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SBB ASCP > Quality > Flashcards

Quality Flashcards

1
Q

10 AABB QSES

A 
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
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2
Q

cGMP

A

Current Good manufacturing Practices (cGMP)

Minimum requirements in 21CFR to ensure the safety, purity, potency, and identity of blood products and services.

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3
Q

QSE1: Organization

A

> Executive Management & Medical Director > Quality System > Policies Processes & procedures > Emergency preparedness > Communication of Concerns > Customer Focus >

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4
Q

QSE2: Resources: Qualification

A

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
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5
Q

QSE2: Resources: Training

A

Required training
-cGMP for manufacturing of blood and its –components.
-Safety training
-Job-specific training
Use the learning domain to get desired outcome

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6
Q

QSE2: Resources: Competency

A

Assessment of employees who perform testing.

Competency measures an employee’s ability to perform tasks according to procedures.

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7
Q

Assessment of employees who perform testing

A
  • Semiannually during the 1st year

- Annually thereafter

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8
Q

Competency and training program includes:

A
  • Schedule of assessments
  • Defined minimal acceptable performance
  • Remedial measures
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9
Q

QSE3: Equipment

A
  • Maintain a list of qualified, critical equipment
  • Assign unique ID to track all equipment and software
  • Calibrate according to schedule
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10
Q

Calibration:

A

-The act of checking or adjusting (by comparison with a standard) the accuracy of a measuring instrument.

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11
Q

Validation:

A

-The documented act of proving that procedure, process, equipment, material, activity or system, actually leads to the expected results.

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12
Q

Installation Qualification IQ

A

Equipment has been installed correctly to manufacturer’s specifications

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13
Q

Operational Qualification OQ

A

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.)

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14
Q

Performance Qualification PQ

A

Manufacturing process works consistently under normal operating conditions for its intended use.

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15
Q

QSE4: Supplier and Customer Issues

A
  • Supplier Qualification
  • Agreements maintained and reviewed
  • Incoming receipt, inspection and testing before acceptance for use
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16
Q

Supplier Qualification:

A

An evaluation method defined to ensure that materials or services received from supplier meets the facility’s specification

17
Q

QSE5: Process Control (12)

A
  • 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
18
Q

QSE5: Process Control

A

Policies and validated processes and procedures that ensure the quality of blood, blood components, tissues, derivatives and services.

19
Q

QSE6: Documents & Records (5)

A
  • Document
  • Records
  • Policies
  • Process
  • Procedures
20
Q

Document

A

Written or electronically generated information or work instructions

  • SOPs
  • Forms
  • Labels
21
Q

Records

A

Information captured in writing or electronically that provides evidence of activities performed.

22
Q

Policies:

A
  • A documented general principle that guides present and future directions.
  • Describes the INTENT
  • “Why” vs. what to do
23
Q

Process:

A
  • A set of related tasks and activities that accomplish a goal.
  • Describes the BEHAVIOR
  • “What who where when or how it happens”
24
Q

Procedures:

A
  • A documented step-by-step work instruction
  • Describes the EXECUTION
  • “How to do it”
25
Q

QSE7: Deviations, Nonconformances and Adverse Event

A

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
26
Q

Nonconformance:

A

Failure to meet requirements

27
Q

QSE8: Assessments

A
  • Assessments

- Blood Utilization

28
Q

Assessments:

A
  • Internal

- External

29
Q

Blood Utilization:

A

-Peer review of transfusion practices to ensure the effective use of limited blood resources

30
Q

QSE9: Process Improvement

A
  • Corrective Action
  • Preventive Action
  • Quality Monitoring
31
Q

Corrective Action:

A

Eliminate cause of existing deviation

32
Q

Preventive Action:

A

Reduce potential for future deviation

33
Q

Quality Monitoring

A

Evaluate data for trends that may indicate the need for corrective/ preventive action

34
Q

QSE10: Facilities and Safety

A

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

SBB ASCP (8 decks)

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