Quality Auditing Principles Flashcards

What is the difference between a corrective action and a preventive action (CAPA) in quality management?

Answer: Corrective action addresses an existing nonconformance; preventive action addresses a potential nonconformance before it occurs

Corrective actions fix identified problems, while preventive actions proactively eliminate potential causes of nonconformances.

Which audit technique involves direct observation of study personnel performing their tasks?

Answer: Witnessing

Witnessing is the audit technique where the auditor observes study activities in real time to verify adherence to protocol and SOPs.

What is the purpose of an audit trail in a GLP electronic records system?

Answer: To record who created, modified, or deleted data entries and when

An electronic audit trail captures the who, what, and when of all data changes to ensure data integrity and traceability.

During a GLP audit, what does 'traceability' mean in the context of raw data?

Answer: The ability to link any piece of data back to its original source and to the personnel who generated it

Traceability ensures that every data point can be traced back to the original observation, instrument, and person responsible.

What is the recommended timeframe for issuing a formal audit report after completion of the audit?

Answer: Within 30 days of the audit

Industry best practice and many SOPs recommend issuing formal audit reports within 30 days of audit completion.

What does 'audit scope' define in a GLP quality audit?

Answer: The boundaries of what will be examined, including specific studies, time periods, or facility areas

Audit scope defines what is included and excluded from the audit, preventing scope creep and ensuring focused coverage.