Quality Management Flashcards
7 cards from real STP 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 Management flashcards as text
A laboratory implements a new centrifuge. Which pre-analytical quality consideration is MOST directly affected by centrifuge speed and time settings?
Answer: Adequate separation of serum or plasma from cells
Centrifuge speed (RCF) and duration determine whether serum or plasma is adequately separated from cellular components, directly affecting sample quality.
In risk management for laboratories (ISO 22367), what is the formula used to calculate a Risk Priority Number (RPN) in a Failure Mode and Effects Analysis (FMEA)?
Answer: Severity × Occurrence × Detectability
RPN = Severity × Occurrence × Detectability; higher RPNs identify failure modes requiring the most urgent mitigation action.
What is the key difference between 'validation' and 'verification' of a laboratory method?
Answer: Validation is done by manufacturers; verification is done by users to confirm performance in their setting
Manufacturers validate methods by establishing performance claims; laboratories verify those claims are achieved in their specific environment before clinical use.
When reviewing a Pareto chart of laboratory errors, the bars represent which of the following?
Answer: Error types ranked in descending order of frequency with a cumulative percentage line
A Pareto chart ranks defect categories from most to least frequent with a cumulative percentage line, applying the 80/20 rule to prioritize improvement efforts.
A critical value (panic value) result is generated in the laboratory. What is the MOST important next step according to quality and patient safety standards?
Answer: Immediately communicate the result to the responsible clinician and document the notification
Critical values must be communicated immediately to the responsible clinician, with the notification documented including time, recipient, and read-back confirmation.
Which term describes the ability of an analytical method to measure only the analyte of interest and not cross-react with similar substances?
Answer: Specificity / Analytical specificity
Analytical specificity is the ability of a method to measure only the target analyte without interference from structurally similar compounds or matrix components.
In a laboratory quality audit, the auditor finds that corrective actions from a previous audit cycle were documented but never implemented. This BEST represents a failure in which quality system element?
Answer: Corrective and Preventive Action (CAPA) effectiveness monitoring
CAPA systems require not only documenting actions but verifying their implementation and effectiveness; failure to implement documented actions reflects a CAPA monitoring breakdown.