Standard Individual QRM Roles
| Individual QRM Roles |
|---|
| QRM Facilitator: Person(s) with the competence and skills to facilitate the QRM process as an independent QRM expert; Facilitate Quality Risk Assessment sessions and provide guidance for completion of QRM documents and risk control, risk communication, and risk review activities. |
| Quality Risk Assessment (QRA) Lead: Person(s) with the competence and skills to lead a risk assessment in terms of planning, completion, communication, review, and approval of QRM deliverables as well as tracking of risk controls measures (in some companies this role is the same as a facilitator role, but in a company mature in the application of QRM principles, a QRA Lead is its own role). |
| Subject Matter Expert (SME): Person(s) with expertise in the area/topic being risk assessed who are able to provide technical expertise to support QRM activities including identification of hazards and implementation of risk controls. |
| QRM Program Manager: Person(s) with the competence to develop and consistently deploy a QRM program across the manufacturing site/operation within the area of responsibility. |
| Other QRM Users: Person(s) with basic QRM understanding who apply it as an enabler to the Quality Systems. These include staff in all areas of GMP who are expected to apply risk-based principles within their work (e.g., change controls, deviations, batch record review) |
| Quality Unit Members: Person(s) with the competence to review, assess, and approve QRM documents within their areas of responsibility and ensure compliance with internal Quality System requirements and external regulations. |
| Senior Management/Decision Makers: Person(s) with the competence and authority to make timely QRM decisions and who is authorized to accept the risk and direct response strategies for risk mitigation and follow-up. Person(s) with the authority to provide resources to conduct QRA and QRM activities, including the implementation of risk control measures. |