Skip to content

LABORATORY QUALITY GLOSSARY

root cause analysis

Last reviewed

Definition

Root cause analysis is a structured investigation of why a problem occurred and which underlying conditions allowed it to happen. Its purpose is to identify actionable causes rather than stop at the visible error. Depending on complexity, tools may include a process map, repeated why questions, a cause-and-effect diagram, or a review of the sequence of events and existing controls.

Start with verified facts, define the problem clearly, and involve people who understand the work. Test proposed causes against evidence rather than accepting the first plausible explanation. Problems can have several interacting causes; there need not be one simple root. Statements such as staff error or lack of attention rarely explain why the system failed to prevent, detect, or recover from the event.

Why it matters for accreditation

For accreditation, an investigation is convincing when selected actions address demonstrated causes and subsequent checks show improvement. Retraining alone may be appropriate for a genuine knowledge gap, but not for confusing interfaces, impossible workloads, or missing safeguards. Preserve the reasoning and evidence so another reviewer can understand why the chosen changes are expected to work.