CQE (CQE) 3 — Questions and Answers
Question 1: Which type of failure mode and effects analysis (FMEA) is performed on manufacturing or assembly processes?
- Design FMEA (DFMEA)
- System FMEA
- Process FMEA (PFMEA) (Correct answer)
- Functional FMEA
Correct answer: Process FMEA (PFMEA)
PFMEA evaluates how process failures could affect product quality, safety, or customer satisfaction.
Question 2: In hypothesis testing, a Type II error (β) occurs when:
- A true null hypothesis is rejected
- A false null hypothesis is not rejected (Correct answer)
- The p-value exceeds the significance level
- The sample size is too large
Correct answer: A false null hypothesis is not rejected
A Type II error is failing to detect a real effect — accepting H₀ when it is actually false.
Question 3: The purpose of a gauge R&R study is to:
- Calibrate measuring instruments to a national standard
- Quantify the variation contributed by the measurement system (Correct answer)
- Determine the optimal sample size for acceptance testing
- Calculate the uncertainty budget of a test laboratory
Correct answer: Quantify the variation contributed by the measurement system
Gauge R&R separates measurement variation into repeatability (equipment) and reproducibility (appraiser) components.
Question 4: ISO 9001:2015 adopts which management framework as its organizing structure?
- DMAIC improvement cycle
- High Level Structure (Annex SL) (Correct answer)
- Balanced Scorecard
- Total Quality Management (TQM)
Correct answer: High Level Structure (Annex SL)
ISO 9001:2015 uses the Annex SL (now Annex L) High Level Structure, enabling alignment with other ISO management system standards.
Question 5: A scatter diagram showing a strong positive correlation between two variables means:
- One variable causes the other to increase
- As one variable increases, the other tends to increase (Correct answer)
- The variables are perfectly linearly related
- A cause-and-effect relationship has been proven
Correct answer: As one variable increases, the other tends to increase
Positive correlation indicates a tendency for both variables to move in the same direction, but does not prove causation.
Question 6: Which element is NOT typically part of a Quality Management System (QMS) document hierarchy?
- Quality manual
- Procedures
- Work instructions
- Marketing brochures (Correct answer)
Correct answer: Marketing brochures
A QMS document hierarchy consists of quality manuals, procedures, work instructions, and records — not marketing materials.
Question 7: In reliability engineering, the bathtub curve describes:
- The relationship between sample size and detection probability
- Three distinct failure rate phases over a product's life (Correct answer)
- The cumulative distribution function of the Weibull distribution
- Customer satisfaction over the product lifecycle
Correct answer: Three distinct failure rate phases over a product's life
The bathtub curve shows infant mortality (decreasing failure rate), useful life (constant rate), and wear-out (increasing rate) phases.
CQE (CQE) 3
Which type of failure mode and effects analysis (FMEA) is performed on manufacturing or assembly processes?