FMEA Analysis which is an acronym that represents Failure Mode and Effects Analysis is a failure analysis method that works by discovering potential failures that may exist within the design of a product or process.
It can be fragmented into two parts:
- Failure mode: Failure modes are how 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 a negative consequence associated with the failure.
FMEA aims to allow 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
1. Design FMEA
DFMEA is a systematic technique for detecting possible hazards that are added to a new or modified product/service design. Design functions, failure modes, and their impacts on the customer are first identified via the Design FMEA along with a corresponding severity ranking and effect danger. Subsequently, the failure mode’s causes and corresponding mechanisms are determined.
The occurrence rating of high-probability causes may motivate preventative or mitigation measures to lessen the cause’s influence on the failure mode. The capacity of particular tests to verify the failure mode and/or causes are eliminated is highlighted by the detection ranking. Through the decrease of Risk Priority Numbers (RPNs), the DFMEA also monitors improvements. A history of progress and risk reduction can be shown by contrasting the RPNs before and after. Learn more here
2. Process FMEA
The analytical tool known as Process Failure Mode and Effects Analysis (PFMEA) is used to assess and pinpoint possible operational process failures. Vulnerabilities that lead to problems with productivity, quality assurance, and safety are known as possible failure modes. Continuous improvement is Process FMEA’s (PFMEA) “big picture” objective.
Although PFMEA is useful for optimizing various operational processes, it is especially prevalent in the industrial manufacturing sector. To reach their daily production targets, manufacturers depend on dozens, if not hundreds, of pieces of equipment. PFMEA assists O&M management in locating, addressing, and removing the underlying causes of manufacturing process failure modes.
Error-proofing techniques allow facilities to provide high-quality outputs in the safest, most economical, and efficient manner possible. Learn more here
We also have Functional FMEA: Functional analyses are needed as an input to determine correct failure modes, at all system levels.
Read Also: Failure analysis – Methods and Steps for carrying it out
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.
Read Also: HAZOP study | Steps to carry out a HAZOP study
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 the potential effects of each failure
- Assign Severity rankings: This is based on the consequence of the failure.
- Assign occurrence rankings: Use a customized ranking scale.
- Assign detection rankings: Chances that failure will be detected prior to occurrence.
- Calculate the RPN (Risk Priority Number): See formula 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 static, it has to be updated when the need arises.
Read Also: Understanding COMAH and how it works
When To Update the FMEA Document
Throughout the product development cycle, changes 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 points where an 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.
- 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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