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
In a quality management system, what is the primary purpose of a Control Chart?
Answer: To monitor process variation over time and distinguish common from special cause variation
Control charts display process data over time and use statistical limits to differentiate inherent (common cause) variation from unexpected (special cause) variation.
Which ISO standard specifically addresses quality management systems for medical laboratories?
Answer: ISO 15189
ISO 15189 specifies requirements for quality and competence in medical laboratories, covering both technical and management aspects.
A laboratory's Internal Quality Control (IQC) result falls outside ±3SD on a Levey-Jennings chart. What action is MOST appropriate?
Answer: Reject the run, investigate the cause, and do not report patient results
A result beyond ±3SD triggers rejection of the analytical run; patient results must be withheld until the cause is identified and corrected.
What does 'fitness for purpose' mean in the context of laboratory quality?
Answer: The analytical performance of a method is adequate for its intended clinical application
Fitness for purpose means the measurement uncertainty, precision, and accuracy of a method are appropriate for the clinical decisions it will support.
In Six Sigma methodology, what sigma level corresponds to approximately 3.4 defects per million opportunities?
Answer: 6 Sigma
Six Sigma (6σ) quality level equates to 3.4 defects per million opportunities, representing near-perfect process performance.
Which of the following BEST describes a 'non-conformance' in a quality management system?
Answer: Any failure to meet a specified requirement
A non-conformance is any instance where a product, service, or process fails to fulfill a defined requirement, regardless of impact severity.
What is the role of a Quality Indicator (QI) in laboratory quality management?
Answer: To measure the performance of a process and monitor trends over time
Quality indicators are measurable variables used to track and evaluate laboratory processes, enabling identification of improvement opportunities.