Comprehensive Guide to Documentation of CAPA in Quality Assurance

1) Purpose

The purpose of this SOP is to establish a standardized process for documenting Corrective and Preventive Actions (CAPA) in quality assurance. Proper documentation ensures traceability, regulatory compliance, and continuous improvement in manufacturing processes and quality systems.

2) Scope

This SOP applies to all CAPA activities, including the identification, investigation, implementation, and monitoring of corrective and preventive actions. It is relevant to quality assurance personnel, regulatory affairs, and all departments involved in addressing non-conformities or potential risks.

3) Responsibilities

– Quality Assurance (QA): Oversees the CAPA process, ensures accurate documentation, and approves CAPA records.
– CAPA Coordinator: Manages the CAPA documentation system, tracks progress, and ensures timely resolution.
– Department Heads: Provide input for CAPA investigation and implementation within their areas of responsibility.
– Regulatory Affairs: Verifies that CAPA documentation complies with applicable regulations and standards.

4) Procedure

4.1 Identification and Initiation of CAPA
4.1.1 Trigger Events
– Identify CAPA triggers, including:
– Non-conformities detected during audits or inspections.
– Customer complaints or product recalls.
– Deviations in manufacturing processes.
– Data trends indicating potential risks.

4.1.2 CAPA Request Form
– Initiate CAPA by completing a CAPA Request Form (CRF) that includes:
– Description of the issue or potential risk.
– Reference documents, such as audit reports or complaint logs.
– Date of initiation and responsible personnel.

4.1.3 QA Review
– QA reviews the CRF to verify the need for CAPA and assigns a unique CAPA identification number.
– Approve or reject the initiation of CAPA based on the assessment.

4.2 Investigation and Root Cause Analysis
4.2.1 Data Collection
– Gather relevant data and supporting documents, including process records, equipment logs, and inspection reports.
– Include photographic evidence or diagrams, if applicable.

4.2.2 Root Cause Analysis
– Conduct a thorough root cause analysis using tools such as the Fishbone Diagram, 5 Whys, or Fault Tree Analysis.
– Document findings in the CAPA Investigation Report, specifying the identified root cause(s) and contributing factors.

4.2.3 Impact Assessment
– Assess the impact of the identified issue on product quality, safety, and regulatory compliance.
– Include an analysis of affected batches, processes, or customers.

4.3 Development of Corrective and Preventive Actions
4.3.1 Corrective Actions
– Define immediate actions to address the root cause of the issue, such as:
– Adjusting process parameters.
– Repairing or replacing defective equipment.
– Retraining employees.

4.3.2 Preventive Actions
– Develop long-term measures to prevent recurrence, including:
– Revising SOPs or work instructions.
– Implementing additional quality checks.
– Updating risk management plans.

4.3.3 Documentation
– Record all proposed actions in the CAPA Action Plan, specifying:
– Action description.
– Responsible personnel.
– Target completion dates.

4.4 Implementation and Monitoring
4.4.1 Execution of Actions
– Execute corrective and preventive actions as per the approved CAPA Action Plan.
– Ensure proper coordination among departments for timely implementation.

4.4.2 Progress Tracking
– Update the CAPA Tracker with the status of each action (e.g., In Progress, Completed).
– Document any delays or changes in the action plan, including justifications.

4.4.3 Effectiveness Verification
– Verify the effectiveness of implemented actions by:
– Conducting follow-up inspections or audits.
– Monitoring process performance and quality metrics.
– Reviewing customer feedback or complaints.

4.4.4 Documentation
– Record verification results in the CAPA Effectiveness Review Report, including supporting evidence.

4.5 Closure of CAPA
4.5.1 QA Approval
– QA reviews all documentation, including the CAPA Investigation Report, Action Plan, and Effectiveness Review Report.
– Approve CAPA closure only after confirming that all actions have been completed and verified.

4.5.2 Record Retention
– Archive CAPA records, including all related documents, in the CAPA database or document management system.
– Retain records for a minimum of five years or as required by regulatory agencies.

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4.6 Audits and Continuous Improvement
4.6.1 Internal Audits
– Conduct regular audits of CAPA documentation to ensure compliance with this SOP and regulatory requirements.
– Address any identified deficiencies through corrective actions.

4.6.2 Trend Analysis
– Perform periodic trend analysis of CAPA data to identify recurring issues or improvement opportunities.
– Use findings to refine processes and enhance quality systems.

5) Abbreviations

– CAPA: Corrective and Preventive Actions
– QA: Quality Assurance
– CRF: CAPA Request Form
– SOP: Standard Operating Procedure

6) Documents

– CAPA Request Form (CRF)
– CAPA Investigation Report
– CAPA Action Plan
– CAPA Tracker
– CAPA Effectiveness Review Report

7) Reference

– ISO 13485: Medical devices – Quality management systems
– FDA CFR Title 21, Part 820.100: Corrective and Preventive Action
– ISO 14971: Application of Risk Management to Medical Devices

8) SOP Version

– Version: 1.0
– Effective Date: DD/MM/YYYY
– Approved by: [Name/Title]

Annexure

Annexure 1: CAPA Request Form Template

Date	CAPA ID	Description of Issue	Root Cause	Proposed Actions	Responsible Person
DD/MM/YYYY	CAPA-001	Issue Description	Root Cause Details	Corrective/Preventive Actions	Responsible Name

Annexure 2: CAPA Tracker Template

CAPA ID	Action Description	Status	Start Date	Target Completion Date	Remarks
CAPA-001	Action Details	In Progress/Completed	DD/MM/YYYY	DD/MM/YYYY	Additional Notes