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.