Failure Modes and Effects Analysis (FMEA)
Failure Modes and Effects Analysis is a formal methodology for identifying potential failure modes and their associated hazards which is suitable for the detailed engineering design of a product or process. The steps are as follows:
- Describe the system or process whose failure modes are sought.
- Identify the ways in which the system or process might fail. These failure modes may be identified by historical data, personal experience, or a process similar to brainstorming.
- Identify the symptoms of each failure mode that might aid in detection.
- Determine the effects of each failure mode should it occur – look at property damage and hazard to people.
- Assess the probability of each failure mode occurring. A qualitative ranking may be used if statistical data is not available – a low ranking means a low probability of occurrence.
- Assess the risk (probability) of personal injury and property damage for each failure mode. Again, a qualitative ranking may be used in the absence of statistical data.
- Compute a “danger index” from the numbers assigned – multiply the probabilities or rankings together.
Also Read: ACCEPTED STANDARD FOR MITIGATIVE MEASURES FOR ALL OCCUPANCY
The FMEA is normally presented as a table. The danger index is a ranking of the risks associated with each design. The failure modes should be examined for possible mitigation through design changes starting with the highest danger index and proceeding to the lowest. It is usually not possible to completely eliminate all failure modes from a consumer product but the hazard to people should be minimized as much as possible. This process should also minimize the exposure of the manufacturer to product liability litigation.
A risk priority number (RPN) is computed as follows: RPN = (failure severity) X (probability of occurrence) X (probability of detection)
The failure modes should be ranked in descending order by RPN and those at the top of the list should be addressed first. A high RPN indicates a significant risk of system failure and hazard that should be mitigated if possible by redesigning the system to reduce effect severity, reduce the probability of occurrence, and increase the probability of detection. Once changes have been made to the design, the severity, occurrence, detection, and RPN values are recomputed for the affected failure modes. All potential failure modes cannot be eliminated from all systems, but the goal of the design process should be to minimize the RPNs of the system. A minimum RPN should correspond to maximum public safety and minimum exposure to litigation.
Also Read: ACCEPTED STANDARD BENCHMARK and MITIGATIVE MEASURES
By Antonia Beri
Technical and Process Safety Expert
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