Quality Assurance & Compliance Flashcards

A passage discusses the 'normalization of deviance,' a concept describing how organizations gradually accept small deviations from standards until a catastrophic failure occurs. Which scenario best illustrates this concept?

Answer: Engineers repeatedly approve components that slightly exceed temperature tolerances because no failures have occurred yet, until a major system failure results

Repeated minor tolerance exceedances that go unpunished create a new informal standard, illustrating how deviance becomes normalized until a catastrophic threshold is crossed.

An author argues that compliance functions should report directly to the board rather than to operational management. What is the primary rationale this argument most likely assumes?

Answer: Reporting through operational management creates conflicts of interest when compliance findings implicate those managers

Independence from operational management protects compliance functions from pressure to suppress or minimize findings that could embarrass or implicate the managers they report to.

A passage contrasts 'detection controls' with 'prevention controls' in a quality framework. Which of the following correctly classifies a given control?

Answer: Final product inspection is a detection control; error-proofing (poka-yoke) devices are prevention controls

Final inspection finds defects after production (detection), while error-proofing devices make it physically impossible to perform a step incorrectly (prevention).

A researcher finds that organizations with high compliance scores in self-assessments have lower compliance scores in independent audits. What is the most likely explanation the passage would support?

Answer: Independent auditors use stricter criteria and have no incentive to inflate results, while self-assessors may unconsciously rate themselves favorably

Self-assessment bias and the absence of independent scrutiny explain why organizations rate themselves higher than external evaluators do.

A passage argues that 'compliance fatigue' — the erosion of diligence caused by prolonged exposure to compliance requirements — is a systemic risk in heavily regulated industries. Which policy response would most directly address the root cause as described?

Answer: Streamlining redundant requirements so the compliance burden does not exceed organizations' attentional capacity

If fatigue stems from an overwhelming compliance burden, reducing that burden by eliminating redundant requirements directly addresses the cause rather than trying to overcome it with external pressure.

An author concludes that the widespread adoption of quality management systems has not reduced product liability litigation. Which of the following, if true, would best explain this paradox?

Answer: As quality systems proliferated, consumer expectations and legal standards for acceptable product performance rose correspondingly

If consumer expectations and legal standards rise in parallel with quality improvements, litigation rates can remain stable even as absolute defect rates fall — a moving-target paradox.

A passage claims that effective quality cultures share one trait: 'psychological safety for raising concerns.' What does this claim imply about the relationship between culture and compliance outcomes?

Answer: Early detection of problems depends on individuals feeling safe to report them, so culture mediates the effectiveness of formal compliance mechanisms

The claim positions culture as the mechanism through which formal systems succeed or fail — unless individuals report concerns, even well-designed compliance systems cannot surface and correct problems early.