Risk Management Quiz - Vee Care Asia

Risk Management Quiz

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1. Manufacturer does not need to document a policy for establishing criteria for risk acceptability.

a) True

b) False

2. Positive impact on patient management or public health is not defined as benefit

a) True

b) False

3. Probability of occurrence of harm is equal to probability of a hazardous situation occurring times the probability of a hazardous situation leading to harm.

a) True

b) False

4. Information for safety is now an accepted risk control option under the MDR

a) True

b) False

5. Production and post-production information have become activities.

a) True

b) False

6. Visual representation is the only approach to evaluate overall risk.

a) True

b) False

7. Risk Management Review could be done every 2 years.

a) True

b) False

8. Process qualification is NOT a risk control measure.

a) True

b) False

9. Benefit-Risk Analysis is conducted when residual risk is not acceptable.

a) True

b) False

10. User error is part of the reasonably foreseeable misuse.

a) True

b) False

1. Which of the following is the correct sequence of Risk Management Process?

a) Risk Analysis > Risk Control > Risk Evaluation > Overall Risk Evaluation > Production & Postproduction Activities

b) Risk Analysis > Risk Evaluation > Risk Control > Overall Risk Evaluation > Production & Postproduction Activities

c) Risk Analysis > Risk Evaluation > Overall Risk Evaluation > Risk Control > Production & Postproduction Activities

d) Risk Evaluation > Risk Analysis > Risk Control > Overall Risk Evaluation > Production & Postproduction Activities

e) None of the above

2. Which of the following is a risk evaluation criterion?

a) State of art

b) Clinical data

c) Competitive products

d) International standards

e) All of the above

3. Which of the following is not an appropriate risk analysis tool?

a) Preliminary Hazard Analysis (PHA)

b) State of Arts (SOA)

c) Hazard Analysis and Critical Control Point (HACCP)

d) Failure Modes and Effects Analysis (FMEA)

e) None of the above

4. Which of the following is the correct sequence of Hazard Risk Relationship?

a) Hazard > Sequence of Events > Hazardous Situation > Harm

b) Hazard > Hazardous Situation > Sequence of Events > Harm

c) Hazard > Sequence of Events > Harm > Hazardous Situation

d) Hazard > Hazardous Situation > Harm > Sequence of Events

e) None of the above

5. Which of the following item is NOT a foreseeable misuse?

a) Device use more frequent than intended

b) Single use device is being use multiple times

c) Insulin syringe is being for intravenous injection

d) Adult intended product is being for children

e) Device is being used longer than intended

6. Which of the following is NOT a criterion for risk acceptability policy?

a) Applicable regulatory requirements

b) International standards

c) Development costs

d) State of art

e) Alternative treatment

7. Benefit-Risk analysis should be conducted….

a) for identified risk(s)

b) for new risk(s)

c) for all residual risk(s) after mitigation

d) for unacceptable residual risk(s) mitigation

e) for overall risk only

8. Which of the following is the borderline acceptable cell on the Risk Matrix Table?

a) S1/O5

b) S2/04

c) S3/02

d) S4/O4

e) S5/01

9. Which of the following is NOT an approach for evaluating overall risk?

a) Weighing Benefit/Risk

b) Expert Opinions

c) Visual Representation

d) Product Testing

e) Comparison to similar device

10. Which of the following is the design hazard for a surgical mask with inadequate blood splash resistance?

a) Flammable materials

b) Inadequate filtering

c) Poor welding process

d) Product size variation

e) Poor user instruction

11. Which of the following is the hazardous situation for a surgical mask with inadequate blood splash resistance?

a) Routine Eye Examination

b) Blood splash during an operation

c) Vaccination

d) Non-biocompatible materials

e) Wrong mask size

12. Which of the following is the harm for a surgical mask with inadequate blood splash resistance?

a) Thermal burnt

b) Irritation

c) Bacterial Infection

d) Electrical shock

e) Chemical burnt

13. Who will be harmed for a surgical mask with inadequate blood splash resistance?

a) Patient

b) User

c) Bystander

d) Property

e) Environment

14. Which of the following is a process hazardous situation for a sterile surgical device?

a) Wrong packing materials

b) Non-biocompatible materials

c) Inappropriate sterilization parameters

d) Non-validated IFU

e) Product being reused

15. What is the potential harm for a non-biocompatible urinary catheter?

a) Infection

b) Allergy or Sensitivity

c) Occlusion

d) Bleeding

e) Urethral injury

16. What is the risk control method for the potential harm in Q15?

a) Biocompatibility Test

b) Performance Test

c) Clinical Study

d) Animal Study

e) Production Process Validation

17. Which of the following is a risk-control method by design for single used device?

a) Self-destruction after use

b) Warning on the IFU

c) Obvious indicator after first use

d) Educational video

e) Sterile packing

18. Which of the following is a risk-control method by protective measure for an electrical medical device?

a) Low voltage design

b) 60601-1 compliant power supply

c) Insulting protective case

d) Warning on high voltage parts

e) Insultation test during product release

19. Which of the following is a risk-control by information for a Covid-19 Rapid Antigen Test?

a) Plastic protective wrap

b) Test instruction on external pack

c) 3-year verified shelf life

d) Compliance to ASTM 4169 transport test

e) Clinical study

20. Which of the following is a NOT risk-control method for X-ray machine?

a) Protective shield

b) Operational software validation

c) Equipment Sanitization

d) Routine Maintenance

e) User Product Training

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