What is FMEA (Failure Mode Effect Analysis)

 

What is FMEA (Failure Mode Effect Analysis)?

Failure mode and effect analysis is a systematic, proactive method for evaluating a process to identify where and how it might fail and to assess the relative impact of different failures in order to identify the parts of process that are most in need of change.

In other words FMEA is a simple way or tool for predicting what might go wrong by using a structured method, result can be quantified and hence compared.

FMEA includes review of the following:

v  Failure of Steps in the process

FAILURE in process refers: Any malfunction, error, defect due to which process is not performing as per desired requirement or standard.

v  Failure mode (what should go wrong)

Failure mode refers: Anything that could go wrong during the completion of the process

 

v  Failure causes (why would failure happens)

Failure cause refer: All possible mean that result in failure mode

 

v  Failure effect (what would be the consequences of each failure)

Effect of failure refer: customer dissatisfaction that result from failure mode.

WHY an FMEA

v  To identify and prioritize the process that need improvement

v  To improve the quality, reliability and safety of product and services

v  To increase customer satisfaction

v  To document and track actions taken to reduce risk

When to Use an FMEA

1. v  When new services or process are being improved, designed and redesigned is called Process FMEA
2. v  When a process is created, improved or redesigned is called Process FMEA
3. v  When existing process is to be used in new environment and to evaluate the potential existing problem is called system FMEA.
4. v  When improvement goals are planned for an existing process, product or service

How to do FMEA:

Step involving in FMEA

1.     Define topic

Select the topic depending upon the purpose of analysis. The choice of topic is important, it should not be selected only for the sake of introducing the change.

The topic should be chosen on the basis of data collected for the quality assurance and audit as well as performance problems.

Brainstorming can be useful to identify the potential issues.

 2.      Assigned the Team

Team should be committed to identifying opportunities for improvement and to implementing the change. Team members must be allocated sufficient time and resources to allow the process to be successful and management support is essential for the success of FMEA.

 

3.      3.    Develop the process MAP

A detailed chart of the process should be constructed by the team, for the complete understanding steps. Number the every step of process and be specific as possible.

It may take several meeting to complete this step i.e process mapping.

Details of each process should be accurate and comprehensive.

 4.    Conduct a risk or Hazard Analysis for each sub process

Each of the sub process in which potential failure could occur should be identified I.e. identification of the failure mode. Failure mode is anything that may go wrong during the completion of a step in the process.

Members of the team undertaking the FMEA should estimate the severity and impact of the effect of the each failure mode.

Each failure mode that is identified should be scored according to its potential for severity and impact.

The Higher the ranking (on a scale of 1-10), the more severe is the effect of a potential failure mode.

Table 1   show an example of scoring scale for the severity of effects.

Table 2 The higher the ranking (scale of 1-10), the more likely it is for the failure mode to occur

Table 3 Next the team focuses on the probability that a failure mode will be detected

 

 

The higher the raking (scaling of 1-10), the less likely it is that failure mode will detected.

The Risk priority (RPN) also referred to as the criticality index is a quantitative measures used to evaluate and assess a failure mode.

RPN is derived from the product of numeric rating for severity, probability of occurrence and detectability as described in the above graph.

 

RPN = severity × probability of occurrence × detectability

 

RPN is helpful in prioritization of the failure modes and to highlight the failure modes that exceeded the acceptable limit and should therefore be addressed.

 1.      Develop and implement an action plan to redesign the process

Failure mode with highest RPNs are probably the most important parts of the process on which to focus improvement efforts. Failure mode with very low RPNs are not likely to effect the overall process very much therefore it should be of least priority.

 ·         Use FMEA to plan actions to reduce harm from failure modes

§  If failure mode is likely to occur

§  If the failure is unlikely to be detected

§  If the failure is likely to cause severe harm

·         Use FMEA to evaluate the potential impact of change under consideration

·         USE FMEA to monitor and track improvement over time.

2.      6.    Monitor, Sustain, share and re-evaluate the implementation

This process is a continuous process once team member become facile with the FMEA process their skill can be used to identify additional opportunities and to share their experience as new staff member and trained them.

Process should be reassessed to ensure that implemented changes are having the desired impact.

 

Template for the FMEA: download

Sample of FMEA: Download

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