Why FMEA ≠ ISO 14971

The anwser can be short, ISO 14971 is a risk mangement process, FMEA is a tool.

But it goes further, ISO 14971 requires studying risks under NORMAL and fault conditions.

These two conditions cannot be met by using the FMEA tool alone.

Go back to the risk fundamental concept:

From the intended purpose of the medical device, the risk analysis process consists of the following steps:

1. Description of the intended use of the medical device and reasonably foreseeable misuse;
2. Identification of the characteristics of the medical device that are related to safety;
3. Identification of hazards and hazardous situations associated with the medical device;
4. Estimation of risks for each hazardous situation.

To identify hazards and hazardous situations, the manufacturer may use the following methods (non-exhaustive list):

• Preliminary Hazard Analysis (PHA)
• Fault Tree Analysis (FTA)
• Event Tree Analysis (ETA)
• Failure Mode and Effects Analysis (FMEA)
• Hazard and Operability Study (HAZOP)
• Hazard Analysis and Critical Control Point (HACCP)

??Whatever tool you use, you must describe it in your risk management plan and its contribution must be clearly identified in your hazard traceability matrix.

FMEA could be part of your risk management process (like other tool), but it doesn't meet the standard's requirements on its own.

FMEA (bottom-up) focuses on identifying and analyzing specific failure modes and their effects on a system or process.

Here's a simplified approach:

Due to this techniques, FMEA is NOT intended to replace ISO 14971, but to contribute to ISO 14971:

Using this technique in your risk analysis process has 4 benefits:

• FMEA checks each element for Failure Modes and their effects. This boosts product reliability and quality. It spots and fixes Failure Modes early, cutting development costs by avoiding late changes.
• FMEA uncovers missing or wrong requirements. It can show high criticality ratings, leading to needed design changes.
• FMEA finds Hazards and event sequences that lead to them. It helps estimate System risk using occurrence ratings of Failure Modes.
• Start FMEAs early with concept and block diagrams. Update and repeat as design details emerge. This method spots and fixes design flaws early and assesses new changes for safety after release.

As a reminder, the ISO 14971 process must:

• Start with hazards deduced from intended use and reasonably foreseeable misuse
• Identify hazardous situations arising from the sequence of events
• (P) and (O) must be indexed to harm
• Risk is the combination of the probability of occurrence of harm and the severity of that harm.

All the elements you need to have an ISO 14971 compliant process are included in our Risk Management Bundle.