Root cause analysis
rca
Structured investigation to identify the underlying cause(s) of a problem so corrective action eliminates recurrence — not just the symptom.
RCA is the analytical core of every CAPA, deviation investigation and NCR closure. Techniques range from quick (5 Whys for simple, single-path causes) to structured (Ishikawa/fishbone for complex multi-factor problems, 8D for supplier and customer-facing issues, Fault Tree Analysis for safety-critical systems, Apollo or Kepner-Tregoe for high-stakes investigations).
A defensible RCA always (a) describes the problem in measurable terms, (b) gathers data before guessing, (c) distinguishes causal factors from root causes, (d) verifies the proposed root cause against the data, and (e) sizes corrective action to the root cause — not the symptom.
- 21 CFR 820.100
- ICH Q10 §3.2.2
- ISO 13485 §8.5
Free trial, no credit card, onboard in days, not months.