Delivering High-Impact Projects in an Operational Pharmaceutical Facility

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1 Delivering High-Impact Projects in an Operational Pharmaceutical Facility This white paper identifies five ways to mitigate owner risk on construction projects completed within a fully operational pharmaceutical facility. It includes information on what to look for when choosing a construction team for this highly specialized form of construction. By John Buescher and Tom Kreher, McCarthy Building Companies, Inc. If charged with selecting a construction team to renovate a pharmaceutical facility without disrupting ongoing operations, the questions we might ask prospective firms would include this one: Which situation poses the greater risks: a) completing construction atop a 50-story building without safety harnesses, or b) completing construction in an operating pharmaceutical environment? Explain your answer. A construction firm s response to this question will reveal much about its knowledge and experience, both inside and outside a pharmaceutical environment. The best responses will go to the heart of what makes high-impact pharmaceutical projects so much more challenging than other types of construction: they pose formidable risks to the owner. While risk is inherent in any construction project, the financial stakes are typically much higher in a pharmaceutical environment. There is a risk of compromising the quality of the products already being manufactured. There is a risk of invalidating an FDAcompliant cgmp process line. There are risks associated with new equipment that does not arrive on time, and operations that must be temporarily shut down. All of these risks can have substantial impact on the owner s bottom line. There are also ways to mitigate these risks and others. Here are five of the most important ones: 1. Define roles and responsibilities upfront, and in excruciating detail. This may seem obvious. But the truth is, a significant portion of pharmaceutical construction problems occur because the involved parties do not clearly understand the full scope of their responsibilities. Consider, for example, the issue of equipment procurement, and what it means to productivity when a project is delayed while awaiting the equipment s arrival. Some persons might consider such a delay to be an equipment manufacturing problem or a factory testing problem. In many cases, however, it is at its root a procurement problem caused by the persons responsible for procurement not fully understanding their responsibilities. If they work in-house for the owner, such responsibilities may go above and beyond their normal duties and include detailed expediting, tracking, scheduling and McCarthy Building Companies White Paper January 2007 Page 1 of 5

2 other tasks needed to ensure that equipment is manufactured according to design, shipped on time, and is tested and fully operational in accordance with the schedule s critical path. But they will not know that unless the owner/construction manager makes these responsibilities crystal clear from the start. Roles and responsibilities must be similarly defined in other areas. For example, an emergency action plan should be developed that clearly identifies who will respond in case of incidents or accidents, and which parties are responsible for any remediation or repair that might be required. A project-specific quality plan should also be formulated; it should detail which parties are responsible for testing, inspections, and reporting. Identifying these issues up front reduces confusion and possible rework later. 2. Develop an execution plan BEFORE making a schedule. On high-impact pharmaceutical construction projects, even activities as simple as taking out construction debris must be carefully orchestrated. At a recent project, the debris from an interior space under renovation was stockpiled and stored in the area during the week then taken out on weekends when the plant was not operating. Multiple dumpsters were brought in and staged on Friday night solely to remove this debris. Knowing HOW these various types of construction activities will be accomplished and sequenced is necessary before a construction manager can realistically begin to determine WHEN they might be completed. Determining the HOW is the purpose of the execution plan. Developed by the construction manager in conjunction with the owner s user groups, this plan should identify everything from the path the construction team takes to enter the facility, to how operations personnel will be notified of any temporary shutdowns. A key component of most execution plans is a protocol for clean construction which defines how a facility will maintain its existing room cleanliness standards. It provides explicit directions on what construction personnel wear, how tools and materials enter and leave the building to minimize the potential for contamination, and guidelines on a wide range of other topics specific to the facility s clean room classification. For example, it is typical to conduct continuous air pressure monitoring between a construction zone and the rest of a plant to ensure no construction dust has the opportunity to migrate to ongoing operations. There are different ways to achieve negative air pressure in the construction area. The option chosen is often not as critical as recognizing the need for it up front and making it part of the execution plan. Perhaps the most important and often most overlooked element of the execution plan is what happens at the back end of a project: the testing, startup, commissioning and validation of new systems and equipment. From day one, the construction manager should fully understand these requirements so it can plan to accommodate them. McCarthy Building Companies White Paper January 2007 Page 2 of 5

3 Achieving the entire project team s buy-in on the sequence of events leading up to these backend activities is key. The make-up of the owner group participating in execution plan development is also important. While it varies from one project to another, it should certainly include the owner s project manager, facilities and operations staff, and health and safety representatives, as well as other parties impacted, if only tangentially, by the construction. Consider, for example, renovations completed recently at a manufacturing facility shared by two pharmaceutical companies. While each had its own distinct manufacturing space, the two companies shared common utilities. The execution plan s utility shutdown plans, access strategies, personnel flow and product movement plans were all impacted by the presence of the second tenant, who was included on the owner s project team. 3. Expect construction to require multiple phases. Many construction projects are completed in phases. Very few, however, have the number or complexity of phases required by a project constructed with FDA cgmp validated facilities and systems operating around it. These projects resemble a checkerboard. Work must be sequenced so contractors complete one square before they can move on to another while not disturbing the other squares around them. With every jump on the checkerboard, the space must be again commissioned and validated before it can begin or resume production. Scheduling becomes even more challenging when construction includes both renovation and expansion of existing facilities, or is within or adjacent to a sterile environment. On one current project in a human-drug manufacturing plant, all of these factors are present. The construction manager is overseeing construction of purification suites, retrofit of a buffer prep area, installation of a CIP/COP system and modifications to an HWFI system much of which is within or adjacent to Class 1000 areas of the plant. In the first five months of the project, the work required 10 separate phases. To minimize exposure to the exterior building addition, for example, interior barriers were constructed and maintained while the new addition was completed and tied into existing systems. Temporary doors were installed at key points to allow construction personnel and materials access to the areas being renovated. Air handling unit supply duct systems and associated controls were modified to accommodate the construction being done in the various areas. McCarthy Building Companies White Paper January 2007 Page 3 of 5

4 4. Don t presume phased pharmaceutical construction must ALWAYS cost more. It is true: Phased pharmaceutical renovation projects generally cost approximately 20 percent more than greenfield construction 1. But with effective planning, a construction manager can reduce that premium, along with overall project risk, sometimes substantially. One way is to schedule the project so that work is performed using double or triple shifts. Such an approach minimizes the facility s overall exposure to construction activities since the construction duration is shorter and can often be accomplished without paying a premium for the second or third shift. The key to containing shift differential costs is to plan for them BEFORE the construction bid package goes out for bid. That s when contractors are in a competitive mode and will quote their lowest price for multiple shift contracts. When owners choose a multipleshift approach AFTER the contracts are awarded, they will invariably pay a premium for it. Some cost models, it should be noted, indicate that overall project costs are lower whenever project duration is reduced even with paying the cost of a shift differential. This is because the construction manager s and subcontractors general conditions costs the cost of being on-site are lower due to the shorter schedule. 5. Update the execution plan and schedule frequently, and track quality with painstaking detail. High impact pharmaceutical projects require more of everything: more planning, more details and more frequent updates than perhaps any other type of construction. If shutdown of an air handler or the WFI system or other plant utility is required to make a tie-in, this shutdown can be coordinated far in advance with the facility s production group and be done at the same time as a break in production (over a three-day holiday weekend, for example.) In addition, it should be mandatory for the owner and construction manager to conduct weekly walk-throughs of a construction zone and the spaces adjacent to it. Only a walk- through provides a true picture of how the construction activities impact surrounding operations. This continuous monitoring also makes it easier to keep the execution plan and construction schedule updated, which should also happen weekly. To help minimize risks on a daily basis, best practices call for the day to begin with a task review and job risk analysis. In a session that typically takes only 15 to 20 minutes, the foreman and work crews use a standardized process to review the task to be performed, assess the risks associated with it, and outline what they will do to prevent them. They also identify the response or recovery plan should the worst occur. McCarthy Building Companies White Paper January 2007 Page 4 of 5

5 Consider, for example, a project that requires a work crew to tie into an existing high- water system. In the job-hazard analysis, the crew would be required to think purity through all of the steps involved with making the new connection, including the cleaning and flushing requirements and other steps needed before the water line can be returned to use. The crew will also devise a plan of action if the existing line were to become contaminated in any way. If validation is involved, the owner may get involved as well. Each step would then be written in a project execution plan to document construction quality and to serve as a reference during validation. A number of these principles can also be applied to construction of a new facility. While some of the roles and responsibilities of new construction may vary somewhat from those of renovation construction inside an existing facility, it is still extremely important to define them for each party. And it is always good practice and more advantageous to update a project s execution plan and schedule more frequently. Whether it is material being delivered late or a subcontractor having a problem adequately manning the project, issues and problems come to light and are noticed and addressed sooner. Finally, if a portion of the new facility has to open earlier than the remainder of the facility due to revenue or startup requirements, the issues surrounding multiple-phased construction come into play since work will be going on around the operating portion of the plant. Lower risks = better projects It is impossible, of course, to eliminate owner risks on high impact pharmaceutical construction projects. Just like a harness is no guarantee of safety when working on 50- story building, a detailed and frequently updated execution plan is no guarantee of success on a project in a fully operational pharmaceutical facility. But everyone has more confidence and thus performs better when such safeguards, like the five ways to mitigate risk addressed in this article, are in place. McCarthy Building Companies contact information: Corporate Headquarters 1341 North Rock Hill Road St. Louis, Missouri / (phone) 314/ (fax) stl@mccarthy.com McCarthy Building Companies White Paper January 2007 Page 5 of 5