Quality Assurance & Compliance Flashcards
7 cards from real CARS 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 Assurance & Compliance flashcards as text
A compliance officer argues that risk-based inspection prioritization is superior to random sampling because it concentrates resources on the highest-probability violations. What is the strongest counter-argument?
Answer: Risk-based models may overlook violations in entities classified as low-risk, creating blind spots
By definition, risk-based prioritization allocates fewer resources to low-risk entities, which can miss unexpected violations that emerge in categories deemed safe.
A passage describes a tension between 'output quality' (conformance to specification) and 'outcome quality' (fitness for user purpose). Which scenario best illustrates this tension?
Answer: A product passes all dimensional tolerances but fails to perform the function customers actually need
A product conforming perfectly to specification yet failing user purpose exemplifies the gap between output quality (meeting the spec) and outcome quality (serving the need).
An author uses the phrase 'regulatory capture' to explain why some industries self-regulate ineffectively. What does this concept most likely mean in context?
Answer: Regulators become so familiar with industry norms that they begin to advocate for industry interests over public ones
Regulatory capture refers to the process by which a regulatory agency comes to serve the interests of the industry it is supposed to regulate rather than the public interest.
A passage reports that organizations with ISO 9001 certification have lower product recall rates than uncertified peers. A skeptic argues this is a selection effect. What does the skeptic mean?
Answer: Organizations that pursue certification already have stronger quality cultures, so the standard itself may not be the cause
A selection effect means the outcome difference predates the treatment — quality-oriented firms seek certification, so certification correlates with rather than causes better performance.
An essay argues that zero-defect goals are counterproductive because they incentivize concealment of errors rather than open reporting. This argument relies on which assumption about organizational behavior?
Answer: Employees weigh personal consequences of reporting errors against organizational learning benefits
The argument assumes that when reporting errors carries high personal cost, rational employees will conceal them, undermining the learning feedback loop that quality systems depend on.
A regulatory passage states that 'corrective action' addresses the symptom, while 'preventive action' addresses the root cause. Which of the following is the most accurate application of this distinction?
Answer: Retraining an employee who made an error is corrective; redesigning the process to prevent that error class is preventive
Retraining addresses the instance (symptom/corrective), while process redesign eliminates the conditions that allow the error class to occur (root cause/preventive).
A critic argues that compliance metrics are lagging indicators and therefore poor tools for managing quality risk prospectively. What does 'lagging indicator' mean in this context?
Answer: The metric reflects outcomes that have already occurred rather than predicting future failures
A lagging indicator measures what has already happened, so relying on it means quality failures must occur before the metric signals a problem, limiting its predictive utility.