CLSSYB-001 practice question 13 of 25

A tool we use to identify possible failures (defects) in our process and the impact they may have is the _________________.

Full set: 120 questions
Answer options
A: Shewhart Analysis
B: Juran Journey
C: FMEA Correct answer
D: SIPOC
Correct Answer:
C. FMEA
Explanation

Failure Mode and Effects Analysis (FMEA) is a systematic, proactive risk assessment tool used to identify potential failures in a process, product, or system. The methodology involves identifying all potential "failure modes" (ways in which a process can fail), analyzing their potential "effects" (the impact of the failure on the customer or downstream processes), and identifying their root causes. By quantifying risk, often through a Risk Priority Number (RPN), FMEA allows teams to prioritize the most significant potential failures and implement preventative actions, directly aligning with the question's description.

Why Incorrect

A. Shewhart Analysis: This refers to the use of Shewhart control charts, which are statistical tools for monitoring process variation over time to maintain control, not for proactively identifying potential failure modes.
B. Juran Journey: This is a broad management philosophy for quality improvement (the Juran Trilogy), not a specific analytical tool used to identify and assess individual process failures and their impacts.
D. SIPOC: A SIPOC (Suppliers, Inputs, Process, Outputs, Customers) diagram is a high-level process mapping tool used in the Define phase of DMAIC to scope a project, not to analyze potential failures.

References

1. Liu, H. C., Liu, L., & Liu, N. (2013). Risk evaluation approaches in failure mode and effects analysis: A literature review. Expert Systems with Applications, 40(2), 828-838. In the introduction (Section 1, Paragraph 1), FMEA is defined as "a systematic procedure for the analysis of a system to identify the potential failure modes, and their causes and effects on system performance." DOI: https://doi.org/10.1016/j.eswa.2012.08.010

2. De Feo, J. A., & Juran, J. M. (2010). Juran's Quality Handbook: The Complete Guide to Performance Excellence (6th ed.). McGraw-Hill. Chapter 14, "Process Measurement and Control," discusses Shewhart control charts as tools for monitoring process stability. Chapter 5 discusses the Juran Trilogy as a management approach.

3. Pyzdek, T., & Keller, P. A. (2018). The Six Sigma Handbook (5th ed.). McGraw-Hill Education. In Chapter 18, "Failure Mode and Effects Analysis," the text states, "FMEA is a structured approach to... identifying potential ways a product or process can fail... [and] estimating the risk associated with specific causes." The SIPOC diagram is described in Chapter 12 as a tool for defining process boundaries.

4. MIT OpenCourseWare. (2004). 16.853: Advanced System Design and Management. Fall 2004. Lecture 11, "Risk Management," slide 11, describes FMEA as a tool to "Identify potential failure modes, determine their effect on the operation of the product, and identify actions to mitigate the failures." Retrieved from https://ocw.mit.edu/courses/16-853-advanced-system-design-and-management-fall-2004/

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