Automation Project Management at Baxter: On Time and Within Budget
In this article, excerpted from the March 2007 Pharmaceutical Manufacturing magazine, co-authored by Baxter Healthcare and Emerson Process Management project managers, key considerations are outlined to ensure on time, on-budget implementation of a manufacturing project. Examples in the article illustrate the important interaction of software, device, and engineering services suppliers as integral project team members toward achieving the project's goals.
In pharmaceutical industry automation project management, every minute counts. Any new drug has only 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, mistakes, unnecessary work and missed schedules.
The control system team must be ready when the plan construction is complete. The plant must manufacture its compliance lots on schedule and archive FDA validation within the shortest possible time frame. This article suggests steps to help achieve project goals and gives examples of how these best practices are being applied at Baxter Healthcare facilities.
Set Goals and Priorities
Once the project is approved by management, the project manager must define its goals and priorities and communicate them to the entire team.
For any project, three general priorities compete: functionality, budget, and project schedule. All are important, but they can't be equally important. Team members-- including project engineering, process engineering, quality validation, procurement, construction management, and plant operations-- must select and agree upon the most important priority to set the pace for the others.
Occasionally priorities will change due to external factors-like a competitor launching a similar product-so reduced time to market may supersede the previous budget priority. New expectations should be quickly realigned so the team can change its course with minimal efficiency loss.
A Baxter grassroots facility was designed to make two distinct product groups using different processes. The plan was to complete validation of the first process, the start work on the second. However, delays in validation in the first process, and changing market conditions prompted Baxter to start the commissioning and validation of the second process while the first was still being validated.
This decision could have wrought havoc, but impact was avoided by assembling a cross-functional team including control engineer, along with quality manufacturing representatives and engineers from the project's 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 automation system's simulation software. This allowed validation of the first process to proceed on production equipment, while the software for the second process was validated on the simulation system using the FDA's risk-based approach.
Communications vital
On another Baxter project, the project manager initially communicated to team members that budget adherence was the key priority. Throughout the project, he made sure his team members as well as the vendor's team understood that for any additional cost, there would be trade-offs by eliminating other work. As a result, the project was completed on budget and on time with excellent quality.
In a small project in an existing unit in which Emerson Process Management supplied field equipment as well as automation software, the Baxter team communicated daily with Emerson through project scheduling software that was updated and shared each time an event occurred that affected the schedule. This tool vas invaluable in spotting delays early so the team could take corrective action s to keep the project on schedule.
Avoid Data Hoarding
Sometimes, project managers may unintentionally keep priorities a secret or assume that all are equally important, leading team members to visualize the wrong goal. Alternately they may assume that team members-particularly vendors-may use this knowledge to minimize the work they do for the project. These concerns are usually groundless, and any resulting losses are dwarfed by the gains achieved by having everyone working toward the same goal.
Adopt a Project Methodology
Since the overall goal in life sciences is decreasing time to market, it is vital to design a methodology that takes into account all steps, from the beginning of the process, to delivery of saleable product. One of the best ways to understand the impact of methodology decisions on the schedule is to create a detailed plan schedule that shows the dependencies of activities and considers the impact that changing one deliverable will have on others.
Another important task is to clearly document the expected content of the purpose of each step, making sure all parties review and approve the plan. If the project methodology includes developing process descriptions, functional specifications and detailed designs but does not define the content of all three documents in the beginning there is a good chance that the process descriptions will have too much or too little information from which to create functional specifications.
In a recent Baxter project, a staff of process and control engineers with guidance from quality staff was assembled to complete the process description and functional specifications in house. Since the facility was highly automated, the control engineers took the lead in writing the functional specifications in sufficient detail to send it out to system integrators for bids. And because of the detailed specifications, the selected integrator (Emerson Process Management) was able to move quickly to the design phase, resulting in significant saving in the project schedule, and implementation of the software was completed with few changes and no scheduling delays.
Develop Test Plans for the Entire Project Life Cycle
Considering the entire project life cycle and the type of project-a new facility, retrofit or expansion-helps to develop a methodology that best fits the project goals and eliminates unnecessary duplication of effort.
In a highly automated grassroots facility, the automation software must be developed and tested before any equipment can be operated or tested. In a recent project, Emerson implemented the software, then tested it internally before turning it over to Baxter for a factory or site acceptance test (SAT). Since detailed software validation OQs would be done later the SAT consisted of functionally testing all recipes on a simulation system During the SAT, Emerson people remained on site to correct code issues and to make changes as they were identified. Following the SAT the software was released to the equipment commissioning teams.
Since this was a large project, testing, commissioning and validation were broken up into several parts. This allowed commissioning and validation to occur concurrently, which greatly sped up the project. And since software validation used much of the same equipment, testing was done on a simulation system to minimized scheduling conflicts.
Code that did not require a field element for testing was deemed "low risk" and could be validated in simulation only. After completion of the simulation OQs validation of items requiring field elements such as valves and instruments were tested in software filed OQs.
Decisions about the project methodology can affect the long term operating cost of the plant. For example, which documents will be "living documents, maintained throughout the plant's lifecycle, and which documents will be created for a specific pit in time and not updated as information changes?
All these decisions are consistent with the risk-based approach to validation and should be part of a formal risk analysis prepared at the beginning of the project.
Take a Broad View
The project team should be made up of everyone who affects the automation or is affected by it. This should include people from operations, quality, validation, process design, and automation. Assemble these team early in the project life cycle, because decisions made by one group with affect other groups.
Without developing a team in which every member is doing his or her best to make the entire project successful-rather than simply minimizing the cost and schedule of its part without consideration for the overall result-it will be difficult or impossible to complete the project on time and on budget. For example, a decision by the process engineers to minimize the cost of physical equipment by not standardizing the equipment could drive up the cost and schedule of the automation, commissioning and validation.
There will be trade-offs during any project in which increasing the cost or schedule in one place can decrease the overall cost and schedule.
In one case, due to unavoidable circumstances, Emerson's project lead had to leave the project during the software design phase. This caused a two week schedule delay to bring a new design team leader up to speed. But because of the plant startup, the project end date was immovable.
Through an integrated customer supplier team relationship we were able to find ways to recover the lost schedule time. By adding system integrator resources to the implementation and testing, and Baxter accepting some low level of risk in implementing parts of the code with only preliminary design approval, we were able to recoup the two weeks needed to finish the project on time.
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