developmental-pediatrics/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
Department
CAPA Owner

Section 2: Problem Description

Source of CAPA

• Internal Audit
• External Audit
• Management Review
• Clinical Incident
• Family Complaint
• Assessment Protocol Deviation
• Documentation Error
• Staff Observation
• Other: _______________

Severity Level

• Critical (affects patient safety or diagnostic accuracy)
• Major (significant quality impact)
• Minor (limited impact)

Description of Nonconformity or Issue

(Provide detailed description including what happened, when, where, and who was involved)

Affected Processes/Areas

• Diagnostic Evaluations
• Screening Programs
• School Liaison
• Documentation
• Assessment Administration
• Clinical Protocols
• Training/Competency
• Other: _______________

Section 3: Immediate Action (if applicable)

Immediate Containment Actions Taken

(Actions to prevent immediate recurrence or mitigate impact)

Section 4: Root Cause Analysis

Investigation Method

• 5 Whys
• Fishbone Diagram
• Timeline Analysis
• Other: _______________

Root Cause Findings

(Document the fundamental cause of the problem)

Contributing Factors

• Training inadequacy
• Protocol unclear
• Communication breakdown
• Assessment tool issue
• Workload/scheduling
• Documentation system
• Equipment/materials
• Other: _______________

Section 5: Corrective/Preventive Actions

Action Plan

Action #	Description	Responsible Person	Target Date	Status
1
2
3
4

Type of Action

• Corrective (address detected issue)
• Preventive (prevent potential issue)

Affected Documents/Procedures

(List SOPs, protocols, or forms that need updating)

Training Required

• Yes
• No

If yes, describe:

Section 6: Implementation

Implementation Notes

(Document actions taken)

Implementation Date | |

Implemented By | |

Section 7: Effectiveness Check

Verification Method

• Follow-up audit
• Metric monitoring
• Process observation
• Record review
• Other: _______________

Verification Period

• Start Date: _______________
• End Date: _______________

Effectiveness Results

(Describe results of monitoring - has the issue been resolved?)

Effectiveness Verified By | |

Verification Date | |

Section 8: CAPA Closure

• All actions completed
• Effectiveness demonstrated
• Records complete

Closed By | |

Closure Date | |

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Form FRM-003 Rev 1.0