SQA Common 3 — Questions and Answers
Question 1: What is the primary goal of Failure Mode and Effects Analysis (FMEA)?
- To proactively identify and prioritize potential failure modes before they occur (Correct answer)
- To document failures that have already occurred in production
- To calculate the cost of poor quality
- To verify that all inspection procedures are followed
Correct answer: To proactively identify and prioritize potential failure modes before they occur
FMEA is a proactive risk assessment tool that identifies potential failure modes and evaluates their effects to prioritize prevention efforts.
Question 2: In quality management, what does 'traceability' primarily ensure?
- The ability to track a product's history, application, or location (Correct answer)
- That all products are inspected before shipment
- That quality records are stored for a minimum of five years
- That suppliers are audited annually
Correct answer: The ability to track a product's history, application, or location
Traceability enables tracking of a product's origin, processing history, and distribution, which is critical for recalls and investigations.
Question 3: Which SQA concept refers to quality costs associated with preventing defects from occurring?
- Prevention costs (Correct answer)
- Appraisal costs
- Internal failure costs
- External failure costs
Correct answer: Prevention costs
Prevention costs include activities like training, process improvement, and quality planning aimed at avoiding defects before they arise.
Question 4: What is the role of a 'Management Representative' in an ISO 9001-compliant organization?
- To ensure the QMS is established, implemented, and maintained (Correct answer)
- To approve all nonconformance reports
- To conduct all internal audits
- To sign off on customer complaints
Correct answer: To ensure the QMS is established, implemented, and maintained
The Management Representative is responsible for the overall implementation and maintenance of the quality management system and reports to top management.
Question 5: In statistical process control (SPC), what does a point outside the control limits on a control chart indicate?
- A special cause of variation that requires investigation (Correct answer)
- Normal process variation within expected range
- That the process is producing defective parts
- That the measurement system is unreliable
Correct answer: A special cause of variation that requires investigation
Points outside control limits signal special cause variation, indicating an unusual event that should be investigated and corrected.
Question 6: What distinguishes 'quality control' from 'quality assurance'?
- QC is product-focused and reactive; QA is process-focused and proactive (Correct answer)
- QA inspects products; QC documents procedures
- QC is performed by management; QA is performed by technicians
- QA applies only to manufacturing; QC applies to services
Correct answer: QC is product-focused and reactive; QA is process-focused and proactive
Quality Control detects defects in finished products, while Quality Assurance prevents defects by improving the processes that create them.
Question 7: Which measurement concept describes the degree to which repeated measurements of the same item give consistent results?
- Repeatability (Correct answer)
- Accuracy
- Reproducibility
- Bias
Correct answer: Repeatability
Repeatability measures the variation in results when the same operator measures the same part multiple times with the same equipment.
SQA Common 3
What is the primary goal of Failure Mode and Effects Analysis (FMEA)?