Packaging and Labelling: Artwork core, interfacing and supporting processes

As I 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, I 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.

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I 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, 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.

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, our model high level process consists of five fundamental, or level 1 steps.  Each of these steps are defined briefly below, but are covered in more detail in 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 done 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.

Supporting Processes

Whilst the core processes defines how individual labelling and artwork changes will be carried out, it is not sufficient in itself to provide a complete capability. A number of support processes need to be in place to achieve this. These include:

• Governance
• Performance Management
• Issue Management & Resolution
• Process Lifecycle Management
• Education, Training & Competence Management
• Information Technology Support
• Service Provider Management
• Project & Programme Management
•  Forecasting & Budgeting
• Business Continuity Management

Many organisations will find that they already have one or more of these supporting processes in place that can be adapted or extended in scope to include the necessary artwork process areas. In many instances, this approach is to be recommended, as the artwork capability does not necessarily need its own unique iteration of a supporting process.

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There are a number of questions that need to be considered in making the choice about incorporating artwork into an existing supporting process or creating a separate artwork-specific iteration. These include:

Does a robust supporting process already exist elsewhere in the organisation which has a close fit to the supporting process requirements for artwork?

• Is the existing process owned and managed by a part of the organisation heavily involved in the artwork process?
• Would the owners of the current process consider artwork an appropriate extension of their scope?
• Is the existing process governed by an appropriate steering team that will take fair account of the needs of the artwork process when considering changes to their process?
•  Is the artwork capability sufficiently small in scale to be successfully managed within another support process?

If the answer to any of the above questions is no, then careful consideration should be given to creating an artwork-specific support process rather than trying to force fit artwork into an existing process capability.