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