CTBS Quality Control & Risk Management in Tissue Banking 2 — Questions and Answers
Question 1: Which document type is used to formally record a deviation from an established SOP during tissue processing?
- Corrective Action Report
- Nonconformance Report (Correct answer)
- Change Control Form
- Process Validation Record
Correct answer: Nonconformance Report
A Nonconformance Report (NCR) documents any deviation from established SOPs or specifications during tissue banking operations.
Question 2: In tissue banking, what is the purpose of a 'hold' status applied to a tissue lot?
- To reserve tissue for a specific recipient
- To prevent distribution pending investigation or testing (Correct answer)
- To indicate tissue is ready for final labeling
- To mark tissue for accelerated processing
Correct 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.
Question 3: What statistical tool uses upper and lower control limits to monitor process variability over time?
- Pareto chart
- Fishbone diagram
- Control chart (Correct answer)
- Scatter plot
Correct answer: Control chart
Control charts plot process data with calculated upper and lower control limits to detect trends and out-of-control conditions.
Question 4: Which FDA regulation requires tissue establishments to maintain a list of all suppliers of critical materials?
- 21 CFR Part 11
- 21 CFR Part 820
- 21 CFR Part 1271 (Correct answer)
- 21 CFR Part 606
Correct 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.
Question 5: A tissue bank discovers a processing error that may have affected 12 tissue units already distributed. What is the FIRST action required?
- Notify the FDA within 7 days
- Initiate an urgent medical device recall
- Contact consignees to quarantine or retrieve affected tissue (Correct answer)
- Retest all remaining tissue in inventory
Correct 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.
Question 6: What does the term 'worst-case' testing mean in tissue bank process validation?
- Testing performed on the lowest-quality tissue available
- Testing under the most challenging but still acceptable conditions (Correct answer)
- Testing performed by the least experienced technician
- Testing with the oldest reagents in inventory
Correct 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.
Question 7: Which risk assessment tool involves calculating a Risk Priority Number (RPN) by multiplying severity, occurrence, and detectability scores?
- HACCP
- FMEA (Correct answer)
- Root Cause Analysis
- FTA
Correct answer: FMEA
Failure Mode and Effects Analysis (FMEA) uses RPN = Severity × Occurrence × Detectability to prioritize risks for corrective action.
CTBS Quality Control & Risk Management in Tissue Banking 2
Which document type is used to formally record a deviation from an established SOP during tissue processing?