Regulatory Affairs Certification (RAC) Practice Exam

What is the main goal of conducting quality audits according to the Quality System Regulation?

1. To ensure compliance with marketing laws

2. To evaluate cost-effectiveness of production

3. To ensure product safety and quality

4. To assess employee performance

The correct answer is: To ensure product safety and quality

The primary goal of conducting quality audits according to the Quality System Regulation is to ensure product safety and quality. Quality audits are integral to verifying that a company's quality management system is effective and that processes are in place to maintain high standards for the products being developed. This is essential not only for regulatory compliance but also for protecting public health by ensuring that products meet safety and quality requirements. Quality audits systematically evaluate all aspects of the quality system, including production processes, documentation practices, and compliance with regulatory standards. By focusing on product safety and quality, organizations can identify areas for improvement, prevent non-conformances, and ultimately ensure that the products they release to the market are safe for consumers. The other options, while relevant to broader business operations, do not align directly with the core intent of quality audits under the regulation. Marketing laws and cost-effectiveness may be important considerations within a business framework but do not directly address the essential aspects of safety and quality that audits aim to uphold. Similarly, assessing employee performance, while important for overall organizational efficiency, is not a primary focus of quality audits, which concentrate more on processes and compliance rather than individual evaluations.