In part two of my blog series on how to create excellent packaging artwork capabilities, I looked at some of the main causes of artwork error and the importance of creating a service culture. Here in part three I introduce three important artwork processes and look in greater detail at the core and interfacing artwork processes. I highlight the 5 fundamental core process steps and examine some typical interfacing processes and their interaction with the artwork process.

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 to.

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.

For the purpose of clarity, we will divide our discussions about artwork-related processes into three distinct areas:

Core Processes: The primary activities involved in defining and executing individual artwork changes.

Interfacing Processes: Those business processes that interact directly with the core process, 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 turn 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.

5. Implement

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.

Interfacing processes

The artwork process does not operate in isolation. It is a process which relies on information and activity in many other processes in order to operate successfully. Furthermore, some of these processes are owned and operated by organisations external to the company who owns the core process. Some typical examples of these interfacing processes include:

- Change control process

- Production planning

- ERP data management process

- Physical packaging development process

- Company core datasheet development

- Component code management

The design of the artwork process must clearly take account of each of these interfacing processes. For each process it should be clear at which point the interface(s) occur, what information is interchanged between the processes and in what format.

When designing the artwork process, it is highly unlikely that all of the interfacing processes will provide exactly the right information in the ideal format to support the new artwork process. Consequently, analysis will have to be carried out in each case to decide the best way forward. In some cases it will be necessary to modify the interfacing process to meet the ideal needs of the artwork process. In other cases, it will be necessary to modify the design of the artwork process to accommodate the constraints of the interfacing process. In many cases a compromise solution will result. In some cases it may be necessary to phase the implementation of the new process, initially implementing a less optimal solution which can later be optimised when the corresponding interfacing process can be modified.

In part four I will look in more detail at the third of our defined processes, Supporting Processes and influencing aspects of organisation design.