Using FMEA to Reduce Risk

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FMEA (Failure Modes Effects Analysis) can be a successful risk reduction tool to assist in meeting the risk planning (design and manufacturing process) requirements mandated by ISO 9001:2015.

As an analytical tool, ISO 9001 organizations can use the FMEA to review steps in a process to determine how much risk there is in each specific process step. This documented criteria score (1 – 10) identifies, among other issues, how often the failure occurs and can the issue be detected prior to the product leaving the facility? A completed FMEA highlights the greatest risks requiring an action plan for process improvement to mitigate the risk.

There are other tools to use for risk planning, but the FMEA (Design or Process) is a strong and valuable method to evaluate risk and is regularly used by many aerospace, automotive, and medical device manufactures.

It is also important to mention that ISO 9001:2015 (8.5.1g) requires "implementation of actions to prevent human error." How an organization addresses this requirement is left to their discretion. However, one of the common tools used is error proofing or mistake proofing - installing a device to help the operator perform a task without making an error. This could be a tool to use after completing a design or process FMEA. Error proofing can be very useful in high volume production where it is difficult to catch 100% of the problems.

Evaluating risk is a new concept for ISO 9001 organizations and standard writers made it very clear that planning for risk (6.1.2 b) 1) shall be performed throughout the quality management system. However, organizations need to apply good judgment when implementing a program that is proportionate to the potential impact on the conformity (6.1.2 b) to products and services.

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