BMAT Quality Control & Assurance 2 — Questions and Answers
Question 1: Which statistical tool is used to determine whether a process is in statistical control by plotting sample means over time?
- Pareto chart
- Control chart (Correct answer)
- Scatter diagram
- Histogram
Correct answer: Control chart
Control charts (also called Shewhart charts) plot process measurements over time to detect shifts or trends indicating the process is out of control.
Question 2: In quality management, 'validation' differs from 'verification' in that validation confirms:
- The product meets internal specifications
- The product fulfills its intended use by the end user (Correct answer)
- All components passed inspection
- The manufacturing process is documented
Correct answer: The product fulfills its intended use by the end user
Validation ensures the product does what it is intended to do in the real-world context, while verification checks conformance to specified requirements.
Question 3: A company finds that 3 out of every 500 items produced are defective. What is the defect rate expressed as parts per million (PPM)?
- 600 PPM
- 6,000 PPM (Correct answer)
- 60 PPM
- 300 PPM
Correct answer: 6,000 PPM
(3/500) × 1,000,000 = 6,000 PPM is the defect rate.
Question 4: Which quality management principle emphasizes that processes and systems should be designed with built-in safeguards to prevent human errors?
- Kaizen
- Poka-yoke (Correct answer)
- Kanban
- Gemba
Correct answer: Poka-yoke
Poka-yoke (mistake-proofing) refers to mechanisms designed to prevent errors or make defects immediately obvious when they occur.
Question 5: In ISO 9001:2015, which clause specifically addresses 'Risk-based thinking'?
- Clause 4 – Context of the organization
- Clause 6 – Planning (Correct answer)
- Clause 7 – Support
- Clause 9 – Performance evaluation
Correct answer: Clause 6 – Planning
Clause 6 (Planning) in ISO 9001:2015 requires organizations to identify risks and opportunities and plan actions to address them.
Question 6: An Ishikawa (fishbone) diagram is primarily used to:
- Track defect frequency over time
- Identify potential root causes of a problem (Correct answer)
- Prioritize quality improvement projects
- Map process flow steps
Correct answer: Identify potential root causes of a problem
The Ishikawa diagram categorizes potential causes of a problem (typically into people, process, equipment, materials, environment, and management) to aid root cause analysis.
Question 7: In acceptance sampling, the Acceptable Quality Level (AQL) represents:
- The maximum allowable defect rate for a rejected lot
- The worst tolerable process average still acceptable (Correct answer)
- The average outgoing quality limit
- The minimum sample size required
Correct answer: The worst tolerable process average still acceptable
AQL is the worst quality level that is still considered acceptable as a process average; lots at or better than AQL should be accepted most of the time.
BMAT Quality Control & Assurance 2
Which statistical tool is used to determine whether a process is in statistical control by plotting sample means over time?