Quality Assurance and Improvement Flashcards

ISO 9001:2015 adopts a 'risk-based thinking' approach, which means organizations must:

Answer: Identify risks and opportunities and plan actions to address them

Risk-based thinking requires identifying potential risks and opportunities as part of planning and continual improvement.

Which chart is most appropriate for monitoring the number of defects per unit when the subgroup size varies?

Answer: u-chart

The u-chart tracks defects per unit and adjusts control limits for varying subgroup sizes.

In quality improvement, a 'benchmark' is best defined as:

Answer: A performance standard based on best practices from high-performing organizations

Benchmarking compares your processes or results against recognized best-in-class performers to identify improvement gaps.

The concept of 'continual improvement' in ISO 9001 is primarily driven by:

Answer: Proactively using data and analysis to enhance processes and customer satisfaction over time

ISO 9001 continual improvement is a proactive, data-driven cycle rather than reactive problem-solving.

A quality engineer wants to determine whether two process variables are related. The most appropriate tool is a:

Answer: Scatter diagram

A scatter diagram plots two variables against each other to visually assess correlation.

Which of the following best describes the purpose of a control plan in quality assurance?

Answer: To specify controls for product and process characteristics to ensure customer requirements are met

A control plan is a living document that outlines inspection, measurement, and reaction plans for key characteristics.

In acceptance sampling, an Operating Characteristic (OC) curve shows:

Answer: The probability of accepting a lot as a function of the true lot quality

The OC curve plots the probability of lot acceptance versus the actual incoming defect rate, showing the sampling plan's discriminating power.