Standard Operating Procedure for Handling of Returned Goods

1) Purpose

The purpose of this SOP is to establish procedures for the receipt, evaluation, handling, and disposition of returned goods to ensure compliance with regulatory requirements and customer satisfaction.

2) Scope

This SOP applies to all returned goods received by the manufacturing facility, including 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 returned goods from customers.

3.2 Quality Assurance (QA) Personnel:

Responsible for evaluating returned goods to determine the reason for return and initiating appropriate actions.

3.3 Production Supervisor:

Responsible for coordinating actions related to returned goods within the manufacturing department.

4) Procedure

4.1 Receipt of Returned Goods:

4.1.1 Receive returned goods from customers via designated channels.
4.1.2 Document details of returned goods in the Returned Goods Log.
4.1.3 Assign a unique return authorization number for tracking purposes.

4.2 Evaluation and Assessment:

4.2.1 Inspect returned goods to determine the reason for return (e.g., quality issue, incorrect product, damaged during transit).
4.2.2 Record findings of the evaluation and assessment.
4.2.3 Categorize returned goods based on condition and disposition requirements.

4.3 Disposition of Returned Goods:

4.3.1 Determine appropriate disposition of returned goods (e.g., rework, repair, quarantine, disposal).
4.3.2 Initiate necessary actions to implement the chosen disposition.
4.3.3 Document disposition decisions and actions taken.

4.4 Communication and Reporting:

4.4.1 Communicate disposition decisions to relevant departments (e.g., Quality Assurance, Production).
4.4.2 Prepare a summary report of returned goods, including reasons for return and actions taken.
4.4.3 Archive returned goods records according to established document retention policies.

5) Abbreviations, if any

QA – Quality Assurance

6) Documents, if any

1. Returned Goods Log
2. Evaluation and Assessment Records
3. Disposition Documentation
4. Summary Report of Returned Goods

7) Reference, if any

1. FDA Guidance on Handling Returned Goods
2. ISO 9001 Quality management systems — Requirements

8) SOP Version

Version 1.0