Quality Compliance Root Cause Analysis
We go beyond the obvious. Surface-level corrections address symptoms. We identify the systemic conditions that allowed the problem to occur — and that will allow it to recur if left unaddressed.
- 5 Why analysis with verification at each level
- Fishbone (Ishikawa) diagramming
- Fault tree analysis for complex failures
- Is/Is Not analysis for problem definition
- Human factors assessment when applicable
CAPA Plan Development
A good CAPA plan is specific, measurable, and owned. We help you develop action plans that describe exactly what will change, who is responsible, and how you will verify it worked.
- Corrective action scoping (proportional to risk)
- Preventive action identification across similar processes
- Timeline development with realistic milestones
- Resource and responsibility assignment
Effectiveness Verification
The most neglected step in CAPA is also the most important. We design effectiveness checks that genuinely test whether the corrective action solved the problem — not just whether the paperwork was completed.
- Effectiveness criteria defined at CAPA initiation (not after the fact)
- Statistical verification where applicable
- Monitoring period determination based on risk
- Closure criteria that satisfy regulatory expectations
CAPA System Assessment
If your CAPA system is generating hundreds of open actions with low closure rates, the system itself needs attention. We assess your CAPA process end-to-end and identify where it breaks down.
- CAPA aging analysis and backlog reduction
- Process bottleneck identification
- Trending of repeat CAPAs (same root cause reappearing)
- System redesign for efficiency and regulatory alignment
Common Problems We See
- CAPAs that fix the instance but not the system — replacing a damaged gasket without asking why gaskets are failing
- Root cause analysis that stops too early — "operator error" is never the root cause; the system that allowed the error is
- Effectiveness checks that measure activity, not outcome — "retraining completed" does not prove the problem is fixed
- CAPA overload — opening a CAPA for every minor deviation drowns the system and dilutes focus
Regulatory Context
FDA expects CAPA systems to demonstrate that organizations can identify, investigate, and prevent quality problems (21 CFR 820.90). During inspections, investigators frequently review CAPA records to assess whether the organization understands its own failure modes. A well-functioning CAPA system is often the difference between an inspection that closes cleanly and one that generates a 483.