Errors in packaging labelling and artwork presents a significant compliance and reputation risk to pharmaceutical and medical device companies, a topic which I have explored in a previous blog article . Here I will discuss how to assess your end-to-end capabilities in this area, in order that you can understand where you are and what, if any improvements you need to make.
The complexity of the area is often underestimated.
The devil is in the detail and there is a lot of detail!
Whilst significant omissions and errors can be the cause of packaging labelling and artwork errors, it is often the smallest of details that are the cause of incidents and recalls, e.g. missing decimal points or a vital piece of text being masked by an image. Therefore, to be successful, any packaging labelling and artwork capability needs to ensure that the smallest of details are correct. If we also consider that each artwork is unique and, more often than not, contains thousands of individual elements, the overall capability has to have a very high degree of accuracy.
To a large extent it’s about people
An effective end-to-end packaging labelling and artwork process relies on coordinating activity across several functions in an organisation and between several different organisations. Often, many of the people involved in the process change for each product and market being considered. Furthermore, many of these individuals perform their packaging labelling and artwork activities as a very small proportion of their overall role. In a large company, it is entirely feasible for the process to involve many thousands of people. Therefore, ensuring that every person know exactly what to do and when becomes a significant challenge.
Technology is critical to success
Today, it is impossible to conceive of a packaging labelling and artwork capability not involving some element of technology. At minimum, organisations all use technology to create source text documents and artwork in order that they can efficiently and effectively communicate them with the different participants in the process. Tools such as electronic proof reading technology provide excellent safety nets to detect errors if used in the right context. At their most sophisticated, organisation use integrated technology suites to manage the end-to-end capability and automate many aspects of it. Given that the smallest of error can lead to a patient safety risk, many of these tools need to be managed under a strict quality assurance regime, often referred to as validation.
For additional reading, refer to my article on Technology.
As we discuss at length in our book, Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities, we argue that designing and implementing an end-to-end capability involving many different elements is the only way to deliver error free packaging labelling and artwork. Whilst there are many ways in which one could break down these capability elements, we define them under the following high level areas:
- Governance and leadership
- Core processes
- Supporting processes
- Interfacing processes
- Organisation and roles
- Education and training
- Supply chain partners and service providers
One of the starting points for understanding your current risks, issues and opportunities is to perform a comprehensive capability assessment against each of these areas of the end-to-end capability. Typically, such an assessment would consist of three stages: current situation assessment; gap analysis; improvement recommendations development.
Current Situation Assessment
A capability assessment should seek to understand the current situation for each element of the capability. In all but the smallest of companies, there are often different groups or organisations that perform the same function, but often in very different ways. Any assessment needs to ensure that it looks at a representative sample of the way in which activities are performed.
An excellent starting point for assessing any capability is to have a comprehensive model from which to base the assessment. Using such a model ensures that all elements of the capability are assessed against a proven benchmark. It is also helpful if such a model recognises that there are several ways to achieve the same result.
This stage looks at the current situation and assesses it for gaps, which in turn will lead to the development of improvement recommendations. In order to do this effectively, it must be recognised that not all organisations need to be at the same level of sophistication or maturity to meet their particular business needs. Any particular solution needs to be “fit for purpose”. Therefore, a gap analysis needs to reflect these different levels of sophistication.
A scale of capability levels that I have found useful is:
- In compliance & control
- Efficient and effective
- World class
In discussion with senior stakeholders, their current business situation can often be translated into an appropriate target capability level for each of the elements of the end-to-end capability. This then allows an appropriate gap analysis conclusion to be reached.
Improvement Recommendation Development
I would recommend that all studies of this type result in some concrete recommendations about what to do next. Depending on the particular circumstances of an organisation, the degree of activity in this stage of the study can vary significantly.
At one end of the scale, an organisation may simply be looking to understand where they are and if there are indeed any significant issues, risks or gaps. In this case it may be appropriate to end such a study with some high level recommendations for the consideration of further work to assess options to resolve particular gaps. Often a number of “quick wins” or “just do it” type recommendations will also be possible.
At the other end of the scale, an organisation may need to move straight from this type of study into approval of subsequent activities requiring significant investment. In this case, the development of improvement options, their assessment and the subsequent planning and costing activity is significantly more onerous than in the previous case. The time and resources required to perform this additional activity needs to be factored in to such a study from day one.
Therefore, the exact requirements of this phase of a study need to be agreed up front with key stakeholders in order to ensure that their needs are appropriately met.
Key Stakeholder Involvement
Such a study also provides an excellent opportunity to engage with the key management stakeholders associated with the end-to-end packaging labelling and artwork capability, to ensure they understand the area and involve them in the appropriate decision making. Indeed, unless the recommendations for improvement activity are small and well contained in impact, it will be impossible to implement any recommendations without this engagement.
A well designed study will integrate this stakeholder engagement into the core of the way in which the study is done to ensure the key stakeholders are brought along with the work as it progresses and that they are appropriately prepared and equipped to make key decisions when necessary.
As an absolute minimum, the key stakeholders responsible for the different groups and organisations will have to agree to the study being performed, as resources in their area will be impacted (however minimally) with the assessment study. Furthermore, they need to be given the opportunity to communicate the study and it’s purpose to their teams to ensure the work is positioned in the right way.
Whilst such a study always has some level of impact on people across the organisation, this can be minimised if the study is designed and implemented well. Indeed, the study itself can be very motivating for individuals in an organisation as they potentially get an opportunity to contribute their thoughts and ideas to improving the current situation.
Please do not hesitate to contact me at firstname.lastname@example.org if you feel that your organisation could benefit from this type of study. We have significant experience in performing this type of activity for all sizes of organisation and have the proven underlying capability model, methodologies, consulting skills and experienced staff to do it efficiently and effectively.