Certified Pharmaceutical GMP Professional Practice

Which step follows identifying all events that contributed to a risk in root cause analysis?

1. Determining root causes

2. Designing strategies to enhance employee performance

3. Documenting past failures

4. Implementing new marketing techniques

The correct answer is: Determining root causes

After identifying all events that contributed to a risk in root cause analysis, the subsequent step is to determine the root causes. Root cause analysis is a systematic approach used to identify the underlying reasons for a problem or risk event. Once the contributing events are gathered, the next logical step is to analyze and pinpoint the specific root causes that led to those events. This process provides critical insights for effective problem-solving and preventative measures. Determining root causes involves critically evaluating the identified events to understand their interrelationships and uncover the fundamental issues. This approach is essential in GMP (Good Manufacturing Practice) to ensure that processes are thoroughly examined, allowing for more informed decisions on how to mitigate risks and improve overall quality. In contrast, the other options such as designing strategies to enhance employee performance, documenting past failures, and implementing new marketing techniques do not directly follow the identification of events in a risk context. Instead, they represent separate considerations that may be part of a larger strategic initiative or operational improvement process, but not the immediate next step in root cause analysis.