Going beyond UDI compliance – implementation of dedicated labeling system at LiNA Medical Polska Sp. z o.o.
Objective of the implementation:
- Meeting the UDI standard within the deadline
- Streamlining the labeling process
- Integration of a new solution with the enterprise’s master system
Benefits of the implementation:
LiNA Medical is a privately held Danish corporation operating in the field of minimally invasive gynecology. Through close interaction with physicians they develop innovative products, specifically designed for gynecology, based on their vision of improving quality of life for women all over the world undergoing treatments for gynecological conditions. The company distributes products globally. LiNA’s supply chain, quality, manufacturing and engineering operations are housed in Poland, while research and development is in Denmark. The company must comply with UDI guidelines when it ships products to the United States.
UDI (Unique Device Identification) is a system of FDA unique products identifiers which was designed to track medical devices throughout the entire distribution and use cycle.
LiNA Medical had a homegrown standalone labeling system that wasn’t integrated with its ERP system. Labels were created in the labeling system, and production work orders came from the ERP system. The company markets and sells Class I and Class II medical devices. Some products have three levels of packaging: individual pieces, inner box and outer box. Others have only one or two levels of packaging. LiNA ships product all over the world, so labels needed to be printed in multiple languages.
- 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
- 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.
As the Class II UDI compliance deadline approached, LiNA Medical realized they had an opportunity to drive process improvement as part of their UDI compliance initiative. LiNA Medical engaged SKK, a NiceLabel partner in Poland, to create a standardized solution that would help them achieve compliance and streamline their entire labeling process.
- Standardized labeling
LiNA Medical’s work orders are now integrated with its labeling processes. A separate database houses packaging unit information and a streamlined user interface connects to label printing to reflect the appropriate piece and box information for each product. A database management form maintains the number of units and labels for each level of packaging. Print operators can easily choose a work order and label quantities are calculated based on the information stored in the packaging database. The system also selects the appropriate printer according to the label size.
With the new system, print operators make minimal edits to the form. The only editable field is “quantity”. This information is populated from the work order and print operators can edit if necessary. In the case of an issue with the default printer, operators can choose the printer from the dropdown. The remaining production identifier (PI) values are fixed and can’t be changed.
- Document management system built for labeling
LiNA Medical now has a centralized document management system for UDI compliant labeling. A digital label catalog has replaced the paper based binders of approved, hard copy labels. Label design and approval workflows are streamlined and happen within the system. Labeling is now transparent and the company can keep track of labels printed with production orders, including label versions, which print operator initiated the print job, detailed traceability and quantities. In addition, they can reprint labels.
Print operators still share an active directory login however an additional login screen within the print form allows LiNA Medical to track the activity of individual operators.
- Process optimization and cost reduction
LiNA Medical’s improved labeling process is significantly reducing labor costs and saving the company countless man hours in streamlining the label creation and approval process, and reducing the need for excessive quality control tasks.
- Mitigated risk of product recalls
As LiNA Medical moves toward its goal of a zero-error environment, they have become much more agile and responsive. Label changes and approvals happen in a fraction of the time they used to take, saving the company time and money. They have a completely transparent label approval process and have visibility to who changed a label, when it was changed and where it was printed. The risk of a product recall due to mislabeling has significantly dropped.
- Reduced quarantined product and shipping delays
Mislabeling has all but disappeared, meaning the company no longer needs to delay shipping while product is held in quarantine. Product no longer needs to be re-worked or relabeled.