Authorization and Inspection of Cyclotron Facilities Inspections.

Authorization and Inspection of Cyclotron Facilities

Inspections


Objective

• To understand the role of the inspections and procedures applicable to a cyclotron facility.


1) Functions and responsibilities;

2) Inspection Program;

3) Preparation of the inspection;

4) Checklist;

5) Inspection Report ;

6) Coercion.


Duties and Responsibilities

The inspector may, at any time, enter and inspect a place where the inspector thinks, for valid reasons, that

• There is contamination by a radioactive substance.

• A radioactive substance is being used, in a way that it may cause excessive risk.


Duties and Responsibilities

A facility is operating in a manner that may cause an excessive risk to the environment, health or safety of persons.


Powers of an Inspector

The inspector may:

• Use any equipment or cause any equipment to be used;

• Carry out any test on a vehicle or in relation to anything in a vehicle or place that the inspector has been designated to inspect;

• Examine any place and make or cause to be made a record of anything in any place that the inspector has been designated to inspect and remove anything from a place for a reasonable period for the purpose of making a record of it;



The inspector may:

• Open or request the opening of any container;

• Take and dispose of any sample;

• Examine any records that are required to be kept or reports that are required to be made or any books, records, electronic data or other documents that the inspector believes on reasonable grounds relate to such records or reports.



The inspector may:

• Question any person within or in connection with any place that the inspector has entered or inspected.

• Require any person to take actions that the inspector considers necessary to protect the environment, health or safety of individuals.


Inspector’s Identification Card

An inspector’s card issued under the Legislation, shall include:

the name and signature of the inspector; a photograph showing the face of the inspector; the name of the employer of the inspector; a statement of designation; the name, position and signature of the person

who issued the card; and the expiry date of the card.


Inspection Program

Risk t he higher priority is assigned to the larger facilities with a high workload, as well as to those facilities with poor compliance history.

Or:

substantial change in the licensed activity or the radiation safety program of the facility.


Inspection Program (frequency)

• The construction site (license to construct) should be inspected at least once, preferably before issuing the license to operate-to-commission. At that time the inspection verifies the compliance with the Legislation, safety standards and the license conditions (e.g. application). Any items of non-compliance which require added construction are easier to correct at this stage.


The operation of the cyclotron facility should be inspected regularly.

Upon completion of decommissioning the inspection is performed to verify that there is no fixed or removable contamination and that the facilities and the land can be returned to non-controlled use.

Inspection Program (frequency)


Pre-inspection preparation

• Forming the inspection team and assigning the tasks (2 or more inspectors, one leads).

Pre-inspection preparation includes:

• Researching the records and reports of the facility (license, license applications for construction and operation, Annual compliance reports, incident reports, compliance history).


Pre-inspection preparationPre-inspection preparation includes:

• Discussing the results of the research with the team and generating the plan of the inspection.

• Choosing the appropriate radiation instruments for use in the inspection:



Verifying proper energy response for detecting high energy neutrons and gamma.

Verifying that the instruments response is unaffected by high magnetic and RF fields.

Verifying that the instruments are calibrated and bear proper calibration stickers (should not be older than one year).



Verifying that all inspectors are trained and comfortable with the instruments.

Verifying the functionality of the instruments under the controlled conditions (i.e. in the Laboratory if possible).



•Lead inspector communicates the inspection plan to the contact person of the cyclotron facility. The inspection check list (with the compliance expectations) is sent to the licensee.

• Various logistical aspects of the inspection are worked out with the licensee, such as the time-schedule, availability of operators and technical staff, safety and security arrangements, etc.


Conduct inspection using a check list

• Inspection check list contains the appropriate regulatory (sections of the Legislation and license conditions) and performance (e.g. engineering controls, QA program, training and emergency preparedness, security) requirements which are risk classified.

• The inspection should begin with a meeting with the Radiation Protection Officer and the holder of the Authorization for Operation.


Conduct inspection using a check list

• The purpose of the inspection must be clearly communicated and discussed.

• During the actual inspection the inspectors will communicate verbally their major findings and observations to the licensee’s representatives. Any discussion or challenges to the findings may be addressed immediately or deferred to the exit meeting.


Practical considerations

• Perform radiological survey of the facility operating at the most adverse conditions to verify the adequacy of the shielding. Use your own instruments (which should be pre-selected and checked). Survey the points of highest calculated dose rates.

• Verify the functionality of the safety systems by asking the operators or the RPO to test them in your presence.



• Interview operators and other staff (as appropriate) to verify their radiation safety training and knowledge of emergency procedures.

• Verify that various records required by the Legislation and the license are kept (e.g. RP manual, operator’s manual, servicing manual, training, transport records, log-books, etc.)


• Verify that the safety equipment for operation and emergencies is kept and maintained

• Verify that the radiation measuring instruments are available, appropriate for the type of radiation, have proper energy response, and are calibrated.



Finding of a major breach of safety culture

• Inspector may choose to consult with the superior officer and, upon his/her approval, request that the licensee stops the operation in case of major violations of the Legislation or a license condition which (if not corrected) can have immediate health and safety implications.


Major offence leading to possible prosecution

• If a finding is that there is a major offence under the Legislation (e.g. an overexposure of a worker leading to an injury or a major contamination) the lead inspector will inform the licensee that the inspection stops. The licensee is then informed about their rights under the appropriate legislation. At that time the inspection will start gathering evidence for possible prosecution (becomes an investigation).


Inspection report

• Upon completion of an inspection, the inspectors will meet and discuss the findings. The findings will be summarized and agreed upon between the inspectors before an exit meeting with the licensee.

• The lead inspector will make a preliminary written report summarizing the findings. It is important that both positive and negative findings are reported.


THE EXIT MEETING

• The preliminary inspection report is presented to the licensee.

• The corrective actions (if necessary) that the licensee must take are discussed and the deadlines for taking those actions agreed upon and written in the report.

• One copy of the preliminary inspection report and one copy of the check list become the licensee’s records.


THE EXIT MEETING

• The final report, which must be approved by the Inspector’s supervisor, is sent to the licensee by the Regulatory Body. This report is binding to the licensee.

• The feedback from the licensee on the quality of the inspection and clear communication of the goals and the findings is sought and recorded.

Authorization and Inspection of Cyclotron Facilities Inspections.

Documents

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