CPS Quality Control & Compliance 2 — Questions and Answers
Question 1: A process shows a Cpk of 0.85. What does this indicate?
- The process is centered and capable
- The process is capable but not centered
- The process is not capable of meeting specifications (Correct answer)
- The process has no variation
Correct 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.
Question 2: Which document formally authorizes a quality audit and defines its scope?
- Audit checklist
- Audit charter (Correct answer)
- Corrective action report
- Quality manual
Correct answer: Audit charter
An audit charter formally authorizes the audit function and defines its purpose, authority, and scope.
Question 3: What is the primary purpose of a control chart's upper and lower control limits (UCL/LCL)?
- Indicate customer specification boundaries
- Detect when a process is out of statistical control (Correct answer)
- Set targets for process improvement
- Define acceptable defect rates
Correct 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.
Question 4: A company receives a major customer complaint about a recurring defect. The FIRST step in the 8D problem-solving process is to:
- Identify the root cause
- Form a cross-functional team (Correct answer)
- Implement a permanent corrective action
- Contain the problem immediately
Correct 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.
Question 5: ISO 9001:2015 uses a 'risk-based thinking' approach. Which clause most directly addresses this?
- Clause 4 – Context of the organization
- Clause 6 – Planning (Correct answer)
- Clause 8 – Operation
- Clause 9 – Performance evaluation
Correct answer: Clause 6 – Planning
Clause 6 of ISO 9001:2015 requires organizations to address risks and opportunities as part of quality management system planning.
Question 6: Which sampling method selects every nth item from a production run?
- Random sampling
- Stratified sampling
- Systematic sampling (Correct answer)
- Cluster sampling
Correct answer: Systematic sampling
Systematic sampling selects items at fixed intervals (every nth item), making it practical for continuous production processes.
Question 7: When a gauge R&R study results in measurement variation exceeding 30% of total variation, the appropriate action is to:
- Accept the measurement system as adequate
- Investigate and improve the measurement system (Correct answer)
- Tighten specification limits
- Increase sample size for inspections
Correct 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.
CPS Quality Control & Compliance 2
A process shows a Cpk of 0.85.
What does this indicate?