CDT Dental Lab Quality Management 3 — Questions and Answers
Question 1: A quality audit reveals that 30% of zirconia restorations returned for remake had incorrect shade selection. Which improvement tool prioritizes this problem among several others?
- Failure mode and effects analysis (FMEA)
- Pareto analysis (Correct answer)
- Control charts
- Scatter diagrams
Correct answer: Pareto analysis
Pareto analysis applies the 80/20 rule to identify the vital few defects that account for the majority of quality problems, helping prioritize corrective action.
Question 2: What does 'incoming inspection' of dental materials involve in a QMS-compliant laboratory?
- Testing materials only when a complaint is received
- Verifying materials meet specifications before use in production (Correct answer)
- Accepting all materials from approved suppliers without inspection
- Inspecting only materials above a certain dollar value
Correct answer: Verifying materials meet specifications before use in production
Incoming inspection verifies that received materials and components meet specified requirements before they enter the production process.
Question 3: Which element of risk management, as defined by ISO 14971, involves estimating the probability and severity of potential harms from a dental prosthetic?
- Risk evaluation
- Risk estimation (Correct answer)
- Risk control
- Residual risk assessment
Correct answer: Risk estimation
Risk estimation involves determining the probability of occurrence of harm and its severity to quantify the risk associated with a hazardous situation.
Question 4: A lab manager wants to reduce variability in porcelain firing temperatures. Which approach is most consistent with continual improvement under ISO 13485?
- Replace all furnaces immediately
- Monitor temperatures using calibrated equipment and analyze trends over time (Correct answer)
- Rely on technician experience rather than instruments
- Reduce firing cycles to save time
Correct answer: Monitor temperatures using calibrated equipment and analyze trends over time
Continual improvement under ISO 13485 requires monitoring process performance using calibrated equipment and data analysis to identify and reduce variability.
Question 5: What is the significance of 'lot traceability' for materials used in dental laboratory production?
- It allows the lab to charge more for premium materials
- It enables recall of specific product batches if a material defect is discovered (Correct answer)
- It is only required for precious metal alloys
- It simplifies billing to the dentist
Correct answer: It enables recall of specific product batches if a material defect is discovered
Lot traceability allows a laboratory to identify all products made with a specific material batch so that targeted recalls can be initiated if a defect is discovered.
Question 6: During an internal audit, a technician's training record is missing for a new digital impression software. Under ISO 13485, what action is required?
- Document the finding and initiate a corrective action to complete the training record (Correct answer)
- Terminate the technician's employment
- Ignore it if the technician appears competent
- Wait until the next external audit to address it
Correct answer: Document the finding and initiate a corrective action to complete the training record
Internal audit findings of nonconformances must be documented and addressed through the corrective action process to close the gap and prevent recurrence.
Question 7: A dental lab's management review meeting must evaluate which of the following inputs according to ISO 13485?
- Staff vacation schedules and payroll adjustments
- Customer feedback, audit results, process performance, and regulatory changes (Correct answer)
- Equipment purchase wish lists from technicians
- Marketing strategies for attracting new dentist clients
Correct answer: Customer feedback, audit results, process performance, and regulatory changes
ISO 13485 requires management review to evaluate inputs including customer feedback, audit results, process and product performance, and applicable regulatory requirements.
CDT Dental Lab Quality Management 3
A quality audit reveals that 30% of zirconia restorations returned for remake had incorrect shade selection.
Which improvement tool prioritizes this problem among several others?