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Quality Control Changes

Quality Control Changes. Organization Resources Equipments Supplier Issues. Process Control . Documentation. Deviations. Assessments. Process Improvement. Facility & Safety. AABB Standards. Organization Resources Equipments Supplier Issues. Process Control . Documentation.

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Quality Control Changes

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  1. Quality ControlChanges

  2. Organization Resources Equipments Supplier Issues. Process Control. Documentation. Deviations. Assessments. Process Improvement. Facility & Safety. AABB Standards

  3. Organization Resources Equipments Supplier Issues. Process Control. Documentation. Deviations. Assessments. Process Improvement. Facility & Safety. AABB Standards

  4. AABB Standard5.0 Process Control • The blood bank or transfusion services shall have policies and validated processes and procedures that ensure the quality of the blood, blood components, tissue, derivatives, and services. The blood bank or transfusion services shall ensure that these policies, processes, and procedures are carried out under controlled conditions.

  5. AABB Standard5.0 Process Control • The blood bank or transfusion services shall have policies and validated processes and procedures that ensure the quality of the blood, blood components, tissue, derivatives, and services. The blood bank or transfusion services shall ensure that these policies, processes, and procedures are carried out under controlled conditions.

  6. AABB Standard5.0 Process Control • The blood bank or transfusion services shall have policies and validated processes and procedures that ensure the quality of the blood, blood components, tissue, derivatives, and services. The blood bank or transfusion services shall ensure that these policies, processes, and procedures are carried out under controlled conditions.

  7. 5.0 Process Control5.1 General Elements 5.1.1 Change Control. 5.1.2 Proficiency Testing Program. 5.1.3 Quality Control. 5.1.4 Use of Materials. 5.1.5 Sterility. 5.1.6 Identification & Traceability. 5.1.7 Inspection. 5.1.8 Handling, Storage, and Transportation

  8. 5.0 Process Control5.1 General Elements 5.1.1 Change Control. 5.1.2 Proficiency Testing Program. 5.1.3 Quality Control. 5.1.4 Use of Materials. 5.1.5 Sterility. 5.1.6 Identification & Traceability. 5.1.7 Inspection. 5.1.8 Handling, Storage, and Transportation

  9. 5.1.3 Quality Control A program of quality control shall be established that is sufficiently comprehensive to ensure that reagents, equipments, and methods perform as expected. Chapter 9, Process Improvement Through Corrective and Preventive Action, applies.

  10. 5.1.3 Quality Control A program of quality control shall be established that is sufficiently comprehensive to ensure that reagents, equipments, and methods perform as expected. Chapter 9, Process Improvement Through Corrective and Preventive Action, applies.

  11. AABB Standard

  12. 2004 Re-accreditation 2006 Re-accreditation 2008 Re-accreditation 2010 Re-accreditation 2012 Re-accreditation KCBB-Accreditation

  13. 2004 Re-accreditation 2006 Re-accreditation 2008 Re-accreditation 2010 Re-accreditation 2012 Re-accreditation Non-Conformance STD-5.1.3 Quality Control KCBB-Accreditation

  14. AABB Standard

  15. KCBB QC layout

  16. KCBB Layout • No Process Improvement. • No Corrective Action taken. • No Quality insured. • STD 9 not followed

  17. KCBB Layout • No Process Improvement. • No Corrective Action taken. • No Quality insured. • STD 9 not followed

  18. KCBB Layout • No Process Improvement. • No Corrective Action taken. • No Quality insured. • STD 9 not followed

  19. Quality Control Lab. • QC. • Validation. • Evaluation. • Calibration. • CBC (Patients, Apheresis).

  20. Corrective Action (1) 2006 • Validation SOP (Committee). • Inline filtration. • NAT. • Others.

  21. Corrective Action (2) 2006 • Validation SOP (Committee). • Evaluation SOP (Committee).

  22. Quality ControlChanges

  23. AABB Standard

  24. AABB Standard Lab/Sec SOP QM Audit

  25. Quality ControlLaboratory

  26. General Laboratory Quality Control Laboratory

  27. QC Laboratory

  28. QC Program

  29. Action Plan 2011

  30. Starting Point

  31. Out of Range • Discard. • Initiate non-compliance report for investigations.

  32. Delayed Action Oct, 2012

  33. QC LAB SOPs • Total No. 62 • 1 POL, 61 TECH. • Per test. • QC of Platelets, QC of RBC. • Maintenance PRISM, maintenance OLYMPUS. • Complicated training. • Complicated internal assessment.

  34. General Lab SOPs • Total No. 18 • 1 POL, 10 TECH, 7 QC SOP • Per process • Sample Receiving SOP’s & Forms. • Requested Test Results SOP’s. • Less complicated training. • Less complicated internal assessment.

  35. Conclusion

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