Quality Auditing Principles Flashcards

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

Answer: Evidence-based auditing

Evidence-based auditing requires all findings to be supported by factual, objective evidence gathered during the audit.

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

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

Observations flag risks or improvement opportunities without a clear regulatory violation, while nonconformances document actual departures from requirements.

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

Answer: Verification that the corrective action has been effectively implemented

Nonconformance closure requires the auditor to verify that the corrective action has been implemented and is effective.

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

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

A process audit examines how a specific work process (e.g., sample processing, data recording) is performed compared to written procedures.

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

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

Retrospective data audits review completed study records to assess data integrity and GLP compliance of the documented study conduct.

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

Answer: ISO 19011

ISO 19011 provides guidelines for auditing management systems, including principles, audit program management, and auditor competence.