FMEA Flashcards
What is design FMEA?
design failure mode and effects analysis
a proactive approach documenting weaknesses in product design that may cause system failures
How does design FMEA help?
- identifies potential product failure modes early in the development cycle
- identifies characteristics requiring special control and highlighting areas for improvement
- increases likelihood that all potential failure modes and their effects are considered
- establishes priority for design improvement
- assists in evaluating product design improvements
- improves system safety
What is the basic DFMEA process?
cross functional teams:
1) analyze product design
2) recommend design change
3) follow through on recommended action
What is process FMEA?
a proactive approach to identify potential process failures and effects early in the process planning cycle
What are the benefits of PFMEA?
- assists in the development of process control plans
- establishes a priority for improvement activity
- documents rationale behind process changes
- guides future process improvement projects
- identifies potential SSG projects
FMEA is a systematized group of activities to:
1) recognize and evaluate potential failure of a product or process, and its effects
2) identify actions that could eliminate or reduce the occurence of the potential failure
3) document the process by managing associated risks
4) optimizing reliability, maintainability, and associated costs
What are the 7Ms?
1) Materials
2) Methods
3) Measurements
4) Machines
5) Management
6) Mother Nature
7) Manpower
Which levels can FMEA be applied to?
system, sub-system, process, service
What is a system?
a group of interdependent processes and people that together perform a common mission to produce one or multiple products
What are the steps of DFMEA? (6)
1) an owner, a methodology, and team of experts work together to produce a robust and effective living document
2) team evaluates failure modes of related 7Ms
3) meaningful scales will be developed for each failure mode and the related effects
4) appropriate steps, activities, and mitigation strategies will be detailed and documented within the 7Ms structure
5) scoring and prioritization will take place at the granular and aggregate levels
6) additional tools may be used to augment the findings as necessary and detailed documentation is done
What is a RPN?
Risk Priority Number
a measurement for prioritization based on the following criteria:
1) severity of the effects of failure
2) frequency of the failure
3) ease of detection
What is severity and how do you measure it?
the seriousness of the effect of the potential failure mode, typically 1 = no severity and 10 = hazardous
What is frequency of occurrence and how do you measure it?
likelihood that a failure will occur, typically 1 = remote chance of failure and 10 = very high chance of failure
What is detection and how do you measure it?
how well the prevention and detection controls can detect and prevent failure, typically 1 = high probability of detection and 10 = almost impossible to detect
How do you calculate RPN?
Severity X Occurrence X Detection