Program Information

FMEA Severity Scores - Do We Really Know?

J Tonigan*, J Johnson, S Kry, P Balter, L Court, F Stingo, D Followill, UT MD Anderson Cancer Center, Houston, TX

Presentations

SU-E-T-192 Sunday 3:00PM - 6:00PM Room: Exhibit Hall

Purpose: Failure modes and effects analysis (FMEA) is a subjective risk mitigation technique that has not been applied to physics-specific quality management practices. There is a need for quantitative FMEA data as called for in the literature. This work focuses specifically on quantifying FMEA severity scores for physics components of IMRT delivery and comparing to subjective scores.

Methods: Eleven physical failure modes (FMs) for head and neck IMRT dose calculation and delivery are examined near commonly accepted tolerance criteria levels. Phantom treatment planning studies and dosimetry measurements (requiring decommissioning in several cases) are performed to determine the magnitude of dose delivery errors for the FMs (i.e., severity of the FM). Resultant quantitative severity scores are compared to FMEA scores obtained through an international survey and focus group studies.

Results: Physical measurements for six FMs have resulted in significant PTV dose errors up to 4.3% as well as close to 1 mm significant distance-to-agreement error between PTV and OAR. Of the 129 survey responses, the vast majority of the responders used Varian machines with Pinnacle and Eclipse planning systems. The average years of experience was 17, yet familiarity with FMEA less than expected. Survey reports perception of dose delivery error magnitude varies widely, in some cases 50% difference in dose delivery error expected amongst respondents. Substantial variance is also seen for all FMs in occurrence, detectability, and severity scores assigned with average variance values of 5.5, 4.6, and 2.2, respectively. Survey shows for MLC positional FM(2mm) average of 7.6% dose error expected (range 0-50%) compared to 2% error seen in measurement. Analysis of ranking in survey, treatment planning studies, and quantitative value comparison will be presented.

Conclusion: Resultant quantitative severity scores will expand the utility of FMEA for radiotherapy and verify accuracy of FMEA results compared to highly variable subjective scores.

Funding Support, Disclosures, and Conflict of Interest: Work supported by grants CA10953 and CA81647 (NCI, DHHS).

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