Lessons Learned: Weaving a solid Internal Culture & Capturing Business Returns

In the previous article we looked at the development of standard solutions, the need for appropriate levels of resourcing, provision of the right leadership and the need to stay abreast of the continually evolving legislation.  In this, the final article in this series, we look at the remaining three learning points – the involvement of local country teams, getting an end-to-end solution working early and the non-legislative benefits of serialisation.

Learning 11: Involve local country teams and management early

In many cases, particularly in track and trace serialisation models, local country teams will have to work with the local supply chain and local suppliers to ensure that robust local el­ements of the overall serialisation solution are implemented. This is in addition to the local responsibilities with respect to interpreting the legislation that we have described elsewhere.

A few things need to be considered for this to be successful. Firstly, local country manage­ment is typically sales and marketing focused which often means that supply chain and technology issues are not high on their agenda. Secondly, the lead-times required to deliver complex serialisation solutions are often far longer than typical local project timelines in sales and marketing organisations. Thirdly, local IT and engineering resources are either non-existent, or very thinly spread across many issues.

Local teams are often most appropriate to deliver local solutions. However, it is often neither efficient nor effective for such teams to operate in isolation of central or other resources who have established experience of designing and implementing serialisation solutions. This is particularly important where the implementation of standard solutions is required and will always be the case when interfacing local solutions with central capabilities. We recommend that central teams and their governance consider carefully how to ensure this happens effectively.

As difficult as the technical challenges are to overcome, the cultural and geographical chal­lenges of distance can often be greater. Good change management practice is essential to ensure that effective relationships are formed, collaborative design activity is carried out and implementation is managed in a coordinated way. We have found that there is no effective substitute for some degree of face-to-face activity throughout a project, with its implications on travel budgets and resource time. Furthermore, constant focus needs to be given to es­tablishing effective day-to-day ways of working between remote teams. Simple issues such as establishing effective video/teleconference facilities can often be surprisingly challenging.

Another aspect which needs to be considered is that of culture. Central teams need to understand the local culture, particularly with respect to local decision making, day-to-day working styles and risk and issue management. Once understood, mechanisms need to be put in place to ensure a culturally effective management and governance approach is established.

Therefore, we would recommend engaging with local country management and resources early to ensure that robust and timely local plans are in place, supported by the right level of competent resources and ways of working.

Learning 12: Get an end-to-end solution working early

The end-to-end serialisation solution in any organisation is complex and holds a myriad of opportunities for individual solution elements to not work as planned, interfaces to fail and other things to go wrong. In our experience, organisations benefit a great deal from learn­ing first-hand how to deal with these practical complexities and put the appropriate support capabilities to deal with them through the implementation of early end-to-end solutions.

It is also the case that certain aspects of serialisation present significantly more difficult challenges, complexity and knock-on impact than others. An obvious example of this is im­plementing track and trace capability and the requirement to aggregate product to shippers and shipments that it drives.

Whilst an organisation may not have the legislative drive to implement complex capabilities early, there are likely to be many learning benefits in implementing such a complex end-to-end solution early. This can test and prove solutions as well as creating lessons learnt from these early and complex implementations at a time of lower business risk.

Buy-in by senior management to such an approach is essential, as investment decisions will need to be supported earlier than they otherwise would.

 Learning 13: Do not forget the non-legislative benefits of serialisation

Our experience suggests that serialisation programs often set out from one of two places. On the one hand, there is the first group of programs that are very pragmatic and strive to deliver solutions which are focused on meeting hard legislative requirements and nothing more.

On the other hand, there is the second group that strives to deliver a broader capability and benefit to the organisation at the outset. For example, capabilities that can be leveraged to enhance product security, improve customer relationships and provide product movement information and supply chain visibility. Often, senior management is rightly concerned in getting the maximum return for the organization’s significant investment in this area.

Regardless of the starting point, many programs quickly iterate towards the first category as the practical reality of the size of the legislative task alone hits home.

Whilst it is often appropriate for a program to focus in the shorter term on delivering to the hard legislative deadlines, it is unfortunate if this is also done by limiting scope and capability designed into solutions to merely meet these short term needs. If this is allowed to happen, then reaping the broader future benefits from the solutions may prove to be significantly more difficult than it otherwise might have been.

Therefore, we would recommend putting mechanisms in place to monitor the ability of solutions to properly support the broader solution requirements, even when these are not immediate priorities.


From all of the above, there are some key learnings that should be borne in mind when defining your serialisation strategy:

  Recognise the significant supply risk and manage it accordingly, establishing senior cross functional governance early.

 Mobilise your regulatory, legal and technical teams to establish effective access to, and interpretation of, the emerging legislative and technical standards.

  Actively interpret the evolving requirements and standards for the organisation using tools such as the ‘Target Response’.

  Establish a programme of activity to build organisational and extended supply chain capability.

 Be realistic about the emerging nature of these capabilities and build in adequate time and resource to effectively test and iterate solutions.

 Design serialisation activities to closely couple related actions to minimise the possibility for errors due to abnormal events.

 Design both the normal processes and the regularly occurring non-standard events to avoid product supply quickly grinding to a halt.

 Ensure cross-functional teams are established to carefully design the interfaces between departmental and organisational boundaries.

 Ensure adequate time is allowed for packaging design changes to be made to accommodate serialisation features required.

  Be cautious about suppliers who have little practical experience in this area.

Pharmaceutical product serialisation is being introduced across the world to prevent fraud and improve patient safety. Achieving this across your company supply chain has the potential to be a costly and complex undertaking however we hope in these series of tips we have covered the key areas to consider. We believe using these ideas when devising your serialisation strategy will reduce your risk and ensure a successful implementation.

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