I always consider that ‘Right-First-Time’ is the fundamental metric for an artwork service. This is a simple pass or fail metric – did the artwork pass through the process once or was any change required? This is difficult to achieve on a consistent basis and requires focus and persistence. This is the subject I am going to explore further in this series of Right-First-Time blogs, along with 10 essential tips to help you get it Right-First-Time.
Why is it that there are so many issues with pharmaceutical artwork? Well, getting artwork right is tricky. It requires gathering all the correct different elements, from different departments in the company, often from different countries and making sure they are placed onto a piece of artwork in exactly the right position, accurately.
Companies often jump straight into designing the artwork thinking that getting ahead of the game will speed up the overall process, but they are mistaken. Consistently, I have seen that proceeding this way not only makes it more likely for mistakes to happen but often the overall timescales are longer.
One analogy is to think of the situation where you are arranging for your house to be painted. You test to get the colours you want and then agree that up front with your painters. You don’t get them to try different colours until you see one you like and you don’t want to have to pay them again if they use a colour you don’t like!
Events either inside or outside a company will result in the need to introduce new artwork or change existing artwork. So a ‘change’ is required. I always recommend to clients, to have all the information before starting and make sure it is correct. The ‘change’ is captured in an artwork brief and signed off as approved by key parties before starting. A perennial source of artwork not being right-first-time is incorrect input information or a key stakeholder not agreeing the change during artwork approval.
A good brief is a clear and concise record of the change required with no room for any misinterpretation and containing the following information:
All this information is collated and presented as one brief.
A powerful use of the brief comes from the key stakeholders agreeing this is the change required. The signatories will need to be defined for each part of your company and their approval forms a critical control point in your process.
The final artwork review and approval would be made against the artwork brief, by the same signatory departments and ideally the same people who approved the brief, making sure all the changes required have been implemented and that no other changes have been made inadvertently.
When you start to measure the right-first-time figures, your approach to improve it may be to root cause each incident as it arises. This is a good idea. However, there is a risk, even when you have thoroughly investigated incidents, that you only fix parts of the problem. Issues continue to arise because fundamentally the current process is not ideal.
To really improve your right-first-time metric it is best to review the process as a whole and where possible get external independent expertise. This will enable you to design a process which uses best in class principles and is more likely to include elements which ‘future proof’ the process.
Map the end-to-end process considering the various different scenarios that arise in your company. The steps for external artwork approval in the EU will differ to that of the US.
Mapping the ‘as-is’ process and redesigning it will require a number of workshops and support from the senior management team. However the effort will be worth it as you will end up with a process that works, is understood by all and has received full team commitment.
When mapping each step be clear what should be done, by whom and ensure the performance expectations for each step are defined and agreed. Look at it with fresh eyes where possible. Take the opportunity to achieve your ideal process.
It is useful when mapping the process not to be too bound by the current staffing structures as this can constrain the thinking and prevent a more streamlined process from emerging. This process will almost certainly result in changes in certain roles and you can expect some friction but if this mapping process is done as a group and agreed with the senior team, then it is more likely people will be engaged and go along with the changes.
Once you have designed the new process, you should ‘trial’ it prior to implementation or configuring any software. Choose a number of scenarios and trial it with the people from each department involved on a day-to-day basis. Then walk through each scenario testing each step and checking they work as expected. Doing this properly will ensure that all the steps are there and in every case, someone is accountable. Only then should you have the confidence to update procedures and configure any systems.
There is typically a four-step process to assure the quality of the master artwork file.
- The initial check carried out by the artwork operator who has created the file, following the brief.
- The second check is a full and independent proof read, carried out by the proof reader, reviewing all text and graphics against the brief and including a detailed technical check.
- The third check is done by the regulatory group reviewing the text and content, ensuring any local requirements are met.
- The final check is done by QA or their representative, checking only that the correct process has been followed and documented.
All these people in the chain must be aware of the responsibilities they are undertaking when reviewing and approving at each stage.
There is a danger that we are not prescriptive enough when saying what needs to happen when performing a check. If procedures are too vague there is the potential for elements of the artwork to not be correctly reviewed. In particular we often see ‘thick’ SOPs in the central artwork team versus very ‘thin’ SOPs for the regulatory checks done by the affiliates.
So it's important to spell out in SOPs the responsibilities for each stage and back this up with detailed checklists showing which elements must be checked and by whom. Don’t fall into the trap that everyone checks every element, because actually not everyone is qualified to perform some checks. Only the local language expert can check the context of the language on a leaflet, for example, to confirm how the text will be understood by the local patient or medical professional.
It is important to define not only what needs to be checked but how it will be done and with what equipment, if required. State exactly what is involved in each check and what to check against. Regulatory checks will need to be referenced to listed key documents, for example, as well as the brief. Proof readers will need to be clear what equipment they need, for example, to check bar codes and braille.
In the next article, I will explore the topic of right-first-time further and present tips six, seven and eight, which look at the importance of effective staff training and suitability, cross functional governance groups and some of the key tools available for IT support in the artwork process.
Should you have any questions about this or our artwork or our proofreader and document verification training, please contact Be4ward at [email protected].