CAPA (Corrective & Preventive Action) Management Checklist [FREE PDF]
Quality managers and compliance officers use this checklist to manage CAPA processes per ISO 9001:2015 Clause 10.2 nonconformity and corrective action and FDA 21 CFR 820.90 for medical device manufacturers.
- Industry: Manufacturing & Medical Device
- Frequency: Monthly
- Estimated Time: 15-20 minutes
- Role: Quality Manager
- Total Items: 8
- Compliance: ISO 9001:2015 Clause 10.2, FDA 21 CFR 820.90
Investigation & Root Cause
Verify CAPAs have adequate investigation and root cause analysis.
- Has root cause analysis been completed using appropriate methods (5-Why, Ishikawa)?
- Has the scope of the nonconformity been assessed (similar products/processes)?
- Are CAPAs progressing within established timelines?
- Investigation notes
Effectiveness Verification & Closure
Confirm corrective actions are effective and CAPAs properly closed.
- Are corrective actions fully implemented as planned?
- Has effectiveness been verified with objective evidence (data, audits)?
- Are closed CAPAs documented with evidence of effectiveness in the quality record?
- Effectiveness and closure notes
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Why Use This CAPA (Corrective & Preventive Action) Management Checklist [FREE PDF]?
This capa (corrective & preventive action) management checklist [free pdf] helps manufacturing & medical device teams maintain compliance and operational excellence. Designed for quality manager professionals, this checklist covers 8 critical inspection points across 2 sections. Recommended frequency: monthly.
Ensures compliance with ISO 9001:2015 Clause 10.2, FDA 21 CFR 820.90. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the CAPA (Corrective & Preventive Action) Management Checklist [FREE PDF] cover?
This checklist covers 8 inspection items across 2 sections: Investigation & Root Cause, Effectiveness Verification & Closure. It is designed for manufacturing & medical device operations and compliance.
How often should this checklist be completed?
This checklist should be completed monthly. Each completion takes approximately 15-20 minutes.
Who should use this CAPA (Corrective & Preventive Action) Management Checklist [FREE PDF]?
This checklist is designed for Quality Manager professionals in the manufacturing & medical device industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.
Can I download this checklist as a PDF?
Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.