Standard Operating Procedure for Handling of Complaints

1) Purpose

The purpose of this SOP is to establish procedures for the receipt, evaluation, investigation, and resolution of product complaints to ensure customer satisfaction and compliance with regulatory requirements.

2) Scope

This SOP applies to all complaints received by the manufacturing facility related to products manufactured or distributed by the company.

3) Responsibilities

The responsibilities for this SOP are divided among various roles:

3.1 Customer Service Representative:

Responsible for receiving and documenting product complaints from customers.

3.2 Quality Assurance (QA) Personnel:

Responsible for evaluating and investigating complaints to determine root causes and implement corrective actions.

3.3 Regulatory Affairs:

Responsible for reporting serious complaints to regulatory authorities as per regulatory requirements.

4) Procedure

4.1 Complaint Receipt and Registration:

4.1.1 Receive complaints via designated channels (phone, email, website, etc.).
4.1.2 Document complaint details in the Complaint Log.
4.1.3 Assign a unique complaint number for tracking purposes.

4.2 Complaint Evaluation:

4.2.1 Evaluate the complaint to determine if it meets the definition of a reportable event.
4.2.2 Verify the identity of the complainant and product details.
4.2.3 Categorize complaints based on severity and potential impact.

4.3 Complaint Investigation:

4.3.1 Initiate an investigation into the root cause of the complaint.
4.3.2 Gather and analyze relevant data, including batch records, testing results, and