Root Cause Analysis & CAPA Consulting
Most CAPAs fail because they fix the symptom instead of the cause. We find the real root, build a corrective action that holds, and give you the evidence your auditor needs.
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Fix the system, not just the paperwork
Root Cause Analysis (RCA) is a structured investigation method to determine the fundamental cause of a nonconformance, complaint, deviation, or adverse event. Corrective and Preventive Action (CAPA) is the documented process for eliminating that cause and preventing recurrence.
For FDA-regulated companies, an inadequate CAPA system is one of the most cited warning letter violations. For ISO-certified companies, weak CAPAs are a primary source of major nonconformances at surveillance audits. The problem is usually the same: organizations identify actions, not causes.
Who needs RCA / CAPA consulting?
FDA-regulated manufacturers
- Medical device companies under 21 CFR Part 820 or ISO 13485
- Organizations with FDA warning letters or 483 observations related to CAPA
- Companies preparing for MDSAP or FDA inspections
ISO-certified organizations
- Recurring nonconformances that keep coming back after “correction”
- Major CAPA-related findings from registrar audits
- QMS teams that struggle to close CAPAs on time and with evidence
Organizations after incidents
- Customer complaints, product escapes, or field failures
- Safety incidents requiring regulatory reporting
- Supply chain failures that need a structured investigation before next steps
Our approach to RCA / CAPA
Systematic, evidence-based, and built to satisfy both auditors and engineers.
- 1
Problem definition
We scope the problem precisely — what happened, where, when, how often, and what it is not. Vague problem statements produce vague root causes.
- 2
Root cause investigation
Using 5 Whys, Fishbone (Ishikawa), Fault Tree Analysis, or Is/Is Not analysis — chosen to match the problem type and regulatory context.
- 3
Corrective action design
Actions targeted at the verified root cause — with owners, timelines, and objective evidence criteria defined upfront.
- 4
Effectiveness verification
We define and conduct the effectiveness check: has the corrective action actually eliminated the cause and prevented recurrence?
What you get
RCA investigation report
Documented investigation using your method of choice, with verified root cause, contributing factors, and supporting evidence.
CAPA plan
Action plan with owners, due dates, and objective evidence requirements — in your QMS format or ours.
Effectiveness check protocol
Pre-defined criteria and method for verifying that the corrective action worked before closing the CAPA.
Regulatory-ready documentation
Documentation formatted to meet FDA 21 CFR Part 820, ISO 13485, ISO 9001, or MDSAP CAPA record requirements.
CAPA system assessment
Optional review of your existing CAPA process to identify systemic weaknesses causing repeated failures or late closures.
RCA training
Hands-on training for your QA team using real nonconformances from your own system — builds internal capability, not dependency.
Related services
GMP / ISO 13485
Medical device quality system consulting, including CAPA system design and FDA compliance.
Learn moreInternal Auditing
Internal audits that surface nonconformances before the registrar does — feeding a healthy CAPA system.
Learn moreMDSAP / HIPAA
MDSAP audit preparation including CAPA process review and mock audit services.
Learn moreReady to fix your CAPA process?
The first conversation is always free. We’ll scope the work, give you a realistic timeline, and tell you whether we’re the right fit.
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