All processes need governance to ensure they operate effectively within and across companies.
Due to the potential significant impact of errors created by the artwork process on patients and the company, it would seem appropriate for the governance of the process to be at a relatively senior level in the business.
The end-to-end artwork process operates across functional and potentially organizational boundaries and therefore any governance should include senior representation from all of the impacted stakeholder groups. Without this, there is a significant danger that the process will not be managed or executed successfully and will fail.
The governance team would normally ensure:
• A strategy for the end-to-end artwork capability is developed and communicated.
• Change to the capability is managed effectively.
• Ongoing operations are managed effectively.
The governance team would not normally be responsible for the day to day management of the capability.
When auditing artwork capabilities, look for the following:
• Evidence that the end-to-end artwork process is governed by a team including representation from all the impacted functions.
• Evidence that the governance team meet regularly and that the agenda covers the topics discussed above.
This is one in a series of blogs giving a view of the Top 20 things auditors should think about when reviewing packaging and labelling artwork management capabilities in the pharmaceutical, healthcare and other highly regulated industries. Please help me improve the thinking by adding your comments and share this with others who may have a view.
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