Part 1: Tips for Revamping Your Artwork Approval Process

Overhauling the artwork approval process? A senior labeling manager at Bausch Health shares tips about what to consider before you start.

In label management, breakdowns in communication and bottlenecks can cause delays in packaging implementation.
In label management, breakdowns in communication and bottlenecks can cause delays in packaging implementation.

In label management, breakdowns in communication and bottlenecks can cause delays in packaging implementation and can even lead to product recalls if the approved content isn’t correctly incorporated during production.

Nicole Quallis, Senior Labeling Manager at Bausch Health, recently spoke on a panel at Pharma Packaging and Labeling East Coast 2019 about her experience with overhauling the artwork approval process. Over the next two issues, she’s sharing tips on what to consider before you start.

  1. Map it out

Many times companies experience communication breakdowns between artwork approval and implementation, but as Quallis notes, “These issues can happen anywhere in the process due to lack of proper methods. Who handles all the downstream activities after a labeling component is approved and who needs to be notified because of it?”

Bausch’s recent process overhaul included the following steps:

  • A six-sigma team worked with the labeling senior management team led by their Senior Director, Yvette Henderson. Together they mapped out the entire label approval process and identified gaps.

  • They noted all the stakeholders in the process and talked with their management to understand their involvement, current role and how they could benefit from overhauling the system.

  • Areas for improvement were proposed. A new process rollout was run through all parties and upper management for several months to drill down on the final backbone for the new process.

  • Once the final process was approved, a pilot based on what was designed was performed to work out the kinks before actual rollout.

  1. Ensure changes are triggered from the right group

Before the team began the streamlining process, change control records were initiated at the beginning of a labeling change, and were used as the trigger for label changes. “We could not start an artwork change until another functional group created a change control record, which was a bottleneck that could take weeks while the clock was ticking. After an urgent labeling change—like an FDA approval—it’s imperative that we begin artwork revisions as soon as possible. Waiting for a change control to be initiated to revise urgent changes was a huge obstacle.”

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