Process failure mode and effects analysis for external beam radiotherapy: Introducing a literature-based template and...

Area of Science:

• Medical Physics
• Radiation Oncology
• Quality Improvement

Background:

• External beam radiotherapy (EBRT) involves complex processes with potential failure modes.
• Effective risk assessment and prioritization are crucial for ensuring patient safety in radiation oncology.
• Existing methods for failure analysis may not be optimally adapted to the specific needs of radiation oncology.

Purpose of the Study:

• To develop a generalizable Process Failure Mode and Effects Analysis (PFMEA) template for analyzing potential failures in EBRT.
• To adapt and validate a novel Action Priority (AP) method for radiation oncology (RO AP), considering different rating systems for severity, occurrence, and detectability.

Main Methods:

• Developed an EBRT-PFMEA template by adapting the Automotive Industry Action Group (AIAG) PFMEA approach and incorporating findings from a literature survey.
• Defined a new RO AP using a weighted sum of severity, occurrence, and detectability ratings.
• Utilized Monte Carlo simulations to compare the original AIAG AP, the RO AP, and the Risk Priority Number (RPN), and to parameterize the RO AP.

Main Results:

• Compiled an EBRT-PFMEA template identifying 75 high-risk failure modes.
• The RO AP required fewer additional corrective actions per failure mode (1.3–3.5) compared to the RPN (3.6) and was comparable to the AIAG AP (1.7).
• Successfully parameterized the RO AP to equally evaluate severity, occurrence, and detection ratings within the department's specific rating system.

Conclusions:

• An adjustable EBRT-PFMEA template is provided as a practical foundation for developing institution-specific failure analysis tools.
• The RO AP offers transparent and adaptable action levels suitable for diverse rating systems in radiation oncology, enhancing risk management.