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 has developed methodologies and solutions specific to manual batch records and manual batch record processes which minimise non-value add activity and maximise accuracy, throughput and velocity. Our 'Real Time Review' approach is based on sound carefully adapted Lean principles. Remember, Batch record processes are not the same as manufacturing and a generic Lean approach will not work well.
BSM tackle both:
- the batch record:
- to improve the layout, sequencing and formatting of the document,
- and eliminate unnecessary entries to significantly improve accuracy and Right First Time (RFT) performance.
- and the process:
- to level the workload, eliminate queuing and speed up error correction in order to achieve reduced, consistent lead-times.
The benefits of our approach include:
- 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.
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.
- That consistent review and approval lead-times can only be achieved if the review workload is levelled.
- That the review process lead-time should be one or two days not weeks.
- In involving shop floor and support personnel in the detailed design of improved processes.
- In communicating frequently to process users and support personnel during an improvement project.
- In building structured performance management processes including definition of suitable metrics and daily review huddles.
No other consulting company has BSM's knowledge and experience of successfully re-engineering manual batch records and batch record processes. But don't just take our word for it……ask our clients.
Tom Reynolds will respond to your query.