Project Description

The challenge

A global biopharmaceutical company had experienced serious quality issues and recognised the need to fundamentally rethink its approach to managing quality across all of R&D.

The senior leadership team in a global biopharmaceutical company had serious concerns about their organisation’s capability to deliver reliable quality and compliance in R&D. Inspection findings and a string of issues had damaged confidence in the internal quality and risk management.

Silos and the fragmentation of quality related groups were seen as an important root cause of this situation. Our client, therefore, decided to put in place an integrated Quality & Risk Management platform.

However, it was evident that establishing an integrated platform would not address other underlying issues. Fundamental changes to the way the organisation was thinking about quality and risk would be required.

Our approach

Kinapse helped to establish an integrated quality and risk management platform operating across business units and to address the underlying issues which had put the organisation at risk.

We supported the organisation design of the new integrated platform. After considering all options, a partnership model was chosen.

This model comprised of an integrated central platform linked via clear interfaces to quality resources located in each part of the business. This facilitated the crucial alignment and integration, while also ensuring that the business was supported by quality people who understood their needs.

Even though many of the fundamental issues in the organisation were already known, the evidence was largely anecdotal.

A formal diagnostic cast a clearer light on the problems:

  • A fundamental disconnect between Quality teams and the business, resulting in a ‘tickbox’ mentality and little ownership of quality.
  • Process documents that were long, confusing and often overlapping made it difficult to comply and contributed to inefficiencies.
  • Spot-checks were an ineffective substitute for building quality into processes.
  • Quality Control and issue escalation mechanisms did not reliably detect and manage critical issues.
  • Risk-management was disconnected from day-to-day work.

In order to address the underlying causes of these issues, we worked with a cross-functional client team and Kinapse subject matter experts.

The team took a holistic perspective, acknowledging that better management of quality and risk would require not only process changes. Equally important would be changes in mindset, better infrastructure, appropriate incentives and effective training.

The client is now changing the way quality and risk are managed:

  • The Quality Platform acts as a knowledgeable partner and advisor to a business that fully owns and understands quality.
  • Building quality into every process and review of Quality Control and oversight processes in all R&D teams.
  • Establishing an effective SOP Governance process which will result in a smaller number of high quality process documents.
  • Integrating issue and risk management across former silos and facilitating transversal learning.
  • Using performance indicators to allow management to establish accountability for quality and guide continuous improvement.

The result

The new platform will operate as a valuable partner to a business which takes full ownership for quality.

The client expects concrete benefits from this change programme. These include not only a reduction of quality issues but also cost savings and ultimately better quality data and more efficient R&D.

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