CAPA & Root Cause Analysis
Quality deviations, out-of-specification results, and compliance events require thorough investigation, true root cause identification, and effective corrective actions. Inadequate CAPA systems are consistently cited in FDA warning letters—superficial investigations that address symptoms rather than systemic causes lead to recurring deviations and regulatory scrutiny. Quality teams face investigation backlogs, inconsistent analytical rigor, and generic CAPAs that fail to prevent recurrence.
Workflow goal
Accelerate quality investigations and improve root cause identification to reduce investigation cycle time by 50-60% while decreasing recurring deviations and strengthening regulatory compliance.
Stakeholders
Head of Quality Assurance
Quality Engineers
Manufacturing Operations
Regulatory Compliance
End-to-End Agentic Flow
1
Exception Detection
Ingest quality event with preliminary classification
Assess risk based on product, process, and regulatory impact
Assign to appropriate investigator based on expertise and workload
2
Evidence Gathering
Retrieve batch records, equipment logs, environmental data
Pull training records and procedure histories
Compile relevant documentation from quality systems
3
Guided Root Cause Analysis
Deploy structured RCA methodologies (5 Whys, Fishbone, Fault Tree)
Prompt investigator with relevant follow-up questions
Analyze historical patterns to identify systemic issues
Challenge premature conclusions with evidence requirements
4
CAPA Recommendation
Generate corrective and preventive action suggestions
Draw from regulatory guidance and organizational history
Predict effectiveness based on historical data
Ensure SMART CAPA criteria (Specific, Measurable, Achievable, Relevant, Time-bound)
5
Investigation Documentation
Auto-compile comprehensive investigation report
Include all evidence, analysis, and rationale
Ensure regulatory-compliant formatting
Maintain complete audit trail
6
Documentation
Assign tasks to responsible parties
Track progress with automated notifications
Schedule effectiveness verification
Monitor for recurring deviations
Platform features highlighted
Intelligent risk-based triage
Structured RCA methodology deployment
Historical pattern recognition
Evidence-based CAPA recommendation
Quality engineer validation of root cause conclusions
Management approval of corrective actions
Effectiveness verification by independent reviewer
Read-only access to manufacturing systems
Investigation cycle time (initiation → closure)
Root cause analysis depth score
Recurring deviation rate
CAPA on-time closure rate
Regulatory observation rate