clinical-research-template/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.

2. Scope

This procedure applies to:

• Product and process nonconformities
• Customer complaints
• Audit findings
• Process deviations
• 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

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 Management

• Provides resources for CAPA implementation
• Reviews CAPA trends
• Ensures timely closure

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
4. Assign CAPA owner

5.2 Investigation

1. Gather relevant data and evidence
2. Interview personnel involved
3. Review related documents and records
4. Use appropriate investigation tools:
   • 5 Whys
   • Fishbone Diagram
   • Failure Mode Analysis

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

5.4 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

5.5 Implementation

1. Execute approved actions
2. Document implementation evidence
3. Update affected documents/processes
4. Provide training as needed

5.6 Effectiveness Verification

1. Define effectiveness criteria
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

6. CAPA Metrics

Quality Assurance shall track and report:

• Number of open CAPAs
• CAPA aging
• On-time closure rate
• Effectiveness rate
• CAPAs by category/source

7. Related Documents

• FRM-003 CAPA Form
• SOP-003 Nonconforming Product Control
• SOP-004 Customer Complaints

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Revision History

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