Root Cause Analysis for medical equipment calibration laboratory nonconformities

Solving problems effectively is part of being an effective organization. Beneath every problem is a cause for that problem. In order to solve a problem one must identify the cause of the problem and take steps to eliminate the cause. Root Cause Analysis (RCA) is a method that is used to address a problem or non-conformance, in order to get to the “root cause” of the problem. One of the main requirements of medical equipment calibration laboratory accreditation process is the laboratory policy to address the problem of nonconformance of its activity. This paper presents an established and accredited procedure for the control of nonconforming calibration work and/or results. The procedure is based on the experience of the Medical Equipment Calibration Lab (MECL) of the Systems and Biomedical Engineering Department (SBME), Cairo University. A description of some nonconformity problem cases reports and their root cause analysis is also provided.