Circular No. 10/2006/TT-BKHCN guiding specialized inspection on radiation safety and control

CIRCULAR
Guidelines for specialized inspection on radiation safety and control

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Pursuant to Decree No. 54/2003/NĐ-CP dated May 19, 2003 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Science and Technology, and Decree No. 28/2004/NĐ-CP dated January 16, 2004 of the Government amending and supplementing certain articles of Decree No. 54/2003/NĐ-CP dated May 19, 2003;

Pursuant to Decree No. 41/2005/NĐ-CP dated March 25, 2005 of the Government detailing and guiding the implementation of certain provisions of the Inspection Law;

Pursuant to Decree No. 50/1998/NĐ-CP dated July 16, 1998 of the Government detailing the implementation of the Radiation Safety and Control Ordinance;

The Ministry of Science and Technology issues guidelines for specialized inspection on radiation safety and control as follows:

A. GENERAL PROVISIONS

I. Scope and Applicability

1. These Guidelines guide the inspection of compliance with laws on radiation safety and control for organizations and individuals conducting activities related to ionizing radiation (referred to collectively as the inspected entities).

2. Inspections of entities conducting activities related to ionizing radiation that require confidentiality within the purview of management by the Ministry of National Defense and the Ministry of Public Security shall be carried out by competent agencies of the Ministry of National Defense and the Ministry of Public Security under the guidance of the Ministry of Science and Technology on business procedures.

II. Authority for Specialized Inspection on Radiation Safety and Control

1. Specialized inspection on radiation safety and control (hereinafter referred to as radiation safety inspection) under the Ministry of Science and Technology performs the function of specialized inspection on radiation safety and control within the scope of state management over radiation safety and control by the Ministry of Science and Technology.

2. Radiation safety inspection under the Department of Science and Technology performs the function of specialized inspection on radiation safety and control within the scope of duties and powers of the Department Director.

Radiation safety inspection under the Department of Science and Technology is subject to guidance on work and procedures from the radiation safety inspection under the Ministry of Science and Technology.

III. Forms of Specialized Inspection on Radiation Safety

1. Radiation safety inspection activities are conducted in the following forms: Program-based inspection and ad hoc inspection.

2. Program-based inspection is carried out according to programs and plans approved by competent authorities. Annual inspection programs and plans for radiation safety ensure that organizations and individuals conducting radiation work will be inspected regularly at frequencies dependent on the level of risk associated with the radiation work and specified in Appendix I attached hereto.

3. Ad hoc inspection is conducted to address complaints and reports about radiation safety and control; upon proposal by the inspection organization or inspector when signs of violation of laws on radiation safety and control within the purview of management by the head of the state management agency at the same level are discovered; and to perform tasks assigned by the head of the state management agency with authority.

B. PROCEDURE FOR RADIATION SAFETY INSPECTION

I. Preparation for Inspection

1. Issuance of Inspection Decision

a) Authority to issue radiation safety inspection decisions is implemented in accordance with Article 37 and Article 38 of Decree No. 41/2005/NĐ-CP dated March 25, 2005 of the Government detailing and guiding the implementation of certain provisions of the Inspection Law (hereinafter referred to as Decree No. 41/2005/NĐ-CP).

b) Radiation safety inspection decisions are issued in accordance with Model No. 2 promulgated by Decision No. 04/2005/QĐ-BKHCN dated May 4, 2005 of the Minister of Science and Technology issuing models of inspection records and decisions used in inspection activities and administrative penalty enforcement in the field of state management of science and technology (hereinafter referred to as Decision No. 04/2005/QĐ-BKHCN).

2. After the inspection decision is issued, the Head of the Inspection Team must carry out preparatory work, including:

a) Requesting the licensing authority or unit to provide necessary information related to the licensing dossier (if any) of the inspected entity. Conduct research to develop an appropriate inspection plan.

b) Developing an inspection plan: clearly defining the purpose, content, methods, scope, and schedule of the inspection. The inspection scope should focus on areas showing signs or having high potential for non-compliance with radiation safety requirements.

c) Preparing a list of items to be checked during the inspection process: Based on the defined inspection scope, develop a checklist suitable for each type of radiation work. For industrial irradiation, well logging, nuclear instrument usage, industrial radiography, nuclear medicine, medical X-ray, and radiotherapy, the checklist is developed in accordance with the guidance provided in Appendix II attached hereto.

d) Preparing relevant legal regulations and technical standards.

đ) Arranging transportation means and preparing necessary equipment.

e) Summoning the Inspection Team to brief members on requirements, contents, plans, inspected entities, schedules, and assignments.

g) Sending an inspection notification to the inspected entity at least five days before the arrival of the Inspection Team (except in cases of ad hoc inspections). The notification must include the following requirements:

- Requesting the inspected entity to prepare a written report on the use of radiation sources and radiation safety management;

- Notifying the program and time of the Inspection Team's work;

- Requesting the content of files and documents the inspected entity needs to prepare for presentation to the Inspection Team;

- Requesting the inspected entity to appoint a representative to work with the Inspection Team during the inspection process. The appointed representative must have the authority to sign and stamp all documents prepared during the inspection, including inspection records and administrative violation records.

II. Conducting Inspection

1. Announcing the Inspection Decision

Before commencing the inspection, the Head of the Inspection Team must announce the inspection decision to the inspected entity. The participants in the meeting to announce the inspection decision shall include: A representative from the inspected entity authorized to work with the Inspection Team, the person responsible for radiation safety, and other individuals related to the content of the inspection. The announcement of the inspection decision must be recorded in a minutes document kept in the inspection file.

After announcing the inspection decision, the Head of the Inspection Team requests the inspected entity to report on the management of radiation safety and to present relevant documents for the Inspection Team to review.

2. Reviewing documents and records

Examine and review all documents and records that the Inspection Team has requested through prior notifications, and may examine and review additional related documents if deemed necessary.

3. On-site inspection

a) When conducting an on-site inspection, the following requirements must be ensured:

- Verify the accuracy of the contents in the inspected entity's radiation safety assessment report;

- Examine and evaluate the implementation of laws and regulations concerning radiation safety and control by the inspected entity.

b) Depending on the scale of the entity and the content of the inspection, the Head of the Inspection Team may organize a single team or divide it into smaller groups to carry out the inspection, but each group must consist of at least two people and must have personnel from the entity accompanying them.

c) The on-site inspection must be conducted in areas using radiation sources, focusing on high-risk zones with significant safety risks. The on-site inspection will follow the checklist developed during the preparatory phase of the inspection.

d) During the inspection, audio recording, video recording, and photography can be performed to serve as evidence in the inspection file or to record additional information not included in the inspection checklist. It is essential to ensure confidentiality principles for documents provided by the inspected entity according to the law.

III. Conclusion of the Inspection

1. Meeting of the Inspection Team after the conclusion of the inspection

After all members of the Inspection Team have completed their assigned tasks, the Head of the Inspection Team requests each group and individual members to report on the inspection results according to their assigned content. Based on the inspection results, the Inspection Team discusses and agrees on the content of the inspection, observations, conclusions, and proposed or recommended actions to be included in the inspection minutes. In case of differing opinions, the Head of the Inspection Team makes the final decision and assumes responsibility for it.

2. Preparing the inspection minutes

Based on the results of the post-inspection meeting of the Inspection Team, the Inspection Team must prepare the inspection minutes according to Model No. 18 issued together with Decision No. 04/2005/QĐ-BKHCN.

In the inspection minutes, the recommendations section (if any) of the Inspection Team should clearly state the requirements for rectification, deadlines for implementing the Inspection Team's requirements, and conditions limiting the activities of the inspected entity.

If the inspected entity commits violations of laws concerning radiation safety and control, the Head of the Inspection Team or the Inspector will prepare an administrative violation record according to Model No. 19 issued together with Decision No. 04/2005/QĐ-BKHCN and proceed with administrative penalties according to the law on administrative penalties.

3. Final meeting of the inspection

a) Prior to concluding the inspection, the Inspection Team meets with the inspected entity, with the following participants: Members of the Inspection Team, representatives of the inspected entity, the person responsible for radiation safety, and other representatives proposed by the inspected entity.

b) The content of the meeting includes the following steps:

- The Head of the Inspection Team reads the inspection minutes and the administrative violation record (if any).

- The representative of the inspected entity expresses opinions on the contents of the minutes and the Inspection Team's conclusions. If there is disagreement with the contents of the minutes and the Inspection Team's conclusions, the representative of the inspected entity has the right to note their opinion in the inspection minutes and the administrative violation record but must sign and stamp the minutes prepared by the Inspection Team.

IV. Reporting on the Results of the Inspection, Inspection Conclusions, and Inspection File

1. Within fifteen days from the date of completion of the inspection, the Head of the Inspection Team must submit a report on the inspection results to the person who made the inspection decision as stipulated in Article 42 of Decree No. 41/2005/NĐ-CP. The content of the report on the inspection results must include the following information:

a) The situation of the inspection and the contents that were inspected;

b) Details of the implementation of laws and regulations concerning radiation safety and control and the conditions of the facility's permits;

c) Violations (if any) and proposals for handling measures;

d) Disagreements between the Head of the Inspection Team and members of the Inspection Team regarding the content of the inspection report.

2. Upon receiving the report on the inspection results, the person who made the inspection decision is responsible for reviewing the content of the report and signing the inspection conclusion as stipulated in Article 42 of Decree No. 41/2005/NĐ-CP.

3. All materials (in textual, audio, and visual form) generated during the inspection process (from preparation to conclusion) must be compiled into a file and properly stored and utilized according to the legal provisions on information confidentiality and file storage.

V. Responsibilities for Implementing Inspection Conclusions and Decisions on Handling Violations Concerning Radiation Safety and Control

1. The Radiation Safety Inspection under the Ministry of Science and Technology and the Radiation Safety Inspection under the Department of Science and Technology are responsible for monitoring, inspecting, and urging the implementation of inspection conclusions, recommendations, and decisions on handling violations according to the inspection conclusion document.

2. The inspected entity is responsible for implementing the inspection conclusions and decisions on handling violations as stipulated in Article 45 of Decree No. 41/2005/NĐ-CP.

C. IMPLEMENTATION PROVISIONS

This Circular takes effect fifteen days after its publication in the Official Gazette. Any difficulties encountered during implementation should be promptly reported to the Ministry of Science and Technology for resolution./.