quality control changes
DESCRIPTION
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. - PowerPoint PPT PresentationTRANSCRIPT
Quality ControlChanges
AABB Standards1. Organization2. Resources3. Equipments4. Supplier Issues.5. Process Control.6. Documentation.7. Deviations.8. Assessments.9. Process Improvement.10. Facility & Safety.
AABB Standards1. Organization2. Resources3. Equipments4. Supplier Issues.5. Process Control.6. Documentation.7. Deviations.8. Assessments.9. Process Improvement.10. Facility & Safety.
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.
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.
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.
5.0 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
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
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.
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.
Quality Control
Data Analysis
Action
Accepted
Process Lab/Sec
Rejection
Corrective Action• Root Cause
AABB Standard
• 2004 Re-accreditation• 2006 Re-accreditation• 2008 Re-accreditation• 2010 Re-accreditation• 2012 Re-accreditation
KCBB-Accreditation
• 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
Quality Control
Data Analysis
Action
Accepted
Process Lab/Sec
Rejection
Corrective Action• Root Cause
AABB Standard
Quality Control
Data Analysis
Action
Accepted
Process Lab/Sec
Rejection
Corrective Action• Root Cause
KCBB QC layout
Process Lab/Sec
Quality Control
Data Analysis
Reject
Accept
• No Process Improvement.• No Corrective Action taken.• No Quality insured.• STD 9 not followed
KCBB Layout
Preparation Lipemic Quality Control
Data Analysis
Reject
Accept
• No Process Improvement.• No Corrective Action taken.• No Quality insured.• STD 9 not followed
KCBB Layout
Cryo-Preparation QC FVIII Data Analysis
Reject
Accept
• No Process Improvement.• No Corrective Action taken.• No Quality insured.• STD 9 not followed
KCBB Layout
Quality Control Lab.
• QC.• Validation.• Evaluation.• Calibration.• CBC (Patients, Apheresis).
Corrective Action (1)
2006• Validation SOP (Committee).– Inline filtration.– NAT.– Others.
Corrective Action (2)
2006• Validation SOP (Committee).• Evaluation SOP (Committee).
Quality ControlChanges
Quality Control
Data Analysis
Action
Accepted
Process Lab/Sec
Rejection
Corrective Action• Root Cause
AABB Standard
Quality Control
Data Analysis
Action
Accepted
Process Lab/Sec
Rejection
Corrective Action• Root Cause
AABB Standard
Lab/SecSOP
QMAudit
Quality ControlLaboratory
General Laboratory
Quality ControlLaboratory
QC Laboratory
Lab/Section QCAction• Reject• Accept
Laboratories/ Sections
General Lab.
QC Program
Quality Control Program
Lab/Sec
Sample Collection
Data Analysis
Corrective Action
Audit Report
General
Sample Processing
QM
Audit Report
• Sample Collection.• Send to GL.• Data Collection.• Data Processing.• Data Blotting.• Corrective plan for non-
complaints.
Laboratory or
Section
• Bio-chemistry• pH• Clotting Factors• CBC• WBC• Culture• Calibration
General Laborator
y
• Audit• Non-complains• Internal Assessment
Quality Managemen
t
Action Plan 2011
July 1
June 30
June 1Starting Point
Lab/Section
QC SOPs
Program in Action
General Lab
Re-Arrange SOPs
Program in Action
Quality Management
Non-Compliance
SOPs
Program in Action
Document Control of
SOPs
Program in Action
Starting Point
• Sample Collection.• Send to GL.• Data Collection.• Data Processing.• Data Blotting.• Corrective plan for non-
complaints.
Laboratory or
Section
Out of Range
• Discard.• Initiate non-compliance report for
investigations.
Delayed Action
Oct, 2012
• Bio-chemistry• pH• Clotting Factors• CBC• WBC• Culture• Calibration
General Laborator
y
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.
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.
• Audit• Non-complains• Internal Assessment
Quality Managemen
t
Conclusion
What is Accomplished
July 1
June 30
June 1Starting Point
Lab/Section
QC SOPs
Program in Action
General Lab
Re-Arrange SOPs
Program in Action
Quality Management
Non-Compliance
SOPs
Program in Action
Document Control of
SOPs
Program in Action
Conclusion
• QC is done at all blood banks
But……
IS IT EFFECTIVE
QC Concept
• Linear• Action based on results
Process Lab/Sec
Quality Control
Data Analysis
Reject
Accept
QC Concept
• Interactive.• Process improvement.
Laboratories/ Sections
General Lab.
QC Concept
TEST
QC Concept
PROCESS
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