1. Organization and Personnel
Effective Date: 02/07
Point of Contact: Quality Engineer for Regulatory Programs
The organization of the project is the standard Battelle project-based system. The project represents staff from a cross-section of multiple Battelle organizations. All project staff report to the project manager for project activities. These same staff report to their organizational line management for all other activities.
The project manager and staff comply with the Training and Qualification for Staff and Non-Staff subject area. Staff shall be trained to project-specific technical and administrative procedures as applicable to their work scope.
The project manager and staff are responsible for knowing at a minimum the Roles, Responsibilities, Accountabilities, & Authorities (R2A2s) associated with their role(s) within the project. See the Project Specific R2A2s exhibit for the R2A2s associated with the Quality Representative.
The project management complies with the Project Management subject area in performing project activities.
The project manager complies with the Stopping and Re-starting Work (Safety Rights and Responsibilities) subject area when it has been determined that undesirable trends related to quality, safety, security, safeguards, or other measurable performance indicators exist.
All project staff have safety rights and responsibilities and therefore must comply with the Stopping and Re-starting Work (Safety Rights and Responsibilities) subject area. This subject area discusses these rights and responsibilities, how these rights and responsibilities are exercised, and the process by which staff may stop work.
The project manager documents any unique functions and R2A2s that are not described in Battelle's existing framework or this plan.
The project manager designates an individual responsible for assessing the project and for performing the Quality Representative's role. The individual may be a Quality Engineer or the directorate Quality Manager. The individual responsible for assessing performance cannot be responsible for the work performed.
References
Project Management subject area
Roles, Responsibilities, Accountabilities, & Authorities (R2A2s)
Stopping and Re-starting Work (Safety Rights and Responsibilities) subject area
Training and Qualification for Staff and Non-Staff subject area