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:

1. Recognize and evaluate the potential failure of a product or process and its effects.
2. Identify actions that could eliminate or reduce the chance of potential failures.
3. 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:

1. What could go wrong (failure) with a system or process?
2. How bad can it get (risks), if something goes wrong (fails)?
3. 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:

1.  The impact of a failure – Severity
2.  The frequency of the causes of the failure – Occurrence
3.  How easy is it to detect the cause of failure - Detection

→ It 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.
→ 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.

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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).

→ By the early 1960s, contractors for the U.S National Aeronautics and Space Administration (NASA) were using variations of FMEA under a variety of names. 
→ NASA programs using Failure Mode and Effects Analysis variants included Apollo, Viking, Voyager, Magellan, Galileo, and Skylab.

→ The civil aviation industry was an early adopter of Failure Mode and Effects Analysis, with the Society for Automotive Engineers (SAE) publishing ARP926 in 1967.

→ During the 1970s, the use of FMEA and related techniques spread to other industries.
→ 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.

→ In 1993, the Automotive Industry Action Group (AIAG) first published a Failure Mode and Effects Analysis standard for the automotive industry. 

→ Failure Mode and Effects Analysis manual is now latest available in its fourth edition.

→ The SAE first published related standard J1739 in 1994.
→ 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

    ● 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 organizational 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

👉 See Also:

1. All Topics
2. Lean Manufacturing & Top 26 Lean Manufacturing Tools
3. ISO 9001:2015
4. 7 QC Tools
5. Quality Core Tools (MSA, PPAP, APQP, SPC)
6. QA & QC Topics
7. Six Sigma