Regulatory Compliance & Quality Assurance Flashcards

Which audit type is performed by an organization's own personnel or on its behalf to verify its own system?

Answer: Internal (first-party) audit

First-party audits are internal self-assessments of the organization's own quality system.

A root cause analysis technique that repeatedly asks 'why' to trace a problem to its source is called:

Answer: 5 Whys

The 5 Whys method drills down through successive causes to the underlying one.

Under HIPAA, which is considered protected health information (PHI)?

Answer: Individually identifiable health information held by a covered entity

PHI is identifiable health data created or held by covered entities or their business associates.

What is the main goal of a management review in a quality management system?

Answer: Evaluate the system's suitability, adequacy, and effectiveness at planned intervals

Top management periodically reviews the QMS to ensure it remains effective and aligned with strategy.

Which statistical tool is used to prioritize problems by showing that a few causes drive most defects?

Answer: Pareto chart

Pareto charts rank causes by frequency, highlighting the vital few.

When a regulation changes, what is the best first step for a compliance team?

Answer: Assess impact on existing policies and procedures, then update and train

Impact assessment followed by updates and training keeps operations compliant.

What is the purpose of a quality audit finding classified as 'major'?

Answer: It indicates a significant failure or systemic breakdown requiring prompt corrective action

Major findings reflect serious or systemic noncompliance and demand timely correction.