14 Jun 2018Posted By: Mudit Handa

What is the complete procedure of Failure Modes and Effects Analysis in an organisation?

ISO certification 9001 specifies a clear-cut methodology on the strategic management for a hassle-free growth and development of the Quality Management System of any organization. Unquestionably, every entrepreneur encounters numerous glitches in due course of advancement of any quality management system. There are several viable strategies to track and outdo such bottlenecks to smooth progress of a Quality Management System. One of them is the FMEA approach.


#1. What is the concept of FMEA?

Failure Modes and Effects Analysis (FMEA) is a systematised mechanism for detecting all the insight causes of failures, also known as the failure modes in a particular project or products and services of an organisation and assessing their impacts on the basis of their intensity, recurrence and intricacy, which is called Effects Analysis.


#2. What steps are to be taken before conducting FMEA process?

You need to first fully prepared for carrying out the FMEA process. For this-

  1. Make an all-inclusive team of people from various departments of an organization, having miscellaneous knowledge about a process, product or service as per the client expectation. Their functions are diverse such as designing, manufacturing, QC testing, credibility analysis, maintenance, sales, marketing and customer support.
  2. Map out the scope of your FMEA, i.e. recognize its applicability vis-à-vis system, blueprints, processes and/or services. Besides, you need to assess the limitations of the current system. It’s preferable to use flowcharts to define the scope as to make it discernable for every team member.
  3. Now fill the information in your FMEA form. The format of the FMEA form is shown below-


#3. What is the complete process of FMEA?

Next is to initiate the process of FMEA. Here’s how to go about it-


  1. Underline the main tasks of your scope. For this, you need to identify the purpose of your design, process, or products and the customer expectations with regard to ISO certification. On that basis, the scope can be classified into different parts or processes or steps.
  2. Spot all the probable failure modes for each function. These are basically prospective failure modes that are to be dealt with.
  3. Now, identify all the adverse impacts of each of the failure modes on the product or project. These potential effects can hamper the main objectives of ISO 9001.
  4. Determine the severity of every effect, also called severity rating, or S. The S rates range from 1 to 10, where 1 means minute while 10 means disastrous. Specify the effects on the FMEA table in the descending order of their severity.
  5. Find out all the root causes of all failure modes. Enlist all those causes for the failure modes on the FMEA table.
  6. Now assess the occurrence rating or O of every cause. This rating helps in ascertaining the probability of failure for that cause throughout the span of the scope. This is also rated from 1 to 10, where 1 means most unlikely and 10 means most often.
  7. For each of these causes, evaluate process controls in place. These are basically tests, processes or mechanisms are in place to avoid failures from affecting the consumer.
  8. Ascertain the detection rating or D for all process controls. This rating tells how well the controls usually detect either the cause or the failure mode after occurrence but before it has reached the customer. Again the rating is from 1 to 10, where 1 means the process control is excellent and 10 means that it is poor.
  9. Now, compute the Risk Priority Number (RPN) which is-

RPN= S × O × D

  1. Calculate the danger level by multiplying severity by occurrence, i.e. S × O. These calculations help in for grading potential failures in the order of their priority.
  2. Chalk out the necessary measures. These actions can be in the form of reforms to reduce severity & occurrence, or as additional controls to advance intelligence.
  3. Jot down the results after the measures have been implemented with the date on the FMEA table along with S, O or D rate and the improved RPNs.


A systematic and thorough FMEA approach as explained above can effectively help in the elimination of all risks and hindrances to QMS enhancement.


If you require any guidance regarding the ISO certification, feel free to contact our business advisor at 8881-069-069.

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