Applicable Standards

  • Select those standards that apply.

Documents Reviewed

  • Written Program

  • Risk Assessments / Exposure Reports

  • Radiation Safety Medical Surveillance Records

  • Training Program

  • Training Records

  • Inventory of radioactive materials, radioactive sealed sources, and ionizing or non-ionizing radiation-producing equipment

Program Execution

  • License No:

  • License Type:

  • Last Regulatory Audit:

  • Any deficiencies noted?

  • Corrective Actions Taken (N/A or provide a Description):

  • Is there a named Radiation Safety Officer for the site?

  • How many people are in the Radiation Safety Program?

  • Has the organization established and maintained up to date an inventory of all radioactive materials, radioactive sealed sources, and ionizing or non-ionizing radiation producing equipment?

  • Has the organization established implemented and maintained authorization by the necessary local/state/national regulatory agency to receive and use/operate all materials and/or equipment?

  • Has the organization established, implemented and maintained a documented Radiation Safety Program to identify measure and control potential employee exposures to ionizing and non-ionizing radiation?

  • Has the organization established, implemented and maintained a process to assure that only authorized and appropriately trained personnel use sources of ionizing and/or non-ionizing radiation producing equipment identified by the site inventory?

  • Has the organization established, implemented and maintained a process to document and keep up to date all data and records associated with the sources of radiation (ionizing and non-ionizing)?

Training

  • What is the frequency of training?

  • Does the training program cover the required program elements?

  • Is the extent of the training/instructions to personnel commensurate with the potential for and type of radiation exposure/dose?

Medical Evaluation

  • Has the organization established, implemented and maintained a process for medical surveillance and recordkeeping on ionizing and non-ionizing radiation based on formal risk assessment in accordance with J&J requirements?

  • Is the list of participants in the GOH radiation safety medical surveillance program aligned with the list of employees who work with radiation?

  • What is the system for notifying those in the radiation safety program when they are due for medical surveillance?

  • Are potential cases of over exposure to radiation investigated and documented?

Risk Assessment & Exposure

  • Has the organization established implemented and maintained a process to assess the risks of off-site occupational exposures to ionizing and non-ionizing radiation, (i.e. visits to clinical/medical facilities, contract laboratories, contract sterilizers, or external manufacturers?

  • Are records of the assessment maintained?

  • Has the organization established, implemented and maintained a process to review materials, equipment and/or procedures to determine applicable regulatory requirements and the potential for employee dose/exposure risk to ionizing and/or non-ionizing radiation?

  • Are records of the assessment maintained?

  • Has the organization established, implemented and maintained a program for conducting and maintaining records of personal monitoring when appropriate to evaluate: employee exposures to occupational sources of ionizing and non-ionizing radiation; and that controls are effective, work practices are followed and exposures/doses have not occurred?

  • Has the organization established, implemented and maintained a program for selection of appropriate controls to minimize operator, site employee and visitor exposures to ionizing and non-ionizing radiation.

  • Has the organization established, implemented and maintained controls to ensure the environment and local community are protected from potential radiation exposures and release of radioactive materials?

  • Has the organization established, implemented and maintained a program to ensure the transfer/disposal (internal and external) of radioactive materials and/or radiation producing equipment meets all applicable regulatory requirements?

  • Has the organization established, implemented and maintained a process to communicate the following: Personal exposure monitoring and medical surveillance results to sampled employees and: results interpretation and recommendations from risk assessments and sampling/data to occupational health and other appropriate functional groups?

Employee Discussions

  • Discussions were held with the following groups or employees on site. List number of people when applicable.

  • Were employees generally familiar with the radiation sources in their work area and the controls in placed to limit exposure?

  • Has the organization established, implemented and maintained a program to ensure the shipping (offsite) of radioactive materials meets all applicable regulatory requirements?

Plant Tour

  • Has the organization established, implemented and maintained a program to ensure the security of its radioactive materials and/or radiation producing equipment?

  • Does the program have sufficient controls to prevent unauthorized access to the materials and/or equipment by employees, contractors and visitors?

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