Reference no: EM131429521

Project Part 2 - FMEA - Failure Modes Effect Analysis

You still have a work day during which you should make significant progress on an FMEA (to be discussed shortly).

Today's Objectives

• To understand the use of Failure Modes Effect Analysis (FMEA)
• To learn the steps to developing FMEAs

FMEA Benefits

• Allows us to identify areas of our process that most impact our customers
• Helps us identify how our process is most likely to fail
• Points to process failures that are most difficult to detect

What Is A Failure Mode?

Failure Mode Effect Analysis -

• This is a methodology that facilitates process improvement
• Identifies, eliminates or reduces concerns
• Improves internal and external customer satisfaction
• Focuses on prevention
• FMEAs are sometimes customer requirement (likely contractual)
• FMEA may be required by an applicable

Quality Management System Standard (possibly ISO)

An FMEA is a structured approach for:

• Identifying the ways in which a product or process can fail
• Estimating risk associated with specific causes
• Prioritizing the actions that should be taken to reduce risk

FMEA Procedure -

1. For each process step (start with high level steps), determine the ways in which the input can go wrong (failure mode)

2. For each failure mode, determine effects - Select a severity level for each effect

3. Identify potential causes of each failure mode - Select an occurrence level for each cause

4. List current controls for each cause - Select a detection level for each cause

5. Calculate the Risk Priority Number (RPN)

6. Develop recommended actions, assign responsible persons, and take actions

- Give priority to high RPNs

- MUST look at severities rated a 10

7. Assign the predicted severity, occurrence, and detection levels and compare RPNs.

Attachment:- Assignment Files.rar