FMEA, or Failure Mode and Effects Analysis, is an effective tool to identify and eliminate possible failures in a process or business. Many companies use it as a means of assessing risk, and it has been in place for decades as a valuable tool.
FMEA was first started by the US Space program, to ensure that the program did not suffer loss of life. The automotive industry adopted FMEA as one of their Core Quality Tools, and other industries including healthcare, medical devices, oil/gas, and semiconductor electronics have adopted it as a key tool to eliminate or minimize failures in the product and process design stage.
FMEA technique asks the process owner to assess possible ways a process or product can fail, and eliminate, or mitigate, these failure modes. This is done by listing all the possible ways that a product can fail, and then reducing risk to an acceptable level, by altering the severity of the failure (typically only done through design change), the occurrence of the failure (how often it happens), or the detection of the failure (how good are you at discovering the problem?).
By using FMEA to identify potential weaknesses in your design or process, you can adequately identify the risks that your business may face, and determine what risks are acceptable, and which are not (and have to be addressed).
The ISO 9001:2015 standard requires:
6.1.2 Plan actions to address risks and opportunities commensurate with the possible impact on the product/service quality and customer satisfaction. Plan how to 1) assimilate and implement the actions into the QMS (per 4.4) and 2) evaluate the actions’ effectiveness.
NOTE 1 Addressing risk can include avoiding risk, taking risks to pursue opportunities, eliminating source of risk, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decision.
NOTE 2 Opportunities can lead to embracing new practices, introducing new products/services, exploring new markets, developing new technologies and other possibilities to meet org. or its customers’ needs.
NOTE 1 is important because it describes the various methodologies that risk drives – taking risks, avoiding risks, changing the likelihood of risk (as we talk about above, in occurrence), or knowingly accepting the risk as it stands (an acceptable Risk Priority Number as a result of our FMEA analysis.
For more information on FMEA courses, visit our workshops page, or our training section for our in-house class, where we customize the class examples to your business, so we work on your actual process during class.