Lean in Regulatory Affairs

Historically the focus within Regulatory Affairs (RA) has very much been on compliance and “getting the job done whatever the cost”, with minimal focus on Lean and the improvements in speed, productivity and reliability that it can deliver.  The opportunity to apply Lean in Regulatory Affairs (RA) is not intuitively obvious, because RA activities are project-based with workloads which are both variable and unpredictable. 

BSM has shown that 'Real Lean' practices can help RA Organisations to provide a better Quality service and also deliver exceptional improvements in Productivity and Leadtime. This applies to the full spectrum of regulatory activities from strategy / content contribution, the associated manage and build activities, through to publishing and archiving.

Common Features of RA Organisations

  • Workload volatility
  • Over resourcing to cope with peak workloads
  • Insufficient  visibility of open projects and future workload constraints
  • Extensive individual participation in planning
  • Poor process harmonization across sites
  • Poor process definition and role responsibility
  • Reliance on expensive outsourcing
  • Significant “Tribal” knowledge
  • Product specific personnel dedication
  • Long times between work elements – “forget and re-learn”
  • Delays and inefficiencies frequently manifesting at the end of the value stream.

 Our Solutions: Built on the Real Lean principles

  • Levelling
  • Flow
  • Standard Work
  • Visual Management 

The results are typically as follows

  • Productivity -  improved by up to 100 % and often even more
  • Quality - 50% reduction in quality  issues
  • Compliance - reduced audit observations and reportable events
  • Speed - reduced task cycle times.
  • High Visibility and the means to realise further Continuous Improvement Opportunities.