— Briefing . Operational Excellence

The Waste Outside the Regulated Process

By Carina Veloso · Real World Quality Exec · May 2026 · 2 min read

While watching the video “Inappropriate Processing: Biggest in 30 Years!” by Paul Allen, I couldn’t help but think about pharmaceutical manufacturing. A real example of value stream analysis, identifying significant waste right at the point of customer demand.

In a highly regulated environment like pharmaceutical manufacturing, attention naturally concentrates on the regulated parts of the process. This is correct. When materials or products are not compliant, the impact on quality or safety can be significantly far greater than the cost of ordering “too much” of a material. Time waste from non regulated activities is less visible. It does not trigger a deviation. It does not appear in a quality metric. However it consumes resources, delays value, and quietly compounds across every cycle.

In Paul Allen’s example, the production process itself appears to be controlled and aligned with the organisation’s plans. The “inappropriate processing” was identified by VSM in the information flow between internal customer and internal supplier. For instance, it could be from the moment the sales team makes a demand until that request reaches the production site. A step that can be smooth, well configured handover, just like that, it was instead the bottleneck.

In my experience of working with different pharmaceutical manufacturing organisations and hierarchies, this is a common pattern. While regulated processes should certainly receive the most attention, some of the biggest lean waste occurs precisely in the processes that fall outside the regulatory framework. Nobody has mapped these processes. They are not a priority. Their impact on resources is not immediately apparent. They just run year after year.

Some organisations look to the software for answers. The point is not the electronic system, but rather the way in which certain organisations use the software. Whether it is SAP or any other platform, the system will execute the process design that has been given to it. A poorly designed information flow is executed as faithfully as a well-designed one every time, at scale. In the example presented, the flow was configured to require managerial approval at different steps, and that was precisely what was happening. Clearly, oversight has its place. Good leaders and managers know which decisions require their involvement and which the process should handle autonomously. When approval becomes a hierarchical reflex rather than an evaluation, it is a waste in itself. No large project is required to resolve this issue. It is an administrative and responsibility adjustment.

References

Video “Inappropriate Processing: Biggest in 30 Years!”, Paul Allen, May 2026