Standard Operating Procedure for Management of Returned Goods in Otic Manufacturing Unit
1) Purpose
To establish procedures for the handling, investigation, and disposition of returned goods from customers or distributors to ensure compliance, product safety, and customer satisfaction.
2) Scope
This SOP applies to all returned goods received by the Otic manufacturing unit, including but not limited to defective products, damaged goods, expired products, or any other returns due to quality issues.
3) Responsibilities
Quality Assurance (QA) Department: Responsible for overseeing the returned goods process, investigation, and documentation.
Quality Control (QC) Department: Responsible for conducting investigations into quality-related returns and providing analytical support.
Production Department: Responsible for coordinating with QA and QC departments for investigation and disposition.
Sales and Distribution: Responsible for initiating the return process and providing necessary documentation.
4) Procedure
4.1 Receipt of Returned Goods
4.1.1 Notification
4.1.1.1 Sales or Distribution notifies QA and QC departments upon receipt of returned goods.
4.1.1.2 QA verifies the authenticity of the returned goods and initiates the return process in the documentation system.
4.1.2 Initial Assessment
4.1.2.1 QC inspects returned goods for visible damage or discrepancies.
4.1.2.2 QA records initial observations and assigns a unique identification number to each returned item.
4.2 Investigation and Evaluation
4.2.1 Root Cause Analysis
4.2.1.1 QA initiates a formal investigation into the reason for the return.
4.2.1.2 QC conducts analytical tests, if required, to determine the root cause of quality-related returns.
4.2.2 Documentation
4.2.2.1 Document investigation findings, including photographs, test results, and analysis.
4.2.2.2 QA reviews investigation reports and recommends corrective and preventive actions (CAPAs) if necessary.
4.3 Disposition of Returned Goods
4.3.1 Decision Making
4.3.1.1 QA, in consultation with QC and Production, determines the disposition of returned goods (e.g., reprocessing, destruction, return to stock, or disposal).
4.3.1.2 Obtain necessary approvals from authorized personnel before proceeding with disposition activities.
4.3.2 Documentation and Record Keeping
4.3.2.1 Maintain detailed records of all decisions and actions taken regarding returned goods.
4.3.2.2 Archive records in accordance with document retention policies.
4.4 Communication
4.4.1 Customer Notification
4.4.1.1 QA communicates disposition decisions to the customer or distributor.
4.4.1.2 Provide necessary documentation, such as a return receipt or credit note, as applicable.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
QC: Quality Control
CAPA: Corrective and Preventive Actions
6) Documents, if any
Returned goods log
Investigation reports
Disposition records
7) Reference, if any
GMP guidelines for pharmaceutical manufacturing
Regulatory requirements for product returns and complaints
8) SOP Version
Version 1.0
