CPS Quality Control & Compliance 3 — Questions and Answers
Question 1: Which quality tool is BEST suited for prioritizing the most significant sources of defects in a process?
- Histogram
- Scatter diagram
- Pareto chart (Correct answer)
- Run chart
Correct answer: Pareto chart
A Pareto chart ranks defect categories by frequency, allowing teams to focus on the vital few causes that account for most problems.
Question 2: A process audit differs from a product audit in that a process audit:
- Evaluates finished goods against specifications
- Examines whether processes are followed as documented (Correct answer)
- Reviews financial compliance records
- Tests raw materials before production
Correct answer: Examines whether processes are followed as documented
A process audit verifies that documented procedures are being followed correctly, while a product audit evaluates conformance of the output.
Question 3: Which type of control chart is most appropriate for monitoring the proportion of defective units in a large batch?
- X-bar and R chart
- p-chart (Correct answer)
- c-chart
- Individuals (I-MR) chart
Correct answer: p-chart
The p-chart monitors the proportion (fraction) defective in subgroups and is used when subgroup size varies.
Question 4: What is the key difference between verification and validation in quality management?
- Verification checks design requirements; validation confirms fitness for intended use (Correct answer)
- Validation is done before verification in the product lifecycle
- Verification is performed by customers; validation by suppliers
- They are interchangeable terms in ISO 9001
Correct answer: Verification checks design requirements; validation confirms fitness for intended use
Verification confirms the product meets specified requirements, while validation confirms it meets the needs of the intended use or application.
Question 5: A supplier consistently delivers parts that are within spec but at the edge of tolerances. Which quality concept addresses the cost of this scenario?
- Cost of poor quality (COPQ)
- Taguchi loss function (Correct answer)
- Acceptance quality level (AQL)
- Zero defects principle
Correct answer: Taguchi loss function
The Taguchi loss function shows that any deviation from the target value — even within spec — causes increasing quality loss.
Question 6: Under 21 CFR Part 820 (FDA Quality System Regulation), which document provides the overall framework for a medical device manufacturer's quality system?
- Device master record (DMR)
- Quality system regulation (QSR) manual (Correct answer)
- Design history file (DHF)
- Device history record (DHR)
Correct answer: Quality system regulation (QSR) manual
The Quality System Regulation manual describes the overall quality system and how the manufacturer meets 21 CFR Part 820 requirements.
Question 7: Which statistical distribution is typically assumed when applying acceptance sampling plans from ANSI/ASQ Z1.4?
- Normal distribution
- Poisson distribution
- Hypergeometric distribution
- Binomial distribution (Correct answer)
Correct answer: Binomial distribution
ANSI/ASQ Z1.4 is based on the binomial distribution, which models the probability of a given number of defectives in a sample.
CPS Quality Control & Compliance 3
Which quality tool is BEST suited for prioritizing the most significant sources of defects in a process?