Complaints KPI

Philip B

Quite Involved in Discussions
EU MDR article 88 (Trend Reporting) asks manufacturers to report 'any statistically significant increase in the frequency or severity of incidents that are not serious incidents...etc'.

I am raising this here as there is clearly an overlap between 'incidents' and 'complaints' and that some form of metric of incidents has to be monitored to look for a 'statistically significant increase'?

I'm interested how others manage this?
 

Bev D

Heretical Statistician
Leader
Super Moderator
In the same way as ‘complaints’. There is no better way to detect a statistical increase in any ongoing stream of events than with control charts.
You need to think about how to subgroup properly: by lot or date code or month of production as the critical element is when the thing was produced and not when it occurred.. there are certain incidents or events that are based on when the event occurred (such as a software upgrade to every device in use, or if your device uses consumables and it is the introduction of a new lot of consumables that creates the incident, etc.).

Again specifics will help us provide the best subgrouping scheme….
 
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