Prepare For Success With A Failure Mode And Effects Analysis And Control Plan

How to handle potential process or product errors before they occur by taking advantage of accumulated knowledge.


In order to proactively handle potential process or product errors before they occur in manufacturing or on a customer’s production line, many organizations implement a Failure Mode and Effects Analysis (FMEA) and Control Plan (CP). Used as a process tool by the US military as early as 1949, FMEAs and CPs have evolved and gained popularity in many industries ranging from automotive, to pharmaceutical, to semiconductor fabrication.

The FMEA is a methodology for analyzing potential reliability problems early in the development cycle where it is easier to take actions to overcome these issues, thereby enhancing reliability through design. The CP is a complimentary tool that summarizes all actions that can be taken to minimize and/or mitigate potential failure modes. FMEAs and CPs are living documents that help remove the human element—specifically poor memory and communication—from process, product and system design.

Diligent use of a FMEA and CP can save an organization a considerable amount of time and resources, reducing the number of production problems, eliminating customer issues and the resultant troubleshooting, while shortening the time it takes to develop and implement new products, processes or business systems.

Uses of FMEA & CP
Brewer Science’s implementation of FMEAs and CPs is different from many other organizations’, in that newly identified failures and their effects are continually compiled into a master “book of knowledge.” This collection of failure modes, or “Master FMEA,” ensures that all potential failure modes are evaluated during the development of a product or process, and those that are applicable can be designed out or mitigated before they cause problems.

Creating a “Master FMEA” in this manner may take several years, but, in doing so, an organization has the ability to draw upon experiences which otherwise would have been long forgotten. Uses of a “Master FMEA” include:

  • Design of new processes, systems and products
  • Adaptation of existing products or processes to new applications or environments
  • Development and identification of methods or procedures to test products and processes to ensure failures are eliminated
  • Track and manage potential risks in design

The FMEA and CP are useful tools for identifying and communicating potential failure modes and the means to mitigate them before they become costly. Product development and manufacturing organizations alike can benefit from these tools through improved product quality, shortened design times, and reduced scrap and rework costs.

Benefits of FMEA & CP
FMEAs and CPs are designed to help improve the quality and consistency of the design process to create a better product and process for the future. Properly used, the FMEA and CP provide several benefits, including the following:

  • Drive down failures
  • Increase customer satisfaction
  • Early identification and elimination of potential product/process failure modes
  • Capture/retain history of organization’s work and knowledge
  • Document risk and actions taken to reduce risk
  • Provide focus for improved testing and development
  • Reduce late changes and accompanying costs
  • Drive teamwork and idea exchange between an organization’s Manufacturing, Engineering, Quality Assurance and R&D teams
  • Serve as a living document to be updated as processes and products change

By creating a FMEA and CP, an organization can take advantage of knowledge gained over long periods of time and from many disparate sources. As the demand for high quality, reliable products continues to increase, having a FMEA and CP in place provides an organization the ability to create better processes and products for their customers.

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