KPIs (Key Performance Indicators) and Risk Management Process (ISO14971:2007)

S

Sanne

#1
Hi there,

I am currently defining KPIs for our Risk Management Process (ISO14971:2007) and having some difficulties since I've never done this before.
Here is what I came up with so far:

TIME:
Are Risk Reviews done in time as planned
How long does it take to approve Risk Management Documents

PERFORMANCE
How often is Risk Analysis updated due to feedback from field (the more updates the less is the quality of the Risk Analysis)

RESOURCES:
Is Risk Management Team available when needed and "stable"...

Maybe anyone of this forum has an idea what else could be a key performance indicator...

Thanks a lot!!!

Cheers
Sanne
 
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yodon

Staff member
Super Moderator
#2
A few points to consider:

1) Tying the number of updates due to feedback from the field to an indicator of quaility of the risk analysis might send the wrong signals. If someone is being measured by this, then it could lead to suppressing feedback from the field. The system is designed to be updated as a result from actual use so to tie negative connotations to something that's supposed to happen might result in a less effective process.

2) Not exactly sure how this would be accomplished, but an examination of the effectiveness of the controls might be good information. Did the controls limit the number of occurrences and/or detectability?

3) Based on field data, were there risks that were not identified? This might be a good indicator of having the right resources.

When all this is said and done, I hope you re-post whatever you come up with and give us some feedback on if the measures are effective.
 
S

Sanne

#3
Thank you a lot for the input!!!! :)
I'll let you know what I came up with, once I have defined all KPIs.
 

yodon

Staff member
Super Moderator
#5
I don't think that measuring the frequency of risk analysis updates is an effective measure for risk analysis quality. Over the life of a project, it's rather natural that the frequency decreases. The product stabilizes and so the need for risk analysis meetings diminishes.

Also not sure the measures for product safety will be meaningful. For example, unless you have a homogenous product line, it's not likely that an average risk for each project will mean anything. Similar concerns about measuring severity across product lines.

IMO, what you should focus on for risk management is an post-release analysis to determine if you identified all the risks, if the estimated rate of occurrence and estimated severity was realistic, and if the controls were sufficient.

For example, if you identified a risk that you considered minor severity and unlikely to occur and after the product was fielded, there were frequent serious injuries (or worse), then irrespective of the number of updates and reviews you held, your risk analysis was not sufficient. Similarly, if you implemented controls to bring the risk to an acceptable level yet you saw serious injuries in the field, then you know your controls were inadequate.

Don't get so tied up in the process that you lose sight of the goal (safety and effectiveness).
 
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