CAPA Review and Effectiveness Verification Checklist
A robust CAPA system is a cornerstone of pharmaceutical quality management. This checklist reviews CAPA quality, root cause adequacy, timely closure, and effectiveness verification per FDA 21 CFR 820.100 and ICH Q10 requirements.
- Industry: Pharmaceutical & Life Sciences
- Frequency: Monthly
- Estimated Time: 30-45 minutes
- Role: QA Manager / Quality Director
- Total Items: 31
- Compliance: FDA 21 CFR 820.100 - Corrective and Preventive Action (Medical Devices), FDA 21 CFR 211.192 - Production Record Review (Pharma), ICH Q10 Pharmaceutical Quality System Section 3.2 CAPA, ISO 9001:2015 Section 10.2 Nonconformity and Corrective Action
CAPA Initiation and Documentation
Review CAPA initiation quality and completeness.
- CAPA problem statements clearly describe what, where, when, extent, and impact?
- All CAPAs appropriately risk-classified with timelines assigned?
- Immediate containment actions documented for all critical CAPAs?
- Any CAPAs requiring regulatory notification (field alert, MDR) identified and filed?
- CAPAs initiated from all required sources: complaints, audits, OOS, deviations, AERs?
Root Cause Analysis Quality
Assess root cause analysis adequacy.
- Appropriate RCA methodology used (5-Why, Fishbone, FTA) and documented?
- Root cause identifies systemic issue, not just proximate cause?
- Root cause supported by data and evidence?
- Detection and systemic causes identified in addition to occurrence cause?
- Risk of similar occurrence in other areas/products assessed?
Corrective Action Plans
Review corrective and preventive action quality.
- Corrective actions directly address identified root causes?
- Preventive actions implemented to reduce recurrence risk?
- SOP and documentation updates included where process gaps identified?
- Training actions included where human error or knowledge gaps identified?
- Each action assigned to responsible owner with specific due date?
Timeliness and Closure
Review CAPA closure timeliness.
- At least 80% of CAPAs closed by original target date?
- All extensions to target dates justified and approved by QA?
- No overdue critical or major CAPAs?
- Objective evidence of completed actions attached to each CAPA?
- QA verification of completed actions performed before closure?
Effectiveness Verification
Review effectiveness check quality.
- Effectiveness verification (EV) plan defined for all CAPAs?
- EV scheduled at appropriate interval to detect recurrence?
- EV completed for all CAPAs past EV due date?
- EV acceptance criteria defined and met for closed CAPAs?
- Failed EV resulting in CAPA re-opening or new CAPA initiation?
Trend Analysis and Management Review
Review CAPA trends and management oversight.
- No significant repeat CAPAs indicating ineffective root cause or action?
- CAPA data trended by source, classification, and area?
- CAPA metrics reported at management review?
- CAPA KPIs (on-time closure, overdue rate, repeat rate) meeting targets?
- Personnel completing CAPAs trained on RCA methodology?
- Monthly CAPA review report prepared and distributed?
Related Pharmaceutical Life Sciences Checklists
- Pharmaceutical Deviation and Non-Conformance Investigation Checklist
- Pharmaceutical Data Integrity and ALCOA Plus Compliance Checklist
- Pharmaceutical Change Control Review and Approval Checklist
- Pharmaceutical CAPA Review and Effectiveness Check Checklist
- Pharmaceutical QC Laboratory Inspection Checklist
- Pharmaceutical Microbiological Contamination Testing Checklist
- Pharmaceutical Water System Inspection Checklist
- Pharmaceutical Supplier Qualification Audit Checklist
Related Quality Systems Checklists
- Pharmaceutical CAPA Review and Effectiveness Check Checklist - FREE Download
- Pharmaceutical Data Integrity and ALCOA+ Compliance Audit Checklist - FREE Download
- Pharmaceutical Deviation and Non-Conformance Investigation Checklist - FREE Download
- Pharmaceutical Data Integrity and ALCOA Plus Compliance Checklist - FREE Download
- Pharmaceutical Change Control Review and Approval Checklist - FREE Download
Why Use This CAPA Review and Effectiveness Verification Checklist?
This capa review and effectiveness verification checklist helps pharmaceutical & life sciences teams maintain compliance and operational excellence. Designed for qa manager / quality director professionals, this checklist covers 31 critical inspection points across 6 sections. Recommended frequency: monthly.
Ensures compliance with FDA 21 CFR 820.100 - Corrective and Preventive Action (Medical Devices), FDA 21 CFR 211.192 - Production Record Review (Pharma), ICH Q10 Pharmaceutical Quality System Section 3.2 CAPA, ISO 9001:2015 Section 10.2 Nonconformity and Corrective Action. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the CAPA Review and Effectiveness Verification Checklist cover?
This checklist covers 31 inspection items across 6 sections: CAPA Initiation and Documentation, Root Cause Analysis Quality, Corrective Action Plans, Timeliness and Closure, Effectiveness Verification, Trend Analysis and Management Review. It is designed for pharmaceutical & life sciences operations and compliance.
How often should this checklist be completed?
This checklist should be completed monthly. Each completion takes approximately 30-45 minutes.
Who should use this CAPA Review and Effectiveness Verification Checklist?
This checklist is designed for QA Manager / Quality Director professionals in the pharmaceutical & life sciences 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.