SQA Common 2 — Questions and Answers
Question 1: Which statistical tool is most commonly used in SQA to identify the root cause of quality problems by categorizing defects?
- Pareto chart (Correct answer)
- Control chart
- Scatter diagram
- Histogram
Correct answer: Pareto chart
A Pareto chart applies the 80/20 rule to prioritize the most significant defect categories, directing root cause analysis efforts effectively.
Question 2: In quality assurance, what is a 'corrective action' in response to a nonconformance?
- Action taken to eliminate the cause of a detected nonconformity (Correct answer)
- Immediate fix applied to a defective product
- Documentation update to reflect new standards
- Preventive measure implemented before a problem occurs
Correct answer: Action taken to eliminate the cause of a detected nonconformity
Corrective action addresses the root cause of a detected nonconformity to prevent recurrence, not just the symptom.
Question 3: What does the term 'validation' specifically refer to in the context of SQA?
- Confirming that a product meets intended use requirements (Correct answer)
- Verifying that a product meets design specifications
- Reviewing documentation for completeness
- Testing a product under extreme conditions
Correct answer: Confirming that a product meets intended use requirements
Validation confirms that the product fulfills its intended purpose and user needs, as opposed to verification which checks specifications.
Question 4: Which type of audit evaluates a supplier's quality system from a customer's perspective?
- Second-party audit (Correct answer)
- First-party audit
- Third-party audit
- Internal audit
Correct answer: Second-party audit
A second-party audit is conducted by a customer or their representative to assess a supplier's quality management system.
Question 5: In SQA, what is the primary purpose of a Quality Management Plan (QMP)?
- To define quality standards, resources, and activities for a project (Correct answer)
- To document all nonconformances found during testing
- To train personnel on quality procedures
- To establish the organizational chart for the quality team
Correct answer: To define quality standards, resources, and activities for a project
A Quality Management Plan outlines how quality policies, objectives, and responsibilities will be applied to a specific project.
Question 6: What is 'process capability' as measured by Cpk?
- A measure of how well a process meets specification limits relative to its variability (Correct answer)
- The total output rate of a manufacturing process
- The number of defects per million opportunities
- The ratio of actual to planned production output
Correct answer: A measure of how well a process meets specification limits relative to its variability
Cpk measures process capability by comparing the process spread and centering to the specification limits.
Question 7: Which document establishes the minimum quality requirements that a supplier must meet?
- Quality Assurance Agreement (QAA) (Correct answer)
- Statement of Work (SOW)
- Corrective Action Report (CAR)
- Certificate of Conformance (CoC)
Correct answer: Quality Assurance Agreement (QAA)
A Quality Assurance Agreement formally defines the quality expectations, responsibilities, and standards a supplier must adhere to.
Which statistical tool is most commonly used in SQA to identify the root cause of quality problems by categorizing defects?