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