# 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]