KPI's

To be able to improve in Validation measurements are required. This section provides an overview of measurements that may be defined for the Project Phase or Operational Phase of a validated automation system. The measurements are defined as Key Performance Indicators (KPI). Suggestions for other KPI's are welcome!!!

 

Project Phase

KPI's for the Project phase may be defined as:

KPI Details Remarks

amount of validation hours

per activity

per person

more useful when suppliers participate also
system risk category    
validation approach    
number of requirements per risk category

per software . hardware category

 

number of assessment findings

type of finding  
 number of documents number of pages

template used

type

number of versions

 

number of signatures

document

type

function / person

 

number of changes

 

 
 

number of reviews

number of comments

review type

document

reviewers

 
 

number of tests

type

name

result

number of retest on failure

is subject tested more then once

 
     

Operational Phase

KPI's for the Operational phase may be defined as:

KPI Details Remarks

number of alarms

type

priority

 

number of incidents

   

number of changes

   
OEE

 

 Overall Equipment Effectiveness