nicu-picu/SOPs/SOP-002-CAPA.md

Standard Operating Procedure: Corrective and Preventive Action (CAPA)

Document ID	SOP-002
Title	Corrective and Preventive Action
Revision	1.0
Effective Date	[DATE]
Author	[AUTHOR]
Approved By	[APPROVER]
Department	Quality Assurance

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1. Purpose

To establish a systematic process for identifying, investigating, correcting, and preventing nonconformities and potential nonconformities that affect patient care quality and safety in the NICU/PICU.

2. Scope

This procedure applies to:

• Patient safety events and near-misses
• Healthcare-associated infections
• Medication errors and adverse drug events
• Equipment failures
• Process deviations
• Audit findings
• Regulatory findings
• Potential nonconformities identified through risk analysis

3. Definitions

Term	Definition
Corrective Action	Action to eliminate the cause of a detected nonconformity
Preventive Action	Action to eliminate the cause of a potential nonconformity
Root Cause	Fundamental reason for a nonconformity
Effectiveness Check	Verification that implemented actions achieved desired results
Sentinel Event	Unexpected occurrence involving death or serious physical/psychological injury

4. Responsibilities

4.1 CAPA Owner

• Investigates the issue
• Identifies root cause
• Develops and implements corrective/preventive actions
• Verifies effectiveness

4.2 Quality Assurance

• Manages CAPA system
• Assigns CAPA numbers
• Tracks CAPA status
• Reviews and approves CAPAs
• Reports CAPA metrics to management

4.3 Unit Leadership

• Provides resources for CAPA implementation
• Reviews CAPA trends
• Ensures timely closure
• Communicates serious events to appropriate parties

5. Procedure

5.1 CAPA Initiation

1. Identify nonconformity or potential nonconformity
2. Document issue on CAPA Form (FRM-003)
3. Classify severity and priority:
   • Critical (patient harm or high risk)
   • Major (potential for patient harm)
   • Minor (process deviation, no patient impact)
4. Assign CAPA owner
5. Notify Risk Management if patient safety event

5.2 Investigation

1. Gather relevant data and evidence
2. Interview personnel involved
3. Review related documents and records
4. Review patient chart if applicable
5. Use appropriate investigation tools:
   • Root Cause Analysis (RCA)
   • Failure Mode and Effects Analysis (FMEA)
   • 5 Whys
   • Fishbone Diagram

5.3 Root Cause Analysis

1. Identify potential root causes
2. Verify root cause through evidence
3. Document root cause determination
4. Consider systemic implications
5. Identify contributing factors

5.4 Action Development

1. Develop corrective/preventive actions
2. Assign responsibilities and due dates
3. Assess actions for:
   • Appropriateness to problem severity
   • Impact on other processes
   • Resource requirements
   • Sustainability

5.5 Implementation

1. Execute approved actions
2. Document implementation evidence
3. Update affected documents/processes
4. Provide staff training as needed
5. Communicate changes to all affected personnel

5.6 Effectiveness Verification

1. Define effectiveness criteria (measurable outcomes)
2. Allow sufficient time for actions to take effect
3. Collect and analyze data
4. Document verification results
5. If ineffective, reopen CAPA for further action

5.7 Closure

1. Review all CAPA documentation
2. Verify all actions completed
3. Confirm effectiveness verified
4. Obtain approval for closure
5. Share lessons learned with team

6. CAPA Metrics

Quality Assurance shall track and report:

• Number of open CAPAs by category
• CAPA aging
• On-time closure rate
• Effectiveness rate
• CAPAs by source (safety event, infection, medication error, etc.)
• Repeat events

7. Related Documents

• FRM-003 CAPA Form
• SOP-005 Patient Safety Event Reporting
• Risk Management Policies

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Revision History

Rev	Date	Description	Author
1.0	[DATE]	Initial release	[AUTHOR]