Six Sigma is a systematic, data-driven methodology for improving processes by reducing waste, defects, or errors. The critical measure within Six Sigma is the defect caused by variation. Six Sigma metrics (measurements) to tally defects include the defect rate, sigma level, process efficiency, and capability.
The histology process presents some unique challenges to reducing defects. It remains a time-intensive, primarily manual process, with a persistent prevalence of batch processing and a lack of industry-wide standards. A large amount of manual handling creates process variations and a propensity for human errors, such as mislabeling cassettes and slides.
Many experts feel that the time has come for industry-wide standards to be applied to histology practice. Six Sigma offers many tools to help the histology laboratory standardize, increase efficiency, and reduce errors. Some specific Six Sigma tools that can help histology laboratories identify error-prone steps and process inefficiencies include root cause analysis (RCA), failure mode effect analysis (FMEA), and the use of standard operating procedures (SOPs), which will all help histology laboratories reduce variation and errors.
