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