FMEA / Failure Mode and Effect Analysis / Types of FMEA

Introduction of FMEA

 - Failure Mode and Effect Analysis (FMEA), also known as “Potential Failure Modes and Effects Analysis” as well as “Failure Modes, Effects and Criticality Analysis (FMECA)” is a systematic method for identifying possible failures that pose the greatest overall risk for a process, product, or service which could include failures in design, manufacturing or assembly lines. 

 - The purpose of FMEA is an early estimation & elimination of failure mode involved in the product system, design, and manufacturing process. FMEA helps to deliver a quality product to customers on time.

 - FMEA follows the principle of preventing failure instead of a after treating failure recognition and –correction (failure handling) through in time identification of potential failure causes at the development phase.

A process analysis tool, it depends on identifying:

 - Failure mode: One of the ways in which a product can fail; one of its possible deficiencies or defects

 - Effect of failure: The consequences of a particular mode of failure

 - Cause of failure: One of the possible causes of an observed mode of failure

 - Analysis of the failure mode: Its frequency, severity, and chance of detection

History of FMEA

 - The first widely known use of FMEAs was by the US Military at the end of the 1940s. The military developed the technique to reduce sources of variation and corresponding potential failures in the production of munitions – and it proved a highly effective tool.

 - Once it was recognized that project risk was reduced by the military’s use of FMEAs, NASA adopted the methodology as a crucial project planning technique as well. FMEAs proved to be vital to the success of the Apollo (and subsequent) NASA missions. FMEAs are widely used by the civil aviation industry to assess aircraft safety.

 - The automotive industry was an early adoptee of FMEAs as well. The Ford Motor Company led the way as an internal response to their safety and public relations issues with the Ford Pinto model in the mid-1970s. Other automotive manufacturers in the US, Europe and UK soon followed Ford’s lead.

- AIAG was formed in 1982 to get fierce (US) auto industry competitors to collaborate and agree on standardized use of quality improvement tools and practices such as FMEAs, SPC (statistical process control), MSA (measurement system analysis) and related practices.

When to perform FMEA

There are several times at which it makes sense to perform a Failure Mode and Effects Analysis:

 - A product is having its design updated or is getting a new design (includes new products altogether)

 - A service is being transformed with additional, new, modified ways

 - A process or a supply chain is being altered, changed and modified

 - You are developing new or updated control plans.

 - You are creating improvement goals.

 - You are analyzing failures of existing processes, products or services.

 - There are periodic checks during the life of a product, service or process.

Why FMEA

FMEA is one of many tools used to discover failure at its earliest possible point in product or process design. Early estimation and controlling of potential failure in design/process helps to

 - to avoid product recall.

 - to avoid customer dissatisfaction

 - to avoid loss of market share

 - to avoid loss of reputation

 - to avoid legal action

 - to mitigate risk (risk management)

Advantages of FMEA

 - On-time delivery of the Quality product to a customer.

 - Higher accuracy in designing & manufacturing of products.

 - Better control of verification and validation of design.

 - Better co-ordination between design, manufacturing engineering, supplier, quality team.

 - Less rework in the design phase.

 - No/very low risk of product failure in the market.

 - Less rework and repair in the pre-production phase.

 - Better customer satisfaction & better market reputation.

Types of FMEA

System FMEA - This type of FMEA mainly conducted to detect potential failure modes within the system due to the interaction of different components. This FMEA is commonly known as S-FMEA.

Eg. S-FMEA of a new car’s drive system to cross-check torque & speed rating

Design FMEA - Design FMEA (DFMEA) is a methodology used to analyze risks associated with a new, updated or modified product design and explores the possibility of product/design malfunctions, reduced product life, and safety and regulatory concerns/effects on the customer derived from: Material Properties, Geometry, Tolerances and Interfaces with other components and/or systems

Service FMEA - A service FMEA is a structured procedure for identifying and preventing service-related product failures, i.e., failures due to improper installation, operation, maintenance, or repair.

Software FMEA - Software FMEA is a type of Design FMEA that analyzes the software elements, focusing on potential software-related deficiencies, with emphasis on improving the software design and ensuring product operation is safe and reliable during useful life.

Process FMEA - Process FMEA (PFMEA) discovers failure that impacts product quality, reduced reliability of the process, customer dissatisfaction, and safety or environmental hazards derived from: Human Factors, Methods followed while processing, Materials used, Machines utilized, Measurement systems impact on acceptance, Environment Factors on process performance.

When should FMEA need to update?

 - On-going engineering changes in the product

 - Increased customer complaints

 - Change in the manufacturing process

 - Changes in the raw material, specification

 - Localization of existing products in the new market and at a new manufacturing site.

 - Changes in the product to meet statutory and regulatory requirements in the country of sale.

 - Change in the manufacturing location

 - Product recall

 - To meet improved Quality goals / KPI.

 - Migration from manual work to automation or vice versa.

Is FMEA is living document?

 - Yes, FMEA is a live document. 

- Whether it’s system, design, or process FMEA, FMEA will remain as a live document until the production & end of the life of the product. 

 - Once the product is phased out, FMEA documents are still retained as reference & legal documents.