Project Manager Skills.
Within the skills of a Project Manager or Project Director, whether in qualification projects or any other type of project, there are many and varied tasks, but the most important and common to all of them are the following:
- Create a master project start-up document containing all the information about the project, objective, scope, and responsibilities, including those of the client, project development phases, and execution milestones.
- Organize and plan the work: identify who is going to do each task, specify the deadlines to deliver, estimate the available resources, and foresee how to react to possible unforeseen events.
- Set a schedule that includes the deadlines for each task required to complete the plan.
- Lead the team: it is necessary to know how to coordinate and manage the work of each of the team members, motivating them at all times and managing crises, because no matter how good the planning is, unforeseen events can always arise and must be faced while minimizing risks.
- Ensure compliance with the requirements, checking that everything is complete and accurate before delivery.
Time and resource management.
To manage a qualification project properly, time and resource management is a very important aspect. One of the main reasons is that qualification is the last step before the equipment/system begins its operation and often, accumulated delays can occur and the equipment and/or system must be able to start with a process validation test.
Understanding what tasks can or cannot be used from the commissioning to the qualification phase, making risk analysis-based decisions, verifying that all systems are installed according to the client and regulatory requirements, and ensuring accuracy through collaboration with quality will ultimately save time and money. On the other hand, the impact of not testing and not verifying can result in problems; clients need to understand the critical nature of testing and the parameters that must be used. An effective project manager understands the associated processes of the critical systems/equipment under test and is able to identify any issues/misalignments with expectations that may compromise the qualification performance of another system or equipment and communicate/correct them accordingly. Therefore, the use of tools that help us to manage processes is a very important aspect in order to achieve the goals of the project. For example:
1. Perform an Impact Systems Analysis.
The first step is to define the criticality level of the equipment and/or systems of a C&Q project and for this purpose, we will perform an Impact Assessment of all the systems and equipment that are part of the project. The systems and equipment are classified according to their risk for product quality and patient safety.
The classification of systems according to their impact is based on the method described in the ISPE Baseline® Guide: Commissioning and Qualification (Second Edition), which defines eight questions to determine if a system has direct impact or no impact on product quality. The system classification establishes whether a system is commissioned and qualified or only commissioned:
- Direct Impact Systems are commissioned and qualified;
- Noimpact systems are commissioned only.
2. Use of the Leveraging Strategy.
Another important point for the management of a qualification project is to take advantage of all the options allowed to save resources and time. For this reason, not repeating tests once they have been executed is a very valid strategy recommended since 2019 by the commissioning and qualification guides. Before starting to perform any of the qualification phases and once we know the scope, the PM must know exactly how the commissioning of each equipment and/or system is performed and how these activities can be used for subsequent qualification. The more that is known on the front end, the more likely the back end for qualification will run smoothly.
It is at this point, when we define the different phases of the qualification project, that we must correctly identify the leveraging strategy. It must be very well defined from the beginning which systems or equipment are susceptible to follow this strategy and under what conditions we can make use of it. For those who are not familiar with the term, ISPE defines leveraging strategy as “the use of previous verification activities performed and documented according to good engineering and documentation practices, performed during commissioning and start-up or during vendor testing, can be used during qualification (IQ and OQ), avoiding unnecessary repetitions and reducing qualification time and costs.”
This strategy, and which test is susceptible to carry it out or not, must be set out in a document and this activity corresponds to the PM. This document that links the qualification strategy, the scope of all the equipment/systems/services, and the responsibilities of the different members of the team is known as the Commissioning & Qualification Plan (CQP) or what we usually call the Validation Master Plan (VMP).
It is very important that the PM continually communicates with the client. Therefore, before starting to perform any task of the project, the CQP must be reviewed and approved by the client. The drafting of a good CQP is a time-consuming task, but it is time worth spending as it will be the basis of the whole project. It is an essential document for all team members to know the strategy: who must be involved at what time, the scope of qualification, and which test has to be performed in each system/team/service phase.
Once we have this CQP defined and confirm our ability to complete it, another important document that should also be considered, in the initial phases of a global qualification project, is a document map. This map represents all the documents that must be done in each qualification phase of the different systems/equipment/services and their relationship to each other. Consider which services should be qualified before starting to qualify an equipment or system that provides service to other equipment, for example, commissioning the black utilities or qualifying the purified water generation plant before qualifying the WFI generation, as the outcome of a certain system’s parameters can interfere with the proper functioning of the following systems.
With everything organized and agreed upon, and when the strategy is approved by the client, we can now start to carry out the different tasks we have planned.
A good project manager should create work groups, define tasks according to the experience of all team members, and receive feedback on the activities performed. For this reason, holding periodic meetings is important because it allows everyone to know who is working on what, how the project is moving forward and above all, to keep the whole team involved and committed.
Depending on the estimated duration of the project, it is recommended to hold global meetings of the entire project team to report on the status, client comments, and upcoming dates. In addition, weekly meetings to organize the important milestones of the week, and sometimes even daily planning meetings, with those responsible for the different teams and where the milestones of previous days are reviewed and the work to be done at that moment is planned, are essential.
At PQE, we strive to set goals and objectives for two-week time periods once the overall project scope has been created. By project managing tasks within shorter intervals, we can identify what exactly is or is not occurring, what may impact our process/progress and what may need adjusting before starting down a new path.
Often, companies will require reworks that can lead to delays. The project manager who is managing the required modifications and overseeing these decisions to carry them out should also do everything possible to keep the entire team involved and engaged. Ensuring that all members of the support team (i.e. directors, managers, in-house engineers, quality, consultants, etc.) are aligned with the project goals and understand how certain action items could be opportunities to identify gaps in procedures that will ultimately allow the team to work smarter and not harder is a primary goal of the project manager; not just to be the technical expert but also to understand expectations and how these can be implemented into each phase of work.
In the end, quality compliance will always be the number one goal. As long as compliance and quality meet industry standards, the project is successful.
This comes with patience, hard work, collaboration, and communication throughout the entire team. Led by an effective project manager, companies can create a way of proceeding with future similar projects, avoiding unnecessary steps, saving time and money, and ensuring successful project completion.
iSpeak Blog posts provide an opportunity for the dissemination of ideas and opinions on topics impacting the pharmaceutical industry. Ideas and opinions expressed in iSpeak Blog posts are those of the author(s) and publication thereof does not imply endorsement by ISPE.