Corrective and Preventive Action Form

CAPA template

Corrective and Preventive Action Form for medical device CAPA management

Use this editable Corrective and Preventive Action to record nonconformities, root causes, corrective and preventive actions, and verify their effectiveness.

Structure CAPA workflowsMove from detection to root cause, action and effectiveness.

Link to audits and complaintsConnect CAPA inputs to audit findings and post-market feedback.

Demonstrate ISO 13485 complianceProvide objective evidence of effective corrective action.

Best for: CAPA processes, nonconformity management, root-cause analysis and effectiveness checks.
Includes: editable sections for problem description, root cause, action plan and effectiveness verification.
Format: editable template available through the standard WooCommerce download flow.

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Lexqara helps manufacturers build CAPA systems that close quality gaps and satisfy notified-body expectations. Explore the Resource Center or review our Quality Management System Audit Services.

Description:
This CAPA form standardises how we document and close corrective and preventive actions with clear traceability and objective evidence.

Assign a unique CAPAYYYY-XXX and record the Type of CAPA (Corrective Action / Preventive action).
Capture a durable Description of the problem and Traceability to devices involved (lot/batch/SN).
Complete Risk Assessment for safety, performance, and regulatory compliance (ISO 13485).
Document Investigation scope (DHF/DHR/DMR/QMS, testing, suppliers) and Health Hazard Evaluation applicability.
Perform Root-Cause Analysis using Ishikawa Diagram (6M) and 5 Why.
Define Containment Item and action items with owners, dates, and evidence.
Run Effectiveness Review with Acceptance Criteria and record outcomes.
Finalise Closure with Approval stage, signature, and dates.

Your needs:

CAPA form
CAPA form for ISO 13485, MDR compliance
Reduce rework, control timelines, and lower repeat audit findings.

Use this form when nonconformities, complaints, PMS signals, or audit findings require documented containment, root cause, and corrective/preventive actions.

It covers the full CAPA lifecycle. Root-cause analysis identifies why the issue happened so actions prevent recurrence. Effectiveness review verifies outcomes against acceptance criteria so closure is evidence-based.

Assign CAPA ID and origin record for traceability.
Evaluate recurrence sources (complaints, audits, PMS, suppliers).
Complete safety/performance/compliance impact assessment.
Document investigation need and HHE rationale.
Record containment and CAPA actions with evidence.
Confirm adverse impact assessment for changes.
Close with approval, signature, and archiving.

At Lexqara, we align CAPA workflows with complaint handling, audits, and risk management, and support training and inspection-ready documentation. Resource Center [https://lexqara.com/resource-center] and Audit & Inspection Support [https://lexqara.com/services/audit-and-inspection-support]. ISO 13485 [https://www.iso.org/standard/59752.html]. Download the template or request a short gap assessment.

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Template preview: Corrective and Preventive Action

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Identification

Initiation date	YYYY-Mon-DD
Initiated by

Type of CAPA	Corrective Action Preventive action
CAPA initiated following	Indicate the record that required the initiation of the CAPA
Description of the problem
Include a detailed a clear description of the problem that can be understood by another employee or several years later
Traceability to devices involved:			Applicable Non-Applicable
Device reference:		Lot/batch/SN

Evaluation

Evaluation by
Name
Position
Date

Recurrence
Complaints	Record number or N/A	FSCA	Record number or N/A
Internal audits	Record number or N/A	Post-market surveillance	Record number or N/A
Supplier audits	Record number or N/A	Clinical Evaluation Report	Record number or N/A
External audits (e.g., NB)	Record number or N/A	PMCF	Record number or N/A
Management Review	Record number or N/A	Risk Management File	Record number or N/A
NC Products	Record number or N/A	Other	Record number or N/A

Risk Assessment
Device safety impact	Applicable Non-Applicable	Are patients/users exposed to possible risks?
Device performance impact	Applicable Non-Applicable	Is the device compliant to its specifications? Is the device performance maintained?
Impact on regulatory compliance	Applicable Non-Applicable	Are the ISO 13485 requirements or associated regulatory requirements still met?

Preliminary Impact Assessment

May the problem affect products already on the market?

Applicable

Non-Applicable

Is the market affected?

Is the problem due to the absence of procedure?

Applicable

Non-Applicable

Indicate “A” when there is no procedure and “N/A” if the procedure is existing but incomplete.

Priority

Critical/Major/Minor/Non-Significant

Investigation

Investigation by
Name
Position
Date

Need of investigation

Yes

Justification when no investigation is required:

e.g., the investigation and root-cause have already been determined via CAPAYYYY-XXX.

Health Hazard Evaluation
Applicable, the problem identified has a field safety impact	Document number:
Non-Applicable, the problem identified does not have any field safety impact

Detailed investigation

DHF documents

Applicable

Non-Applicable

Include a justification if N/A