A streamlined failure mode and effects analysis

Med Phys. 2014 Jun;41(6):061709. doi: 10.1118/1.4875687.


Purpose: Explore the feasibility and impact of a streamlined failure mode and effects analysis (FMEA) using a structured process that is designed to minimize staff effort.

Methods: FMEA for the external beam process was conducted at an affiliate radiation oncology center that treats approximately 60 patients per day. A structured FMEA process was developed which included clearly defined roles and goals for each phase. A core group of seven people was identified and a facilitator was chosen to lead the effort. Failure modes were identified and scored according to the FMEA formalism. A risk priority number,RPN, was calculated and used to rank failure modes. Failure modes with RPN > 150 received safety improvement interventions. Staff effort was carefully tracked throughout the project.

Results: Fifty-two failure modes were identified, 22 collected during meetings, and 30 from take-home worksheets. The four top-ranked failure modes were: delay in film check, missing pacemaker protocol/consent, critical structures not contoured, and pregnant patient simulated without the team's knowledge of the pregnancy. These four failure modes had RPN > 150 and received safety interventions. The FMEA was completed in one month in four 1-h meetings. A total of 55 staff hours were required and, additionally, 20 h by the facilitator.

Conclusions: Streamlined FMEA provides a means of accomplishing a relatively large-scale analysis with modest effort. One potential value of FMEA is that it potentially provides a means of measuring the impact of quality improvement efforts through a reduction in risk scores. Future study of this possibility is needed.

MeSH terms

  • Feasibility Studies
  • Female
  • Humans
  • Outcome and Process Assessment, Health Care
  • Pacemaker, Artificial / adverse effects
  • Patient Safety
  • Pregnancy
  • Pregnancy Complications, Neoplastic / radiotherapy
  • Quality Improvement*
  • Radiotherapy* / standards
  • Risk Assessment
  • Risk Management / methods*
  • Total Quality Management
  • Workflow