Calculated field and number of decimals (for Medical Device Risk Management)
Dear all,
We are a medical device manufacturer and are setting up our Risk Management documentation in JAMA Cloud.
I have created a template for a so-called FMEA.
I created it as a Set that holds FMEA items that correspond with risks that could occur with our device. This is all in line with what's known as ISO-14971.
In Risk Management you work with risk occurrence probability values (most often called P1, P2) such as 1 in 1000, 1 in 100.000.
To come to a combined probability number, you multiply the probability values (P1 x P2). Google gives a nice abstract of this industry-standard approach: https://www.google.com/search?q=risk+management+p1+and+p2
What I created in JAMA
I have added a field that performs this calculation of P0 x P1, yet run into the issue that I can increase the decimals over 4.
Whereas a normal (non-calculated) Float field, does allow up to... 8 or 9 decimals?
So in our template if P1 = 0.01 is multiplied with P2 = 0.001%, JAMA will fill the calculated field with 0.0000. Which is incorrect.
How do I solve this? Or what is a different approach?
Happy to hear.
R Brouns
Microsure
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Comments
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Hi,
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we are also a medical device manufacturer and use Jama for our risk analysis. But instead of using numbers and calculations, we use the newly introduced lookup matrices feature.
P1 and P2 can have one of the following "values":
1 - Improbable
2 - Remote
3 - Occasional
4 - Probable
5 - Frequent
Ptotal is than automatically "calculated" based on the following lookup matrix:
The resulting Ptotal is than used to determine the risk level based on the following lookup matrix using the severity as second input:
Patrick
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Original Message:
Sent: 05-30-2023 02:46
From: R Brouns
Subject: Calculated field and number of decimals (for Medical Device Risk Management)Dear all,
------------------------------
We are a medical device manufacturer and are setting up our Risk Management documentation in JAMA Cloud.
I have created a template for a so-called FMEA.
I created it as a Set that holds FMEA items that correspond with risks that could occur with our device. This is all in line with what's known as ISO-14971.
In Risk Management you work with risk occurrence probability values (most often called P1, P2) such as 1 in 1000, 1 in 100.000.
To come to a combined probability number, you multiply the probability values (P1 x P2). Google gives a nice abstract of this industry-standard approach: https://www.google.com/search?q=risk+management+p1+and+p2
What I created in JAMA
I have added a field that performs this calculation of P0 x P1, yet run into the issue that I can increase the decimals over 4.
Whereas a normal (non-calculated) Float field, does allow up to... 8 or 9 decimals?
So in our template if P1 = 0.01 is multiplied with P2 = 0.001%, JAMA will fill the calculated field with 0.0000. Which is incorrect.
How do I solve this? Or what is a different approach?
Happy to hear.
R Brouns
Microsure
------------------------------
Patrick0
