FMEA: Combining Risk Assessment & Quality In One Tool!

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Organisations are always looking to be the best in every way possible. Being the best should always consider the employees’ and consumers’ safety, product/service quality, customer satisfaction, etc. To achieve high quality in every aspect, one should go through the risk assessment process to avoid any small or high risks in every procedure and working process. This is why many companies rely on the FMEA (Failure Mode and Effects Analysis) method.

 

The FMEA method was developed by the US army in the 1940s, and in the 1960s NASA was widely applying this method in their missions. This tool aimed to identify all potential failures in a design, manufacturing process and a product or service and their corresponding consequences.

 

So,  what does FMEA mean? What is the FMEA procedure or process?

 

What is FMEA?

 

FMEA and FMECA (Failure Mode Effects and Criticality Analysis), which is an extension of FMEA, are step-by-step and well-structured methods to identify possible failure modes in a process or system, their causes and their effects on the performance.

 

  • Failure Mode: it means that a certain process, procedure or system might fail. They are errors, and defects that might affect all stakeholders. They can be potential or already occurred.
  • Effect Analysis: as it mentions, it is all about the consequences and the impact of these failures.
  • Criticality Analysis: it combines the likelihood of failures and the severity of their consequences.

 

Therefore the FMEA method is perfectly suitable for production plants to anticipate any failure or defect in the production chain process and to implement corrective actions quickly.

 

Usually, the FMEA process is carried out by a multidisciplinary team making sure that all the aspects of the analysed situation are covered, to help the risk manager in the identification of any failure mode and mitigating it. All this process aims to improve the performance of the company and the analysed process. This is why the FMEA goes above and beyond the simple risk analysis process or a risk assessment tool and is also considered a quality management tool. Therefore, FMEA is adopted by many organisations to cover simultaneously risk and hazard mitigation and develop high-quality performances.

 

FMEA will prioritise the failures according to the severity of their consequences. Therefore, as for every risk assessment, an evaluation/risk matrix will be generated based on the assessment of the criticality of the failure. The rating scales of the evaluation matrix go from 1 (the least degraded) to 10 (the most degraded).

 

Three main parameters are considered to perform the FMEA:

  • Occurrence (O): the probability of failure or problem occurrence;
  • Severity (S): refers to the degree of impact and consequences of failures
  • Detection (D): or the probability of non-detection of failures before they occur.

 

The risk priority number (RPN) is then the result of these 3 parameters: “RPN = O x S x D”

 

The RPN will then determine the priority to treat a certain failure before another. The criticality score will be between 1 and 1000. And depending on the score a priority level or action priority (AP) can be determined and divided into three categories: High, Medium and Low priority. The aim of FMEA is thus to eliminate or mitigate these failures starting with the highest priority.

 

FMEA plays an important role in the continuous improvement process. All the actions and knowledge about the risks and failures are documented and archived and can always be used and reviewed for the monitoring of ongoing projects. FMEA is implemented from the start of a process and accompanies it till the end, even in the consumers' hands.

 

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When to use FMEA?

 

The FMEA method is used for many reasons. Here are some examples: when a new product is being developed; when a production process is updated after quality function development; when an existing product is used in a new way; when analysing and regular checks of failures, equipment and products; or when companies and departments should comply with new regulations and standards. 

 

Due to the diversity of the FMEA application, there are different types of FMEA, and it can be applied in many various types of industries.

 

Here is an example of an FMEA template or worksheet:

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There are 3 main types of FMEA:

 

Design-FMEA. This type of FMEA is used in to analyse the product design during its manufacturing. So basically it is applied from the preliminary preparations until its usage by the customer. Moreover, the design-FMEA is used to meet the client's requirements and expectations. The design-FMEA should identify the failures and risks all along the production chain and break down all the elements to avoid any unfortunate events.

 

Process FMEA. It is used to analyse failure modes in new and existing processes and validate the reliability and quality of a manufacturing process. Process FMEA focuses on how to avoid the happening of anomalies and unconformities, and what could be their consequences on product quality, reliability, customer satisfaction and safety hazards.

 

System FMEA. This type of FMEA is built upon many subsystems. It focuses on system-related deficiencies: integration, relationships between processes and subsystems, interactions with the environment and society, interaction with workers, system safety, and any other problem that can lead to the failure of the overall working system.

 

Of course, there are many other types of FMEA applications, such as:

Machinery FMEA. This FMEA is used to check and increase the reliability of the machinery and equipment. It is all about identifying the critical points in the equipment as early as possible and analysing the potential consequences of a failure in the production process and environment.

Functional FMEA. It focuses on the potential operational failures of a certain design or concept.

Flow FMEA. This FMEA is all about the identification of failures and problems related to the supply chain (raw materials or information).

 

Finally, no matter the use and application of the FMEA method, in the end, a report should be issued and it is the same in every type. The report should contain, the reliability plan, monitoring plan, quality control plan, preventive maintenance plan, security plan, corrective and preventive actions plan, etc.

 

How to perform the FMEA process?

 

The FMEA method is a risk analysis method and a quality tool, but also it is an important tool for communication and the exchange of information.

 

To start with the FMEA analysis, it is necessary to define first the process to analyse and its scope (usually choose the process that is most problematic in the facility).

Once the scope and the process are defined, a multidisciplinary working team (from different departments) is created and a team leader is appointed to monitor and manage the working process.

Every team member should then know their mission to identify the failures and generate the risk assessment matrix (as described above) and in further steps choose to prioritise the highest priorities and actions to be taken. The team will also determine a threshold limit of acceptance according to the RPN scores, below which no actions will be taken. This is important because the focus will be on high-priority risks.

Failures are prioritised and ranked according to the defined acceptance threshold (high, medium and low priority).

The team is responsible for finding all the necessary solutions according to the priority of each detected and recorded failure and planning the associated corrective actions. Of course, the highest-priority failures must be on the top of the agenda.

And just before issuing the FMEA report, an improvement evaluation of the implemented actions is conducted to check the success of the applied method.

 

Every FMEA report should contain (in addition to the list previously described): the specifications of the product, service or process; the results of all the carried out tests and evaluations; risk assessment; the action plan; and the success or failure of the improvement are evaluated in the report.

 

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How can FMEA benefit from digital technology?

 

A risk analysis of any kind represents significant administrative work that can be simplified to increase productivity and secure data.

 

Relying on a digital tool to implement the FMEA method brings great benefits, among which, is the advantage of centralising the data on a single collaborative platform and easily accessible by all members of the FMEA working team and concerned stakeholders. In addition, a digital tool maintains the feature of automatically generating the RPN scores and the corresponding evaluation matrix, an automated action and a GANTT chart with automatic notifications and reminders. The working procedures documents are directly monitored and they can evolve depending on the real-time data feed, a great guarantee of quality for effective daily monitoring.



The FMEA method guarantees quality monitoring of products and services by identifying, mitigating or eliminating the risk of failure at its source. This method fits perfectly into proactive risk prevention and continuous improvement approach. Finally, it is the ideal tool to directly combine risk assessment and quality control.

 

To go further: 

> To improve your risk assessment process discover the occupational risks and the risk assessment template application on the BlueMarket.

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