Real Lean Transformation

Batch Disposition Process (Release)

There are two distinct parts to a Real Lean Disposition project. 
  1. Streamlining the Batch Record Review 

    1. Continuous Incremental Review
    2. Visual Release Queues
    3. Levelling
    4. Streamline the Error Correction loop
  2. Batch Record Optimisation

    1. Batch record re-engineering – error reduction, work content reduction

Batch Record Review 

The BSM philosophy for Batch Record Review

  • "Review as early as possible"... therefore Continuous Incremental Review is always the preferred approach!
  • Batch Records or sections of Batch Records that cannot be reviewed in Real Time are queued and reviewed in a level manner.
  • Consistent review and approval lead-times can only be achieved if the review workload is levelled.
  • Review process lead-time should be one or two days not weeks.
  • Involve shop floor and support personnel in the detailed design of improved processes.
  • Highlight priorities by making queues as visual as possible in the office area.

Batch Record Optimisation

Life Science companies have always put significant effort, resources and cost into their manual batch records. Despite this, Right First Time performance and lead-times are almost always poor.

BSM believe that 'error reduction drives' will not sustainably improve RFT performance. The underlying causes must be tackled by re-engineering the batch record document to reduce the propensity for error.

BSM Batch Record Optimisation addresses

  • the layout, sequencing and formatting of the document,
  • unnecessary entries to significantly improve accuracy and Right First Time (RFT) performance.

The Benefits of our Approach

  • Significantly reduced review and approval lead-times
  • Increased reviewer productivity
  • Reduced batch record costs
  • Less errors, improved accuracy and better RFT
  • Faster error correction
  • Consistent predictable performance
  • A culture of pro-active performance management and continuous improvement.

No other consulting company has BSM's knowledge and experience of successfully re-engineering manual batch records and batch record disposition processes. But don't just take our word for it……ask our clients.