1.5.2.3 Process owner

​​​​​​​​A. Background & Definitions

Every process needs a leader who has a vision (or shares the EQIPD vision), takes responsibility of the QS and its implementation and is willing to drive the process forward.​​

Process owner is a person within the organization (research unit) who has the necessary competence and resources or access to them, and typically has the authority to implement the steps needed to establish the EQIPD Quality System (QS). It is understood that the process owner is not always the head (director, president, CEO, etc.) of the research unit and may, therefore, have no ultimate authority.

Therefore, functionally, process owner is the person within the research unit who makes sure that the Core Requirements are implemented and maintained.

This Toolbox item refers to one of the Core Requirements (Core Requirement 1 - "Process owner must be identified for the Quality S​ystem") and describes the very first step that any research unit has to make when implementing the EQIPD QS (Implementation Strategy​).​

​B. Guidance & Expectations

Process Owner is typically expected to:

• Drive the implementation of the QS forward by setting up a team that will be involved in the implementation and providing all necessary resources
• If the research unit decides to use the Planning Tool for the QS implementation, keep the Planning Tool up to date and for providing other team members access to this tool
• Keep a track of the status of all NEEDs that are relevant for the research unit and for the implementation of the QS;
• Once the system is implemented, estimate and provide the resources necessary for maintaining the QS​
• Have the authority to delegate and to assign responsibilities in relation to planning tool tasks;
• Communicate regularly to colleagues, stakeholders and management about the progress of implementation​ and use of the QS, including any issues that may arise (if applicable)

It is typically expected that the Process Owner is someone who directs the work of the research unit (e.g. a professor, group leader, principal investigator, CEO or department head) and is competent about the role and importance of quality in research.

For large research units (companies, institutes), Process Owners, while maintaining the overall responsibility and decision-making authority, may delegate the task of running the EQIPD QS implementation to their associates (e.g. lab managers).

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Next item: 1.5.2.4 Principal investigators and study directors​

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