FMEA means Failure Mode Effects Analysis and is a proactive method of analysis. The method can be used to carry out in-depth analysis of a delimited working process for the purpose of implementation of improvements.

This method is useful when there in a department is suspicion that some processes contain unidentified risk factors. If several identified internal failures or adverse events related to a specific process are detected.

All potential risk factors has to be identified, both directly observed as indirectly that can not be readily seen. This assumes, of course, a professional and independent auditor, with extensive experience in analysis and auditing of business processes.

Any risk assessment can be made generally or at a specific process. At a general assessment there will be taking into account all the extensive measuring equipment, appliances, decor, applicable procedures, communication, learning and training of staff.

Detecting of any risks to a specific process, is directly comparable to audit of the process, where assessing the risk starts at first contact and continuous throughout the process. Is the whole process ‘In Compliance’ or is there any discrepancy in greater or lesser degree.

It is based on the following:

  • Procedures/Instructions/Specifications (availability)
  • Validity of appliances and Measurement
  • Working environment
  • Introduction, training and education
  • Communication
  • Barriers against failures

Objective evidence uncovered for established risk factors, the analyzes documented in subsequent reporting and last but not less important, prepared action plan for implementation of improvement measures.