Labelling and Artwork


Packaging, labelling and artwork present a significant compliance risk. They also represent one of the largest causes of recalls in the healthcare industry. For many companies, their current capabilities are struggling to meet today’s requirements.

There are important and immediate business challenges facing the pharmaceutical and healthcare industry. Delivering many new products variants into as many different markets as quickly as possible is vital for their short and long-term viability. At the same time, companies need to enhance their reputation with regulators, governments, the public and other key stakeholders. Packaging artwork management capabilities are critical to delivering this business strategy. An essential element is the need to be able to develop, deliver and maintain a significantly increased number of packaging artwork designs for a rapidly expanding number of markets.

Delivering quality artwork is a complex endeavour involving many moving parts. In the largest organisations, artwork capabilities involve thousands of people, working across many internal functions, in more than one hundred countries, involving hundreds of external organisations. The capabilities require the skilful design and management of integrated business processes, organisations and facilities, which are enabled by a suite of sophisticated IT systems. In smaller companies, whilst the scale is reduced, the fundamental challenges remain unchanged.

Establishing and delivering improvements in artwork capabilities is a significant, but achievable change management challenge. Delivering change in this area requires the management of a complex interaction of business processes: people in many different functions, organisations and countries using many, often validated IT tools. Successfully achieving this requires very specific project and change management skills, if significant compliance risks are to be avoided.

Excellence is achievable and Be4ward has transformed and managed the global artwork operations for many healthcare companies worldwide.

Where to start

More often than not there are one of two drivers for improving labelling and artwork operations: a desire by key individuals in the organisation to enhance the performance of the area, or a significant performance shortfall or issue that needs resolved. In either case the logical place to start is to assess the current state of your labelling and artwork service, so you understand what you have and what your issues are. You need to decide the scope you wish to assess and the people you need to have involved. The assessment needs to consider your processes, organisation, people, tools, systems and capabilities. For larger organisations, this can be a significant piece of work.

At Be4ward, we have developed a comprehensive Gap Analysis tool to enable such assessments, comparing your company’s capabilities against best practices we have gained from our experience across the industry. This provides a comprehensive and structured output of improvements needed.

From here, a ‘future state’ for the service can be defined and expressed in terms of processes, organisation, people, tools, systems and capabilities. A staged programme of improvements and projects can then be executed to deliver the future state in a prioritised manner.

What we've learned

Change management expertise is critical in delivering sustainable improvements

Looking at the many improvement programmes we have been involved in, they are typically based on a process redesign and/or a technology implementation. These typically create a series of issues impacting process end-users, including:

  • Changes to roles and responsibilities
  • Changes to organisation designs
  • New capabilities and competencies with subsequent education and training requirements
  • Different performance measures and expectations

So even if the improvement is heavily focussed around technology, there is a people-element that needs to be considered. It is people that will use the new processes and technology therefore, artwork development is a highly people-driven process and these people are key to the success of any artwork change activity. Moreover, because of the cross-functional and cross-geographical aspect to labelling and artwork processes, these people-issues are usually more significant than expected.

It is therefore important to ensure that the design of any improvement programme has the appropriate change management activities built in to deliver a successful and sustainable outcome. The design of a labelling and artwork improvement project needs to be done in a way that involves all impacted stakeholders. This will help to ensure that the people impacted by the change feel involved in the development of the new capability and understand the decisions that were taken during the design. It will also help to ensure their buy-in. Making this sort of change happen is difficult and it takes time and a reasonable amount of resource to do it well. It then takes a continuous resource level to sustain it successfully. You need to ensure that your organisation understands this and puts the right level of resource behind the change activity to be successful.