Test yourself on FMEA - Failure Modes and Effects Analysis

Test yourself in FMEA - Failure Modes and Effects Analysis

1. Which of the following is most important to know when creating a User FMEA?

How will the suppliers ensure on time delivery of components needed to build the product?

How will the product be assembled / manufactured?

How will the user interact / use the product in the field?

Question 1 of 35

2. RPN is an acronym for for which of the following?

Reverse Polish Notation

Risk Priority Number

Rational Positive Number

Question 2 of 35

3. The lowest risk will be when RPN is which of the following (assume the FMEA uses rating scale of 1 to 5 for each: Severity, Occurrence, and Detection)?

None of the above

Question 3 of 35

4. A design FMEA was created for an electrically operated medical device based on its usage in England; now the device will be sold in SE Asian countries. Which of the following is most appropriate action for the company?

Re-evaluate the FMEA to determine if any of the failure modes, causes and effects will be different / change and / or update it accordingly.

No action needed - since there is no design change

Update the corresponding Process FMEA since the product will be sold in a different country

Question 4 of 35

5. The Probability of Harm determines the Severity rating in an FMEA. Select the most appropriate answer.

True

Only for medical devices

Only for Aerospace FMEAs

False

Question 5 of 35

6. A top down approach to perform FMEA on a system / assembly with multiple parts / assemblies is which of the following?

Starting from process and moving to product

Starting with lower indenture parts / assemblies and proceed to higher indenture assemblies / systems

Starting with higher indenture assemblies / systems and proceed to lower indenture parts / assemblies

All of the above

Question 6 of 35

7. A criticality matrix includes which elements from the list below? (Select all that apply)

Occurrence

Severity

Detection

Failure mode

Cause

Question 7 of 35

8. The Probability of Harm and the Probability of Occurrence are the same thing, just expressed in two different ways. Select the most appropriate answer.

Only for Aerospace FMEAs

True

False

Only for medical devices

Question 8 of 35

9. When it comes to products and FMEAs for the same, it is a given that the severity of effect of product failure is always linked to the design of the product, and not influenced by the manufacturing of a product. Select the most appropriate answer.

None of the above.

Only for high risk products

False

True

Question 9 of 35

10. If the rating tables for FMEA have a scale of 1 to 5 - which of the following interpretations is most appropriate with respect to Detection? (Select the best answer)

Rating of 3 indicates there is nothing in place to detect or prevent the failure

Rating of 1 indicates the failure is sure to be detected and prevented

Rating of 5 means a highly severe impact or harm will occur for sure

Rating of 7 means multiple fatalities could occur

Question 10 of 35

11. FMEA is best conducted by (select the best answer):

By getting input from the suppliers

An individual on their own

A team effort

Question 11 of 35

12. Current controls identified in a FMEA refer to which of the following (select the best answer):

Controls that should be actually in place to detect or prevent the failure from happening

Controls that are actually in place to detect or prevent the failure from happening

Measures that could be deployed to make the process run smoothly

Question 12 of 35

13. The highest risk will be when RPN is which of the following (assume the FMEA uses rating scale of 1 to 5 for each: Severity, Occurrence, and Detection)? Select the most appropriate answer.

None of the above

Question 13 of 35

14. The RPN is a product of:

Numerical ratings assigned to Severity, Occurrence, and Detection

User testing

Occurrence and detection ratings

Question 14 of 35

15. All FMEAs have two dimensions to study risk - Severity, and Occurrence

True

False

Question 15 of 35

16. According to ISO 13485, FMEAs need to be conducted throughout the life cycle of a product / service.

False

True for high risk implantable devices

True

Question 16 of 35

17. An aircraft mechanic notices a crack in a turbine blade - this is (select the most appropriate answer):

An engine failure

Failure mode for the engine

A potential cause for engine failure

Question 17 of 35

18. The post mitigation RPN should be below which of the following? (Select the best answer)

Above the RPN before mitigation

Below the threshold RPN

Question 18 of 35

19. Severity is linked to which of the following?

Components listed in the Bill of Materials

Effect of the Failure Mode

Frequency of the cause

Question 19 of 35

20. FMEA is a requirement under which of the standards / regulations listed below?

None of the above

ISO 27001

ISO 19001

ISO 13485

Question 20 of 35

21. The RPN should be calculated right after:

Prototype testing

Product is launched

None of the above

Severity ratings are assigned

Question 21 of 35

22. The RPN for an FMEA that used a rating scale of 1 to 5 for each of the three dimensions (Severity, Occurrence, and Detection) is 23. This indicates which of the following? Select the most appropriate answer.

The risk level is rather low since 23 is much smaller than the highest RPN of 1000.

The FMEA must have used a rating scale of 1 to 5 for one of the three dimensions

None of the above.

There is an error in computation of the RPN or assignment of ratings.

Question 22 of 35

23. DFMEA focuses on the design of a product and PFMEA on the Procedures for designing the product

False

True

Question 23 of 35

24. User FMEA is best conducted by (select the best answer):

Examining each manufacturing process step and asking what can go wrong here?

Examining incoming inspection records of materials used for all products

Seeing / asking users how the product will be used and what can go wrong as the product is used?

Question 24 of 35

25. A computer power supply is found to be defective; it does not show any voltage at the output (power connector that plugs into the laptop). Upon inspection it is found that the cable is damaged / broken right at the junction of the connector. Which of these should be considered a failure mode of the power supply as a product? (Select the best answer)

Frayed connection

Broken connector

No voltage at the connector

Damaged cable

Question 25 of 35

26. The Probability of Occurrence is the same as the Probability of Detection. Select the most appropriate answer.

None of the above.

False

Only for high risk failures

True

Question 26 of 35

27. A bottom up design FMEA needs to be initiated right at the user requirements stage for a new product that has never been designed before (no BOM exists).

True

False

True for high risk implantable devices

Question 27 of 35

28. The best time to do a user FMEA on new products is (select the best answer):

Right after the first complaint is received

When prototypes can be examined for usability

After product is launched

Question 28 of 35

29. The rating table for detecting Failures was constructed as below. What is wrong with this rating table?

1 - Failure is unlikely or impossible to be detected

2 - It is hard to detect

3 - Failure can be detected with some effort

4 - Failure is easy to detect

5 - Failure is sure to be prevented / detected automatically

The ratings are for severity rather than detection

The ratings are for occurrence and not for detection

The ratings from 1 to 5 are in the reverse order

Question 29 of 35

30. Process FMEA is best conducted by (select the best answer):

Examining each process step and asking what can go wrong here?

Examining each component of the product / assembly

An individual on their own

Question 30 of 35

31. According to the PDCA cycle shown in ISO 9001:2015 - FMEAs should be done during P (Plan) step, and again at the A (Act) step.

False

For products that are meant for local consumption in the country of origin

True

Question 31 of 35

32. If a SIPOC is used to identify failure modes in a process, Severity could be linked to which of the following? (Select the best answer)

S - Services

O - Outputs of the process

C - Controls

I - Immediate results

Question 32 of 35

33. Which of the following would be more useful to conduct a Design FMEA for an assembly such as a power supply, or a hydraulic pump?

The bill of materials

A process map showing how the product is built

User manual

Repair manual

Question 33 of 35

34. The cause is directly linked to which of the following? (select the most appropriate answer)

Severity

Failure Mode

Design

Process

Question 34 of 35

35. An SPC Chart shows a process violates the UCL. An auditor thinks the Severity associated with this incident should be a 5, the highest in the scale used. Do you agree? (Select the best answer)

No - definitely not

Yes - it's rating should be a 5

Cannot determine based on given information.

Question 35 of 35