.8.1.1 Developing the inspection programme/system

The regulatory body should be empowered to have free access to all facilities and activities to verify

compliance with regulatory requirements. This should include the ability of the regulatory body to

conduct not just programmed inspections, but reactive inspections as a result of an incident or

unplanned event.

An inspection programme, be commensurate with the radiation risks associated with the facility or

activity and covering all areas relevant to safety and radiation protection, should be established and

implemented. The inspection programme should include both announced and unannounced

inspections. The inspection programme should cover the entire life cycle of a facility.

The inspection programme should include examination of the authorized party’s management system,

including safety culture. The programme should cover the entire range of regulated activities in the

Member State, including the transport of radioactive material. Where appropriate, the programme

should extend to manufacturers and suppliers.


Inspection procedures should be developed, approved and implemented. These procedures should

cover all pre-inspection, inspection and post-inspection activities. The procedures should include the

requirement for inspectors to conduct tests and take measurements as appropriate for independent

verification of safety of facilities and activities. The procedures should include checklists as required.

32

Procedures for joint inspections with other organizations and bodies should ensure effective

coordination.

5.8.1.3 Inspector training and qualification

A plan should be developed for increasing the number of staff with the required competencies to be

nominated as inspectors. A formal programme for inspector training and qualification should be

established.


• Formal ISO accreditation of inspection activities.

• Conduct of “verification” inspections to identify institutions and individuals who require

an authorization but who have never applied; and the requirement for them to either

obtain authorization or cease the activities.

5.9 Module 8: Enforcement

There are five subject groups associated with enforcement:

a) Developing the enforcement programme: Documentation of violations; legal basis for

authority.

b) Developing enforcement policy, tools and guidance: Enforcement policy; reviewing

enforcement tools; developing guidance; provisions for appeal.

c) Graded approach: including legal basis.

d) Sanctions: Range of sanctions, against both organizations and individuals.

x) Other: Any other enforcement subject not included above.

As Table 9 shows, there were 105 observations related to enforcement, with only one Good Practice

identified. Table 9 shows that almost all of the observations in Module 8 relate to the establishment of

the enforcement policy and the associated tools and guidance.

Table 8 Number of observations by subject group for Enforcement


a Establishing the enforcement policy and system 38 13 2

b Developing enforcement tools and guidance 17 21 1

c Graded approach 0 2 0

d Sanctions 4 6 0

x Other 1 0 0



5.9.1.1 Establishment of an enforcement policy

Detailed procedures for determining and exercising enforcement actions should be established. Staff

should be trained in, and knowledgeable about, these procedures.

Inspectors should have the authority to require corrective actions where there is significant safety

hazard.

33

5.9.1.2 Development of enforcement tools and guides

Procedures to implement the enforcement policy should be kept up-to-date. Enforcement tools should

be harmonized and applied using a graded approach.

Occupational exposure should be controlled in all activities, including transport of radioactive

material, so that dose limits are not exceeded.

5.10 Module 9: Regulations and guides

There are five subject groups associated with regulations and guides:

a) Developing of regulations and guides in general: Policy, strategy, plans of; resources; review

of the process; identification and issuance of regulations and guides; external support; public

involvement; performance-based standards; use of international standards.

b) Review of regulations and guides: Need for; feedback from interested parties; for inclusion of

specific issues; defining periodicity; order of priority; terminology.

c) Basic safety requirements: Observations related to conformance of Member State regulations

and guides with GSR Part 3: Radiation Protection and Safety of Radiation Sources:

International Basic Safety Standards.

d) Specific regulation or guide topics: Observations related to a specific document or topic

except for those covered by GSR Part 3.

x) Other: Any other regulations and guides subject not included above.

There were 633 observations related to regulations and guides, and as Table 10 shows, these

observations were mostly related to the development of regulations and guides in general. Although

there were a large number of observations related to specific regulations or guides, no pattern emerged

from the nature of these observations.

Table 9 Number of observations by subject group for regulations and guides


a Development of regulations and guides in general 53 38 17

b Review of regulations and guides 12 18 2

c Basic safety requirements 171 73 9

d Specific topics for regulations and guides 151 75 14

x Other 0 0 0



5.10.1.1 Developing regulations and guides in general

Processes for establishing or adopting, promoting and amending regulations and guides, including

consultation with interested parties, should be developed. These processes should take into account

internationally agreed standards and the feedback of relevant experience. Regulations and guides

should be in place for all regulated facilities and activities.

5.10.1.2 Basic safety requirements

Regulations and guides should be consistent with GSR Part 3 and should address worker, public and

medical exposures. The regulations should include requirements for adequate records of both

34

individual and workplace monitoring. The regulations should address the concepts of exemption and

clearance.

The regulations should require that workers are provided with training and the necessary equipment to

protect themselves from radiological hazards, and that workers use any provided equipment. In cases

where workers perform work in radiological areas not under control of their employer, the regulations

should require appropriate coordination and allocation of radiation protection responsibilities.

Conditions of service of workers should be independent of whether they are, or could be, subject to

occupational exposure. The concept of dose constraints should be an aspect of optimization of

protection for occupationally exposed workers.

The regulatory body should initiate development of requirements and develop associated guidance for

verification of compliance with discharge limits for all facilities.

5.10.1.3 Specific topics for regulations and guides

Many of the recommendations and suggestions were very specific. However, some issues that were

mentioned more than once include regulations regarding authorized party management systems,

problem identification and corrective action programmes, transport of radioactive material,

environmental protection, decommissioning and spent fuel and radioactive waste management.

5.11 Module 10: Emergency preparedness and response (regulatory aspects)

There are six subject groups associated with the regulatory aspects of emergency preparedness and

response:

a) Guidance and procedures for EPR: Use of IAEA safety standards and technical guidance;

operation of on-site emergency staff and the emergency staff of the regulatory body.

b) Communication/cooperation with other participants: With technical support organizations

and with local, governmental and national authorities; data and information exchange

mechanisms; harmonization of arrangements.

c) Emergency planning: Coordination with national emergency plans; coverage of various

stages of emergency; participation in reviewing; graded approach in planning.

d) Training and exercises: Systematic training programme; basic training for participants and

partners; full-scale and field exercises; frequency of exercises; expansion of scope of

exercises.

e) Complying with emergency preparedness and response requirements: Complying with GS-

R-2 in general; performing hazard assessment; establishing emergency classification system;

meeting minimum staffing requirements.

x) Other: Any other subject not included above.

There were 304 observations related to the regulatory aspects of emergency preparedness and

response. Table 11 shows that most observations in Module 10 were related to emergency planning.

Note that there was also a high number of Suggestions related to complying with technical

requirements.

Table 10 Number of observations by subject group for Module 10

Subject groups in Module 10 R S GP

a Guidance and procedures for participants 77 36 5

b Communication and cooperation with other participants 14 25 9

c Emergency planning 49 33 11

35

d Training and exercises 19 15 8

e Complying with EPR requirements 1 1 1

x Other 0 0 0

Σ Sum of Observations in the module 160 110 34


5.11.1.1 Guidance and procedures for participants

Roles and responsibilities for emergency preparedness and response should be clearly identified and

understood.

Authorized parties should be required to develop and update hazard assessments, implement a system

for classifying potential emergencies and for activation of an adequate level of emergency response.

The regulatory body should develop arrangements so that it can fulfil its emergency response roles.

Criteria should be established in advance for designating emergency workers in advance, including

making arrangements for their protection.

Operational criteria, including operational interventional levels, should be established so that effective

early protective actions and other response actions can be taken.

5.11.1.2 Communication and cooperation with other participants

Formal arrangements should be made for the involvement of stakeholders as part of the emergency

management system.

The emergency communication system should use diverse means and be available 24/7. This includes

the identification of a national contact point that is continuously available.

5.11.1.3 Emergency planning

Legislation and guidance should clearly define specific requirements on emergency preparedness and

response consistent with the IAEA Safety Standards. Legislation should assign the appropriate roles

and responsibilities on both the authorized party and the regulatory body for on-site emergency

response, provision of information to the public, for recovery work and for the transition to normal

activities.

The emergency classification system should be consistent with GSR Part 7.

Emergency preparedness and response activities should be covered by a comprehensive quality

assurance programme.

Medical facilities should be predesignated for initial treatment in case of radiological emergencies.

5.11.1.4 Training and exercises

Staff responsible for critical response functions should participate in regular training exercises and

drills, and these exercises and drills should be evaluated, both by the authorized party and the

regulatory body. Member States should consider conducting a large-scale emergency response

exercise.

36

Sufficient personnel should be trained to enable a long-term response to a nuclear or radiological

emergency.


• A database and process to systematically track all recommendations from emergency

exercises, including those of other organizations.

• The information to the public on emergency planning prior to an emergency is very

efficient in reaching all sectors of the population.

• Lessons learned from the Fukushima Daiichi NPP accident were promptly implemented

by updating emergency preparedness and response requirements for multi-unit accidents.

• Nuclear and radiological emergencies are well integrated on national and regional levels

and the regulatory body has a key role should a nuclear or radiological emergency occur.

5.12 Overall analysis of subject groups

Figure 19 shows the subject groups with the highest number of observations.

Regarding the subject group of “Specific topics for regulations and guides”, although there were a

large number of observations, these observations referred to many different Safety Requirement and

Safety Guide document. Within this broad range, there were a number of observations regarding the

need to introduce or update regulations and guides related to four topics:

• Transport of radioactive material;

• Environmental protection;

• Decommissioning of nuclear facilities;

• Spent fuel and radioactive waste management.

Regarding the topic of processes, procedures and guidance, these observations were broken out in the

various modules for management system, authorization, review and assessment, inspection,

enforcement and emergency preparedness and response. Taken together, however, they account for

289 Recommendations and 230 Suggestions, making the topic of procedures and guidance the most

frequent observation.

37

Figure 19 Subject groups with highest number of Recommendations and Suggestions

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Figure 20 shows the subject groups with the highest number of Good Practices. Note that in this case,

the subject group for specific topics for regulations and guides was excluded from the figure as no

pattern emerged from the observations.

Figure 20 Subject groups with highest number of Good Practices

Note that the following subject groups appear in both Figure 19 and Figure 20:

• Cooperation / interaction among organizations;

• National policies / strategies;

• Providing / using the legal framework;

• Developing an (integrated) management system;

• Authorization procedures and guidance;

• Developing the inspection programme;

• Inspection procedures and guidance;

• Development of regulations and guides;

• Emergency planning.

Again, if you combine the various Good Practices related to the topic of processes, procedures and

guidance, this number is also the largest by far, with IRRS reviewers identifying 56 Good Practices in

total.

0

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39

6 Follow-up missions

6.1 Closure rates for Recommendations and Suggestions

Not all Member States that have hosted an IRRS mission have hosted, or requested to host, a follow-

up mission. The main purpose of the follow-up mission is to review progress in implementing

improvements resulting from the initial IRRS mission Recommendations and Suggestions. The

follow-up mission peer reviewers will determine if each Recommendation and Suggestion can be

closed or remains open.

During the initial missions, the Recommendations and Suggestions are directed to either the Member

State government, or to the regulatory body, or to both. For the cases where follow-up missions have

taken place, during the initial missions, 69 Recommendations and Suggestions were directed to both

the government and the regulatory body, 224 Recommendations and Suggestions were directed to the

government alone and 960 Recommendations and Suggestions were directed to the regulatory body

alone.

Of the 293 Recommendations and Suggestions directed to Member State governments, 215 were

closed during the follow-up mission, while 79 remained open. Overall, the closure rate for Member

State governments is 73%. Of the 1018 Recommendations and Suggestions directed to regulatory

bodies, 854 were closed during the follow-up mission, while 164 remained open. Overall, the closure

rate for regulatory bodies is 84%. Given the large number of data points, there is a significant

difference in the two closure rates.

Upon closer examination, the difference is even more profound in some Member States. In three of the

initial missions, no Recommendations or Suggestions were directed to the Member State government.

In nine other cases, all of the Recommendations and Suggestions directed to the government were

closed, resulting in a closure rate of 100%. In addition to the cluster at 100%, ten missions had a

closure rate between 80 and 97%, seven missions had a closure rate between 44 and 79%, and there

was one outlier data point at 0%.

For regulatory bodies, the closure rate varied from 41% to 100%, with 18 regulatory bodies above

90%.

6.2 New observations resulting in Recommendations and Suggestions in follow-up missions

In addition to reviewing the progress made dealing with the Recommendations and Suggestions from

the initial mission, the follow-up mission may also include new review areas or may expand the

review of areas covered in the initial mission. In these cases, the follow-up mission will include new

observations, with the resulting Recommendations, Suggestions and Good Practices. Every follow-up

mission from 2006 to 2016 included new observations.

40

Figure 21 New references in follow-up missions

As Figure 21 shows, more than 40% of these new observations reference a requirement in GSR Part 1.

GSR Part 7, GSR Part 3 and Other Requirements documents each account for around 14% of the

references, while various Safety Guides are referenced in about 10% of the observations. GSR Part 2

is referenced in about 5% of the observations.

Figure 22 New references to GSR Part 1 in follow-up missions

Figure 22 shows that the GSR Part 1 requirements most frequently referenced in new

Recommendations or Suggestions in follow-up missions are:


• Requirement 7: Coordination with different authorities;

• Requirement 33: Review of regulations and guides.

0

20

40

60

80

100

120

GSR Part 1 GSR Part 7 GSR Part 3 OtherRequirements

Documents

Safety Guides GSR Part 2

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Recommendations

Suggestions

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Recommendations

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41

• Requirement 16: Organizational structure of the regulatory body and allocation of

resources;

• Requirement 20: Liaison with advisory bodies and support organizations.

Figure 23 Comparison between GSR Part 1 references (Recommendations & Suggestions) in initial and follow-up

missions

Referring to Figure 23, the relative frequency of references to GSR Part 1 Requirement 18, staffing

and competence of the regulatory body, is high in both initial and follow-up missions.

Figure 23 also shows that the following GSR Part 1 requirements, are least frequently referenced in

both initial and follow-up missions:

• Requirement 12: Interfaces of safety with nuclear security and with the State system for






• Requirement 5: Prime responsibility for safety.

0

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4

6

8

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12

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18

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2 24 32 18 4 29 27 7 23 33 22 19 16 26 25 30 1 20 31 10 36 11 28 17 15 3 14 34 35 9 5 13 8 6 21 12

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42

7 Analysis of IRRS missions related to the regulation of operating nuclear power plants (NPPs)

7.1 Introduction

Some IRRS missions reviewed the regulation of operating NPPs. In total, 540 Recommendations, 618

Suggestions and 296 Good Practices identified during IRRS missions relate to the regulation of

operating NPPs. It should be noted that many of these findings are not exclusively associated with the

regulation of operating NPPs. This chapter provides some analysis of these findings.

7.2 Reference to IAEA Safety Standards

The following analysis is based on those IRRS mission findings that are applicable to the regulation of

operating NPPs.

Figure 24 References to IAEA Safety Standards for observations related to operating NPPs

As Figure 24 shows, references to GSR Part 1 account for more than 55% of the findings related to the

regulation of operating NPPs, with Safety Guides, GSR Part 2, other Safety Requirements documents

and GSR Part 7 each accounting for around 10% of the references. GSR Part 3 accounted for less than

5% of the references.

For all of the Requirements documents, the references were split almost equally between

Recommendations and Suggestions, while for the Safety Guides, the majority of the references were

for Suggestions. In every case where an IAEA Safety Guide is used as a basis for a Recommendation,

there is also an IAEA Safety Requirements document as a basis.

0

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200

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GSR Part 7 GSR Part 3

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43

Figure 25 References to GSR Part 1 for observations related to operating NPPs

As Figure 25 shows, the most frequently referenced GSR Part 1 requirements are:

• Requirement 32: Regulations and guides




• Requirement 4: Independence of the regulatory body.

Figure 25 also shows that the least frequently referenced GSR Part 1 requirements are:

• Requirement 9: System for protective actions to reduce existing or unregulated radiation

risks (not referenced);



• Requirement 34: Promotion of regulations and guides to interested parties;



• Requirement 21: Liaison between the regulatory body and authorized parties.

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Figure 26 Number of Good Practice references to GSR Part 1 for observations related to operating NPPs

Figure 26 shows that the most frequently referenced GSR Part 1 requirements for Good Practices

related to operating NPPs are:




• Requirement 25: Review and assessment of information relevant to safety;

• Requirement 27: Inspection of facilities and activities.

The following GSR Part 1 requirements were not referenced with respect to a Good Practice related to

operating NPPs:


• Requirement 9: System for protective actions to reduce existing or unregulated radiation

risks;


• Requirement 30: Establishment of an enforcement policy;

• Requirement 31: Requiring of corrective action by authorized parties.

7.3 Reference by subject group

Table 11 shows the subject groups with the most number of observations related to operating NPPs.

Table 11 Subject Groups with the most number of observations related to operating NPPs

Subject group R S

9d Specific topics for regulations and guides 27 37

1b National policies, strategies 30 28

9c Basic safety requirements (regulations and guides) 35 22

1d Providing / using the legal framework for regulatory activities 42 13

7a Developing the inspection programme / system 21 26

10a Guidance / procedures for participants (emergency preparedness and response) 19 21

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45

4a Developing an integrated management system, general 28 11

9a Development of regulations and guides, general 19 17

5d Authorization procedures and guidance 14 17

1h Independence of the regulatory body 23 7

3a Staffing of the regulatory body 15 15

10c Emergency planning 16 13

3b Competence of the regulatory body 12 17

1a Cooperation / interaction among organizations, bodies 15 13

6b Review and assessment procedures and guidance 9 18

7c Inspection procedures and guidance 4 23

4b Details and documentation of the management system 12 14

46

8 Analysis of IRRS missions related to the regulation of radioactive sources

8.1 Introduction

Most, but not all, IRRS missions included a review of the regulatory control of radioactive sources. In

total, 1605 Recommendations, 932 Suggestions and 268 Good Practices identified during IRRS

missions relate to the regulatory control of radioactive sources. It should be noted that many of these

findings are not exclusively associated with the regulation of radioactive sources. This chapter

provides some analysis of these findings.

8.2 Reference to IAEA Safety Standards

Figure 27 References to IAEA Safety Standards

As Figure 27 shows, references to GSR Part 1 account for 50% of the findings related to the regulation

of radioactive sources, with GSR Part 3 accounting for almost 20% of the findings. GSR Part 7,

Safety Guides and GSR Part 2 each accounted for 7-9% of the findings.

For all of the Requirements documents, more references were for Recommendations than Suggestions,

while for the Safety Guides, the majority of the references were for Suggestions. In every case where

an IAEA Safety Guide is used as a basis for a Recommendation, there is also an IAEA Safety

Requirements document as a basis.

0

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GSR Part 1 GSR Part 3 GSR Part 7 Safety Guides GSR Part 2 OtherRequirements

GSR Part 5

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Recommendations

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47

Figure 28 References to GSR Part 1 for observations related to radioactive sources

As Figure 28 shows, the following GSR Part 1 requirements were most frequently referenced with

respect to radioactive sources:





• Requirement 4: Independence of the regulatory body.

The least frequently referenced GSR Part 1 requirements with respect to radioactive sources were:






• Requirement 13: Provision of technical services.

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Recommendations

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48

Figure 29 Number of Good Practice references to GSR Part 1 for observations related to radioactive sources

As Figure 29 shows, the following GSR Part 1 requirements were most frequently referenced for

Good Practices associated with radioactive sources:





and assistance;

• Requirement 33: Review of regulations and guides

• Requirement 27: Inspection of facilities and activities.

Figure 29 also shows that the following GSR Part 1 requirements were not referenced for a Good

Practice associated with radioactive sources:





• Requirement 30: Establishment of an enforcement policy.

0

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8

10

12

14

16

18 36 32 14 33 27 24 2 20 7 4 22 29 11 35 1 19 26 10 17 15 34 21 23 16 9 31 3 28 25 5 8 30 13 6 12

49

Figure 30 References to GSR Part 3 for observations related to radioactive sources

Figure 30 shows that the following GSR Part 3 requirements are referenced most frequently for

Recommendations and Suggestions associated with radioactive sources:




• Requirement 3: Responsibilities of the regulatory body;


situations;

• Requirement 32: Monitoring and reporting (public exposure).

These same requirements, but in a different order, are the most frequently referenced GSR Part 3

requirements for all observations for all missions.

8.3 Reference by subject group Table 12 Subject Groups with the most number of observations related to radioactive sources

Subject group R S

9c Basic safety requirements (regulations and guides) 155 61

1b National policies, strategies 116 37

1d Providing / using the legal framework for regulatory activities 123 26

5d Authorization procedures and guidance 94 50

9d Specific topics for regulations and guides 105 31

1a Cooperation / interaction among organizations, bodies 57 46

10a Guidance / procedures for participants (emergency preparedness and response) 72 29

4a Developing an integrated management system, general 64 21

7a Developing the inspection programme / system 47 24

10c Emergency planning 44 27

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Recommendations

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50

9a Development of regulations and guides, general 44 26

1h Independence of the regulatory body 53 15

5c Authorization by licensee, graded approach 37 22

4e Knowledge management and information technology tools 19 32

7c Inspection procedures and guidance 19 31

9 Outlook The analysis of results of IRRS missions indicates that regulatory bodies are continuously working to

enhance the effectiveness of their regulatory systems. The missions have identified strengths (Good

Practices) and opportunities for improvement in the Member States visited. Mission reports contain

specific Recommendations and Suggestions on actions needed to address the intent of the relevant

IAEA safety requirements. Sharing of IRRS recommendations, suggestions and good practices

remains of utmost importance for enhancing nuclear and radiological safety worldwide.

The following provides an outlook of some regulatory issues that are still work underway in various

Member States. The level of completion of tasks associated with these issues varies from Member

State to Member State.

In some Member States, work is not yet completed to fully satisfy the fundamental principle of the

effective separation between functions of the regulatory body and those of any other body or

organization concerned with the promotion or utilization of nuclear energy. This separation is essential

to ensure that the regulatory body is free from any undue pressure from interested parties.

The development of an integrated management system in the regulatory body is a cornerstone of

regulatory effectiveness. There is also a need to integrate safety culture into the integrated

management process so that the management system supports leadership and safety culture. The

regulatory body needs to conduct systematic self-assessments of its own safety culture.

Processes, procedures and guidance are required for the regulatory body to conduct its functions in a

consistent way. These are essential elements of the integrated management system.

The sharing of knowledge and experience among regulatory bodies is of utmost importance.

International cooperation programmes are important mechanisms to exchange information and to

establish data basis to assist regulatory bodies and authorized parties.

Transparency and openness in the regulatory process is significantly improving as part of new

communication practices and consultations with the public and other interested parties.

The harmonization between national safety standards and the IAEA Safety Standards is notably

increasing.

Finally, the acceptance of the IRRS mission Recommendations and Suggestions, and the high closure

rates noted during most follow-up missions, indicate the Member States respect and value the benefits

of the IRRS peer review process.

51

Appendix 1: Mapping of GS-R-1 to GSR Part 1

GS-R-1 GSR Part 1 GS-R-1 GSR Part 1 GS-R-1 GSR Part 1

para. sub. Req. para. sub. para. sub. Req. para. sub. para. sub. Req. para. sub.

2.1 16 4.5 3.1 22 4.26 5.13 5) 27 4.51

2.2 1) 2 2.5 3.2 1) 32 - 6)

2) 4 2.7 2) 26 4.41 5.13 end 27 4.49

" 17 4.6 3) 24 … 5.14 29 4.50

3) 4) 27 - 5.15 28 -

4) 4 2.8 5) 31 … 5.16 28 -

5) 4 2.9 6) 31 4.54 … 5.17 27 4.51

6) 10 3.3 1) 5.18 30 -

7) 6 2.17 2) 24 4.37 " 31 4.54,4.55

8) 8 … 3) 24 4.34 5.19 31 4.54,4.55

9) 2 2.5 13) 4) 5.20 31 4.59

10) 5) 24 4.39 5.21 31 4.54,4.55

11) 13 2.41 6) 36 4.66 5.22 31 4.56

2.3 5 - 7) 15 3.3 … 5.23 31 4.58

2.4 2 2.5 8) 35 … 5.24

1) 2 2.5 1) 9) 33 - 5.25 32 4.61

2) 2 2.5 2) 10) 25 4.46 5.26 32 4.62

3) 2 2.5 3) 11) 4 2.8 5.27

4) 2 2.5 7) 12) 24 4.30 5.28 33 4.61

5) 3,4 2.8 13) 6.1

6) 2 2.5 17) 3.4 7 2.18 6.2 8

7) 2 2.5 11) 3.5 6.3 8 2.22

8) 2 2.5 6) 4.1 16 4.5 6.4

9) 20 4.18 4.2 2 2.6 6.5 8 2.23

10) 1 2.3 e) " 4 2.12 6.6 8 2.24

" 11 2.38 " 7 2.18 6.7 10 2.28,2.29

11) 4.3 20 4.19,4.20 6.8

12) 4.4 20 4.22 6.9 10 …

13) 2 2.5 16) 4.5 19 … 6.10 6 2.16

14) 2 2.5 18) 4.6 18 4.11 … " 10 2.28

15) 1 2.3 b) 4.7 18 4.13 6.11 35 4.64

16) 36 4.66 4.8 20 4.22 6.12 10 2.31

17) 4.9 20 4.18 6.13 10 2.32

2.5 4 2.12 4.10 21 4.24 6.14 9 2.25

2.6 1) 4.11 14 3.2 6.15 9 2.26

2) 32 5.1 - 4.2 6.16 9 2.26

3) 4 2.13 5.2 23 - 6.17

4) 4 2.13 5.3 24 4.33 A.1 1) 25 4.45 1)

5) 23 - 5.4 24 4.34 2) 25 4.45 3)

6) 24 4.38 5.5 24 4.31 3) 25 4.45 4)

" 26 4.46 5.6 24 4.37 4) 25 4.45 7)

7) 27 - 5.7 26 4.40 5)

" 2 2.5 11) 5.8 22 4.26 6) 25 4.45 15)

8) 2 2.5 10) 5.9 25 4.41, 4.42 7) 25 4.45 14)

" 36 4.66 a) 5.10 26 4.40 " 25 4.45 19)

9) 36 4.66 b) 5.11 25 4.44 A.2

10) 36 4.66 c) 5.12 27 4.52 A.3

11) 36 4.66 d) 5.13 1) 27 A.4

12) 36 4.66 e) 2) A.5

13) 21 4.23 3) A.6

" 7 4) A.7

14) A.8