Regulatory Compliance & Quality Assurance Flashcards

Which principle requires that records be attributable, legible, contemporaneous, original, and accurate (ALCOA)?

Answer: Data integrity

ALCOA describes the attributes of trustworthy data under data integrity expectations.

A supplier qualification program primarily helps an organization to:

Answer: Ensure purchased materials and services meet quality requirements

Qualifying suppliers verifies they can consistently meet specified requirements.

In the PDCA cycle, what occurs in the 'Check' phase?

Answer: Results are measured and compared against expected outcomes

Check evaluates whether the implemented change achieved the planned results.

What is the key difference between a 'correction' and a 'corrective action'?

Answer: Correction fixes the detected issue; corrective action addresses its cause

A correction eliminates the nonconformity itself, while corrective action eliminates its cause.

Which situation is the clearest example of a conflict of interest in compliance?

Answer: An auditor reviewing a department they personally manage

Auditors must be objective and impartial, so they should not audit their own work.

Records retention schedules exist mainly to:

Answer: Specify how long records must be kept to meet legal and business requirements

Retention schedules define minimum keeping periods based on legal and operational needs.

A 'whistleblower' protection policy is intended to:

Answer: Protect employees who report suspected violations from retaliation

Anti-retaliation protections encourage good-faith reporting of misconduct.