Team: Oversees the complaint handling process to ensure that it complies with regulatory requirements and company policies. QA ensures that corrective actions are implemented and documented.

Regulatory Affairs Team: Ensures that the complaint handling process complies with applicable regulatory requirements and that necessary reports are submitted to regulatory authorities, if needed.

4. Accountability

The Manufacturing Manager is accountable for ensuring that complaints are handled promptly and in accordance with this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Receiving and Logging Complaints

1. Complaints may be received via multiple channels, including phone calls, emails, online forms, or directly from customers. The Customer Service Team is responsible for logging the complaint in the Complaint Log (Annexure-1) and acknowledging receipt to the customer.
2. The Complaint Log should include the following details:
   • Customer contact information
   • Product details (e.g., product name, batch number, expiry date)
   • Description of the complaint (e.g., product defect, safety issue, performance problem)
   • Details of the customer’s experience (e.g., when and how the issue was noticed)
   • Any immediate actions taken (e.g., return or replacement of product)
3. Once logged, the complaint should be forwarded to the QC team for further investigation.

5.2. Investigating the Complaint

1. The QC team will review the complaint details and determine the appropriate course of action. This may involve:
   • Reviewing the batch records associated with the product to identify any anomalies in the manufacturing process.
   • Testing samples from the affected batch to assess whether the complaint is related to product quality or performance.
   • Inspecting raw materials used in the batch to determine if the issue could be related to materials.
2. If the complaint is related to a specific defect, QC will perform additional tests on similar products, if necessary, to check for consistency in the issue.
3. If the issue is safety-related, the investigation will be escalated immediately, and the necessary regulatory authorities will be notified, if required.

5.3. Root Cause Analysis and Corrective Actions

1. If the complaint is found to be valid, the QC team will conduct a root cause analysis to identify the underlying cause of the issue. This could involve reviewing:
   • Manufacturing process steps
   • Equipment calibration and maintenance records
   • Raw material specifications
   • Operator training and procedures
2. Once the root cause is identified, corrective actions must be implemented. Corrective actions may include:
   • Improving manufacturing processes or procedures
   • Repairing or calibrating equipment
   • Retraining personnel on proper procedures
   • Modifying raw material specifications or sources
3. The Corrective Action Log (Annexure-2) must be used to document all corrective actions, including the person responsible, implementation date, and status of the action.

5.4. Customer Communication

1. Once the investigation is complete and corrective actions have been taken, the Customer Service Team should inform the customer of the findings and any actions taken to resolve the issue.
2. If the complaint involves a product defect, the company may offer the customer a replacement, refund, or another form of compensation as per company policy.
3. Keep the customer informed of the progress throughout the investigation process, especially if the issue requires additional time to resolve.

5.5. Documentation and Record-Keeping

1. All complaint documentation, including the Complaint Log (Annexure-1), investigation reports, corrective actions, and customer communication, must be stored securely in the document management system.
2. Ensure that all records are accessible for future reference, including internal reviews and external audits by regulatory authorities.
3. Complaint records must be retained for a minimum of 3 years or as required by regulatory guidelines.

5.6. Follow-Up and Preventive Measures

1. After the corrective actions have been implemented, the QA team will follow up to verify that the actions have resolved the issue and prevent its recurrence.
2. Preventive actions should be taken if necessary, such as:
   • Modifying quality control procedures to detect similar issues in the future.
   • Enhancing training programs for employees involved in manufacturing, quality control, or customer service.
   • Updating product specifications or raw material quality requirements to avoid potential issues.
3. Preventive actions and their outcomes should be documented in the Preventive Action Log (Annexure-3).

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• PPE: Personal Protective Equipment
• SOP: Standard Operating Procedure
• QA: Quality Assurance

7. Documents

1. Complaint Log (Annexure-1)
2. Corrective Action Log (Annexure-2)
3. Preventive Action Log (Annexure-3)
4. Customer Communication Log (Annexure-4)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• ISO 9001:2015 – Quality Management Systems

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Complaint Log

Complaint ID	Customer Name	Product Name	Complaint Description	Action Taken	Resolution Date
COM-001	John Doe	Aerosol Can	Underfill detected	Replaced product	10/02/2025

Annexure-2: Corrective Action Log

Complaint ID	Corrective Action	Implementation Date	Responsible Person	Outcome
COM-001	Re-calibrated filling machine	12/02/2025	Rajesh Patel	Resolved

Annexure-3: Preventive Action Log

Complaint ID	Preventive Action	Implementation Date	Responsible Person	Outcome
COM-001	Improved calibration checks	14/02/2025	Rajesh Patel	Implemented successfully

Annexure-4: Customer Communication Log

Complaint ID	Communication Date	Action Taken	Customer Feedback
COM-001	09/02/2025	Notified customer of product replacement	Customer satisfied with the solution

12. Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	V 1.0	Initial Release	First Issue	Anjali Sharma	Page 1	[Ref Point]	First Release
01/01/2025	V 2.0	Updated complaint handling process	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures