Having established the status, scope and critical controls of the artwork management process in the relevant Quality Management Systems, the next area to look at is the definition of the process activities themselves.
Given the detailed nature of the artwork process and the fact that it often involves many individuals from all over the world doing the same tasks, it is important to ensure that the description of tasks are sufficiently detailed to ensure work is carried out consistently, completely and correctly.
To achieve this, companies employ a variety of different process documentation tools, each with increasing levels of detail contained within them. Typical document types may include:
• Standard operating procedures (SOP).
• Work instructions, guidelines, job aids.
We often find that the process is only documented in SOPs at a very high level, with the focus being on “what” needs to be done, and very little explanation of “how” activities must be performed. It is our experience that, unless there is consistency around “how” critical tasks in the artwork process are performed, there will be a high risk of artwork errors.
When reviewing an artwork capability, look for evidence that the way in which key activities are to be performed is documented at a level of detail that will ensure complete and consistent execution of the tasks.
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.