4.1.2 Self assessment

​​​​​​​​​​A. Background & Definitions

This item refers to one of the Core Requirements (Core Requirement 17 - "An approach must be in place to monitor the performance of the EQIPD QS, and address identified issues") and is, therefore, considered as essential.

The self-assessment:

• ​answers the question whether the RU has everything in place needed for proper performance of the fit-for-purpose Quality System
• sets the basis for internal or external quality checks / accreditation mechanism

Depending on the organization, self-assessments may be supplemented by internal assessments conducted by qualified members outside the RU but within the same organization (e.g., dedicated quality professionals).

B. Guidance & Expectations

Self-assessment must be conducted by the Process Owner who may involve other members of the RU (or delegate certain tasks).

Defining the scope and content of the self-assessment

• Process Owner should define the scope of the self-assessment (involving the RU members as needed), e.g.
  • Are the RU's quality goals and objectives reached?
  • Is the RU prepared to seek or maintain a formal EQIPD Quality System accreditation?
• Together with the RU members, Process Owner should define:
  • How often self-assessments are to be conducted (depends on the characteristics of the RU, research that is conducted, and the risks that are likely to be encountered)?
  • How often should the spot checks on completed studies be conducted? What is the procedure for such spot checks?
  • Should any issues be identified, what is the procedure to address these issues? What is the procedure to address the effectiveness of the corrective measures?
• It is up to the Process Owner to decide whether the self-assessment procedure (with/without associated metrics) should be documented and, if yes, in what form

Conducting the self-assessment

• ​​If the EQIPD Planning Tool is used, it may be advised to support the self-assessment procedure using the Action Plan. During the period of time separating consecutive self-assessments, Process Owner (or someone to whom this task is delegated) may record all relevant information in the correponding fields of the Action Plan. Having all information and notes in one place will facilitate the completion of the self-assessment report
• The solutions developed by the RU to address the EQIPD Core Requirements and beyond (e.g., in the Action Plan) shall be checked for their effectiveness (Process Owner should involve members of the research unit, as needed). If changes are required, these should be implemented and described in the self-assessment report.
• The self-assessment report may be prepared using the template provided by EQIPD (please see the link below in section C).

Internal assessment

• Goals and objectives for an internal assessment are typically set by the RU's parent organization
• Internal assessment is performed by a dedicated quality professional or by another trusted and qualified colleague outside the RU but within the same organization.
• Internal assessment assures a quality transparency towards the institution and provides additional confidence when preparing for an external assessment.

PLEASE DO NOT FORGET

• To make sure that all members of the RU receive access to and become familiar with the outcome of the self-assessment
• To act upon issues identified during the self-assessment
• To conduct self-assessments and spot checks at regular intervals

RISK ASSESSMENT

• For an effective self-assessment it is important to be as objective and as unbiased as possible

C. Resources

Template for documenting self-assessments

• Word-file 4.1.2 Self assessment.docx
• Excel-file 4.1.2 Self assessment.xlsx

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