Returned Goods Procedure
The Returned Goods Procedure takes a returned device from return-goods authorization through controlled receipt, identification and segregation to a recorded disposition. It covers checks of the product and its lot or serial information, investigation when needed, and decisions such as return to stock or scrap.
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Editable Microsoft Word procedure supplied as a digital download. Adapt responsibilities and workflows to your organization before approval and implementation.
Returned-device receipt, evaluation and disposition
The procedure specifies what happens at the loading dock and at final disposition. A returned package is segregated in a designated quarantine area, checked for possible biohazard, and matched to its authorization for item number, quantity and lot or serial number. A return without an RGA or required information remains in quarantine. Return to stock depends on the original packaging remaining unaltered; scrap or further nonconformance investigation is also documented. The disposition record includes a date and signature, and the RGA records are retained under the records procedure.
Related identification and disposition
The Identification Procedure covers product and status identification across the quality system. When a return does not meet requirements, see the Nonconforming Material Procedure for review and disposition.
Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.
Practical guide
Read Medical Device Production Records, Line Clearance and Shipment for workflow guidance, a checklist and common mistakes.
