Quality Control

Correct Answer: Conduct a root cause analysis to identify the source of the deviation

The best action in this scenario is to conduct a root cause analysis to identify the source of the deviation. This approach is aligned with project management best practices and quality control principles. Here's why this is the correct choice: 1. It addresses the underlying issue rather than just treating the symptom. 2. It helps prevent similar deviations in future batches. 3. It follows proper quality management procedures in pharmaceutical production. 4. It demonstrates a commitment to continuous improvement and quality assurance. The other options are incorrect for the following reasons: Releasing the batch with a warning label is not appropriate as it doesn't address the quality issue and may pose risks to patients. Adjusting the potency level by adding more active ingredients is unethical and potentially dangerous. It violates good manufacturing practices and could lead to inconsistent medication effects. Implementing a temporary change in the quality control process to allow for this deviation compromises quality standards and may lead to more serious issues in the future. In conclusion, conducting a root cause analysis is the most responsible and effective approach to address this quality control issue in a pharmaceutical project.

Correct Answer: Control chart

The best statistical tool to analyze and visualize the issue of a critical component consistently failing to meet required specifications is a Control chart. Control charts are specifically designed to monitor process stability and consistency over time. They help identify whether a process is in statistical control or if there are any unusual variations or trends. In this scenario, where a critical component is consistently failing to meet specifications, a control chart would be ideal for visualizing the data points, detecting patterns, and identifying whether the failures are due to common cause variation or special cause variation. The other options are less suitable for this specific situation: A scatter diagram is used to show the relationship between two variables, which is not the primary concern in this quality control issue. A histogram with a normal distribution curve overlay would show the frequency distribution of measurements but wouldn't effectively track the consistency of failures over time. A Pareto chart is useful for identifying the most significant factors contributing to a problem, but in this case, we're dealing with a single critical component rather than multiple types of failures. The control chart is the most appropriate tool for monitoring and analyzing the ongoing performance of a critical component in a quality control context.

Correct Answer: quality

The correct answer is 'quality' requirements. Quality Control is a process within project management that focuses on inspecting and verifying project deliverables to ensure they meet the predetermined quality standards and requirements. This process is essential to maintain the overall quality of the project output. Here's why 'quality' is the best answer: 1. Quality Control is specifically designed to check and validate the quality of deliverables. 2. It involves comparing the actual results with the quality standards set for the project. 3. The primary goal is to ensure that the final product or service meets the quality expectations of stakeholders. Why the other options are incorrect: 'Scope' requirements: While scope is an important aspect of project management, Quality Control is not primarily focused on verifying scope. Scope management has its own processes. 'Time' requirements: Quality Control is not directly related to checking time requirements. Time management is a separate knowledge area in project management. 'Cost' requirements: Although cost is a crucial factor in projects, Quality Control does not primarily deal with cost verification. Cost control is handled through other project management processes. In summary, Quality Control is specifically concerned with ensuring that project deliverables meet the defined quality requirements, making 'quality' the most appropriate answer in this context.