Certified Pharmaceutical GMP Professional Practice

What is a key component of risk assessment in quality risk management?

1. Only identifying hazards

2. Analysis and evaluation of risks associated with hazards

3. Documenting previous incidents unrelated to current risks

4. Conducting employee interviews

The correct answer is: Analysis and evaluation of risks associated with hazards

A key component of risk assessment in quality risk management is the analysis and evaluation of risks associated with hazards. This process involves systematically identifying potential hazards that could affect product quality, safety, and efficacy and then evaluating the risks linked to these hazards. The analysis phase typically includes assessing the likelihood of a risk occurring and the potential consequences should it occur. Evaluation helps prioritize the risks based on their severity and probability, allowing organizations to implement appropriate risk control measures. By focusing on this systematic approach, organizations can better protect their processes and products, ensuring compliance with regulatory standards and quality assurance protocols. Other choices, while relevant to certain aspects of risk management, do not represent the comprehensive approach necessary for effective risk assessment. Identifying hazards is certainly a part of the process, but without the subsequent analysis and evaluation, it lacks the depth required for a robust risk management strategy. Documenting previous incidents may provide context but does not directly contribute to the current risk assessment process. Conducting employee interviews could yield valuable insights but is not a fundamental part of risk assessment itself.