skip to main content
OSTI.GOV title logo U.S. Department of Energy
Office of Scientific and Technical Information

Title: TU-FG-201-11: Evaluating the Validity of Prospective Risk Analysis Methods: A Comparison of Traditional FMEA and Modified Healthcare FMEA

Abstract

Purpose: To examine the ability of traditional Failure mode and effects analysis (FMEA) and a light version of Healthcare FMEA (HFMEA), called Scenario analysis of FMEA (SAFER) by comparing their outputs in terms of the risks identified and their severity rankings. Methods: We applied two prospective methods of the quality management to surface image guided, linac-based radiosurgery (SIG-RS). For the traditional FMEA, decisions on how to improve an operation are based on risk priority number (RPN). RPN is a product of three indices: occurrence, severity and detectability. The SAFER approach; utilized two indices-frequency and severity-which were defined by a multidisciplinary team. A criticality matrix was divided into 4 categories; very low, low, high and very high. For high risk events, an additional evaluation was performed. Based upon the criticality of the process, it was decided if additional safety measures were needed and what they comprise. Results: Two methods were independently compared to determine if the results and rated risks were matching or not. Our results showed an agreement of 67% between FMEA and SAFER approaches for the 15 riskiest SIG-specific failure modes. The main differences between the two approaches were the distribution of the values and the failure modes (No.52,more » 54, 154) that have high SAFER scores do not necessarily have high FMEA RPN scores. In our results, there were additional risks identified by both methods with little correspondence. In the SAFER, when the risk score is determined, the basis of the established decision tree or the failure mode should be more investigated. Conclusion: The FMEA method takes into account the probability that an error passes without being detected. SAFER is inductive because it requires the identification of the consequences from causes, and semi-quantitative since it allow the prioritization of risks and mitigation measures, and thus is perfectly applicable to clinical parts of radiotherapy.« less

Authors:
 [1]; ;  [2]
  1. Myongji Hospital, Goyang-si (Korea, Republic of)
  2. University of California, San Diego, La Jolla, CA (United States)
Publication Date:
OSTI Identifier:
22653992
Resource Type:
Journal Article
Resource Relation:
Journal Name: Medical Physics; Journal Volume: 43; Journal Issue: 6; Other Information: (c) 2016 American Association of Physicists in Medicine; Country of input: International Atomic Energy Agency (IAEA)
Country of Publication:
United States
Language:
English
Subject:
60 APPLIED LIFE SCIENCES; 61 RADIATION PROTECTION AND DOSIMETRY; HAZARDS; LINEAR ACCELERATORS; RISK ASSESSMENT; VISIBLE RADIATION

Citation Formats

Lah, J, Manger, R, and Kim, G. TU-FG-201-11: Evaluating the Validity of Prospective Risk Analysis Methods: A Comparison of Traditional FMEA and Modified Healthcare FMEA. United States: N. p., 2016. Web. doi:10.1118/1.4957534.
Lah, J, Manger, R, & Kim, G. TU-FG-201-11: Evaluating the Validity of Prospective Risk Analysis Methods: A Comparison of Traditional FMEA and Modified Healthcare FMEA. United States. doi:10.1118/1.4957534.
Lah, J, Manger, R, and Kim, G. Wed . "TU-FG-201-11: Evaluating the Validity of Prospective Risk Analysis Methods: A Comparison of Traditional FMEA and Modified Healthcare FMEA". United States. doi:10.1118/1.4957534.
@article{osti_22653992,
title = {TU-FG-201-11: Evaluating the Validity of Prospective Risk Analysis Methods: A Comparison of Traditional FMEA and Modified Healthcare FMEA},
author = {Lah, J and Manger, R and Kim, G},
abstractNote = {Purpose: To examine the ability of traditional Failure mode and effects analysis (FMEA) and a light version of Healthcare FMEA (HFMEA), called Scenario analysis of FMEA (SAFER) by comparing their outputs in terms of the risks identified and their severity rankings. Methods: We applied two prospective methods of the quality management to surface image guided, linac-based radiosurgery (SIG-RS). For the traditional FMEA, decisions on how to improve an operation are based on risk priority number (RPN). RPN is a product of three indices: occurrence, severity and detectability. The SAFER approach; utilized two indices-frequency and severity-which were defined by a multidisciplinary team. A criticality matrix was divided into 4 categories; very low, low, high and very high. For high risk events, an additional evaluation was performed. Based upon the criticality of the process, it was decided if additional safety measures were needed and what they comprise. Results: Two methods were independently compared to determine if the results and rated risks were matching or not. Our results showed an agreement of 67% between FMEA and SAFER approaches for the 15 riskiest SIG-specific failure modes. The main differences between the two approaches were the distribution of the values and the failure modes (No.52, 54, 154) that have high SAFER scores do not necessarily have high FMEA RPN scores. In our results, there were additional risks identified by both methods with little correspondence. In the SAFER, when the risk score is determined, the basis of the established decision tree or the failure mode should be more investigated. Conclusion: The FMEA method takes into account the probability that an error passes without being detected. SAFER is inductive because it requires the identification of the consequences from causes, and semi-quantitative since it allow the prioritization of risks and mitigation measures, and thus is perfectly applicable to clinical parts of radiotherapy.},
doi = {10.1118/1.4957534},
journal = {Medical Physics},
number = 6,
volume = 43,
place = {United States},
year = {Wed Jun 15 00:00:00 EDT 2016},
month = {Wed Jun 15 00:00:00 EDT 2016}
}