Failure Modes and Effects Analysis is the subject of an international standard, IEC 60812-Analysis techniques for system reliability-Procedure for failure mode and effects analysis (FMEA)
The only international standard that applies for FMEA is IEC 60812, which shows general application, but does not show the use of the tool in risk management.An extension to the FMEA allows analysis of the criticality of a failure, such an analysis is called FMECA or Failure Mode and Effects Criticality Analysis
Most medical device companies use FMECA, although they incorrectly label it as “FMEA”
Failure Modes and Effects Analysis was developed as a tool to explore the effects of failure of components on the reliability of various products.The tool was developed as a tool for use in the field of reliability engineering to explore where more rugged components would be required to obtain desired product life
The title of the standard, Analysis techniques for system reliability-Procedure for failure modes and effects analysis (FMEA), reflects its correct use
Use of FMEA
As an input to the Risk Management process FMEA should be used to:
–Identify Effects of failures of the product design that can cause harm to people, property, or the environment
–Identify Effects of failure in the manufacturing process that can result in the product causing harm to people, property or the environment
–These safety-related effects identified in either Design FMEA or Process FMEA become Hazards in the Risk Analysis
–The Hazardous Situation that may lead to Harm must be identified during the Risk Analysis
– Sometimes the Hazardous Situation may be identified as part of the FMEA process
How to Use FMEA Properly
– FMEA may be used to identify hazards, and indicate Severity of any possible Effect
– FMEA may also be used to identify the Probability of the Hazard occurring
– We must find the Probability of the Harm occurring which may require use of Fault Tree Analysis
– Severity of the Harm usually requires input from Clinicians
– The information gathered (hazard, hazardous situation, and estimation of the severity of effect and probability of occurrence of the hazard) from FMEA is then recorded in a specific Risk Analysis document
– A document similar to that in GHTF SG3/n15r8 IMPLEMENTATION OF RISK MANAGEMENT PRINCIPLES AND ACTIVITIES WITHIN A QUALITY MANAGEMENT SYSTEM in AnnexC
-It is preferable to have a specific Risk Analysis document because of the number of other tools required to be used to perform a complete analysis , to identify hazards, and to provide the required traceability from hazard to control measure to verification of effectiveness of control