REGULATORY COMPLIANCE – THE PROBLEM

regulatory compliance

I THOUGHT THE DISTRIBUTOR WAS TAKING CARE OF OUR REGISTRATION”

“NO ONE TOLD US WE HAD TO DO  ALL THIS OTHER STUFF”

These comments are heard far too often. Unfortunately, this is a big misconception in this industry. The fact is, it is the OWNERS responsibility to comply with their State regulatory requirements, it is NOT the responsibility of the manufacturer, distributor or installer.

Owners often struggle to determine what their State Radiation Control Agency regulatory requirements are for registering and operating this type of radiation emitting equipment. There simply has been nowhere to turn for complete assistance. Until now!

Many new and existing facility owners of cabinet x-ray inspection machines are rarely informed by the company or salesperson who sold them the radiation machine of their State regulatory obligations, therefore; the owner lacks the knowledge, support, guidance, resources and information necessary to achieve and maintain full regulatory compliance after x-ray machine acquisition.

RCE Consulting can put you on the right path immediately and act as your liason if we need to contact a State agency.

If you have questions, send an email to rce1020@gmail.com or call the Office at 843-650-9724 or Mobile at 865-696-9117 and you will be contacted within 24 hours.

RCE Consulting offers owners several compliance and training options for any State and for any budget. Take a look at the AVAILABLE REGULATORY COMPLIANCE & RADIATION SAFETY TRAINING COURSES page to decide which option will best fit your needs. In all cases, you can speak to a real person to discuss your needs once we receive your email request.

FAILURE TO COMPLY WITH STATE REQUIREMENTS CAN RESULT IN CITATIONS, SUSPENSION AND FINES TO BOTH THE MANUFACTURER, DISTRIBUTOR AND THE OWNER IF THE SYSTEM IS NOT REGISTERED.

The most frequent regulatory violations cited by State Inspectors today include:

  • X-Ray System(s) not registered with the State Radiation Control Agency
  • No written Radiation Protection Plan and no documented annual review of the RPP
  • No copy of the State regulations or x-ray machine operating manuals on site
  • Not providing radiation safety training to the x-ray machine operators
  • Not providing dosimetry radiation monitoring badges, when required (e.g., KS, KY, NV, NJ, NC and SC).
  • Not performing x-ray machine safety device testing (E-Stops, safety interlocks and warning indicators)
  • Not performing routine inspections and a radiation leakage emission survey at the State required frequency
  • Not using annually calibrated radiation detection instrumentation for radiation surveys.
  • Not informing the State in writing when changes occur that effect the accuracy of the original registration application.
  • Not verifying your machine installer is registered as a Vendor / Assembler in the 35 States that require this, see STATE CABINET X-RAY MACHINE REGISTRATION REQUIREMENTS – OWNERS & INSTALLERS page.