Many of the tasks that need to be performed in the end-to-end artwork process rely heavily on the skill and competence of the operators. Particular examples of this would be artwork operators, proof readers and other document reviewers.

Some operators are regularly involved in the process, whilst others are not. For example, many local market representatives may only deal with the artwork process a small number of times a year, whilst proof readers may execute the process many times each day.

Therefore, the education, training and competence assessment of individuals performing roles in the end-to-end artwork process needs to be carefully designed to ensure everyone will carry out their tasks completely, correctly and competently.

When auditing artwork capabilities, look for evidence that the competency requirements of all roles have been assessed and that the appropriate education, training and competence assessment has been put in place to ensure that:

• Users are competent when they start their role.
• Users are competent to execute any changes to the process.
• Users undergo periodic refresher training and competence re-assessment.

Furthermore, look for evidence in individual training records that the above steps are being carried out.


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.

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