What should be documented when conducting a Root Cause Analysis?

When conducting a Root Cause Analysis (RCA), it's essential to document the Quality Review Event (QRE) or the specific incident being investigated. This documentation serves as a foundational aspect of the analysis, allowing the team to clearly identify what occurred, the circumstances surrounding the event, and the impact it had on safety, quality, or compliance.

Having a detailed account of the QRE or incident enables the team to trace back through the events leading to the outcome, identify contributing factors, and formulate corrective actions. This thorough documentation helps ensure that all relevant information is captured for analysis, making it easier to address the root causes and prevent similar issues in the future.

The other options listed are less relevant to the RCA process. For instance, documenting the quantity of product sold or the number of staff on duty may provide context but doesn't directly analyze the causes of an incident. Similarly, recording the marketing strategy is unrelated to the purpose of an RCA, which focuses on identifying errors or failures in processes rather than promotional or sales tactics.