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]

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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]

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TABLE OF CONTENTS

1. Purpose
2. Scope
3. Definitions
4. Responsibilities
5. Procedure
   • 5.1 Corrective Action Process
   • 5.2 Preventive Action Process
   • 5.3 CAPA Prioritization
   • 5.4 Investigation and Root Cause Analysis
   • 5.5 Action Planning and Implementation
   • 5.6 Effectiveness Review
   • 5.7 CAPA Closure
6. Records
7. References
8. Attachments

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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).

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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]

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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)

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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

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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

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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

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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

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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

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END OF PROCEDURE

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Document Number: SOP-8.5-001 Revision: 00 Page: [X] of [X]