Failure mode and effects analysis: A community practice perspective.

Area of Science:

• Medical Physics
• Radiation Oncology
• Quality Assurance

Background:

• High-profile radiation therapy accidents underscore the need for robust process evaluation.
• Implementing complex quality assurance (QA) processes is increasingly significant in radiation oncology.
• The transition to new QA paradigms like TG-100 necessitates adaptable risk assessment tools.

Purpose of the Study:

• To document the initial implementation of Failure Mode and Effects Analysis (FMEA) within a community radiation oncology practice.
• To provide practical guidance for other community practices aiming to integrate FMEA into their QA programs.
• To evaluate the feasibility and effectiveness of FMEA in a non-academic setting.

Main Methods:

• A multidisciplinary team was assembled, and a trained FMEA facilitator guided the process.
• Stereotactic radiosurgery (SRS) was selected for the initial FMEA due to its self-contained nature and potential for high-impact failures.
• Process mapping involved detailed subprocess identification, followed by FMEA evaluation using Risk Priority Number (RPN) scoring.

Main Results:

• The SRS process map comprised 15 major steps and 183 subprocesses, designed for replicability by other teams.
• Continuous facilitator involvement ensured consistent scoring, and identified high-risk areas (RPN > 100 or severity 9-10) led to practice changes.
• Implemented changes reduced RPN scores below the high-risk threshold, with an estimated 258 person-hours for project completion.

Conclusions:

• The initial FMEA implementation in a community practice was successful, offering a feasible model for QA integration.
• The detailed process provides a roadmap for other practices considering FMEA adoption.
• This experience supports the broader adoption of systematic risk assessment tools in radiation oncology QA.