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What is FMEA analysis?

FMEA analysis – or failure mode and effects analysis – is a means to predict the failure of your products. Using a cross-functional team to provide the analysis, you can help review design processes to ensure that there are fewer faults with your products, therefore making them more competitive and successful on the market. We will explore how you can use this form of analysis to get results, as well as some of the pros and cons of using it for this purpose.

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What is FMEA analysis?

This type of analysis broadly refers to analysis that allows you to identify and prevent what are known as ‘failure modes’ in products (as well as processes or services). ‘Failure modes’ are any circumstances in which your product is likely to fail. By preventing failure modes in your product or process, you may be able to save time and money, as you can expose them before production or purchasing materials.

While FMEA analysis can be useful in spotting potential faults in your product or process, it works ideally as a complement to good engineering. Stopping faults from emerging as early on in the product’s life cycle as possible can save time and money. 

When is it useful to apply FMEA analysis?

You might find it useful to apply this type of analysis to your product if:

  • you are looking to improve the quality of a pre-existing product or service
  • you are designing a new product or service
  • you are looking to make changes to the way you complete a process
  • a product or process has failed, and you are looking to assess the reasons why

You might find it useful to conduct FMEA analysis throughout your product or process’s lifecycle, so you can continuously look for potential faults that could affect its quality.

What you can assess with FMEA analyses 

Assessing a product vs a process requires a slightly different approach to this analysis. Products require a design FMEA analysis, while processes tend to require a process FMEA analysis. 

Design FMEA

Design FMEA involves assessing the following aspects of your product: 

  • materials
  • geometry
  • system components
  • engineering ‘noise’
  • tolerances

Process FMEA 

Process FMEA, on the other hand, involves assessing the following aspects of your process:

  • materials you are using
  • human factors
  • environmental factors
  • machines used
  • process methods
  • measurement systems and parameters

How to conduct FMEA analysis

In order to successfully complete this type of analysis, you follow a logical step-by-step order. Each step has some key activities that it is important to follow before moving on to the next one. 

While this may prove to be slow in some cases, there are different models available that may make your method more efficient. Some FMEA analysis models have fewer or more steps, so it is best to decide on which is right for you. However, overall, the steps of your analysis encompass the key processes below.

  1. Assembling a FMEA team, as well as pre-work document collection. This may include a diverse range of different employees, who understand your customer’s needs (perhaps assessing customer reviews), as well as the functionalities of the product itself.
  2. Identify what needs you are looking to cover using FMEA. This includes whether it’s for a process, service, product or other requirement. Consider identifying the scope of the analysis using flowcharts. This is also a useful time to decide how detailed your analysis needs to be, as well as the boundaries of the analysis.
  3. Create an FMEA form. Typical formats for FMEA might take the form of a table, with columns for ‘function’, ‘potential failure mode’, ‘potential effects of the failure’, ‘potential causes of failure’, ‘current process controls’, ‘recommended actions’, ‘responsibility and completion date’ and your action results. It can also be useful to use a scoring system for the severity of failures identified, as well as the occurrence rating of the failure.
  4. Identifying your scope’s functions. This involves also considering customer expectations about your product, as well as how they expect to use it. You can break down this step into specific systems or assemblies if required.
  5. Identifying possible failures. At this point, you can start to consider the kinds of failures that your process, product or service might have the capacity to experience according to each function that you have identified.
  6. Identify the consequences of the failure. Consider whether the failure(s) you have identified will affect customers or other aspects of your product, service, systems or other related systems. Here, you are essentially identifying the ‘what’ of the failure: ‘what’ would a customer experience if the product or service failed in a particular way, for instance. 
  7. Use a scoring system to determine the severity of the failure. Using a ranking system from 1 to 10 where one is the least severe and 10 is the most severe, you can record the determined severity of the failure you have identified. It is usually a good idea to record the score on your FMEA form.
  8. Determine the root cause of your failure, as well as the occurrence, detection ratings and critical characteristics. Consider using cause analysis tools to uncover the reason for the possible failure. You can also at this point record whether the failure is likely to occur, using an occurrence rating system on your FMEA form. Secondly, record the detection rating of the failure, which means how well your controls can detect the failure mode before the customer is affected. 
  9. You may also need to identify whether the failure mode you have identified has what is known as a ‘critical characteristic’. This means that the characteristic could affect the safety or compliance of the product with regulations. If you identify a critical characteristic, then you may need to use special controls. 
  10. Identify which actions you will need to take. This can involve changing the design of your product, or the structure of your process. Ideally, you’ll be looking to lower the severity or occurrence of possible failures.
  11. Calculate your risk priority number. This can involve the following calculation: severity x occurrence x detection. This can help you to rank the severity of each potential failure you have recorded. To get a risk priority score based on criticality, you can multiply severity by occurrence. This gives you a different priority outcome, meaning that It is then a good idea to ensure that all results are completed and added to the FMEA form. 

Pros and cons of using FMEA

In this next section, we consider some of the pros and cons of using FMEA analysis. Whether this process is right for you will depend on the time and resources your business has access to, as well as the urgency of the analysis itself.

Pros of using FMEA

Some pros of using this analysis include:

  • identifying failure modes more effectively
  • prioritising possible failures in order of priority
  • allowing users to record the risk priority of a failure mode
  • helping users to identify actions to reduce the possibility of failures

Cons of using FMEA

Some of the cons of FMEA include:

  • becoming too time-consuming as many FMEA methods have lots of steps
  • requiring specialist knowledge of engineers, which may not be easily communicable at enterprise level;
  • failures may be holistically linked or interact and FMEA does not take this into consideration.

FMEA analysis can be a useful way of predicting failures in products, systems and services, giving businesses the ability to act on them and reduce them. While this method of analysis can help users easily identify risks according to priority, it may become a slow and time-consuming process. It therefore may be useful to apply this analysis during the earlier stages of a product’s development or redesign. 

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