Regulatory Affairs Certification (RAC) Practice Exam

Why does having only one internal auditor in a small company not meet the requirements for performing internal quality system audits?

1. Compliance with external standards.

2. Auditor independence has not been ensured.

3. Lack of auditor training.

4. Insufficient audit frequency.

The correct answer is: Auditor independence has not been ensured.

Having only one internal auditor in a small company raises significant concerns about auditor independence, which is critical for the integrity and objectivity of internal quality system audits. When a single individual is responsible for auditing the quality system, there is an inherent risk that their findings could be biased or influenced by personal interests or relationships within the company. This lack of independence can lead to conflicts of interest, where the auditor might be auditing processes or policies they themselves are involved in or responsible for, compromising the audit's impartiality. Moreover, many quality management systems and regulatory standards emphasize the importance of auditor independence to ensure that the audit results are credible and actionable. The presence of multiple auditors helps establish checks and balances, allowing for a more accurate assessment of compliance with quality standards and fostering a culture of accountability within the organization. While the other options address various aspects related to internal audits, they do not directly relate to why the singular presence of an auditor fails to meet the rigorous requirements for conducting effective internal quality audits. Compliance with external standards may be necessary, but it often requires more than just one dedicated auditor. Similarly, while auditor training is essential for effective audits and audit frequency contributes to a comprehensive audit plan, these do not specifically address the independence issue that fundamentally undermines audit