Risk Identification

Correct Answer: Root Cause Analysis

Root Cause Analysis (RCA) is the most appropriate technique in this situation because: When dealing with deviating test results in a medical device, it's crucial to understand the underlying causes of the variations. RCA is specifically designed to: 1. Identify the fundamental source of the problem 2. Track patterns of deviation 3. Determine why the unusual pattern is occurring 4. Help prevent similar issues in the future Why other options are less suitable: Statistical Process Control and Trend Analysis would help monitor the process but wouldn't identify the root cause of the unusual pattern. Expert Interview and Documentation Review might be helpful as a secondary step but wouldn't provide the systematic approach needed to analyze the specific deviation pattern. Monte Carlo Simulation is more suitable for forecasting future scenarios and probability assessment, not for analyzing existing quality issues.

Correct Answer: Historical Data Analysis

Historical Data Analysis is the most effective technique for determining whether a risk is unique or recurring because: 1. It allows you to review past project documentation and records to identify patterns of risk occurrence 2. You can track the frequency and impact of similar risks across multiple projects 3. It provides concrete evidence rather than theoretical assumptions 4. It helps establish whether the risk has manifested before in similar projects Why other options are less suitable: Advanced statistical modeling would be excessive for simply determining if a risk is recurring, and might not be as reliable for this specific purpose. Expert judgment, while valuable, is more subjective and might not provide the clear historical perspective needed to determine if a risk is recurring. Root cause analysis is more focused on identifying the source of problems rather than determining the frequency pattern of risks.

Correct Answer: Scenario Analysis

Scenario Analysis is the correct answer because the described situation involves team members exploring potential future events and their impacts based on a specific trigger (regulatory change). This is a classic example of scenario analysis, where different possible future scenarios are examined to identify risks. In this technique, team members consider 'what-if' situations and their potential consequences, which is exactly what's happening when discussing possible future impacts of the regulatory change. The other options are incorrect because: - Root cause identification looks backward at causes of known issues, not forward at potential future scenarios - Expert evaluation with historical data analysis focuses on past patterns rather than future possibilities - Structured risk documentation is about recording and organizing risk information, not identifying new risks Scenario Analysis is particularly useful when dealing with uncertain future events, like regulatory changes, as it helps teams anticipate and prepare for various possible outcomes.