also ensures compliance with GMP guidelines throughout the process.

Regulatory Affairs Team: Responsible for ensuring that the root cause analysis and corrective actions comply with regulatory requirements and communicating with regulatory bodies if necessary.

4. Accountability

The QA Manager is accountable for overseeing the Root Cause Analysis process, ensuring proper investigation, and implementation of corrective actions. The Production Manager is responsible for providing support during the investigation and ensuring that corrective actions are implemented. The QC Manager is responsible for assisting in identifying product failures and supporting the investigation.

5. Procedure

5.1 Identification of Product Failure

1. Product failures may be identified through various sources, such as:
   • QC testing (e.g., product not meeting specifications)
   • Customer complaints
   • Deviations from product specifications during production
   • Internal audits or inspections
2. Once a failure is identified, the production team must notify the QA team immediately, documenting the failure in the Non-Conformance Report (Annexure-1).
3. The QA team will review the initial data and determine if a Root Cause Analysis is needed.

5.2 Root Cause Investigation

1. The QA team leads the root cause investigation. The investigation should be comprehensive, examining all possible factors that could have contributed to the failure, including:
   • Raw materials
   • Equipment malfunction
   • Process deviations
   • Human error or lack of training
   • Environmental factors
2. The team will collect all relevant data, including production records, equipment logs, test results, and staff training records.
3. All team members will collaborate to identify the most likely root causes and rule out other possible factors.
4. The investigation should use tools like the 5 Whys technique, Fishbone diagram, or Failure Mode and Effect Analysis (FMEA) to systematically identify the root cause.

5.3 Root Cause Identification and Documentation

1. Once the root cause is identified, it should be documented in the Root Cause Analysis Report (Annexure-2), including:
   • A description of the issue
   • Steps taken during the investigation
   • Root cause(s) identified
   • Evidence or data supporting the root cause
2. All findings must be verified by the QA team and signed off by the Production Manager and QC Manager to confirm accuracy and completeness.

5.4 Corrective and Preventive Action Plan (CAPA)

1. Based on the findings of the root cause analysis, the team will develop a Corrective and Preventive Action (CAPA) plan. The CAPA plan must address:
   • The corrective actions needed to resolve the issue immediately
   • The preventive actions to ensure the issue does not recur in the future
   • A timeline for implementing the corrective and preventive actions
   • The person responsible for each action
2. The CAPA plan should be documented and reviewed by the QA Manager before being finalized.
3. The corrective actions should be implemented as soon as possible, and preventive actions should be scheduled for long-term implementation.

5.5 Monitoring and Verification of Corrective Actions

1. After the CAPA plan is implemented, the QA team will monitor the effectiveness of the corrective and preventive actions.
2. Follow-up audits or inspections should be scheduled to verify that the actions taken have effectively addressed the root cause and prevented recurrence of the failure.
3. If the corrective actions do not prove effective, the root cause analysis process should be revisited to identify additional or alternate actions.

5.6 Documentation and Record-Keeping

1. All documentation related to the root cause analysis, including the investigation report, CAPA plan, and follow-up verification records, must be retained according to GMP guidelines.
2. Records should be stored in a secure, controlled document management system to ensure that they are accessible for future reference or audits.
3. All records must be retained for at least two years or as specified by regulatory agencies.

6. Abbreviations

• GMP: Good Manufacturing Practices
• QA: Quality Assurance
• QC: Quality Control
• SOP: Standard Operating Procedure
• CAPA: Corrective and Preventive Action

7. Documents

1. Annexure-1: Non-Conformance Report
2. Annexure-2: Root Cause Analysis Report
3. Annexure-3: CAPA Plan

8. References

• Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
• International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• FDA Guidance for Industry: Root Cause Analysis and CAPA

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Non-Conformance Report

Issue Description	Product Affected	Batch Number	Detected By	Date Detected
Viscosity Out of Specification	Vanilla Cream	Batch 12345	QC Inspector	21/01/2026

Annexure-2: Root Cause Analysis Report

Root Cause	Contributing Factors	Corrective Actions	Preventive Actions
Incorrect mixing time	Equipment malfunction, Operator error	Repair equipment, retrain operators	Implement double-check system for mixing time

Annexure-3: CAPA Plan

Corrective Action	Preventive Action	Responsible Person	Implementation Date
Fix mixing time settings on equipment	Train operators on mixing procedures	Production Manager	28/01/2026

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/03/2024	1.0	Initial Version	New SOP Creation	QA Head
01/03/2025	2.0	Format Revision and Updates	Standardization of Document	QA Head