Artwork Matters

Effective cross-functional governance with Serialisation Projects

Andrew Love
Contributor: Andrew Love
Posted: 07/26/2016

In my last article I talked through the need to think through the capabilities required from a global, regional and local perspective and that this was a key success factor in a serialisation strategy. I talked about the need to be flexible so you can respond to the changing legislation and finally I discussed the role of the governance team. In this article I build on these ideas with more discussion on establishing the right inclusive leadership and governance team and finally some advice on where to start

This concludes the series, with final tips 9 and 10 for developing and implementing your serialisation strategy.

Tip 9: Implement effective cross-functional governance

Given the cross-functional and cross-organisational nature of the serialisation capabilities, establishing the right inclusive leadership and governance is key to the long-term success of the activity. All stakeholder groups involved in the delivery of the serialisation capability need to contribute effectively or the whole process is at risk of failure. Therefore, all parties must buy into their roles in the processes and actively contribute to them. This will rarely happen if they are simply passive bystanders in the design of the capabilities or the delivery of the resulting activities.

A cross-function governance team should therefore be established to steer the definition, establishment, ongoing delivery and development of the overall serialisation service across the multiple stakeholder groups involved. This governance body should include membership from all of these stakeholder groups involved in the processes, including, where appropriate, external service providers. Typical activities that would be included in the role of such a Serialisation Governance Team include ensuring:

  • A clear vision and strategy is defined and communicated.
  • 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 are required.
  • Changes to the target response are carefully managed and cascaded to all impacted groups.
  • Appropriate approval serialisation capability designs.
  • The performance of the serialisation service is meeting business needs.
  • The programme of legislative responses and improvement activities are prioritised and approved.
  • Resources are in place for the serialisation service and improvement activity.
  • Stakeholder group conflicts are effectively resolved.

Tip 10: Understand where to start

As a place to start, we would recommend a small focused piece of work which has the following objectives:

  • Understand the issue as it relates to your business.
  • Understand the likely impact across your organisation.
  • Identify, educate and mobilise an effective cross-functional governance team.
  • Establish an effective legislative monitoring capability.
  • Define an initial ‘Target Response’.
  • Define a plan of action.
  • Identify any initiatives that are currently underway and define how they should proceed.
  • Understand the high level budgetary implications.

From here, a programme of activity can be implemented to effectively manage the legislative risk and oversee subsequent capability deployment.

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. 

Andrew Love
Contributor: Andrew Love
Posted: 07/26/2016

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