As we have discussed in earlier articles, creating correct artwork is an activity that requires many groups to act together in an orchestrated way to deliver a successful result, on time. The way of ensuring that these people act together in a co-ordinated way is to define a set of processes that everyone adheres too.
Whilst there will always be many ways to reach the same result, and artwork creation is no exception, we will present a high level process here as a basis for discussion. This process is based on experience working with a number of different companies, and if you are involved in artwork processes we are sure you will recognise many elements of it.
We will divide our discussions about artwork-related processes into three distinct areas, in an attempt to make things clearer. The three areas are:
Core Process: The primary activities involved in defining and executing individual artwork changes.
Interfacing Processes: Those business processes that interact directly with the core process, and will have an influence on the core process and may be modified as a result of this interaction.
Supporting Processes: The business processes that are required to support the core process and other artwork capabilities.
We will deal with each of the process areas in different articles and will start here with the core process.
High level core process steps
At its highest level, creating artwork is no more complex than defining what is required, creating a work product such as an artwork and then verifying that this output meets the requirement initially defined. This is a very familiar process to anyone involved in quality systems.
For the purposes of this discussion, we have defined a high level process consisting of five fundamental, or level 1 steps.
1 - Create Local Language Text
2 - Define Change
3 - Produce Artwork
4 - Produce Printer Proof
5 - Implement
We define each of these steps very briefly below. For a much more in-depth discussion on the Level 1 and 2 process in each of these steps please get a copy of our book Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities.
1. Create Local Language Text
Create and approve local language source text document(s) for each of the packaging components to be created or modified.
2. Define Change
Define exactly what is required to be created or modified as part of this change.
3. Produce Artwork
Produce a new or revised artwork that complies with the requirements defined in the Define Change step.
4. Produce Printer Proof
Produce a modified artwork file that can be used directly in the packaging component printing process. This file differs from the artwork produced in step 3 in that it is modified to include all features that will allow it to be successfully printed via a specific printing route.
It is possible to eliminate this step through the use of a print ready process.
Ensuring that, at minimum, the first time a new or modified artwork is used to create packaging components for use in the manufacture of real product, that they are correct.
Critical control points
It is worth pausing at this point and briefly discussing process critical control points. Given that this process produces information that, if incorrect, can have a significant and potentially fatal impact on patients, it is critical that there are defined control points in the process to ensure that the quality of the output of the process is to the highest standard practically achievable.
To achieve this, companies have found it useful to define critical control points in the artwork process to ensure that all necessary tasks have been completed to a high quality before moving to the next phase. Each control point would normally include a quality check for accuracy as well as a formal approval by key individuals to proceed. In addition, some control points will provide an approval of a master document which will form a part of a master record source for GxP information.
This series of articles, taken from our book Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities, describes the key capabilities required to deliver right-first-time packaging artwork in today’s environment. They also discuss potential future developments in the area to help the reader design any improvement activity with these in mind. Finally, they look at how an organisation can go about understanding how they need to adapt and improve their capabilities to meet their evolving business strategy and go about the often complex change-management journey to achieve it.