Team: Responsible for ensuring that customer complaint handling and resolution comply with relevant regulatory requirements.

Production Team: Responsible for providing any information on manufacturing conditions, processes, and raw materials related to the complaint and assisting in implementing corrective actions.

4. Accountability

The QA Manager is accountable for overseeing the complaint investigation process, ensuring timely resolution and documentation of actions taken. The Production Manager is responsible for providing necessary production-related information, and the Customer Service Manager ensures effective communication with customers.

5. Procedure

5.1 Complaint Receipt and Logging

1. When a customer complaint is received, the Customer Service Team is responsible for logging the complaint into the complaint management system (CMS), including the following details:
   • Customer information (name, contact details)
   • Date of complaint
   • Product name and batch number
   • Nature of the complaint (e.g., packaging, quality, odor, texture, etc.)
   • Details of the complaint (e.g., damaged packaging, foreign object, product malfunction)
2. The complaint must be assigned a unique complaint number for tracking purposes and to ensure that it is handled systematically.
3. The Customer Service Team will acknowledge the complaint to the customer within 48 hours of receipt, confirming that the complaint is being investigated.

5.2 Initial Assessment

1. The QA team, along with the Production Team, will conduct an initial assessment to determine whether the complaint is related to a product defect or an external issue (e.g., damage during shipping or handling).
2. If the complaint is product-related, a thorough investigation will be initiated. If the complaint is external (e.g., shipping damage), the Customer Service Team will work with logistics to resolve the issue and close the complaint.
3. If required, the QA team will communicate with the customer for further details or clarification on the complaint.

5.3 Root Cause Analysis and Investigation

1. If the complaint is determined to be related to a product issue, the QA team will initiate a root cause analysis (RCA) to determine the underlying cause of the problem. The RCA process may include:
   • Reviewing production records (e.g., batch records, raw material logs, and equipment logs)
   • Conducting a detailed investigation into the production process, equipment, and materials used for the batch in question
   • Testing samples from the affected batch and conducting appropriate laboratory tests (e.g., microbiological testing, chemical analysis, sensory evaluation)
   • Investigating any external factors, such as transportation, storage conditions, or packaging
2. The QC team will perform necessary tests on product samples to verify that the product does not meet specifications. If a failure is identified, the relevant test results and findings will be documented in the complaint report.

5.4 Corrective and Preventive Actions (CAPA)

1. Based on the root cause analysis, the QA team will develop a Corrective and Preventive Action (CAPA) plan. The CAPA plan will include:
   • Corrective actions to address the immediate issue (e.g., product recall, batch hold, packaging revision)
   • Preventive actions to ensure that the issue does not recur in future batches (e.g., process modification, additional checks, supplier quality improvements)
   • A timeline for implementation of corrective and preventive actions
   • Identification of the responsible person or department for each action
2. The CAPA plan will be reviewed and approved by the QA Manager before being communicated to the relevant teams for implementation.

5.5 Customer Communication

1. Once the investigation is complete, and corrective actions are identified, the Customer Service Team will inform the customer of the investigation results and any corrective actions taken. This communication should include:
   • Confirmation that the complaint was investigated
   • The root cause of the issue (if identified)
   • Details of corrective and preventive actions taken or planned
   • Any compensation or replacement offered (if applicable)
2. All customer communications should be documented in the complaint management system for future reference and audits.

5.6 Documentation and Record-Keeping

1. All steps of the complaint handling process, including the investigation, CAPA, and customer communication, must be documented in the complaint management system and stored securely.
2. Records should include:
   • Customer complaint details
   • Investigation results and test data
   • Root cause analysis and CAPA plan
   • Customer communication and resolution
3. All records must be retained for a minimum of two years or as required by regulatory guidelines.

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: Customer Complaint Report
2. Annexure-2: Root Cause Analysis Template
3. Annexure-3: CAPA Plan Template

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: Handling Customer Complaints

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Customer Complaint Report

Customer Name	Product Name	Complaint Type	Complaint Description	Date of Complaint
John Doe	Vanilla Cream	Packaging Issue	Damaged packaging on delivery	21/01/2026

Annexure-2: Root Cause Analysis Template

Issue Description	Root Cause	Corrective Action	Preventive Action
Packaging damage during transit	Incorrect sealing method	Revise packaging procedure	Train staff on proper sealing methods

Annexure-3: CAPA Plan Template

Corrective Action	Preventive Action	Responsible Person	Implementation Date
Re-seal all affected batches	Re-train packaging staff	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