STP Quality Management 2 — Questions and Answers
Question 1: In a quality management system, what is the primary purpose of a Control Chart?
- To document standard operating procedures
- To monitor process variation over time and distinguish common from special cause variation (Correct answer)
- To rank defects by frequency of occurrence
- To assign responsibility for quality failures
Correct 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.
Question 2: Which ISO standard specifically addresses quality management systems for medical laboratories?
- ISO 9001
- ISO 14001
- ISO 15189 (Correct answer)
- ISO 17025
Correct answer: ISO 15189
ISO 15189 specifies requirements for quality and competence in medical laboratories, covering both technical and management aspects.
Question 3: A laboratory's Internal Quality Control (IQC) result falls outside ±3SD on a Levey-Jennings chart. What action is MOST appropriate?
- Report results and flag as borderline
- Repeat the control only, then report if it passes
- Reject the run, investigate the cause, and do not report patient results (Correct answer)
- Apply a correction factor to all patient results
Correct 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.
Question 4: What does 'fitness for purpose' mean in the context of laboratory quality?
- A method meets regulatory approval regardless of clinical need
- The analytical performance of a method is adequate for its intended clinical application (Correct answer)
- Equipment passes annual calibration checks
- Staff qualifications match their job descriptions
Correct 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.
Question 5: In Six Sigma methodology, what sigma level corresponds to approximately 3.4 defects per million opportunities?
- 3 Sigma
- 4 Sigma
- 5 Sigma
- 6 Sigma (Correct answer)
Correct answer: 6 Sigma
Six Sigma (6σ) quality level equates to 3.4 defects per million opportunities, representing near-perfect process performance.
Question 6: Which of the following BEST describes a 'non-conformance' in a quality management system?
- A minor deviation from best practice with no patient impact
- Any failure to meet a specified requirement (Correct answer)
- An equipment failure requiring immediate repair
- A complaint raised by an external customer only
Correct 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.
Question 7: What is the role of a Quality Indicator (QI) in laboratory quality management?
- To set the acceptable range for analyte results
- To measure the performance of a process and monitor trends over time (Correct answer)
- To define the frequency of proficiency testing
- To certify that staff competency assessments are complete
Correct 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.
STP Quality Management 2
In a quality management system, what is the primary purpose of a Control Chart?