In pharmaceutical industry automation project management, every minute counts. Any new drug has only a limited time to capture a market, gain a following among physicians and extract maximum value from sales before its patent runs out and generic versions hit the market. Millions of dollars worth of investment are riding on the project team, which must prevent time-consuming haggles, turf battles, disagreements, false starts, mistakes, unnecessary work and missed schedules.
The control system team must be ready when the plant construction is complete. The plant must manufacture its compliance lots on schedule and achieve FDA validation within the shortest possible time frame. This article will suggest some steps that will help achieve project goals, and give examples of how these best practices are being applied at Baxter Healthcare facilities.
Set Goals and Priorities
Once the project is approved by senior management, the project manager must define its goals and priorities, and communicate them to the entire team. For example, the goals may be to have Plant A in operation by the second quarter of 2008 (please note that, generally, it is not a good idea to specify a date) and be able to produce any of three target drugs currently in the pipeline with a staff of X number of people.
Unless care is taken on the front end of the project to prioritize the teams efforts, the project can very easily get off-track. For any project, three general priorities compete: functionality, budget and project schedule. Theyre all important, but they cant all be equally important. Select the most important one, initially, to set the pace for the rest. (In Figure 1 below, adherence to schedule was chosen as the critical factor.)
Figure 1: All project goals cant be equally weighted. Begin by deciding which one is most important or the team may make the wrong assumptions. Click photo to view larger image.
A kickoff meeting should then be held, during which the projects priorities and goals should be set and agreed to by all project team members, including: Project Engineering and Management, Process Engineering, Quality, Validation, Procurement, Construction Management and Plant Operations. Priorities and goals should also be set with each vendor at kick-off meetings.
Occasionally, priorities will change due to factors outside the project teams control. For example, if a competitor launches a product that competes with the new drug, the need to reduce time to market may outweigh previously established budget constraints. This situation is manageable as long as everyone on the team realizes that disruptions will have serious consequences for overall project efficiencies. New expectations should be aligned quickly so that the team can correct its course with minimal loss of efficiency.
For example, one Baxter Healthcare grassroots facility was designed to make two distinct groups of products using different processes. Initially, the plan was to complete validation and start up the facility with one process, then start work on the second process. However, due to delays in validating the first process and in response to changing market demands, Baxter decided to start the commissioning and validation of the second process while the first was still being validated.
This decision could have wrought havoc, but any impact was avoided by assembling a cross-functional team. Including controls engineers, representatives from quality, manufacturing and engineering and from the projects system integrator, Emerson Process Management, the team developed a new project plan for the second process that could work around the validation efforts of the first process.
The team made extensive use of the FDAs risk-based approach to validate as much of the automation software as possible on a simulated system. This allowed validation of the first process to proceed on the production equipment while the software for the second process was validated on the simulation system. Reusing much of the software for the first process greatly reduced the amount of validation work required for the second process. Finally, by combining both projects on the same schedule, we were able to quickly identify and resolve conflicts between the projects.
Communication is Vital
On another recent project, the project engineer made it clear to everyone at the beginning of the project that the projects budget was limited. He said it was everyones job to meet the automation objectives and the schedule while staying within that budget. He then encouraged the entire team to look at every item with a critical eye and ask the question: Is this required to meet the projects automation goals or is this a luxury (and a sign of creeping elegance)?
From the very beginning, the project manager did an excellent job of communicating that he was serious about meeting the budget. Any work that would increase project cost had to be offset by eliminating other work, or he would not approve the change. The project manager also made sure that his team, as well as the vendors teams, knew that they were all responsible for meeting the budget. He consistently monitored the expected cost at completion and made the necessary trade-offs between parts of the project to accommodate unexpected costs that could not be avoided. As a result, the project was completed on budget and on time, with excellent quality.
Avoid Data Hoarding
Sometimes, with the best of intentions, project managers may keep priorities a secret or assume that they are all equally important, leading to a situation where everyone else on the team must scramble to figure out which goal is most important. Very often, they wind up visualizing the wrong goal, leading to misunderstandings and possibly finger pointing later on.