Vision Systems: Do You Really Understand What You've Just Printed?

For medical device manufacturers, ensuring accurate and consistent product labeling remains a challenge. From compliance demands for a design-to-print audit log to the complex mix of variable barcodes, images, and text required on each label, the process is undoubtedly demanding.

Warren Ward-Stacey

Yet the vast majority of companies are still using some form of manual checking -- if they are checking at all. Whether it is a first/last of the print run check; random check; or the use of a template to ensure something (not necessarily the required information) has been printed in each of the required fields, the combination of human and printer fallibility (from ribbon creasing to driver conflict) can only lead to mistakes.

And, as a result, the industry continues to accept print errors, and the attendant implications of potential product recall, expensive legal action, and brand damage.

Furthermore, medical device manufacturers do not only need to ensure label accuracy; organizations also need complete traceability. To respond to FDA requirements, medical device manufacturers need to be able to demonstrate the full audit trail – from who designed the label, including how the data is checked, validated, and approved, to the design approval process, what was sent to the printer, and critically, what was actually printed and failures managed/reprinted.

Sadly, in far too many cases, the last components of this process are either managed manually or overlooked completely; too much trust is placed on what was sent to the printer instead of what was actually printed.

Organizations require not only an audit log of the print output but also a log of what was checked, how it was checked, and critically, what action was taken in the event of label failure.

The only way to truly streamline and automate this process, avoiding the risk of human error whilst also delivering a robust secure source of information to support both internal and external audits, is to create a single end-to-end solution from design creation through automated visual check and audit creation in a single software solution.

Taking this approach, the vision systems detect errors such as incorrect barcodes and label elements that are unreadable to the human eye; they flag lines or creases due to ribbon creases; poorly defined characters or print hat has been offset. But they also create a single source of design-to-print label information that can be used both internally and externally -- internally to highlight specific printer/operator problems that can be rapidly addressed; and externally to provide an end to end audit trail that minimizes the risk of legal action or compliance breach.

By adopting a vision system that is integrated with the original label design package, medical device manufacturers can finally eliminate the "print and hope" approach to label validation.

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Warren Ward-Stacey, Sales Director, Prisym ID

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