09 Jun 2018Posted By: Mudit Handa

What is the significance of the FMEA in ruling out glitches to QMS enhancement?

It is quite evident that for the ultimate goal of resolute quality management, one needs to implement the principles of strategic management in addition to strict adherence to the acquired quality standard.

Undoubtedly, ISO certification 9001 lays out clear guidelines on the strategic management for unhindered growth and advancement of the QMS of any institution. Unquestionably, every entrepreneur encounters numerous glitches in due course of advancement of a quality management system. The hindrances and failures are bound to come in the way due to the existence of certain anomalies in a particular project or an organization as a whole.


The ISO 9001:2015 certification has laid out certain outstanding strategies for mastering the art of quality efficiency. Among them, we going to discuss the essential approach of FMEA.


#1. What is all about FMEA?

Failure Modes and Effects Analysis (FMEA) is a stepwise approach that helps in tracing of all the probable causes (modes) of failures in a particular project, a developed design, a manufacturing or assemblage process, or a product/service.


#2. What do we mean by the Failure Modes in FMEA?

In due course of progression in project or endeavor, there are strong possibilities of facing errors or technical glitches, that might hamper the central aspect of client satisfaction. Such anomalies or shortcomings are referred to as Failure Modes, that can be potential, impending or actual. Failure Modes can be the worst threat to any organization in the long run and they must be wiped out prudently.


#3. What do we mean by Effects analysis in FMEA?

Effects analysis means analyzing the consequences of the failure modes. For this, the Failure modes are prioritized on the basis of the severity, frequency, and complexity of their consequences.


#4. When is the process of FMEA needed?

The process of FMEA is needed in the following scenarios:


  • While analysis of the failure modes of a current process, product or service.
  • Whenever a process, product or service is in the course of development or reconstruction after quality function deployment.
  • While devising the strategy for controlling a new or a modified process.
  • Whenever a current process, product or service is being implemented with a new concept.
  • While setting goals for enhancement of an existing process, product or service.
  • Regularly, throughout the entire journey of a process, product or service


#5. What are the significant instances of application of FMEA approach?


The FMEA approach was first employed by the US military in the World War-II during the 1940s. Later, during the Cold War, this strategy was frequently implemented by the US army and by NASA in the most complex of their missions.

For instance, In 1966 NASA released its FMEA procedure for use on the Apollo program. FMECA was also subsequently used on other noteworthy NASA programs including Viking, Voyager, Magellan, and Galileo.


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

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