



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 t he 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

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.





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



