CAPA Root Cause Investigation Toolkit
5-Why, fishbone, fault tree, failure mode classification, CAPA investigation report, and recurrence prevention evidence templates — the investigation depth FDA expects for complex nonconformances.
What You Get
5-Why Root Cause Analysis Template (FDA CAPA Format)
Structured 5-Why template with FDA CAPA documentation standards. Covers problem statement formulation, causal chain documentation, evidence requirement at each 'Why' level, the distinction between contributing factors and root cause, and the stop criteria that prevent superficial analysis. Includes the branching 5-Why methodology for multi-causal problems.
Fishbone (Ishikawa) Diagram Template for Medical Device Nonconformances
Pre-configured fishbone template for medical device failure analysis across the six standard cause categories: Method, Machine, Material, Measurement, Man, and Environment. Includes cause category prompt questions specific to manufacturing nonconformances, complaint investigations, and audit findings. Structured for Design History File and CAPA file documentation.
Fault Tree Analysis (FTA) Template
Fault tree analysis template for complex system failures and multi-contributor root causes. Covers top event definition, Boolean gate structure, basic event identification, cut set analysis, and probability estimation when quantitative risk data is available. Includes simplified FTA worksheet for nonconformances that do not require full quantitative analysis.
Failure Mode Root Cause Classification Matrix
Classification matrix linking observed failure modes to probable root cause categories. Covers 40+ medical device failure mode patterns organized by failure type (dimensional, material, functional, labeling, process, software) with the most frequently correct root cause category for each pattern. Reduces investigation time by focusing analysis on the highest-probability root causes first.
CAPA Investigation Report Template (FDA Submission Format)
Comprehensive CAPA investigation report template structured for FDA inspection and, where applicable, 510k or PMA submission. Covers problem description, scope and impact assessment, containment actions, root cause investigation methodology and findings, corrective and preventive action plan, implementation verification, and effectiveness check design.
Recurrence Prevention Evidence Package Template
Template for assembling the recurrence prevention evidence that FDA investigators specifically look for during CAPA system audits. Covers systemic root cause linkage (not just symptom fix), preventive action scope (similar processes and products), training evidence for process changes, and the monitoring plan that demonstrates the corrective action is holding.
FAQ
What root cause analysis method does FDA prefer?
FDA does not mandate a specific RCA method but expects documented evidence of systematic investigation. The depth of investigation must be proportional to the risk. For significant nonconformances, a structured method like 5-Why or fishbone with documented evidence at each step is expected.
What is the most common CAPA deficiency FDA cites?
Fixing the symptom without identifying the true systemic root cause. FDA frequently cites CAPAs that implement immediate corrections without demonstrating that the underlying process or system gap was addressed. This results in recurrence and repeat 483 observations.
What format are the documents?
All documents are editable Word and Excel templates ready for direct use in your CAPA file.
Ready to get started?
For informational purposes only. Not legal or regulatory advice. Legal