FMEA | What is FMEA (Failure Mode and Effects Analysis)?

FMEA Failure Mode and Effects Analysis.
FMEA 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 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.

1) 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).
History of FMEA

→ 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 FMEA variants included Apollo, Viking, Voyager, Magellan, Galileo, and Skylab.
History of FMEA

→ The civil aviation industry was an early adopter of FMEA, with the Society for Automotive Engineers (SAE) publishing ARP926 in 1967.
History of FMEA

→ 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 FMEA in the assessment of offshore petroleum exploration.
→ The automotive industry began to use FMEA by the mid-1970s.
 The Ford Motor Company introduced FMEA to the automotive industry for safety and regulatory consideration.
 Ford applied the same approach to processes (PFMEA) to consider the potential process induced failures prior to launching production.
History of FMEA

 In 1993, the Automotive Industry Action Group (AIAG) first published an FMEA standard for the automotive industry. 
History of FMEA

→ FMEA (Failure Mode and Effects Analysis) is now in its fourth edition.

FMEA 4th Edition

→ The SAE first published related standard J1739 in 1994.
 This standard is also now in its fourth edition.

2) 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:
     (A) Recognize and Evaluate the potential failure of a product or process and its effects.
     (B) Identify actions that could eliminate or reduce the chance of potential failures.
     (C) Document the Process.

→ Failure modes and effects analysis (FMEA) 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:
     (A) What could go wrong (failure) with a system or process?
     (B) How bad can it get (risks), if something goes wrong (fails)?
     (C) What can be done (corrective action) to prevent things from going wrong (failures)?

→ FMEA attempts to identify and prioritize potential process or system failures. 
     The failure is rated on three criteria:
     (A) The impact of a failure – Severity
     (B) The frequency of the causes of the failure – Occurrence
     (C) How easy is it to detect the cause of failure - Detection

3) Changes in FMEA (Failure Mode and Effects Analysis) 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.

4) When to do FMEA (Failure Mode and Effects Analysis)?

→ The FMEA 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.

➤ It is therefore important to review and/or update the FMEA (Failure Mode and Effects Analysis)  when:

→ 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.

5) 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
    ● Quality Department
    ● Testing & Validation
    ● Human Resources
    ● Maintenance
    ● Supplier
    ● Marketing & Sales etc...

6) There are 4 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

7) Benefits of FMEA (Failure Mode and Effects Analysis):

→ Improve product or process quality, reliability, and cost-effectiveness.
→ FMEA Increase 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
→ FMEA 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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 See Also:
👉 FMEA  - Quality Core Tool
👉 PFMEA - Learn in Simple 10 steps
👉 MSA Study - Quality Core Tool
👉 PPAP - Quality Core Tool
👉 Severity - FMEA Basics
👉 Occurrence - FMEA Basics
👉 Detection - FMEA Basics
👉 RPN Number - FMEA Basics