Send the Quality Officer to a training on Failure-Mode-Effect-Analysis


A Failure Mode Effect Analysis (FMEA) is one of the most important elements in continuous improvement of the laboratory. An FMEA is a process analysis and helps you to get insights in what can go wrong (called "failure modes") and analyze the severity of the consequences when it goes wrong ("effect analysis"). The FMEA helps you to get control over the failure modes by giving you the opportunity to formulate preventive actions and control steps and/or minimize the consequences if something goes wrong with appropriate corrective actions.


Later in phase 4 an FMEA needs to be performed on all procedures of the laboratory. An FMEA is a complicated procedure that can only be performed by trained persons. Hence the Quality Officer should be sent to training in FMEA.


There are some useful resources on FMEA in the health care environment on the webpage of the Veterans' Affairs National Centre for Patient Safety. Permission to provide the link kindly provided by the Office of Quality, Safety & Value of the United States Department of Veterans' Affairs National Center for Patient Safety.

How & who

Laboratory Manager:

  1. Search for funding to send the Quality Officer on a training in FMEA.
  2. Select an appropriate training.
  3. Send the Quality Officer to the selected FMEA training.
  4. After the Quality Officer has been trained: include a copy of the training certificate in his/her personnel file and update this file.


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This activity belongs to the QSE Personnel


ISO15189:2007: 4.1.5 4.11.1 4.12.1 4.12.5 5.1.10
ISO15189:2012: 4.11 4.12 5.1.5