Going Beyond UDI Compliance: How LiNA Medical drove process improvement as part of its UDI compliance initiative

Challenges

High cost of label errors and non-compliance

LiNA Medical had a manual labeling process that required its print operators to have a lot of knowledge. While label templates with fixed product data were maintained in the company’s homegrown labeling system, UDI production identifier (PI) data like batch number, production date and expiration date were manually entered by print operators who referenced work orders for each production line. Misspelling and other data entry errors caused problems in the production process so each batch of printed labels had to be carefully checked requiring additional quality control tasks. If errors were found, labels were discarded and products had to be reworked and relabeled. The extra quality control and manual label verification added significant labor cost and was time consuming.

Each of LiNA Medical’s various levels of product packaging needed to be appropriately labeled. The labeling and ERP systems weren’t integrated, and LiNA Medical needed to modernize its labeling process and connect master data (production information) with labeling to avoid the huge potential cost of a product recall caused by mislabeling.

Delays in production time

When entering production data, operators could change labels by accident, editing the wrong field or the wrong file. Re-working and relabeling would cause a significant order fulfillment delay because mislabeled products had to be quarantined before being relabeled. Fortunately, LiNA Medical did not have any product recalls due to the extra quality controls that they had in place, however they were conscious of the risk and the potential cost.

Print operators had to find the right template for each product and with almost 3,000 label variations across their product line, operators had to spend time carefully selecting the correct template. LiNA Medical needed a way to integrate label printing with work orders.

Cumbersome label change and approval process

LiNA Medical manually maintained two identical paper-based catalogs of label templates: one for the quality department, and the other for production. When label changes were made, the template was printed, verified, manually approved via a paper-based signature and then stored in the label catalogs. While LiNA Medical could see where changes were made and who made them, it was a very time consuming and cumbersome process. Print history was manually tracked. While label designers and approvers had unique domain logins, print operators shared a single active directory login, making the process of tracking who printed what for compliance quite difficult.