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This publication has been superseded by GSG-13.

IAEA
SAFETY
STANDARDS
SERIES

Regulatory Inspection
of Nuclear Facilities
and Enforcement
by the Regulatory Body

SAFETY GUIDE
No. GS-G-1.3
INTERNATIONAL
ATOMIC ENERGY AGENCY
VIENNA
This publication has been superseded by GSG-13.

IAEA SAFETY RELATED PUBLICATIONS

IAEA SAFETY STANDARDS


Under the terms of Article III of its Statute, the IAEA is authorized to establish standards
of safety for protection against ionizing radiation and to provide for the application of these
standards to peaceful nuclear activities.
The regulatory related publications by means of which the IAEA establishes safety
standards and measures are issued in the IAEA Safety Standards Series. This series covers
nuclear safety, radiation safety, transport safety and waste safety, and also general safety (that
is, of relevance in two or more of the four areas), and the categories within it are Safety
Fundamentals, Safety Requirements and Safety Guides.
Safety Fundamentals (blue lettering) present basic objectives, concepts and principles of
safety and protection in the development and application of nuclear energy for peaceful
purposes.
Safety Requirements (red lettering) establish the requirements that must be met to ensure
safety. These requirements, which are expressed as ‘shall’ statements, are governed by
the objectives and principles presented in the Safety Fundamentals.
Safety Guides (green lettering) recommend actions, conditions or procedures for meeting
safety requirements. Recommendations in Safety Guides are expressed as ‘should’ state-
ments, with the implication that it is necessary to take the measures recommended or
equivalent alternative measures to comply with the requirements.
The IAEA’s safety standards are not legally binding on Member States but may be
adopted by them, at their own discretion, for use in national regulations in respect of their own
activities. The standards are binding on the IAEA in relation to its own operations and on States
in relation to operations assisted by the IAEA.
Information on the IAEA’s safety standards programme (including editions in languages
other than English) is available at the IAEA Internet site
www.iaea.org/ns/coordinet
or on request to the Safety Co-ordination Section, IAEA, P.O. Box 100, A-1400 Vienna, Austria.

OTHER SAFETY RELATED PUBLICATIONS


Under the terms of Articles III and VIII.C of its Statute, the IAEA makes available and
fosters the exchange of information relating to peaceful nuclear activities and serves as an inter-
mediary among its Member States for this purpose.
Reports on safety and protection in nuclear activities are issued in other series, in
particular the IAEA Safety Reports Series, as informational publications. Safety Reports may
describe good practices and give practical examples and detailed methods that can be used to
meet safety requirements. They do not establish requirements or make recommendations.
Other IAEA series that include safety related sales publications are the Technical
Reports Series, the Radiological Assessment Reports Series and the INSAG Series. The
IAEA also issues reports on radiological accidents and other special sales publications.
Unpriced safety related publications are issued in the TECDOC Series, the Provisional Safety
Standards Series, the Training Course Series, the IAEA Services Series and the Computer
Manual Series, and as Practical Radiation Safety Manuals and Practical Radiation
Technical Manuals.
This publication has been superseded by GSG-13.

REGULATORY INSPECTION
OF NUCLEAR FACILITIES
AND ENFORCEMENT
BY THE REGULATORY BODY
This publication has been superseded by GSG-13.

The following States are Members of the International Atomic Energy Agency:
AFGHANISTAN GHANA PANAMA
ALBANIA GREECE PARAGUAY
ALGERIA GUATEMALA PERU
ANGOLA HAITI PHILIPPINES
ARGENTINA HOLY SEE POLAND
ARMENIA HUNGARY PORTUGAL
AUSTRALIA ICELAND QATAR
AUSTRIA INDIA REPUBLIC OF MOLDOVA
AZERBAIJAN INDONESIA ROMANIA
BANGLADESH IRAN, ISLAMIC REPUBLIC OF RUSSIAN FEDERATION
BELARUS IRAQ SAUDI ARABIA
BELGIUM IRELAND SENEGAL
BENIN ISRAEL SIERRA LEONE
BOLIVIA ITALY SINGAPORE
BOSNIA AND HERZEGOVINA JAMAICA SLOVAKIA
BOTSWANA JAPAN SLOVENIA
BRAZIL JORDAN SOUTH AFRICA
BULGARIA KAZAKHSTAN SPAIN
BURKINA FASO KENYA SRI LANKA
CAMBODIA KOREA, REPUBLIC OF SUDAN
CAMEROON KUWAIT SWEDEN
CANADA LATVIA SWITZERLAND
CENTRAL AFRICAN LEBANON SYRIAN ARAB REPUBLIC
REPUBLIC LIBERIA TAJIKISTAN
CHILE LIBYAN ARAB JAMAHIRIYA THAILAND
CHINA LIECHTENSTEIN THE FORMER YUGOSLAV
COLOMBIA LITHUANIA REPUBLIC OF MACEDONIA
COSTA RICA LUXEMBOURG TUNISIA
CÔTE D’IVOIRE MADAGASCAR TURKEY
CROATIA MALAYSIA UGANDA
CUBA MALI UKRAINE
CYPRUS MALTA UNITED ARAB EMIRATES
CZECH REPUBLIC MARSHALL ISLANDS UNITED KINGDOM OF
DEMOCRATIC REPUBLIC MAURITIUS GREAT BRITAIN AND
OF THE CONGO MEXICO NORTHERN IRELAND
DENMARK MONACO UNITED REPUBLIC
DOMINICAN REPUBLIC MONGOLIA OF TANZANIA
ECUADOR MOROCCO UNITED STATES OF AMERICA
EGYPT MYANMAR URUGUAY
EL SALVADOR NAMIBIA UZBEKISTAN
ESTONIA NETHERLANDS
VENEZUELA
ETHIOPIA NEW ZEALAND
VIET NAM
FINLAND NICARAGUA
YEMEN
FRANCE NIGER
YUGOSLAVIA,
GABON NIGERIA
FEDERAL REPUBLIC OF
GEORGIA NORWAY
ZAMBIA
GERMANY PAKISTAN
ZIMBABWE

The Agency’s Statute was approved on 23 October 1956 by the Conference on the Statute of the
IAEA held at United Nations Headquarters, New York; it entered into force on 29 July 1957. The
Headquarters of the Agency are situated in Vienna. Its principal objective is “to accelerate and enlarge the
contribution of atomic energy to peace, health and prosperity throughout the world’’.
© IAEA, 2002
Permission to reproduce or translate the information contained in this publication may be
obtained by writing to the International Atomic Energy Agency, Wagramer Strasse 5, P.O. Box 100,
A-1400 Vienna, Austria.
Printed by the IAEA in Austria
August 2002
STI/PUB/1130
This publication has been superseded by GSG-13.

SAFETY STANDARDS SERIES No. GS-G-1.3

REGULATORY INSPECTION
OF NUCLEAR FACILITIES
AND ENFORCEMENT
BY THE REGULATORY BODY
SAFETY GUIDE

INTERNATIONAL ATOMIC ENERGY AGENCY


VIENNA, 2002
This publication has been superseded by GSG-13.

VIC Library Cataloguing in Publication Data


Regulatory inspection of nuclear facilities and enforcement by the regulatory
body : safety guide. — Vienna : International Atomic Energy Agency,
2002.
p. ; 24 cm. — (Safety standards series, ISSN 1020–525X ; no. GS-G-1.3)
STI/PUB/1130
ISBN 92–0–114102–5
Includes bibliographical references.
1. Nuclear power plants — Inspection. 2. Nuclear facilities — Safety
measures. I. International Atomic Energy Agency. II. Series.
VICL 02–00291
This publication has been superseded by GSG-13.

FOREWORD

by Mohamed ElBaradei
Director General

One of the statutory functions of the IAEA is to establish or adopt standards of


safety for the protection of health, life and property in the development and application
of nuclear energy for peaceful purposes, and to provide for the application of these
standards to its own operations as well as to assisted operations and, at the request of
the parties, to operations under any bilateral or multilateral arrangement, or, at the
request of a State, to any of that State’s activities in the field of nuclear energy.
The following bodies oversee the development of safety standards: the
Commission on Safety Standards (CSS); the Nuclear Safety Standards Committee
(NUSSC); the Radiation Safety Standards Committee (RASSC); the Transport Safety
Standards Committee (TRANSSC); and the Waste Safety Standards Committee
(WASSC). Member States are widely represented on these committees.
In order to ensure the broadest international consensus, safety standards are
also submitted to all Member States for comment before approval by the IAEA Board
of Governors (for Safety Fundamentals and Safety Requirements) or, on behalf of the
Director General, by the Publications Committee (for Safety Guides).
The IAEA’s safety standards are not legally binding on Member States but may
be adopted by them, at their own discretion, for use in national regulations in respect
of their own activities. The standards are binding on the IAEA in relation to its own
operations and on States in relation to operations assisted by the IAEA. Any State
wishing to enter into an agreement with the IAEA for its assistance in connection with
the siting, design, construction, commissioning, operation or decommissioning of a
nuclear facility or any other activities will be required to follow those parts of the
safety standards that pertain to the activities to be covered by the agreement.
However, it should be recalled that the final decisions and legal responsibilities in any
licensing procedures rest with the States.
Although the safety standards establish an essential basis for safety, the
incorporation of more detailed requirements, in accordance with national practice,
may also be necessary. Moreover, there will generally be special aspects that need to
be assessed on a case by case basis.
The physical protection of fissile and radioactive materials and of nuclear
power plants as a whole is mentioned where appropriate but is not treated in detail;
obligations of States in this respect should be addressed on the basis of the relevant
instruments and publications developed under the auspices of the IAEA. Non-
radiological aspects of industrial safety and environmental protection are also not
explicitly considered; it is recognized that States should fulfil their international
undertakings and obligations in relation to these.
This publication has been superseded by GSG-13.

The requirements and recommendations set forth in the IAEA safety standards
might not be fully satisfied by some facilities built to earlier standards. Decisions on
the way in which the safety standards are applied to such facilities will be taken by
individual States.
The attention of States is drawn to the fact that the safety standards of the
IAEA, while not legally binding, are developed with the aim of ensuring that the
peaceful uses of nuclear energy and of radioactive materials are undertaken in a
manner that enables States to meet their obligations under generally accepted
principles of international law and rules such as those relating to environmental
protection. According to one such general principle, the territory of a State must not
be used in such a way as to cause damage in another State. States thus have an
obligation of diligence and standard of care.
Civil nuclear activities conducted within the jurisdiction of States are, as any
other activities, subject to obligations to which States may subscribe under
international conventions, in addition to generally accepted principles of international
law. States are expected to adopt within their national legal systems such legislation
(including regulations) and other standards and measures as may be necessary to
fulfil all of their international obligations effectively.

EDITORIAL NOTE

An appendix, when included, is considered to form an integral part of the standard and
to have the same status as the main text. Annexes, footnotes and bibliographies, if included, are
used to provide additional information or practical examples that might be helpful to the user.
The safety standards use the form ‘shall’ in making statements about requirements,
responsibilities and obligations. Use of the form ‘should’ denotes recommendations of a
desired option.
The English version of the text is the authoritative version.
This publication has been superseded by GSG-13.

CONTENTS

1. INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Background (1.1–1.3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Objective (1.4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Scope (1.5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Structure (1.6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

2. OBJECTIVES OF REGULATORY INSPECTION AND


ENFORCEMENT (2.1–2.5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Legal authority (2.6–2.10) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

3. MANAGEMENT OF INSPECTION (3.1–3.3) . . . . . . . . . . . . . . . . . . . . . 5

Types of inspection (3.4–3.13) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6


Selection of inspection areas (3.14–3.16) . . . . . . . . . . . . . . . . . . . . . . . . . 9
Organization and technical resources for inspections (3.17–3.18) . . . . . . 10
External relationships (3.19–3.28) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

4. PERFORMANCE OF REGULATORY INSPECTIONS . . . . . . . . . . . . . 13

Internal guidance (4.1–4.2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13


Inspection programme (4.3–4.13) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Preparation for an inspection (4.14–4.15) . . . . . . . . . . . . . . . . . . . . . . . . . 16
Methods of inspection (4.16–4.28) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Inspection reports and findings (4.29–4.39) . . . . . . . . . . . . . . . . . . . . . . . 20

5. REGULATORY ENFORCEMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Management of enforcement actions (5.1–5.6) . . . . . . . . . . . . . . . . . . . . . 23


Factors in determining enforcement actions (5.7–5.8) . . . . . . . . . . . . . . . 25
Methods of enforcement (5.9–5.13) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Performance of the enforcement process (5.14–5.17) . . . . . . . . . . . . . . . . 26
Records of enforcement (5.18) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

6. ASSESSMENT OF INSPECTION AND ENFORCEMENT


ACTIVITIES (6.1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
This publication has been superseded by GSG-13.

APPENDIX: INSPECTION AREAS FOR NUCLEAR FACILITIES . . . . . . . . 29

REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
GLOSSARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
CONTRIBUTORS TO DRAFTING AND REVIEW . . . . . . . . . . . . . . . . . . . . . 45
BODIES FOR THE ENDORSEMENT OF SAFETY STANDARDS . . . . . . . . 46
This publication has been superseded by GSG-13.

1. INTRODUCTION

BACKGROUND

1.1. The achievement and maintenance of a high level of safety in the siting, design,
construction, commissioning, operation and decommissioning of nuclear facilities
and in the closure of waste disposal facilities requires a sound legal and governmental
infrastructure, including a regulatory body with well defined responsibilities and
functions. One of the key functions of the regulatory body is inspection for
monitoring compliance with regulatory requirements and, in the event of non-
compliance, taking enforcement action to bring about compliance.

1.2. The IAEA Safety Requirements publication on Legal and Governmental


Infrastructure for Nuclear, Radiation, Radioactive Waste and Transport Safety [1] sets
out the requirements for a regulatory infrastructure. These include requirements in
respect of the establishment of an independent regulatory body for nuclear facilities
and the responsibilities and functions to be assigned to it.

1.3. Four interrelated IAEA Safety Guides provide recommendations for satisfying
the requirements concerning particular responsibilities and functions of the
regulatory body in the regulation of nuclear facilities. The present Safety Guide
addresses regulatory inspection and enforcement; three related Safety Guides cover,
respectively, the organization and staffing of the regulatory body [2], regulatory
review and assessment [3], and documentation relating to the regulatory process [4].

OBJECTIVE

1.4. The purpose of this Safety Guide is to provide recommendations for regulatory
bodies on the inspection of nuclear facilities, regulatory enforcement and related
matters. The objective is to provide the regulatory body with a high level of
confidence that operators have the processes in place to ensure compliance and
that they do comply with legal requirements, including meeting the safety objectives
and requirements of the regulatory body. However, in the event of non-compliance,
the regulatory body should take appropriate enforcement action.

SCOPE

1.5. This Safety Guide covers regulatory inspection and enforcement in relation to
nuclear facilities such as: enrichment and fuel manufacturing plants; nuclear power
plants; other reactors such as research reactors and critical assemblies; spent fuel
reprocessing plants; and facilities for radioactive waste management, such as

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treatment, storage and disposal facilities. This Safety Guide also covers issues
relating to the decommissioning of nuclear facilities, the closure of waste disposal
facilities and site rehabilitation.

STRUCTURE

1.6. Section 2 sets out the objectives of regulatory inspection and enforcement.
Section 3 covers the management of regulatory inspections. Section 4 covers the
performance of regulatory inspections, including internal guidance, planning and
preparation, methods of inspection and reports of inspections. Section 5 deals with
regulatory enforcement actions. Section 6 covers the assessment of regulatory
inspections and enforcement activities. The Appendix provides further details on
inspection areas for nuclear facilities.

2. OBJECTIVES OF REGULATORY INSPECTION


AND ENFORCEMENT

2.1. “Regulatory inspection and enforcement activities shall cover all areas of
regulatory responsibility. The regulatory body shall conduct inspections to satisfy
itself that the operator is in compliance with the conditions set out, for example, in
the authorization or regulations. In addition, the regulatory body shall take into
account, as necessary, the activities of suppliers of services and products to the
operator. Enforcement actions shall be applied as necessary by the regulatory body in
the event of deviations from, or non-compliance with, conditions and requirements.”
(Ref. [1], para. 5.12.) Inspection by the regulatory body shall not relieve the operator
of its responsibility for ensuring nuclear safety.

2.2. The principal objectives of regulatory inspection and enforcement are to


provide a high level of assurance that all activities performed by the operator at all
stages of the authorization process (see the Appendix in Ref. [4]) and all stages during
the lifetime of a nuclear facility (siting, design, construction, commissioning,
operation and decommissioning or closure) have been executed safely and meet the
safety objectives and licence conditions.

2.3. Regulatory inspection is performed to make an independent check on the


operator and the state of the facility, and to provide a high level of confidence that
operators are in compliance with the safety objectives prescribed or approved by the
regulatory body. This should be achieved by confirming that:

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(a) All applicable laws, regulations and licence conditions and all relevant codes,
guides, specifications and practices are complied with;
(b) The operator has a strong and effective management, good safety culture and
self-assessment systems for ensuring the safety of the facility and the protection
of workers, the public and the environment;
(c) The required quality and performance are achieved and maintained in the safety
related activities of the operator and in the structures, systems and components
(SSCs) of the facility throughout its lifetime;
(d) Sufficient numbers of personnel, who have the necessary competences for the
efficient and safe performance of their duties, are available at all times and
throughout all stages of the facility’s lifetime;
(e) Deficiencies and abnormal conditions are identified and promptly evaluated and
remedied by the operator and duly reported to the regulatory body as required;
(f) Any other safety issue that is neither specified in the authorization nor
addressed in the regulation is identified and appropriately considered.

2.4. Regulatory inspection should include a range of planned and reactive


inspections over the lifetime of a nuclear facility and inspections of other relevant
parts of the operator’s organization and contractors to ensure compliance with
regulatory requirements. The methods of inspection should include examination and
evaluation of the facility, procedures, records and documentation, and surveillance
and interviewing of personnel, as well as tests and measurements. In addition to the
regulatory body’s staff, outside consultants may be used for inspection tasks.
Regulatory inspections may be carried out by resident or non-resident inspectors,
depending on the regulatory regime and the size of the State (Ref. [2], paras
3.20–3.22). The findings of regulatory inspections should be documented in
inspection reports drawn up by the regulatory body. The technical bases for these
reports — their scope, layout, content, timing and distribution — should be
determined by the regulatory body. A programme to monitor and follow up inspection
findings should also be in place.

2.5. Regulatory enforcement actions are actions taken to deal with non-compliance
by the operator with specified conditions and requirements. These actions are
intended to modify or correct any aspect of an operator’s procedures and practices or
of a facility’s SSCs as necessary to ensure safety. Enforcement actions may also
include the imposition or recommendation of civil penalties and other sanctions.

LEGAL AUTHORITY

2.6. In accordance with Ref. [1], the regulatory body shall be granted legal authority
for conducting and co-ordinating inspection and enforcement actions during site

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evaluation, design, construction, commissioning, operation and decommissioning or


closure of nuclear facilities under its authority.

2.7. With regard to regulatory inspection, the regulatory body shall have the
authority to:

— Establish regulations and issue guidance which, among other things, will serve
as the basis for inspection;
— Enter the premises of any facility that is subject to any stage of the regulatory
process or any related establishment at any time for the purposes of inspection;
— Require the preparation of, access to and submission of reports and documents
from operators and their contractors when necessary;
— Seek the co-operation and support of other governmental bodies and consultants
with competences or qualifications relevant to regulatory inspections;
— Communicate information, findings, recommendations and conclusions from
regulatory inspections to other governmental bodies or interested parties,
including high level officials, as appropriate in view of the significance of the
issue.

2.8. The regulatory body shall have the authority and powers necessary to carry out
its inspections. However, the co-operation of the operator should be forthcoming to
ensure that the regulatory inspection can be carried out in an effective, informed and
unhindered manner. The operator shall give inspection personnel free and prompt
access to any area of the facility and its site for the purposes of regulatory inspection.
The only necessary limitation to this requirement may arise when the operator can
demonstrate that such access would give rise to a hazard. The operator should also
provide regulatory inspectors with free and prompt access to all personnel at the
nuclear facility and to all relevant documentation. The operator should additionally
make appropriate arrangements to provide personnel conducting a regulatory
inspection with access to its contractors and consultants where such access is
deemed necessary by the regulatory body for the discharge of its responsibilities for
inspection. Any findings from an inspection should be formally communicated to the
operator.

2.9. With regard to enforcement, the regulatory body shall have the authority:

— to require the operator to take action to remedy deficiencies and prevent their
recurrence, to curtail activities or to shut down the facility when the results of
a regulatory inspection or another regulatory assessment indicate that the
protection of workers, the public and the environment might be
inadequate;

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— to impose or recommend civil penalties or other sanctions for non-compliance


with specified requirements.

2.10. The regulatory body shall be given adequate powers and authority to enforce
compliance with its requirements and licence conditions, and should have available a
number of methods of enforcement to provide the flexibility to use the method best
suited to the seriousness of the violation and the urgency of corrective actions. The
degree of authority of the regulatory inspectors should be clearly specified and clear
administrative procedures should be adopted and implemented.

3. MANAGEMENT OF INSPECTION

3.1. The management within the regulatory body of inspection activities is an


important element of the authorization process. Consideration should be given to
assigning managerial responsibility to a single individual or organizational unit.
These responsibilities should include:

— programming inspection activities;


— developing guidelines for inspection;
— determining the type of inspection;
— determining the resources to be used in an inspection;
— making the necessary arrangements for the co-ordination of inspection
activities with the regulatory review and assessment process, particularly where
there is a tentative agreement between the operator and regulatory body (if such
an agreement exists);
— making arrangements for co-ordination with consultants or other organizations,
as appropriate;
— maintaining a record of inspection activities;
— ensuring that follow-up actions from inspections, including dissemination of
findings, are taken;
— ensuring that the findings from an inspection at a particular facility are fed back
to inspectors involved in inspections at similar facilities;
— qualification and training of inspectors.

3.2. Specific responsibilities of the regulatory body in respect of inspection and


enforcement include:

— conducting planned inspections at all stages of the authorization process;

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— carrying out reactive inspections, if appropriate, in response to events, incidents


or accidents;
— identifying and recommending necessary changes to the requirements approved
by the regulatory body, specified in the authorization or contained in the
regulations;
— preparing reports to document its inspection activities and their findings;
— verifying the operator’s compliance with regulatory requirements and confirming
adherence to safety objectives;
— ensuring that the operator has adequate, comprehensive and up to date
information on the status of the facility and information for demonstrating its
safety, and a procedure to maintain this information up to date;
— verifying that corrective actions have been undertaken by the operator to
resolve safety issues identified previously;
— tracking recurrent problems and non-compliance;
— developing such procedures and directives as may be necessary for the effective
conduct and administration of the inspection programme;
— determining and recommending suitable enforcement actions when non-
conformance with requirements is encountered.

3.3. “Inspection by the regulatory body, both announced and unannounced, shall be
a continuing activity.” (Ref. [1], para. 5.15.) The major activities of the inspection
process are related to the stages of the authorization process. The regulatory body
should organize and modify its inspection activities to conform to the stage of the
facility’s lifetime in order to make the most effective and efficient use of resources
for inspections. Specifically, as a facility passes from one stage to another, the
regulatory body will normally find it necessary:

— to adjust the levels of attention given to particular inspection areas and to


redeploy its human resources accordingly;
— to alter the extent to which various inspection techniques and methods are
employed;
— to modify the rigour and frequency of the inspections.

TYPES OF INSPECTION

3.4. The regulatory body should conduct two general types of inspection,
namely planned inspections (including special inspections) and reactive
inspections. Inspections may be conducted by individuals or teams and may be
announced or unannounced, as part of a general programme or with specific
aims.

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Planned inspections

3.5. Planned inspections are carried out in fulfilment of, and in conformity with, a
structured and largely prearranged or ‘baseline’ inspection programme developed by
the regulatory body. They may be linked to operator schedules for the performance or
completion of certain activities at all stages of the authorization process. Planned
inspections differ from reactive inspections in that they are scheduled in advance by
the regulatory body and are not initiated because of unusual or unexpected
circumstances. Planned inspections provide an opportunity for the examination of the
operator’s activities in order to confirm the operator’s performance and to identify
potential problems at an early stage. Considerations in relation to performing planned
inspections should include:

— the requirements of the authorization regime;


— the safety significance of the areas to be inspected;
— the operator’s overall performance in the areas to be inspected;
— operational experience and lessons learned from events or problems at other
facilities or in other States.

3.6. In planned inspections, the observation and assessment of continuing safety


activities are usually emphasized in order to assess the effectiveness of the operator’s
performance. Less emphasis is usually placed on carrying out detailed ‘desktop’
reviews of programme descriptions and related procedures for reviewing paper-
work.

3.7. Special inspections may be carried out to consider specific issues which may be
of interest to the regulatory body, such as refurbishment, new findings from research
and development work and experience from other facilities. Special inspections are
usually in the category of planned inspections, since they are scheduled in advance;
however, in certain circumstances they may be reactive inspections. This type of
inspection may range from a single inspector reviewing a specific inspection area to
a team of inspectors reviewing different inspection areas.

3.8. Team inspections, which may be multidisciplinary, provide an in-depth,


independent and balanced assessment of the operator’s performance. This type of
inspection may vary in both scope and complexity. Team inspections are of particular
value once safety problems have been identified, since normal inspections cover only
small samples of the operator’s activities in any particular area. Inspections of this
type will identify underlying causes of problems in order to determine whether a
safety concern represents isolated cases or may signify a broader, more serious
problem.

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3.9. Different approaches may be used in planning team inspections, some of which
may be broad in focus and cover a wide subject area (‘horizontal slice’) in the
programme area of interest. For example, during operation a team of inspectors may
assess the performance of facility operations, or a team of maintenance and
engineering inspectors may assess activities during an outage of the facility. Other
team inspections may be narrow in focus and cover a smaller subject area (‘vertical
slice’). For example, a number of specialist inspectors may review in depth a single
safety system in order to confirm that the system is in full compliance with the
regulatory requirements or a team may inspect the same aspect at similar nuclear
facilities in the State.

Reactive inspections

3.10. Reactive inspections, by individuals or teams, are usually initiated by the


regulatory body in response to an unexpected, unplanned situation or incident in
order to assess its significance and implications and the adequacy of corrective
actions. A reactive inspection may be occasioned by an isolated incident or a series
of lesser events occurring at the particular facility under consideration. Similarly,
a reactive inspection may be made in response to a generic problem encountered
at another plant or identified by the review and assessment staff of the regulatory
body. Unlike planned inspections, which are scheduled, reactive inspections are
only partly subject to planning by the regulatory body and may disrupt regulatory
programmes and schedules. The regulatory body should assume that there will be
a need for reactive inspections and should plan to meet its needs for staff and
consultants accordingly. For example, in implementing the inspection programme,
the regulatory body should establish a graded approach in responding to
unforeseen circumstances. All available resources may be needed in responding to
a serious event, whereas in the simplest of cases only one inspector may be
needed. This pre-established graded approach in responding to special
circumstances will assist in determining the appropriate level of resources for use
in inspections.

3.11. The regulatory body should use the operator’s reports of safety related
activities or events for assistance in preparing for both planned and reactive
inspections. Matters to be included in reports from the operator should be clearly
defined so that difficulties in interpretation can be avoided. This information should
include, for example, notification of:

— deficiencies in construction and non-compliances in design;


— abnormal test results;
— radioactive releases;

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— any violation of operational limits and conditions;


— modifications and corrective actions;
— unexpected exposure of personnel;
— unavailability of safety related equipment;
— any other situation giving rise to potential hazards for workers, the public
and the environment;
— events which may lead to misinterpretation by the public or matters which
concern the public.

Announced and unannounced inspections

3.12. An announced inspection is an inspection of which the operator has been


notified in advance by the regulatory body. The timing of the announcement may vary
according to the circumstances of the inspection to be performed. Inspections may be
announced, for example, when the regulatory body wishes to observe a specific test
or activity, or to review a specific self-assessment by the operator while it is in
progress.

3.13. The main advantage of announced inspections is that the regulatory inspector
is able to discuss plans and needs with the operator’s personnel in advance in order
to secure assurances that documentation will be available for inspection, personnel
will be available for interview and activities can be inspected as scheduled. Hence,
the announcement of inspections may enhance their effectiveness. The advantage of
unannounced inspections is that the actual state of the facility and the way in which
it is being operated can be observed. Inspections may be carried out at any time of
the day or night so as to provide a more complete picture of the situation at the
facility.

SELECTION OF INSPECTION AREAS

3.14. Inspections by the regulatory body should be concentrated on areas of


safety significance. These are those SSCs and activities affecting safety or
processes important to safety which are identified as such in the safety
documentation submitted by the operator or in the findings of the regulatory
body’s review and assessment, or which are stipulated in the conditions attached
to the licence.

3.15. The regulatory body’s attention to major inspection areas does not begin and
end in a single stage but continues with varying degrees of emphasis throughout

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the lifetime of the facility. This Safety Guide covers a wide range of types of
facility, and it is not possible to provide for each type details of specific areas that
would be subject to inspection at each stage of its lifetime. The degree to which
the areas should be considered will depend on the nature of the facility and the
risks associated with it. Major inspection areas for nuclear facilities are listed in
the Appendix.

3.16. Whenever the operator makes use of the services or products of a contractor,
the regulatory body should include the contractor’s activities in its inspection
programme in all stages of the authorization process. This may comprise inspection
and surveillance of the design and manufacturing of components, including, where
appropriate, activities performed in other States.

ORGANIZATION AND TECHNICAL RESOURCES FOR INSPECTIONS

3.17. The regulatory body, including a dedicated support organization if


appropriate, should have staff capable of performing the activities needed for its
inspection programme or, if outside consultants are used, staff capable of
adequately supervising the consultants’ work and independently evaluating its
quality and the results.

3.18. It is neither necessary nor practicable for the regulatory body to be entirely
self-sufficient in all technical areas relating to inspection. It may therefore be
necessary for it to use consultants in specialized areas. It may occasionally be
necessary owing to a heavy short term workload to augment the regulatory body’s
inspection staff with consultants having as much knowledge and experience as the
regulatory body’s inspection staff. Such consultants may be any of the following:

— Experts provided by other governmental bodies, technical societies or research


institutes;
— Consultants or members of advisory committees with recognized skills and
experience, provided that they are effectively independent of the operator and
its contractors;
— Experts provided by or under the auspices of international organizations.

When consultants are engaged, arrangements should be made for them to have access
to the facility and to any information necessary to perform their tasks. “The use of
consultants shall not relieve the regulatory body of any of its responsibilities. In
particular, the regulatory body’s responsibility for making decisions and
recommendations shall not be delegated.” (Ref. [1], para. 4.4.)

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EXTERNAL RELATIONSHIPS

Relationship with the operator

3.19. The regulatory body should establish requirements and guidelines for the
operator that govern notification and reporting periods and the formats in which the
notices and reports should be submitted.

3.20. The operator should, at all times, provide personnel conducting regulatory
inspections with such equipment, assistance and support as may be necessary for
discharging their responsibilities. This may include:

— on-site working facilities;


— transport at the site;
— access to means of communication;
— facilitation of access to all pertinent information;
— copies of relevant documents;
— meetings with appropriate staff;
— personal protection, including equipment for radiation protection.

Relationship with other governmental bodies

3.21. In addition to the regulatory body, other governmental bodies may participate
in the regulatory process according to national practices. The regulatory body should
establish and maintain liaison throughout the lifetime of the facility with other
relevant governmental bodies, and should develop and, where practicable, formalize
working procedures with such bodies, whether at the national, regional or local level.
Such bodies may undertake their own inspections of the facility, and it may be
appropriate for the regulatory body to conduct joint inspections with one or more of
them. In planning an inspection programme and determining a specific inspection
plan, the regulatory body should consider whether inspectors from these bodies
should participate in the inspection.

3.22. It is particularly important that there should be liaison with other


governmental bodies when enforcement action is contemplated. The regulatory body
should keep the relevant governmental bodies informed since these bodies may be
considering taking enforcement actions under different legal provisions and, if so,
co-ordination of the enforcement actions should be considered. Similarly, the
regulatory body should be advised of any enforcement actions under consideration
by other bodies.

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3.23. The areas which may be inspected by other governmental bodies should be
identified. The latter could include but are not limited to:

— environmental protection authorities;


— authorities responsible for public liability issues;
— authorities for physical protection and/or safeguards;
— authorities for planning the use of water resources and land;
— authorities responsible for public and occupational health and safety;
— fire protection authorities;
— transport authorities;
— law enforcement bodies;
— bodies with responsibilities for civil engineering structures and buildings, and
electrical and mechanical equipment;
— other bodies with responsibilities for emergency preparedness;
— other bodies with responsibilities for limits on releases of radioactive
effluents.
— other regulatory authorities, particularly those performing similar functions.

3.24. The regulatory body should be aware of the relationships between the operator
and other governmental bodies such as may be determined by national legislation,
regulations and practices.

Relationship with regulatory bodies of other States and international bodies

3.25. “The safety of facilities and activities is of international concern. Several


international conventions relating to various aspects of safety are in force. National
authorities, with the assistance of the regulatory body, as appropriate, shall establish
arrangements for the exchange of safety related information, bilaterally or regionally,
with neighbouring States and other interested States, and with relevant
intergovernmental organizations, both to fulfil safety obligations and to promote co-
operation.” (Ref. [1], para. 4.11.)

3.26. There may be specific technical areas in which a regulatory body can obtain
useful information for the inspection activities. It would be particularly useful to
obtain information from regulatory bodies in other States with experience in
inspecting similar facilities and it should be considered whether to set up an
international grouping of such regulatory bodies. The IAEA and other international
bodies are also sources of information and expertise.

3.27. A regulatory body may seek information internationally for such reasons as:

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— the introduction of a type of facility of which experience has been gained in


another State or other States;
— to add to the database of operating experience with specific facilities;
— to gain knowledge of different approaches to inspection;
— to gain knowledge of the management of the inspection activities;
— to gain knowledge of any of the operator’s contractors in another State.

3.28. Information may be exchanged by means of meetings, submissions of


documents, visits by experts and participation in inspections, but none of these means
should in any way relieve the national regulatory body of its responsibilities for
making decisions or recommendations.

4. PERFORMANCE OF REGULATORY INSPECTIONS

INTERNAL GUIDANCE

4.1. To ensure that all nuclear facilities in a State are inspected to a common
standard and that their level of safety is consistent, the regulatory body should
provide its inspectors with written guidelines in sufficient detail. The guidelines
should be followed to ensure a systematic and consistent approach to inspection while
allowing sufficient flexibility for inspectors to take the initiative in dealing with new
concerns that arise. Appropriate information and guidance should be provided to the
inspectors and each inspector should be given adequate training in following this
guidance. Consideration should be given to the extent to which this guidance should
be made available to the operator or to the public. Appropriate subjects for guidance
and instructions for inspectors could include:

(a) how to develop an inspection programme;


(b) the legal basis for regulatory inspection and the scope of the inspector’s
authority;
(c) the use of regulatory requirements, regulations and guides and industrial standards;
(d) implementation of the inspection programme, including:
— areas to be subject to inspection,
— method of inspection to be used,
— methods for selection of inspection samples,
— relevant technical information and questionnaires;
(e) reporting requirements and practices for inspectors;
(f) policies of the regulatory body as they may affect inspection;

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(g) standards of conduct of inspectors;


(h) enforcement policy, procedures and practices.

4.2. The authority vested in inspectors should oblige them to conduct themselves on
the site in a manner that inspires confidence in and respect for their competence and
integrity. They should, for example, make adequate preparation by gathering and
reviewing all relevant information and data before proceeding on assignment and
should be knowledgeable about the area which they are required to inspect. The
importance of objectivity and fairness on the part of inspectors should also be stressed
by the regulatory body in its guidance, together with the need to respect the rules for
the facility as established by the operator.

INSPECTION PROGRAMME

4.3. “The regulatory body shall establish a planned and systematic inspection
programme. The extent to which inspection is performed in the regulatory process
will depend on the potential magnitude and nature of the hazard associated with the
facility or activity.” (Ref. [1], para. 5.14.)

4.4. Regulatory inspection programmes should be comprehensive and should be


developed within the overall regulatory strategy. These programmes should be thorough
enough to provide a high level of confidence that operators are in compliance with the
regulatory requirements and are identifying and solving all actual and potential
problems in ensuring safety. The inspection programme should be developed so that the
regulatory body can determine whether the operator has a functional self-assessment
system of high quality and is conducting its activities in accordance with its own
established procedures for ensuring that regulatory objectives and requirements are
met.

4.5. Different methods may be used in establishing or modifying an inspection


programme, with associated priorities, to achieve the objectives of regulatory
inspections. The regulatory body should consider the following:

— the results of previous inspections;


— the safety analysis performed by the operator and the results of regulatory
review and assessment;
— performance indicator programmes or any other systematic method for the
assessment of the operator’s performance;
— operational experience and lessons learned from operating the facility and other
similar facilities as well as results of research and development;

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— inspection programmes of the regulatory bodies in other States.

4.6. The regulatory body should have the capability to undertake inspection
activities at any time as necessitated by the normal operation of a facility or by any
fault conditions or operator activities at a facility. For verification of the overall
performance of the operator, inspections of adequate depth should be conducted in a
wide range of subject areas and at appropriate intervals. Each planned inspection
should have objectives which have previously been specified by the regulatory body
to serve to the extent practicable as guidance for inspection personnel.

4.7. The planning of the programme of inspections will also be influenced by the
locations of the regulatory body’s offices and of the facility to be inspected. In
particular, it will depend on whether inspectors are permanently at the facility site
(resident inspectors) during one or more stages of the facility’s lifetime. The general
advantages and disadvantages of relying on resident inspectors, as opposed to non-
resident inspectors, are considered in paras 3.20–3.22 of Ref. [2]. The use of resident
inspectors may be more beneficial at certain stages than at others: for example, the
use of resident inspectors may be particularly beneficial during commissioning to
permit direct observation of commissioning tests.

4.8. Arrangements should be made to ensure that all relevant staff of the regulatory
body can fully contribute to the planning of inspections and in particular, if the offices
of the regulatory body are distributed over a wide area, that resident inspectors are
involved in the planning process. This will ensure the best use of the skills and
knowledge of its staff.

4.9. The regulatory body should have an overall plan for the programme of
inspections that it is to undertake at a facility. In determining the intervals between
inspections and the level of effort to be applied, the regulatory body should take into
account the relative significance for the safety of the facility of each authorization
stage and each inspection area.

4.10. The particular aspects that should be considered in determining the intervals
between inspections in the various areas and the level of effort to be applied in the
inspection include:

— the safety significance of the issues;


— the inspection methods and approaches used (for example, the use of
resident inspectors may influence the intervals and the intensity of
inspections);
— the qualified personnel and other resources available to the operator;

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— the performance record of the operator and the facility, for example, the number
of violations, deficiencies, incidents and problems and the number of reactive
inspections;
— the results of the regulatory review and assessment;
— the type of facility;
— the personnel and other resources available to the regulatory body;
— the results of previous inspections.

4.11. To facilitate management of the allocation of resources for inspections, the


regulatory body should develop site specific inspection plans in which the
aforementioned factors are taken into account. The inspection plans should be
recorded in such a way that they can easily be modified to take into account
continuing activities, and they should be reviewed periodically and modified as
necessary.

4.12. The inspection plan should be flexible enough to permit inspectors to respond
to particular needs and situations. In a number of States it is the practice to allocate
about three quarters of the resources of the overall inspection programme for planned
inspections and to keep the remaining quarter available for reactive inspections. The
regulatory body should establish a process of periodically evaluating the findings of
inspections, identifying generic issues and making arrangements to enable inspectors
from various plants, locations or projects to meet to exchange views and discuss the
findings and issues.

4.13. The operator should notify the regulatory body of its schedules for carrying out
activities and tests of regulatory interest and should submit or make available to the
regulatory body in a timely manner the procedures for these activities. To facilitate
this process, the regulatory body should specify well in advance to the operator the
activities and tests of which it wishes to be informed. Notification to the regulatory
body by the operator should be as prompt as is warranted by the situation according
to established procedures.

PREPARATION FOR AN INSPECTION

4.14. Before an inspection is carried out, the inspection personnel should be


thoroughly prepared for the task. The type of preparation will depend on the type
and method of inspection. Preparation may include a review of the following:

— regulatory requirements relating to the inspection area;


— past operating experience relating to the inspection area;

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— findings of previous inspections and enforcement actions relating to the


inspection area;
— past correspondence between the regulator and the operator relating to the
inspection area;
— the safety documentation and operational limits and conditions;
— documentation on operation and design for the facility;
— the operator’s management procedures and quality assurance programme.

4.15. Preparations should be made by the individual or team (including any


consultants) who will be conducting the inspection. Furthermore, it may be useful to
establish a special plan for the inspection and to compile a questionnaire and a list of
the documents to be reviewed with the operator.

METHODS OF INSPECTION

4.16. The inspection programme of the regulatory body should incorporate and use
a variety of methods:

— monitoring and direct observation (such as of working practices and equipment);


— discussions and interviews with personnel of the operator and the
contractor;
— examinations of procedures, records and documentation; or
— tests and measurements.

In individual inspections, one or more of these methods should be employed in a


balanced way, depending on the specific issues being considered.

Monitoring and direct observation

4.17. The inspection programme of the regulatory body should include provision for
direct monitoring of SSCs, human factors significant to safety (performance of
operating personnel, managerial attitudes), tests and other safety related activities
carried out by the operator.

4.18. The regulatory body may prescribe certain categories of SSCs, tests and
activities which should be directly observed by its inspectors in whole or in part. In
some cases, the regulatory body may require regulatory monitoring of a specific
structure, system, component, test or activity as a condition for the operator to be
permitted to proceed to subsequent stages of work or operation. Monitoring is most
likely to be of benefit during the commissioning stage, or as a means of verifying

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corrective action at any stage over the lifetime of the facility as required by the
regulatory body after an abnormal occurrence or a finding of serious non-compliance.

4.19. The regulatory inspection programme should provide time for general
surveillance of the facility site by regulatory inspectors. Such surveillance is aimed at
gaining an overall impression of the operator’s capabilities and performance and is
not restricted to specifically designated components and systems or designated
scheduled activities and tests. Examples of areas for observation include:

— the control room and shift handovers;


— radiation protection practices including boundaries of controlled areas;
— safety systems;
— fire barriers;
— housekeeping;
— the presence of management;
— internal and external interfaces and communications;
— arrangements for emergency preparedness.

Discussion and interviews with operator personnel

4.20. Regulatory inspectors should, as appropriate, communicate directly with the


operator’s personnel responsible for supervising and performing the activities and tests
being inspected. This is especially important in follow-up investigations in which the
inspector is engaged in reconstructing events and assessing the operator’s response.

4.21. The operator’s personnel should be kept appropriately informed of inspection


activities and it should be ensured that the operator responds to inspection findings.
These considerations can be partly satisfied by means of discussions and interviews.
Interviews with the facility manager and, as appropriate, with other senior managers
should be standard features of most inspection visits. In interacting with the
operator’s personnel, the inspector should exercise mature judgement concerning the
prerogatives and responsibilities of the facility’s management.

Examination of procedures, records and documentation

4.22. The operator should be required to record all activities, results and
considerations important to safety in the siting, design, construction, commissioning,
operation and decommissioning or closure of the facility.

4.23. Examination of the operator’s documentation contributes to the regulatory


body’s verification of the operator’s compliance without unduly disrupting work

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schedules or interfering with the operator’s primary responsibility for the safe siting,
design, construction, commissioning, operation and decommissioning of the facility.
Documentation examined by regulatory inspectors may include:

— procedures and schedules for maintenance and testing;


— quality assurance records;
— test results and data;
— operational and maintenance records;
— records of deficiencies and incidents;
— modification records including modifications to management and operating
procedures;
— training records;
— radiological safety records.

4.24. The regulatory body should examine samples of the operator’s documentation
sufficient to satisfy itself that the operator is fulfilling the requirements for
authorization and is operating in accordance with the practices proposed by the
operator and approved by the regulatory body.

4.25. The examination of documentation by regulatory inspectors may in some cases


take place in part off the site, for example at headquarters, and can contribute towards
their preparation for inspection of the facility.

Tests and measurements

4.26. The extent to which the regulatory body does its own testing and measurement
work independently of the operator varies greatly between States, depending upon
such factors as the qualifications of personnel available to the regulatory body, its
regulatory philosophy, and the experience and demonstrated performance of operators.
However, the regulatory body should not engage in the conduct of tests or
measurements which would necessitate its assuming direct operational control of the
facility or any of its systems. In some States, the inspection staff of the regulatory body
conduct physical tests and measurements as part of the inspection programme. Tests
of components and systems of the facility should only be undertaken after consultation
with the facility’s management. In most instances, these tests and measurements
replicate and serve as an independent verification of tests and measurements
performed by the operator. The conduct of these tests and measurements by the
regulatory body shall not relieve the operator of its prime responsibility for safety.

4.27. Since the regulatory body itself conducts only limited testing, a detailed review
should be carried out of a sample of the operator’s procedures for tests and its

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interpretation of their results. If external experts are used to monitor the tests and
measurements, their reports also should be reviewed.

4.28. Whatever its inspection programme may be, the regulatory body should be able
to carry out tests and measurements as necessary or should obtain the capability by
using consultants.

INSPECTION REPORTS AND FINDINGS

4.29. A report of each regulatory inspection should be prepared by the


inspector (or inspectors) who performed the inspection. The report should be
reviewed and approved according to established internal procedures. The scope,
layout, content, timing and distribution of inspection reports may vary according
to the:

— general administrative and legal structure in the State and the requirements
established by the regulatory body;
— type of facility and its stage of authorization;
— location of the inspection, whether on or off the site;
— type of the inspection, whether planned or reactive.

4.30. Depending on practices in the States concerned, inspection reports should be


written for each team inspection, each special inspection and each site visit by non-
resident site inspectors or, for example, for weekly inspection activities carried out by
resident inspectors.

Purposes of inspection reports

4.31. The purposes of inspection reports are to:

— record the results of all inspection activities relating to safety or of regulatory


significance;
— document and record an assessment of the operator’s activities in relation to
safety;
— record discussions held with facility staff, plant management and other
concerned persons;
— provide a basis for notifying the operator of the findings of the inspection and
of any non-compliance with regulatory requirements, and to provide a record
of any enforcement actions taken;
— record any findings or conclusions reached by inspectors;

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— record any recommendations by inspectors for future actions by the operator or


the regulatory body and to record progress on recommendations from previous
inspections;
— inform other members of the regulatory body;
— contribute to maintaining an institutional memory.

Content of inspection reports

4.32. Inspection reports should typically contain:

— identification of the facility inspected, the purpose and date of the inspection
and the inspectors’ names;
— the methods used in the inspection (interviews, observations, review of
documents);
— reference to applicable requirements;
— criteria used in the assessment;
— details of facility areas, activities, documents, processes, systems or
components which have been inspected, assessed or reviewed;
— a record of actual or potential problems relating to safety;
— a record of the results of any checks for compliance with the terms and conditions
of the authorization for the facility and applicable national regulations;
— a record of any deficiency or violation found in regulatory inspections,
including a record of which requirements or regulations have been contravened;
— a record of any regulatory action taken by inspectors and any consequent action
taken by the operator in the period covered by the report;
— a record of discussions held with the facility’s staff, the operator’s managers
and other persons, including a record of discussions with facility managers
about points of concern;
— a record of the inspectors’ opinion about the operator’s or relevant facility
manager’s response to any matter of concern to which their attention was drawn
after a regulatory inspection;
— a record of the findings or conclusions of the inspectors, including corrective or
enforcement actions that should be taken;
— a record of recommendations made by inspectors for future action, such as
a need to advise other inspectors or operators about particular problems,
proposals for further inspections or proposals for enforcement actions.

Distribution and use of inspection reports

4.33. Inspection reports should be distributed according to established procedures in


order to provide for the following:

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— a basis for future regulatory action;


— a contribution to maintenance of the regulatory history of the facility by
providing a record of inspections, discussions and associated findings and
conclusions;
— a basis for identifying major or generic issues which necessitate special
inspections, changes to inspection plans or generic regulatory action;
— information to regulatory staff responsible for review and assessment;
— information to regulatory staff responsible for reporting incidents;
— information to regulatory staff responsible for regulations and guides;
— a basis for periodic reviews of inspection findings, including trends and root
causes;
— information to regulatory staff responsible for the development of requirements
for authorization or new regulations;
— a means of sharing information with other site inspectors working at different
locations;
— a means of passing information to interested parties or governmental
bodies;
— self-assessment activities.

4.34. Inspection findings should typically be discussed at regular meetings attended


by groups of site inspectors. The inspection reports should be distributed according
to an established procedure. This should include internal distribution of the reports
within the regulatory body, including distribution to personnel performing regulatory
review and assessment if they are in different organizational units. The procedure
may also provide for external distribution to bodies supervising the regulatory body
or to organizations with jurisdiction over the facility.

4.35. Inspection findings should be forwarded to the operator for necessary


corrective action. Whenever corrective action is needed, a formal communication
including findings detailed in inspection reports should be sent to the operator as
part of the enforcement procedures. In some States the full inspection report is
forwarded to the operator. In communications with the operator, caution should be
exercised in identifying individuals by their name or their post because of the
possible implications (including those of a legal nature) for the individuals
concerned.

4.36. Documents that are made available to the inspector by the operator during an
inspection should be referenced in the inspector’s report of the inspection. Inspection
reports and copies of documents received should be stored in a manner that permits
ready retrieval.

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Publication of inspection findings

4.37. In order to inform the public of the safety of nuclear installations and of the
effectiveness of the regulatory body, findings of inspections and regulatory
decisions may be made publicly available. The extent to which such information
is made publicly available will depend on the legal provisions in the State
concerned.

4.38. Although it may be the practice in some States to publish individual inspection
reports, some inspection reports may contain confidential information, such as
security information, information which the regulatory body may wish to use in
connection with future regulatory actions, personal or medical information relating to
individuals and proprietary information. Such information should be withheld.
However, in the interests of confidentiality it may be undesirable to show which
information has been withheld. In such cases, therefore, only the general findings of
the inspection and regulatory decisions should be made available to the general
public.

4.39. All information exchanged between the regulatory body, other govern-
mental bodies, the operator, its contractors, advisory committees and the
regulatory body’s consultants and, as appropriate, members of the public should be
formally recorded upon receipt and stored in a manner that permits ready
retrieval.

5. REGULATORY ENFORCEMENT

MANAGEMENT OF ENFORCEMENT ACTIONS

5.1. The organizational structure of the regulatory body should enable enforcement
actions to be taken at an appropriate level. The managerial responsibilities for
enforcement actions include:

— applying the policy of the regulatory body with regard to enforcement actions;
— determining the level of an inspector’s authority to carry out enforcement
actions;
— ensuring that enforcement actions are carried out properly and in accordance
with due legal process in the State concerned and that corrective actions are
performed.

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5.2. The regulatory body shall have statutory powers to enforce compliance with its
requirements as specified in the applicable regulations and in licence conditions,
including the authority to require an operator to modify, correct or curtail any aspect
of a facility’s operation, procedures, practices or SSCs, as necessary, to ensure that
the required level of safety is achieved. Within the legal framework in which it is
established, the regulatory body may develop and issue enabling regulations detailing
procedures for determining and exercising enforcement actions as well as the rights
and obligations of the operator.

5.3. “Enforcement actions are designed to respond to non-compliance with


specified conditions and requirements. The action shall be commensurate with the
seriousness of the non-compliance. Thus there are different enforcement actions,
from written warnings to penalties and, ultimately, withdrawal of an authorization.
In all cases the operator shall be required to remedy the non-compliance, to
perform a thorough investigation in accordance with an agreed time-scale, and to
take all necessary measures to prevent recurrence. The regulatory body shall ensure
that the operator has effectively implemented any remedial actions.” (Ref. [1],
para. 5.18.)

Inspector’s authority in relation to enforcement

5.4. “The extent of the authority of the regulatory inspectors to take on the
spot enforcement actions shall be determined by the regulatory body.” (Ref. [1],
para. 5.23.) The degree of authority given to an inspector may depend on
the structure of the regulatory body and on the inspector’s role and experience.

5.5. “Where on the spot enforcement authority is not granted to individual


inspectors, the transmission of information to the regulatory body shall be suited to
the urgency of the situation so that necessary actions are taken in a timely manner;
information shall be transmitted immediately if the inspectors judge that the health
and safety of workers or the public are at risk, or the environment is endangered.”
(Ref. [1], para. 5.24.)

5.6. Enforcement actions taken on the spot by regulatory inspectors are appropriate
only in abnormal situations. In normal situations, decisions concerning enforcement
actions, particularly those involving fines, curtailment of activity or suspension of
authorization, should be approved by the regulatory body in accordance with the
procedures established in the State concerned.

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FACTORS IN DETERMINING ENFORCEMENT ACTIONS

5.7. A range of enforcement actions should be available to the regulatory body, such as
the issuing of written requirements, warnings or directives or orders to curtail activities,
the modification or revocation of licences or authorizations and the imposition of
penalties. The enforcement should depend on consideration of the factors listed in para.
5.8, but in many cases it may be possible to resolve the non-compliance by means of
discussion with the operator. Whenever such a process is inappropriate or has been
unsuccessful it may be necessary to invoke one of the formal measures; however, caution
should be exercised in considering the imposition of penalties. In determining the
enforcement measure to be applied, it should be noted that for some facilities or at
some stages of a facility’s lifetime the option to curtail activities may not be available.

5.8. The factors to be taken into account by the regulatory body in deciding which
enforcement action is appropriate in each case should include:

— the safety significance of the deficiency and the complexity of the correction
that is needed;
— the seriousness of the violation;
— whether a violation of a less serious nature has been repeated;
— whether there has been a deliberate or wilful violation of the limits and
conditions specified in the authorization or in regulations;
— who identified and reported the non-conformance;
— the past performance of the operator and the trend in performance;
— the need for consistency and transparency in the treatment of operators.

METHODS OF ENFORCEMENT

Written warnings or directives

5.9. Deviations from or violations of authorization requirements or unsatisfactory


conditions may occur at any stage of the facility’s lifetime. Under such circumstances
the regulatory body should consider issuing a written requirement, warning or
directive to the operator.

5.10. Any written requirement, warning or directive should specify the nature of and
the regulatory basis for each violation, deviation or unsatisfactory situation; it should
also specify a period of time for taking corrective action and may provide guidance
on the nature of the corrective action. This is the most common form of enforcement
action and should, in most cases, suffice to remedy the safety issue.

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Orders to curtail specific activities

5.11. The regulatory body should require the operator to curtail specific activities in
the event of serious non-compliance in the construction stage, apparent deterioration
of the facility’s SSCs or serious violations which in the judgement of the regulatory
body pose an imminent radiation hazard to workers, the public or the environment.
In the operational stage, for example, this could mean requiring reductions in power,
pressure, temperature or other parameters, including, if necessary, temporary
shutdown of the facility.

Modification, suspension or revocation of the authorization

5.12. In the event of persistent or extremely serious non-compliance or significant


contamination of the environment due to a serious malfunction or damage to the
facility, the regulatory body should modify, suspend or revoke the authorization,
depending on the nature and severity of the conditions at the facility. In considering
the withdrawal of authorization, the regulatory body should give careful
consideration to ensuring that activities vital to safety, even in a shutdown state,
continue to be performed by a legally authorized operator.

Penalties

5.13. The regulatory body should have the authority to impose or recommend
penalties, such as fines on the operator as a corporate body or on individuals, or
to institute prosecution through the legal process, depending upon the legal
system and authorization practices in the State concerned. The use of penalties
is usually reserved for serious violations, for repeated violations of a less
serious nature or for deliberate and wilful non-compliance. Experience in some
States shows that imposing penalties on the organization rather than on
individuals is preferable and is more likely to lead to improvements in safety
performance.

PERFORMANCE OF THE ENFORCEMENT PROCESS

5.14. The regulatory body should adopt clear administrative procedures and
guidelines governing the use and implementation of enforcement actions. All
inspectors and other staff of the regulatory body should be trained in and should be
knowledgeable about the procedures and guidelines. The procedures and guidelines
should state the policy of the regulatory body for the use of regulatory and

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enforcement measures and the associated authority delegated to inspectors and other
regulatory body staff. Depending on national practices, the need to allow the operator
to state a point of view on regulatory decisions, to respond to enforcement
notifications and to appeal against enforcement decisions should be recognized and
taken into account in the procedures and guidelines. The procedures and guidelines
should cover in detail the decision making approach of the regulatory body in
determining the level of actions to be taken and the way in which the actions should
be taken, including dealing with failure of the operator to comply with requirements
for regulatory enforcement.

5.15. Provided that there is no immediate threat to safety, the regulatory body should
allow reasonable periods of time for the operator to complete corrective actions.
These time periods should depend on the seriousness of the issues and the complexity
of the corrective actions required. However, in an integrated approach to safety, the
contribution of each deficiency for which corrective action is required to the total risk
for the facility should be considered.

5.16. Procedures should stipulate which other governmental organizations, if any,


should be informed in the event of enforcement notifications. In some States, public
notification is required or is undertaken as a matter of common practice.

5.17. The circumstances under which it is appropriate to carry out further inspections
to determine whether the operator has responded to regulatory and enforcement
measures should be stated in the regulatory procedures. The purpose of these
inspections should be:

— to confirm that the operator has complied with the enforcement measures
within the period of time specified;
— to check that the enforcement measures intended to protect the workers, the
public and the environment from potential radiological consequences have
been taken by the operator even though the operator may intend to appeal
against the notification of the regulatory body.

RECORDS OF ENFORCEMENT

5.18. “All enforcement decisions shall be confirmed to the operator in writing”


(Ref. [1], para. 5.22.). Internal records of decisions concerning enforcement actions
and any supporting documentation should be kept in such a way that they will be
readily accessible and retrievable.

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6. ASSESSMENT OF INSPECTION
AND ENFORCEMENT ACTIVITIES

6.1. The regulatory body should have a system to audit, review and monitor all
aspects of its inspection and enforcement activities to ensure that they are being
carried out in a suitable and effective manner. It should be ensured by means of this
system that any changes necessary in inspection and enforcement activities owing to
improvements in methods are implemented. The following points should be
considered in this system:

— internal guidance for inspections;


— inspection methods;
— allocation of resources for inspections;
— procedures in the regulatory body relating to inspection activities such as
procedures for planning inspections and for dealing with outstanding issues;
— procedures for co-ordinating inspection activities with the regulatory review
and assessment process;
— procedures for involving consultants in inspection activities;
— procedures relating to enforcement actions;
— the effectiveness of enforcement actions;
— record keeping and documentation.

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Appendix

INSPECTION AREAS FOR NUCLEAR FACILITIES

A.1. This appendix sets out areas of nuclear facilities that may be of particular
interest for inspection at different stages of the authorization process.

SITE EVALUATION STAGE

A.2. Before the construction of a nuclear facility is begun, the regulatory body
should monitor as appropriate, by means of its inspection programme, site
preparation activities undertaken by the operator, including verification of site
characteristics and authorized excavation and earthwork.

A.3. The specific objectives of regulatory inspection in these areas include


verification that the operator is undertaking siting activities in full conformity with
existing regulatory requirements and assurance that the work on site preparation
does not proceed beyond that permitted by any authorization in force. During site
preparation, the regulatory body should also confirm that the site characteristics
remain consistent with the description presented by the operator in its licence
application and in the subsequent supporting documentation submitted to the
regulatory body. This is vital for disposal sites, for which the action of a major barrier
to the movement of radionuclides is dependent on the characteristics of the site. In
addition, inspectors should be alert to any new conditions or information revealed as
a result of activities for site preparation, which should then be considered by the
regulatory body in making subsequent decisions on authorization.

DESIGN AND CONSTRUCTION STAGE

A.4. The chief objectives of the regulatory inspection programme in the design and
construction of the facility are to verify that:

— Safety related materials and SSCs meet the requirements established by the
regulatory body and conform to good practices;
— Construction activities associated with manufacturing and installing SSCs and
items are conducted in accordance with regulatory requirements and in
conformity with general safety objectives;

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— The as-built configuration of SSCs is in conformity with the assumptions made


in the regulatory review and assessment, any deviation is analysed and justified
and the documentation is updated accordingly;
— The operator’s system and procedures for quality assurance and inspection
are adequate to ensure the conformance of equipment to the technical
specifications.

A.5. The regulatory body should inspect design and construction activities in a
number of areas in order to attain these objectives. In particular, the following areas
should receive close attention in the construction stage, primarily because of the
difficulty of detecting and correcting deficiencies in these areas once fissile and
radioactive material has been brought to the site and the facility enters the active
commissioning stage:

(a) mixing and placement of concrete and its reinforcement, especially in:
— foundations,
— safety related structures, particularly containment structures;
(b) construction of cooling intakes and discharge systems;
(c) installation of safety related components, particularly:
— containment and shielding boundaries,
— internals of vessels which will contain fissile and radioactive material,
— equipment to be used in radiation areas;
(d) installation of safety related control, protection and power systems;
(e) areas of the facility that are inaccessible after construction is completed,
particularly systems and components embedded in the foundations or the
building structure;
(f) housekeeping in respect of safety related SSCs;
(g) the quality assurance systems of the designer, manufacturer and constructor.

COMMISSIONING STAGE

A.6. Activities associated with commissioning will normally begin before


construction is completed. Accordingly, the regulatory body should be prepared to
inspect areas of commissioning activity in parallel with activities of the construc-
tion stage. In some States the regulatory body approves the commissioning
programme and its agreement should be obtained before advancing beyond certain
hold points.

A.7. Inspection by the regulatory body during the commissioning stage should focus
on four broad areas of the operator’s activity:

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(1) testing before the introduction of fissile and radioactive material;


(2) initial introduction of fissile and radioactive material;
(3) testing of operations involving fissile and radioactive material;
(4) other commissioning activities.

Testing before the introduction of fissile and radioactive material

A.8. The inspection area of testing before the introduction of fissile and radioactive
material encompasses those activities and tests performed before the introduction of
such material by the operator in order to demonstrate that SSCs function properly and
conform to design requirements. It also covers the inspection and acceptance criteria
for the receipt at the facility of fissile and radioactive material. The regulatory
inspection programme should include:

— examination of documented procedures to verify that they accord with the


conclusions of the regulatory review and assessment;
— review of the implementation of these procedures;
— direct observation of the performance of certain key pre-operational tests;
— examination of the results of selected tests;
— confirmation of the integrity of any engineered barriers.

A.9. The number of tests and the key tests that are to be examined and directly
witnessed by the regulatory body will vary depending on such factors as the
importance of the test for safety and whether the facility to be commissioned is the
first of its kind or one of several similar facilities. The regulatory body should,
however, place particular emphasis on inspection by the examination of
documentation and by the direct observation of some of the tests performed on:

— SSCs that prevent unsafe conditions or that mitigate the consequences of


anticipated operational occurrences and accident conditions;
— SSCs whose failure to operate properly will require action from one or more
safety related components or systems.

A.10. This may involve the regulatory body in inspecting tests of:

— safety systems (such as instrumentation and control systems, shutdown systems


and standby systems);
— the integrity of the containment and shielding boundaries (such as hydraulic
tests of pressurized structures) as appropriate;
— the susceptibility of SSCs to vibration or to other design loads;

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— secondary containment integrity (such as overpressure and leak rate tests) as


appropriate;
— emergency power systems as appropriate;
— communication capabilities;
— ventilation systems;
— integrated cold and hot functional tests.

Initial introduction of fissile and radioactive material

A.11. In the regulatory inspection programme, close attention should be paid to


operator activities relating to the preparation for and actual introduction of fissile and
radioactive material. Regulatory inspection personnel should be present at the facility
site to observe some of these activities directly.

A.12. Although some of these tests may be performed at times other than the time
when fissile and radioactive material is first introduced, the regulatory body should
inspect the following:

— tests of the main control room;


— access control and implementation of the radiation protection programme;
— emergency preparedness and demonstration of the emergency plan;
— systems for monitoring radioactive releases and meteorological monitoring
systems;
— the distribution of fissile and radioactive material (such as the fuel loading
pattern in a reactor) and process calculations and/or criticality calculations, as
appropriate;
— systems involved in the handling or movement of radioactive or fissile
material.

Testing of operations involving fissile and radioactive material

A.13. The inspection area of testing of operations involving fissile and radioactive
material encompasses activities of the operator performed in conditions up to nominal
operating conditions. At this point, SSCs are tested in an operational environment to
ensure that they have been constructed and installed properly and are capable of
functioning in compliance with the design requirements. Consideration should be
given to the performance of radiation surveys of facility shielding (such as concrete
walls) during starting up of the facility. This will help to identify any voids or faulty
joints in the shielding or any radiation penetrating through joints. In the event of such
an occurrence, alterations should be made prior to further operation. During this
period the operator carries out tests at increasing operational levels; this testing

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includes the recording and analysis of data relating to temperatures, pressures,


radiation levels, flows and variations in process parameters as well as other relevant
parameters.

A.14. Regulatory inspection personnel shall examine and assess the safety aspects of
a sample of the operator’s procedures for conducting operational tests. In addition, as
the tests are completed, a sample of the test documentation and the results of the
inspection should be examined by regulatory personnel to verify that the tests have
been completed in accordance with the test instructions and that the results are
acceptable. Regulatory inspection should also include the monitoring and direct
observation of several tests.

A.15. Tests during this stage, which should be subject to regulatory review and
inspection, will depend on the type of facility being commissioned. They include tests
to demonstrate as far as possible that:

— the facility is being operated in accordance with the descriptions given in the
safety analysis report;
— systems respond to malfunctions in accordance with the claims made in the
safety analysis report.

Other commissioning activities

A.16. In addition to the examination of documentation and the surveillance of tests,


there are a number of other areas necessitating inspection by the regulatory body in
the commissioning stage. The ability of the operator’s management to progress from
supervising construction to supervising operation and its arrangements for doing so
should also be inspected. This inspection should cover the management’s provisions
for putting the emergency plan into effect and for the training and qualification of
operating personnel. Hold points during the operational testing stage and into the full
operational stage should be closely monitored. These areas largely overlap,
necessitating continuing attention in inspections during the operation stage.

OPERATION STAGE

A.17. Once the facility has attained the authorized operation stage, the regulatory
body shall implement an inspection programme to verify systematically the
operator’s compliance with regulatory requirements and achievement of general
safety objectives, and to detect potential safety problems. This verification should
consist of: a balanced approach to monitoring and direct observation of activities;

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interviews with personnel, including managers; review of qualifications of the


operator’s personnel; and sampling of documentation. For waste management
facilities and particularly for waste disposal facilities, the structure of the programme
and the tests to be carried out will primarily relate to conformance to the relevant
design criteria and waste acceptance criteria for the facility and will constitute an
element in providing confidence for the long term safety case. For all facilities, these
inspections should cover the aspects detailed in paras A.18–A.41.

Operations

A.18. The area of operations should include the control and execution of activities
directly relating to operating a facility to the operational limits and conditions
established by regulatory requirements or by procedures or specifications. Inspection
personnel should perform safety verification of: operating procedures; the operating
configuration of safety related systems; control room activities; and the abilities of
the operations staff to perform their duties. Simulator training and the responses of
operating staff to abnormal events and emergency conditions, as well as the
adequacy of the management’s actions, should also be assessed. In performing this
safety verification, the reviews described in paras A.19–A.22 should be carried out.

A.19. Operating procedures. A sampling review of operating procedures should be


performed, including all the procedures for normal operations, anticipated operational
occurrences and accident conditions. Inspections should be focused on the operating
personnel’s adherence to procedures, including operational limits and conditions. The
usability and adequacy of the procedures should also be evaluated. This may
necessitate sustained observations in the control room. The inspection programme in
this area may necessitate sustained observation to cover 24 hour operation as
necessary, in particular shift turnovers. The inspectors should check the availability
of safety systems and the presence of alarm systems, and the way in which they are
handled by the operations staff.

A.20. Operator’s training programme. The adequacy of the operator’s staff training
programme should be assessed routinely to ensure that the training reflects actual
conditions in the facility.

A.21. Safety systems. A sampling review of safety systems should be performed to


evaluate: any identified degraded equipment; discrepancies between installed
components and/or system hardware and the facility drawings; controls for
performing maintenance on equipment; and the quality of performance of the
operations staff in log keeping and record keeping and in routine monitoring of
equipment. Note should be taken of the effectiveness of the operations staff in getting

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the degraded equipment repaired by the maintenance staff or its prompt evaluation to
ensure operability. Inspection of the facility should also include observations of non-
safety-related areas to ensure that they have no adverse effects on the safety related
areas of the facility. The adequacy of the fire protection and prevention programme,
including the management’s attention to this area, should be noted in these
inspections.

A.22. Management. The management’s involvement in the facility and its


effectiveness in paying appropriate attention to operational issues, including
abnormal events, should be evaluated. In inspections it should be considered: whether
the organizational structure is suitable; whether there are adequate numbers of staff;
how well management and staff communicate; and how the management emphasizes
the importance of safety and fosters safety culture.

Outages

A.23. Inspections should cover outage activities. In addition to providing


opportunities to observe modifications being made to the facility, outages provide
opportunities to observe activities in areas that are not always accessible during
normal operation. Certain activities such as inspections in highly radioactive areas or
the maintenance and repair of highly contaminated systems present a challenge to the
operator’s organization. Outages can provide valuable insights into the management’s
ability to perform tasks outside the normal operational mode. Furthermore,
movements of fissile and radioactive material need to be well controlled and special
checks may be necessary before returning the facility to normal operation to ensure
that it is still within its safety justification. Before returning the facility to normal
operation, it is usual for the regulatory body to perform a special inspection.

Radiation protection and radioactive waste management

A.24. The area of radiation protection should cover all related activities at the facility,
including radiation protection of staff and contractor personnel and of the public
[5–7]. The area of radioactive waste management should cover treatment,
conditioning, storage and transport of waste, the release of effluents and the
environmental monitoring programme [8].

A.25. Organizational structure for radiation protection. The structure of the


organization responsible for the implementation of the radiation protection
programme, the procedures necessary for implementation of the programme, the
effectiveness of the management and its commitment with respect to radiation
protection, including application of the optimization principle, should all be assessed

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in the inspection. Indicators of the effectiveness of the management are the levels of
exposure of personnel, levels of contamination in working areas, levels of releases of
effluents, and the understanding on the part of management and workers of their
responsibilities in the implementation of the radiation protection programme. Any
self-assessments performed by the operator under this programme should be
reviewed.

A.26. Records of occupational radiation doses. Inspection personnel should


selectively review records of individual occupational doses, including internal and
external doses. Activities should be observed to ensure that procedural and
management controls are effective. This includes controls for radiation areas and
contamination areas as well as inspection of activities for internal and external
dosimetry. Exposures of personnel that result in the operator’s reference levels for
effective doses or intakes being exceeded should be noted. Records of radiation
protection training and retraining should be assessed.

A.27. Effluents. The inspection programme should include verification that any
releases of effluents are within the authorized discharge limits. This should include
the review of systems for the treatment of radioactive waste and for the monitoring
of effluents. Training and qualifications for technicians and workers employed in the
areas concerned should also be reviewed.

A.28. Environmental monitoring. The environmental monitoring programme


should be reviewed to ensure that all environmental monitoring is performed in
accordance with established procedures. Independent measurements may be
performed to verify the accuracy of the operator’s monitoring equipment and the
results of measurements.

A.29. Waste management. The implementation of arrangements for on-site waste


treatment, conditioning and storage should be reviewed and records should be
inspected. In particular, the waste characterization process, the compliance with any
requirements for waste storage or disposal, and the records for these processes should
be subject to inspection.

A.30. Whenever unpackaged waste is stored or waste packages are stored or have
been placed in a waste repository pending a decision on closure of the facility,
degradation of the waste with time may occur. The storage conditions for the waste
and the waste packages should be inspected at appropriate intervals to provide
confidence that the waste remains suitable for treatment or that the waste packages
will be suitable for retrieval, transport and further steps in radioactive waste
management, as necessary.

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A.31. Transport arrangements for radioactive material on the site should be


examined. Receipt and dispatch arrangements should be inspected and attention
should be paid to the integrity of packages, residual levels of contamination and
associated records.

Maintenance and testing

A.32. Inspection in the area of maintenance and testing should comprise assessments
of the implementation of the maintenance and testing programme. These should
cover:

— all types of maintenance performed on SSCs and maintenance of the physical


condition of the facility;
— testing, including the conduct of all surveillance testing activities, all in-service
inspection and testing, calibration of instruments, equipment operability tests
and other special tests.

A.33. Direct observation by the regulatory body should include a sampling of the
operator’s inspection and testing activities, including such tests as: calibration of
nuclear instrumentation systems; verification of containment integrity; testing of
local leak rates for the containment; testing of piping support and restraint systems;
tests for safety pumps, valve capacity and stroke timing; and surveillance tests for
breakers and transformers. Inspectors should note the capability of the individuals
performing the tests and, for complex surveillances, should assess the interface
between the surveillance personnel and the operations staff involved in the
performance of the test. The adequacy and usability of the procedures should be
assessed and the control and calibration of the test equipment should be observed.
The inspection personnel should observe the manager’s involvement in these
programmes to ensure that the programmes are effective and that safety equipment is
properly maintained, with few recurring problems. Maintenance backlogs, the
intervals at which repetitive equipment repairs are carried out and the amount of
maintenance work actually being performed should be routinely noted, as these may
be early indicators of declining performance in the maintenance programme. In this
connection, a large backlog of repairs, a high number of equipment failures and a low
level of maintenance activity may be indicative of a maintenance programme that is
difficult to manage and requires a disproportionate amount of documentation. Self-
assessment activities in these programmes should be observed and their findings
should be routinely reviewed.

A.34. A sample of maintenance activities including inspection and testing should be


routinely observed to assess the adequacy of programmes and procedures and the

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capability of the maintenance technicians to perform their assigned tasks. The


planning and scheduling of maintenance should be assessed to ensure that
maintenance activities are performed by competent staff and are properly co-
ordinated, and that repairs to equipment are handled in accordance with appropriate
priorities. All types of maintenance activities should be observed. Before initiating
maintenance work, special attention should be paid to the isolation and tagging of
safety systems which are out of service. Inspectors should observe the compliance
with procedures for these isolation and tagging controls in order to evaluate their
adequacy and should evaluate the procedures for ensuring that systems are returned
correctly to their operational state. The in-service inspection programme and the in-
service testing programme should be reviewed to ensure that their purpose, which is
to ensure the early detection of degradation of equipment and components, is being
served. Programmes, procedures and data should be reviewed and evaluated,
particularly for those maintenance tasks that can be performed only during outages.
Data which may indicate that a high number of component systems need repair may
necessitate an in-depth review of the programmes. Repairs to piping systems, pumps,
valves, electrical systems and instrumentation and control systems should all be
selectively sampled for review. Welding on systems of safety significance should be
observed, including examination by non-destructive means.

Engineering

A.35. Engineering usually provides necessary support to the operations or


maintenance staff anywhere in the facility at any time. Engineering usually assists
operations staff with the evaluation of non-conforming or degraded conditions and
assists maintenance staff in the performance of activities in the course of which
problems may arise. Inspection personnel should review a sample of the evaluations
for non-conforming or degraded conditions for both adequacy and quality, and should
observe the interface between the maintenance and engineering support groups.

A.36. The inspector should walk down part of a system to assess how well systems
are being maintained and should note any non-conformance. Any problems identified
by the inspector but not known to the facility’s management would call into question
the adequacy of the support programme for system engineering.

Modifications

A.37. Modifications may be simple or complex and may involve changes to


engineering, operating procedures and the organizational structure. For major
modifications to the SSCs of a facility, most of the planning, design and manufacture
will be performed prior to outages. The regulatory body should inspect the operator’s

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record to determine whether its modification process has been effective in controlling
modifications in a manner which is appropriate for their safety significance. Where
required, the regulatory body should also inspect submissions by the operator to the
regulatory body concerning a modification. The details of the process should be
checked in the inspections by sampling specific modifications and reviewing their
execution and their implications for documentation, such as the need for changes to
safety related documentation, for updating of maintenance schedules and engineering
drawings and for changes to operational procedures and training modules. These
checks may involve other parts of the regulatory body in addition to the inspection
unit. The regulatory body should also determine whether the qualifications of the
operator’s staff who perform the modifications are suitable for the function they are
performing.

Emergency preparedness

A.38. Inspection of the area of emergency preparedness and response should include
a review of emergency response plans and procedures in order to verify that the
means of coping with an emergency are adequate. Procedures for the detection and
classification of an emergency and for decision making in an emergency should be
assessed. Procedures for notification, communication, shift staffing, shift
augmentation, dose calculation and dose assessment should also be evaluated.
Emergency exercises should be witnessed to ensure that the emergency planning is
adequate and that its implementation is effective.

Physical protection

A.39. Inspection of the area of security should include a review of all activities
relating to access control, the physical protection of equipment in safety related areas
and fitness for duty programmes, as applicable. Inspection personnel should routinely
monitor the controls on access to the facility. The effects of the hardware for physical
protection on accessibility and the ability of the operator to operate the facility safely
should be routinely assessed. Inspection personnel should also review the fitness for
duty programme and assess its effectiveness.

Quality assurance programme

A.40. The operator’s quality assurance programme should be reviewed to ensure that
it is comprehensive and adequately implemented. The review should cover, in
addition to the activities discussed earlier, such activities as: procurement, receipt,
storage and handling of equipment; document control; and operational experience. In
particular, the adequacy and effectiveness of the operator’s performance of a

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programme of internal audit and self-assessment and implementation of the resulting


corrective actions should be assessed.

Effectiveness of management systems

A.41. Inspection of the area of effectiveness of management systems should include


inspection of those indicators which demonstrate that the management system is
focused on safe operation and on the identification and remediation of problems and
weaknesses within the programme. This includes the management’s involvement in
day to day operations and its routine presence in the facility. What is most important
is whether the management demonstrates a willingness to hear of problems and then
to ensure that problems are promptly evaluated and solved. The management’s ability
to create an environment in which problems are openly identified and discussed and
self-assessment programmes are effectively supported helps to foster an appropriate
safety culture for operation.

DECOMMISSIONING STAGE

A.42. During the decommissioning stage of a nuclear facility, inspection activities


should be concentrated on:

— the adequacy of the operator’s procedure for the control of each stage of
decommissioning;
— the removal of radioactive material;
— the strategy for management of radioactive material;
— the drainage of any fluid;
— decontamination and dismantling activities;
— the waste management strategy for the treatment, conditioning, storage and
disposal of all radioactive waste;
— the physical condition of the facility, especially surveillance of the integrity
and/or the availability of relevant SSCs, including protective barriers, and the
appropriateness of the procedures at each stage of decommissioning;
— characterization of the residual activity;
— physical protection, safeguards and access control;
environmental monitoring, radiological monitoring and surveillance, including
plans for radiation protection for workers and the public;
— the adequacy and maintenance of instrumentation and control systems for long
term safety;
— decommissioning records.

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A.43. After a long period of safe enclosure, some of these regulatory inspection
activities may be reduced in thoroughness and frequency.

Closure of waste disposal facilities

A.44. Before the regulatory body considers the release of any waste disposal facility
from further regulatory control, inspection activities should be concentrated on:

— conformance with the overall waste inventory;


— sealing arrangements for the facility including any measures to prevent
intrusion;
— arrangements for any environmental monitoring after closure.

Areas of interest relating to the release of a facility and/or site from regulatory
control

A.45. Before releasing a site from any further control, the regulatory body should
carry out an inspection to confirm that any residual activity has been reduced to
acceptable levels. For waste disposal facilities, the release from control will be related
to the long term safety of the facility as set out in the post-closure safety case.

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This publication has been superseded by GSG-13.

REFERENCES

[1] INTERNATIONAL ATOMIC ENERGY AGENCY, Legal and Governmental


Infrastructure for Nuclear, Radiation, Radioactive Waste and Transport Safety, Safety
Standards Series No. GS-R-1, IAEA, Vienna (2000).
[2] INTERNATIONAL ATOMIC ENERGY AGENCY, Organization and Staffing of the
Regulatory Body for Nuclear Facilities, Safety Standards Series No. GS-G-1.1, IAEA,
Vienna (2002).
[3] INTERNATIONAL ATOMIC ENERGY AGENCY, Review and Assessment by the
Regulatory Body for Nuclear Facilities, Safety Standards Series No. GS-G-1.2, IAEA,
Vienna (2002).
[4] INTERNATIONAL ATOMIC ENERGY AGENCY, Documentation for Use in
Regulating Nuclear Facilities, Safety Standards Series No. GS-G-1.4, IAEA, Vienna
(2002).
[5] INTERNATIONAL ATOMIC ENERGY AGENCY, Occupational Radiation Protection,
Safety Standards Series No. RS-G-1.1, IAEA, Vienna (1999).
[6] INTERNATIONAL ATOMIC ENERGY AGENCY, Assessment of Occupational
Exposure Due to Intakes of Radionuclides, Safety Standards Series No. RS-G-1.2,
IAEA, Vienna (1999).
[7] INTERNATIONAL ATOMIC ENERGY AGENCY, Assessment of Occupational
Exposure Due to External Sources of Radiation, Safety Standards Series No. RS-G-1.3,
IAEA, Vienna (1999).
[8] INTERNATIONAL ATOMIC ENERGY AGENCY, Radiation Protection and
Radioactive Waste Management in the Operation of Nuclear Power Plants, Safety
Standards Series No. NS-G-2.7, IAEA, Vienna (2002).

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This publication has been superseded by GSG-13.

GLOSSARY

assessment. The process, and the result, of analysing systematically the hazards
associated with sources and practices, and associated protection and safety
measures, aimed at quantifying performance measures for comparison with
criteria.

authorization. The granting by a regulatory body or other governmental body of


written permission for an operator to perform specified activities. Authorization
could include, for example, licensing, certification, registration, etc.

closure. Administrative and technical actions directed at a repository at the end of its
operating lifetime — e.g. covering of the disposed waste (for a near surface
repository) or backfilling and/or sealing (for a geological repository and the
passages leading to it) — and termination and completion of activities in any
associated structures.

commissioning. The process during which systems and components of facilities


and activities, having been constructed, are made operational and verified to
be in accordance with the design and to have met the required performance
criteria.

decommissioning. Administrative and technical actions taken to allow the removal


of some or all of the regulatory controls from a facility (except for a repository
which is closed and not decommissioned).

enforcement. The application by a regulatory body of sanctions against an operator


intended to correct and, as appropriate, penalize non-compliance with condi
tions of an authorization.

licence. A legal document issued by the regulatory body granting authorization to


perform specified activities related to a facility or activity.

operator (operating organization). Any organization or person applying for


authorization or authorized and/or responsible for nuclear, radiation,
radioactive waste or transport safety when undertaking activities or in relation
to any nuclear facilities or sources of ionizing radiation. This includes, inter
alia, private individuals, governmental bodies, consignors or carriers,
licensees, hospitals, self-employed persons, etc.

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regulatory body. An authority or a system of authorities designated by the


government of a State as having legal authority for conducting the regulatory
process, including issuing authorizations, and thereby regulating nuclear,
radiation, radioactive waste and transport safety.

regulatory inspection. An examination, observation, measurement or test


undertaken to assess structures, systems, components and materials, as well as
operational activities, processes, procedures and personnel competence.

repository. A nuclear facility where waste is emplaced for disposal.

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CONTRIBUTORS TO DRAFTING AND REVIEW

Almeida, C. Comissão Nacional de Energia Nuclear, Brazil

Ito, H. International Atomic Energy Agency

Kim, Jin-Hong International Atomic Energy Agency

Karbassioun, A. International Atomic Energy Agency

Vaughan, G.J. Health and Safety Executive, United Kingdom

Weedon, C.J. Environment Agency, United Kingdom

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This publication has been superseded by GSG-13.

BODIES FOR THE ENDORSEMENT


OF SAFETY STANDARDS

Nuclear Safety Standards Committee

Argentina: Sajaroff, P.; Belgium: Govaerts, P. (Chair); Brazil: Salati de Almeida, I.P.;
Canada: Malek, I.; China: Zhao, Y.; Finland: Reiman, L.; France: Saint Raymond,
P.; Germany: Wendling, R.D.; India: Venkat Raj, V.; Italy: Del Nero, G.; Japan:
Hirano, M.; Republic of Korea: Lee, J.-I.; Mexico: Delgado Guardado, J.L.;
Netherlands: de Munk, P.; Pakistan: Hashimi, J.A.; Russian Federation: Baklushin,
R.P.; Spain: Mellado, I.; Sweden: Jende, E.; Switzerland: Aberli, W.; Ukraine:
Mikolaichuk, O.; United Kingdom: Hall, A.; United States of America: Murphy, J.;
European Commission: Gómez-Gómez, J.A.; IAEA: Hughes, P. (Co-ordinator);
International Organization for Standardization: d’Ardenne, W.; OECD Nuclear
Energy Agency: Royen, J.

Waste Safety Standards Committee

Argentina: Siraky, G.; Australia: Williams, G.; Belgium: Baekelandt, L. (Chair);


Brazil: Schirmer, H.P.; Canada: Ferch, R.; China: Xianhua, F.; Finland: Rukola, E.;
France: Averous, J.; Germany: von Dobschütz, P.; India: Gandhi, P.M.; Israel:
Stern, E.; Japan: Irie, K.; Republic of Korea: Suk, T.; Netherlands: Selling, H.;
Russian Federation: Poluehktov, P.P.; South Africa: Pather, T.; Spain: Gil López, E.;
Sweden: Wingefors, S.; Ukraine: Bogdan, L.; United Kingdom: Wilson, C.; United
States of America: Wallo, A.; IAEA: Hioki, K., (Co-ordinator); International
Commission on Radiological Protection: Valentin, J.; International Organization for
Standardization: Hutson, G.; OECD Nuclear Energy Agency: Riotte, H.

Commission on Safety Standards

Argentina: D’Amato, E.; Brazil: Caubit da Silva, A.; Canada: Bishop, A., Duncan,
R.M.; China: Zhao, C.; France: Lacoste, A.-C., Gauvain, J.; Germany: Renneberg,
W., Wendling, R.D.; India: Sukhatme, S.P.; Japan: Suda, N.; Republic of Korea: Kim,
S.-J.; Russian Federation: Vishnevskij, Yu.G.; Spain: Martin Marquínez, A.; Sweden:
Holm, L.-E.; Switzerland: Jeschki, W.; Ukraine: Smyshlayaev, O.Y.; United
Kingdom: Williams, L.G. (Chair), Pape, R.; United States of America: Travers, W.D.;
IAEA: Karbassioun, A. (Co-ordinator); International Commission on Radiological
Protection: Clarke, R.H.; OECD Nuclear Energy Agency: Shimomura, K.(Co-ordi-
nator); International Commission on Radiological Protection: Clarke, R.H.; OECD
Nuclear Energy Agency: Shimomura, K.

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