SQA Quality Auditing Principles 2

Question 1

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

Accepted Answer

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

Answer

Corrective action is performed by management; preventive action is performed by QAU

Answer

Corrective action is mandatory under GLP; preventive action is optional

Answer

Corrective action focuses on equipment; preventive action focuses on personnel

Question 2

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

Accepted Answer

Witnessing

Answer

Document review

Answer

Interview

Answer

Retrospective review

Question 3

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

Accepted Answer

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

Answer

To back up raw data to a secondary server

Answer

To encrypt sensitive study data

Answer

To archive completed study records

Question 4

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

Accepted Answer

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

Answer

The process of encrypting data during transfer

Answer

The storage of data in tamper-proof containers

Answer

The use of sequential numbering on all laboratory notebooks

Question 5

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

Accepted Answer

Within 30 days of the audit

Answer

Within 24 hours of the audit

Answer

Within 6 months of the audit

Answer

Only at the end of the study

Question 6

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

Accepted Answer

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

Answer

The total number of auditors assigned to the audit

Answer

The regulatory citations that may apply to findings

Answer

The corrective action timeline expected from management