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MINISTRY
OF SCIENCE AND TECHNOLOGY
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SOCIALIST
REPBLIC OF VIETNAM
Independence - Freedom Happiness
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No:
10/2006/TT-BKHCN
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Hanoi,
May 17th, 2006
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CIRCULAR
GUIDES
ON INSPECTION SPECIALIZING IN RADIATION SAFETY AND CONTROL
Pursuant to the Decree No.
54/2003/NĐ-CP issued by the Government on the 19th May 2003 specifying the
functions, responsibilities, authorities, and organizational structure of the
Ministry of Science and Technology and the Decree No. 28/2004/NĐ-CP issued by
the Government on the 1st January 2004 on amending and supplementing some of
the provisions of the Decree No. 54/2003/NĐ-CP issued on the 19th May 2003;
Pursuant to the Decree No. 41/2005/NĐ-CP issued by the Government on the March
15th, 2005, providing details for the implementation of some provisions of the
Inspection Law;
Pursuant to the Decree No. 50/2003/NĐ-CP issued by the Government of July 16,
1998, providing details for the implementation of the Ordinance on Radiation
Safety and Control
The Ministry of Science and
Technology issues the following guides for radiation safety and control
specialized inspection:
A. GENERAL PROVISIONS
I. SUBJECTS AND SCOPE OF
APPLICATION
1. This Circular provides guides
on the inspection of compliance by organizations and individuals who conduct
ionization radiation related activities (hereinafter referred collectively to
as inspected entities) with the relevant law, regulations and conditions
established in the authorizations.
2. Inspecting the entities
conducting ionization radiation related activities under the management of the
Ministry of National Defense and of the Ministry of Public Security which
require confidentiality shall by taken responsibility by the functional bodies
of the Ministry of National Defense and of the Ministry of Public Security in
accordance with professional guidance of the Ministry of Science and
Technology.
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1. Specialized radiation safety
and control inspector (hereafter referred collectively to as radiation safety
inspector) under the Ministry of Science and Technology shall exercise the
function of specialized radiation safety and control inspection within the
State management scope of radiation safety and control of the Ministry of
Science and Technology.
2. Radiation safety inspector
under Departments of Science and Technology shall exercise the function of
specialized radiation safety and control inspection in accordance with the
respective duties, powers of the Directors.
Radiation safety inspector under
Departments of Science and Technology shall be instructed on missions,
professions by inspector of the Ministry of Science and Technology.
III. FORMS OF SPECIALIZED
RADIATION SAFETY AND CONTROL INSPECTION
1. Specialized radiation safety
and control inspections shall be carried out in the forms: programmed
inspections, planned inspections and unscheduled inspections.
2. Programmed inspections,
planned inspections shall be carried out by programs, plans approved by the competent
level. Yearly radiation safety inspection programs, plans shall be elaborated
to ensure that organizations, individuals conducting practices shall be
inspected regularly with the frequency depending on dangerous level of
practices and provided in the Annex I promulgated together with this circular.
3. Unscheduled inspections shall
be carried out to resolve complaints and/or denunciations of radiation safety
and control; to be pursuant to proposals of inspection organizations and/or
inspectors detecting violations of legislation radiation safety and control
within the management scope of the leaders of the same level State management
bodies; to carry out the duties commissioned by the leaders of the competent
State management bodies.
B. PROCESS OF RADIATION
SAFETY INSPECTION
I. PREPAREDNESS FOR INSPECTION
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a) Competence to issue a
decision on radiation safety inspection is in accordance with regulations in
the Article 37, Article 38 of the Decree no. 41/2005/NĐ-CP dated the 25 March,
2005 by the Government detailing the implementation of the Law on Inspection
(hereafter referred to as the Decree no. 41/2005/NĐ-CP).
b) An inspection decision is in
the Form number 2 issued with the Decision no. 41/2005/NĐ-BKHCN dated 04 May,
2006 by the Science and Technology Minister on Forms of reports and decisions
used in inspection, sanctioning administrative violations in the field of
science and technology (here after referred to as the Decision No.
04/2005/QD-BKHCN).
2. Just after issuing an
inspection decision, the Chief of the inspectorate, for the inspections
purpose, shall:
a) Require the licensed agency
or unit to provide necessary information related to the licensing record (if
any) of the inspected subject; organize studies to set up appropriate
inspection plans.
b) Set up an inspection plan:
identify the target, content, method, area and schedule of the inspection. The
inspection area should be reserved to areas having signs of failing or likely
not to meet requirements on radiation safety.
c) Prepare a list of
verification contents which will be carried out during the inspection: based on
the identified inspection area, the list of corresponding verification contents
shall be determined appropriately according type of radiation practice. For
radiation practice like industrial irradiation, geophysics for drilling wells,
using nuclear measuring meters, industrial radiography, nuclear medicine,
medical X-ray and tele-therapy, the list of verification contents shall be
determined pursuant to the Guide in the Annex II to this Circular.
d) Prepare instruments of
necessary regulations, technical standards.
dd) Arrange the transport means
and prepare necessary equipment.
e) Convene the inspectorate to
disseminate inspection requirements, plan, subjects and schedule and assign
tasks to each member of the inspectorate.
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- Requirement for the inspected
subject to prepare the report in writing on state of using radiation sources
and radiation safety management;
- The inspectorates working
program and schedule;
- Requirement for documents, record
the inspected subject must prepare to present to the inspectorate;
- Requirement for the inspected
subject to appoint a representative to work with the inspectorate during the
inspection. The representative shall have competence to sign and seal documents
drawn up during the inspection, including the inspection minute, and
administration violation minute.
II. CARRY OUT AN INSPECTION
1. Declare/Announce an
inspection decision
Before conducting an inspection,
the Chief of the inspection delegation have to declare/inform the inspection
decision to the entity. Participants of the declaration meeting are:
representatives from the entity, assigned to work with the inspection
delegation, staff taking the responsibility of radiation safety and other
relating individuals. The inspection decision must be written in the minutes
stored in the inspection record.
After the inspection decision is
announced, in order to verify, the Chief of the inspection delegation requires
the entity to make a report of the radiation safety situation and show all the
related documents.
2. Verify records and documents
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3. On location inspection
a) When conducting on location
inspection, it is necessary to ensure these requirements:
- Verify the accuracy
information written in the entitys report on the radiation safety;
- Examine, evaluate the state of
implementing laws on radiation safety and control by the entity.
b) Depend on the scale of
facilities and inspection requirement, the Chief of the inspection delegation
can decide to form one delegation or divide the delegation into groups to
conduct the inspection. There are at least 2 people (one from facilities) in
each group.
c) The practical inspection must
be carried out in location where radiation sources are in used, especially, in
high dangerous and unsafe location. The practical inspection should be carried
out according to the list of content prepared in the preparation step.
d) During the inspection, it is
possible to record sound, images, take photos for documentation purposes or
take note any information not shown in the inspection list. Information
security measures is required for records/documents provided by entity as
stipulated in law.
III. FINISH OF INSPECTION
1. Holding a meeting of
Inspection Delegation after finishing the inspection
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2. Making inspection report
Based on results of the
Delegations meeting after finishing inspection, the Delegation has to make
inspection report according to Sample 18 issued with the Decision no.
04/2005/QD-BKHCN.
In the inspection report, the
Delegation needs to specify in recommendation part (if any) requests for
necessary repairs, duration for implementing requests of the Delegation,
conditions for limiting activity of inspected subjects.
In case inspected subjects have
any actions violating law on radiation safety and control, the leader of the
Delegation or inspectors will make report on administrative violence according
to Sample 19 issued with Decision 04/2005/QD-BKHCN and fine for administrative
violence according to regulations of law on fine for administrative violence.
3. Final meeting of inspection
a) Before finishing the
inspection, the Delegation holds a meeting with inspected subjects including
members of the Delegations, representative of inspected subjects and those who
are responsible for radiation safety and other representatives requested by
inspected subjects.
b) Content of the meeting
includes followed steps:
- Leader of the Delegation reads
statement of inspection and report on administrative violence (if any).
- Representative inspected
subjects makes speech on content of reports and conclusion of the Delegation.
In case the representative do not agree with the content and conclusion, he has
right to write his opinion on the inspection statement and report on
administrative violence with signature and seal on that statement or report.
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1. After maximum 15 days since
the day of finishing the inspection, the leader of the Delegation has to make writing
report on the inspection and send to whom issued the inspection decision
according to regulations of Article 42, Decree 41/2005/ND-CP. The report needs
to include followed contents:
a) The implementation status of
inspection and inspected contents
b) Details on the implementation
of regulations of law on radiation safety and control and conditions of
facilities licenses,
c) Violence behaviors (if any)
and recommendations for handling;
d) Opposite opinions between the
leader of the Delegation and members of the Delegation on reported contents.
2) After receiving the report on
inspection results, inception decision-maker is responsible for reviewing
reported content an inspection conclusion according to regulations of Article
42, Decree 41/2005/ND-CP.
3) All documents (in writing,
voice and image) made during the inspection process (from the preparing to
finishing step) are collected in an inspected file and are preserved and used
according to regulations of law on data security and file archives.
V. RESPONSIBILITY OF
IMPLEMENTING CONCLUSION, DECISION ON VIOLENCE OF RADIATION SAFETY AND CONTROL
1. Inspection division on
radiation safety under Ministry of Science and Technology and inspection
division on radiation safety under Department of Science and Technology are
responsible for monitoring, supervising and speeding up the implementation of
conclusion, recommendation, and decision on violence of inspection according to
the conclusion statement of the Delegation.
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C. EXCUSION PROVISION
The Circular is put into effect
after 15 days from the day of announcing on official gazette. During the implementation
of the Circular, if there are any difficulties, it is requested to inform the
Ministry of Science and Technology for solution.
PP.
MINISTER
VICE MINISTER
Le Dinh Tien