USFDA Complaint Laboratory KPIs Measurements

Analytical Laboratory KPIs:

Turnaround Time (TAT)

• Average: 2-5 days (routine tests)
• Best-in-class: <2 days

Test Completion Rate:

• Average: 98-99%
• Best-in-class: ≥99.5%

Accuracy and Precision:

• Average: 99-99.5% (method validation)
• Best-in-class: ≥99.9%

Instrument Uptime:

• Average: 95-98%
• Best-in-class: ≥99%

Sample Rejection Rate:

• Average: 1-2%
• Best-in-class: <0.5%

Quality Control KPIs:

Out-of-Specification (OOS) Rate:

• Average: 0.5-1.5%
• Best-in-class: <0.5%

Out-of-Trend (OOT) Rate:

• Average: 1-2%
• Best-in-class: <1%

Deviation Rate:

• Average: 0.5-1.5%
• Best-in-class: <0.5%

Corrective Action/Preventive Action (CAPA) Effectiveness:

• Average: 90-95%
• Best-in-class: ≥95%

Read also:

• Investigation of OOS | FDA Guidance
• Out of Trend (OOT) in Pharmaceutical Industry

Resource Person: Rajesh Jain