One of the most basic causes of artwork error is not carrying out every change that is necessary as a result of a change trigger. For example, if a local regulator introduces a new packaging regulation requirement, one of the first questions that needs to be answered is: which markets; products; packs; components and therefore artwork is impacted.
For this reason it is critical that there is a robust process in place to assess the impact of any trigger for change and ensure all the existing and new packaging components which are impacted are identified. For each component that is impacted, there needs to be a robust mechanism to ensure the required changes actually occur.
This is often achieved by formally triggering an artwork change process at this point.
For changes such as critical safety changes, it may also be necessary for a company to be able to report on the successful completion of the resulting pack changes to some external regulators.
When auditing artwork processes, we suggest you look for evidence of the following:
• Change triggers are documented in a formal change control process.
• An effective impact assessment is carried out to identify ALL impacted markets; products; packs; components and therefore artworks.
• The artwork change process is triggered for all artworks identified in the impact assessment.
• The original change control is not closed until successful completion of all impacted artwork changes.
• There is a management mechanism in place to address artwork changes that were identified as necessary in an impact assessment, but have either not been triggered or completed on time.
This is one in a series of blogs giving a view of the Top 20 things auditors should think about when reviewing packaging and labeling artwork management capabilities in the pharmaceutical, healthcare, and other highly regulated industries. Please help us improve the thinking by adding your comments and share this with others who may have a view.