SQA Quality Auditing Principles 3

Question 1

Which auditing principle requires the auditor to base findings on objective, verifiable evidence rather than personal opinion?

Accepted Answer

Evidence-based auditing

Answer

Risk-based auditing

Answer

Compliance-based auditing

Answer

Systems-based auditing

Question 2

Under the SQA auditing framework, what is the key distinction between an 'observation' and a 'nonconformance'?

Accepted Answer

An observation is a potential concern or improvement opportunity; a nonconformance is an actual regulatory or procedural violation

Answer

An observation must be reported to the FDA; a nonconformance is internal only

Answer

An observation requires immediate corrective action; a nonconformance can be deferred

Answer

An observation is verbal; a nonconformance is always written

Question 3

Which activity must occur before an auditor can close a previously identified nonconformance?

Accepted Answer

Verification that the corrective action has been effectively implemented

Answer

Sponsor approval of the corrective action

Answer

Study Director signature on the audit report

Answer

FDA notification of the nonconformance

Question 4

What is a 'process audit' in the context of GLP quality assurance?

Accepted Answer

An audit that evaluates a specific work process against defined criteria such as SOPs or regulations

Answer

An audit of the test article manufacturing process

Answer

A financial review of study costs

Answer

An audit limited to the statistical analysis process

Question 5

In GLP auditing, what is the purpose of a retrospective data audit?

Accepted Answer

To review completed raw data and records to verify accuracy, completeness, and GLP compliance after the fact

Answer

To reanalyze statistical data for correctness

Answer

To assess whether archived records are accessible

Answer

To verify that the Study Director was present during data collection

Question 6

Which international standard provides guidance on auditing management systems and is widely referenced in quality auditing training?

Accepted Answer

ISO 19011

Answer

ISO 17025

Answer

ISO 9001

Answer

ISO 13485