What is a Returned Goods Authorization (RGA) Form?
A returned goods authorization (RGA) form is a document used to manage the return of products that may be defective, damaged, or no longer needed. This form ensures that returned products are processed efficiently and in compliance with regulatory requirements. The RGA form helps manufacturers track and analyze trends, identify potential quality issues and implement corrective actions. The RGA process may overlap with corrective action/ preventive action (CAPA) and complaint processes.
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Tips on Returned Goods Authorizations:
Completing an RGA for a medical device is critical to address quality concerns and to ensure customer satisfaction. Here are three tips to keep in mind:
- Clearly state the reason for return, thoroughly document the return condition and conduct a rigorous assessment of the product.
- Determine if the return warrants a complaint. Products returned for planned service or upgrades typically do not warrant a complaint.
- Document any repairs or upgrades, detailing procedures and methods and citing any relevant procedures and/ or work instructions. Provide objective evidence that repairs have been completed and file with the RGA within the device history record.
GOT QUESTIONS?
FAQ About Returned Goods Authorizations
Here are some answers to frequently asked questions about Returned Goods Authorizations.
Why is an RGA important in the medical device industry?
What information is required to initiate an RGA?
How does the RGA process benefit customers?
What are common challenges in managing RGAs?
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