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!!!
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 |
|
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 |
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