Project stakeholders are not project team members, but have a vested interest in the CQV project execution as they are impacted either directly or indirectly by the successful implementation of the project. While project stakeholders can be internal or external, for our purpose, these project stakeholders are typically company employees that will be responsible to provide the needed support (think developing Standard Operating Procedures, staff training, startup support, analytical support and the like) once the project is nearing turnover to the end users.
Subject Matter Experts
A subject-matter expert (SME) is a person who has accumulated great knowledge in a particular field or topic and this level of knowledge is demonstrated by the person’s degree, licensure, and/or through years of professional experience with the subject. In pharmaceutical and biotechnology areas, ASTM International standard E2500 specifies SMEs for various functions in project and process as:
“Subject Matter Experts are defined as those individuals with specific expertise and responsibility in a particular area or field (for example, quality unit, engineering, automation, development, operations). Subject Matter Experts should take the lead role in the verification of manufacturing systems as appropriate within their area of expertise and responsibility.” —ASTM E2500 §6.7.1 and §6.7.2.
For one project there may be several people identified as an SME for one or more systems such as HVAC, compressed air or gases, process water, process machines, process, packaging, storage, distribution, and supply chain management.
If your company does not have internal SME system experts on, for example, HVAC, or other facility utilities, then the project team should determine where SMEs are required and acquire services of consulting SMEs in the areas where such internal knowledge is lacking. These hired consulting SMEs work for the project team. Medvacon has an extensive network of SMEs that can be brought onto the project team.
The services of a SME for, say, pharmaceutical-grade water, may not be full-time for the duration of the project, but the consulting SME should be part of the development of user requirements, functional specifications, system design working with the design engineers, evaluating vendor proposals, and assisting with system installation inspections, system start-up, commissioning, and qualification. She or he will come into the project team when needed by the schedule or activity, or when requested by the team.
The importance of an SME’s role within the project team cannot be overstated.
MEDVACON and our team of Quality Experts have conducted several CQV projects, some of which involved multidisciplinary teams and others with just one or a few resources. MEDVACON can scale to handle your CQV project.