Companies are faced with several specific issues when managing serialisation related legislation, these include:
Identifying and interpreting the emerging and evolving legislation.
Serialisation legislation, particularly in its early iterations, tends to be somewhat vague, incomplete and sometimes contradictory. Interpreting the legislation and predicting it’s impacts can present significant challenges, requiring specific serialisation knowledge as well as new legislative relationships with local legislators.
This is further compounded when considering the time lines allowed in the legislation. History has shown that timelines are often vague and subject to change. However, when implementation dates are finally set, they often do not allow enough time for robust implementation.
Given the uncertainties in requirement and timing, organisations need to ensure that there is a clear way of communicating their considered view of the legislative requirements at any particular moment. Failing to do this will potentially result in individual functions or groups creating their own interpretations, which at minimum is wasteful of resources, but at worst results in capabilities being implemented which do not meet the eventual requirements of the legislation.
Understanding the full impact of these multiple pieces of legislation on the company and product supply chain.
We have already discussed the potentially broad impact of the legislation on a typical organisation.
It is important to engage all of the potentially impacted parties early in the impact assessment phase to ensure that comprehensive solutions can be defined.
A further challenge is that the multiple pieces of evolving legislation will often impact many of the same capabilities. Understanding these potential impacts and their likely evolution over time is key to ensuring effective solutions are defined and implemented in a timely manner.
Defining optimal solutions and implementation plans which strike the optimal balance between ensuring product supply and the caution that is prudent with this evolving legislation.
There are often a number of supply chain configuration and technical options that can be brought to bear to deal with particular serialisation legislative requirement. Short term tactical options have to be weighed against longer term strategic solutions.
Defining the timing of implementation plans, to a large extent, needs to be considered hand-in-hand with the solutions themselves. One risk that also needs to be considered is that of the “last minute rush”, or “Y2K effect”. By this we mean the risk that, as so often is the case with this type of legislation, everyone waits until the last minute to implement solutions, only to find that the supply base cannot cope with the peak in demand, driving up costs and forcing companies into non-compliance.
Understanding the immature and evolving solution supply base and selecting appropriate implementation partners.
Serialisation legislation is relatively new to the Pharmaceutical industry and therefore the solutions available from the supply base are correspondingly immature and in many cases evolving. Supplier selection will often be the start of a very long relationship, as solutions that are initially implemented will need to be supported and adapted to new requirements over time. There have already been several examples of suppliers that have come and gone as legislation has evolved or been delayed. Understanding the supply base and choosing the most appropriate suppliers will be critical to long term success.
Defining complete requirements covering all aspects of the solution’s lifecycle and then realistically judging the supplier’s ability to meet these requirements also presents challenges.
Resourcing implementation projects with sufficient serialisation specific knowledge to minimise the risk of wasted resources, delays and implementation failure.
The specific challenge during the design, build, test and implementation phases of solution projects is to resource them with sufficient serialisation subject matter skills and knowledge to avoid common pitfalls, reduce wasted effort and the risks of delay and solution failure.
Organisations need to plan for these resource requirements and build sufficient capabilities internally and secure access to sufficient external resources where appropriate.
Cross Functional Governance
Given the cross-functional and cross-organisational nature of the impact of serialisation legislation, coupled with the significant product supply risk it presents, many organisations establish a cross functional governance team to ensure that:
Decision making is taken with all impacted parties, at the right levels in each of the organisations involved.
A “Target Response” is defined that specifies what the organisation must achieve and by when, given the current state of legislation and the organisation’s considered view of how and when capabilities will be required.
Changes to the Target Response are carefully managed and cascaded to all impacted groups.
Appropriate cross-functional and cross-organisational resources are mobilised to address the issues in a coordinated and timely manner.
Timely approval and funding of the program of activities is achieved.
Progress, priorities, risks and issues are managed in an optimal way for the organisation as a whole.
This is one in a series of articles outlining the requirements of serialisation and related product coding legislation, discussing what needs to be done to address it and identifing some next steps to effectively manage the risk. Please help us improve the thinking by adding your comments and share this with others who may have a view.