NRRC Stakeholders Guidelines

Kingdom of Saudi Arabia

Development of Radiation
Protection Program

NRRC-SG-020
2023
NRRC-SG-020
Classification: Public

Stakeholder Guideline
Development of Radiation Protection Program
2023
NRRC-SG-020

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Stakeholder Guideline for Development of
Radiation Protection Program

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Preamble

In accordance with the provisions of the NRRC’s approved Regulations,

this stakeholder guideline describes criteria and/or techniques that are
considered appropriate for satisfying the requirements stipulated in the
NRRC’s regulations.
This stakeholder guideline has been prepared on the basis of Interna-
tional Atomic Energy Agency (IAEA) standards, as well as the and the
international best practices and the experiences of similar international
regulatory bodies, and in accordance with the Kingdom’s international
commitments, and it has been approved by the NRRC’s CEO resolution
No. 1384 dated 16/07/2023.

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Radiation Protection Program

Contents

1. Purpose 4
2. Scope 4
3. Abbreviations 4
4. Preparation of Radiation Protection Program (RPP) 5
4.1 Content of Radiation Protection Program 5
4.2 Introduction- Description of Facility 6
4.3 Objective and Scope 7
4.4 References for RPP 7
4.5 Organizational Structure and Responsibilities 7
4.6 Dose Limits and Dose Constraints 8
4.7 Classification of Areas, and local rules. 8
4.8 Radiation Monitoring 10
4.9 System for Investigation and Reporting of Overexposure 11
4.10 Emergency Preparedness and Response 23
4.11 Security and Accountability of Sources 24
4.12 Contamination Control and Handling Arrangements 25
4.13 Radiation Protection Training Program 25
4.14 Health Surveillance 26
4.15 Radioactive Waste management 27
4.16 Conditions of Service 27
4.17 Record Keeping 28
4.18 Quality Assurance 29
4.19 Definitions and Abbreviations 30

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5. Additional Contents for Medical Radiation Facilities 30

5.1 Medical Exposure Control Responsibilities 31
5.2 System for Investigation and Reporting of Medical
Overexposure 31
5.3 Calibration and Clinical Dosimetry 32
5.4 Quality Assurance of Medical Exposure 33
5.5 Activity Levels for Patients on Discharge 33
5.6 Guidance Levels for Medical Exposure 34
6. Review and Revision of Radiation Protection Program 34
7. Related documents and files 35
Annex-I: Applicable Sections of Regulatory Guide According
to Type of Facility 37
Annex-II: Example of Organizational Chart of the Facility 49
Annex-III: Typical Assignment of Roles and Responsibilities 41
Annex-IV: Contents of Investigation Report on Radiation
Overexposure Event 49
Annex-V: Contents for Training Program 50

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Stakeholder Guideline for Development of
Radiation Protection Program

1. Purpose
Nuclear and Radiological Regulatory Commission (NRRC) has devel-
oped an effective regulatory framework for the safety and security of
nuclear and radioactive material throughout their life cycle against un-
authorized removal and sabotage. Under the regulatory framework, the
prime responsibility for safety and security of nuclear and radioactive
material lies with the authorized person.
Section 25 of the Regulation on Radiation Safety (NRRC-R-01) estab-
lishes specific requirements for the development, content, revision,
and approval of the documented Radiation Protection Program (RPP)
by the authorized person as part of the authorization and continuous
compliance requirements. To ensure the health and safety of persons in
proximity at the authorized activity and/or facility, a radiation protec-
tion program for the activity and/or facility is mandatory requirement
to be submitted for approval and implemented in accordance with the
Regulation on Radiation Safety (NRRC-R-01) for minimizing radiation
exposure to workers and to members of the public.
This guideline provides guidance for the applicant and/or the autho-
rized person for the preparation of RPP with the goal of protecting
workers, patients, the public and the environment from unnecessary
radiation exposure.
2. Scope
This guideline is applicable for the preparation of RPP for radiation
activities and facilities that shall be complied as prescribed in Article
74 and 75, of the Regulation on Radiation Safety (NRRC-R-01), that
shall be submitted by the applicant for assessment and approval by
the NRRC, as part of the documentation required for authorization

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process; and shall be documented, reviewed and updated in a way that

reflect the actual state of the implemented measures, arrangements and
processes for the activity and or at the facility during NRRC inspec-
tion. This guideline provides guidance to the authorized person in the
preparation of RPP.
3. Abbreviations
Abbreviation Definition
ALARA As Low as Reasonably Achievable
CT Computed Tomography
IAEA International Atomic Energy Agency
ICRP International Commission on Radiological Protection
kVp Kilovoltage peak
mA milliampere
OSL Optically Stimulated Luminescence
PET Positron Emission Tomography
PPE Personal Protective Equipment
QAP Quality Assurance Program
RPP Radiation Protection Program.
RSO Radiation Safety Officer
RPC Radiation Protection Committee
SPECT Single Photon Emission Computed Tomography
SSDL Secondary Standard Dosimetry Laboratory (SSDL)
TLD Thermoluminescent Dosimeter

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Stakeholder Guideline for Development of
Radiation Protection Program

4. Preparation of Radiation Protection Program (RPP)

To ensure that radiation safety is being maintained and radiation pro-
tection measures as required by the Commission laws, particularly
requirements prescribed in (NRRC-0R-01), are taken effectively, the
applicant or the authorized person is required to submit RPP as part
of authorization requirement as well as compliance assurance. The RPP
describes the ways in which management structures, policies, proce-
dures, and organizational arrangements are implemented to protect
workers, patients, the members of public and the environment from
undue radiation exposure. It also covers the safe transport, receipt,
handling, use and storage of radioactive materials. The licensee submits
the RPP for review and assessment by the NRRC to ensure that safe
conditions for the proper use of radiation are maintained, radiation ex-
posures are kept ALARA, operations and transport of radioactive ma-
terial are in compliance with the requirement of the Commission laws.
The objectives of the RPP are as follows:
• Ensure the effective monitoring and control of internal and
external radiation doses for onsite personnel and the public;
• Ensure the effective monitoring and control of releases of ra-
dioactive material to the environment; and
• Keep radiation exposure as low as is reasonably achievable
(ALARA).

4.1. Content of Radiation Protection Program

The RPP considers radiation protection in both normal and ab-
normal modes of operation and is based on sound engineering

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principles and proven practices. The RPP ensures that over the
lifetime of the activity and/or facility, any exposure to personnel
or individual members of the public will be within the limits es-
tablished in (NRRC-R-01).
Depending on the type and nature of radiation activities or facili-
ties, the basic structure of the RPP should contain, but not limited
to, the following sections with an appropriate level of outlines as
indicated in preceding paragraphs:
i. Introduction- Description of Facility;
ii. Objective and Scope;
iii. Basis of the RPP;
iv. Organizational Structure and Responsibilities;
v. Dose Limits and Dose Constraints;
vi. Classification of Areas and Access Control;
vii. Radiation Monitoring;
viii. System for Investigation and Reporting of Overexposure.
ix. Emergency preparedness and Response;
x. Security of Radioactive Material;
xi. Contamination Control/Handling Program;
xii. Radiation Protection Training Program;
xiii. Health Surveillance;

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xiv. Radioactive Waste Handling;

xv. Conditions of Service;
xvi. Program Revision Frequency;
xvii. Record Keeping; and
xviii. Quality Assurance;
xix. Definitions and Abbreviations
4.2. Introduction- Description of Facility
The RPP should describe an introduction and a general descrip-
tion of the facility to enable the reviewer to obtain a basic un-
derstanding of the overall activities and facility. Following details
should at least be described:
i. Description of activity and types of authorization applied
to NRRC;
ii. Legal name of the facility and name or designation of the
authorized person with clear description that if the facili-
ty is a standalone entity or it is part of a larger set-up i.e.,
organization/hospital, etc.;
iii. All sources of radiation exposure at the installation and
facility which includes:
a. Available radiation generators (e.g., superficial, and
deep X-ray therapy, linear accelerators, Computed
Tomography (CT) alone or combined with Single

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Photon Emission Computed Tomography (SPECT)

or Positron Emission Tomography (PET), etc.) with
complete specifications including peak tube poten-
tial (kVp), current (mA), manufacturer, model, serial
number, date of installation, etc. and in case of neu-
tron generators, the neutron flux and mean energy,
etc.;

b. Available sealed radiation sources, their purpose and

complete specification including source ID or seri-
al number, physical form, type of radiation emitted
from sources with energy, activity with specified
units, reference date and location;
c. Unsealed radioactive material, their purpose, ra-
dioisotopes, type of radiation emitted from sources
with energy, maximum expected activity to be held/
acquired by the facility in a certain period of time.
iv. Available exposure devices serving the purpose of trans-
port container (portable, fix), transport packages, source
changers, storage containers and ancillary equipment
along with valid design certificate, design specifications,
manufacturer, model, serial number, authorized contents,
shielding, etc.; and
v. For transport of radioactive material outside the facility,
information related to type, nature, and number of pack-
ages to be shipped annually, mode of transport, convey-
ance type, shipping documents, etc.

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4.3. Objective and Scope of the RPP

The RPP should describe the aim and goal intended to be achieved
to meet the overall radiation protection goal. The objective of RPP
should include implementation of the requirements of the Com-
mission Laws and to keep the radiation doses of workers and pub-
lic within applicable dose limits and ALARA. There should also
be a description of all activities and workers which the RPP is
applicable to.
4.4. References for RPP
All the documents used in the preparation of RPP should be doc-
umented and properly quoted. Reference documents that com-
monly refers to may be:
i. Provision of the Commission laws.
ii. Standards and guides of IAEA.
iii. ICRP.
4.5. Organizational Structure and Responsibilities

4.5.1. Organizational Structure

The RPP should describe organizational arrangements and
lines of communication that result in an appropriate flow
of information on protection and safety at and between the
various levels in the entire organization. For this purpose,
the RPP should describe:

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i. Overall organizational chart based on hierarchy of the fa-

cility showing different sections of the organization and
reporting and communication lines for the protection and
safety as given in Annex II (A).
ii. The organizational chart should reflect the designations of
all relevant personnel of the facility such as owner, admin-
istrator, RSO, any qualified personnel, radiation worker,
technician, persons responsible for transport of radioac-
tive material etc. as required by NRRC; and
iii. Composition of any advisory body, oversight group or ra-
diation protection committee as practiced at the facility.
4.5.2. Roles and Responsibilities
The RPP should provide description of all proposed func-
tions, responsibilities, and authorities of each of the individ-
uals or positions identified in organization structure with
respect to radiation protection and safety in management,
operation, maintenance, emergency response, record keep-
ing, etc. at the facility and transport of radioactive materi-
al outside the facility, including the interface with security.
These individuals or positions may include:
i. Authorized person (owner or management i.e., Chief
Executive Officer (CEO), Director, Head, etc.);
ii. Advisors, oversight committees or Radiation Protec-
tion Committee (RPC);

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iii. RSOs;
iv. Qualified personnel;
v. Radiological medical practitioner;
vi. Radiation workers;
vii. Other workers;
viii. Personnel involved in transport of radioactive mate-
rial; and
ix. Any other person who is involved in performing, su-
pervising, over-sighting, handling or operating radia-
tion equipment or sources at the facility.
The sample responsibilities of authorized person, RSO, ra-
diation workers and RPC are attached as in Annex III.
4.6. Dose Limits and Dose Constraints
This RPP should include description of process/mechanism per-
formed by the authorized person to restrict normal exposure of
individuals so that neither the total effective dose nor the total
equivalent dose to relevant organs or tissues, caused by the possi-
ble combination of exposures from authorized practices, exceeds
any relevant dose limit specified in the Commission laws.
There should be description of process/mechanism implemented
by the authorized person to optimize the radiation safety mea-
sures associated with a given practice so that the resulting doses
to the workers of the facility and the public (in case of any source

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that can release radioactive substances to the environment) do

not exceed dose constraints specified in Commission laws or any
lower values agreed by the NRRC. In the case of transport of ra-
dioactive material, relevant regulatory limits defined in the Reg-
ulation on Safe Transport of Radioactive Materials (NRRC-R-15)
and Regulation on Packaging and Transport of Radioactive Mate-
rials (NRRC-R-15-SR01) shall apply.
The dose limits and dose constraints applicable at the facility,
their compliance, and specific actions if doses exceed the limits/
set dose constraints shall also be included.
4.7. Classification of Areas, and local rules.
This RPP should describe the classification area of the facility i.e.,
controlled area and supervised area based on the dose limits. A
layout of the facility showing classification of areas, description
of rules and procedures and necessary arrangements required by
the facility to work in respective areas including access control,
removal of tools/items, use of protective items and monitoring
equipment, etc. should be provided. The arrangements made for
demarcation of the areas within the facility or during field work
should be described. The area for preparation of packages/ship-
ment within the facility should also be classified based on dose
assessment.
4.7.1. Controlled Area
Any area of the facility should be designated as a controlled
area where there is a likelihood of receiving an effective

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dose greater than 6 mSv in a year or an equivalent dose

greater than three tenths of the relevant dose limit as pre-
scribed in Regulation on Radiation Safety (NRRC-R-01). In
this area, specific protective measures or safety provisions
are (or could be) required for:
i. Controlling normal exposures or preventing the
spread of contamination; and
ii. Preventing or limiting the extent of potential expo-
sures.
Information on controlled area should include the following:
i. Arrangements for delineation of controlled areas by
physical means;
ii. Display of warning signs and instructions at access
points and other appropriate locations within con-
trolled area; and
iii. Description of local rules, procedures applied by the
facility for entering, working, and leaving controlled
areas and supervision of work with radiation sources.
For example, in case of nuclear medicine, the following areas may
be designated as controlled areas:
i. Rooms for preparation, storage, and injection of the ra-
diopharmaceuticals;
ii. Imaging rooms and injected patient waiting areas;

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iii. Isolation rooms for therapeutic patients; and

iv. Rooms for temporary storage of radioactive waste.
In radiotherapy, the treatment and simulator rooms are desig-
nated as controlled areas. The control panel area and other areas
adjacent to the treatment room might also be designated as con-
trolled areas.
4.7.2. Supervised Area
Any area of the facility should be designated as a supervised
area where there is a likelihood of receiving an effective dose
greater than 1 mSv in a year or an equivalent dose greater
than one tenth of the relevant dose limit as prescribed in
Regulation on Radiation Safety (NRRC-R-01). There is a
need to keep the occupational exposure conditions under
review even though specific protection measures and safe-
ty provisions are not normally needed. The description of
each supervised area and facility arrangements to delineate
and identify the supervised areas should be included in this
section.
4.7.3. Personal Protective Equipment
The RPP should describe:
i. Type, nature, and specification of personal protective
equipment/items available;
ii. The conditions or circumstances when these are to be
used;

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iii. List of protective equipment or items available at the fa-

cility (e.g., protective clothing, lead aprons, gloves, organ
shields, protective respiratory equipment, etc.); and
iv. Arrangements for regular testing and maintenance of per-
sonal protective equipment.
4.8. Radiation Monitoring
RPP should describe the radiation monitoring arrangements for
assessment of radiation exposure to workers at the facility.
4.8.1. Individual Dose Monitoring Arrangements
The RPP shall provide a description of the facility arrange-
ments for the assessment of occupational exposures of
workers which shall at least include all workers who work
in controlled area prescribed in Regulation on Radiation
Safety (NRRC-R-01). This section should describe:
i. Name of Dosimetry Service Provider;
ii. Nature of the dosimetry services e.g., beta, gamma,
neutron doses;
iii. Type of dosimeters to be used e.g., TLD, Film Badge
or OSL dosimeter;
iv. Frequency of individual monitoring;
v. Duration for use of dosimeter as agreed with service
provider;

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vi. Number of dosimeters/badges;

vii. Arrangement for personal alarm monitors in industri-
al radiography facilities
viii. Description and evaluation of dosimetry service pro-
viders used by the authorized persons;
ix. Arrangements made with service providers for dis-
patch and receipt of dosimeters or badges and results
including arrangements for immediate accidental
monitoring of workers;
x. Description of the alternative methods applied to as-
sess occupational exposure when individual monitor-
ing is not used;
xi. Arrangements for information and access of workers
to their dose records;
xii. Assessment of the committed doses if there is a poten-
tial of intake of radioactive substances;
xiii. Arrangements to retain the exposure records at least
until the worker attains or would have attained the age
of seventy-five (75) years and not less than thirty (30)
years after the termination of work involving occupa-
tional exposure;
xiv. Arrangements for keeping the workers record of the
periods of employment with other facilities, if any, and
the corresponding doses in each period; and

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xv. Recording level, investigation level and action level; as

prescribed in Article 296 of Regulation on Radiation
Safety (NRRC-R-01), established by the facility with
respect to individual radiation dose and correspond-
ing actions to be taken if these are exceeded.
xvi. Arrangements to ensure the submission of relevant in-
dividual occupational exposure data to the centralized
national database established by the NRRC.
4.8.2. Workplace Monitoring Arrangements
The RPP shall describe the facility arrangements for estab-
lishing, maintaining, and keeping under review the pro-
gram for monitoring of workplace as prescribed in Section
51 of Regulation on Radiation Safety (NRRC-R-01). Infor-
mation on workplace monitoring may include the follow-
ing:
i. Nature of monitoring (area monitoring and surface
monitoring);
ii. Where and when the measurements are to be made
and at what frequency;
iii. Quantities (units) to be measured at the facility;
iv. Reference levels (i.e., recording level, investigation
level and, action level) established by the facility with
respect to workplace monitoring results and corre-
sponding actions to be taken if these are exceeded;

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v. Reference to measurement methods and procedures;

and
vi. Type and specifications of the monitoring equip-
ment/instruments of the facility and list of available
equipment/instruments along with calibration fre-
quency of these instruments/equipment from SSDL.
4.8.3. Effluent Monitoring Arrangements
The RPP should describe the facility arrangements for
establishing, maintaining, and keeping under review the
program for monitoring of effluents. The following infor-
mation may be prepared to provide effluent monitoring ar-
rangement at the facility:
i. Nature of monitoring (liquid effluent and air borne efflu-
ent);
ii. Where and when the measurements are to be made and
at what frequency;
iii. Quantities (units) to be measured at facility;
iv. Reference levels (i.e., recording level, investigation level
and, action level) established by the facility with respect to
workplace monitoring results and corresponding actions
to be taken if these are exceeded;
v. Reference to measurement methods and procedures; and
vi. Type and specifications of the measurement equipment or

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instruments of the facility and list of available equipment

or instruments along with calibration frequency of these
instruments or equipment from SSDL.
4.9. System for Investigation and Reporting of Overexposure
This section of RPP should describe the mechanism for notifica-
tion of an incident/accident/event of overexposure, detail of inter-
nal system for investigation and subsequent reporting of acciden-
tal occupational exposure to the NRRC. Contents of investigation
report on radiation overexposure event are attached as Annex IV.
4.10. Emergency Preparedness and Response
NRRC is ensuring safety and security of radiation sources that ad-
dress the emergency and preparedness for any potential radiolog-
ical situation through provision of requirement for an emergency
plan and regulatory oversight to the authorized person. Article
107 of Regulation on Radiation Safety (NRRC-R-01) make pro-
vision that “The authorized person shall prepare an Emergency
Plan for the protection of people and the environment reflecting
findings from the safety assessment taking into consideration the
likelihood of an emergency affecting either workers or members
of the public as part of emergency preparedness and response”
with the goal to protect people and the environment from any
potential harmful effect of radiation. There should be a descrip-
tion on the arrangement of emergency preparedness and response
at the facility including measures and means of communication
for notification to the NRRC about any abnormal/emergency at

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the facility. Furthermore, the authorized person is also required

to describe the existing system for emergency preparedness and
include the contact points from NRRC in case of emergency com-
munications. For activities and/or facilities with radioactive mate-
rial of category 1, 2 and 3. A specific Emergency Plan as defined in
Stakeholder Guideline Preparation of Radiation Emergency Plan
for Radiation Activities/Facilities shall be dedicatedly prepared
for NRRC approval.
4.11. Security of Radioactive Material
The of RPP should include the provisions for, maintaining records
of source inventory including, for instance, records of receipt, use
and transfer of sources and the confirmation that source is not
transferred unless the receiver possesses a valid license or autho-
rization from NRRC. Records of sources should be maintained
including the following details:
i. Radioisotopes;
ii. Model No.;
iii. Identification No.;
iv. Activity of sources (Reference activity);
v. Location of sources; and
vi. Date of import.
There should also be included in the provision for conducting of
periodic physical verification of sources and immediate reporting
of any security related event to the NRRC. For activities and/or

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facilities with radioactive material of category 1, 2 and 3. A specif-

ic Security Plan as defined in Stakeholder Guideline in Develop-
ment of Security Plan for Radioactive Material shall be dedicated-
ly prepared for NRRC approval.
4.12. Contamination Control and Handling Arrangements
The RPP should provide description of the mechanism to control
the spread of contamination, arrangements to control the con-
tamination of workers and equipment, and decontamination of
facilities, to handle the fixed and removable contamination from
items and individuals, contamination limits applicable for trans-
port packages and conveyances, their compliance, and specific ac-
tions if contamination limits exceed the regulatory limits given in
Regulation on Management of Radioactive Waste (NRRC-R-16)
and other relevant NRRC’s regulations. In case of spread of con-
tamination during transport activity, arrangements for control of
contamination should be described.
4.13. Radiation Protection Training Program
The RPP should include facility program to conduct training and
retraining (with defined frequency) on radiation safety matters of
all individuals either performing or supervising activities using
radioactive sources or radiation generators as prescribed in sec-
tion 57 of Regulation on Radiation Safety (NRRC-R-01).
There should also be provided with information on arrangements
available at the facility to conduct such trainings including re-

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source persons, training material and facilities and description,

if some or all the trainings are arranged from outside the organi-
zation, as the case may be and records of trainings provided. The
contents of the training program are described in Annex V.
4.14. Health Surveillance
The RPP should provide information on arrangements to conduct
health surveillance that assess the initial and continuous fitness
of worker(s) designated to work in controlled areas as required
in Section 55 of Regulation on Radiation Safety (NRRC-R-01).
Information related to health surveillance that should be included
are:
i. Medical examination of worker(s) at the time of recruit-
ment;
ii. Periodic medical examination with defined frequency for
health surveillance based on general principles of occupa-
tional health;
iii. Tests or examinations to be conducted and tests reports
examination of the health screening program performed
by a qualified medical practitioner;
iv. Policy or arrangement of the facility regarding the provi-
sion of adequate information on health risks due to their
occupational exposure to the radiation worker including
female workers; and
v. Facility arrangements, in case of radiation accident situa-

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tions, for administration of first aid and for carrying out

external decontamination of affected persons as applica-
ble.
4.15. Radioactive Waste management
The authorized person shall maintain radiation protection mea-
sures during the management of radioactive waste. Necessary ra-
diation protection arrangements for proper handling of radioac-
tive waste generated at the facility should also be described. Some
of the examples are such as, providing radiation dose monitoring
devices, remote handling tools and personal protective clothing/
equipment to workers involved in handling of radioactive waste
and working in the radioactive waste management areas, classi-
fication of waste management area, segregation/classification of
waste with proper marking of waste containers, casks, drums, etc.
4.16. Conditions of Service
The RPP should described policy regarding employment of ra-
diation worker’s which includes refrain from providing any ben-
efits to workers as a substitute of proper protection and safety
measures as prescribed in Article 172 of Regulation on Radiation
Safety (NRRC-R-01), notification of pregnancy by female work-
ers to authorized person, change in workers assigned jobs due to
worker’s health problems to avoid occupational radiation expo-
sure and prohibition of individual to work as occupational worker
under the age of eighteen (18) years. No individual between the
ages of 16-18 years should be allowed to work in a controlled area
unless supervised and then only for the purpose of the training.

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4.17. Record Keeping

The type and nature of records which will be maintained at the
facility along with period of time for which these records will be
maintained/retained as prescribed in Section 86 of Regulation
on Radiation Safety (NRRC-R-01). These records should at least
include, but not limited to following:
i. Records for radiation exposure to the worker
- Personal dosimetry in routine operation: effective
dose (monthly) and period covered;
- Effective dose resulting from specific exposures (inci-
dents, accidents, or emergencies), and the date of these
exposures;
- Committed effective dose from internal exposures.

ii. Health surveillance records;

iii. Radiation survey/workplace monitoring records;
iv. Inventory of radiation sources (sealed radioactive sources
and radiation generators);
v. Instrument or equipment calibration/maintenance re-
cords;
vi. Inventory of radiation monitors and protective equip-
ment;
vii. Radiation protection training (and retraining) records;
and

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viii. Documents (plan and procedures) revision record.

ix. Recruitment, termination, or exchange of radiation work-
ers.
x. Import/export records.
xi. Radiation incidents and accidents.
xii. Transfer of ownership of radiation source.
xiii. NRRC inspection visits (including enforcement action).
xiv. Handling/transportation of radioactive materials.
xv. Emergency and security plan testing records.
xvi. Movement of radiation source from/to the storage loca-
tion.
xvii. Other information required by NRRC from time to time.
4.18. Quality Assurance
The applicant and/or authorized person should describe quality
control mechanisms and procedures to review and assess the
effectiveness of radiation protection and safety measures
within the facility and for transport of radioactive material (if
applicable). The following information should be provided in
supporting the QA requirements and compliance:

i. Appropriate organizational structure;

ii. Availability of qualified & trained personnel;

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iii. Availability of appropriate equipment and their periodic

tests/checks;
iv. Development, review, and implementation of plans/pro-
cedures;
v. Mechanisms for surveillance/monitoring of workers;
vi. Self-assessment;
vii. Internal and external audits;
viii. Exercises and drills; and
ix. Maintaining records of various activities.
4.19. Definitions and Abbreviations
The RPP shall be systematic and organized that facilitates
reference and understanding of all relevant parties. The RPP
should include definitions of technical terminology and
abbreviations used in radiation protection programs.
5. Additional Contents for Medical Radiation Facilities
Depending on the type and nature of medical radiation facility, the
RPP should additionally contain following sections:
i. Medical Exposure Control Responsibilities;
ii. System for Investigation and Reporting of Medical Acci-
dental Exposure;
iii. Calibration and Clinical Dosimetry;

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iv. Quality Assurance of Medical Exposure;

v. Activity of Patients on Discharge; and
vi. Guidance Levels for Medical Exposure.
5.1. Medical Exposure Control Responsibilities
The authorized person shall ensure that health professionals are
assigned the primary task and obligation of ensuring overall pa-
tient protection and safety in the prescription of, and during the
delivery of, medical exposure in line with provision of Article 206
of Regulation on Radiation Safety (NRRC-R-01). This RPP should
include the responsibilities of individuals designated by autho-
rized person who have overall task of medical exposure protec-
tion.
5.2. System for Investigation and Reporting of Medical
Overexposure
This authorized person should describe a mechanism to inves-
tigate unintended medical exposure to minimize the likelihood
of repetition of such incidents. The investigation of accidental,
abnormal, or unplanned medical exposures should be aimed at:
i. Establishing the cause of event;
ii. Identifying the failure;
iii. Deciding on remedial action to minimize the chance of a
similar failure; and

30
NRRC-SG-020
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iv. Estimating the expected radiation doses received by the

patient.
The authorized person shall notify about an incident, accident,
event to NRRC on priority and within 24 hours as prescribed in
article 238 and also submit written report to the NRRC, within
thirty (30) days after discovery of the incident. The investigation
should be undertaken by the RSO, and the report should describe
the occurrence, its cause(s) and effects, the radiation doses re-
ceived and all necessary corrective and preventive actions. Detail
om the necessary lines of reporting within the organization and
to NRRC should also be clearly described.
5.3. Calibration and Clinical Dosimetry
The RPP should describe the facility arrangement for calibration
of sources used for medical exposure traceable to SSDL as pre-
scribed in Article 216 of Regulation on Radiation Safety (NR-
RC-R-01), with the following details:
i. In case of radiotherapy facility, the arrangement and fre-
quency of calibration in terms of the relevant dosimetric
quantities and irradiation conditions;
ii. In case of nuclear medicine facility, the arrangement and
frequency of calibration of the equipment used for activ-
ity measurement of unsealed sources to be administered;
iii. Calibration of all dosimeters used for dosimetry of pa-
tients; and
iv. Facility policy to calibrate the equipment at time of com-
missioning, after any maintenance affecting calibration
31
Stakeholder Guideline for Development of
Radiation Protection Program

and frequency set by facility for calibration at regular in-

tervals.
5.4. Quality Assurance of Medical Exposure
The frequency set by the facility for periodical measurement of
the physical parameters of the radiation generators including
therapeutic and diagnostic equipment as required by Article 255
of Regulation on Radiation Safety (NRRC-R-01). This frequency
should not be more than twelve (12) calendar months after the
initial measurement at the time of commissioning.
This should also be supported by description on facility mecha-
nism for verification of appropriate physical and clinical factors
used in diagnosis and treatment along with mechanism and iden-
tification of written records of relevant procedures and results to
be retained. In the case of radiotherapy facilities, it should also
indicate the facility arrangement, if any, of independent quality
audit reviews of the quality assurance program.
5.5. Activity Levels for Patients on Discharge
The authorized person should provide facility policy about max-
imum activity level to permit the discharge of a patient who
has undergone a procedure with sealed or unsealed sources as
specified in Article 230 of Regulation on Radiation Safety (NR-
RC-R-01). There should be information that specify the maxi-
mum activity levels for patient discharge from hospital with writ-
ten instructions/precautions provided to patient on discharge and
also describe the facility mechanism to document the justification

32
NRRC-SG-020
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and authorization if a patient discharged from hospital is to be

permitted before the activity level falls below the specified levels.
5.6. Guidance Levels for Medical Exposure
This section of the RPP should describe the guidance levels for
medical exposure practiced at the facility, including specifying
if guidance levels (with reference to document) other than pre-
scribed by NRRC are used by the authorized person.
6. Review and Revision of Radiation Protection Program
The RPP of the activity or facility should be reviewed/revised at least
once in five years or whenever necessary in the light of:
• Change in application or location of radiation sources, or
facility;
• Lessons learned from emergency exercises/drills;
• National and international experience feedback;
• Revision in the reference documents and day to day ac-
tivities;
• Changes in the regulatory requirements.
The revised RPP should be submitted to NRRC for review and
approval.

33
Stakeholder Guideline for Development of
Radiation Protection Program

7. Related documents and files

Document Document Document Relation to the
Name Type Number procedure
Sets out the general safety
requirements in ensuring
the protection of people and
Radiation Safety Regulation NRRC-R-01 the environment against the
harmful effects of ionizing
radiation and for the safety of
radiation sources.
Sets out the safety requirements
in ensuring the protection of
Safe Transport people and the environment
of Radioactive Regulation NRRC-R-15 against the harmful effects of
Materials ionizing radiation and for the
safety of radiation sources
during transport.
Management Presents the requirements for
Regulation
of Radioactive NRRC-R-16 the management of radioactive
Waste waste.

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NRRC-SG-020
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Document Document Document Relation to the

Name Type Number procedure
Presents the requirements for
the security of radioactive
Security of
materials throughout their
Radioactive Regulation NRRC-R-17
life cycle against unauthorized
Materials
removal of the radioactive
material and sabotage.
Packaging and Present detail technical
Transport of requirements to support
Regulation NRRC-R-15-SR01
radioactive the implementation of
Material NRRC-R-15
Present detail technical
Development of requirement and
Emergency Plan Stakeholder recommendation to support
NRRC-SG-018
for Radiological Guideline the submission of Emergency
Facilities Plan as part of authorization
compliance requirements
Present detail technical
requirement and
Development of
Stakeholder recommendation to support
Nuclear Security NRRC-SG-001
Guideline the submission of Security
Plan
Plan as part of authorization
compliance requirements

35
Stakeholder Guideline for Development of
Radiation Protection Program

Annex-I: Applicable Sections of Regulatory Guide According to

Type of Facility
Applicable Content
Num Scope of Guidance
(Para)
Medical Facilities
i. Complex Medical Centers
4, 5 and 6
ii. Nuclear Medicine/Cardiology
4 (except 4 (except
4.2.8.3), 5 (if
internal transportation
(from port to end-
users) is responsibility
of authorized importer/
1 clearing agent then
this section may not be
Radiotherapy
applicable} & 6), 5 {if
internal transportation
(from port to end-
users) is responsibility
of authorized importer/
clearing agent then
this para may not be
applicable} and 6
i. Industrial Facilities including industri-
al radiography, oil well logging, nuclear
gauges with radioactive sources of cate-
gory 1, 2 and 3 etc.
ii. Scanners including vehicle/cargo scan-
2 ners (using radioactive sources) 4 (except 4.2.8.3) and 5
iii. Importers/exporters/traders of radioac-
tive material/sealed radioactive sources
and unsealed sources.
iv. Any organization/facility involved in
transport of radioactive material
36
NRRC-SG-020
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Applicable Content
Num Scope of Guidance
(Para)
4 (except 4.2.8.3) and 5 {if
internal
i. Irradiators including industrial irradia-
transportation (from
tors for food and sterilization, agricul-
port to end-users)
tural irradiators, and blood irradiators.
3 is responsibility of
ii. Calibration and Dosimetry service pro-
authorized importer/
vider having radioactive sources of cat-
clearing agent then
egory 1, 2 and 3
this para may not be
ap p l i c a b l e }
i. Scanners including vehicle/cargo scan-
ners (using X-rays).
4 (except 4.2.8.3,
4 i. Manufacturers of radiation generators
4.2.11, 4.2.12, 4.2.15)
i. Research, education, and training insti-
tutes having radiation generators
Manufacturers include manufacturers of
consumer products, radioactive sources/special
form radioactive materials, packages/casks
5 containing radioactive material as component 4 and 5
and radioisotope production facilities. This
also includes stockiest having bulk storage of
consumer products, sealed/unsealed sources
Research, education, and training institutes
6 4
having radioactive sources of category 1, 2 and 3
Any other facility or practice so identified To be prescribed based
7
by NRRC on identified facility

37
Stakeholder Guideline for Development of
Radiation
"(($!Protection Program "(($H!0,HIJI!
0<5=>7?@6>:!,936>@3A>!B?:!C:>D5:5<3?A!?B! $@5KK3B3E5<3?AL!C9;@3E!
(5635<3?A!C:?<>E<3?A!C:?F:5G!
"(($! "(($H!0,HIJI!
0<5=>7?@6>:!,936>@3A>!B?:!C:>D5:5<3?A!?B! $@5KK3B3E5<3?AL!C9;@3E!
(5635<3?A!C:?<>E<3?A!C:?F:5G!
!
Annex-II: Example of Organizational Chart of the Facility
/55)FGHHI*MF3;&?)*'7*N%:352O342'53?*@P3%4*'7*4P)*B3-2?24J*
!
!
/55)FGHHI*MF3;&?)*'7*N%:352O342'53?*@P3%4*'7*4P)*B3-2?24J*
A. /"!MF3;&?)*'7*N1)%3??*N%:352O342'53?*@P3%4*'7*4P)*B3-2?24J
Example
!
of Overall Organizational Chart of the Facility !

/"!MF3;&?)*'7*N1)%3??*N%:352O342'53?*@P3%4*'7*4P)*B3-2?24J
!"#$%&'%(#)*+*,-%
!

!"#$%&'%(#)*+*,-%

:#$*#,*&0%;3&,"),*&0%
=&//*,""%

:#$*#,*&0%;3&,"),*&0%
=&//*,""%
!"#$%&'%.$/*0% !"#$%&'%(*0#0)"% !"#$%&'%4")53*,-% !"#$%&'%6")70*)#+%
1"2#3,/"0, 1"2#3,/"0,% 1"2#3,/"0,% 1"2#3,/"0,%

!"#$%&'%.$/*0% !"#$%&'%(*0#0)"% !"#$%&'%4")53*,-% !"#$%&'%6")70*)#+%

1"2#3,/"0, 1"2#3,/"0,% 1"2#3,/"0,% 1"2#3,/"0,%
.88*90%:&+"%'&3%
:#$*#,*&0%;3&,"),*&0%

.88*90%:&+"%'&3%
:#$*#,*&0%;3&,"),*&0%
.88*90%:&+"%'&3%
<0$58,3*#+%4#'",-%
!
.88*90%:&+"%'&3%
<0$58,3*#+%4#'",-%
!
!
B. Q"!MF3;&?)*'7*N%:352O342'53?*@P3%4*7'%*B$5-42'53?*8'?)*7'%*8392342'5*
Example
! of Organizational Chart for Functional Role for Radia-
#%'4)-42'5*
tionQ"!MF3;&?)*'7*N%:352O342'53?*@P3%4*7'%*B$5-42'53?*8'?)*7'%*8392342'5*
Protection
#%'4)-42'5* !"#$%&'%'#()*)+,%

!"#$%&'%'#()*)+,%

-#$)#+)&.%/0&+"(+)&.%
1&22)++""

-#$)#+)&.%/0&+"(+)&.%
1&22)++""

-#$)#+)&.%3#'"+,%4'')("0

-#$)#+)&.%3#'"+,%4'')("0

-#$)#+)&.%5&06"078&+9"0%
:&06"07

-#$)#+)&.%5&06"078&+9"0% !
:&06"07

!
! ! C5F>!""!?B!"#!

! ! C5F>!""!?B!"#!

38
NRRC-SG-020
Classification: Public

Annex-III: Typical Assignment of Roles and Responsibilities

1. Responsibilities of the Authorized Person
The responsibilities of the authorized person (Owner, Decision
Makers, or Senior Management i.e., Chief Executive Officer
(CEO), Director, Head, etc.) should include following:

a. Ensure safe use of ionizing radiations at facility premises;

b. Ensure that for all workers, occupational exposures are lim-

ited as specified by the NRRC and promptly report to NRRC
if any relevant dose limits are exceeded;
c. Ensure that only workers who are designated in application
by name and qualification credentials, as having key assign-
ments related to protection and safety, operation or trans-
port/handling are permitted to undertake and fulfill such
required assignments and tasks;
d. Ensure that all radiation workers including female workers
are aware of hazards associated with their work and their
obligations and responsibilities;
e. Ensure that, under normal operational conditions, the dose
limits for persons under 18 years of age are complied with.
f. Ensure compliance and implementation of the Commission
laws, local rules, and procedures;
g. Designate a RSO and facilitate the functional role as defined
by NRRC;

39
Stakeholder Guideline for Development of
Radiation Protection Program

h. Establish and ensure implementation of policies and proce-

dures to maintain radiation exposures ALARA;
i. Ensure that suitable and adequate facilities for protection and
safety are provided to radiation workers including personal
protective items and radiation monitoring equipment;
j. Ensure that requirements related to safety culture are being
implemented;
k. Ensure arrangements for initial and continuous health sur-
veillance of radiation workers;
l. Ensure training and retraining of radiation workers;
m. Ensure that necessary arrangements for the consultation of
and co-operation with workers to ensure the effective imple-
mentation of the regulatory requirements for protection and
safety are in place;
n. Ensure that necessary arrangements related to the control of
outside workers are in place;
o. Record any report received from a worker regarding unsafe
conditions or circumstances and take appropriate remedial
action;
p. Devise a mechanism to refrain the workers from any willful
action that could put themselves/others in situations that are
harmful and contravene the regulatory requirements; and
q. Ensure integration of management system and radiation pro-

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NRRC-SG-020
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tection program so that safety may not be compromised due

to equipment/packages malfunction.
In addition to the above, following responsibilities related to medical
exposure protection should be included to ensure:

a. No patient is administered a diagnostic or therapeutic med-

ical exposure unless the exposure is prescribed by a medical
professional;

b. Medical or health professionals are available at the facility as

needed and have appropriate training to adequately discharge
assigned tasks in the conduct of diagnostic or therapeutic
procedures;
c. Exposures of individuals incurred knowingly while volun-
tarily helping in the care, support, or comfort (other than in
their occupation) are constrained as specified in Section 82 of
Regulation on Radiation Safety (NRRC-R-01).
d. Medical exposures are justified and optimized as per the re-
quirements of Regulation on Radiation Safety (NRRC-R-01);
e. Representative values of clinical dosimetry parameters are
determined and documented; and
f. Calibration, dosimetry, and quality assurance are performed
under the supervision of a qualified medical physicist.

41
Stakeholder Guideline for Development of
Radiation Protection Program

2. Responsibilities of Radiation Safety Officer (RSO)

Responsibilities of RSO (in-charge of radiation protection and safety)
should include the following:
a. Prepare and update the radiation protection program when
necessary or requested by NRRC.

b. Prepare emergency planning and preparedness programs i.e.,

emergency plan, reporting of any radiological emergency to
NRRC and incident investigation.
c. Identify and analyze radiological hazards in the work area
and environment.
d. Implement radiation equipment maintenance program an-
nually.
e. Implement a program to store radiation sources, calibration
and maintenance of radiation equipment and plan for appro-
priate radioactive waste disposal methods.
f. Organize an annual medical surveillance program for radia-
tion workers.
g. Identify the type and level of radiation protection training for
radiation workers.
h. Classify work areas in accordance with the Regulation on Ra-
diation Safety (NRRC-R-01) requirements.
i. Prepare and implement dose monitoring program for radia-
tion worker, area, and environment.

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j. Ensure radiation protection equipment is used by radiation

workers and remains in good condition.
k. Ensure the recruitment, termination and retirement of radia-
tion workers comply with the procedures set by NRRC.
l. Assess personal background of new radiation workers prior
to the hiring.
m. Assess the level of trustworthiness and reliability of radiation
workers.
n. Ensuring that any change of location of the radiation equip-
ment receives prior permission from NRRC in advance.
o. Supervise the following works;
i. High risk work such as planned exposure.
ii. Maintenance work done on radiation equipment.
iii. Control and rescue operations during emergencies.
iv. Transport of radioactive materials.
v. Prepare a Security Plan with radioactive sources of
Category 1, 2 and 3.
vi. Testing the effectiveness of the Securities Plan.
p. Prepare, record, update and manage records provided in para
4.17 of this guideline.

q. Ensure security of radioactive materials facilities to time to

prevent from any risk of loss, sabotage, or theft.
43
Stakeholder Guideline for Development of
Radiation Protection Program

r. Comply with the security measures set by the authorized per-

son.
s. Report any unforeseen event that threatens the security ele-
ment within 24 hours from the time of the occurrence of the
related event.
t. Implement and fully test the Securities Plan approved by the
AELB Department and document the implementation re-
port.
u. Stop work operation when violation to the Commission laws
is identified.
3. Responsibilities Radiations Workers
Responsibilities of technicians and other workers of the facility
designated as occupational radiation workers or assistants/trainees
should include at-least the following:

a. Be familiar with ionizing radiation and protect themselves

and others from any potential hazard associated with their
work;

b. Follow applicable instructions and procedures for protection

and safety and comply with all instructions from RSO;
c. Wear assigned radiation dosimeter during work in radiation
area for personnel monitoring and its safe keeping in radia-
tion free area during off working hours;

44
NRRC-SG-020
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d. Properly use the monitoring devices and protective items

provided;
e. Abstain from any willful action that could put themselves
or others in situations that are harmful and contravene the
regulatory and administrative requirements; and
f. Promptly report to the management/RSO any abnormal oc-
currence or any circumstances that could adversely affect
safety conditions.
4. Responsibilities of Radiation Protection Committee
The responsibilities of the radiation protection committee should
include, but not be limited to:
a. Regular review of all aspects of the radiation protection pro-
gram;

b. Review of occupational radiation doses and any accident re-

ports prepared by the RSO;
c. Making recommendations for improvements in the RPP;
d. Provision of guidance and direction on the performance of
the RSO’s duties; and
e. Preparation and dissemination of regular reports to all staff
about relevant radiation safety issues.

45
Stakeholder Guideline for Development of
Radiation Protection Program

Annex-IV: Contents of Investigation Report on Radiation

Overexposure Event
1. Name/address of institution/facility/consignor;
2. Authorization Reference No.;
3. Type of radiation facility;
4. Name and identification Number of overexposed person;
5. Designation, qualification, and job experience of overexposed per-
son;
6. Dosimeter No./Code;
7. Period of use of dosimeter;
8. Dose received from radiation overexposure;
9. Collective dose of last five (5) years;
10. Circumstances and causes of overexposure;
11. Findings of investigation;
12. Corrective measures to prevent recurrence of event;
13. Name and signature of Radiation Safety Officer;
14. Name and signature of Authorized Person.

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Annex-V: Contents for Training Program

Training topics may include:
1. Introduction and compliance requirements to the Commission
Laws
2. Responsibilities of a radiation worker.
3. Health risks and precautionary requirements as a radiation worker.
4. Radiological incident preventive measures.
5. Methods and safety measures working/using radiation source de-
vices including with a dose limitation system.
6. Description of the safety measures on the specific radiation source
device use at workplace
7. Classification of control, supervise and clean areas.
8. Normal operating plans and procedures.
9. Plans and procedures in the event of a radiation incident/accident.
10. Recovery measures after a radiation incident/accident.
11. Radiological emergency training.
12. Maintenance training on the authorized radiation source device
used during activity or at facility.
13. Safety and Security culture training.
14. Security of radioactive material (facility with radioactive source)

47
Stakeholder Guideline for Development of
Radiation Protection Program

©Nuclear and Radiological Regulatory Commission , 2023

King Fahd National Library Cataloging-in-Publication Data
L.D. no. 1444/12374
ISBN: 978-603-92052-7-2

48
NRRC-SG-020
Classification: Public

49
Kingdom of Saudi Arabia
@saudinrrc
nrrc.gov.sa