Table 2.

Rating scale of the severity occurrence, and detection scores for FMEA

Score	Description
Severity
1	No impact to patient safety
	Minor impact to data quality/integrity or protocol compliance
	Significant impact to operational feasibility
4	Minor impact to patient safety
	Significant impact to data quality/integrity or protocol compliance
	Major impact to operational feasibility
7	Significant impact to patient safety
	Major impact to data quality/integrity or protocol compliance
	Severe impact to operational feasibility
10	Major impact to patient safety
	Major impact to both data quality/integrity and protocol compliance
Occurrence
1	Remote: failure is unlikely
4	Moderate: occasional failures
7	High: repeated failures
10	Very high: failure is almost inevitable
Detection
1	Failure is detected immediately
3	Failure is detected with quality control checkpoint
5	Failure is detected with subsequent check
7	Failure is detected with random internal audit
9	Failure is detected with external audit inspection
10	Failure will not be detected at all

Abbreviation: FMEA, failure mode and effects analysis.