Test yourself on FMEA - Failure Modes and Effects Analysis

Test yourself in FMEA - Failure Modes and Effects Analysis

1. 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 1 of 35

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

True

False

Question 2 of 35

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

True

False

Question 3 of 35

4. 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 4 of 35

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

Reverse Polish Notation

Risk Priority Number

Rational Positive Number

Question 5 of 35

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

None of the above.

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

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

Question 6 of 35

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

A team effort

An individual on their own

By getting input from the suppliers

Question 7 of 35

8. 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 1 indicates the failure is sure to be detected and prevented

Rating of 7 means multiple fatalities could occur

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

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

Question 8 of 35

9. 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 from 1 to 5 are in the reverse order

The ratings are for severity rather than detection

The ratings are for occurrence and not for detection

Question 9 of 35

10. 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 10 of 35

11. 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 11 of 35

12. 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)

No voltage at the connector

Damaged cable

Frayed connection

Broken connector

Question 12 of 35

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

ISO 13485

ISO 19001

ISO 27001

None of the above

Question 13 of 35

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

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

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

Question 14 of 35

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

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

All of the above

Starting from process and moving to product

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

Question 15 of 35

16. 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 user interact / use the product in the field?

How will the product be assembled / manufactured?

Question 16 of 35

17. The RPN is a product of:

Numerical ratings assigned to Severity, Occurrence, and Detection

Occurrence and detection ratings

User testing

Question 17 of 35

18. 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?

User manual

Repair manual

A process map showing how the product is built

The bill of materials

Question 18 of 35

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

When prototypes can be examined for usability

After product is launched

Right after the first complaint is received

Question 19 of 35

20. 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

I - Immediate results

O - Outputs of the process

C - Controls

Question 20 of 35

21. 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 21 of 35

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

Process

Failure Mode

Design

Severity

Question 22 of 35

23. 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.

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

False

True

Question 23 of 35

24. The RPN should be calculated right after:

Product is launched

Prototype testing

None of the above

Severity ratings are assigned

Question 24 of 35

25. 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

False

True

Only for medical devices

Question 25 of 35

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

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

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

Examining incoming inspection records of materials used for all products

Question 26 of 35

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

Failure mode for the engine

A potential cause for engine failure

An engine failure

Question 27 of 35

28. 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)

Yes - it's rating should be a 5

No - definitely not

Cannot determine based on given information.

Question 28 of 35

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

Examining each component of the product / assembly

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

An individual on their own

Question 29 of 35

30. 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 30 of 35

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

Failure mode

Severity

Cause

Occurrence

Detection

Question 31 of 35

32. 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 32 of 35

33. 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 33 of 35

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

Only for medical devices

True

False

Only for Aerospace FMEAs

Question 34 of 35

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

True for high risk implantable devices

False

True

Question 35 of 35