FMEA Analysis (Failure Mode and Effects Analysis) is a failure analysis method which works by discovering potential failures that may exist within the design of a product or process.
FMEA Analysis (Failure Mode and Effects Analysis) can be fragmented into two-part:
- Failure mode: Failure modes are the ways in which a process can fail.
- Effect: Effects are the ways that these failures can lead to waste, defects or harmful outcomes. It can be said to be negative consequence associated with the failure.
FMEA aim at allowing organizations to anticipate failure during the design stage by identifying all of the possible failures in a design or manufacturing process.
FMEA is divided into two (2) broad categories –
- Design FMEA (DFMEA)
- Process FMEA (PFMEA) and
We also have Functional FMEA: Functional analyses are needed as an input to determine correct failure modes, at all system levels.
When to use FMEA Analysis
FMEA is needed:
- When a process, product or service is being designed or redesigned, after quality function deployment (QFD).
- When an existing process, product or service is being applied in a new way.
- Before developing control plans for a new or modified process.
- When improvement goals are planned for an existing process, product or service.
- When analyzing failures of an existing process, product or service.
- Periodically throughout the life of the process, product or service.
Steps to do FMEA analysis
Ten (10) steps are considered when carrying out FMEA, these steps include:
- Review the process and identify each process component
- Brainstorm to identify potential failure modes. Review existing documentation and data for clues about all of the ways each component can fail.
- List potential effects of each failure
- Assign Severity rankings: This is based on the consequence of the failure.
- Assign occurrence rankings: Use customize ranking scale.
- Assign detection rankings: Chances that failure will be detected prior to occurrence.
- Calculate the RPN (Risk Priority Number): See formular below
- Severity X Occurrence X Detection – See link to understand how to determine these parameters here
- Develop the action plan based on the RPN (Risk priority number). Focus on high RPN.
- Take action: Implement the improvements identified by your Process Failure Mode and Effects Analysis team.
- Re-calculate the RPN: Re-evaluate each of the potential failures once improvements have been made and determine the impact of the improvements.
At the end of this analysis, the result is documented.
NOTE: This document is not a static document, it has to be updated when need arises.
Read Also: Understanding COMAH and how it works
When to update FMEA document
Throughout the product development cycle, change and updates are made to the product and process. These changes can and often do introduce new failure modes. It is therefore important to review and/or update the FMEA.
Below are point where FMEA update will be necessary.
Update FMEA when:
- A new product or process is being initiated.
- Changes are made to the operating conditions the product or process is expected to function in.
- A change is made to either the product or process design.
- New regulations are instituted.
- Customer feedback indicates problems in the product or process.
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