In a failure mode and effects analysis (FXIEA). the focus should be on

The primary objective of a Failure Mode and Effects Analysis (FMEA) is to proactively identify and mitigate potential risks in a product or process. Prioritization of these risks for action is a key step. This is accomplished using the Risk Priority Number (RPN), which is calculated as Severity × Occurrence × Detection. Items with the highest RPNs are typically addressed first. However, a critical rule in FMEA is that any failure mode with a high Severity rating (e.g., a 9 or 10, indicating a potential safety hazard or regulatory non-compliance) must be given special attention and considered for corrective action, regardless of its overall RPN. Therefore, the focus for implementing action is on items with either high RPNs or high Severity values.

A. Using an arbitrary RPN threshold (e.g., >100) is a discouraged practice; prioritization should be relative and must consider high severity independently.

B. Flowcharts are process definition tools typically created before an FMEA is conducted, not as a corrective action for high-risk items.

C. Alpha risk (Type I error) is a concept from statistical hypothesis testing and is not a metric used within the FMEA methodology.

1. Laman

S. A.

& Burke

S. E. (Eds.). (2017). The Certified Quality Engineer Handbook (4th ed.). ASQ Quality Press. In Chapter 19

"Risk Management Tools

" it is stated

"The RPN is used to prioritize the failure modes... Special attention is given to high severity rankings" (p. 258). This supports prioritizing based on both high RPN and high severity.

2. Stamatis

D. H. (2003). Failure Mode and Effect Analysis: FMEA from Theory to Execution (2nd ed.). ASQ Quality Press. The author emphasizes

"A high severity rating of 9 or 10 is a flag for special attention regardless of the RPN. The team must give special consideration to these items for corrective action" (p. 101).

3. Automotive Industry Action Group (AIAG) & Verband der Automobilindustrie (VDA). (2019). FMEA Handbook (1st ed.). In the modern FMEA approach

the Action Priority (AP) methodology replaces RPN thresholds. The AP tables (pp. 103-105) demonstrate that any failure mode with a Severity of 9 or 10 automatically results in a High or Medium action priority

mandating consideration for action

which reinforces the principle of focusing on high severity.