nicu-picu/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

• Patient Safety Event
• Medication Error
• Healthcare-Associated Infection
• Equipment Failure
• Internal Audit
• External Audit/Survey
• Family Complaint
• Process Deviation
• Sentinel Event
• Management Review
• Other: ____________

Priority

• Critical (patient harm occurred or high risk - 5 business days)
• Major (potential for patient harm - 15 business days)
• Minor (process deviation, no patient impact - 30 business days)

Section 3: Problem Description

(Describe the nonconformity or potential nonconformity - include patient impact if applicable)

Section 4: Immediate Containment

(Actions taken to contain the immediate impact and protect patient safety)

Section 5: Root Cause Investigation

Investigation Method Used

• Root Cause Analysis (RCA)
• Failure Mode and Effects Analysis (FMEA)
• 5 Whys
• Fishbone Diagram
• Fault Tree Analysis
• Other: ____________

Root Cause Determination

Contributing Factors

Section 6: Corrective/Preventive Actions

Action	Responsible	Due Date	Status

Section 7: Staff Communication and Training

Training/Communication Required	Target Audience	Completion Date

Section 8: Effectiveness Verification

Criteria	Method	Result

Verification Date: ____________ Verified By: ____________

Section 9: Closure

Role	Name	Signature	Date
CAPA Owner
Quality Approval

Lessons Learned

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Form FRM-003 Rev 1.0