Line Clearance Procedure

Prevent medical device production and labeling mix-ups before a new work order starts. This editable Line Clearance Procedure and related forms guide checks of the manufacturing, labeling and packaging areas, removal of materials from the prior order, and documented clearance in the device history record.

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Supplied as one editable Microsoft Word document, with its forms included as attachments, in a digital download.

Manufacturing and labeling line-clearance checks

The Line Clearance Procedure assigns tasks and responsibilities for required line clearance activity for production lines. The Line Clearance Procedure includes unique requirements for each production area and includes line clearance forms that are made part of the Device History Records (DHR).

Before a production run, the procedure calls for clearing materials and documentation from the preceding order and confirming that only the new order is present at the workstation or kit racks. Personnel check the work area, equipment, labels and required records before starting. A recorded clearance helps prevent a mix-up between lots or product codes and shows that the line was ready for the next operation.

Related production documentation

For compiling the manufacturing and release records after production, see the Device History Record Procedure.

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.