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 insight 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 (preformulated) corrective actions.


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

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.

For indepth information on how to perform FMEA in health care according to a very usefull structured method click here. A lot more information on FMEA (not specific for health care) can be found by clicking here.

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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