Label Management · UDI
Medical device identification
How a manufacturer achieved zero errors in device identification and package labelling

This European company is an innovator in minimally invasive devices. It markets products glabally and has to comply with US regulations. Its manufacturing plant is in East Europe.

The problem

The company had homegrown standalone labelling system. This was not integrated with the ERP system although it produced the work orders.

Labels had to be printed in multiple languages. Some products had two or three levels of packaging: individual pieces, inner box and outer box.

Requirements

Cut costs of label errors and non-compliance

The manual labelling process required its print operators to have a lot of knowledge. They sometimes made errors keying in data from the work orders This resulted in extra quality control steps that added cost and time to the process.

Eliminate risk of recalls

Their verification procedures were successful. There had been no product recalls, but the company was well aware of the risk and potential costs.

Eliminate delays in production

The print operators had to find the right templates for each work order. This took time as there were thousands of 3,000 label variations. Work orders had to drive label printing.

Replace the cumbersome label change and approval process

The company kept two identical paper-based catalogues of label templates: one for quality and the other for production. The change and approvals process was complicated and very time consuming.

Solutions

Integrated labeling

Work orders and labelling are integrated with a separate database for packaging information. When operators select a work order, the system calculates label quantities for each packaging level, and selects printers according to label size. The only editable field is “quantity” which operators change when necessary

Document management system built for labelling

A centralised document management system for labelling replaced the old catalogue binders. The label design and approval workflows are within the system. There is a full detailed log of labels printed.

Results

  1. Cost reduction: countless hours saved in quality control and in label creation and approval.
  2. Much lower risk of product recalls: label change and approval is a secure process and operators cannot make errors.
  3. Elimination of shipping delays: mislabeling has all but disappeared so there no delays to shipping for rework.

Downloads

Related Applications

NiceLabel LMS

Medical devices

Manufacturer achieves zero errors in device identification and package labelling

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