Quality Control & Risk Management in Tissue Banking 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 Control & Risk Management in Tissue Banking flashcards as text
Which document type is used to formally record a deviation from an established SOP during tissue processing?
Answer: Nonconformance Report
A Nonconformance Report (NCR) documents any deviation from established SOPs or specifications during tissue banking operations.
In tissue banking, what is the purpose of a 'hold' status applied to a tissue lot?
Answer: To prevent distribution pending investigation or testing
A 'hold' status prevents distribution of tissue while an investigation, additional testing, or quality review is completed.
What statistical tool uses upper and lower control limits to monitor process variability over time?
Answer: Control chart
Control charts plot process data with calculated upper and lower control limits to detect trends and out-of-control conditions.
Which FDA regulation requires tissue establishments to maintain a list of all suppliers of critical materials?
Answer: 21 CFR Part 1271
21 CFR Part 1271 governs human cells, tissues, and cellular and tissue-based products (HCT/Ps) and requires supplier qualification records.
A tissue bank discovers a processing error that may have affected 12 tissue units already distributed. What is the FIRST action required?
Answer: Contact consignees to quarantine or retrieve affected tissue
The immediate priority is contacting consignees to quarantine or retrieve potentially affected tissue to prevent patient harm.
What does the term 'worst-case' testing mean in tissue bank process validation?
Answer: Testing under the most challenging but still acceptable conditions
Worst-case testing validates that a process succeeds even under the most challenging conditions that could realistically occur within acceptable parameters.
Which risk assessment tool involves calculating a Risk Priority Number (RPN) by multiplying severity, occurrence, and detectability scores?
Answer: FMEA
Failure Mode and Effects Analysis (FMEA) uses RPN = Severity × Occurrence × Detectability to prioritize risks for corrective action.