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Updated July 27, 2021

Template: FMEA: Risk Acceptance Matrix

Dr. Oliver Eidel
ISO 14971

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Failure Mode and Effects Analysis (FMEA): Risk Acceptance Matrix

This document defines under which circumstances risk are acceptable. It defines probabilities and severities and each probability-severity combination is either acceptable or not, as shown in the risk acceptance matrix at the bottom.

Risk Policy

Generally describe what your company’s risk policy is. Most likely, that’s something along the lines of “our products are generally safe and shouldn’t cause more harm than the next-best alternative”. So, if you’re in the business of predicting Covid infections, maybe you’d compare yourself to people not using your software and doing a non-professional google research about their symptoms. Obviously, that’s a worse alternative. In your clinical evaluation you should collect data on those alternatives to be able to compare yourself to them :)

Severity

Define what can go wrong with your product here. Make the examples specific - chances are, your product can’t cause skin lacerations. In all likelihood it also doesn’t cause death. So, feel free to remove severity rows here. But most importantly, customize the definitions and examples so that they resemble the harms in your product.

Severity Definition and Examples
S1: Negligible Minor, reversible damage, e.g. superficial skin irritation, delay of non-critical treatment
S2: Marginal Minor, reversible damage with required medical intervention, e.g. skin laceration requiring stitches
S3: Critical Major, irreversible damage with required medical intervention, e.g. irreversible deterioration of disease
S4: Catastrophic Death

Probability

Define your probabilities. You can probably just use these definitions. The idea is that each probability row is 10^2 apart from adjacent ones.

Also, change the “Estimated Maximum Event Count”. That’s the usage number you estimate for your (not yet released product) during its entire lifecycle (which you need to define). So, if you assume that your product will be on the market for 4 years and that it’ll be used 100 times per day, that results in 146.100 usages (100 usages/day * 365.25 days/year * 4 years). The numbers in the lower columns of “Estimated Maximum Event Count” are simply the total usage number multiplied with the upper limit probability of the same row, e.g. you want to know “how often can probability P3 occur if the product is being used 100 times per day?”

Probability Upper Limit Lower Limit Estimated Maximum Event Count
P5: Certain 1 10^-2 1000000 (change this)
P4: Likely 10^-2 10^-4 10000
P3: Possible 10^-4 10^-6 100
P2: Unlikely 10^-6 10^-8 1
P1: Rare 10^-8 0 0

Risk Acceptance Matrix

The most important part. You assess each severity-probability combination whether it’s acceptable for you as a company. There are no definitive rules on what’s deemed acceptable. It depends on your company’s risk policy and, more importantly, the benefits of your product which you show in your clinical evaluation. So, for example, if you product saves 10 lives per day, it might be acceptable to cause one death per day. If your product doesn’t save any lives, it might not be acceptable to cause any deaths. You get the idea, I hope.

Probability S1: Negligible S2: Marginal S3: Critical S4: Catastrophic Estimated Maximum Event Count
P5: Certain acceptable unacceptable unacceptable unacceptable 1000000
P4: Likely acceptable unacceptable unacceptable unacceptable 10000
P3: Possible acceptable acceptable unacceptable unacceptable 100
P2: Unlikely acceptable acceptable acceptable unacceptable 1
P1: Rare acceptable acceptable acceptable acceptable 0

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