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Batch right first time and deviations
Track batches released without deviation and how fast deviations are closed.
Quality & testingPharma & life sciences
How it's worked out
- RFT = released without deviation ÷ batches. Timeliness = closed in 30 days ÷ raised
- One month or quarter
NoteInspectors look closely at overdue CAPAs and repeat deviations. A falling right-first-time rate is an early warning.
Source: FDA Quality Metrics programme; ICH Q10 pharmaceutical quality system
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