Title
Why
Through standardized monitoring of indicators the functioning and continuous improvement of the quality management system can be measured. Recording these data in Quarterly Reports will enable the Laboratory Manager and Quality Officer to make relevant plans tailor made to the current performance of the laboratory and the quality management system.
What
The functioning of the quality management system must be monitored using indicators. What follows is a list of suitable indicators (note that you can add additional indicators yourself):
- External quality assessment (participation started in phase 2)
- Internal quality control scheme (established in phase 2)
- Trend and risk analyses
- Internal audits
- External audits
- Status of completion of action plans (including the Quality Year Plan action plan)
- Review of complaints received by the laboratory
- Review of nonconformities and results of corrective actions take
- Adherence to turnaround time (monitoring started in phase 3)
- Training followed by staff
Note that some of the above indicators are not yet implemented. However, for clarity's sake already a complete overview was given of indicators that need to be included in the Quarterly Reports when the complete quality management system is in place. Start recording data in Quarterly Reports of only the activities that you already perform, e.g. the completion of action plans and results of external quality assessments.
An example of a Quarterly Report is provided in the right-hand column to give you an idea of the outline and extensiveness.
How & who
Quality Officer:
- Divide the quality year in four parts and define the months in which a Quarterly Report needs to be drafted.
- Make a useful outline for the Quarterly Reports.
- Start producing Quarterly Reports.
- Discuss each Quarterly Report in the bilateral meeting with the Laboratory Manager.
- Make a new folder entitled "Quarterly Reports".
- Sign and date the Quarterly Report and store it in the Quarterly Reports folder at a secure location.
- Document the procedure for making Quarterly Reports in an SOP.
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