Failure mode & effects analysis, also known as FMEA, is a popular technique and powerful tool used by product development contract manufacturers during risk analysis.

The FMEA process breaks down complex manufacturing and assembly processes into manageable steps, identifies possible failure modes, evaluates factors causing those failure modes, and predicts effects that these failures are likely to have on the final product, including performance, cost, quality, or delivery. 

Essentially, what FMEA does is it identifies elements and operations with a system that renders it vulnerable. The results of FMEA are then used as a basis for design, further analysis, or to guide the deployment of manufacturing resources. 

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Top Reasons to Perform Risk Analysis:

  • Prioritize potential failures for correction, prevention, or redesign. 
  • Monitor critical process parameters and guide the process control plan. 
  • Collaborate with OEM design and engineering teams to help eliminate problems before they cause costly production delays or line shutdowns.
  • Reduce development and production costs while maintaining quality and performance standards.
  • Limit customer/end-user exposure to failure risk and OEM exposure to warranty claims. 

Applications That Can Benefit From FMEA:

  • A newly introduced technology or process. 
  • A current process that has been modified or updated. 
  • A current process that is unchanged but moved to a different location or exposed to a new environment. 

When it comes to risk mitigation, PEKO is here to help. We have plenty of experience with FMEA risk assessments and are happy to assist startups manage the application of FMEA in their new product development project. To mitigate risks in a new product design, we’ll begin by looking at all the different ways that we can change the design, system, or process to minimize risks or reduce the frequency at which they occur.  

PEKO can help with a few different types of FMEA:

  • Design FMEA: Analyzes the product during the design stage (also called DFMEA).
  • Functional FMEA: Analyzes the functions of a system (sometimes called System FMEA).
  • Process FMEA: Analyzes the process control objectives (also called PFMEA).
  • Manufacturing FMEA: Analyzes the manufacturing processes.

PEKO has successfully conducted failure mode and effects analysis on a variety of contract manufacturing projects, including a narcotic supply dispensing unit for a pharmaceutical company, a solar crystal growth furnace enclosure for a solar energy manufacturer, and a vapor mitigation system for the a global chemical company, among others. 

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