A significant cause of error in artwork processes is a lack of adequate planning and resource level management.
To be successful, many individuals from many different locations, functions and often companies need to play their part in the artwork process at the right time. Furthermore, there is often a significant safety or business imperative to do this work in a relatively tight timescale.
In today’s business world, nobody is sitting around waiting for work to arrive, we are all very busy. If adequate mechanisms are not in place to ensure that individuals know when they will need to carry out their tasks, then the resulting “surprise” will often result in either a delayed process, or rushed work with the resulting error risk.
Furthermore, there should be mechanisms in place to ensure that, on an ongoing basis, there are sufficient levels of competent resource available to carry out the workload. If not, then more often than not, individuals will resort to cutting corners in order to meet the required timeline, which clearly leads directly to a significant error risk.
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.