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Defects in products can be a costly expense for any business and are not often perceived until later stages in the development process – adding on significant costs and delays. It is more of a challenge, yet beneficial to identify the defects before they arise by designing in quality and reliability at the beginning of the development process.

In order to achieve this Lean Six Sigma, practitioners incorporate the Failure Mode and Effects Analysis (FMEA). This useful tool is for identifying potential problems in the design of a product, and their impact. Failure modes are the ways in which processes may fail, while effects are what these failures can lead to – waste, defects, or injury to the customer. The analysis of these failures and effects identifies them and prioritizes them, so changes can be made to reduce the defects arising.

So Why Perform a FMEA?

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The earlier a defect is identified, the less time and money it will cost a business. Once identified, this results in cutting back on numerous re-designs and wasted materials, or even customer injury and the possible settlement fees associated.

Using FMEA can help identify areas within design and processes that will arise these defects. Whether it’s the use of a particular material, a step within the process, or equipment used during the designing and manufacturing process. Resulting in a safer, more reliable and customer-pleasing end product or service.

How Often Should You Complete a FMEA?

FMEA is a qualities and systematic tool, usually created in a spreadsheet format and consists of seven main steps, individually processed by appropriate team members.  

  1. Collect relevant documentation and a group of team members.
  2. Insert functions, failures modes, effects of failure and severity ranking using the collect documentation.
  3. Potential causes and prevention controls identified.
  4. Testing and detection controls, through detection ranking.
  5. Action Priority and Assignment.
  6. Actions Taken, and Design Review.
  7. Re-Ranking Risk Priority Number (RPN) and Closure.

It is essential to take part in all seven steps to truly recognize a difference in the process/design. In Step 7 when the risk priority number is re-calculated and measured against the starting RPN the level of improvement, and if there is further room for improvement, can be clearly seen.

There are several times in which to take part in a FMEA to truly benefit from the tool.

  • In the design stages of a new product, process, or service to identify any potential failures in the new design.
  • When modifying an existing process to work in a new way to identify any potential failures in the new application of the process.
  • During a quality improvement process, in order to achieve a goal.
  • Even as a post-failure measure to identify why a failure occurred, so it can be understood and improved to prevent further occurrences.

It is also advised to partake in a FMEA throughout the lifetime of a process, assuring life-long reliability and quality. Regular examination and improvements result in continued optimal results.

FMEA should not be used in replacement of engineering, but as an enhancement to apply knowledge and experience from past products/processes to improve future ones.