Quality Control & Compliance Flashcards

A process shows a Cpk of 0.85. What does this indicate?

Answer: The process is not capable of meeting specifications

A Cpk below 1.0 indicates the process is not capable of consistently producing output within specification limits.

Which document formally authorizes a quality audit and defines its scope?

Answer: Audit charter

An audit charter formally authorizes the audit function and defines its purpose, authority, and scope.

What is the primary purpose of a control chart's upper and lower control limits (UCL/LCL)?

Answer: Detect when a process is out of statistical control

Control limits are statistically derived boundaries used to distinguish common cause variation from special cause variation.

A company receives a major customer complaint about a recurring defect. The FIRST step in the 8D problem-solving process is to:

Answer: Form a cross-functional team

8D Step 1 (D1) requires forming a cross-functional team with the knowledge and authority to solve the problem.

ISO 9001:2015 uses a 'risk-based thinking' approach. Which clause most directly addresses this?

Answer: Clause 6 – Planning

Clause 6 of ISO 9001:2015 requires organizations to address risks and opportunities as part of quality management system planning.

Which sampling method selects every nth item from a production run?

Answer: Systematic sampling

Systematic sampling selects items at fixed intervals (every nth item), making it practical for continuous production processes.

When a gauge R&R study results in measurement variation exceeding 30% of total variation, the appropriate action is to:

Answer: Investigate and improve the measurement system

Measurement system variation above 30% is generally unacceptable and requires investigation and improvement of the gauge or measurement process.