Risk = ๐๐๐ซ๐๐ง๐๐ฉ๐ฎ of harm x ๐ฅ๐ง๐ค๐๐๐๐๐ก๐๐ฉ๐ฎ of occurrence of harm
Don’t panic! Even if you were traumatized by eighth-grade algebra and sent into full PTSD by 11th-grade AP calculus, you can handle risk management – I promise.
ISO 14971:2019 defines harmย as โinjuryย or damage to the health of people, or damage toย property or the environmentโ – but how do you determine severity and probability?
There are two primary ways that probability is referenced in risk management – P1 and P2.
P1 is the probability of a sequence of events leading to a hazardous situation which exposes a hazard.
P2 is the probability of a harm occurring as a result of exposure to a hazard.
Stay with me, mathemaphobics, and take deep cleansing breaths. We’re not wading into deep calculus waters here, trust me.
So we’ve established that P1 X P2 will give you the second half of the risk management equation, but there does severity come into play?
You have to look at the potential risks for each hazardous situation by performing a consequence analysis, a qualitative, semi-quantitative or quantitative estimation of probability, and asses the effectiveness of your existing controls.
More simply put : ๐๐๐ฏ๐๐ง๐ + ๐๐๐ฆ๐ช๐๐ฃ๐๐ ๐ค๐ ๐๐ซ๐๐ฃ๐ฉ๐จ = ๐๐๐ฏ๐๐ง๐๐ค๐ช๐จ ๐๐๐ฉ๐ช๐๐ฉ๐๐ค๐ฃ
Now before your head bursts into flame, remember that risk management does not require a college degree in advanced mathematics – most of it is done established charts and spreadsheets. But you do still have to do a comprehensive analysis of your device and consider all of the potential risks, no matter how inconsequential they may seem.
Is there the possibility that patients will use your device in the shower or in the pool, even though your IFU explicitly says not to? Then THAT has to be included in your risk assessment, even if the probability is very low.
That is not the best example, but it gives you an idea of just how many things you need to consider when performing your risk analysis.
Remember: Risk = ๐๐๐ซ๐๐ง๐๐ฉ๐ฎ of harm x ๐ฅ๐ง๐ค๐๐๐๐๐ก๐๐ฉ๐ฎ of occurrence of harm
And even when you’ve completed the initial risk assessment, you still need to manage risk throughout the product lifecycle by incorporating customer complaints and feedback, CAPAs, and the results of your internal audits.
However, risk management does not simply apply to the manufacture and use of your device. It can – and should – be applied to just about every aspect of your company’s operations.
Click here to learn even more about risk management from the master himself – Edwin Bills.
And if you still need help staying afloat, give us a call. We can help with your risk analysis, risk assessment, and other quality management system requirements.
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