135 lines
3.2 KiB
Markdown
135 lines
3.2 KiB
Markdown
# Standard Operating Procedure: Corrective and Preventive Action (CAPA)
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| Document ID | SOP-002 |
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|-------------|---------|
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| Title | Corrective and Preventive Action |
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| Revision | 1.0 |
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| Effective Date | [DATE] |
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| Author | [AUTHOR] |
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| Approved By | [APPROVER] |
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| Department | Quality Assurance |
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---
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## 1. Purpose
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To establish a systematic process for identifying, investigating, correcting, and preventing nonconformities and potential nonconformities.
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## 2. Scope
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This procedure applies to:
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- Product and process nonconformities
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- Customer complaints
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- Audit findings
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- Process deviations
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- Potential nonconformities identified through risk analysis
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## 3. Definitions
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| Term | Definition |
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|------|------------|
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| Corrective Action | Action to eliminate the cause of a detected nonconformity |
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| Preventive Action | Action to eliminate the cause of a potential nonconformity |
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| Root Cause | Fundamental reason for a nonconformity |
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| Effectiveness Check | Verification that implemented actions achieved desired results |
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## 4. Responsibilities
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### 4.1 CAPA Owner
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- Investigates the issue
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- Identifies root cause
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- Develops and implements corrective/preventive actions
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- Verifies effectiveness
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### 4.2 Quality Assurance
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- Manages CAPA system
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- Assigns CAPA numbers
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- Tracks CAPA status
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- Reviews and approves CAPAs
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- Reports CAPA metrics to management
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### 4.3 Management
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- Provides resources for CAPA implementation
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- Reviews CAPA trends
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- Ensures timely closure
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## 5. Procedure
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### 5.1 CAPA Initiation
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1. Identify nonconformity or potential nonconformity
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2. Document issue on CAPA Form (FRM-003)
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3. Classify severity and priority
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4. Assign CAPA owner
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### 5.2 Investigation
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1. Gather relevant data and evidence
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2. Interview personnel involved
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3. Review related documents and records
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4. Use appropriate investigation tools:
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- 5 Whys
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- Fishbone Diagram
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- Failure Mode Analysis
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### 5.3 Root Cause Analysis
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1. Identify potential root causes
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2. Verify root cause through evidence
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3. Document root cause determination
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4. Consider systemic implications
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### 5.4 Action Development
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1. Develop corrective/preventive actions
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2. Assign responsibilities and due dates
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3. Assess actions for:
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- Appropriateness to problem severity
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- Impact on other processes
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- Resource requirements
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### 5.5 Implementation
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1. Execute approved actions
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2. Document implementation evidence
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3. Update affected documents/processes
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4. Provide training as needed
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### 5.6 Effectiveness Verification
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1. Define effectiveness criteria
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2. Allow sufficient time for actions to take effect
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3. Collect and analyze data
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4. Document verification results
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5. If ineffective, reopen CAPA for further action
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### 5.7 Closure
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1. Review all CAPA documentation
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2. Verify all actions completed
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3. Confirm effectiveness verified
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4. Obtain approval for closure
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## 6. CAPA Metrics
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Quality Assurance shall track and report:
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- Number of open CAPAs
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- CAPA aging
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- On-time closure rate
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- Effectiveness rate
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- CAPAs by category/source
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## 7. Related Documents
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- FRM-003 CAPA Form
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- SOP-003 Nonconforming Product Control
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- SOP-004 Customer Complaints
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---
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## Revision History
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| Rev | Date | Description | Author |
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|-----|------|-------------|--------|
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| 1.0 | [DATE] | Initial release | [AUTHOR] |
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