claude-code-arcane 1.0.0

package/skills/fda-consultant-specialist/references/fda_capa_requirements.md

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+# FDA CAPA Requirements
+
+Complete guide to Corrective and Preventive Action requirements per 21 CFR 820.100.
+
+---
+
+## Table of Contents
+
+- [CAPA Regulation Overview](#capa-regulation-overview)
+- [CAPA Sources](#capa-sources)
+- [CAPA Process](#capa-process)
+- [Root Cause Analysis](#root-cause-analysis)
+- [Action Implementation](#action-implementation)
+- [Effectiveness Verification](#effectiveness-verification)
+- [Documentation Requirements](#documentation-requirements)
+- [FDA Inspection Focus Areas](#fda-inspection-focus-areas)
+
+---
+
+## CAPA Regulation Overview
+
+### 21 CFR 820.100 Requirements
+
+```
+§820.100 Corrective and preventive action
+
+(a) Each manufacturer shall establish and maintain procedures for
+implementing corrective and preventive action. The procedures shall
+include requirements for:
+
+(1) Analyzing processes, work operations, concessions, quality audit
+    reports, quality records, service records, complaints, returned
+    product, and other sources of quality data to identify existing
+    and potential causes of nonconforming product, or other quality
+    problems.
+
+(2) Investigating the cause of nonconformities relating to product,
+    processes, and the quality system.
+
+(3) Identifying the action(s) needed to correct and prevent recurrence
+    of nonconforming product and other quality problems.
+
+(4) Verifying or validating the corrective and preventive action to
+    ensure that such action is effective and does not adversely affect
+    the finished device.
+
+(5) Implementing and recording changes in methods and procedures needed
+    to correct and prevent identified quality problems.
+
+(6) Ensuring that information related to quality problems or nonconforming
+    product is disseminated to those directly responsible for assuring
+    the quality of such product or the prevention of such problems.
+
+(7) Submitting relevant information on identified quality problems, as
+    well as corrective and preventive actions, for management review.
+```
+
+### Definitions
+
+| Term | Definition |
+|------|------------|
+| **Correction** | Action to eliminate a detected nonconformity |
+| **Corrective Action** | Action to eliminate the cause of a detected nonconformity to prevent recurrence |
+| **Preventive Action** | Action to eliminate the cause of a potential nonconformity to prevent occurrence |
+| **Root Cause** | The fundamental reason for the occurrence of a problem |
+| **Effectiveness** | Confirmation that actions achieved intended results |
+
+### CAPA vs. Correction
+
+```
+Problem Detected
+    ├── Correction (Immediate)
+    │   └── Fix the immediate issue
+    │       Example: Replace defective part
+    │
+    └── CAPA (Systemic)
+        └── Address root cause
+            Example: Fix process that caused defect
+```
+
+---
+
+## CAPA Sources
+
+### Data Sources for CAPA Input
+
+**Internal Sources:**
+- Nonconforming product reports (NCRs)
+- Internal audit findings
+- Process deviations
+- Manufacturing data trends
+- Equipment failures
+- Employee observations
+- Training deficiencies
+
+**External Sources:**
+- Customer complaints
+- Service records
+- Returned product
+- Regulatory feedback (483s, warning letters)
+- Adverse event reports (MDRs)
+- Field safety corrective actions
+
+### CAPA Threshold Criteria
+
+**Mandatory CAPA Triggers:**
+
+| Source | Threshold |
+|--------|-----------|
+| Audit findings | All major/critical findings |
+| Customer complaints | Any safety-related |
+| NCRs | Recurring (3+ occurrences) |
+| Regulatory feedback | All observations |
+| MDR/vigilance | All reportable events |
+
+**Discretionary CAPA Evaluation:**
+
+| Source | Consideration |
+|--------|---------------|
+| Trend data | Statistical significance |
+| Process deviations | Impact assessment |
+| Minor audit findings | Risk-based |
+| Supplier issues | Frequency and severity |
+
+### Trend Analysis
+
+**Statistical Process Control:**
+
+```markdown
+## Monthly CAPA Trend Review
+
+### Complaint Trending
+- [ ] Complaints by product
+- [ ] Complaints by failure mode
+- [ ] Geographic distribution
+- [ ] Customer type analysis
+
+### NCR Trending
+- [ ] NCRs by product/process
+- [ ] NCRs by cause code
+- [ ] NCRs by supplier
+- [ ] Scrap/rework rates
+
+### Threshold Monitoring
+| Metric | Threshold | Current | Status |
+|--------|-----------|---------|--------|
+| Complaints/month | <10 | | |
+| NCR rate | <2% | | |
+| Recurring issues | 0 | | |
+```
+
+---
+
+## CAPA Process
+
+### CAPA Workflow
+
+```
+1. Initiation
+   ├── Problem identification
+   ├── Initial assessment
+   └── CAPA determination
+
+2. Investigation
+   ├── Data collection
+   ├── Root cause analysis
+   └── Impact assessment
+
+3. Action Planning
+   ├── Correction (if applicable)
+   ├── Corrective action
+   └── Preventive action
+
+4. Implementation
+   ├── Execute actions
+   ├── Document changes
+   └── Train affected personnel
+
+5. Verification
+   ├── Verify implementation
+   ├── Validate effectiveness
+   └── Monitor for recurrence
+
+6. Closure
+   ├── Management approval
+   ├── Final documentation
+   └── Trend data update
+```
+
+### CAPA Form Template
+
+```markdown
+## CAPA Record
+
+### Section 1: Identification
+CAPA Number: ________________
+Initiated By: ________________
+Date Initiated: ______________
+Priority: ☐ Critical ☐ Major ☐ Minor
+
+Source:
+☐ Audit Finding     ☐ Complaint        ☐ NCR
+☐ Service Record    ☐ MDR              ☐ Trend Data
+☐ Regulatory        ☐ Other: ____________
+
+### Section 2: Problem Description
+Products Affected: _______________________
+Processes Affected: _____________________
+Quantity/Scope: _________________________
+
+Problem Statement:
+[Clear, specific description of the nonconformity or potential problem]
+
+### Section 3: Immediate Correction
+Correction Taken: _______________________
+Date Completed: _________________________
+Verified By: ____________________________
+
+### Section 4: Investigation
+Investigation Lead: _____________________
+Investigation Start Date: _______________
+
+Data Collected:
+☐ Complaint records      ☐ Production records
+☐ Test data              ☐ Training records
+☐ Process documentation  ☐ Supplier data
+
+Root Cause Analysis Method:
+☐ 5 Whys    ☐ Fishbone    ☐ Fault Tree    ☐ Other
+
+Root Cause Statement:
+[Specific, factual statement of the root cause]
+
+Contributing Factors:
+1. _____________________________________
+2. _____________________________________
+
+### Section 5: Action Plan
+
+#### Corrective Actions
+| Action | Owner | Target Date | Status |
+|--------|-------|-------------|--------|
+|        |       |             |        |
+
+#### Preventive Actions
+| Action | Owner | Target Date | Status |
+|--------|-------|-------------|--------|
+|        |       |             |        |
+
+### Section 6: Verification
+Verification Method: ____________________
+Verification Criteria: __________________
+Verification Date: _____________________
+Verified By: ___________________________
+
+Verification Results:
+☐ Actions implemented as planned
+☐ No adverse effects identified
+☐ Documentation updated
+
+### Section 7: Effectiveness Review
+Effectiveness Review Date: ______________
+Review Period: ________________________
+Reviewer: _____________________________
+
+Effectiveness Criteria:
+[Specific, measurable criteria for success]
+
+Results:
+☐ Effective - problem has not recurred
+☐ Not Effective - additional action required
+
+Evidence:
+[Reference to data showing effectiveness]
+
+### Section 8: Closure
+Closure Date: _________________________
+Approved By: __________________________
+
+Management Review Submitted: ☐ Yes ☐ No
+Date: ________________________________
+```
+
+---
+
+## Root Cause Analysis
+
+### 5 Whys Technique
+
+**Example: Device Fails Final Test**
+
+```
+Problem: 5% of devices fail functional test at final inspection
+
+Why 1: Component X is out of tolerance
+Why 2: Component X was accepted at incoming inspection
+Why 3: Incoming inspection sampling missed defective lot
+Why 4: Sampling plan inadequate for component criticality
+Why 5: Risk classification of component not updated after design change
+
+Root Cause: Risk classification process did not include design change trigger
+```
+
+**5 Whys Template:**
+
+```markdown
+## 5 Whys Analysis
+
+Problem Statement: _________________________________
+
+Why 1: _____________________________________________
+Evidence: __________________________________________
+
+Why 2: _____________________________________________
+Evidence: __________________________________________
+
+Why 3: _____________________________________________
+Evidence: __________________________________________
+
+Why 4: _____________________________________________
+Evidence: __________________________________________
+
+Why 5: _____________________________________________
+Evidence: __________________________________________
+
+Root Cause: ________________________________________
+
+Verification: How do we know this is the root cause?
+________________________________________________
+```
+
+### Fishbone (Ishikawa) Diagram
+
+**Categories for Medical Device Manufacturing:**
+
+```
+                    ┌─────────────────────────────────────────┐
+                    │              PROBLEM                     │
+                    └─────────────────────────────────────────┘
+                                       ▲
+           ┌───────────────────────────┼───────────────────────────┐
+           │                           │                           │
+    ┌──────┴──────┐             ┌──────┴──────┐             ┌──────┴──────┐
+    │  PERSONNEL  │             │   METHODS   │             │  MATERIALS  │
+    │             │             │             │             │             │
+    │ • Training  │             │ • SOP gaps  │             │ • Supplier  │
+    │ • Skills    │             │ • Process   │             │ • Specs     │
+    │ • Attention │             │ • Sequence  │             │ • Storage   │
+    └─────────────┘             └─────────────┘             └─────────────┘
+           │                           │                           │
+           └───────────────────────────┼───────────────────────────┘
+                                       │
+    ┌──────────────┐            ┌──────┴──────┐            ┌──────────────┐
+    │  MEASUREMENT │            │  EQUIPMENT  │            │ ENVIRONMENT  │
+    │              │            │             │            │              │
+    │ • Calibration│            │ • Maintenance│           │ • Temperature│
+    │ • Method     │            │ • Capability │           │ • Humidity   │
+    │ • Accuracy   │            │ • Tooling   │            │ • Cleanliness│
+    └──────────────┘            └─────────────┘            └──────────────┘
+```
+
+### Fault Tree Analysis
+
+**For Complex Failures:**
+
+```
+                    Top Event: Device Failure
+                              │
+              ┌───────────────┼───────────────┐
+              │               │               │
+           AND/OR          AND/OR          AND/OR
+              │               │               │
+        ┌─────┴─────┐   ┌─────┴─────┐   ┌─────┴─────┐
+        │ Component │   │  Software │   │   User    │
+        │  Failure  │   │  Failure  │   │   Error   │
+        └─────┬─────┘   └─────┬─────┘   └─────┬─────┘
+              │               │               │
+         Basic Events    Basic Events    Basic Events
+```
+
+### Root Cause Categories
+
+| Category | Examples | Evidence Sources |
+|----------|----------|------------------|
+| Design | Specification error, tolerance stack-up | DHF, design review records |
+| Process | Procedure inadequate, sequence error | Process validation, work instructions |
+| Personnel | Training gap, human error | Training records, interviews |
+| Equipment | Calibration drift, maintenance | Calibration records, logs |
+| Material | Supplier quality, storage | Incoming inspection, COCs |
+| Environment | Temperature, contamination | Environmental monitoring |
+| Management | Resource allocation, priorities | Management review records |
+
+---
+
+## Action Implementation
+
+### Corrective Action Requirements
+
+**Effective Corrective Actions:**
+1. Address identified root cause
+2. Are specific and measurable
+3. Have assigned ownership
+4. Have realistic target dates
+5. Consider impact on other processes
+6. Include verification method
+
+**Action Types:**
+
+| Type | Description | Example |
+|------|-------------|---------|
+| Process change | Modify procedure or method | Update SOP with additional step |
+| Design change | Modify product design | Add tolerance specification |
+| Training | Improve personnel capability | Conduct retraining |
+| Equipment | Modify or replace equipment | Upgrade inspection equipment |
+| Supplier | Address supplier quality | Audit supplier, add requirements |
+| Documentation | Improve or add documentation | Create work instruction |
+
+### Change Control Integration
+
+```
+CAPA Action Identified
+        │
+        ▼
+Change Request Initiated
+        │
+        ▼
+Impact Assessment
+├── Regulatory impact
+├── Product impact
+├── Process impact
+└── Documentation impact
+        │
+        ▼
+Change Approved
+        │
+        ▼
+Implementation
+├── Document updates
+├── Training
+├── Validation (if required)
+└── Effective date
+        │
+        ▼
+CAPA Verification
+```
+
+### Training Requirements
+
+**When Training is Required:**
+- New or revised procedures
+- New equipment or tools
+- Process changes
+- Findings related to personnel performance
+
+**Training Documentation:**
+
+```markdown
+## CAPA-Related Training Record
+
+CAPA Number: _______________
+Training Subject: ___________
+Training Date: ______________
+Trainer: ___________________
+
+Attendees:
+| Name | Signature | Date |
+|------|-----------|------|
+|      |           |      |
+
+Training Content:
+- [ ] Root cause explanation
+- [ ] Process/procedure changes
+- [ ] New requirements
+- [ ] Competency verification
+
+Competency Verified By: _______________
+Date: _______________
+```
+
+---
+
+## Effectiveness Verification
+
+### Verification vs. Validation
+
+| Verification | Validation |
+|--------------|------------|
+| Actions implemented correctly | Actions achieved intended results |
+| Short-term check | Long-term monitoring |
+| Process-focused | Outcome-focused |
+
+### Effectiveness Criteria
+
+**SMART Criteria:**
+- **S**pecific: Clearly defined outcome
+- **M**easurable: Quantifiable metrics
+- **A**chievable: Realistic expectations
+- **R**elevant: Related to root cause
+- **T**ime-bound: Defined monitoring period
+
+**Examples:**
+
+| Problem | Root Cause | Action | Effectiveness Criteria |
+|---------|------------|--------|----------------------|
+| 5% test failures | Inadequate sampling | Increase sampling | <1% failure rate for 3 months |
+| Customer complaints | Unclear instructions | Revise IFU | Zero complaints on topic for 6 months |
+| NCRs from supplier | No incoming inspection | Add inspection | Zero supplier NCRs for 90 days |
+
+### Effectiveness Review Template
+
+```markdown
+## CAPA Effectiveness Review
+
+CAPA Number: _______________
+Review Date: _______________
+Reviewer: __________________
+
+### Review Criteria
+Original Problem: _________________
+Effectiveness Metric: ______________
+Success Threshold: ________________
+Review Period: ____________________
+
+### Data Analysis
+| Period | Metric Value | Threshold | Pass/Fail |
+|--------|--------------|-----------|-----------|
+| Month 1 |             |           |           |
+| Month 2 |             |           |           |
+| Month 3 |             |           |           |
+
+### Conclusion
+☐ Effective - Criteria met, CAPA may be closed
+☐ Partially Effective - Additional monitoring required
+☐ Not Effective - Additional actions required
+
+### Evidence
+[Reference to supporting data: complaint logs, NCR reports, audit results, etc.]
+
+### Next Steps (if not effective)
+___________________________________
+___________________________________
+
+### Approval
+Reviewer Signature: _______________ Date: _______
+Quality Approval: _________________ Date: _______
+```
+
+### Monitoring Period Guidelines
+
+| CAPA Type | Minimum Monitoring |
+|-----------|-------------------|
+| Product quality | 3 production lots or 90 days |
+| Process | 3 months of production |
+| Complaints | 6 months |
+| Audit findings | Until next audit |
+| Supplier | 3 lots or 90 days |
+
+---
+
+## Documentation Requirements
+
+### CAPA File Contents
+
+```
+CAPA File Structure:
+├── CAPA Form (all sections completed)
+├── Investigation Records
+│   ├── Data collected
+│   ├── Root cause analysis worksheets
+│   └── Impact assessment
+├── Action Documentation
+│   ├── Action plans
+│   ├── Change requests (if applicable)
+│   └── Training records
+├── Verification Evidence
+│   ├── Implementation verification
+│   ├── Effectiveness data
+│   └── Trend analysis
+└── Closure Documentation
+    ├── Closure approval
+    └── Management review submission
+```
+
+### Record Retention
+
+Per 21 CFR 820.180:
+- Records shall be retained for the design and expected life of the device
+- Minimum of 2 years from date of release for commercial distribution
+
+**CAPA Record Retention:**
+- Retain for lifetime of product + 2 years
+- Include all supporting documentation
+- Maintain audit trail for changes
+
+### Traceability
+
+**Required Traceability:**
+- CAPA to source (complaint, NCR, audit finding)
+- CAPA to affected products/lots
+- CAPA to corrective actions taken
+- CAPA to verification evidence
+- CAPA to management review
+
+---
+
+## FDA Inspection Focus Areas
+
+### Common 483 Observations
+
+| Observation | Prevention |
+|-------------|------------|
+| CAPA not initiated when required | Define clear CAPA triggers |
+| Root cause analysis inadequate | Use structured RCA methods |
+| Actions don't address root cause | Verify action-cause linkage |
+| Effectiveness not verified | Define measurable criteria |
+| CAPA not timely | Set and track target dates |
+| Trend analysis not performed | Implement monthly trending |
+| Management review missing CAPA input | Include in management review agenda |
+
+### Inspection Preparation
+
+**CAPA Readiness Checklist:**
+
+```markdown
+## FDA Inspection CAPA Preparation
+
+### Documentation Review
+- [ ] All CAPAs have complete documentation
+- [ ] No overdue CAPAs
+- [ ] Root cause documented with evidence
+- [ ] Effectiveness verified and documented
+- [ ] All open CAPAs have current status
+
+### Metrics Available
+- [ ] CAPA by source
+- [ ] CAPA cycle time
+- [ ] Overdue CAPA trend
+- [ ] Effectiveness rate
+- [ ] Recurring issues
+
+### Process Evidence
+- [ ] CAPA procedure current
+- [ ] Training records complete
+- [ ] Trend analysis documented
+- [ ] Management review records show CAPA input
+
+### Common Questions Prepared
+- How do you initiate a CAPA?
+- How do you determine root cause?
+- How do you verify effectiveness?
+- Show me your overdue CAPAs
+- Show me CAPAs from complaints
+```
+
+### CAPA Metrics Dashboard
+
+| Metric | Target | Calculation |
+|--------|--------|-------------|
+| On-time initiation | 100% | CAPAs initiated within 30 days |
+| On-time closure | >90% | CAPAs closed by target date |
+| Effectiveness rate | >85% | Effective at first review / Total |
+| Average cycle time | <90 days | Average days to closure |
+| Overdue CAPAs | 0 | CAPAs past target date |
+| Recurring issues | <5% | Repeat CAPAs / Total |
+
+---
+
+## Quick Reference
+
+### CAPA Decision Tree
+
+```
+Quality Issue Identified
+        │
+        ▼
+Is it an isolated incident?
+├── YES → Correction only (document, may not need CAPA)
+│         Evaluate for trend
+│
+└── NO → Is it a systemic issue?
+         ├── YES → Initiate CAPA
+         │         Determine if Corrective or Preventive
+         │
+         └── MAYBE → Investigate further
+                     Monitor for recurrence
+                     May escalate to CAPA
+```
+
+### Root Cause vs. Symptom
+
+| Symptom (NOT root cause) | Root Cause (Address this) |
+|--------------------------|---------------------------|
+| "Operator made error" | Training inadequate for task |
+| "Component was defective" | Incoming inspection ineffective |
+| "SOP not followed" | SOP unclear or impractical |
+| "Equipment malfunctioned" | Maintenance schedule inadequate |
+| "Supplier shipped wrong part" | Purchasing requirements unclear |
+
+### Action Effectiveness Verification
+
+| Action Type | Verification Method | Timeframe |
+|-------------|---------------------|-----------|
+| Procedure change | Audit for compliance | 30-60 days |
+| Training | Competency assessment | Immediate |
+| Design change | Product testing | Per protocol |
+| Supplier action | Incoming inspection data | 3 lots |
+| Equipment | Calibration/performance | Per schedule |
+
+### Integration with Other Systems
+
+| System | CAPA Integration Point |
+|--------|------------------------|
+| Complaints | Trigger for CAPA, complaint closure after CAPA |
+| NCR | Trend to CAPA, NCR references CAPA |
+| Audit | Findings generate CAPA, CAPA closure audit |
+| Design Control | Design change via CAPA, DHF update |
+| Supplier | Supplier CAPA, supplier audit findings |
+| Risk Management | Risk file update post-CAPA |