By: John Lyons
Sr. Process Engineer
IPS-Integrated Project Services, LLC
Human nature draws us to things that are shiny and new; it’s a tendency that crosses all geographical and cultural boundaries. There are departments, businesses and in fact entire industries whose primary purpose is to leverage this tendency into sales and profit. These forces are active on us whether we are aware of it or not throughout most aspects of our personal and professional lives. When starting a new project what comes to mind first? What are the juicy bits everyone wants to jump into – Site Planning, Equipment Selection, Color Pallets, and Architectural Details? While those of us trained to operate within a regulated industry may be slightly more aware of these internal and external forces acting upon us, or at least the unbalanced focus on the end product, we are far from immune. How do we resist the temptation to shortcut thorough evaluation and jump straight to pre-conceived solutions? Simple – Focus on the Process.
Focusing on the process can lead to improvements in a number of aspects of life; in terms of life sciences, from inception to full scale commercial operation it’s a keystone to success. Unfortunately though, “the process” is essentially intangible compared to other shiny bits and pieces that come together for a successful project. As a result, it can take a back seat or not be considered altogether until it’s too late. It is, however, the process definition that brings together man and material into a well-structured and smooth flowing operation. Compromise it and you’ll be suffering the work-around for years to come.
In practical and simplified terms a project would follow a basic hierarchy of: Process => Equipment => Facility => SOPs (standard operating procedures). The Process drives equipment selection. The facility provides appropriate space for the process and equipment. Finally the SOPs provide guidance to personnel on how to interact with the Process, Equipment and Facility to deliver the desired end product. SOPs are most easily followed and managed when they are primarily serve to bring together previously defined and designed steps and processes.
Putting the cart before the horse: Difficulties arise when the facility or equipment are not designed for the process and work-arounds are required. This expands the detail and often technique required to follow SOPs increasing rigor and strain to operators, ultimately reducing robustness of the operation. In a worst case scenario, work-arounds are not sufficient and equipment or facility replacement or modifications are required.
A “Process First” mindset is not always the easiest approach, but it will go a long way in providing a consistent frame of reference for decision making and ensuring you arrive at the destination you envisioned the start of your journey.