FMEA | What is FMEA (Failure Mode and Effects Analysis)?
What is FMEA (Failure Mode and Effects Analysis)?
→ "FMEA (Failure Mode and Effects Analysis) is an Analytical
Technique that combines the technology and Experience of People in identifying predictable failure modes of a Product or Process and planning for its elimination."
➥ FMEA can be explained as a group of activities intended to:
- Recognize and evaluate the potential failure of a product or process and its effects.
- Identify actions that could eliminate or reduce the chance of potential failures.
- Document the Process.
→ Failure mode and effects analysis is a rigorous step-by-step process,
to identifying all possible failures in a design, manufacturing,
assembly process, product or service.
➥ FMEA drives systematic thinking about a product or process by asking and attempting to answer three basic questions:
- What could go wrong (failure) with a system or process?
- How bad can it get (risks), if something goes wrong (fails)?
- What can be done (corrective action) to prevent things from going wrong (failures)?
➥ FMEA attempts to identify and prioritize potential process or system failures and the failure is rated on three criteria:
- The impact of a failure – Severity
- The frequency of the causes of the failure – Occurrence
- How easy is it to detect the cause of failure - Detection
→ It was made from two different words as mentioned below:
→ “Failure modes” means the ways, or modes, in which something might fail.
→ Failures are any errors or defects, especially ones that affect the customer and can be potential or actual.
→ “Effects analysis” refers to studying the consequences of those failures.
History of FMEA (Failure Mode and Effects Analysis):
→ Procedures for conducting FMEA were described in US Armed Forces Military procedures document MIL-P-1629 in (1949).→ NASA programs using Failure Mode and Effects Analysis variants included Apollo, Viking, Voyager, Magellan, Galileo, and Skylab.
→ In 1971 NASA prepared a report for the U.S Geological Survey recommending the use of Failure Mode and Effects Analysis in the assessment of offshore petroleum exploration.
→ The automotive industry began to use it by the mid-1970s.
→ The Ford Motor Company introduced Failure Mode and Effects Analysis to the automotive industry for safety and regulatory consideration.
→ This standard is also now in its fourth edition.
Changes in FMEA Manual in 4th Edition:
→ An improved format, easier to read.→ Better examples to improve utility.
→ Reinforces need for management support.
→ Strengthens linkage between DFMEA / PFMEA.
→ Ranking tables better reflect real-world use.
→ Introduces alternative methods in use.
→ Suggests better means than RPN to assess risk.
→ Recommends threshold RPN values to initiate the required action.
When to do Failure Mode and Effects Analysis?
→ It is a live document.
→ Throughout the product development cycle, the FMEA is changed and
updated as appropriate when the product and process changed.
→ These changes can introduce new failure modes.
→ We can begin as soon as a project is selected for a certain Process,
System or Design.➤ Review and/or updating of the FMEA:
→ FMEA Should be revised as improvement or changes made to a process.→ A new product, process or service is being initiated (at the beginning of the cycle).
→ 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.
→ Changes are made to the operating conditions the product, process or service.
→ When analyzing failures of an existing process, product or service.
→ When the product design is changed the process is impacted and vice-versa.
→ Periodically throughout the life of the process, product or service
→ New regulations are instituted.
→ Customer feedback indicates problems in the product or process.
➤ Who does an FMEA (Failure Mode and Effects Analysis)?
→ This is a Team Process.
→ Team sizes may vary, but the recommended size is approximately 5 to 7 members.
→ Depending upon the type of FMEA being done, members may come from:
● Research and Development
● Manufacturing
● Testing & Validation
● Human Resources
● Maintenance
● Supplier
● Quality Department
→ Team sizes may vary, but the recommended size is approximately 5 to 7 members.
→ Depending upon the type of FMEA being done, members may come from:
● Research and Development
● Manufacturing
● Testing & Validation
● Human Resources
● Maintenance
● Supplier
● Quality Department
● Marketing & Sales etc...
➤ Four Common Classes of FMEA:
● System FMEA – Focuses on how interactions among
systems might fail.
● Design FMEA – Focuses on how product design might
fail.
●
Process FMEA
– Focuses on how processes that make the product might
fail.
● Equipment FMEA – Focuses on how machinery
that performs processes might fail
Benefits of FMEA (Failure Mode and Effects Analysis):
→ Improve product or process quality, reliability, and
cost-effectiveness.
→ It Increases customer satisfaction
→ Decrease inhouse defects and line stoppage issues
→ Early identification and elimination of potential failure modes related to product or process
→ It helps to prioritize product or process deficiencies
→ FMEA improves engineering and organization knowledge
→ It emphasizes problem prevention rather than detection
→ It is an important tool for risk assessment and actions taken for reducing the risk
→ FMEA is a catalyst for teamwork and idea exchange between functions
→ It Increases customer satisfaction
→ Decrease inhouse defects and line stoppage issues
→ Early identification and elimination of potential failure modes related to product or process
→ It helps to prioritize product or process deficiencies
→ FMEA improves engineering and organization knowledge
→ It emphasizes problem prevention rather than detection
→ It is an important tool for risk assessment and actions taken for reducing the risk
→ FMEA is a catalyst for teamwork and idea exchange between functions
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