neurophysiology-eeg/Forms/FRM-003-CAPA-Form.md

Corrective and Preventive Action (CAPA) Form

Form ID	FRM-003	Revision	1.0

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Section 1: CAPA Identification

Field	Entry
CAPA Number
Date Initiated
Initiated By
CAPA Owner
Target Closure Date

Section 2: Classification

Type

• Corrective Action
• Preventive Action

Source

• Customer Complaint
• Internal Audit
• External Audit
• Process Deviation
• Nonconforming Product
• Management Review
• Other: ____________

Priority

• Critical (5 business days)
• Major (15 business days)
• Minor (30 business days)

Section 3: Problem Description

(Describe the nonconformity or potential nonconformity)

Section 4: Immediate Containment

(Actions taken to contain the immediate impact)

Section 5: Root Cause Investigation

Investigation Method Used

• 5 Whys
• Fishbone Diagram
• Fault Tree Analysis
• Other: ____________

Root Cause Determination

Section 6: Corrective/Preventive Actions

Action	Responsible	Due Date	Status

Section 7: Effectiveness Verification

Criteria	Method	Result

Verification Date: ____________ Verified By: ____________

Section 8: Closure

Role	Name	Signature	Date
CAPA Owner
Quality Approval

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Form FRM-003 Rev 1.0