Quality Flashcards
10 AABB QSES
QSE1: Organization QSE2: Resources: Qualification, Training, Competency QSE3: Equipment QSE4: Supplier and Customer Issues QSE5: Process Control QSE6: Documents & Records QSE7: Deviations, Nonconformances and Adverse Event QSE8: Assessments QSE9: Process Improvement QSE10: Facilities and Safety
cGMP
Current Good manufacturing Practices (cGMP)
Minimum requirements in 21CFR to ensure the safety, purity, potency, and identity of blood products and services.
QSE1: Organization
> Executive Management & Medical Director > Quality System > Policies Processes & procedures > Emergency preparedness > Communication of Concerns > Customer Focus >
QSE2: Resources: Qualification
A process must exist to ensure and adequate number (quantitative) of qualified individuals (qualitative) are deployed to produce safe and effective products
- Education
- Continuing education
- Training and/or experience
QSE2: Resources: Training
Required training
-cGMP for manufacturing of blood and its –components.
-Safety training
-Job-specific training
Use the learning domain to get desired outcome
QSE2: Resources: Competency
Assessment of employees who perform testing.
Competency measures an employee’s ability to perform tasks according to procedures.
Assessment of employees who perform testing
- Semiannually during the 1st year
- Annually thereafter
Competency and training program includes:
- Schedule of assessments
- Defined minimal acceptable performance
- Remedial measures
QSE3: Equipment
- Maintain a list of qualified, critical equipment
- Assign unique ID to track all equipment and software
- Calibrate according to schedule
Calibration:
-The act of checking or adjusting (by comparison with a standard) the accuracy of a measuring instrument.
Validation:
-The documented act of proving that procedure, process, equipment, material, activity or system, actually leads to the expected results.
Installation Qualification IQ
Equipment has been installed correctly to manufacturer’s specifications
Operational Qualification OQ
Tests functional elements and insures that the system will meet all defined user requirements under all anticipated conditions of manufacturing. Include a condition(s) encompassing upper and lower operating limits (worst case conditions.)
Performance Qualification PQ
Manufacturing process works consistently under normal operating conditions for its intended use.
QSE4: Supplier and Customer Issues
- Supplier Qualification
- Agreements maintained and reviewed
- Incoming receipt, inspection and testing before acceptance for use
Supplier Qualification:
An evaluation method defined to ensure that materials or services received from supplier meets the facility’s specification
QSE5: Process Control (12)
- Standard operating procedures
- Change control of policies, processes or procedures
- Proficiency testing program
- Quality control
- Use of materials according to manufacturer’s directions
- Sterility- bacterial contamination
- Identification and traceability (includes labeling)
- Inspection procedures
- Handling, storage and transportation
- Collection, manufacturing and testing requirements
- Transfusion service related activities
- Evidence of record keeping
QSE5: Process Control
Policies and validated processes and procedures that ensure the quality of blood, blood components, tissues, derivatives and services.
QSE6: Documents & Records (5)
- Document
- Records
- Policies
- Process
- Procedures
Document
Written or electronically generated information or work instructions
- SOPs
- Forms
- Labels
Records
Information captured in writing or electronically that provides evidence of activities performed.
Policies:
- A documented general principle that guides present and future directions.
- Describes the INTENT
- “Why” vs. what to do
Process:
- A set of related tasks and activities that accomplish a goal.
- Describes the BEHAVIOR
- “What who where when or how it happens”
Procedures:
- A documented step-by-step work instruction
- Describes the EXECUTION
- “How to do it”
QSE7: Deviations, Nonconformances and Adverse Event
Blood Bank facilities must report:
- Biologic product deviations (BPD) to FDA. This is regardless of facility’s FDA registration or licensure.
- Fatalities to FDA center for Biologics, Evaluation and Research (CBER) within 7 days of event
Nonconformance:
Failure to meet requirements
QSE8: Assessments
- Assessments
- Blood Utilization
Assessments:
- Internal
- External
Blood Utilization:
-Peer review of transfusion practices to ensure the effective use of limited blood resources
QSE9: Process Improvement
- Corrective Action
- Preventive Action
- Quality Monitoring
Corrective Action:
Eliminate cause of existing deviation
Preventive Action:
Reduce potential for future deviation
Quality Monitoring
Evaluate data for trends that may indicate the need for corrective/ preventive action
QSE10: Facilities and Safety
Policies, processes and procedures to ensure the provision of safe environmental conditions.
- Safe environment – Facilities and workflow
- Biological, chemical and radiation safety
- Discard of components, tissues, and derivatives
