Failure Mode & Effect Analysis

 FMEA

A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction. It is expressed as the organizational goals and aspirations, policies, processes, documented information and resources needed to implement and maintain it. Early quality management systems emphasized predictable outcomes of an industrial product production line, using simple statistics and random sampling. In Modern time QMS has five core tools and FMEA is one of them today we are going through it.

Failure Mode & Effect Analysis (FMEA)

The five core tools of Quality Management System are:

APQP: Advance Product Quality Planning

PPAP: Production Part Approval Process

MSA: Measurement System Analysis

SPC: Statistical Process Control

FMEA: Failure Mode & Effect Analysis

Today we are going for FMEA. Let’s start.

 

Failure Mode & Effect Analysis is one of the five core tools of QMS (Quality Management System); the tools will be discussed later. Let see the history of FMEA.


What is FMEA?

FMEA or Failure Mode and Effect Analysis as a concept have been around hundreds of year but the QMS tool was first used in aerospace industries in NASA (National Aeronautics & Space Administration) during the Apollo program in 1960’s. It was practice to think through all the possible causes of failure of mission to increase the percentage of success.  And after that in 1970’s the concept was conceived by automobile industries across the world. FMEA was incorporated in QS – 9000 & Advanced Product Quality Process in 1994 as a system requirement.  In present date FMEA is used across the world in every segment of business. 

 

FMEA Approach

 

 What are the Benefits of FMEA?

 

FMEA identifies design or process related failure modes before they happen.

It determines the effect and severity of these failure modes.

It helps to identify the causes and probability of occurrence of Failure modes.

It identifies the controls and their effectiveness.

It quantifies and prioritizes the risk associated with failure modes.

It develops and documents action plans that will occur to reduce risk and implement them. 

 

Frequent Terminology Used in FMEA

 

#01 Failure Modes (Specific loss of function): it is a concise description of how a part, system or manufacturing process may potentially fail to perform its function.

#02 Failure Mode Effect: It is a description of the consequence or ramification of a system or part failure. A typical failure mode may have several effects depending on which customer you consider.

#03 Severity Ranking/Rating: It may be defined as seriousness of effect and it is numerical rating of impact.

#04 Failure Mode cause: It is a description of design/process deficiency (Global cause/root level cause) that results in failure mode.

#05 Occurrence Rating/Ranking: It is a estimate number of frequencies of cumulative no. of failure (based on experience) that will occur (in design) for a given cause over the intended life of a design.

#06 Failure Mode Control: The mechanisms, methods, tests procedures or controls that we have in place to prevent the cause of failure mode or detect the failure mode/cause should it occur.

#07 Detection Rating: It is defined as a numerical rating of probability that a given set of controls will discover a specific cause of failure mode to prevent bad parts leaving facility of getting to ultimate customer.

#08 Action Planning: It is thoroughly thought and well developed FMEA with high risk patterns that is not followed with corrective actions has little or no value other than having a chart for an audit.

#09 Risk Priority Number or RPN: It is a numerical value defined as product of severity, occurrence and detection or mathematically Severity X Occurrence X Detection.

 

Action plans should be taken very seriously if ignored you may have probably wasted much of your valuable time. FMEA based analyses mainly focuses on reducing severity rating, occurrence rating and detection rating.  

 

The three main type of FMEA are:

 

System FMEA: System FMEA or SFMEA concerns with whole system and it also can contain associated interaction failures between subsystems and interaction failure with environment.

Design FMEA: Design FMEA or DFMEA focuses on subsystem and component failures also interaction between components and subsystems with their relevant failures.

Process FMEA: The process FMEA or PFMEA focuses on the failures associated with the manufacturing and assembly process.

 

 

 

 

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