SQA Quality Auditing Principles 2 — Questions and Answers
Question 1: What is the difference between a corrective action and a preventive action (CAPA) in quality management?
- Corrective action addresses an existing nonconformance; preventive action addresses a potential nonconformance before it occurs (Correct answer)
- Corrective action is performed by management; preventive action is performed by QAU
- Corrective action is mandatory under GLP; preventive action is optional
- Corrective action focuses on equipment; preventive action focuses on personnel
Correct 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.
Question 2: Which audit technique involves direct observation of study personnel performing their tasks?
- Witnessing (Correct answer)
- Document review
- Interview
- Retrospective review
Correct answer: Witnessing
Witnessing is the audit technique where the auditor observes study activities in real time to verify adherence to protocol and SOPs.
Question 3: What is the purpose of an audit trail in a GLP electronic records system?
- To record who created, modified, or deleted data entries and when (Correct answer)
- To back up raw data to a secondary server
- To encrypt sensitive study data
- To archive completed study records
Correct 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.
Question 4: During a GLP audit, what does 'traceability' mean in the context of raw data?
- The ability to link any piece of data back to its original source and to the personnel who generated it (Correct answer)
- The process of encrypting data during transfer
- The storage of data in tamper-proof containers
- The use of sequential numbering on all laboratory notebooks
Correct 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.
Question 5: What is the recommended timeframe for issuing a formal audit report after completion of the audit?
- Within 30 days of the audit (Correct answer)
- Within 24 hours of the audit
- Within 6 months of the audit
- Only at the end of the study
Correct answer: Within 30 days of the audit
Industry best practice and many SOPs recommend issuing formal audit reports within 30 days of audit completion.
Question 6: What does 'audit scope' define in a GLP quality audit?
- The boundaries of what will be examined, including specific studies, time periods, or facility areas (Correct answer)
- The total number of auditors assigned to the audit
- The regulatory citations that may apply to findings
- The corrective action timeline expected from management
Correct 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.
SQA Quality Auditing Principles 2
What is the difference between a corrective action and a preventive action (CAPA) in quality management?