MO‐F‐CAMPUS‐T‐01: A Comparison of Two Risk Analysis Techniques for Surface Image Guided Radiosurgery

Abstract

Purpose:Failure Modes and Effects Analysis (FMEA) techniques have been used to analyze surface image guided radiosurgery (SIG‐RS). Hazard model, a modified FMEA approach developed by the Dutch, is applied to SIG‐RS risk assessment and evaluated against the AAPM's FMEA approach.Methods:The SAFER approach uses a risk inventory matrix to categorize hazards (rather than probabilities). A multidisciplinary team was assembled to create the process map of SIG‐RS and 91 steps and 167 failure modes were determined. Each failure mode was categorized for frequency (weekly, monthly, quarterly, yearly and less than once a year) and severity (negligible, minor, moderate, major and catastrophic) according to the SAFER procedures. All failure modes are placed in the matrix of arbitrary risk score matrix: very high, high, low, and very low. The top 14 high risk failure modes from the Result of FMEA and SAFER analysis were compared.Results:167 failure modes categorized in the risk inventory matrix with 1 very high, 13 high, 66 low and 87 very low. Comparison of top 14 high risk failure modes between two techniques shows 9 common failure modes and 5 isolated failure modes. Two failure modes (FM: 58, 145) with the highest risk priority number (both RPN=288) in FMEA are also ranked as high risk in SAFER analysis. However one failure mode (FM: 154) with very high risk score in SAFER is not recognized by FMEA analysis due to its low “lack of detectability” score.Conclusion:FMEA is a well‐established technique for prospective risk analysis. SAFER is a practical alternative that is easy to implement with a reliable category structure. Also the risk inventory matrix is conceptually straightforward to obtain agreement among multidisciplinary team members but still demonstrates a full scale of criticality.