Six documents for a defensible CAPA system — procedure, root cause analysis, tracking log, effectiveness verification, trend metrics, and FDA audit prep.
Instant download. For QA managers at FDA-regulated device companies.
FDA QMSR §820.100 and ISO 13485 §8.5 require a documented CAPA system covering investigation, root cause analysis, corrective and preventive actions, and effectiveness verification. The most common gaps: inadequate root cause investigation, missing effectiveness checks, and trend data not reaching management review.
This toolkit gives you the procedure, the forms, the RCA methods, the effectiveness protocol, and the FDA audit prep guide — everything needed to build a CAPA system that holds up under inspection.
From problem identification through effectiveness verification and management review reporting.
Complete CAPA SOP per FDA QMSR §820.100 and ISO 13485 §8.5. Covers problem identification, investigation, root cause analysis, corrective/preventive action planning, implementation, effectiveness verification, and management review reporting. Includes decision trees for CAPA vs immediate correction.
Five structured RCA methods for medical device nonconformances: 5-Why, fishbone/Ishikawa, fault tree analysis, FMEA-based analysis, and process mapping. Includes worked examples for manufacturing defects, complaint investigations, and audit findings. Template worksheets for each method.
CAPA initiation form with all required fields (source, problem description, disposition, containment, investigation, root cause, actions, verification). Companion tracking log for CAPA status, owner, due dates, and effectiveness check schedule. Designed as controlled QMS documents.
Structured effectiveness verification framework — the step FDA investigators most frequently find missing or inadequate. Covers verification methods (re-audit, data trending, complaint monitoring), success criteria definition, timeframe selection, and documentation requirements for closure.
Monthly CAPA metrics template for management review: open/closed counts, average cycle time, source distribution (complaints, audits, NCRs, CAPAs), recurrence rate, and overdue CAPA escalation. Pre-built for ISO 13485 §8.4 and FDA QMSR management review inputs.
What FDA investigators actually look for in CAPA systems — 483 observation patterns, common documentation gaps, and the questions inspectors ask. Includes a pre-inspection CAPA readiness checklist and guidance on presenting your CAPA program to investigators.
The most common CAPA failure FDA cites: fixing the symptom without identifying root cause. The RCA toolkit gives you five structured methods to get to the real cause every time.
FDA consistently flags CAPAs closed without evidence of effectiveness. The effectiveness check protocol tells you exactly how to define, execute, and document a defensible verification.
ISO 13485 and QMSR both require CAPA trend data at management review. The dashboard template is ready to populate — open/closed, cycle time, recurrence rate, source breakdown.
“I built these templates from 12 years of running a Class II/III medical device manufacturing operation. Every document reflects what FDA investigators actually ask for — not what consultants think they ask for. We use these exact frameworks at AB Medical.”
Joshua Millage, CEO — AB Medical Technologies
“When you've been through enough FDA inspections, you learn what documentation gaps get flagged and which ones slide. These templates close the gaps that matter. We developed them alongside our own QMS buildout and they've held up under audit.”
Rick, Director of Engineering & Regulatory — AB Medical Technologies
An immediate correction (or containment) addresses the affected product or process right now — quarantine, rework, withdrawal. A CAPA addresses root cause to prevent recurrence. FDA QMSR §820.100 requires both: you must correct AND investigate root cause for significant nonconformances. The CAPA procedure template includes the decision tree for when each is required.
There is no regulatory timeframe — it must be risk-based. The toolkit includes a tiered cycle time framework based on nonconformance severity: critical (30 days), major (60 days), minor (90 days). FDA investigators look for CAPAs open for an unreasonably long time and CAPAs closed prematurely without effectiveness verification.
An effectiveness check is objective evidence that the corrective action actually prevented recurrence. FDA QMSR §820.100(a)(7) requires it. Timing depends on the action — typically 30-90 days after implementation. The effectiveness check protocol template covers method selection, success criteria, and documentation.
No. This is a practitioner reference toolkit. Consult your regulatory counsel for formal compliance opinions.
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Six documents. Instant download. FDA QMSR §820.100 + ISO 13485 §8.5.