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This article presents an overview of ISPE's guide on project management.
There are many elements of project management that are generic across both project and industry types; however, there are some specific challenges within the pharmaceutical industry. The ISPE Good Practice Guide: Project Management for the Pharmaceutical Industry (PM GPG) was developed to address those challenges with certain key aims in mind (1). This formed the basis of the business case, which further detailed key objectives.
The first objective was to create a document to discuss and compile best practices for project-management concepts within the context of the pharmaceutical industry, which has unique needs and challenges. The second aim was to have the PM GPG serve as a toolkit to help pharmaceutical project managers deliver successful projects quickly. The developers set out to offer content that addresses managing risks common to pharmaceutical projects and to promote and support a common language for the pharmaceutical project-management community.
Furthermore, in reviewing current trends in both project management and the delivery of pharmaceutical projects, a hypothesis was developed around how the value of project management needed to be developed within the pharmaceutical industry (see Figure 1). Although the purpose of the guide was not to duplicate generic project management practices already contained in other standard project management guidance documents, the guide should and would highlight areas of project management where improvement was value-added (e.g., people management and risk management) even if the challenges for their management were not distinctly different from other industries.
Figure 1: The Project Management Good Practice Guide hypothesis. (FIGURES 1-5 COURTESY OF ISPE)
Once the business case for the guide gained ISPE approval, the project for developing the guide began. A project director and project manager were appointed, and a team of key stakeholders was formed. The team developed a vision of success for the project.
With this key structure in place, the core team agreed that for the team to achieve success, all had to behave as "good practice" project managers. The team had to use its combined project-management expertise to deliver quality content in an effective, value-added way. The fundamental philosophy driving the delivery was summarized in one phrase: "practice what we preach." In other words, the team needed to use good practice in project management throughout the guide project. The development of a robust project delivery plan (PDP), therefore, was a key requirement.
A PDP requires a project team to fully consider all elements of project delivery before actually starting to deliver the project. For example, in the PM GPG project, the PDP allowed the team to consider its strategy for stakeholder management before making any announcement requiring writers or reviewers involvement.
The PDP also ensured that the team gained agreement with ISPE on the governance process for publication, agreed-on key stage gates, and "go or no/go" decisions throughout the writing, reviewing, and publishing process. Figure 2 shows an example of the stage-gate process developed for pharmaceutical projects. It emphasizes the lifecycle approach to project management and the value of stage gates as a way to check that progress should continue; key questions are asked and answered with supporting data.
Figure 2: A stage-gate approach to project management.
The approach to managing stakeholders involved working as a small core team to develop the guide structure and key concepts. Involvement of subject-matter experts (SMEs) was requested so that small chapter teams could be formed, each led by a member of the core team. A schedule was developed based on the agreed-on stage gates, and milestones were used to review progress with each chapter team.
In this way, the guide team avoided the usual collaborative document development process of starting with too many eager volunteers who slowly decline to be the active team of writers. In order to effectively engage the industry, the team needed to develop the guide quickly and in a lean manner. Those wanting to get involved, but without the time, were encouraged to get involved in the industry review, a crucial aspect of the whole process.
Defining the scope
Once the full delivery strategy had been developed and approved, the guide team focused on the introduction chapter detailing the guide purpose, benefits, industry context, and scope.
The scope was the hardest part of this work. There are many project types as a pharmaceutical product moves from an idea to a manufactured drug for sale in the market. A boundary had to be drawn (see Figure 3), thus giving the chapter teams clear guidance that linked to their subject-matter expertise.
Figure 3: The scope of the guide.
The discussions on scope led into agreement on which project types would be supported by the guide and also the fundamental concepts to direct SME chapter writers on what content should be included or not included in each chapter (see Figure 4). The eight key concepts were a checklist of content relevance, approach, and value to pharma products.
Figure 4: The guide’s key concepts.
Once Chapter One was written, the delivery of the lifecycle chapters began (Figure 5). In any project, the management of uncertainty becomes the key focus, and the guide project was no different. The guide was managed using a risk-based approach; all areas of uncertainty were identified and managed. A good example is the way that chapter content and schedule adherence were reviewed.
Figure 5: The key structure of the guide.
Each chapter team was clear on the definition of project success: "develop a valuable industry guide and launch it at the 2011 ISPE Annual Meeting in record time (18 months from start to finish)." Schedule and technical-content risks were analyzed using the Risk Matrix (see Figure 6). Risks were assessed for probability of occurrence and impact on the chapter goals should they occur. Each chapter was given a red, amber, green (RAG) rating dependent on these two factors, thereby enabling the core steering team to predict likely success. Control of the project schedule and risk profile were managed through regular virtual meetings, allowing a one-team approach no matter where in the world a team member was located.
Figure 6: The risk matrix. (FIGURE 6 COURTESY OF MIME)
The guide team attributed a significant part of its success in having true "working sessions" via a webex platform. Action logs were generated "live" with no need to write lengthy minutes after the fact. Chapters were written and reviewed "live," thereby avoiding the need for team members to have extended writing sessions outside of the virtual environment. Work was available on a shared e-area, which avoided revision conflicts and emailing large documents. Through lean working, the team was able to write high quality chapters in agile time-scales to allow the guide to go out for a full industry review only eight months after the project was launched.
Writing the guide, however, was only one stage in its lifecycle. The review process involved a wider group of stakeholders whose role was to evaluate the guide in terms of technical accuracy, appropriateness, and value to the industry. This review was managed in a structured way to ensure that all comments were responded to by the team.
The guide was launched at the ISPE Annual Meeting in Dallas, Texas in November 2011 as a part of the project-management track. The launch, less than 18 months from kick-off, was due to a team effort born out of a combined desire to share knowledge, provide good practices to improve project outcomes, and demonstrate the value of project management across the industry.
The launch success was only the start of the final stage of the guide project: benefits realization. Success can only be truly determined by sustainable use of the guide, continual feedback from users, and continuous improvement.
To support the guide's objectives, the core team remain in place to assist ISPE by continuing to foster awareness of and educate the pharmaceutical industry about the guide. The members of the ISPE Project Management Community of Practice (PM COP) continue to promote the guide and its adoption in the pharmaceutical industry.
To support achievement of the benefits, key metrics were developed against each of the goals described previously (see Table I). These indicate a strong release of benefits in the first six months since the guide's launch.
Table I: Benefits realization plan of the ISPE Project Good Practice Guide.
Ultimately, the success of the guide will be its continued use and development within the industry. The objective of the guide project was to develop a resource to improve project delivery success, and the guide is only one aspect of the support the ISPE PM COP wants to have available to those involved in projects.
Ongoing development of the key areas, those that are different or more challenging for pharmaceutical projects, will continue, and the ISPE PM COP remains dedicated to this development.
The author of the article wishes to acknowledge the work completed by the PM GPG Core Team, all chapter teams, and the ISPE Guidance Document Executive Committee (GDEC) on this project.
Trish Melton, BSc (Hons), PhD, MBA, CEng, CSci, FIChemE, is managing director at MIME Solutions Ltd. and author team leader of the ISPE Good Practice Guide: Project Management for the Pharmaceutical Industry, firstname.lastname@example.org.
1. ISPE, ISPE Good Practice Guide: Project Management for the Pharmaceutical Industry (Tampa, FL, 2011).