@saibolla/ada 0.1.2

package/skills/iso-13485-certification/assets/templates/procedures/CAPA-procedure-template.md

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+# Corrective and Preventive Action (CAPA) Procedure Template
+
+**Document Number:** SOP-8.5-001
+**Title:** Corrective and Preventive Action (CAPA)
+**Revision:** 00
+**Effective Date:** [DATE]
+**Page:** 1 of [X]
+
+---
+
+## DOCUMENT CONTROL
+
+### Approval Signatures
+
+| Role | Name | Signature | Date |
+|------|------|-----------|------|
+| Author | [NAME] | | [DATE] |
+| Reviewer | [NAME] | | [DATE] |
+| Approver (Quality Manager) | [NAME] | | [DATE] |
+
+### Revision History
+
+| Revision | Date | Description of Changes | Approved By |
+|----------|------|------------------------|-------------|
+| 00 | [DATE] | Initial release | [NAME] |
+|  |  |  |  |
+
+---
+
+## TABLE OF CONTENTS
+
+1. [Purpose](#1-purpose)
+2. [Scope](#2-scope)
+3. [Definitions](#3-definitions)
+4. [Responsibilities](#4-responsibilities)
+5. [Procedure](#5-procedure)
+   - 5.1 [Corrective Action Process](#51-corrective-action-process)
+   - 5.2 [Preventive Action Process](#52-preventive-action-process)
+   - 5.3 [CAPA Prioritization](#53-capa-prioritization)
+   - 5.4 [Investigation and Root Cause Analysis](#54-investigation-and-root-cause-analysis)
+   - 5.5 [Action Planning and Implementation](#55-action-planning-and-implementation)
+   - 5.6 [Effectiveness Review](#56-effectiveness-review)
+   - 5.7 [CAPA Closure](#57-capa-closure)
+6. [Records](#6-records)
+7. [References](#7-references)
+8. [Attachments](#8-attachments)
+
+---
+
+## 1. PURPOSE
+
+This procedure establishes requirements for:
+
+- Corrective action to eliminate causes of nonconformities and prevent recurrence
+- Preventive action to eliminate causes of potential nonconformities and prevent occurrence
+- Systematic investigation and analysis of problems and risks
+- Implementation and verification of effective actions
+- Continuous improvement of the Quality Management System
+
+This procedure ensures compliance with ISO 13485:2016 Clauses 8.5.2 (Corrective Action) and 8.5.3 (Preventive Action).
+
+---
+
+## 2. SCOPE
+
+This procedure applies to:
+
+- All nonconformities identified through any means (internal audits, customer complaints, process monitoring, product inspection, etc.)
+- Potential nonconformities identified through risk analysis, trend analysis, and proactive reviews
+- All products, processes, and QMS elements
+- All departments and personnel within [COMPANY NAME]
+
+---
+
+## 3. DEFINITIONS
+
+| Term | Definition |
+|------|------------|
+| **CAPA** | Corrective and Preventive Action |
+| **Corrective Action** | Action to eliminate the cause of a detected nonconformity or other undesirable situation to prevent recurrence |
+| **Preventive Action** | Action to eliminate the cause of a potential nonconformity or other potential undesirable situation to prevent occurrence |
+| **Nonconformity** | Non-fulfillment of a requirement |
+| **Root Cause** | The fundamental reason for the occurrence of a problem |
+| **Root Cause Analysis (RCA)** | Systematic process to identify the root cause of a problem |
+| **Effectiveness Check** | Verification that implemented actions have achieved the intended result |
+| **5 Whys** | Iterative questioning technique used to explore cause-and-effect relationships |
+| **Fishbone Diagram** | Visual tool for categorizing potential causes of a problem (also called Ishikawa diagram) |
+
+---
+
+## 4. RESPONSIBILITIES
+
+### 4.1 Quality Manager
+- Overall responsibility for CAPA system
+- Reviews all CAPAs for adequacy
+- Approves CAPA closures
+- Reports CAPA metrics in management review
+- Ensures resources are available for CAPA activities
+
+### 4.2 CAPA Coordinator
+- Manages CAPA database/system
+- Assigns CAPA numbers
+- Tracks CAPA status and due dates
+- Sends reminders for overdue actions
+- Generates CAPA metrics and reports
+- Maintains CAPA records
+
+### 4.3 CAPA Owner (Assigned Personnel)
+- Leads investigation and root cause analysis
+- Develops action plan
+- Implements corrective/preventive actions
+- Coordinates with affected departments
+- Documents all CAPA activities
+- Performs effectiveness checks
+- Requests CAPA closure when complete
+
+### 4.4 Department Managers
+- Provide resources and support for CAPA activities
+- Participate in investigations within their areas
+- Implement actions within their departments
+- Verify implementation of actions
+
+### 4.5 All Personnel
+- Report nonconformities and improvement opportunities
+- Participate in CAPA investigations as requested
+- Implement actions assigned to them
+- Support CAPA effectiveness
+
+---
+
+## 5. PROCEDURE
+
+### 5.1 Corrective Action Process
+
+Corrective actions are initiated in response to identified nonconformities from sources including:
+
+**Sources of Nonconformities:**
+- Customer complaints (per SOP-[NUMBER])
+- Internal nonconforming product (per SOP-[NUMBER])
+- Internal audit findings (per SOP-[NUMBER])
+- Process monitoring out-of-specification results
+- Product inspection failures
+- Supplier nonconformances
+- Regulatory inspections or observations
+- Management review action items
+- Risk management outputs
+- Returned or rejected product
+
+**5.1.1 CAPA Initiation**
+
+1. When a nonconformity is identified, the individual discovering it:
+   - Completes a CAPA Request Form (Attachment A) or enters information into CAPA system
+   - Describes the nonconformity clearly and completely
+   - Attaches supporting documentation (NCRs, complaints, audit findings, etc.)
+   - Submits to Quality department
+
+2. CAPA Coordinator:
+   - Receives CAPA request
+   - Assigns unique CAPA number: CAPA-[YEAR]-[###]
+   - Logs CAPA in tracking system
+   - Routes to Quality Manager for review
+
+3. Quality Manager:
+   - Reviews CAPA request for completeness and clarity
+   - Determines if corrective action is warranted
+   - Assigns priority (see Section 5.3)
+   - Assigns CAPA Owner
+   - Sets due date based on priority
+   - Approves initiation of CAPA investigation
+
+### 5.2 Preventive Action Process
+
+Preventive actions are initiated proactively to address potential problems before they occur.
+
+**Sources of Preventive Action:**
+- Trend analysis of complaints, NCRs, or other data
+- Risk management activities (per SOP-[NUMBER])
+- Process capability studies
+- Near-miss events
+- Lessons learned from other organizations or devices
+- Changes in regulations or standards
+- Proactive process improvements
+- Management review outputs
+- Employee suggestions
+
+**5.2.1 Preventive Action Initiation**
+
+Process is similar to corrective action (Section 5.1.1), but:
+- Describes potential nonconformity and its possible consequences
+- Includes data or rationale supporting the need for preventive action
+- May have different prioritization based on risk of occurrence
+
+### 5.3 CAPA Prioritization
+
+All CAPAs are prioritized based on:
+- Severity of impact (safety, regulatory, customer impact)
+- Frequency or likelihood of occurrence
+- Detectability before reaching customer
+
+**Priority Levels:**
+
+| Priority | Criteria | Due Date for Completion |
+|----------|----------|-------------------------|
+| **Critical** | Safety issue, regulatory requirement, major customer impact, Class I recall potential | [X] days |
+| **High** | Significant quality impact, repeat issue, moderate customer impact, regulatory reporting | [X] days |
+| **Medium** | Moderate impact, isolated occurrence, minor customer impact | [X] days |
+| **Low** | Minor impact, isolated occurrence, no customer impact, improvement opportunity | [X] days |
+
+Priority is determined by Quality Manager in consultation with CAPA Owner and affected department managers.
+
+### 5.4 Investigation and Root Cause Analysis
+
+**5.4.1 Investigation Planning**
+
+CAPA Owner develops investigation plan including:
+- Scope of investigation
+- Team members needed (if applicable)
+- Data to be collected
+- Analysis methods to be used
+- Timeline
+
+**5.4.2 Data Collection**
+
+Collect relevant data:
+- Review related records (batch records, inspection records, training records, etc.)
+- Interview personnel involved
+- Review similar past occurrences
+- Examine physical evidence (product samples, equipment, etc.)
+- Review applicable procedures and work instructions
+- Analyze trend data if available
+
+**5.4.3 Root Cause Analysis**
+
+Use appropriate RCA tools based on complexity:
+
+**For Simple Issues:**
+- 5 Whys technique
+- Cause and effect analysis
+
+**For Complex Issues:**
+- Fishbone (Ishikawa) diagram
+- Fault tree analysis
+- Failure mode and effects analysis (FMEA)
+- Statistical analysis
+
+**RCA Requirements:**
+- Dig beyond superficial causes to find root cause
+- Distinguish between symptoms and causes
+- Consider multiple contributing factors
+- Ask "why" repeatedly until fundamental cause identified
+- Consider human factors, procedural inadequacies, system weaknesses
+- Document analysis process and findings
+
+**5.4.4 Root Cause Documentation**
+
+Document in CAPA record:
+- Summary of investigation findings
+- Root cause(s) identified
+- Supporting data and analysis
+- RCA tool(s) used
+- Team members involved
+- Date investigation completed
+
+Quality Manager reviews and approves root cause determination.
+
+### 5.5 Action Planning and Implementation
+
+**5.5.1 Action Planning**
+
+Based on root cause, CAPA Owner develops action plan:
+
+**Actions must be:**
+- **Effective:** Address root cause, not just symptoms
+- **Achievable:** Realistic with available resources
+- **Measurable:** Include objective success criteria
+- **Timely:** Include target completion dates
+- **Risk-appropriate:** Commensurate with severity and likelihood
+
+**Action Plan includes:**
+- Specific actions to be taken
+- Responsible person for each action
+- Target completion date for each action
+- Resources required
+- Expected outcome/success criteria
+- How effectiveness will be measured
+
+**5.5.2 Types of Actions**
+
+Actions may include:
+- Procedure revisions or clarifications
+- Training or retraining
+- Equipment repair, replacement, or modification
+- Process changes or improvements
+- Design changes (when applicable)
+- Supplier corrective action requests
+- Increased inspection or monitoring
+- Software updates or validation
+- Physical facility changes
+- Organizational changes
+
+**5.5.3 Action Approval**
+
+- CAPA Owner submits action plan to Quality Manager
+- Quality Manager reviews for adequacy and appropriateness
+- Department Managers review actions affecting their areas
+- Quality Manager approves action plan
+- Actions assigned to responsible parties with due dates
+
+**5.5.4 Implementation**
+
+- Responsible parties implement assigned actions
+- Implementation is documented (procedure revisions, training records, etc.)
+- CAPA Owner tracks implementation progress
+- CAPA Coordinator sends reminders for overdue actions
+- Interim updates provided for long-duration CAPAs
+
+**5.5.5 Documentation of Implementation**
+
+For each action, document:
+- Date implemented
+- Evidence of implementation (updated procedures, training records, work orders, etc.)
+- Any deviations from planned actions and justification
+- Responsible person confirmation
+
+### 5.6 Effectiveness Review
+
+**5.6.1 Timing of Effectiveness Check**
+
+Effectiveness is verified after:
+- Sufficient time has passed to observe results
+- Minimum: [X days/weeks] after implementation
+- Extended period for process or trend verification: [X months]
+- Timing based on priority and nature of issue
+
+**5.6.2 Effectiveness Verification Methods**
+
+Methods appropriate to the CAPA may include:
+- Review of process or product data for improved performance
+- Inspection or test results showing improvement
+- Absence of recurrence over defined period
+- Customer feedback or complaint trends
+- Internal audit verification
+- Process capability analysis
+- Statistical analysis of relevant metrics
+- Re-audit of corrective action area
+- Follow-up inspection or testing
+
+**5.6.3 Effectiveness Determination**
+
+CAPA Owner:
+- Collects effectiveness data using planned method
+- Analyzes data to determine if actions achieved intended result
+- Documents findings in CAPA record
+- Recommends effectiveness status:
+  - **Effective:** Actions achieved intended result, no recurrence
+  - **Not Effective:** Actions did not achieve intended result, recurrence observed
+  - **Additional Data Needed:** Insufficient time or data to determine effectiveness
+
+**5.6.4 Ineffective Actions**
+
+If actions determined not effective:
+- CAPA remains open
+- Re-investigation performed
+- Alternative actions developed
+- Cycle repeats until effectiveness achieved
+
+### 5.7 CAPA Closure
+
+**5.7.1 Closure Criteria**
+
+CAPA may be closed when:
+- All planned actions implemented and verified
+- Effectiveness check completed and actions determined effective
+- All documentation complete
+- No recurrence of issue during effectiveness period
+
+**5.7.2 Closure Process**
+
+1. CAPA Owner:
+   - Verifies all closure criteria met
+   - Completes final CAPA summary
+   - Submits closure request to Quality Manager
+
+2. Quality Manager:
+   - Reviews entire CAPA record for completeness
+   - Verifies effectiveness evidence
+   - Approves closure or requests additional information
+   - Signs and dates CAPA closure
+
+3. CAPA Coordinator:
+   - Updates CAPA status to "Closed"
+   - Files CAPA record per retention requirements
+   - Updates metrics and reports
+
+**5.7.3 CAPA Extension**
+
+If additional time needed:
+- CAPA Owner submits extension request with justification
+- Quality Manager reviews and approves/denies extension
+- New due date established
+- Extension documented in CAPA record
+
+---
+
+## 6. RECORDS
+
+Records generated and maintained per this procedure:
+
+| Record | Retention Period | Location | Responsible Party |
+|--------|------------------|----------|-------------------|
+| CAPA Request Forms | [X years or device lifetime] | [LOCATION/SYSTEM] | CAPA Coordinator |
+| CAPA Investigation Records | [X years or device lifetime] | [LOCATION/SYSTEM] | CAPA Coordinator |
+| Root Cause Analysis Documentation | [X years or device lifetime] | [LOCATION/SYSTEM] | CAPA Coordinator |
+| Action Plans | [X years or device lifetime] | [LOCATION/SYSTEM] | CAPA Coordinator |
+| Implementation Evidence | [X years or device lifetime] | [LOCATION/SYSTEM] | CAPA Coordinator |
+| Effectiveness Verification Records | [X years or device lifetime] | [LOCATION/SYSTEM] | CAPA Coordinator |
+| CAPA Closure Approvals | [X years or device lifetime] | [LOCATION/SYSTEM] | CAPA Coordinator |
+| CAPA Metrics and Trend Reports | [X years] | [LOCATION] | Quality Manager |
+
+---
+
+## 7. REFERENCES
+
+- ISO 13485:2016, Clause 8.5.2 - Corrective Action
+- ISO 13485:2016, Clause 8.5.3 - Preventive Action
+- Quality Manual, Section 8.5
+- SOP-[NUMBER] - Control of Nonconforming Product
+- SOP-[NUMBER] - Complaint Handling
+- SOP-[NUMBER] - Internal Audit
+- SOP-[NUMBER] - Risk Management
+- SOP-[NUMBER] - Analysis of Data
+
+---
+
+## 8. ATTACHMENTS
+
+**Attachment A:** CAPA Request Form
+**Attachment B:** Root Cause Analysis Worksheet
+**Attachment C:** CAPA Action Plan Template
+**Attachment D:** Effectiveness Verification Checklist
+**Attachment E:** 5 Whys Worksheet
+**Attachment F:** Fishbone Diagram Template
+**Attachment G:** CAPA Flowchart
+
+---
+
+**END OF PROCEDURE**
+
+---
+
+**Document Number:** SOP-8.5-001
+**Revision:** 00
+**Page:** [X] of [X]