Artwork Auditor Tip 7 – Are roles and responsibilities clearly defined, especially at key control points?

Artwork Auditor Tip 7 – Are roles and responsibilities clearly defined, especially at key control points?

In our opinion, ensuring that the roles and responsibilities are clear for the artwork process is important for a number of reasons.

Firstly, it is critical that, where an individual needs to carry out tasks in the process, they are clear which specific tasks they are expected to complete. Poor definition of roles and responsibilities will often leave detailed task responsibility ambiguous. At best this may mean that certain activities are performed by multiple individuals unnecessarily, wasting some resource effort. At worst, tasks will be omitted completely, leading to the risk that artwork errors will occur.

Secondly, for the end-to-end process to be robust, it is imperative that all the right stakeholders are involved in each step of the process, particularly at review and approval stages. There should be safeguards in place to ensure the appropriate minimum stakeholder involvement at each stage of the process.

When auditing artwork capabilities, look for evidence that roles and responsibilities are defined for all steps of the process. Furthermore, check to ensure that there is a mechanism to define the appropriate stakeholder involvement in the process and then ensure that that involvement is achieved.


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.

To obtain an e-copy of our Top 20 Artwork Auditor Tips booklet, go For a hard copy of the booklet, contact us at

Comment ( 1 )

  • Dinesh Kumar Anchal

    Liked while reading as some checks and cross checks automatically randomly moving in mind. Oh it should be done like this. But still if we back to raised 483/any non compliance letter issued by authority, reveals the simple points in their inspect/audit report. Why it happens when experts or even bunch of them are there. In my understanding interpretation from one to one is differed and real sense is changed while discussing them and things projected in hyper way and motive is collapsed.

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