Quality Assurance & Improvement Flashcards

Which quality improvement tool uses a structured approach of Define, Measure, Analyze, Improve, and Control?

Answer: Six Sigma DMAIC

Six Sigma's DMAIC framework provides a data-driven methodology to improve existing processes by reducing defects and variation.

A process capability index (Cpk) value of 1.33 indicates:

Answer: The process meets a 4-sigma quality level

A Cpk of 1.33 corresponds to a 4-sigma process, yielding approximately 6,210 defects per million opportunities.

In quality management, a 'non-conformance' refers to:

Answer: Failure to meet a specified requirement

A non-conformance is any output or condition that fails to meet a defined requirement or specification.

The primary purpose of a Quality Management System (QMS) is to:

Answer: Ensure consistent processes that meet customer and regulatory requirements

A QMS provides a framework of processes, procedures, and responsibilities to consistently deliver products and services that satisfy customers.

Which statistical tool is used to determine if a process is in statistical control by plotting data over time?

Answer: Control chart

Control charts display process data over time against control limits, distinguishing between common cause and special cause variation.

Cost of Poor Quality (COPQ) includes which of the following categories?

Answer: Internal failure costs and external failure costs

COPQ specifically refers to costs incurred because quality failures occur, including internal failures (scrap, rework) and external failures (warranty, returns).

A quality audit finding classified as a 'major nonconformity' typically means:

Answer: A systemic breakdown that likely results in process failure or product nonconformance

A major nonconformity signals a complete absence or total breakdown of a system requirement, posing significant risk to process integrity.