Thông tư 10/2006/TT-BKHCN

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.

II. AUTHORITIES OF RADIATION SAFETY AND CONTROL SPECIALIZED INSPECTORS

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

1. Issuing a inspection decision

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.

g) Give advance notice of inspection and ensure that the intently inspected and examed subject receive the advance notice at least 5 days. The advance notice contains the followings:

- 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

It is necessary to check and verify all the records and documents required by the inspection delegation (in a notice form sent before). Other related documents can also be verified if needed.

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

After members of the Inspection Delegation completes assigned tasks as planed, the leader of the Delegation requires groups, members of the Delegation make reports on results of the inspection according to assigned tasks. Based on inspection results, the Delegation discusses and goes to consent on inspected contents, comments and conclusions as well as handling forms or request for handling in order to include in the inspection report. In case there are different opinions, the leader makes final decision and responsible for that decision.

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.

IV. REPORT ON INSPECTION RESULTS, CONCLUSION AND FILE.

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.

2. Inspected subjects are responsible for implementing conclusion, decision on violence of inspection according to regulations at Article 45, Decree 41/2005/ND-CP.

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.