Annual Program Review - Radiation Safety

• Audit Title

• Site Name

• Conducted on

  Date

• Auditor

• Location
  Address

• Site EHS Manager

Applicable Standards

• Select those standards that apply.

  Select EHS&S Standard 16 "Radiation Safety"

  • EHS&S Standard 16 "Radiation Safety"

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?

  Yes

  No

  N/A

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

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

  Yes

  No

  N/A

• How many people are in the Radiation Safety Program?

  0 to 5

  5 to 10

  10 to 50

  50+

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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)?

  Yes

  No

  N/A

Training

• What is the frequency of training?

  Select Initial Annual Every 3 Years Initial Only

  • Initial
  • Annual
  • Every 3 Years
  • Initial Only

• Does the training program cover the required program elements?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

• Are records of the assessment maintained?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• Are records of the assessment maintained?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

Plant Tour

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A