Quality Assurance Flashcards
7 cards from real CTBS practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Quality Assurance flashcards as text
What is the primary purpose of a 'hold' or 'quarantine' label placed on tissue or materials in a tissue bank?
Answer: To prevent use of potentially nonconforming tissue or materials pending investigation or disposition
Quarantine labeling prevents inadvertent use of tissue or materials that are under investigation or pending disposition for a potential nonconformance.
Which type of audit involves an assessment of a tissue bank's quality system by an external accreditation organization?
Answer: Third-party audit
A third-party audit is conducted by an independent external organization, such as AATB, to assess compliance with accreditation standards.
In tissue banking quality systems, what does 'lot release' testing refer to?
Answer: Quality testing completed on a batch of tissue before it is released for distribution
Lot release testing is the set of quality tests that must be completed and meet acceptance criteria before a batch of tissue is approved for distribution.
What distinguishes a 'critical' control point from a 'non-critical' step in a tissue processing procedure?
Answer: Critical steps are those where failure could directly compromise tissue safety or quality
Critical control points are process steps where a deviation could directly compromise the safety, sterility, or quality of the tissue, making them subject to stricter controls and monitoring.
Which of the following best describes 'risk-based thinking' as applied in tissue bank quality management?
Answer: Identifying, assessing, and prioritizing quality controls based on the potential impact of failures
Risk-based thinking involves systematically identifying potential failures, assessing their likelihood and impact, and allocating quality controls proportional to the level of risk.
A tissue bank technician notices that a critical piece of processing equipment is past its scheduled calibration date. What is the appropriate QA response?
Answer: Immediately remove the equipment from service, quarantine products processed since last calibration, and initiate an investigation
Equipment past its calibration due date must be taken out of service, and all products processed since the last valid calibration should be quarantined pending investigation of potential impact.
What is the function of a 'change control' process in a tissue bank quality management system?
Answer: To provide a systematic process for evaluating, approving, and implementing changes to controlled documents, equipment, or processes
Change control ensures that any modifications to controlled processes, equipment, or documents are formally evaluated for quality and compliance impact before being implemented.