PEPFAR Quality Control anad Method Validation Activity 13 Handout 1: Mapping the Process

Handout 1: Mapping the Process 1304 Process Map a Complete QC Program for Two Workstations Effective Date: 12/6/2016 HILS1746 7.5 Are budgetary projections based 1.5 Are policies and/or standard on personnel, test, facility and operating procedures (SOPs) for equipment needs, and quality laboratory functions, technical and 8.10 Are QC results monitored and reviewed (including biases and assurance procedures and managerial procedures current, available and approved by Levy-Jennings charts for materials? authorized personnel? quantitative tests)? PROCESS OUTPUT Knowledge 1. Apply appropriate QC rules to gained from alert when a medically significant QC change has occurred in the Workshop measurement procedure. 2. Use quality indicators (Qls) to Handouts monitor the analytical performance Worksheets (accuracy and precision) of the Job Aids workstations on a monthly basis. 3. Document the corrective action taken when alerted by QI or QC rule. indicator (QI) for the analytical hospital management phase of testing SLMTA Training Communicate IP with staff and 10. 13. Utilize monthly SEc as a quality 11. 12. 1 . 2. 3 . 4 . 8. 9. 5. 3.7 Is there a system for competency assessment that covers: a) competency assessments performed according to defined criteria, b) new hires, c) 138 existing staff, and d) retraining and re-assessment where needed?