Would you buy a two bedroom house if you had a family that needed three bedrooms?  That is the same principle behind knowing your process before spending the capital on buying the equipment and facilities.

It is common knowledge that the cost impact of wrong decisions and change is not linear through the life of the project. It increases exponentially as you go through the phases from conceptual to construction and startup and eventually validation to licensure in the case of government regulated facilities.

It is a difficult decision to consciously allow adequate time to develop the process both on a micro level as well as the macro level of the facility layout, material flows, personnel flows, waste streams and future growth.  It is difficult because the cost of doing this can’t be accurately measured with future savings or reduction of risk.

We only statistically know that no plan is perfect and often the decision is made to move forward with risk and we call this contingency.  The question then becomes, when do you move forward?  The logical response is when you know the risk and you can measure the risk relative to the overall capital cost, speed to market and all other financial considerations are well understood.

How then do you understand the risk from a process standpoint?  To know the process is to know the specific steps from raw material dispensing through each formulation step to final packaging, storage and shipping.  Knowing the scale, the facility and utility requirements, the specific equipment design criteria, cleaning methodologies, health and safety impacts.  Knowing each specific parameter, the target value, the acceptable critical range, the hold times, etc. so well that you know it is “fixed” and will not change in a significant way for the scale you intend to produce.

Ironically, if you have been involved in this, even with technology transfers of existing process at the same scale, you know that the process is never exactly fixed when you start the project. So you need a proven, reliable way of assessing the risk to the capital budget from the unknown from the process.  Can you answer the question of “Am I sure that this 400L process vessel is the right size?”  What if it isn’t?  Will you know at the time of purchase?  The vessel is typically one of the longer lead items on a project so you will need to get it on order soon.  Do you oversize the vessel?  That may not be logical as it will impact everything – floor space, structural steel, utility systems, cleaning, etc. And what happens if you were wrong?

The role of the process engineer is to define and clearly communicate this risk in terms of capital and schedule with the level of uncertainty in the process.  The role of project management is to enable the process engineer to do such evaluation in an agreeable time frame. So while defining the process quickly is the holy grail of the process engineers’ work, the correct approach is also identifying the risk due to uncertainty and gaps in the process and effectively updating that risk assessment through the progressing phases of the project.

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