Why are quality goals needed?
- Quality objectives are measurable quality control methods. Their assessment is used to focus the goal(s) from the quality policy into plans for improvement.
- In accordance with requirements set out in the SCTO’s Guidelines for Good Operational Practice (GGOP), quality objectives should be defined and be consistent with a CTU’s quality policy.
Audit observations: What was missing?
- Quality goals and objectives were not formally documented, defined, or managed.
- No process was in place to ensure that quality goals are set and followed up on during the review period.
Recommendations
- Document and formalise a defined process in an SOP.
- Ensure that quality objectives are established and planned in advance based on all relevant functions, levels, and processes.
- Formalise (annual) quality goals in a controlled document (incl. milestones, timelines, and progression).
- Maintain an overview document that allows the completion of objectives to be logged and tracked.
- Review the completion and/or non-adherence of quality objectives in the annual quality management review.
- Extra tips:
- Ensure quality goals are directly or indirectly measurable.
- Ensure that their continuous improvement is based on a risk-based approach and their achievement supports the vision of the CTU’s quality policy.