Implementing continuous improvement methodologies common in other industries is perceived to be difficult in the more heavily regulated areas of industry. In the world of pharmaceuticals, medical devices and biologicals, one rarely hears of “Lean Pharma”.
So the question is: how do you combine Six Sigma, lean manufacturing, 5S and other world class manufacturing techniques with GMP compliance and remain compliant?
Surprisingly, not many manufacturers appreciate that many of the quality processes – like CAPA – were actually developed in the automotive industry as a at line tool to make improve product quality and process efficiency.
Process Improvement Consulting Services
In companies with heavy regulatory compliance requirements, critical business performance indicators such as stock turnover, manufacturing cycle times and QC release times are often well short of the benchmarks of other industries.
Is it possible to combine common continuous improvement tools and techniques in regulated facilities? The trick is to understand how to marry GMP compliance with continuous improvement.
PharmOut has consultants experienced in implementing process improvement in regulated facilities.
- Assess your processes and suggest or implement improvements
- Guide you through the GMP implications of the improvements
- Manage the whole project, leaving you to focus on your core business, or just provide overview process improvement consulting services
- Train your staff in process improvement techniques and how to ensure GMP compliance at the same time.
Lean manufacturing aims to eliminate waste or non-value adding activities in manufacturing processes.
Lean manufacturing combines the principles of: Just in Time, SMED, Value Stream Mapping, Kanban, 5 S and Total Quality, all with the aim of zero paper, zero inventory, zero downtime, zero defects, and zero delays in design, manufacture and distribution.
Now, try doing that whilst ensuring Quality system compliance!
PharmOut’s lean manufacturing consultants have a number of years of extensive experience in introducing such improvement programs in heavily regulated manufacturing environments.
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