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 customer feedback.
4.3.3 Document investigation findings and conclusions.

4.4 Corrective and Preventive Actions (CAPA):

4.4.1 Develop and implement CAPA plans to address identified root causes.
4.4.2 Monitor the effectiveness of CAPA plans.
4.4.3 Update complaint records with details of implemented CAPA.

4.5 Reporting and Closure:

4.5.1 Prepare a complaint investigation report summarizing findings, actions taken, and conclusions.
4.5.2 Close the complaint record once investigation and corrective actions are complete.
4.5.3 Archive complaint records according to established document retention policies.

5) Abbreviations, if any

QA – Quality Assurance
CAPA – Corrective and Preventive Actions

6) Documents, if any

1. Complaint Log
2. Complaint Investigation Report
3. CAPA Plans and Records
4. Regulatory Reporting Forms (if applicable)

7) Reference, if any

1. FDA Guidance on Handling Customer Complaints
2. ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes

8) SOP Version

Version 1.0