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
Which document type describes the step-by-step instructions for performing a specific tissue bank task?
Answer: Standard Operating Procedure (SOP)
SOPs provide detailed, step-by-step instructions for performing specific tasks consistently and correctly.
In a tissue bank QA system, what is the primary purpose of a corrective action?
Answer: To eliminate the root cause of a nonconformance
Corrective actions are designed to identify and eliminate the root cause of a nonconformance to prevent recurrence.
What does a Certificate of Analysis (COA) for a processing reagent typically confirm?
Answer: The reagent meets specified quality criteria for identity, purity, and potency
A COA confirms that a reagent lot meets pre-established specifications for identity, purity, potency, and other relevant quality attributes.
Which regulatory body publishes the Good Tissue Practice (GTP) regulations applicable to human tissue establishments in the US?
Answer: FDA
The FDA publishes 21 CFR Part 1271, which establishes Good Tissue Practice (GTP) requirements for human cells, tissues, and cellular and tissue-based products (HCT/Ps).
During a QA audit of donor records, a tissue bank specialist finds that a donor consent form is missing a required signature. This is an example of:
Answer: A critical nonconformance
A missing required signature on a donor consent form is a critical nonconformance because it violates regulatory and accreditation requirements for donor eligibility documentation.
What is the purpose of environmental monitoring in a tissue processing cleanroom?
Answer: To verify that bioburden levels remain within acceptable limits
Environmental monitoring verifies that air quality, surface bioburden, and other parameters stay within limits that protect tissue sterility.
Which of the following best describes a 'trend analysis' in tissue bank quality assurance?
Answer: Ongoing monitoring of quality data over time to detect patterns
Trend analysis involves continuously monitoring quality metrics over time to identify patterns that may indicate emerging problems before they become critical.