Failure Mode Effect Analysis

Failure mode effect analysis is one of the very important tool to identify and minimize the risk of
processes or task at operational as well as design stage. FMEA is core tool of IATF 16969. Majority of
industries are practicing IATF 16969 standards, those are very much familiar with failure mode effect
analysis tool. Basically large scale industries are doing some outsourcing work with the different
vendors and they expecting to maintain product of service quality. For achieving better product
quality and services requirement process competency and rigidness of operation is very much
important and FMEA tool is very much helpful for identified risk of processes and predict future
process competency based on risk priority number.

Now, let’s start with the basic FMEA understanding. Failure mode is a basic measurement for
particular activity or task to be not performed as per expected condition or not performed as per
desired result due to functional inconsistency. Effect analysis means verify or measure different task
or activity with the help of different parameters such as severity, occurrence and detection.

History of FMEA

FMEA developed in 1940s by US military and first used in 1960s by aerospace industry.

What is the purpose for FMEA study?

Identify and eliminate risk of processes and defects.

Detect and correct process failure mode during production and pre-production activity.

Improve process reliability towards quality aspect.

Improve customer satisfaction (internal as well as external).

Customer’s requirement to prepare P-FMEA and D-FMEA study for processes as per IATF 16969
standard.

Basically there are two types of analysis done for identifying risk of processes.

Process – Failure mode effect analysis (P-FMEA).

Process – FMEA is basically analyze the task or activity at operation stage where process is
performed and the main purpose for conducted P-FMEA study is to minimize the risk, defects and
wrong practices for improving process performance. Process – FMEA study mainly divided into two
parts, first is Assembly and second is manufacturing. Review below attached parameters or tools
that can helpful for developing process – FMEA study.
Review process flow chart or process sequence diagram.

Review the list of poka yoke

Design – Failure mode effect analysis (D-FMEA).

Design – FMEA is basically analyze the task or activity at design stage. In short D – FMEA is helps to
create design of product or services in a such a way to minimize risk of product or services during
production. Majority three aspect require to focused at design stage to analyze the individual
activity with the easy for manufacturing, defect free production and minimize the product criticality.
Review below attached parameters or tools that can helpful for developing design – FMEA study.

• Understand the voice of customer & its requirements.

• Review critical to quality and critical to assembly parameters of processes.

• Review manufacturing quality plan.

• Review quality functional development.

What is RPN in FMEA study?

RPN is basically a risk priority number. During FMEA study basically we list down potential failure
modes, where possibility to fail particular task or activity of processes. For risk priority number
calculation three parameters are very important such as severity, occurrence and detection. Review
below attached formula of risk priority number.

Risk Priority Number (RPN) = Severity * Occurrence * Detection

Now, we are trying to understand each parameter in detail as per below.

FMEA

Severity

Severity is analyzing the failure mode to fulfilling functional requirement of particular task or activity
based on customer aspect. For calculating severity mention individual activity wise rating for
possibility to fulfil functional requirement or not. Basically focused to identify damage possibility for
performing task or expected harm possibility, if we consider safety aspect. Let’s understand severity
with the help of different examples such as possibility to equipment breakdown, possibility to
process stop due to short circuit issue, possibility to functionally task not perform due to skill
operator not available.
Review below attached rating scale for your reference, that user enter for calculating severity effect
based on potential failure mode. Generally, its varies between 1 to 10.

Occurrence

Occurrence is analyzing potential failure mode based on numbers of times same task repetition.
Similar as severity measurement, occurrence is also measure as per rating scale. Occurrence is very
important to measure because repetition is a one of biggest waste for particular potential failure
mode. Repetition is happened due to design weakness or due to error of improper process
correctness. Occurrence rating is also varying from 1 to 10.

Detection

In detection parameters measure the possibility of detection potential failure mode. Sometimes
what happened in actual processes, they are directly fail without the warning or any abnormalities.
Sometimes process monitoring supervisor or operator is not able to detect the abnormalities. So, for
risk priority number calculation detection is also came into picture with the equal weightage like
severity and occurrence. Detection is also measure with the help of rating scale as per mention
below.

Conclusion

In concluding part, the best practices for organization is each and every individual activity identify
potential failure cause and scale the severity, occurrence and detection of each activity and record
the documented information. After providing individual score of each RPN parameters, review high
RPN activity and responsible person identified for minimize the RPN numbers of that particular
activity. Ensure to developed pre-plan for potential failure happened, and plan to how fast the
departmental person will resolve it. As per above attached severity, occurrence and detection rating
scale for RPN calculation not necessary to use as it is, you can modify as per your convenience and
easy for understanding.